A clinical trial is a research study involving human volunteers, and is designed to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find effective treatments, and new ways to improve health.
You can search for all studies that are currently enrolling participants at the University of Rochester by typing in keywords in the search box below. If you don’t find a study that interests you right now, consider signing up for our Volunteer Registry, which will notify you of future studies.
(Myelofibrosis): Dose-Finding Study of Pacritinib in Patients With Primary Myelofibrosis,
Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Previously Treated With Ruxolitinib
Lead Researcher: Jane Liesveld
This study has 3 groups: one group receives 100-mg study drug (pacritinib) dosed once
every day, another group receives 100-mg study drug (pacritinib) dosed twice a day,
and the third group receives 200-mg study drug (pacritinib) dosed twice a day. You
will be randomly (by chance, like flipping a coin). You will have an equal chance
of being assigned to any
of these study groups. You cannot select which group you want to be in for the study.
View Study Details
18F-AV-1451 PET Imaging in Participants Enrolled in the LEARN Study
Approximately 50 participants enrolled in the LEARN study (NCT02488720) will be enrolled
in
the LEARN-Tau study. The study designed to evaluate the imaging characteristics of
18F-AV-1451 in participants enrolled in the LEARN study and to expand the safety database
of
18F-AV-1451.
The study will run in parallel to the LEARN study. In this study, participants will
undergo
up three (3) 18F-AV-1451 PET scans over a 3 year period. Imaging visits will occur
at the
start, middle and end of the participant's participation in the LEARN study (corresponding
to
LEARN Visit 1, between Visit 4 and 6, and Visit 8).
The LEARN-Tau study will (1) look at change in the amount of tau protein in the brain
over
time, measured by the 18F-AV-1451 PET scan, (2) see if tau protein in the brain of
older
individuals is associated with memory problems and (3) evaluate the safety of 18F-AV-1451
and
any side effects that might be associated with it.
Site investigators, participants, and study partners will not be informed of the results
of
the 18F-AV-1451 PET scan results as they relate to the study; however, any findings
that may
be of potential medical concern will be provided for appropriate follow-up.
View Study Details
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
The primary objective of the study is to evaluate the efficacy of monthly doses of
aducanumab
in slowing cognitive and functional impairment as measured by changes in the Clinical
Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants
with
early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab
as
compared with placebo on clinical progression as measured by Mini-Mental State Examination
(MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative
Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version)
[ADCS-ADL-MCI].
View Study Details
A Clinical Trial for the Surgical Treatment of Elderly Distal Radius Fractures
In the United States, over 300,000 individuals over age 65 suffer from distal radius
fractures (DRFs) each year. Despite the frequency of this injury and over 200 years
of
experience treating DRFs, management of elderly DRFs is still controversial. Close
reduction
and casting is a nonsurgical technique that is frequently used, but osteoporotic fractures,
common in the elderly, often collapse and displace. The three currently applied surgical
techniques are close reduction and percutaneous pinning, external fixation with or
without
percutaneous pinning, and internal fixation with volar locking plating. Preliminary
evidence
indicates that locking plate fixation can permit elderly patients to move their hands
and
wrists much sooner in order to return to self-care activities more quickly. Although
these
outcomes are promising, there is no randomized controlled clinical trial to demonstrate
that
the more invasive, and perhaps more costly, plating technique is superior to the other
simpler approaches.
The specific aim of this 24-center randomized controlled trial is to compare outcomes
of
these three surgical techniques in treating unstable DRFs in the elderly. The secondary
aim
is to follow a cohort of elderly patients who choose not to have surgery to evaluate
outcomes
following treatment by close reduction and casting alone. This clinical trial is the
most
ambitious study in hand surgery by assembling most of the leading centers in North
America to
collect evidence-based data to guide future treatment of this prevalent injury in
the growing
elderly population.
View Study Details
A comparison study of immune responses of four licensed FDA approved influenza vaccine.
Lead Researcher: Angela Branche
A study comparing in detail the immune response to four FDA approved influenza vaccines
to see if the way they are manufactured has any affect on the immune response.
View Study Details
A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial
Fractures
This study looks at two types of surgical treatments and hopes to answer the question:
which
is the best way to surgically treat a proximal tibia fracture? Both procedures being
studied
are standard of care (used routinely) and use FDA approved devices. All medical and
surgical
treatment will be the same for participants as non-participants.
View Study Details
A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic
Leukemia
This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent
chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part
1 of the
study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy
regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib
at the
recommended dose determined in Part 1.
View Study Details
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual
Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial
to evaluate
the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC)
compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following
autologous stem cell transplant (ASCT).
View Study Details
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative
Surgeries for Pathologic Fractures of the Femur
The purpose of this study is to look at two different types of surgeries regularly
used for
treating cancer that has spread to and weakened the thigh bone (femur). Because it
is not
known which of these surgeries is best, the investigators will compare the results
of the two
procedures. They are looking to see if differences exist (after surgery) in function,
quality
of life, pain control, and possible complications.
View Study Details
A Safety and Efficacy Study of the Birmingham Hip Resurfacing System
The purpose of this study is to meet a PMA condition of approval of the BHR System.
The study
will evaluate the long term safety and effectiveness of the BHR system in patients
with
non-inflammatory and inflammatory arthritis.
View Study Details
A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide,
Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin,
Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
This Phase III, randomized, double-blind, placebo-controlled study will compare the
efficacy,
safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants
with previously untreated diffuse large B-cell lymphoma (DLBCL).
View Study Details
A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine
With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia
Glasdegib is being studied in combination with azacitidine for the treatment of adult
patients with previously untreated acute myeloid leukemia (AML) who are not candidates
for
intensive induction chemotherapy (Non-intensive AML population).
Glasdegib is being studied in combination with cytarabine and daunorubicin for the
treatment
of adult patients with previously untreated acute myeloid leukemia (Intensive AML
population).
View Study Details
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia
Areata
This study is designed to select up to two doses of baricitinib (referred to as low
dose and
high dose) and assess their efficacy and safety for the treatment of severe or very
severe
alopecia areata.
View Study Details
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal
Junction Cancer (FIGHT)
This is a global, randomized, double-blind, controlled study to evaluate the efficacy
of
bemarituzumab (FPA144) + mFOLFOX6 versus placebo + mFOLFOX6 in patients with FGFR2
selected
Gastric Cancer (as determined by prospective IHC FGFR2b overexpression and/or a ctDNA
blood
assay demonstrating FGFR2 gene amplification)
View Study Details
A study of COPD patients who take Anoro, Incruse or Tiotropium
Lead Researcher: Michael Larj
An observational study to assess the safety of your COPD medication, how well you
tolerate your medication, how well it works in treating your COPD condition and how
it is used in practice by the physician.
Three medications we will collect data on for this study, Anoro, Incruse and tiotropium
are all approved for use with COPD.
View Study Details
A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease
This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate
the
safety and tolerability of at least two dose levels of intravenous (IV) crenezumab
in 24-72
participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination
[MMSE] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be
offered
after the completion of initial double-blind stage.
View Study Details
A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants
With Prodromal to Mild Alzheimer's Disease (AD)
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate
the
efficacy and safety of crenezumab versus placebo in participants with prodromal to
mild AD.
Participants will be randomized 1:1 to receive either intravenous (IV) infusion of
crenezumab
or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will
be
performed at 105 weeks. The participants who do not enter open-label extension will
enter for
a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week
153).
View Study Details
A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With
Recurrent or Progressive Glioblastoma Following Initial Therapy
This is a randomized, active-controlled, multicenter, open-label, parallel groups,
Phase 2
study of DSP-7888 Dosing Emulsion plus Bevacizumab versus Bevacizumab alone in patients
with
recurrent or progressive glioblastoma multiforme (GBM) following treatment with first
line
therapy consisting of surgery and radiation with or without chemotherapy.
View Study Details
A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed
Multiple Myeloma
This research study is studying a combination of study drugs as a possible treatment
for
relapsed and refractory Multiple Myeloma. The interventions involved in this study
are
elotuzumab, pomalidomide, bortezomib, dexamethasone.
View Study Details
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
This multi-center, randomized, double-blind, placebo-controlled parallel-group study
will
evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the
safety
and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants
will be
randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.
Participants who consent to be part of the sub study will undergo positron emission
tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment
is
104 weeks in Part 1, with an option for an additional up to 2 years of treatment in
Part 2,
followed by an open-label extension (Part 3) until July 2020.
The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis
showed a
low probability of meeting the primary outcome measure with the doses studied. The
study has
converted to open-label to investigate higher gantenerumab doses.
View Study Details
A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid
Leukemia
To determine the activity of lenalidomide in the treatment of pediatric subjects with
relapsed/refractory acute myeloid leukemia (AML) (with second or greater relapse or
refractory to at least 2 prior induction attempts) measured by morphological complete
response defined as either a CR or CRi within the first 4 cycles of treatment.
View Study Details
A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants
With Relapsing Multiple Sclerosis
This randomized, double-blind, double-dummy, parallel-group study will evaluate the
efficacy
and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants
with
relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab
600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for
the
first dose and as a single infusion of 600 mg for all subsequent infusions every 24
weeks,
with placebo injections matching interferon beta-1a SC three times per week; or interferon
beta-1a 44 mcg SC injections three times per week (with placebo infusions matching
ocrelizumab infusions every 24 weeks).
View Study Details
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
This randomized, parallel group, double-blind, placebo controlled study will evaluate
the
efficacy and safety of ocrelizumab in participants with primary progressive multiple
sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab
or
placebo. The blinded treatment period will be at least 120 weeks, followed by an Open
Label
Extension (OLE) treatment for participants in both groups who in the opinion of the
investigator could benefit from further or newly initiated ocrelizumab treatment.
Unless
terminated early, all participants will continue their treatment with open-label ocrelizumab
until the last participant who entered the OLE phase reaches 4 years of open-label
ocrelizumab treatment.
View Study Details
A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to
Severely Active Crohn's Disease
The purpose of this program is to evaluate the efficacy and safety of guselkumab in
participants with Crohn's disease.
View Study Details
A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children
With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
The purpose of this study is to compare the effect of a blood thinning drug called
Apixaban
versus no administration of a blood thinning drug, in preventing blood clots in children
with
leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase,
and
have a central line (a catheter inserted for administration of medications and blood
sampling)
View Study Details
A Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in
the Treatment of Subjects with Active Crohn’s Disease
Lead Researcher: Lawrence Saubermann
The purpose of this study is to compare the effectiveness of the drug Ustekinumab
to the drug Adalimumab in patients who have moderate to severe Crohn's disease. The
study will test Ustekinumab compared to Adalimumab for 56 weeks. To determine if the
effectiveness of each drug, patients will come to the clinic regularly to meet with
the study team, complete questionnaires, and have blood work completed.
View Study Details
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide,
Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed
Systemic Amyloid Light-chain (AL) Amyloidosis
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus
cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone
in
treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
View Study Details
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants
With Diabetic Macular Edema
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered
at 8-week intervals or as specified in the protocol following treatment initiation,
compared
with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema
(DME).
View Study Details
A Study to Evaluate the Efficacy and Safety of RO7105705 in Patients With Prodromal
to Mild Alzheimer's Disease
This is a phase II, randomized, placebo-controlled, double-blind study to evaluate
the
efficacy and safety of RO7105705 in participants with prodromal to mild Alzheimer's
disease.
An optional 96-week open-label extension period will be available to participants
who
complete the double-blind treatment period and who, in the judgment of the investigator,
would potentially benefit from open-label RO7105705 treatment.
View Study Details
A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants
With Early Parkinson's Disease
This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will
evaluate
the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52
weeks in
participants with early Parkinson's Disease (PD) who are untreated or treated with
monoamine
oxidase B (MAO-B) inhibitors since baseline. The study will consist of 2 parts: a
52-week,
double-blind, placebo-controlled treatment period (Part 1) after which eligible participants
will continue into an all-participants-on-treatment blinded dose extension for an
additional
52 weeks (Part 2).
View Study Details
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared
With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative
Colitis (UC)
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A
compared with vedolizumab and with placebo in the treatment of participants with moderate
to
severe UC. This study will consist of two parts, Part A and Part B. Part A will test
the
induction of clinical remission and Part B will test the durability of clinical remission.
View Study Details
A Study to Investigate the Efficacy and Safety of Balovaptan (RO5285119) in Participants
With Autism Spectrum Disorder (ASD)
This is a Phase II multi-center, randomized, double-blind, 24-week, 3-arm, parallel
group,
placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics
of
balovaptan (RO5285119) in children and adolescents aged 5-17 years with ASD who are
high
functioning (intelligence quotient [IQ] greater than or equal to [>=] 70). Enrollment
will be
staggered, starting first with adolescents (aged 13 to 17 years) and then with children
(aged
5 to 12 years). Initially, a first cohort of approximately 24 adolescents will be
enrolled
together. Based on pharmacokinetic evaluation, safety, and tolerability in the first
adolescent cohort and determined final doses, enrollment of adolescents will resume
and the
enrollment of a first cohort of approximately 24 children (aged 5 to 12 years) can
commence.
Based on acceptable safety and tolerability in the first children cohort and determined
final
doses, enrollment of children will resume.
View Study Details
Abnormal Cervix Cells: CA-IX, p16, Proliferative Markers, and HPV in Diagnosing Cervical
Lesions in Patients With Abnormal Cervical Cells
Lead Researcher: Richard Moore
The main purpose of this study is to determine whether the presence of Human Papillomavirus
(HPV) and certain chemical substances (biomarkers) in cervical cells can help identify
which women with a cytologic diagnosis of AGC have a benign condition and which have
a pre-cancerous condition or an invasive cancer that requires surgical removal. Each
biomarker will be tested in both cervical cells (obtained similar to a Pap specimen)
and tissue (removed during a surgical procedure). Results of the testing will be
compared to see which biomarker or combination of biomarkers is the most accurate
at identifying which women with a cytologic diagnosis of AGC have a benign condition
and which have a pre-cancerous condition or an invasive cancer.
An additional goal of this study is to study DNA (genetic material) recovered from
tissue to determine if there are changes in the DNA that can tell which women with
a diagnosis of AGC have a benign condition and which have a pre-malignant condition
or invasive cancer.
View Study Details
Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric
and Adult Patients With Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin,
carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients
with germ
cell tumors. Active surveillance may help doctors to monitor subjects with low risk
germ cell
tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin,
carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of
tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading.
View Study Details
ADMET2
Lead Researcher: Anton Porsteinsson
Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled,
masked, 6 month, 10-center randomized clinical trial sponsored by National Institute
of Aging
involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to examine
the
efficacy and safety of methylphenidate as treatment for clinically significant apathy
in AD.
participants. ADMET 2 will enroll participants from real world settings such as outpatient,
nursing
home, and assisted living facilities and will examine the effects of methylphenidate
on apathy and
cognition. ADMET 2 will also conduct careful safety monitoring.
View Study Details
ADNI3
Lead Researcher: Anton Porsteinsson
ADNI3 is not a treatment study. It continues research that began in 2004 (ADNI1) and
will follow people over a five year period using the information collected from thinking
and memory testing, brain imaging, genetics testing, and blood and brain-spinal fluid
testing to help improve the way AD research is conducted. Approximately 1070 - 2000
participants will be enrolled at 59 sites in the US and Canada. Three groups will
be enrolled and evaluated: those with normal thinking and memory, those with mild
cognition problems, and those with mild Alzheimer's disease. The normal thinking cohort
is filled; the study is now only recruiting people with mild cognition problems (MCI)
or mild Alzheimer's disease.
View Study Details
AMPLEX Ankle Fusion
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone
fusion in
a population indicated for single, double, or triple hindfoot arthrodesis or ankle
arthrodesis surgery with supplemental graft material.
View Study Details
Amyloidosis: A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination
With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone
in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
Lead Researcher: Frank Passero
There are two treatment groups in this study. The study medication will be given in
treatment cycles, and each cycle is 28 days long. Group A: Cyclophosphamide, bortezomib
(VELCADE®) and dexamethasone (CyBorD). Group B: Daratumumab plus cyclophosphamide,
bortezomib (VELCADE®) and dexamethasone (CyBorD)
View Study Details
Amyloidosis: S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary
Amyloidosis
Lead Researcher: Frank Passero
All participants will receive the same study drug. If you decide to participate, you
will receive up to 24 cycles (1 cycles = 28 days) of the study drug, isatuximab, as
an outpatient (meaning you will not be admitted to the hospital to receive study drug.
During the first cycle (or 28 days), you will receive isatuximab on Day 1, 8, 15 and
22 by intravenous (IV) infusion (into your vein). For all other cycles (Cycle 2, up
to Cycle 24), you will receive isatuximab on Days 1 and 15.
View Study Details
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A
in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
This study will evaluate the long-term safety and tolerability of UTTR1147A in participants
with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling
up to 320
participants from the Phase Ib Study GA29469 and Phase II Study GA39925 (parent studies).
View Study Details
An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial
Hypertension
This study is an international, multi-center, open-label study designed to provide
oral
treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who
have
completed the TDE-PH-310 study. The purpose of this study is to assess the long-term
safety
of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise
capacity.
View Study Details
Androgen-Deprivation Therapy and Radiation Therapy in Treating Patients With Prostate
Cancer
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation
therapy may stop the adrenal glands from making androgens. Radiation therapy uses
high-energy
x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and
radiation
therapy in treating patients with prostate cancer.
View Study Details
Anti-VEGF Treatment for Prevention of PDR/DME
Multiple studies have implicated vascular endothelial growth factor VEGF as a major
causative
factor in human eye diseases characterized by neovascularization including proliferative
diabetic retinopathy (PDR) and vascular permeability including diabetic macular edema
(DME).
While there is strong evidence that PDR outcomes are markedly reduced in eyes that
are
treated with monthly anti-VEGF therapy (A Study of Ranibizumab Injection in Subjects
With
Clinically Significant Macular Edema (ME) With Center Involvement Secondary to Diabetes
Mellitus: RIDE/RISE) and moderately reduced in eyes that received fairly frequent
dosing
during the 1st year of treatment (Diabetic Retinopathy Clinical Research Network protocol
I),
it is unknown whether or not an earlier but less frequent dosing regimen would result
in
similar, favorable anatomic outcomes, and whether favorable anatomic outcomes subsequently
would result in favorable visual acuity outcomes.
If this study demonstrates that intravitreous aflibercept treatment is effective and
safe for
reducing the onset of PDR or center involved- DME (CI-DME) in eyes that are at high
risk for
these complications, a new strategy to prevent vision threatening complications of
diabetes
will be available for patients. The application of intravitreous aflibercept earlier
in the
course of disease (i.e., at the time when an eye has baseline severe non-proliferative
diabetic retinopathy) could help to reduce future potential treatment burden in patients,
at
the same time resulting in similar or better long-term visual outcomes, if PDR and
DME are
prevented.
The primary objectives of this protocol are to 1) determine the efficacy and safety
of
intravitreous aflibercept injections versus sham injections (observation) for prevention
of
PDR or CI-DME in eyes at high risk for development of these complications and 2) compare
long-term visual outcomes in eyes that receive anti-VEGF therapy early in the course
of
disease with those that are observed initially, and treated only if high-risk PDR
or CI-DME
with vision loss develops.
Secondary objectives include:
- Comparing other visual acuity outcomes between treatment groups, such as proportion
of
eyes with at least 10 or at least 15 letter loss from baseline, or gain or loss of
at
least 5 letters at the consecutive study visit just before and at the 2- or 4-year
visit
- Comparing optical coherence tomography (OCT) outcomes, such as mean change in OCT
central subfield thickness and volume from baseline
- Comparing proportion of eyes with at least 2 and 3-step worsening or improvement
of
diabetic retinopathy severity level (scale for individual eyes) by central reading
center from baseline
- Comparing associated treatment and follow-up exam costs between treatment groups
- Comparing safety outcomes between treatment groups
View Study Details
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients
With Prostate Cancer That Has Been Removed by Surgery
This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation
therapy to see how well it works compared with antiandrogen therapy and radiation
therapy
alone in treating patients with prostate cancer that has been removed by surgery.
Androgen
can cause the growth of prostate cells. Antihormone therapy may lessen the amount
of androgen
made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and
shrink
tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop
the
growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by
stopping them from spreading. Giving antiandrogen therapy and radiation therapy with
or
without docetaxel after surgery may kill any remaining tumor cells.
View Study Details
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring
anticoagulation for the treatment of a VTE.
View Study Details
Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID
3)
The primary objective of this study is to show superiority in the treatment of HMB
of
vilaprisan in subjects with uterine fibroids compared to placebo.
The secondary objectives of this study are to additionally evaluate the efficacy and
safety
of vilaprisan in subjects with uterine fibroids.
View Study Details
Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
Recruited patients will include those about to begin Disease-Modifying Antirheumatic
Drug)
DMARD therapy or about to change DMARD therapy.
Disease activity will be monitored systematically every 3 months by the Disease Activity
Score.
Changes in standard DMARD and/or anti-Tumor Necrosis Factor α (anti-TNFα) therapy
will be
made according to specific recommendations for patients receiving these therapies.
Biomarker samples will be collected every 3 months and prior to change in DMARD and/or
anti-TNF therapy as defined below. A blood sample (40 ml) for serum will be taken
for
biomarker studies and processed according to the international committee of Outcome
Measures
in Rheumatology (OMERACT) recommendations for the minimal handling of biomarker samples.
A
urine sample (20 ml) will also be taken and processed as for serum.
Radiography (X-rays) will be conducted every 6 months (baseline, 6, 12, 18, 24 months).
Patients will be followed for 2 years.
View Study Details
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving
Chemotherapy
Cognitive impairments in cancer patients represent an important clinical problem.
Studies to
date estimating prevalence of difficulties in memory, executive function, and attention
deficits have been limited by small sample sizes and many have lacked healthy control
groups.
More information is needed on promising biomarkers and allelic variants that may help
to
determine the etiology of impairment, identify those most vulnerable to impairment,
and
develop interventions for these difficulties.
This is a longitudinal observational study of cognitive function in breast cancer
and
lymphoma patients receiving chemotherapy to better understand the prevalence of cognitive
difficulties (i.e., problems with memory, executive function, and attention) in these
populations.
View Study Details
Assessment of Prototype Hand-Held Fundus Camera
Assessment of handheld fundus images in comparison to conventional fundus camera images.
View Study Details
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure
or Coverage
The purpose of this study is to characterize the bacteria in the wound "bioburden"
at the
time of definitive wound coverage/closure of severe tibia fractures in both the military
and
civilian populations.
View Study Details
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
The primary objective of this study is to gather post market data on the Penumbra
SMART Coil™
System in the treatment of intracranial aneurysms and other malformations.
View Study Details
Assessment Tool for Older Patients With Cancer
RATIONALE: A study that assesses the ability of older patients to think, learn, remember,
make judgments, and carry out daily activities may help doctors plan treatment for
older
patients with cancer.
PURPOSE: This clinical trial is studying an assessment tool in older patients with
cancer.
View Study Details
Asthma Registry
Lead Researcher: Steve Georas
We are looking for asthmatic and healthy volunteers who are interested in asthma research,
who would like to join the database. Joining the database means you may be contacted
in the future about participating in a clinical study about asthma. Joining the registry
does not automatically put you in a research study.
View Study Details
Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary
Arterial Hypertension - CATALYST
This study assesses the safety and efficacy of bardoxolone methyl relative to placebo
in
patients with connective tissue disease-associated pulmonary arterial hypertension
to
determine the recommended dose range and evaluate the change from baseline in 6-minute
walk
distance (6MWD) following 24 weeks of study participation.
View Study Details
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
Lead Researcher: Michael Stoner
This study will compare the effectiveness of best available surgical treatment with
best
available endovascular treatment in adults with critical limb ischemia (CLI) who are
eligible
for both treatment options.
View Study Details
Biliary Cancer: Phase 1b PEGPH20 with Cis & Gem; PEGPH20 with Atezolizumab, Cis &
Gem; and compared with Cis & Gem alone in HA-High Subjects with Metastatic Intrahepatic
and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma
Lead Researcher: Marcus Noel
If you participate in the Run In portion of this study, you will be assigned to one
of two treatment groups. You can be assigned to receive either PEGPH20 plus Cisplatin
and Gemcitabine or PEGPH20 plus Cisplatin and Gemcitabine and Atezolizumab. If you
participate in the Dose Expansion portion of the study, you will be assigned to one
of three different treatment groups. You can be assigned to receive PEGPH20 plus Cisplatin
and Gemcitabine, PEGPH20 plus Cistplatin and Gemcitabine and Atezolizumab or Cisplatin
and Gemcitabine alone.
View Study Details
Biobanking of Rett Syndrome and Related Disorders
The overarching purpose of this study is to advance understanding of the natural history
of
Rett syndrome (RTT), MECP2-duplication disorder (MECP2 Dup), RTT-related disorders
including
CDKL5, FOXG1, and individuals with MECP2 mutations who do not have RTT. Although all
these
disorders are the result of specific genetic changes, there remains broad clinical
variation
that is not entirely accounted for by known biological factors. Additionally, clinical
investigators currently do not have any biomarkers of disease status, clinical severity,
or
responsiveness to therapeutic intervention. To address these issues, biological materials
(DNA, RNA, plasma, cell lines) will be collected from affected individuals and in
some cases
from unaffected family members, initial evaluation performed to identify additional
biological factors contributing to disease severity, and these materials will be stored
for
future characterization.
View Study Details
Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma
or Ganglioneuroblastoma
This research trial studies biomarkers in tumor tissue samples from patients with
newly
diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue
from
patients with cancer in the laboratory may help doctors identify and learn more about
biomarkers related to cancer.
View Study Details
Bladder Cancer: A Study of Enfortumab Vedotin for Patients With Locally Advanced or
Metastatic Urothelial Bladder Cancer (EV-201)
Lead Researcher: Chunkit Fung
If you choose to take part in this study, the study treatment cycle is 28-days. You
will receive treatment with enfortumab vedotin on Day 1, 8, and 15 of each treatment
cycle. Enfortumab vedotin is given as an infusion into a vein (over about 30 minutes).
View Study Details
Bladder Cancer: Different Strains of BCG With or Without Vaccine in High Grade Non-
Muscle Invasive Bladder Cancer
Lead Researcher: Edward Messing
This study has 3 study groups; Group 1 will receive the usual BCG LIVE (TICE® BCG)
version of BCG in the bladder, Group 2 will receive BCG in the bladder but it will
be the Tokyo-172 version of BCG instead of the BCG LIVE (TICE® BCG) version, and Group
3 will receive a vaccination as an injection under the skin with the Tokyo-172 version
of BCG followed by receiving the Tokyo-172 version in the bladder. A computer will
assign you to treatment groups in the study by chance. This is done by chance because
no one knows if one study group is better or worse than the others. Neither you nor
your doctor will be able to choose your treatment.
View Study Details
Bladder Cancer: Study of Pembrolizumab With or Without Platinum-based Combination
Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma
Lead Researcher: Elizabeth Guancial
If you agree to and are allowed to participate in this study, you will be assigned
by 33% chance (a process called randomization similar to rolling a dice) to one of
three treatment groups:
• Subjects assigned to Treatment Group A, will receive pembrolizumab
• Subjects assigned to Treatment Group B, will receive the combination of pembrolizumab
and chemotherapy (either cisplatin or carboplatin with gemcitabine).
• Subjects assigned to Treatment Group C, will receive chemotherapy (either cisplatin
or carboplatin with gemcitabine).
Both you and your doctor will know which treatment group you have been assigned to.
View Study Details
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic
Leukemia
This randomized phase III trial studies how well blinatumomab works compared with
standard
combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia
that
has returned after a period of improvement (relapsed). Monoclonal antibodies, such
as
blinatumomab, may interfere with the ability of tumor cells to grow and spread. It
is not yet
known whether standard combination chemotherapy is more effective than blinatumomab
in
treating relapsed B-cell acute lymphoblastic leukemia.
View Study Details
Brain Cancer: Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma
Lead Researcher: Nimish Mohile
Glioblastoma is the most common and fastest growing type of brain tumor (lump of abnormal
cells). There are not many treatment options available for glioblastoma. The standard
treatment for glioblastoma involves a combination of removing as much of the tumor
as possible during surgery, followed by radiation therapy (radiotherapy) and chemotherapy
(namely Temozolomide). Unfortunately, even after these treatments, the tumor often
comes back. Because glioblastoma is so difficult to treat, a company called ImmunoCellular
Therapeutics, Ltd. is trying to find a treatment that may work better than the options
that are currently available. Therefore, ImmunoCellular is conducting a study to find
out if adding treatment with an investigational medicine (ICT-107) helps to prevent
brain tumors from coming back so soon after surgery, radiation, and chemotherapy and
if it helps people with brain tumors live longer compared to standard treatment alone.
An “investigational medicine” is a medicine that is being tested and is not approved
for sale in the United States by the U.S. Food and Drug Administration (FDA). It is
a Phase III study, which means that it is designed to confirm results seen in earlier
studies with ICT-107.
View Study Details
Brain Cancer: Radiation Therapy With Concomitant and Adjuvant Temozolomide or Radiation
Therapy With Adjuvant PCV or Temozolomide Alone in Treating Patients With Anaplastic
Glioma
Lead Researcher: Nimish Mohile
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as temozolomide, work in different ways to stop the growth of tumor cells, either
by killing the cells or by stopping them from dividing.
View Study Details
Brain Cancer: Temozolomide With or Without Veliparib in Treating Patients With Newly
Diagnosed Glioblastoma Multiforme
Lead Researcher: Nimish Mohile
This randomized phase II/III trial studies how well temozolomide and veliparib work
and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma
multiforme. Drugs used in chemotherapy, such as temozolomide, work in different ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor
cells by blocking some of the enzymes needed for cell growth. It is not yet known
whether temozolomide is more effective with or without veliparib in treating glioblastoma
multiforme.
View Study Details
Brain Training to Promote Health in Family Dementia Caregivers
Lead Researcher: Kathi Heffner
The purpose of the study is to determine whether two types of in-home “brain-training”
programs may have beneficial health effects, including reduced stress and improved
immune health, for individuals caring for a loved one (spouse, parent, friend, etc)
who has dementia.
Participation involves completing one of our brain training programs with the use
of a computer at home a few times a week (when convenient for you), over eight weeks.
Experience or skill with computers is not necessary. If you do not own a computer,
one may be provided for you to use during the program period.
View Study Details
Breast cancer: Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel
With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
Lead Researcher: Allison Magnuson
This study has two study groups.
Group 1 will get the usual chemotherapy drugs used for this type of cancer: doxorubicin
and cyclophosphamide, followed by paclitaxel.
Group 2 will get the usual chemotherapy drugs used for this type of cancer: doxorubicin
and cyclophosphamide, followed by paclitaxel plus the chemotherapy drug called carboplatin.
View Study Details
Breast Cancer: HOMING Study: Harvest of Circulating Tumor Cells (CTCs) from Patients
with Metastatic Breast Cancer (MBC) using the Parsortix PC1 System
Lead Researcher: Richard Moore
If you participate in this study, you will be asked to allow the study doctor to draw
3 tubes of blood (up to a total of 23mL or 1 1/2 tablespoons of your blood) for the
evaluation of the presence or absence of CTCs and their characterization as well as
to collect information about your health.
View Study Details
Breast Cancer: Phase III study of hormone therapy with or without the study drug (Everolimus)
in high risk hormone receptor positive & HER-2 negative breast cancer (S1207)
Lead Researcher: Michelle Shayne
The purpose of this study is to see whether treatment with everolimus plus hormone
treatment after chemotherapy will increase the time without your cancer returning.
The current standard treatment after chemotherapy is hormone treatment alone. Everolimus
is a drug currently approved for the treatment of patients with advanced or metastatic
kidney cancer or breast cancer. It is considered investigational for non-metastatic
breast cancer patients. In this study you will get hormone treatment with either
everolimus or with placebo (a placebo is a tablet that looks like the active drug,
but has no active drug in it). The combination of hormone-treatment and everolimus
is experimental in patients with breast cancer.
View Study Details
Breast Cancer: Platinum Based Chemotherapy or Capecitabine in Treating Patients With
Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
Lead Researcher: Michelle Shayne
If you participate in this study, you will be randomized to either receive platinum-based
chemotherapy for 12 weeks (you and your doctor will choose between cisplatin or carboplatin)
or you will get the usual approach used for this type of cancer, capecitabine for
18 weeks.
View Study Details
Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral
Breast Cancer
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast
cancer and
may have fewer side effects and improve recovery. Radiation therapy uses high-energy
x rays
to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells
that
remain after surgery.
PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation
therapy
work in treating patients with multiple ipsilateral breast cancer
View Study Details
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults
With Stage IIB or Stage IIIB-IVB Hodgkin Lymphoma
This randomized phase III trial studies brentuximab vedotin and combination chemotherapy
to
see how well they work compared to combination chemotherapy alone in treating children
and
young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological
substances in brentuximab vedotin may be able to carry cancer-killing substances directly
to
Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride,
bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide,
work in
different ways to stop the growth of cancer cells, either by killing the cells, by
stopping
them from dividing, or by stopping them from spreading. It is not yet known if combination
chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin
lymphoma.
View Study Details
Brentuximab Vedotin or Crizotinib and Combination Chemotherapy in Treating Patients
With Newly Diagnosed Stage II-IV Anaplastic Large Cell Lymphoma
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib
and combination chemotherapy works in treating patients with newly diagnosed stage
II-IV
anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab
vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib
and
methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed
for
cell growth. Drugs used in chemotherapy work in different ways to stop the growth
of cancer
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy
is
more effective than crizotinib and combination chemotherapy in treating anaplastic
large cell
lymphoma.
View Study Details
Cancer (Geriatric): Cognitive Rehabilitation For At-Risk Older Cancer Patients Receiving
Chemotherapy: A Pilot Study Evaluating Feasibility And Impact
Lead Researcher: Allison Magnuson
In Phase I all subjects will receive cognitive rehabilitation intervention which includes,
workshops and at-home computer-based cognitive training. In the phase II portion of
the study, depending on the group you are assigned, you may receive cognitive rehabilitation
intervention or usual care. This will help researchers develop a doable approach to
cognitive rehabilitation and see if it helps reduce the risk of developing progressive
cognitive impairments which is a common side effect of chemotherapy.
View Study Details
Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors
This randomized phase IIb trial studies how well low-dose carvedilol works in preventing
heart failure in cancer survivors exposed to high dose anthracyclines for management
of
childhood cancer. Patients who received high-dose anthracycline chemotherapy are at
a much
greater risk for developing heart failure compared to survivors who didn?t get any
anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened
and
can?t pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular
complications.
View Study Details
Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating
Patients With Stage III Non-small Cell Lung Cancer
This randomized phase II trial studies how well chemotherapy and radiation therapy
given with
or without metformin hydrochloride works in treating patients with stage III non-small
cell
lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work
in
different ways to stop the growth of tumor cells, either by killing the cells, by
stopping
them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy
x-rays to kill tumor cells and shrink tumors. Metformin hydrochloride may shrink tumors
and
keep them from coming back. It is not yet known whether chemotherapy and radiation
therapy is
more effective when given with or without metformin hydrochloride in treating stage
III
non-small cell lung cancer.
View Study Details
Chemotherapy With or Without Bevacizumab in Patients With Completely Resected Stage
IB-IIIA Non-small Cell Lung Cancer
This randomized phase III trial studies chemotherapy and bevacizumab to see how well
they
work compared to chemotherapy alone in treating patients with stage IB, stage II,
or stage
IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy
work
in different ways to stop the growth of tumor cells, either by killing the cells,
by stopping
them from dividing, or by stopping them from spreading. Giving more than one drug
(combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such
as
bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab
also may stop the growth of non-small cell lung cancer by blocking the growth of new
blood
vessels necessary for tumor growth. It is not yet known whether chemotherapy is more
effective with or without bevacizumab in treating non-small cell lung cancer.
View Study Details
Chinese Older Adults-Collaboration in Health (COACH)Study
This study will see if education of village doctors and aging workers in identification
and
management of hypertension and depression, using standardized procedures,consultation
with a
psychiatrist as needed, and collaborations between the village doctor and aging worker
in
care elderly patients in the village better achieve better outcomes for their depression
and
high blood pressure than usual care.
View Study Details
Chronic Graft Versus Host Disease (Bone Marrow Transplant): Ibrutinib in Combination
With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects
With New Onset Chronic Graft Versus Host Disease (cGVHD) (iNTEGRATE)
Lead Researcher: Jane Liesveld
Researchers are trying to find out if and how well the study drug, Ibrutinib controls
cGVHD, how people with cGVHD respond to decreasing prednisone doses over 24 weeks,
how the body responds to the study drug, the side effects of the study drug, how long
the study drug stays in the body,
and whether blood tests can predict treatment response.
View Study Details
Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced
NSCLC
Patients with Stage III unresectable non-small cell lung cancer will receive thoracic
radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2
weeks for a
year.
View Study Details
Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients
With Extensive Stage Small Cell Lung Cancer
This randomized phase II clinical trial studies whether the addition of nivolumab
to
cisplatin (or carboplatin) and etoposide will improve outcomes when treating patients
with
extensive stage small cell lung cancer. Drugs used in chemotherapy such as cisplatin,
carboplatin, and etoposide, work in different ways to stop the growth of tumor cells,
either
by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune
system attack the cancer, and may interfere with the ability of tumor cells to grow
and
spread. Giving cisplatin/carboplatin and etoposide together with nivolumab may work
better in
treating patients with extensive stage small cell lung cancer.
View Study Details
Clinical Priority Program-Bone Infection Registry
Establish an international registry of over 400 patients with deep infections involving
the
bone and/or joint from≥20 centers representing all regions of the world with varied
hospital
and surgeon practice settings to ensure that registry analyses and research reflect
typical
clinical practice thereby providing optimal guidance for patients, clinicians, and
healthcare
researchers. Using a data collection platform that minimizes entry burden, collects
most
information at the time of surgery, and uses Internet technology to minimize data
entry. The
registry will include:
1. baseline patient attributes;
2. surgical approach, implants and technology;
3. hospital course;
4. surgeon and institutional characteristics;
5. longitudinal patient outcome,
6. post-procedure complications and revisions,
7. serum/tissue/drainage samples.
View Study Details
Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms
The purpose of this clinical trial is to assess and evaluate the safety and efficacy
of the
Treovance Stent-Graft with Navitel Delivery System in subjects with Abdominal Aortic
Aneurysms (AAA).
View Study Details
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory
Loss
The purpose of this study is to test whether an investigational drug called solanezumab
can
slow the progression of memory problems associated with brain amyloid (protein that
forms
plaques in the brains of people with Alzheimer Disease [AD]).
View Study Details
Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's
Lymphoma That Has Relapsed or Not Responded to Previous Treatment
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways
to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine
and
to see how well it works in treating patients with T-cell or natural killer-cell lymphoma
that has relapsed or not responded to previous treatment.
View Study Details
Cognitive Training for Older Caregivers
The purpose of this study is to test whether certain brain training activities can
promote
cognitive, emotional, and physical health in caregivers of a spouse with dementia.
Numerous
studies show that family dementia caregiving can be stressful, and can increase mental
and
physical health risks. This study aims to understand how to reduce those risks.
View Study Details
Collecting and Storing Biological Samples From Patients With Ewing Sarcoma
This research study is collecting and storing samples of tumor tissue, bone marrow,
and blood
from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue,
bone
marrow, and blood from patients with cancer to test in the laboratory may help the
study of
cancer in the future.
View Study Details
Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
The purpose of this study is to collect and store samples of blood and tumor tissue
from
patients with osteosarcoma. Collecting and storing samples of tumor tissue and blood
from
patients to test in the laboratory may help the study of cancer in the future.
View Study Details
Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed
Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
This research study is collecting and storing samples of bone marrow and blood from
patients
with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting
and
storing samples of bone marrow and blood from patients with cancer to study in the
laboratory
may help doctors learn more about cancer and help predict the recurrence of cancer.
View Study Details
Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma
or Other Soft Tissue Sarcoma
The purpose of this study is to collect and store tumor tissue, blood, and bone marrow
samples from patients with soft tissue sarcoma that will be tested in the laboratory.
Collecting and storing samples of tumor tissue, blood, and bone marrow from patients
to test
in the laboratory may help the study of cancer.
View Study Details
Colon Cancer: Combination Chemotherapy With or Without Atezolizumab in Treating Patients
With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Lead Researcher: Mohamedtaki Tejani
This study has 2 groups. Group 1 will receive the usual chemotherapy treatment of
FOLFOX plus the drug atezolizumab for 6 months, then patients will take atezolizumab
alone for an additional 6 months. Group 2 will receive the usual chemotherapy which
is FOLFOX for 6 months.
View Study Details
Colorectal Cancer: Combination Chemotherapy, Bevacizumab, and/or Atezolizumab in Treating
Patients With Deficient DNA Mismatch Repair Metastatic Colorectal Cancer
Lead Researcher: Marcus Noel
This study has 3 study groups. A computer will, by chance assign you to one of the
groups in the study. This is done because no one knows if one study group is worse
or better than the others. You will have an equal chance of being in groups 1, 2,
or 3. Group 1 will get FOLFOX and bevacizumab, Group 2 will get atezolizumab alone
and Group 3 will receive FOLFOX and bevacizumab plus atezolizumab. The drugs will
be given by infusion.
View Study Details
Colorectal Cancer: Regorafenib in Adults ≥ 70 Years with Metastatic Colorectal Cancer
Lead Researcher: Mohamedtaki Tejani
The standard treatment for metastatic colorectal cancer usually includes chemotherapy
which can have side effects that are more difficult to tolerate for older patients
with cancer. Regorafenib (a non-chemotherapy option) was recently approved by the
FDA for treatment of patients whose cancer had grown on all standard chemotherapy
agents.
This study is being done among elderly patients, whose cancer has grown on all chemotherapy
agents or who are not able to tolerate chemotherapy, to measure the safety of regorafenib
in the elderly population and to assess how well the drug controls cancer growth.
View Study Details
Colorectal Cancer: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride
in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal
Cancer That Cannot Be Removed by Surgery
Lead Researcher: Marcus Noel
If you decide to participate in this study a computer will assign you to one of the
3 study groups. This is done by chance because no one knows if one study group is
better or worse than the other. Group 1 will receive the study drugs trastuzumab and
pertuzumab. The combination of trastuzumab and pertuzumab is investigational (not
approved by the FDA for treatment of colorectal cancer). These drugs will be given
through a vein on Day 1 of every 21 day cycle. Group 2 will receive the usual chemotherapy,
cetuximab and irinotecan, through a vein on Day 1 of every 14 day cycle. If you are
in Group 2 and your cancer gets worse, you may have the option to receive the same
treatment as Group 1, and be placed into Group 3.
View Study Details
Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing
Sarcoma
This randomized phase III trial studies combination chemotherapy to see how well it
works
compared to combination chemotherapy with topotecan hydrochloride in treating patients
with
extracranial Ewing sarcoma that has not spread from the primary site to other places
in the
body. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride,
cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different
ways
to stop the growth of tumor cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving more than one drug (combination
chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy
is more effective with topotecan hydrochloride in treating Ewing sarcoma.
View Study Details
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk
B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
This randomized phase III trial studies how well combination chemotherapy works in
treating
young patients with newly diagnosed B acute lymphoblastic leukemia that is likely
to come
back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase
inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different
ways to
stop the growth of cancer cells, either by killing the cells, by stopping them from
dividing,
or by stopping them from spreading. Giving more than one drug (combination chemotherapy)
and
giving the drugs in different doses and in different combinations may kill more cancer
cells.
View Study Details
Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients
With Acute Lymphoblastic Leukemia
This phase II trial is studying the side effects of giving combination chemotherapy
together
with or without donor stem cell transplant and to see how well it works in treating
patients
with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways
to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving
chemotherapy and total-body irradiation before a donor stem cell transplant helps
stop the
growth of cancer cells. It also stops the patient's immune system from rejecting the
donor's
stem cells. The donated stem cells may replace the patient's immune cells and help
destroy
any remaining cancer cells (graft-versus-tumor effect).
View Study Details
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve
Repair
Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety
and
functional outcomes for the repair of nerve injuries in the hand.
View Study Details
Comparison of Study Drug and Entiviyo on the treatment of Colitis
Lead Researcher: Lawrence Saubermann
Study participation will last just under a year. Subjects will be randomized to receive
different dosages of either the study drug or Vedolizumab or placebo. Subjects are
required to visit the clinic 13 times for study related procedures. Infusions (IV
hookup) is the method for receiving the study drug.
View Study Details
Comprehensive Oncology Measures for Peripheral T-cell Lymphoma Treatment Registry
The COMPLETE registry is a prospective, longitudinal, multinational, observational
study that
will collect data on how patients with peripheral T-cell lymphoma (PTCL) are treated
in
academic and community practices. The registry will enroll newly-diagnosed patients
with PTCL
treated with a variety of regimens. The COMPLETE registry is designed to better understand
PTCL patient characteristics, treatments, and outcomes to help design and understand
future
clinical trials.
View Study Details
Connect® MDS/AML Disease Registry
The purpose of the Connect® MDS/AML Disease Registry is to provide unique insights
into
treatment regimens and sequencing of these regimens as they relate to clinical outcomes
of
patients with newly diagnosed MDS, ICUS or AML in routine clinical practice and evaluate
molecular and cellular markers that may provide further prognostic classification
and/or
might be predictive of therapy outcomes.
View Study Details
Cooperative Huntington's Observational Research Trial
The purpose of this study is to collect prospective data from individuals who are
part of a
Huntington Disease (HD) family, in order to relate phenotypes between individuals
and
families with each other and genetic factors in order to learn more about HD, develop
potential treatments for HD, and to plan for future research studies of experimental
drugs
aimed at slowing or postponing the onset and progression of HD.
View Study Details
Corticosteroids + Bevacizumab vs. Corticosteroids + Placebo (BEST) for Radionecrosis
After Radiosurgery for Brain Metastases
This randomized phase II study aims to investigate whether the addition of bevacizumab
to
standard corticosteroid therapy results in greater improvement in symptoms and less
treatment-induced symptoms compared with standard corticosteroid therapy for patients
with
symptomatic brain radionecrosis following radiosurgery. It is hypothesized that the
addition
of bevacizumab to standard care corticosteroids will reduce treatment-induced toxicities
and
improve neurologic impairments in patients with brain radionecrosis following radiosurgery
for brain metastases.
View Study Details
Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That
Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)
This randomized phase III trial studies how well crizotinib works in treating patients
with
stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has
a mutation
in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK
can make
it very active and important for tumor cell growth and progression. Crizotinib may
stop the
growth of tumor cells by blocking the ALK protein from working. Crizotinib may be
an
effective treatment for patients with non-small cell lung cancer and an ALK fusion
mutation.
View Study Details
Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period
will
have improved neurocognitive outcome at 22-26 months compared to placebo
View Study Details
Deaf Weight Wise 2.0: A Healthy Lifestyle Intervention With Deaf Adults Who Are Overweight
or Obese
The purpose of the Deaf Weight Wise 2.0 (DWW 2.0) study is to test an evidence-based,
comprehensive program to modify obesity-related health behaviors with Deaf people
ages 21 to
70 who use American Sign Language (ASL) as their primary language. Participants will
be
randomized to one of four arms: immediate intervention vs. intervention delayed one
year, and
in-person group intervention vs. individual intervention delivered via videophone.
The
investigators' primary hypothesis is that participants in the immediate DWW 2.0 intervention
will increase their physical activity and reduce their caloric intake and body weight
compared with those in the delayed intervention group (no intervention yet).
View Study Details
Development of allergies in babies
Lead Researcher: Kirsi Jarvinen-seppo
The purpose of this study is to determine the impact of breast milk immune factors
on allergy risk. The immune system protects us from getting diseases, working throughout
the body, including secretions such as saliva and breast milk and in the normal bacteria
in the stomach and intestines. A baby's immune system develops over time and maybe
impacted by the breast milk they consume. By comparing saliva, breast milk (if applicable)and
stool, we can study differences among a group of infants at higher risk of developing
allergies.
View Study Details
Developmental Impact of NICU Exposures (DINE)
The DINE study will test the hypothesis that potentially avoidable NICU-based exposures
contribute to the neuro-cognitive and somatic impairments prevalent among NICU graduates.
This hypothesis is drawn from the documented impact of phthalate exposure on early
development in term-born children, and the acknowledged presence of these toxic chemicals
in
the NICU. Third trimester in utero exposure to phthalates have been linked to poorer
childhood performance in cognition, motor function, attention, hyperactivity and social
behavior. Phthalate exposure is also associated with altered onset of puberty and
asthma. The
multi-site cohort and approach will clarify the role of NICU-based phthalate exposure
on
high-prevalence clinical outcomes.
View Study Details
DISCO-MS
Lead Researcher: Andrew Goodman
Natural history research in Multiple Sclerosis (MS) suggests that risk of relapses
and new Magnetic Resonance Imaging (MRI) changes diminish significantly as people
age, especially in MS patients 55 or older. Thus, the need to continue MS medicines
that reduce relapses and new MRI lesions may also decrease as people age, especially
in those who have not had relapses or MRI scan changes for prolonged times. This study
plans to learn more about the safety of stopping MS medication in this population,
as compared to continuing on the medication.
View Study Details
Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age
22-26
months of donor human milk as compared to preterm infant formula as the in-hospital
diet for
infants whose mothers choose not to provide breast milk or are able to provide only
a minimal
amount. Infants will be randomized to receive donor breast milk or formula during
their
hospital stay. Infant's will be followed until they reach 22-26 months of age.
View Study Details
Dupilumab Study
Lead Researcher: Lisa Beck
Our researchers are studying a new medication called dupilumab to determine how it
affects the immune system, water loss in the skin, and the amount of bacteria in the
skin of adults with atopic dermatitis (eczema).The Food and Drug Administration recently
approved dupilumab for the treatment of moderate-to-severe atopic dermatitis.
You will be randomized (like flipping a coin) with a 66% chance of receiving dupilumab
and 33% chance of receiving placebo for 6 weeks. After 6 weeks everyone will receive
10 weeks of dupilumab. Your skin will be checked for bacteria and barrier function
and your immune system will be monitored.
View Study Details
Effect of MD1003 in Progressive Multiple Sclerosis (SPI2)
The purpose of this study is to demonstrate the superiority of MD1003 over placebo
in the
disability of patients suffering from progressive multiple sclerosis and especially
those
with gait impairment.
View Study Details
Effect of Testosterone Treatment on Embryo Quality
The purpose of this study is to determine the effect of treatment with trans-dermal
testosterone cream compared to placebo on measures of ovarian reserve, oocyte and
embryo
quality, and pregnancy rates among women with evidence of diminished ovarian reserve
that
have persistently low serum testosterone and free testosterone after completing six
previous
weeks of DHEA supplementation.
View Study Details
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy
and Heart Failure After Cancer Treatment
This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers
associated
with cardiomyopathy and heart failure after cancer treatment. Studying samples of
blood in
the laboratory from patients receiving dexrazoxane hydrochloride may help doctors
learn more
about the effects of dexrazoxane hydrochloride on cells. It may also help doctors
understand
how well patients respond to treatment.
View Study Details
Effects of High Dose Calcitriol in Breast Cancer Patients
This research will examine the effectiveness of calcitriol in treating bone loss in
women who
are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected
to
take part in this study. The investigators don't know if bone loss in breast cancer
survivors
should be treated differently than bone loss in other women.
View Study Details
Efficacy and Safety Study as Monotherapy of SA237 to Treat NMO and NMOSD
The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,
pharmacokinetic and immunogenic profiles of SA237 in patients with NMO and NMOSD
View Study Details
Efficacy of Isradipine in Early Parkinson Disease
The purpose of the study is to determine whether treatment with isradipine is effective
in
slowing the progression of Parkinson disease disability.
View Study Details
Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients
With Dementia of the Alzheimer's Type
Participants with agitation secondary to dementia of the Alzheimer's type. The diagnosis
of
probable Alzheimer's disease (AD) will be based on the "2011 Diagnostic Guidelines
for
Alzheimer's Disease" issued by the National Institute on Aging (NIA)-Alzheimer's Association
(AA) workgroups.
View Study Details
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH
Cirrhosis
Lead Researcher: Chelsea DiBella
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate
the
safety and efficacy of emricasan in improving event-free survival based on a composite
clinical endpoint (where all-cause mortality, new decompensation events, and MELD
score
progression are events) in subjects with decompensated NASH cirrhosis.
View Study Details
Endometrial Cancer: Lenvatinib in Combination With Pembrolizumab Versus Treatment
of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309
Per Merck Standard Convention [KEYNOTE-775])
Lead Researcher: Richard Moore
If you decide to participate in this study, you will be assigned by chance to get
either lenvatinib plus pembrolizumab or doxorubicin or paclitaxel. You will know what
treatment you will be assigned to receive.
View Study Details
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations
(A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well ensartinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1
genomic
alterations that have come back or do not respond to treatment and have spread to
other
places in the body. Ensartinib may stop the growth of tumor cells by blocking some
of the
enzymes needed for cell growth.
View Study Details
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH
Treatment Trial)
This phase II Pediatric MATCH trial studies how well erdafitinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have spread
to other
places in the body and have come back or do not respond to treatment with FGFR mutations.
Erdafitinib may stop the growth of cancer cells by blocking some of the enzymes needed
for
cell growth.
View Study Details
Erlotinib Hydrochloride in Treating Patients With Stage IB-IIIA Non-small Cell Lung
Cancer That Has Been Completely Removed by Surgery (An ALCHEMIST Treatment Trial)
This phase III ALCHEMIST trial studies how well erlotinib hydrochloride compared to
observation works in treating patients with stage IB-IIIA non-small cell lung cancer
that has
been completely removed by surgery. Erlotinib hydrochloride may stop the growth of
tumor
cells by blocking some of the enzymes needed for cell growth.
View Study Details
Esophageal Cancer: Study of changes in DNA found in the blood in patients with advanced
cancer of the esophagus
Lead Researcher: Mohamedtaki Tejani
For cancer patients on treatment, CT scans are used to check whether the cancer is
responding
to chemotherapy. These are usually performed after several weeks of therapy. We are
currently conducting a study to evaluate whether it is feasible to use blood samples
to
determine whether treatment is working. This study involves serial blood draws which
will be
used to study various markers that may help predict response to treatment.
View Study Details
Essential Thrombocythemia: Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects
With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
Lead Researcher: Frank Akwaa
This study has two groups. The first group, Group A, will be treated with ruxolitinib
and placebo and the second group, Group B, will be treated with anagrelide and placebo.
You will be randomly assigned (like flipping a coin) to Group A or Group B. Neither
you nor your Study Doctor can identify which group you will be assigned to. You will
have equal chance of receiving ruxolitinib or anagrelide.
View Study Details
Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine
in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA
or MVA/MVA Regimens in HVTN 205
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity
of the
AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults
who
previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN
205 study.
View Study Details
Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of
HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men
This study will evaluate the safety and efficacy of the human monoclonal antibody
(mAb)
VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender
(TG)
persons who have sex with men, in North America, South America, and Switzerland.
View Study Details
Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted
Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants
A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV
(vCP2438)
and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected
adult
participants
View Study Details
Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted
Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults
This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine
used in
combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent
Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.
View Study Details
Evaluating the Use of Oseltamivir for the Treatment of Influenza in Adults
People who are infected with the influenza virus may develop respiratory illnesses,
such as
pneumonia, or other life-threatening complications. Currently, there are four antiviral
medications that are used to treat influenza. This study will examine one of these
medications, oseltamivir, to examine how it affects the shedding of influenza virus
in
infected people.
View Study Details
Evaluating URMC's Massive Transfusion Protocol
Lead Researcher: Majed Refaai
The purpose of the study is to evaluate the efficacy of the University of Rochester
Medical
Center's current Massive Transfusion Protocol.
Upon arrival of trauma level one designated patients the treating team evaluates the
patient's injuries. If the patient is initiated under the facilities Massive Transfusion
Protocol and meets other inclusion and exclusion criteria the patient will be enrolled
in the
study. Study procedures include collection of a blood sample following the transfusion
of
each shipment, through shipment 5, of blood products outlined in the current Massive
Transfusion Protocol.
Each blood sample will be run on a Thromboelastograph to evaluate the patient's hematostatic
state through resuscitation. One final blood sample will be collected 24 hours following
the
discontinuation of the Massive Transfusion Protocol and also ran on the thromboelastograph.
Due to the critical need for medical intervention, consent procedure will be waived
at time
of enrollment. An authorized representative for the patient will be identified and
approached
to obtain consent for use of data collected.
View Study Details
Evaluation of age, flu exposure, and vaccination for flu on the memory (B cell) cells
of the human immune system.
Lead Researcher: Angela Branche
This study is looking at different effects of flu and vaccination upon the B cells.
View Study Details
Evaluation of Multiple Protein and Molecular Biomarkers to Estimate Risk of Cancer
in Gynecology Patients Presenting With a Pelvic Mass.
ANGLE has developed the Parsortix™ Cell Separation System (Parsortix), an automated
system
capable of harvesting rare circulating cells for analysis from a sample of peripheral
blood
based on cellular size and deformability. In a small pilot study, scientists at the
Medical
University of Vienna demonstrated that measurement of a combination of mRNA markers
extracted
from CTCs captured using the Parsortix system could be used to identify women with
ovarian
cancer. This study is designed to provide specimens for optimization of an assay using
clinical and biomarker information (i.e. demographics, imaging results and/or serum
tumor
markers) in combination with mRNA extracted from rare cells in the blood of women
presenting
with a pelvic mass for the detection of malignancy.
Primary Objective: Optimization of an assay/algorithm for the differentiation of women
with
benign pelvic masses from those with malignant pelvic masses using clinical and biomarker
information (i.e. demographics, imaging results and/or serum tumor markers) in combination
with mRNA markers extracted from rare cells isolated from whole blood. Multiple serum
protein
markers and mRNA markers will be measured, and the results will be compared to the
actual
clinical diagnosis made for each subject through other recognized methods (i.e.
histopathology). Statistical modeling will be used to combine the clinical information,
serum
protein markers and/or mRNA markers for estimation of the risk of malignancy. If successful,
the resulting risk algorithm will be evaluated in future, appropriately powered, prospective
studies.
Exploratory Objective: Use statistical modeling to determine the need for and/or preliminary
design of a mathematical algorithm to combine the clinical information, serum protein
markers
and/or mRNA markers for estimation of the risk of malignancy.
View Study Details
Evaluation of the Effects of Age, Prior Exposure, and Previous Vaccination on B Cell
Response to Influenza Vaccine in Healthy Adults and Children
Lead Researcher: Angela Branche
The study will be designed as a prospective surveillance of the immune response to
seasonal
influenza vaccination in 240 healthy children and adults ages 9 and over. Study duration
will
be 5 years, with a participant duration of 6 months. Subjects will receive Fluarix
(GSK)
quadrivalent inactivated influenza vaccine, at a dose of not less than 15 ug of hemagglutinin
(HA), by intramuscular injection in open label fashion on day 0. Blood draws will
occur at
baseline, day 7, 28 and 90. The primary objective of this study is to evaluate the
relationship between first influenza A virus exposure (inferred by age), vaccine history,
and
baseline serum antibody and Memory B cell (MBC) specificity, and the magnitude and
breadth of
the subsequent B cell response to seasonal influenza vaccine in healthy adults and
children.
View Study Details
Exercise and Low-Dose Ibuprofen for Cognitive Impairment in Colorectal Cancer Patients
Receiving Chemotherapy
This randomized phase II trial studies how well exercise and low-dose ibuprofen in
improving
cognitive impairment in patients with colorectal cancer that has not spread to other
places
in the body who are receiving chemotherapy. Anti-inflammatory agents, such as ibuprofen,
may
slow the decline of cognitive processes and diseases involving the brain. Exercise
may also
help alleviating cognitive difficulties during chemotherapy.
View Study Details
Exercise for Breast Cancer Patients (EXCAP)
The purpose of this study is to examine if exercise helps improve cancer-related fatigue.
Hypothesis: A structured home-based walking and progressive resistance exercise program
will
be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic
deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine
profiles in breast cancer survivors as well as those receiving radiation treatment.
View Study Details
Exercise for Prostate Cancer Patients
The purpose of this study is to gain a better understanding of the mechanisms responsible
for
cancer-related fatigue.
View Study Details
Exercise Intervention for LGBT Cancer Survivors
Lead Researcher: Nicole Murray
The purpose of this study is to test preliminary efficacy, as well as acceptability
and
feasibility, of a dyadic exercise intervention, the current study will randomize LGBT
cancer
survivors and their non-professional caregivers as dyads to either an individual or
a dyadic
Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will
be
psychological distress. Analyses will involve pre-post comparisons of outcomes across
the
study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention
will
result in greater improvements in psychological distress than an individual intervention.
View Study Details
Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients
With Pulmonary Hypertension RANGER
This extended access study will assess the long-term safety and tolerability of bardoxolone
methyl in qualified patients with pulmonary hypertension (PH) who previously participated
in
controlled clinical studies with bardoxolone methyl.
View Study Details
Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
Multicenter, open-label, prospective treatment protocol that provides continued access
to
ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting
from
treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying
disease within their region.
View Study Details
Fatty Liver due to NASH and Obeticholic Acid (Trade name: Ocaliva)
Lead Researcher: Jonathan Huang
Study participation is expected to last between 5-7 years. Participants will be randomized
to take either 10mg, 25mg, or a placebo pill once daily of the study medication. A
liver tissue biopsy is required up to 4 times over the course of the study, and 15
ultrasounds of your belly. Fasting blood work and vital signs will be taken at each
clinic visit. Questionnaires and an EKG of your heart will be periodically done at
clinic visits. All study medication and protocol required procedures are covered by
the clinical trial sponsor.
View Study Details
Follow-up Visit of High Risk Infants
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in
which
surviving extremely low birth-weight infants born in participating network centers
receive
neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected
age
(Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data
regarding
pregnancy and neonatal outcome are collected prospectively. The goal is to identify
potential
maternal and neonatal risk factors that may affect infant neurodevelopment.
View Study Details
Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III
Breast Cancer Undergoing Surgery
The study is being conducted to determine whether neoadjuvant endocrine therapy with
fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole
when given before surgery to shrink the cancer and stop it from growing. Anastrozole
inhibits
tumor growth by reducing the levels of estrogen and has been approved by the Food
and Drug
Administration (FDA) of the United States for use after surgery for postmenopausal
women with
estrogen receptor positive breast cancer. It is also considered a standard of care
to give
anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits
tumor
cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not
approved
by the FDA for use in women with early stage breast cancer before or after surgery,
but is
approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive
breast
cancer that has spread to other parts of the body.
View Study Details
Gastric & Gastroesophageal Cancer: A Study of FPA144 Combined With Modified FOLFOX6
in Gastric/Gastroesophageal Cancer (FIGHT)
Lead Researcher: Mohamedtaki Tejani
This study consists of 2 phases. The first phase (Phase 1) of the study will be open
to patients who have gastrointestinal cancer and plan to receive a type of chemotherapy
treatment called mFOLFOX6. The second phase (Phase 3) will include patients who have
gastric or gastroesophageal cancer, whose physician plans to administer chemotherapy
(mFOLFOX6) as therapy, and have a tumor that is FGFR2b positive.
View Study Details
Gastric or Gastroesophageal Junction: Study of Pembrolizumab (MK-3475) Plus Chemotherapy
Versus Placebo Plus Chemotherapy in Participants With Gastric or Gastroesophageal
Junction (GEJ) Adenocarcinoma (MK-3475-585/KEYNOTE-585)
Lead Researcher: Mohamedtaki Tejani
If you decide to participate in this research study, your study doctor will assign
you to one of three chemotherapy treatments: XP (cisplatin and capecitabine), FP (cisplatin
and 5-FU) or FLOT (docetaxel, oxaliplatin, 5-FU and leucovorin). Once you are assigned
a chemotherapy treatment, you will be assigned by chance to receive either chemotherapy
+ pembrolizumab before and after surgery followed by pembrolizumab only or chemotherapy
+ placebo (look-alike with no active ingredients) before and after surgery followed
by placebo only. You may still be able to continue in the study if you are unable
to have or no longer need surgery. The study doctor will discuss this with you.
You will be assigned by chance to get either pembrolizumab or placebo (a look alike
with no active ingredients). You have a 1 in 2 chance of getting placebo only. Neither
you nor the study doctor will know if you are receiving pembrolizumab or placebo.
View Study Details
Gastrointestinal (pancreas) Cancer: Glufosfamide Versus 5-FU in Second Line Metastatic
Pancreatic Cancer
Lead Researcher: Marcus Noel
Glufosfamide is being compared against Fluorouracil (5-FU). Fluorouracil is approved
by the FDA for use in people with rectal cancer. 5-FU was the drug of choice for pancreatic
cancer before gemcitabine and is still used in multiple regimens such as folfox and
Folfirinox as part of standard of care.
The study drug is made of glucose (a sugar made by the body) and a substance which
damages or kills cancer cells. Cancer cells depend on sugar more than normal cells
do, so the cancer cells may take up more of the study drug than normal cells. This
may allow glufosfamide to attack the cancer cells without causing excessive damage
to the normal cells.
View Study Details
Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed by the
Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil
in Treating Patients With Pancreatic Cancer That Has Been Removed by Surgery
This randomized phase II-R/III trial studies gemcitabine hydrochloride with or without
erlotinib hydrochloride followed by the same chemotherapy regimen with or without
radiation
therapy and capecitabine or fluorouracil in treating patients with pancreatic cancer
that was
removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride,
capecitabine, and fluorouracil, work in different ways to stop the growth of tumor
cells,
either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking
some of the
enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill
tumor
cells. Giving chemotherapy together with or without erlotinib hydrochloride and/or
radiation
therapy after surgery may kill any tumor cells that remain after surgery. It is not
yet known
whether chemotherapy is more effective when given with or without erlotinib hydrochloride
and/or radiation therapy in treating pancreatic cancer.
View Study Details
GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to
Studies Based on Apolipoprotein E (APOE) Genotype
The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify
a large
group of people interested in participating in research studies or clinical trials
based in
part on their genetic background. This genetic information will be used to match interested
individuals to studies, providing a recruitment resource to the Alzheimer's scientific
community. Interested individuals should visit www.endALZnow.org/GeneMatch to join
the
GeneMatch program.
View Study Details
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial
Lead Researcher: Jacob Nadler
This is a large pragmatic multicenter trial comparing maintenance of general anesthesia
with
total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane,
or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.
View Study Details
Generic Database of Very Low Birth Weight Infants
The Generic Database (GDB) is a registry of very low birth weight infants born alive
in NICHD
Neonatal Research Network (NRN) centers. The GDB collects observational baseline data
on both
mothers and infants, and the therapies used and outcomes of the infants. The information
collected is not specific to a disease or treatment (i.e., it is "generic"). Data
are
analyzed to find associations and trends between baseline information, treatments,
and infant
outcome, and to develop future NRN trials.
View Study Details
Genetic Susceptibility Biomarkers in Children With Neuroblastoma (Also Known as Neuroblastoma
Epidemiology in North America [NENA])
This research trial studies the genes biomarkers in children with neuroblastoma. Studying
the
genes in a child's cancer cells may help doctors improve ways to diagnose and treat
children
with neuroblastoma.
View Study Details
Genetic Testing in Screening Patients With Stage IB-IIIA Non-Small Cell Lung Cancer
That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)
This phase III ALCHEMIST trial studies genetic testing in screening patients with
stage
IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying
the
genes in a patient's tumor cells may help doctors select the best treatment for patients
that
have certain genetic changes.
View Study Details
GvHD: A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment
of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH1)
Lead Researcher: Jane Liesveld
This is an open-label Study which means that both you and your Study Doctor will know
what Study Drug you are receiving. Eligible subjects will begin treatment at 5 mg
ruxolitinib twice daily. This may be increased to 10 mg twice daily after 3 days depending
on your blood tests.
View Study Details
Gynecologic (Cervical) Cancer: Chemotherapy and Pelvic Radiation Therapy With or Without
Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer
After Radical Hysterectomy
Lead Researcher: Richard Moore
The standard treatment for your type of cervical cancer is cisplatin
chemotherapy plus radiation. The study will determine whether adding chemotherapy
with
carboplatin and paclitaxel (experimental for your type of cervical cancer) to standard
radiation
and cisplatin chemotherapy improves survival without increasing side effects.
View Study Details
Gynecologic (cervical) cancer: Radiation Therapy With or Without Chemotherapy in Patients
With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery
Lead Researcher: Richard Moore
You will get either standard treatment with radiation therapy OR
standard treatment with radiation therapy with the addition of cisplatin chemotherapy.
View Study Details
Gynecologic (endometrial) cancer: Radiation Therapy With or Without Cisplatin in Treating
Patients With Recurrent Endometrial Cancer
Lead Researcher: Richard Moore
Radiation therapy is a cancer treatment that uses radiation beams from outside your
body, or radioactive seeds or pellets placed directly into the tissue to kill cancer
cells.
Radiation therapy alone has not been very effective in treating large tumors that
recur
(come back) in the pelvis, lymph nodes or vagina. Radiation therapy in combination
with weekly treatment with the chemotherapy drug cisplatin has been found to be very
effective in treating patients with advanced cervical cancers. Another purpose of
the
study is to evaluate the side effects of the combination of radiation therapy and
cisplatin.
View Study Details
Hairy Cell Leukemia: Quality of Life and Clinical Outcomes of Hairy Cell Leukemia
Patients: A Longitudinal Study
Lead Researcher: Clive Zent
If you decide to participate in this study, you will be asked to complete a quality
of life questionnaire every 6 months, either in clinic, online or in your home. This
survey will take approximately 45 minutes to 1 hour to complete.
View Study Details
HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's
Combo StEnt
This is a multi-center, single-blind, randomized, active-controlled, clinical trial
in
Percutaneous Coronary Intervention (PCI) subjects. Subjects will be randomized to
receive the
Combo stent as the investigational treatment arm or an Everolimus Eluting Stent (EES)
as the
active-control arm.
View Study Details
Head and Neck Cancer: Radiation Therapy With or Without Cisplatin in Treating Patients
With Stage III-IV Squamous Cell Carcinoma of the Head and Neck Who Have Undergone
Surgery
Lead Researcher: Ronald Maggiore
The purpose of this study is to compare two treatment approaches that are currently
used after surgery for head and neck cancer. One approach is to administer radiation
therapy alone. A second approach is to administer radiation therapy along with the
chemotherapy drug, cisplatin.
View Study Details
Head and Neck Cancer: Study of Pembrolizumab (MK-3475) or Placebo With Chemoradiation
in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-412/KEYNOTE-412)
Lead Researcher: Ronald Maggiore
You will be assigned to one of two possible study drug treatments: pembrolizumab or
placebo in addition to chemoradiation. you have a 1 in 2 chance of getting placebo,
neither you or your study doctor will know which of these you are receiving.
View Study Details
Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment
Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed
by Surgery
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally
as
effective as standard per daily radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial studies how well an accelerated course of
higher per
daily radiation therapy with concomitant boost works compared to standard per daily
radiation
therapy with a sequential boost in treating patients with early-stage breast cancer
that was
removed by surgery.
View Study Details
HOPE-Helping Older People Engage
Lead Researcher: Kimberly Van Orden
The purpose of this study is to compare two activities — reflecting on one’s past
(called “life review”) and volunteering in the community (“volunteering”). We are
interested in learning how these activities may improve social connectedness and well-being
among adults age 60 and older. Volunteering involves participate weekly in a flexible
volunteer program with Lifespan that involves a menu of options including helping
at senior centers, co-leading classes, mentoring/tutoring and many other options.
Life review involves participating in a one-year reminiscence program that is self-guided
and involves completing monthly exercises such as writing about one’s memories.
View Study Details
Hydrocortisone for BPD
The Hydrocortisone and Extubation study will test the safety and efficacy of a 10
day course
of hydrocortisone for infants who are less than 30 weeks estimated gestational age
and who
are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone
or
placebo. This study will determine if hydrocortisone improves infants'survival without
moderate or severe BPD and will be associated with improvement in survival without
moderate
or severe neurodevelopmental impairment at 22 - 26 months corrected age.
View Study Details
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
This randomized phase III trial studies how well imatinib mesylate and combination
chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome
positive
acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells
by
blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work
in
different ways to stop the growth of cancer cells, either by killing the cells, by
stopping
them from dividing, or by stopping them from spreading. Giving imatinib mesylate and
combination chemotherapy may work better in treating patients with Philadelphia chromosome
positive acute lymphoblastic leukemia.
View Study Details
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
Lead Researcher: Deepak Sahasrabudhe
Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma
View Study Details
Impact of Respiratory Pathogens in Infants
This clinical study will investigate the relationships between sequential respiratory
viral
infections, patterns of intestinal and respiratory bacterial colonization, and adaptive
cellular immune phenotypes which are associated with increased susceptibility to respiratory
infections and long term respiratory morbidity in preterm and full term infants. This
is a
prospective, cohort study, enrolling at a single center via two sites (URMC and
URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will
be
accomplished in approximately 15 - 36 months. The study will enroll 280 subjects,
150
pre-term and 130 full-term.
View Study Details
Improving Reproductive Fitness Through Pretreatment With Lifestyle Modification in
Obese Women With Unexplained Infertility
A two-arm, multicenter, prospective, randomized clinical trial of a lifestyle modification
program with tracked increased physical activity and weight loss (intensive) compared
to
recommendations to tracking of increased physical activity alone with weight maintenance
(standard) in women with obesity and unexplained infertility. This 16 week period
of
lifestyle modification will be followed by an open label empiric infertility treatment
regimen consisting of three cycles of ovarian stimulation with oral medication (clomiphene
citrate (CC)), triggering of ovulation with human chorionic gonadotropin (hCG) and
intrauterine insemination (IUI).
View Study Details
Improving Well-Being for Older Adult Family Dementia Caregivers
Lead Researcher: Kathi Heffner
The purpose of the study is to examine the effects of the Mindfulness-Based Stress
Reduction (MBSR) program and the Living Well (LW) for Dementia Caregivers program,
compared to any usual care, to see if the programs might be associated with better
immune function, physical and emotional health, and well-being.
This study is looking for individuals age 55 and up who are caring for a loved one
(such as a spouse, parent, close friend) who has dementia. Participation includes
attending a weekly small group meeting over eight weeks for one of two study programs
(determined randomly). Both programs address ways of improving physical and emotional
well-being in the context of dementia caregiving. These 8-week programs typically
begin in late August at Monroe Community Hospital.
View Study Details
Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer
Based on EBV DNA
There are two study questions we are asking in this randomized phase II/III trial
based on a
blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally
advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard
concurrent chemotherapy and radiation therapy. When this standard treatment is completed,
if
there is no detectable EBV DNA in their plasma, then patients are randomized to either
standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there
is still
detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin
and
fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses
high
energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin,
fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to
stop the
growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by
stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil
is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy
in
treating patients with nasopharyngeal cancer.
View Study Details
Influenza Immunity in Children
This study evaluates how different methods of early exposure to influenza (natural
infection,
live attenuated influenza vaccination, inactivated influenza vaccination) initially
stimulate
immunity and poise the immune system to respond to a future challenge with the inactivated
influenza vaccine.
View Study Details
Iron Status and Myelination in Premature Infants
Premature infants with iron deficiency if supplemented with more elemental iron than
the
routine 2mg/kg/day will have improved brain development.
View Study Details
Kidney Cancer: A Study of Atezolizumab as Adjuvant Therapy in Participants With Renal
Cell Carcinoma (RCC) at High Risk of Developing Metastasis Following Nephrectomy (IMmotion010)
Lead Researcher: Elizabeth Guancial
You will be randomly assigned to one of the following treatment groups: atezolizumab
or placebo. Neither you nor your study doctor may choose the group you will be in.
You will have a 50/50 chance of being placed in either group.
View Study Details
Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis
This trial will compare the effectiveness of two surgical procedures -laparotomy versus
drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal
perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed
with
NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized
to
receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free
survival at 18-22 months corrected age.
View Study Details
Larotrectinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With NTRK Fusions (A Pediatric MATCH
Treatment Trial)
This phase II Pediatric MATCH trial studies how well larotrectinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions
that have
spread to other places in the body and have come back or do not respond to treatment.
Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes
needed for
cell growth.
View Study Details
Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice
in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck
Standard Convention [KEYNOTE-775])
This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib
(E7080)
versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment
of
advanced endometrial cancer. Participants will be randomly assigned to receive either
pembrolizumab and lenvatinib or treatment of physician's choice. The primary study
hypothesis
is that pembrolizumab in combination with lenvatinib prolongs progression free survival
(PFS)
and overall survival (OS) when compared to treatment of physician's choice.
View Study Details
Leukemia (AML & MDS): Connect® MDS and AML: The Myelodysplastic Syndromes (MDS) and
Acute Myeloid Leukemia (AML) Disease Registry
Lead Researcher: Jason Mendler
This study is observational. An observational disease registry study means that only
information about your disease and medical treatment that your study doctor is already
prescribing as part of your standard medical care is collected. Standard medical care
is the treatment normally given for a certain condition or illness.
You will continue with your standard medical care and continue with any medicines
you are now taking, office visits and laboratory testing according to the normal routine
practices of your treating or study doctor(s). No additional medication, or payment
for medication, is provided as part of this study. There is no investigational drug
involved in this study. There will be no additional study visits, procedures, or
testing required for this study. We will only collect this information as it relates
to the standard medical care you are receiving. If you give your consent to participate
in this study, your study doctor will inform your treating doctor(s), if applicable,
that you are taking part in this study.
View Study Details
Leukemia (AML & MDS): Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine
and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid
Leukemia or High-Risk Myelodysplastic Syndrome
Lead Researcher: Kristen O'Dwyer
If you participate in this study you will randomly be assigned to one of the following
treatment groups; Group A: azacitidine alone, Group B: azacitidine and nivolumab,
or Group C: azacitidine and midostaurin. The cycles for all study groups will repeat
until your disease gets worse or you or your study doctor decide you should stop.
Each cycle is 28 days.
View Study Details
Leukemia (AML): An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional
Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an
Isocitrate Dehydrogenase 2 Mutation (IDHENTIFY)
Lead Researcher: Jason Mendler
Isocitrate dehydrogenase 2 (IDH2) is a type of protein involved in metabolism (the
process of providing your body’s cells with energy). In certain types of diseases
such as AML, an abnormal form of the IDH2 protein is present in the diseased cells.
When IDH2 is present in this form, it produced an excess amount of 2-hydroxyglutarate
(2-HG), which is a substance that is normally present at low levels in cells. When
2-HG is present in excessive amounts, it may keep cells from maturing into normal
functioning cells and may cause them to become diseased.
AG-221 is designed to only block the abnormal forms of the IDH2 protein and thus may
reduce 2-HG levels in diseased cells to normal levels. As AG-221 targets only the
abnormal IDH2 protein (rather than the normal form of this protein), you will need
to provide samples of bone marrow and peripheral blood for testing to see if your
diseased cells carry an abnormal IDH2 gene (a gene is a molecular part that deals
with heredity).
View Study Details
Leukemia (AML): Ivosidenib Expanded Access Program in Relapsed/Refractory AML With
an IDH1 Mutation
Lead Researcher: Jason Mendler
This is an expanded access program. The program is sponsored by the pharmaceutical
company named Agios Pharmaceuticals, Inc. (the "Sponsor"). The purpose of this EAP
is to provide access to ivosidenib to qualifying patients during the period of time
prior to the potential approval and commercial availability of ivosidenib.
View Study Details
Leukemia (AMS or MDS): A Biomarker-Directed Phase 2 Trial of SY-1425 in Patients With
Acute Myeloid Leukemia or Myelodysplastic Syndrome
Lead Researcher: Jane Liesveld
The study includes three different groups. Two of these groups will receive SY-1425
alone. The other group will receive SY-1425 along with another drug called azacitidine.
Your study doctor will discuss the study with you to determine which group you will
be assigned.
View Study Details
Leukemia (CLL) & Lymphoma: A Phase 1/2, Open Label, Multicenter Study to Assess the
Safety and Tolerability of Durvalumab (anti-PD-L1 Antibody) as Monotherapy and in
Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia
Lead Researcher: Carla Casulo
Durvalumab is an antibody (a protein that works with your immune system) that attaches
to a molecule known as “programmed-cell-death ligand 1” (PD-L1). Signals from PD-L1
help cancers avoid detection by the immune system. Durvalumab blocks these signals,
interfering with the cancer’s ability to escape the immune system.
View Study Details
Leukemia: A program for monitoring minimal residual disease following treatment of
patients with Acute Myeloid Leukemia or High Grade Myelodysplastic Syndrome.
Lead Researcher: Michael Becker
This study is being performed to develop better tests to determine the impact of the
therapy you are receiving for treatment of your AML or MDS and to determine if these
tests can identify those patients who are at a greater risk for having their disease
relapse. Following therapy, the majority of patients with AML and many patients with
MDS will achieve a remission that is defined by the lack of any evidence of the disease
when viewing bone marrow samples under a microscope. Despite the absence of disease
by this method, many patients in remission will still have what is referred to as
Minimal Residual Disease when more sensitive methods are applied. That is, even though
the disease cannot be seen by routine staining under the microscope, more sensitive
tests can detect its presence. The presence of Minimal Residual Disease following
therapy does not guarantee that the patient will experience a relapse. This is likely
a result of the failure of these techniques to examine those cells that are responsible
for disease relapse. Recent data suggests that in the majority of patients with AML
or MDS only a minor population of the malignant cells are capable of maintaining the
disease and are likely responsible for relapse following therapy. This minor population
of cells can be identified by the proteins they have on their surface. This study
tests the ability to identify Minimal Residual Disease following therapy by performing
special assays that specifically target this minor population of malignant cells.
View Study Details
Leukemia: Characterization of the bone marrow microenvironment in patients with myelodysplastic
syndrome (MDS)
Lead Researcher: Michael Becker
This study is being performed to begin to understand the interactions between MDS
tumor cells and the normal bone marrow supporting cells, termed the bone marrow microenvironment.
View Study Details
Leukemia: Phase I Testing the Addition of Inotuzumab Ozogamicin, to Usual Chemotherapy
in Relapsed and Refractory Acute Leukemia
Lead Researcher: Michael Becker
The purpose of this study is to test the safety of the experimental drug inotuzumab
ozogamicin at different doses to find out what effects, if any, it has on people.
The researchers also want to determine the effects, good and/or bad, of adding inotuzumab
ozogamicin to regular chemotherapy with cyclophosphamide, vincristine and prednisone
(CVP). While researchers hope that adding inotuzumab ozogamicin will be a better
treatment, there is no proof of this.
View Study Details
LifeVest Wearable Cardioverter Defibrillator WEARIT-III Registry
The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure
(including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed
ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry
is to
prospectively document the clinical course of high-risk cardiac patients with heart
failure
and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD),
such
as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator
(ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD),
heart
transplantation, and to assess the benefit of WCD in heart failure patients with ischemic
cardiomyopathy.
View Study Details
Liver Cirrhosis and Emricasan
Lead Researcher: Jonathan Huang
Study participation is about 2-2.5 years. Clinic visits happen once a month for the
first year, then every two months for the remainder of the study. Participants will
receive either 5mg or 25 mg of Emricasan or placebo pill, to be taken twice daily.
Procedures include one CT scan or MRI scan, and an ultrasound of your stomach required
at the start of the study. Blood draws and physical exams occur at each visit. Vital
signs, questionnaires, and a heart EKG to also be done periodically. All study visits
and study medication as required by the study are covered by the clinical trial sponsor.
View Study Details
Liver Cirrhosis and Selonsertib
Lead Researcher: Jonathan Huang
Participation is expected to last up to 5 years. Subjects will be randomized to take
either 6mg, 18mg, or placebo pills once daily of the study medication. A liver tissue
biopsy is required 3 times, an ultrasound of your belly is required 7 times throughout
the study, and blood work, vital signs, and EKG of the heart, and questionnaires will
also be taken/ performed at clinic visits. Study medication and protocol required
procedures are covered by the clinical trial sponsor.
View Study Details
Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment
of Agitation in Patients With Dementia of the Alzheimer's Type
This is an extension study of the Phase 3 Studies 15-AVP-786-301 and 15-AVP-786-302,
which
also allows participants from the Phase 2 Study 12-AVR-131 to be included.
View Study Details
Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group
Studies
This clinical trial keeps track of and collects follow-up information from patients
who are
currently enrolled on or have participated in a Children's Oncology Group study. Developing
a
way to keep track of patients who have participated in Children's Oncology Group studies
may
allow doctors learn more about the long-term effects of cancer treatment and help
them reduce
problems related to treatment and improve patient quality of life.
View Study Details
Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle
(VLP) Vaccine (NoV Vaccine) in Adults
The purpose of this study is to evaluate descriptively the long-term immunogenicity
of at
least 1 NoV vaccine administration.
View Study Details
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements
to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing
Colonopathy)
This is a long-term study in cystic fibrosis patients who are participating in the
Cystic
Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel
disorder
called fibrosing colonopathy (narrowing of the large intestine). Patients will be
followed at
their regular clinical care visits over a 10-year period and approached if they develop
symptoms of fibrosing colonopathy for collection and use of further detailed information.
View Study Details
Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis
This study is an open label, long-term extension study for subjects with moderate
to severe
ulcerative colitis designed to evaluate long term therapy of CP-690,550.
View Study Details
Longitudinal Evaluation of Amyloid Risk and Neurodegeneration - the LEARN Study
The LEARN study a multicenter, observational study will that will evaluate the rate
of
cognitive change in approximately 500 clinically normal older individuals who "screen-fail"
for the A4 trial on the basis of their screening PET imaging not demonstrating evidence
of
elevated amyloid accumulation (Aβ negative) but meet all other A4 study eligibility
criteria.
This study will leverage the A4 infrastructure and maximize the data acquired in screening
a
large number of well-characterized older adults for the A4 trial.
The LEARN observational cohort will provide a critical comparison group for the A4
placebo
arm, and future trials in preclinical AD. Although accumulating longitudinal data
suggest
that older individuals with elevated Aβ burden are at increased risk of cognitive
decline, it
is important to demonstrate a differential rate of clinical decline between Aβe ("Aβ
elevated") and Aβne ("Aβ not elevated") individuals on a standardized set of clinical
outcomes. Over 2000 well-characterized, highly motivated older volunteers will "screen
fail"
for the A4 trial. The LEARN study will follow 500 of these individuals, matched as
closely as
possible to the two treatment arms, in this observation cohort. The LEARN study may
selectively recruit from a specific range of SUVr that fall below the threshold for
"elevated
amyloid" in order to support analyses of the relationship of baseline SUVr to subsequent
cognitive change and amyloid accumulation. The observational cohort will be followed
for 168
weeks with identical clinical/cognitive testing performed every 24 weeks, running
parallel to
the A4 treatment study.
View Study Details
Lung Cancer (NSCLC): A Dose Escalation Study Of PF-06801591 In Melanoma, Head And
Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma
or Other Solid Tumors
Lead Researcher: Megan Baumgart
There are 2 parts to this study: dose escalation (Part 1) and dose expansion (Part
2). For Part 1, different doses and types of administration of PF-06801591 were tested
and the information gathered was used to determine the optimal dosing regimen for
further evaluation in Part 2. This study is currently open to Part 2; you will receive
the investigational drug, PF06801591 every 28 days.
View Study Details
Lung Cancer (NSCLC): A Study Of Lorlatinib Versus Crizotinib In First Line Treatment
Of Patients With ALK-Positive NSCLC
Lead Researcher: Megan Baumgart
If you participate in this research study, you will be assigned by chance (like flip
of a coin or drawing straws) to receive either lorlatinib alone (Group A) or crizotinib
alone (Group B). You will have a 50% (1 in 2) chance of receiving lorlatinib, and
a 50% (1 in 2) chance of receiving crizotinib. Neither you nor your doctor can choose
the group you will be in.
View Study Details
Lung Cancer (NSCLC): Expanded Access For Lorlatinib For Patients With Non Small Cell
Lung Cancer Carrying an ALK or ROS1 Rearrangement
Lead Researcher: Deborah Mulford
This is an expanded access program. The program is sponsored by the pharmaceutical
company named Pfizer, Inc. (the "Sponsor"). The purpose of this program is to allow
patients with advanced non-small cell lung cancer access to lorlatinib treatment and
to find out the good and bad effects of this drug.
View Study Details
Lung Cancer: "Lung-MAP" S1400 ~ Biomarker-Targeted Second-Line Therapy in Treating
Patients With Recurrent Stage IIIB-IV Squamous Cell Lung Cancer
Lead Researcher: Eric Kim
The purpose of this study screening step is to perform genetic tests on your tumor
sample for certain features that investigational targeted agents used in this study
are specifically designed to work against.
The purpose of the treatment part of this study is to compare the effects, good and
bad, of these investigational agents to the usual approach to treating your type of
cancer. It may be possible that you will not be able to participate in the treatment
part of this study. This could happen if it is unsafe for you to receive the investigational
treatment. You may also choose to not participate in the treatment portion of the
study. Before you decide to get treatment on the study, you will be given information
about the study treatment and you will be asked if you wish to continue on this research
study.
The study has two steps:
• The initial screening step where we will examine your tumor tissue, and
• The sub-study treatment step which will be discussed in a separate consent form.
There will be many sub-studies that are open for patients at a given time. The sub-study
that you will be offered will depend on a combination of the results of the testing
done on your tumor sample, and which sub-studies are available when you are ready
to get treatment on this study. The testing done on you tumor sample is examining
the presence or absence of certain biomarkers. These biomarkers are either changes
in genes or proteins in cancer cells that may be associated with cancer growth.
If your tumor has just one biomarker with a sub-study designed for that biomarker,
you will be assigned to that sub-study. If your tumor has multiple biomarkers with
sub-studies designed for them, you will be assigned to one of the related biomarker
sub-studies randomly (by chance).
Additionally, once you are assigned to a sub-study, a computer will assign you by
chance to one of the treatment groups in the sub-study. This is called “randomization.”
This is done by chance because no one knows if one treatment is better or worse than
the other. In each of the sub-studies an investigational treatment will be compared
to a standard treatment.
View Study Details
Lung Cancer: Afatinib Dimaleate With or Without Cetuximab in Treating Patients With
Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung
Cancer
Lead Researcher: Megan Baumgart
If you are in Group 1, you will receive the study drugs afatinib and cetuximab. The
combination of the two drugs is considered investigational. Once every two weeks
you will receive cetuximab which will be given into a vein. Before receiving cetuximab,
you will receive diphenhydramine hydrochloride (Benadryl) to help prevent a hypersensitivity
reaction. You will also take one afatinib tablet every day. Afatinib is to be taken
by mouth on an empty stomach (at least one hour before eating or two hours after a
meal). Every 28 days is considered a "cycle."
If you are in Group 2, you will receive afatinib alone. You will take one afatinib
tablet every day. Afatinib is to be taken by mouth on an empty stomach (at least
one hour before eating or two hours after a meal). Every 28 days is considered a
"cycle."
View Study Details
Lung Cancer: Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating
Patients With Extensive Stage Small Cell Lung Cancer
Lead Researcher: Megan Baumgart
If you decide to participate in this study you will be assigned to one of the two
treatment groups by chance. This is done by chance because no one knows if one study
group is better or worse than the other. Group 1 will receive the study drug nivolumab
in combination with the usual chemotherapy regimen of platinum (cisplatin or carboplatin)
and etoposide administered by an intravenous (IV) infusion. Group 2 will receive the
usual chemotherapy alone administered by an intravenous (IV) infusion.
View Study Details
Lung Cancer: VX15/2503 in Combination With Avelumab in Advanced Non-small Cell Lung
Cancer (CLASSICAL-Lung)
Lead Researcher: Megan Baumgart
There are 2 phases in this study. If you are in the dose finding phase of the study,
the dose level of VX15/2503 that you receive is depends on when you enter the study.
The first group of subjects in this study will get a low dose of VX15/2503. If that
dose is well tolerated by those subjects, then the next group of subjects will get
a higher dose of VX15/2503. This will continue until the highest tolerable, safe dose
of VX15/2503 is reached. The dose expansion phase will begin begin after the highest
tolerable dose, or recommended phase 2 dosage (dose to be tested in expansion), has
been identified in the dose finding phase of the trial.
View Study Details
Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent
Stage IV Squamous Cell Lung Cancer
This phase II/III trial studies how well FGFR inhibitor AZD4547 (AZD4547) works in
treating
patients with stage IV squamous cell lung cancer that has come back after previous
treatment.
This is a sub-study that includes all screened patients positive for the fibroblast
growth
factor receptor (FGFR) biomarker. FGFR can cause tumor cells to grow more quickly.
AZD4547
may decrease the activity of FGFR and may be able to shrink tumors.
View Study Details
Lung-MAP: Durvalumab as Second-Line Therapy in Treating Patients With Recurrent Stage
IV Squamous Cell Lung Cancer and No Matching Biomarkers
This phase II trial studies how well durvalumab works in treating patients with stage
IV
squamous cell lung cancer that has come back after previous treatment. This is a "non-match"
sub-study that includes all screened patients not eligible for a biomarker-driven
sub-study.
Monoclonal antibodies, such as durvalumab, may be able to shrink tumors. Durvalumab
may be
effective in treating patients with squamous cell lung cancer.
View Study Details
Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating
Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers
This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone
in
treating patients with stage IV squamous cell lung cancer that has come back after
previous
treatment. This is a "non-match" sub-study that includes all screened patients not
eligible
for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab,
may be able to shrink tumors. It is not yet known whether nivolumab works better with
or
without ipilimumab in treating patients with squamous cell lung cancer.
View Study Details
Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration
Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer
This phase II/III trial studies how well palbociclib works in treating cell cycle
gene
alteration positive patients with stage IV squamous cell lung cancer that has come
back after
previous treatment. This is a sub-study that includes all screened patients positive
for cell
cycle gene alterations which can cause tumor cells to grow more quickly. Palbociclib
may slow
cell cycle progression and may be able to shrink tumors.
View Study Details
Lung-MAP: Rilotumumab and Erlotinib Hydrochloride or Erlotinib Hydrochloride Alone
as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell
Lung Cancer and Positive Biomarker Matches
This randomized phase II/III compares rilotumumab when given together with erlotinib
hydrochloride against erlotinib hydrochloride alone in treating patients with stage
IV
squamous cell lung cancer that has come back after previous treatment. This is a sub-study
that includes all screened patients positive for the met proto-oncogene (MET)/hepatocyte
growth factor (HGF) biomarker. HGF can interact with MET and can cause tumor cells
to grow
more quickly. Rilotumumab may decrease the activity of HGF and may be able to shrink
tumors.
Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the
enzymes
needed for cell growth. It is not yet known whether giving rilotumumab with erlotinib
hydrochloride works better than erlotinib hydrochloride alone (standard treatment)
in
treating squamous cell lung cancer.
View Study Details
Lung-MAP: Talazoparib in Treating Patients With HRRD Positive Recurrent Stage IV Squamous
Cell Lung Cancer
This phase II trial studies how well talazoparib works in treating patients with homologous
recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer
that has
come back after previous treatment. Talazoparib may stop the growth of tumor cells
by
blocking some of the enzymes needed for cell growth.
View Study Details
Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes
data in patients with hematological malignancies
Lead Researcher: Walter Burack
This research is being done because we hope that a better understanding of hematologic
malignancies will allow us to develop new and better treatments.
View Study Details
Lymphoma (Bone Marrow Transplant): Ibrutinib Before and After Stem Cell Transplant
in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Lead Researcher: Michael Becker
This study has two treatment groups: Group 1: For the first 6 days, you will get the
usual chemotherapy (BEAM or CBV), plus the study drug ibrutinib. Then, you will receive
ibrutinib for 12 months following AutoHCT. Group 2: For the first 6 days, you will
get the usual chemotherapy (BEAM or CBV), plus a placebo (a pill that looks like the
study drug but contains no medication). Then, you will receive a placebo for 12 months
following AutoHCT. However, if you were to progress or relapse while taking the placebo,
you would be offered treatment with the study drug, ibrutinib, at that time. The researchers
want to know if adding ibrutinib to the usual chemotherapy given with AutoHCT could
prevent your lymphoma from returning in the future. However, the addition of this
medication could also cause side effects that the researchers want to know about.
View Study Details
Lymphoma (Diffuse Large B Cell): A Study Evaluating the Efficacy of Axicabtagene Ciloleucel
Compared to Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse
Large B Cell Lymphoma (DLBCL) (ZUMA-7)
Lead Researcher: Patrick Reagan
If you decide to participate in this study, you will be randomized or assigned to
one of two study groups based on your previous response to therapy and the International
Prognostic Index score, a tool used to predict the likely course of your disease.
The Experimental Treatment Group will undergo collection of white blood cells by a
process called leukapheresis in order to manufacture your T cells into axi-cel, three
days of conditioning chemotherapy, and a single infusion of axi-cel. If your Study
Doctor believes the current status of your disease is rapidly progressing, you may
receive steroid therapy while axi-cel is being manufactured.
The Standard of Care (SOC) Treatment Group will receive standard of care therapies
including two or three cycles of second-line platinum-based combination chemotherapy
regimens with rituximab; R-ICE (Rituximab, Ifosfamide, Carboplatin, Etoposide), R-DHAP
(Rituximab, Dexamethasone, High-dose Cytarabine, Platinum) R-ESHAP (Rituximab, Etoposide,
Methylprednisolone, Cytarabine, Cisplatin) or R-GDP (Rituximab, Gemcitabine, Dexamethasone,
Platinum), as selected by your Study Doctor. If your cancer responds to the chemotherapy
treatment, you will also receive high dose therapy and ASCT per your Study Doctor.
View Study Details
Lymphoma (DLBCL): A Study Comparing the Efficacy & Safety of Polatuzumab Vedotin w/
Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone vs Rituximab-Cyclophosphamide,
Doxorubicin, Vincristine, & Prednisone in Diffuse Large B-Cell Lymphoma (POLARIX)
Lead Researcher: Patrick Reagan
If you decide to participate in this study you will be randomly assigned by a computer
program to one of the following treatment groups: polatuzumab vedotin and R-CHP with
placebo, or R-CHOP with placebo. Since the difference between the treatment groups
is polatuzumab vedotin in one group and vincristine (O) in the other, both groups
will receive a placebo, which is a substance that looks like either polatuzumab vedotin
or vincristine but contains no active medication. Neither you nor your study doctor
may choose the group that you will be in. You will have an equal chance of being placed
in either group. Neither you nor your study doctor will know which treatment you
receive.
View Study Details
Lymphoma (FL): Obinutuzumab With or Without PI3K-delta Inhibitor TGR-1202, Lenalidomide,
or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade
I-IIIa Follicular Lymphoma
Lead Researcher: Paul Barr
During the study, you will get either obinutuzumab plus TGR-1202, obinutuzumab plus
lenalidomide, or obinutuzumab plus the usual approach treatment for your cancer.
View Study Details
Lymphoma (Follicular Lymphoma (FL)): Pilot Study to Evaluate Circulating Tumor DNA
in Follicular Lymphoma
Lead Researcher: Paul Barr
If you are eligible and agree to participate in this research study the following
will occur:
Stored tumor tissue from a previous biopsy will be collected to look at genomic changes
in your tumor tissue.
Blood collection; about 4 teaspoons of blood will be collected up to 4 times during
your routine clinic visits to look at tumor genetic changes over time.
View Study Details
Lymphoma (iNHL): A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's
Lymphoma (ILyAD)
Lead Researcher: Jonathan Friedberg
If you decide and are eligible to take part in this study, in addition to the standard
treatment, rituximab, you will be randomized to receive an oral dose of either 2,000
IU vitamin D (also called cholecalciferol) supplementation or placebo. The randomization
will be 2:1. A 2:1 randomization means for every three people enrolled on the study,
two
people will receive vitamin D and one person will receive placebo. This study is conducted
in a double blind fashion, which means neither you nor your doctor will know which
treatment group you are in.
View Study Details
Lymphoma/Leukemia (CLL/SLL): A Study Comparing BGB-3111 With Bendamustine Plus Rituximab
in Patients With Previously Untreated CLL or SLL
Lead Researcher: Paul Barr
If you decide to participate in this study; as part of the screening tests for the
study, your blood will be tested to determine whether you have CLL/SLL that has a
mutation (a change) in one of the chromosomes called ‘17p deletion’.
If you have CLL/SLL that does not have the 17p deletion, you will be in Cohort 1 and
will be randomly assigned by a computer program to one of the following treatment
groups in Cohort 1: BGB-3111 or B+R. When you are “randomly assigned” it means you
are put into a group by chance, like flipping a coin. Neither you nor your study
doctor may choose the treatment you will take. You will have an equal chance of receiving
either treatment in Cohort 1.
If your CLL/SLL has the 17p deletion, you will be assigned to Cohort 2 and will receive
BGB-3111.
View Study Details
Lymphoma/Leukemia (CLL/SLL): Venetoclax in Combination With Ublituximab and Umbralisib
(TGR-1202) in Patients With Relapsed or Refractory CLL/SLL
Lead Researcher: Paul Barr
If you participate in this study, you will start treatment with 3 cycles (each cycle
is 28 days) of the combination of TG-1101 (ublituximab) and TGR-1202. After completing
those 3 cycles, you will be given 4 cycles of treatment with venetoclax and TGR-1202
at different doses to try to find the dose combination that may work the best. Depending
on how your disease responds to treatment, you may then also receive up to 5 cycles
of extended therapy with TGR-1202 alone.
View Study Details
Lymphoma: A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Oral eFT508 in
Subjects With Hematological Malignancies
Lead Researcher: Paul Barr
This research study has two parts. Part 1 will test the safety and tolerability of
the study drug at different doses and using different ways of taking the drug (powder
mixed with a liquid diluent [suspension] taken once per day or capsules taken once
or twice per day) to determine the recommended dose. Part 2 will test what effects
the study drug has on the cancer and the safety of the study drug when given at the
recommended dose.
View Study Details
Lymphoma: A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory
Mantle Cell Lymphoma (ZUMA-2)
Lead Researcher: Patrick Reagan
The sponsor is testing an experimental treatment named KTE-C19, which uses the patient’s
own genetically altered blood cells to treat cancer. KTE-C19 is made from blood cells
that are removed from the patient. A virus (retrovirus) is used to introduce a gene
that creates a protein (called a chimeric antigen receptor or CAR) on the surface
of T cells, a type of blood cell that fights infection and eliminates cancer cells.
The hope is that the CAR on the T cells will bind to and kill cells that express CD19,
a molecule that is found on B-cell lymphomas.
View Study Details
Lymphoma: Brentuximab vedotin and involved site radiotherapy in newly diagnosed, unfavorable
risk Hodgkin lymphoma.
Lead Researcher: Carla Casulo
Early stage, high risk HL has a chance of coming back after standard treatment. The
best treatment for early stage, high risk HL is chemotherapy followed by radiation.
The chemotherapy is called ABVD and has four drugs approved by the Food and Drug Administration
(FDA): doxorubicin, bleomycin, vinblastine, and dacarbazine. This is a pilot phase
II study of a new treatment plan for your HL. The treatment consists of a new drug,
brentuximab vedotin (BV), combined with adriamycin, vinblastine, and dacarbazine (AVD)
chemotherapy followed by radiation. The purpose of this study is to find out whether
BV with AVD chemotherapy and radiation is a safe and effective treatment. BV is a
type of drug called an antibody drug conjugate. BV has 2 parts; a part that targets
cancer cells (the antibody) and a cell killing part (the chemotherapy). The antibody
part of BV sticks to a target called CD30. CD30 is an important molecule on HL cancer
cells and some normal cells of the immune system. The cell killing part of BV is a
chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody
part of BV sticks to.
View Study Details
Macular Degeneration and Aging Study
The purpose of this randomized trial is to examine the effectiveness of a psycho-social
"Preventive Problem Solving Intervention" on emotional well-being, change in future
outlook,
and vision functioning in 250 Age-related Macular Degeneration patients 60 and older.
View Study Details
Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation
Therapy in Treating Patients With Newly Diagnosed Ependymoma
This partially randomized phase III trial is studying maintenance chemotherapy to
see how
well it works compared to observation following induction chemotherapy and radiation
therapy
in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy,
such
as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work
in
different ways to stop the growth of tumor cells, either by killing the cells, by
stopping
them from dividing, or by stopping them from spreading. Giving more than one drug
(combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy
x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose
of
radiation directly to the tumor may kill more tumor cells and cause less damage to
normal
tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow
doctors to save the part of the body where the cancer started.
View Study Details
Maintenance Chemotherapy With or Without Stereotactic Body Radiation Therapy in Treating
Patients With Stage IV Non-small Cell Lung Cancer
This randomized phase II/III trial studies how well giving maintenance chemotherapy
with or
without stereotactic body radiation therapy works in treating patients with stage
IV
non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel,
pemetrexed disodium, and gemcitabine work in different ways to stop the growth of
tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading. Stereotactic body radiation therapy is a specialized radiation therapy
that sends
x-rays directly to the tumor using smaller doses over several days and may cause less
damage
to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation
therapy
together may work better than maintenance chemotherapy alone in treating patients
with stage
IV non-small cell lung cancer.
View Study Details
Management of the PDA Trial
Estimate the risks and benefits of active treatment versus expectant management of
a
symptomatic patent ductus arteriosus (sPDA) in premature infants.
View Study Details
Measuring Surgical Recovery After Radical Cystectomy
The intent of this study is to establish a registry of post‐surgical outcomes in patients
undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating
institutions. The goals of this initiative are to obtain a detailed baseline of multiple
patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various
presenting conditions associated with them, so that future quality improvement interventions
can be evaluated accurately as to their relative contribution to improved outcomes.
View Study Details
Measuring the Peripheral Optical Quality of The Eye
The goal of the study is to quantify wavefront aberration profiles of the eye with
and
without contact lens across the visual field. This will enable us to investigate the
impact
of the aberration on retinal image quality.
View Study Details
Melanoma: Ipilimumab With or Without Nivolumab in Treating Patients With Melanoma
That Is Stage IV or Stage III and Cannot Be Removed by Surgery
Lead Researcher: Deepak Sahasrabudhe
If you decide to participate in this research study, you will be randomly assigned
to one of the treatment groups. This is done by chance, for every patient assigned
to group 1 (ipilimumab alone) the computer will assign 3 patients to group 2 (ipilimumab
and nivolumab). If you are assigned to group 1 (ipilimumab alone), you will receive
the study drug for 12 weeks. If you are assigned to group 2 (ipilimumab and nivolumab)
you will receive both ipilimumab and nivolumab for 12 weeks and then nivolumab alone
for as long as your cancer does not get worse, the side effects are tolerable, and
you agree to stay on study.
View Study Details
Memantine Hydrochloride and Whole-Brain Radiotherapy With or Without Hippocampal Avoidance
in Reducing Neurocognitive Decline in Patients With Brain Metastases
This randomized phase III trial compares memantine hydrochloride and whole-brain radiotherapy
with or without hippocampal avoidance in reducing neurocognitive decline in patients
with
cancer that has spread from the primary site (place where it started) to the brain.
Whole
brain radiotherapy (WBRT) is the most common treatment for brain metastasis. Unfortunately,
the majority of patients with brain metastases experience cognitive (such as learning
and
memory) deterioration after WBRT. Memantine hydrochloride may enhance cognitive function
by
binding to and inhibiting channels of receptors located in the central nervous system.
Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Using
radiation techniques, such as intensity modulated radiotherapy to avoid the hippocampal
region during WBRT, may reduce the radiation dose to the hippocampus and help limit
the
radiation-induced cognitive decline. It is not yet known whether giving memantine
hydrochloride and WBRT with or without hippocampal avoidance works better in reducing
neurocognitive decline in patients with brain metastases.
View Study Details
Metastatic Tumor Research and Outcomes Network
The registry aims to collect patient information such as patient demographics,
co-morbidities, clinical, diagnostic, and therapeutic data, as well as information
on adverse
events and HRQOL outcomes specific for patients with metastatic spine tumor(s).
View Study Details
Mild and Rapidly Improving Stroke Study
The objective of this study is to determine the 90-day outcomes of mild and rapidly
improving
ischemic stroke.
View Study Details
Milrinone in Congenital Diaphragmatic Hernia
Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia
and
persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory
failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant
to
conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased
pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction.
In patients with CDH, left ventricular dysfunction, either caused by right ventricular
overload or a relative underdevelopment of the left ventricle, is associated with
poor
prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic
contraction and diastolic relaxation respectively) with pulmonary vasodilator properties
and
has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used
during
the management of CDH although no randomized trials have been performed to test its
efficacy.
Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND)
and
22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone.
In the recently published VICI trial, 84% of patients with CDH received a vasoactive
medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis
of
CDH will be randomized to receive milrinone or placebo to establish safety of this
medication
in CDH and test its efficacy in improving oxygenation.
View Study Details
Min Implants Max Outcomes Clinical Trial
Objectives Primary objective: Determine if there is a clinically significant difference
in
percent Cobb curve correction in a low- vs. high-implant density cohort through a
prospective
randomized controlled trial.
Design and Outcomes Randomized clinical trial of equivalence to test the efficacy
and safety
of low vs. high implant density instrumentation for spine deformity surgery in AIS
patients
with Lenke IA curve patterns.
Interventions and Duration Intervention: low-implant density group or high-implant
density
group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years
old
with AIS who will undergo instrumented spinal fusion. Sample size needed (power =
90%) is 174
subjects with 87 in each group.
View Study Details
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
The objective of this study is to evaluate the effect of continuing treatment with
caffeine
citrate in the hospital and at home in moderately preterm infants with resolved apnea
of
prematurity on days of hospitalization after randomization.
View Study Details
MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
The purpose of this study is to test whether patients undergoing a breast MRI (magnetic
resonance imaging) before breast surgery will have better results after the surgery.
Breast
tumors are routinely evaluated using mammograms and ultrasound before surgery. This
study
would like to find out if using MRI in addition to mammography before surgery improves
our
ability to evaluate tumors and decide what kind of surgery is best for the patient.
View Study Details
MS PATHS Normative Sub-Study
The primary objective of this study is to determine the normative range of brain volume
and
brain volume change in healthy control (HC) participants whose age, race, and gender
distribution is approximately matched to the age, race, and gender distribution of
patients
with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is
to use
the results of the primary endpoint to ensure consistency of brain volume measurements
across
MS PATHS centers.
View Study Details
Multicenter Automatic Defibrillator Implantation Trial With Subcutaneous Implantable
Cardioverter Defibrillator
The MADIT S-ICD trial is designed to evaluate if subjects with a prior myocardial
infarction,
diabetes mellitus and a relatively preserved ejection fraction of 36-50% will have
a survival
benefit from receiving a subcutaneous implantable cardioverter defibrillator (S-ICD)
when
compared to those receiving conventional medical therapy.
View Study Details
Multiple Cancers: A Study Exploring the Safety and Efficacy of INCAGN01949 in Combination
With Immune Therapies in Advanced or Metastatic Malignancies
Lead Researcher: Marcus Noel
This study has 2 phases; depending on when you are enrolled into the study and what
type of cancer you have, you will participate in 1 of the 2 phases.
Phase 1 is the “Dose Escalation” portion of the Study. Certain dose levels of INCAGN01949,
when given together with nivolumab and/or ipilimumab, will be evaluated in small groups
of subjects (also called “cohorts”) with advanced or metastatic cervical cancer, uterine
cancer, stomach cancer, throat cancer, liver cancer, specific types of skin cancer,
a specific subtype of colon cancer, lung cancer, ovarian cancer, head and neck cancer,
kidney cancer, a certain type of breast cancer, and bladder and urinary tract cancer.
Subjects will be observed for a minimum of 28 days before the dose is increased for
the next cohort. Phase 1 subjects will enroll into 1 of 3 different Study Drug Combination
groups. Enrollment in this phase of the Study will continue until the highest dose
of INCAGN01949 that is safe and tolerated by most subjects is found.Some subjects
will be enrolled into safety expansion cohorts within Phase 1. These subjects will
receive the same combinations and doses given in the dose escalation part of the study,
however the administration of nivolumab and/or ipilimumab will begin after 2 cycles
of INCAGN01949 are given.
Phase 2 is the “Dose Expansion” portion of the Study. The dose of INCAGN01949 determined
to be safe during the Phase 1 (Dose Escalation) portion of the Study will be given
together with nivolumab and/or ipilimumab to subjects with kidney cancer or bladder
and urinary tract cancer in 1 of 6 different Study Drug Combination groups. The dose
of INCAGN01949 you receive in this Study will depend on the dose level being tested
at the time you are enrolled. The doses of nivolumab and ipilimumab administered to
you in this Study will not change.
View Study Details
Multiple Cancers: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Lead Researcher: Paul Barr
If you participate in this study you will receive the study drugs ipilimumab and
nivolumab. You will receive both study drugs through a vein on the first day of each
cycle (or every 6 weeks), and you will receive nivolumab through a vein every 2 weeks.
You will continue to receive study drugs until your disease gets worse or you experience
bad side effects from the study drugs or your study doctor decides that you are not
benefiting from the study drugs.
View Study Details
Multiple Cancers: Targeted Therapy Directed by Genetic Testing in Treating Patients
With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening
Trial)
Lead Researcher: Marcus Noel
If you decide to participate in this study, your tumor cells will be tested to find
out if they have a gene change or mutation targeted by one or more of the drugs used
in this study. If you have a gene change or mutation that matches a substudy, you
will be asked if you want to participate in a specific substudy.
View Study Details
Multiple Myeloma
Lead Researcher: Brea Lipe
The purpose of this study is to collect clinical data along with bone marrow aspirate
samples to see if there is a way to determine which patients are more or less likely
to experience disease progression. This study will involve identifying different
markers on the surfaces of the plasma cells and will look at protein expression.
We will then correlate those findings with data from your medical records over time.
If you decide to take part in this study, you will be asked to allow additional bone
marrow aspirate and blood samples to be collected for research at several time points.
These additional samples will be collected during routine testing time points as required
for your routine care. We will also collect information about your disease and treatment
from your medical record.
View Study Details
Multiple Myeloma or Lymphoma: Study of CLR 131 in Relapsed or Refractory Select B-Cell
Malignancies
Lead Researcher: Brea Lipe
This research is being done to help us determine if the study drug is safe and can
be tolerated for the treatment of multiple myeloma or certain lymphomas.
View Study Details
Multiple Myeloma: A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency
Lead Researcher: Brea Lipe
If you decide to participate in this study you will receive denosumab every 4 weeks
for a total of 12 cycles.
View Study Details
Multiple Myeloma: Selinexor and Backbone Treatments of Multiple Myeloma Patients (STOMP)
Lead Researcher: Brea Lipe
This is an open-label study, which means that both you and your study doctor will
know how much selinexor and the names of other medications you are taking. You, and
all other patients in this study, will take the study drug selinexor, plus dexamethasone
and either pomalidomide, bortezomib, lenalidomide, or daratumumab. The treatment period
consists of blocks of time called cycles. The number of treatment cycles you receive
will depend on how well you are doing on the treatment and how well your cancer responds
to it.
This study includes four different treatment combinations:
• Selinexor, dexamethasone and pomalidomide (abbreviated as SPd)
• Selinexor, dexamethasone and bortezomib (abbreviated as SVd)
• Selinexor, dexamethasone and lenalidomide (abbreviated as SRd)
• Selinexor, dexamethasone, daratumumab (abbreviated SDd)
View Study Details
Myelodysplastic Syndromes: A Safety and Efficacy Study of Pracinostat and Azacitidine
in Patients With High Risk Myelodysplastic Syndromes
Lead Researcher: Jason Mendler
In this research study, you will take either pracinostat or placebo 3 times a week
for 3 weeks in a row followed by 1 week of rest. All subjects will receive azacitidine.
View Study Details
Myocardial Ischemia and Transfusion
The purpose of this study is to compare two red blood cell transfusion strategies
(liberal
and restrictive) for patients who have had an acute myocardial infarction and are
anemic.
View Study Details
Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry
Myotonic dystrophy (DM) and facioscapulohumeral muscular dystrophy (FSHD) are inherited
disorders characterized by progressive muscle weakness and loss of muscle tissue.
The purpose
of this registry is to connect people with DM or FSHD with researchers studying these
diseases. The registry will offer individuals with DM and FSHD an opportunity to participate
in research that focuses of their diseases. The registry will also help scientists
to
accomplish research on DM and FSHD and to distribute their findings to patients and
care
providers.
View Study Details
NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic
Navigation Bronchoscopy™
The purpose of this study is to evaluate outcomes following electromagnetic navigation
bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.
View Study Details
Neuropsychological and Behavioral Testing in Younger Patients With Cancer
This research trial studies neuropsychological (learning, remembering or thinking)
and
behavioral testing in younger patients with cancer. Collecting information over time
from a
series of tests may help doctors develop effective tests to measure neuropsychological
and
behavioral function of patients with cancer.
View Study Details
Nivolumab After Surgery and Chemotherapy in Treating Patients With Stage IB-IIIA Non-small
Cell Lung Cancer (An ALCHEMIST Treatment Trial)
This phase III ALCHEMIST trial studies how well nivolumab after surgery and chemotherapy
work
in treating patients with stage IB-IIIA non-small cell lung cancer. Monoclonal antibodies,
such as nivolumab, may stimulate the immune system in different ways and kill tumor
cells
remaining after surgery and standard of care chemotherapy.
View Study Details
Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II
Meningioma That Has Been Completely Removed by Surgery
This randomized phase III trial studies how well radiation therapy works compared
with
observation in treating patients with newly diagnosed grade II meningioma that has
been
completely removed by surgery. Radiation therapy uses high energy x-rays to kill tumor
cells
and shrink tumors.
View Study Details
Ocaliva with Liver Cirrhosis
Lead Researcher: Jonathan Huang
Study participation is a minimum of 1 year, with up to 2 full years of participation
possible. Subjects will be randomized to take either 10mg or 25mg of Ocaliva or placebo
pill once daily. Subjects must come into the clinic for study related procedures a
minimum of 10 times. A liver biopsy is required.
View Study Details
Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin
Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric
MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well olaparib works in treating patients
with
solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic
acid (DNA) damage repair genes that have spread to other places in the body and have
come
back or do not respond to treatment. Olaparib may stop the growth of tumor cells by
blocking
some of the enzymes needed for cell growth.
View Study Details
Online Problem Solving Skills Training
Parents of children newly diagnosed with cancer experience depression and anxiety,
especially
in the first several months of treatment. Bright IDEAS, an 8-session problem-solving
skills
training (PSST) program has been used in studies with more than 900 mothers including
more
than 125 monolingual Spanish-speaking mothers. It has been shown to significantly
decrease
mothers' distress and to particularly benefit Latina immigrants. This past spring,
the
NCI/NIH designated Bright IDEAS as a Research-Tested Intervention Program and has
included it
in the National Registry of Evidence-based Programs and Practices. To date, Bright
IDEAS has
been available to mothers at only a few cancer centers with specially trained personnel.
This
proposal is designed to bring Bright IDEAS on-line to make it available to mothers
and
fathers 24/7 anywhere with Internet access. The investigators will carefully analyze
acceptability and use to gain insight into the most promising ways of disseminating
interventions like Bright IDEAS using Internet, Internet II, and other emerging technologies.
View Study Details
Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location
Lead Researcher: Lynda Kochman
This is a randomized controlled trial to compare three currently available management
strategies for women with a persisting pregnancy of unknown location (PPUL), which
makes them
at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a
confirmed
PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by
methotrexate (MTX) for some (those that have evidence of a non visualized ectopic
pregnancy)
2) Empiric treatment with MTX for all 3) Expectant management. Randomization will
be 1:1:1
into these three arms. After randomization, they will be followed and treated clinically
as
is indicated by the progression of their condition. Primary outcome measures: uneventful
decline of hCG to 5 IU/mL.
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Ovarian Cancer: A Study of Niraparib Maintenance Treatment in Patients With Advanced
Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Lead Researcher: Richard Moore
If you agree to be in this study, you will either take the Study Drug, niraparib,
capsules or placebo capsules by mouth once daily. You have a 2 in 3 chance of receiving
study drug. Neither you or your study doctor will know if you receive niraparib or
placebo.
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Ovarian Cancer: Pegylated Liposomal Doxorubicin Hydrochloride With Atezolizumab and/or
Bevacizumab in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary
Peritoneal Cancer
Lead Researcher: Richard Moore
This study has 3 study groups, a computer will assign you to a study group by chance.
There is an equal chance of receiving each treatment. This is done by chance, because
no one knows if one study group is better or worse than the others. Group 1 will get
an experimental chemotherapy treatment (liposomal doxorubicin and atezolizumab), group
2 will get an experimental chemotherapy treatment (liposomal doxorubicin and bevacizumab
plus atezolizumab), and group 3 will get a usual chemotherapy treatment for this type
of cancer (liposomal doxorubicin and bevacizumab). The liposomal doxorubicin will
be given into your vein over approximately 60 minutes. The bevacizumab will be given
into your vein over approximately 90 minutes initially, then faster at later visits
if administration goes smoothly at the slower rates. The atezolizumab will be given
into your vein over approximately 60 minutes initially, then faster at later visits
if administration goes smoothly at the slower rates. Treatment will be given on days
1 and 15 of each 28-day period. This period of time is called a cycle, which is a
regular schedule of treatment with periods of rest in between.
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Ovarian Cancer: Phase 2, A Study of Niraparib Combined With Bevacizumab Maintenance
Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line
Platinum-Based Chemotherapy
Lead Researcher: Richard Moore
It is not known how long your participation the study will last. You may receive Niraparib
for up to 3 years and Bevacizumab for up to 15 months. The number of months that you
receive bevacizumab on the study depends on how many months of bevacizumab you received
with chemotherapy before this study.
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Ovarian Cancer: Utilizing Human Ovarian, Fallopian and Primary Peritoneal Cancer Patient
Tissue to Identify Novel Therapies
Lead Researcher: Richard Moore
If you decide to take part in this study, you will be asked to donate tissue and ascites
(left over after the surgery), blood and clinical data. Our study team member will
first review your medical records to obtain information on your health status and
history. Then, when you go in for surgery, on the day of surgery less than 4 tablespoons
of blood and tissue samples and ascites fluid will be collected. You will be followed
for information about your health status and treatment for up to 10 years after your
surgery.
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Ovarian Ultrasound for Healthy Women and Women with Polycystic Ovary Syndrome
Lead Researcher: Kathleen Hoeger
This study aims to characterize the affect of age and weight on the size and shape
of ovaries. We will compare ovary size and shape in women of varying ages and body
sizes. You are eligible if you are female, age 18-45. We plan to recruit up to 120
women with regular menstrual cycles and up to 120 women with histories of Polycystic
Ovary Syndrome. This study is being conducted in collaboration with Dr. Lujan’s lab
at Cornell University.
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Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced
Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations
in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well palbociclib works in treating
patients
with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with
activating
alterations (mutations) in cell cycle genes that have spread to other places in the
body and
have come back or do not respond to treatment. Palbociclib may stop the growth of
cancer
cells by blocking some of the enzymes needed for cell growth.
View Study Details
Pancreatic Cancer: A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in
Adult Patients With Metastatic Pancreatic Adenocarcinoma (CanStem111P)
Lead Researcher: Marcus Noel
There will be two study groups: Group 1 (EXPERIMENTAL TREATMENT): Nab-Paclitaxel with
Gemcitabine plus BBI-608 and Group 2: (NON-EXPERIMENTAL TREATMENT): Nab-Paclitaxel
with Gemcitabine. Researchers are hoping to learn if patients will have a longer cancer
free survival when receiving a standard chemotherapy regimen with the study drug,
BBI-608 versus standard chemotherapy regimen alone.
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Pancreatic Cancer: PEGylated Recombinant Human Hyaluronidase in Combo With Nab-Paclitaxel
+ Gemcitabine VS. Placebo + Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High
Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma
Lead Researcher: Marcus Noel
PEGPH20 is an enzyme that breaks down a specific tissue component called hyaluronan
(HA) produced by some tumors. Currently PEGPH20 is experimental and is being tested
in patients with pancreatic and lung cancers.
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Paramedic Coached ED Care Transitions to Help Older Adults Maintain Their Health
The emergency department (ED) is a common source of acute illness care for older adults.
Many
older adults who are discharged home from the ED return within 30 days due to numerous
challenges faced during the ED-to-home transition. Unless programs to improve the
ED-to-home
transition are identified, the health and financial costs will only increase as the
older
adult population doubles by 2040. This study will apply Coleman's Care Transitions
Intervention to the ED-to-home transition by adapting the program to account for the
unique
aspects of the ED setting. The research will evaluate the process, ED use, and cost
outcomes
of a community-based, paramedic-coordinated Care Transitions Intervention. Upon completion,
this study will provide empiric evidence regarding this innovative approach to help
the
rapidly growing older adult population remain healthy and independent after an ED
visit.
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Peer Led Asthma Self Management for Adolescents: PLASMA
Asthma is a serious chronic health condition particularly in inner-city adolescents,
who
suffer disproportionately high asthma-related morbidity and mortality that place heavy
economic burdens on families and society. There is a consensus that adverse asthma
outcomes
can be ameliorated by an individual's active engagement in adequate self-management.
This
multi-site randomized controlled study proposes to implement and evaluate a peer-led
asthma
self-management for adolescents (PLASMA) program that has demonstrated its feasibility
and
preliminary efficacy in a previous study. PLASMA will be implemented in three cities
(Buffalo
NY, Baltimore MD, and Memphis TN) that have particularly high rates of pediatric asthma
and
asthma-related morbidity, and are thus most likely to benefit from the program. PLASMA
comprises three main components: (a) peer-leader training; (b) a one-day asthma camp
where
peer leaders will deliver manualized self-management content recommended by the national
guidelines; and (c) bi-monthly peer-leader contacts. Specific aims are: (1) to evaluate
the
effectiveness of PLASMA in inner-city adolescents with asthma in improving quality
of life
(primary outcome), and asthma knowledge, attitudes, outcome expectations, self-efficacy,
self-management skills, and asthma control, FEV1 (exploratory outcomes) over time,
compared
to a control group for whom adult leaders will deliver the same program content; (2)
to
examine the mediating effects of the exploratory outcomes on quality of life; (3)
to examine
the moderating effects of personal factors (e.g., age, sex, family support) on the
intervention's primary and exploratory outcomes; (4) to evaluate the effects of PLASMA
on
study outcomes in peer leaders (16-20 years); and (5) to determine the economic impact
of the
intervention. These aims will be accomplished using a two-group randomized controlled
trial
with 378 adolescents (12-17 years) from the three cities (126 for each site). A total
of 42
qualified peer leaders (14 in each site) will be enrolled based on adult nomination.
Eligibility criteria for both peer leaders and adolescent learners include: a current
asthma
diagnosis; persistent asthma; absence of other chronic or mental illness; inner-city
residence; and capability of verbal and written communication in English. Participants
will
provide data at enrollment (T1), camp (T2), and at 3-, 6-, 9-, 12-, and 15-months
post-camp
(T3-T7). Data will be analyzed using a multi-site hierarchical three-level linear
mixed-effects model where level 1 represents repeated measures, level 2 = subject,
and level
3 = site. To determine the economic impact of the program, investigator will measure
the
direct healthcare costs and total costs of the program, and perform net cost analyses
for
each type of costs. In addition, investigator will estimate cost-effectiveness ratios
of the
PLASMA group compared with the control.
View Study Details
Pevonedistat and Azacitidine in MDS or MDS/MPN Patients Who Fail Primary Therapy With
DNA Methyl Transferase Inhibitors
This study will evaluate the treatment combination of pevonedistat and azacitidine
in the
setting of DNA methyltransferase inhibitor(s) failure in patients with relapsed/refractory
myelodysplastic syndrome or myelodysplastic syndrome/myeloproliferative neoplasm.
View Study Details
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
To evaluate the safety and tolerability of BIIB092 in participants with mild cognitive
impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. To evaluate the
efficacy of
multiple doses of BIIB092 in slowing cognitive and functional impairment in participants
with
MCI due to AD or with mild AD. To evaluate the immunogenicity of BIIB092 after multiple
doses
in participants with MCI due to AD or with mild AD.
View Study Details
Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC PB1046
in Subjects With Symptomatic PAH
This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess
the
safety, tolerability, and efficacy of PB1046 at the optimally titrated dose after
16 weeks of
treatment. Subjects will be randomized in a 2:1 ratio to one of two parallel dose
groups: a)
high-dose group where PB1046 will be up-titrated from a 0.2 mg/kg minimally effective
starting dose to a target high dose level of at least 1.2 mg/kg or higher to a maximally
tolerated dose (MTD), or b) a low-dose group that will start at 0.2 mg/kg and remain
at this
minimally effective dose (MED) level with sham up-titration. The total treatment period
will
be comprised of 2 phases: 1) an initial 10 week dose titration phase in which weekly
doses of
PB1046 will be titrated (or sham titrated) up to a target dose level of at least 1.2
mg/kg or
higher to the MTD, and 2) a maintenance of treatment phase that begins when subjects
reach
week 11 and continues for 6 weeks during which no further up-titration should occur.
View Study Details
Phase 3 Alogliptin Pediatric Study
This study will evaluate the efficacy and safety of alogliptin 25 mg once daily (QD)
compared
to placebo when administered as monotherapy, or when added onto a background of metformin
alone, insulin alone, or a combination of metformin and insulin in pediatric participants
10
to 17 years of age with type 2 diabetes mellitus (T2DM).
View Study Details
Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of
BMN165 by Adults With PKU
The BMN 165 clinical development program has been designed to demonstrate the safety
and
efficacy of BMN 165 in reducing blood Phe concentrations in adults with PKU.
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Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary
Biliary Cholangitis
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related
liver
disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis
and
eventual cirrhosis requiring liver transplantation or resulting in death. The investigational
drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived
from the
primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA,
including
its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its
hepatoprotective effects and result in attenuation of injury and improved liver function
in a
cholestatic liver disease such as PBC. The study will assess the effect of OCA compared
to
placebo, combined with stable standard care, on clinical outcomes in PBC patients.
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Phase I/II NabPaclitaxel, Paclitaxel&Carboplatin w RTX Followed by Consolidation in
Patients w Favorable Prognosis Inoperable Stage IIIA/B NSCLC
The investigators propose this phase I/II study to use weekly Nab-Paclitaxel (Abraxane)
and
carboplatin with concurrent radiation in local-regionally advanced lung cancer. There
are no
published human studies combining Nab-Paclitaxel (Abraxane) with radiation. The investigators
will first confirm the tolerated dose (TD) of concurrent Nab-Paclitaxel (Abraxane)
at
50mg/m2, and then will begin enrolling patients into the phase II component using
either
Nab-Paclitaxel (Abraxane) at the TD with carboplatin concurrent with daily radiation
or
paclitaxel with with carboplatin concurrent with daily radiation.
View Study Details
PI3K/mTOR Inhibitor LY3023414 in Treating Patients With Relapsed or Refractory Advanced
Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With TSC or PI3K/MTOR
Mutations (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well PI3K/mTOR inhibitor LY3023414
works in
treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders
with TSC
or PI3K/MTOR mutations that have spread to other places in the body and have come
back or do
not respond to treatment. PI3K/mTOR inhibitor LY3023414 may stop the growth of cancer
cells
by blocking some of the enzymes needed for cell growth.
View Study Details
PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
The objective of this study is to evaluate the safety of long-term treatment with
Kuvan.
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Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of
whole body
hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present
at
<6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study
will
enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly
assign them to either receive hypothermia or participate in a non-cooled control group.
View Study Details
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without
Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled
study
of subjects receiving the HM II LVAD as per the current FDA approved indications for
use.
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Project: Every Child for Younger Patients With Cancer
This research trial studies the Project: Every Child for younger patients with cancer.
Gathering health information over time from younger patients with cancer may help
doctors
find better methods of treatment and on-going care.
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Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation
for Treatment of CLBP
Subjects will be randomized 1:1 Radio Frequency (RF) Ablation arm vs Control arm;
this is an
open-label trial. Subjects in the the RF Ablation arm will receive the Intracept System
procedure to treat up to 4 vertebral bodies (L3 to S1). Subjects in the Control arm
will
continue on non-surgical management therapies to treat their chronic low back pain
(CLBP) and
will be offered optional crossover after 12 months of follow-up.
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Prostate Cancer: A Study of Rucaparib in Patients With Metastatic Castration-resistant
Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)
Lead Researcher: Elizabeth Guancial
This research study is divided into three phases: Screening Phase is performed to
find out if you are eligible for the study. If you qualify, you will be enrolled into
the study and begin treatment. Treatment Phase (continuous dosing with rucaparib)
Follow-up Phase: Follow Up visit (28 days after your last dose of rucaparib) and long
term follow-up approximately every 12 weeks
View Study Details
Prostate Cancer: A Study of Rucaparib Verses Physician's Choice of Therapy in Patients
With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination
Gene Deficiency (TRITON3)
Lead Researcher: Elizabeth Guancial
If you participate in this study, you will be assigned at random to receive treatment
with either an experimental drug (called rucaparib) or one of the following comparator
treatments: abiraterone acetate, enzalutamide, or docetaxel. If you are assigned to
receive comparator treatment, your study doctor will help determine which one of the
three therapy options is most appropriate for you. Approximately two thirds of the
patients will be assigned to receive treatment with rucaparib and one-third will be
assigned to receive comparator treatment.
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Prostate Cancer: Cisplatin in Prostate Cancer
Lead Researcher: Deepak Sahasrabudhe
If you choose to participate in this study, you will receive cisplatin once per week
for 6 weeks and you will continue to receive leuprolide and enzalutamide. You will
also have blood samples collected at enrollment, 3 weeks, 5 weeks, and conclusion
of treatment for research purposes.
View Study Details
Prostate Cancer: ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration
Sensitive Prostate Cancer (ARASENS)
Lead Researcher: Elizabeth Guancial
You will be randomly assigned to a treatment group, Darolutamide (ODM-201) or placebo.
You will have a 1:1 chance of receiving Darolutamide (ODM-201) and a 1:1 chance of
receiving placebo.
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Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph
Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients
With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens
can cause
the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide,
and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens
made by
the body. It is not yet known which regimen of radiation therapy with or without
androgen-deprivation therapy is more effective for prostate cancer.
PURPOSE: This randomized phase III trial is studying prostate radiation therapy to
see how
well it works compared with short-term androgen deprivation therapy given together
with
pelvic lymph node radiation therapy with or without prostate radiation therapy in
treating
patients with a rising PSA after surgery for prostate cancer.
View Study Details
Radiation Therapy (WBI Versus PBI) in Treating Women Who Have Undergone Surgery For
Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
therapy in different ways may kill any tumor cells that remain after surgery. It is
not yet
known whether whole breast radiation therapy is more effective than partial breast
radiation
therapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying whole breast radiation therapy
to see
how well it works compared to partial breast radiation therapy in treating women who
have
undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
View Study Details
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously
Treated With Repeat Breast-Preserving Surgery
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
therapy after surgery kill any remaining tumor cells and may be an effective treatment
for
breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating
women
with locally recurrent breast cancer previously treated with repeat breast-conserving
surgery.
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Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung
Cancer Receiving Cisplatin and Etoposide
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth
of
tumor cells, either by killing the cells or by stopping them from dividing. It is
not yet
known which radiation therapy regimen is more effective when given together with chemotherapy
in treating patients with limited-stage small cell lung cancer. This randomized phase
III
trial is comparing different chest radiation therapy regimens to see how well they
work in
treating patients with limited-stage small cell lung cancer.
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Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal
Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink
tumors.
Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
growth of
tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal
antibodies, such as cetuximab, can block tumor growth in different ways. Some block
the
ability of tumor cells to grow and spread. Others find tumor cells and help kill them
or
carry tumor-killing substances to them. It is not yet known whether radiation therapy
is more
effective with cisplatin or cetuximab in treating oropharyngeal cancer.
PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab
to
see how well it works in treating patients with oropharyngeal cancer.
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Radiation Therapy With Cisplatin, Docetaxel, or Cetuximab After Surgery in Treating
Patients With Stage III-IV Squamous Cell Head and Neck Cancer
This randomized phase II/III trial studies how well radiation therapy works when given
together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery
in
treating patients with stage III-IV squamous cell head and neck cancer. Specialized
radiation
therapy that delivers a high dose of radiation directly to the tumor may kill more
tumor
cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as
cisplatin
and docetaxel, work in different ways to stop the growth of tumor cells, either by
killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab,
can
block tumor growth in different ways. Some block the ability of tumor cells to grow
and
spread. Others find tumor cells and help kill them or transmit tumor killing molecules
to
them. It is not yet known whether radiation therapy is more effective when given with
cisplatin, docetaxel, or cetuximab and docetaxel.
View Study Details
Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients
With Prostate Cancer
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation
to kill
tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells.
Androgen-deprivation therapy may lessen the amount of androgens made by the body.
It is not
yet known whether radiation therapy is more effective with or without androgen-deprivation
therapy in treating patients with prostate cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how
well it
works compared with radiation therapy given together with androgen-deprivation therapy
in
treating patients with prostate cancer.
View Study Details
Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone
Surgery for Locally Advanced Head and Neck Cancer
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor
to
help focus thin beams of radiation directly on the tumor, and giving radiation therapy
in
higher doses over a shorter period of time, may kill more tumor cells and have fewer
side
effects. Monoclonal antibodies, such as cetuximab, can block tumor growth in different
ways.
Some block the ability of tumor cells to grow and spread. Others find tumor cells
and help
kill them or carry tumor-killing substances to them. It is not yet known whether radiation
therapy is more effective when given alone or together with cetuximab in treating
patients
with head and neck cancer that has been removed by surgery.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how
well it
works compared with radiation therapy given together with cetuximab in treating patients
who
have undergone surgery for locally advanced head and neck cancer.
View Study Details
Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk
Malignant Salivary Gland Tumors That Have Been Removed By Surgery
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used
in
chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor
cells,
either by killing the cells or by stopping them from dividing. It is not yet known
whether
radiation therapy is more effective when given together with chemotherapy or alone
after
surgery in treating salivary gland tumors.
PURPOSE: This randomized phase II/III trial is studying radiation therapy with or
without
chemotherapy to see how well it works in treating patients with high-risk malignant
salivary
gland tumors that have been removed by surgery.
View Study Details
Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating
Patients With Esophageal Cancer
This randomized phase III trial studies how well radiation therapy, paclitaxel, and
carboplatin with or without trastuzumab work in treating patients with esophageal
cancer.
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy,
such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor
cells,
either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability
of
tumor cells to grow and spread. It is not yet known whether giving radiation therapy
and
combination chemotherapy together with or without trastuzumab is more effective in
treating
esophageal cancer.
View Study Details
Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF)
on
risk of clinically significant disease reactivation in quiescent SLE patients who
have been
on long-term MMF therapy.
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Rare Diseases Clinical Research Network: Neurophysiological Correlates
The overall purpose of this project is to advance understanding of the neurophysiological
features of Rett syndrome (RTT), MECP2 Duplication (MECP2 Dup) and RTT-related disorders
(CDKL5, FOXG1) to gain insight into disease pathogenesis, with an emphasis on identifying
biomarkers of disease evolution and severity. This specific study is intertwined to
the core
study Natural History of Rett Syndrome and Related Disorders (RTT5211), which characterizes
range of clinical involvement and genotype-phenotype correlations and will provide
phenotypical data for determining the clinical relevance of the neurophysiologic parameters;
study subjects here are co- and primarily enrolled in RTT5211. The proposed studies
will
serve as basis of future translational investigations, including further refinement
of
biomarkers, development of outcome measures, and clinical trials per se.
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Realm-Study of a topical gel for atopic dermatitis
Lead Researcher: Lisa Beck
This is a study to determine if the topical gel, PR022, is safe and effective for
treating eczema or atopic dermatitis. To be eligible you must be 18-65 years old
and have mild to moderate eczema. The study will take 8 weeks to complete with 7 visits
to the clinic. You will get 4 treatments with the gel.
View Study Details
Rectal Cancer: Phase II/III study of FOLFOX chemotherapy with or without radiation
treatment before surgery for locally advanced rectal cancer. (N1048)
Lead Researcher: Mohamedtaki Tejani
The standard treatment for locally advanced rectal cancer involves chemotherapy and
radiation, known as 5FUCMT, (the chemotherapy drugs, 5-fluorouracil/capecitabine and
radiation therapy) prior to surgery. This results in high rates of disease control
with significant side effects.
The purpose of this study is to compare the effects of the standard treatment of chemotherapy
and radiation to chemotherapy alone. The aim of this study is to determine if we
can reduce the side effects while still controlling the disease. The chemotherapy
alone is the combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU),
oxaliplatin and leucovorin). Depending on the response to FOLFOX you may also receive
the standard treatment 5FUCMT. The drugs used in this study are all FDA (Food and
Drug Administration) approved for the treatment of colorectal cancer. The use of FOLFOX
chemotherapy alone in place of 5FUCMT is experimental. In case FOLFOX chemotherapy
alone does not work, you will receive standard treatment which is 5FUCMT followed
by surgery.
View Study Details
Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients
With Newly Diagnosed WNT-Driven Medulloblastoma
This phase II trial studies how well reduced doses of radiation therapy to the brain
and
spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed
type of
brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using
chemotherapy and radiation therapy have been shown to be effective in treating patients
with
WNT-driven medulloblastoma. However, there is a concern about the late side effects
of
treatment, such as learning difficulties, lower amounts of hormones, or other problems
in
performing daily activities. Radiotherapy uses high-energy radiation from x-rays to
kill
cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine
sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth
of tumor
cells, either by killing the cells, by stopping them from dividing, or by stopping
them from
spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill
tumor
cells and may also reduce the late side effects of treatment.
View Study Details
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients
With Non-high Risk Neuroblastoma
This phase III trial studies how well response and biology-based risk factor-guided
therapy
works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor
may
not need treatment until it progresses. In this case, observation may be sufficient.
Measuring biomarkers in tumor cells may help plan when effective treatment is necessary
and
what the best treatment is. Response and biology-based risk factor-guided therapy
may be
effective in treating patients with non-high risk neuroblastoma and may help to avoid
some of
the risks and side effects related to standard treatment.
View Study Details
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or
Myelodysplastic Syndrome in Younger Patients With Down Syndrome
This phase III trial studies response-based chemotherapy in treating newly diagnosed
acute
myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome.
Drugs
used in chemotherapy work in different ways to stop the growth of cancer cells, either
by
killing the cells, by stopping them from dividing, or by stopping them from spreading.
Response-based chemotherapy separates patients into different risk groups and treats
them
according to how they respond to the first course of treatment (Induction I). Response-based
treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome
in
younger patients with Down syndrome while reducing the side effects.
View Study Details
Rheos HOPE4HF (Health Outcomes Prospective Evaluation for Heart Failure With Ejection
Fraction (EF) ≥ 40%) Trial
The purpose of the HOPE4HF trial is to demonstrate the safety and efficacy of the
Rheos
Baroreflex Activation Therapy System in subjects with heart failure with an EF ≥ 40%
in a
prospective, randomized trial.
View Study Details
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk
Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
This partially randomized phase III trial studies the side effects of different combinations
of risk-adapted chemotherapy regimens and how well they work in treating younger patients
with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic
lymphoma that is found only in the tissue or organ where it began (localized). Drugs
used in
chemotherapy work in different ways to stop the growth of cancer cells, either by
killing the
cells, by stopping them from dividing, or by stopping them from spreading. Giving
more than
one drug (combination chemotherapy), giving the drugs in different doses, and giving
the
drugs in different combinations may kill more cancer cells.
View Study Details
Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension
(SSc-PAH)
Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a serious,
life-threatening manifestation of systemic sclerosis (SSc), an autoimmune disease
of the
connective tissue characterized by scarring (fibrosis) and atrophy of the skin, joints
and
tendons, skeletal muscles, and internal organs, and immunological disturbances. One-year
survival for patients with SSc-PAH ranges from 50-81%. There is currently no cure
for SSc-PAH
and treatment is limited to vasodilator therapy used in all forms of PAH. In recent
studies,
immunotherapy was shown to be effective in treating SSc-interstitial lung disease,
another
serious, life-threatening manifestation of SSc. In addition, there are compelling
pre-clinical data and anecdotal clinical reports that suggest modulation of the immune
system
may be an effective strategy for treating SSc-PAH. To test this approach, this trial
will
determine if rituximab, an immunotherapy, has a marked beneficial effect on clinical
disease
progression, with minimal toxicity, in patients with SSc-PAH when compared to placebo.
View Study Details
S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed
Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells
from
dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells
and either
kill them or deliver radioactive tumor-killing substances to them without harming
normal
cells. It is not yet known which monoclonal antibody plus combination chemotherapy
regimen is
more effective in treating non-Hodgkin's lymphoma.
PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies
given
together with combination chemotherapy to see how well they work in treating patients
with
newly-diagnosed non-Hodgkin's lymphoma.
View Study Details
S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients
With Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and
paclitaxel,
use different ways to stop tumor cells from dividing so they stop growing or die.
Combining
more than one drug and giving them after surgery may kill any remaining tumor cells.
It is
not yet known which combination chemotherapy regimen is more effective in treating
resected
breast cancer.
PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination
chemotherapy to see how well they work in treating patients who have undergone surgery
for
stage I, stage II, or stage III breast cancer.
View Study Details
S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy
Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With
Stage I or Stage II Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine,
and prednisone, use different ways to stop cancer cells from dividing so they stop
growing or
die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal
antibodies,
such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and
either
kill them or deliver radioactive cancer-killing substances to them without harming
normal
cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy
may kill
more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy
together
with radiation therapy and monoclonal antibody therapy works in treating patients
with stage
I or stage II non-Hodgkin's lymphoma.
View Study Details
S0801 Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Previously
Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma
RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can
find
cancer cells and carry cancer-killing substances to them without harming normal cells.
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways.
Some
block the ability of cancer cells to grow and spread. Others find cancer cells and
help kill
them or carry cancer-killing substances to them. Drugs used in chemotherapy, such
as
cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways
to stop
the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving a radiolabeled monoclonal antibody together with rituximab and combination
chemotherapy may kill more cancer cells.
PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab
together with rituximab and combination chemotherapy and to see how well it works
in treating
patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin
lymphoma.
View Study Details
S0816 Fludeoxyglucose F 18-PET/CT Imaging and Combination Chemotherapy With or Without
Additional Chemotherapy and G-CSF in Treating Patients With Stage III or Stage IV
Hodgkin Lymphoma
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of
cancer
cells, either by killing the cells or by stopping them from dividing. Giving more
than one
drug (combination chemotherapy) may kill more cancer cells. G-CSF may help lessen
the side
effects in patients receiving chemotherapy. Imaging procedures, such as fludeoxyglucose
F
18-PET/CT imaging, may help doctors predict how patients will respond to treatment.
PURPOSE: This phase II trial is studying fludeoxyglucose F 18-PET/CT imaging to see
how well
it works in assessing response to combination chemotherapy and allow doctors to plan
better
additional further treatment in treating patients with stage III or stage IV Hodgkin
lymphoma.
View Study Details
S1011 Standard or Extended Pelvic Lymphadenectomy in Treating Patients Undergoing
Surgery for Invasive Bladder Cancer
RATIONALE: Lymphadenectomy may remove tumor cells that have spread to nearby lymph
nodes in
patients with invasive bladder cancer. It is not yet known whether extended pelvic
lymphadenectomy is more effective than standard pelvic lymphadenectomy during surgery.
PURPOSE: This randomized phase II trial is studying standard pelvic lymphadenectomy
to see
how well it works compared to extended pelvic lymphadenectomy in treating patients
undergoing
surgery for invasive bladder cancer.
View Study Details
S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone
Initial Hormone Therapy
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs,
such
as abiraterone acetate, may lessen the amount of androgens made by the body. It may
also stop
the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well abiraterone
acetate
works in treating patients with prostate cancer who have undergone initial hormone
therapy.
View Study Details
S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed
by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With
Previously Untreated Mantle Cell Lymphoma
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
ways. Some find cancer cells and help kill them or carry cancer-killing substances
to them.
Others interfere with the ability of cancer cells to grow and spread. Drugs used in
chemotherapy also work in different ways to kill more cancer cells or stop them from
growing.
It is not yet known whether rituximab is more effective with combination chemotherapy
or
bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing
peripheral blood stem cell transplantation.
PURPOSE: This randomized phase II trial studies how well giving rituximab together
with
combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy
and peripheral blood stem cell transplantation works in treating older patients with
previously untreated mantle cell lymphoma.
View Study Details
S1400B Lung-MAP: Taselisib as Second-Line Therapy in Treating Patients With Recurrent
Stage IV Squamous Cell Lung Cancer and Positive Biomarker Matches
This phase II trial studies how well taselisib (GDC-0032) works in treating patients
with
stage IV squamous cell lung cancer that has come back after previous treatment. This
is a
sub-study that includes all screened patients positive for the phosphoinositide 3-kinase
(PI3K) biomarker. PI3K can cause tumor cells to grow more quickly. Taselisib may decrease
the
activity of PI3K and may be able to shrink tumors.
View Study Details
S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis
This phase II trial studies how well isatuximab works in treating patients with primary
amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies,
such
as isatuximab, may interfere with the ability of cancer cells to grow and spread.
View Study Details
S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who
Have Undergone Radical Prostatectomy for Prostate Cancer
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone
therapy
may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy
use different ways to stop tumor cells from dividing so they stop growing or die.
It is not
yet known whether hormone therapy plus mitoxantrone and prednisone is more effective
than
hormone therapy alone for prostate cancer.
PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone,
and
prednisone to see how well they work compared to hormone therapy alone in treating
patients
who have undergone radical prostatectomy for prostate cancer.
View Study Details
Safety and Effectiveness of Cartiva Implant in the Treatment of First CMC Joint Osteoarthritis
Compared to LRTI (GRIP 2)
This study will evaluate whether Cartiva is an effective treatment for individuals
with
osteoarthritis of the first CMC joint in the hand compared to LRTI.
View Study Details
Safety and Efficacy of Chlorthalidone in Type 1 Diabetes
This open-label study will determine if chlorthalidone is safe and effective for the
use of
reducing urinary calcium excretion over 4 weeks in subjects with type 1 diabetes
View Study Details
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic
Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997)
can
cause fibrosis regression and reduce associated complications in adults with cirrhosis
due to
NASH.
View Study Details
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH)
and Bridging (F3) Fibrosis
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997)
can
cause fibrosis regression and reduce progression to cirrhosis and associated complications
in
adults with NASH and bridging (F3) fibrosis.
View Study Details
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity
Disorder (ADHD)
The purpose of this study is to determine if an investigational treatment is effective
in
improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years
old
diagnosed with ADHD.
View Study Details
Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease
(AD)
This randomized, double-blind, placebo-controlled, parallel group study will evaluate
the
efficacy and safety of gantenerumab versus placebo in participants with early (prodromal
to
mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible
participants will be randomized 1:1 to receive either subcutaneous (SC) injection
of
gantenerumab or placebo. The primary efficacy assessment will be performed at the
end of the
double blind period at week 104. Participants will then be offered to enter into an
open-label extension (OLE). Participants not willing to go to the OLE will participate
in a
long term follow-up period for up to 50 weeks after the last gantenerumab dose.
View Study Details
Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated
Urinary Syndromes (FOCUS)
This is a Phase 4, multi-center, open-label, randomized pragmatic superiority clinical
trial
comparing two strategies for initial or step-down oral therapy for complicated urinary
tract
infections (cUTI) after 0-48 hours of parenteral antibiotic therapy. The trial will
evaluate
the success and safety of a strategy of initial or step-down fosfomycin, administered
at a
dose of 3 g once daily, vs. a strategy of initial or step-down levofloxacin administered
at a
dose of 750 mg once daily. Investigator-directed adjustment to another adequate oral
therapy
is allowed 1) if the causative pathogen is not susceptible in vitro to quinolone initial
or
step-down therapy in a subject randomized to the levofloxacin strategy, OR 2) if the
subject
develops a significant related AE (either grade 3 or at the investigator's discretion)
to the
initial or step-down oral therapy. The duration of oral therapy (initial +
investigator-directed adjustment if indicated) in each strategy is 5-7 days of any
per
protocol antibiotic to which the pathogen is susceptible. The dosing of oral therapy
depends
on creatinine clearance (CrCl). The trial will enroll approximately 536 patients that
are
either male or female aged 18 or older with cUTI from outpatient and inpatient settings.
The
study will take place over 25 months in approximately 12 to 15 US sites. The primary
objective is to compare Strategy 1 and Strategy 2 in terms of treatment success rates
at Test
of Cure (TOC).
View Study Details
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe,
Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement
(SURTAVI).
The purpose of the study is to investigate the safety and efficacy of transcatheter
aortic
valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS)
at
intermediate surgical risk by randomizing patients to either Surgical Aortic Valve
Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.
Single Arm: The purpose of this trial is to evaluate the safety and effectiveness
of
transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic
Aortic
Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase
of the
pivotal clinical trial.
View Study Details
Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive
Bladder Cancer
The purpose of this study is to determine if TAR-200, an investigational drug delivery
system, in combination with nivolumab is safe and tolerable in patients with muscle-invasive
bladder cancer (MIBC) who are scheduled for radical cystectomy (RC) during an 84-day
dosing
cycle induction period comprised of four consecutive 21-day dosing cycles.
View Study Details
Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed
With Attention-deficit/Hyperactivity Disorder
To evaluate the long-term safety of SPD489 administered as a daily morning dose (5,
10, 15,
20, and 30 mg/day) in preschool children diagnosed with Attention-deficit/Hyperactivity
Disorder (ADHD). Participants will be enrolled into this study from antecedent study
SPD489-211 (NCT02402166) or SPD489-347 (NCT03260205) (roll-over participants) or through
direct enrollment (direct enrolled pariticpants).
View Study Details
Safety of Intravenous Neridronic Acid in CRPS
The aim of this trial is to investigate the safety of intravenous neridronic acid
in patients
with complex regional pain syndrome (CRPS).
The trial is divided into 3 periods: a 60-day enrollment period, a treatment period
consisting of 4 infusions over 10 days, and a follow-up period of approximately 50
weeks
(with visits at Week 2, Week 6, Week 12, Week 26, Week 39, and Week 52).
View Study Details
Safety of Sildenafil in Premature Infants
Describe the safety of sildenafil in premature infants at risk of bronchopulmonary
dysplasia
and determine preliminary effectiveness and pharmacokinetics (PK) of sildenafil. Funding
Source - FDA OOPD.
View Study Details
Selumetinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations
(A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well selumetinib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with MAPK pathway
activation mutations that have spread to other places in the body and have come back
or do
not respond to treatment. Selumetinib may stop the growth of cancer cells by blocking
some of
the enzymes needed for cell growth.
View Study Details
Skin Cancer: Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Lead Researcher: Sherrif Ibrahim
REGN2810 is a type of drug called a monoclonal antibody. Antibodies are proteins
that are naturally found in your blood stream that fight infections. A monoclonal
antibody is a special kind of antibody that is created in a laboratory. It is a medication
that binds to specific proteins in the body that may be involved in your cancer.
This study is being done to test if REGN2810 can reduce the size of your tumor by
helping the immune system destroy the tumor. The study is also being done to test
the safety of REGN2810 in CSCC patients.
View Study Details
Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating
Patients With Liver Cancer
This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation
therapy to see how well they work compared to sorafenib tosylate alone in treating
patients
with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking
some of
the enzymes needed for cell growth. Stereotactic body radiation therapy may be able
to send
the radiation dose directly to the tumor and cause less damage to normal tissue. Giving
sorafenib tosylate together with stereotactic body radiation therapy may kill more
tumor
cells.
View Study Details
Sound Processing Changes in Babies With Opioid Exposure
Lead Researcher: Perihan Ulema
The purpose of this study is to identify problems with interpreting sounds in babies
that have been exposed to opioids prior to birth. Being able to identify these issues
in infancy may allow us to find children who may have problems with language learning
later in life so that we can try to minimize these.
View Study Details
Squamous Cell Carcinoma of the Head and Neck Cancer: PD 0332991 and Cetuximab in Patients
With Incurable SCCHN
Lead Researcher: Ronald Maggiore
If you participate in this study you will be taking palbociclib and cetuximab as treatment
for your cancer. Palbociclib is taken by mouth once a day and cetuximab is given intravenously
weekly.
View Study Details
Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery
in Treating Patients With Limited Metastatic Breast Cancer
This randomized phase II/III trial studies how well standard of care therapy with
stereotactic radiosurgery and/or surgery works and compares it to standard of care
therapy
alone in treating patients with breast cancer that has spread to one or two locations
in the
body (limited metastatic) that are previously untreated. Standard of care therapy
comprising
chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread
of
tumor cells. Radiation therapy and/or surgery is usually only given with standard
of care
therapy to relieve pain; however, in patients with limited metastatic breast cancer,
stereotactic radiosurgery, also known as stereotactic body radiation therapy, may
be able to
send x-rays directly to the tumor and cause less damage to normal tissue and surgery
may be
able to effectively remove the metastatic tumor cells. It is not yet known whether
standard
of care therapy is more effective with stereotactic radiosurgery and/or surgery in
treating
limited metastatic breast cancer.
View Study Details
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer,
Non-small Cell Lung Cancer, or Prostate Cancer
This phase I trial studies the side effects and the best dose of stereotactic body
radiation
therapy in treating patients with breast cancer, non-small cell lung cancer, or prostate
cancer that has spread to other parts of the body. Stereotactic body radiation therapy
delivers fewer, tightly-focused, high doses of radiation therapy to all known sites
of cancer
in the body while minimizing radiation exposure of surrounding normal tissue.
View Study Details
Steroid Delivery to the Frontal Sinus Opening With a Bioabsorbable Implant vs. a Bioabsorbable
Nasal Dressing
Lead Researcher: Paul Allen
The purpose of this study is to compare how two different post-surgical treatments
that both
deliver steroids to the frontal sinus opening affect your healing after frontal sinus
surgery.
View Study Details
Study of ACE-083 in Patients With Facioscapulohumeral Muscular Dystrophy (FSHD)
Study A083-02 is a multicenter, Phase 2 study to evaluate the safety, tolerability,
pharmacodynamics (PD), efficacy, and pharmacokinetics (PK) of ACE 083 in patients
with FSHD
to be conducted in two parts. Part 1 is open-label, dose-escalation and Part 2 is
randomized,
double-blind, and placebo-controlled.
View Study Details
Study of Ambrisentan in Subjects With Pulmonary Hypertension
This Phase 3, international, multicenter, open-label study will monitor the long-term
safety
of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses
for
this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan
in the United States, Canada, and the European Union are 5 and 10 mg. Investigators
will be
able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between
dose
adjustments is required. Participants receiving other therapies for pulmonary hypertension
that are not contraindicated for concomitant use with ambrisentan are permitted to
enroll in
this study and continue to receive such therapies. Participants enrolled in this study
will
receive treatment with ambrisentan until such time as the investigator or participant
chooses
to stop ambrisentan treatment, ambrisentan becomes commercially available, or the
Sponsor
stops the study.
View Study Details
Study of Arimoclomol in Inclusion Body Myositis (IBM)
Lead Researcher: Elizabeth Luebbe
Funding Source - FDA OOPD. The purpose of this study is to evaluate the safety and
efficacy
of the study drug, Arimoclomol in IBM patients.
View Study Details
Study of Berkeley Life Nitric Oxide on Platelets
Lead Researcher: Scott Cameron
Nitric Oxide has several protective heart benefits. But why it's protective is not
known. We will determine if the dietary supplement, Berkeley Life Nitric Oxide, affects
the function of platelets. Platelets play a negative role in heart disease. We will
determine if nitric oxide affects platelets in such a way as to reduce that negative
affect.
View Study Details
Study of BHV-4157 in Alzheimer's Disease
Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect
from
AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg,
or
placebo, taken orally once daily. Duration of treatment is 48 weeks. There is also
a
screening period of up to 42 days; and a 4-week post-treatment observation period.
View Study Details
Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
SCORE2 is a multicenter, prospective, randomized, phase III clinical trial in which
all
participants enrolled will be followed for up to 2.5 years. SCORE2 is designed as
a
non-inferiority trial, with study eyes randomized to intravitreal bevacizumab (1.25
mg) every
4 weeks vs. intravitreal aflibercept (2.0 mg) every 4 weeks. SCORE2 aims to determine
if
bevacizumab is non-inferior to aflibercept for the treatment of macular edema associated
with
central retinal vein occlusion (CRVO), with the primary outcome of visual acuity measured
at
Month 6.
View Study Details
Study of Eteplirsen in DMD Patients
The main objective of this study is to provide evidence of efficacy of eteplirsen
(AVI-4658)
in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51.
Additional objectives include evaluation of safety, biomarkers and the long-term effects
of
eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).
View Study Details
Study of Kidney Tumors in Younger Patients
This research trial studies kidney tumors in younger patients. Collecting and storing
samples
of tumor tissue, blood, and urine from patients with cancer to study in the laboratory
may
help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and
identify
biomarkers related to cancer.
View Study Details
Study of Resection Combined With Stereotactic Radiosurgery for 1 to 3 Brain Metastases
This study is to look more closely at the tumor removed during your surgery, and to
follow
your condition after your treatment.
The purpose of this study is to determine what side effects are common or more rare
from this
treatment, how well the treatment has worked for you, and to track whether you develop
other
brain metastases.
View Study Details
Study of SRP-4045 and SRP-4053 in DMD Patients
The main objective of this study is to evaluate the efficacy of SRP-4045 and SRP-4053
compared to placebo in Duchenne muscular dystrophy (DMD) patients with out-of-frame
deletion
mutations amenable to skipping exon 45 and exon 53, respectively.
View Study Details
Study of Testosterone and rHGH in FSHD
Lead Researcher: Elizabeth Luebbe
The purpose of this study is to investigate the safety and tolerability of combination
therapy with recombinant human growth hormone (rHGH) and testosterone in adult male
patients
with facioscapulohumeral muscular dystrophy (FSHD) over 24 weeks.
View Study Details
Study to Assess Safety and Efficacy of GKT137831 in Patients With Primary Biliary
Cholangitis Receiving Ursodeoxycholic Acid.
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients
with
Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic
acid (UDCA)
treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase
(ALP).
View Study Details
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate
to Severe Ulcerative Colitis
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are
effective
in treatment of moderate to severe ulcerative colitis.
View Study Details
Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In
Subjects With Alopecia Areata
This is a Phase 2a, randomized, double blind, parallel group, multicenter study with
an
extension period. The study will have a maximum duration of approximately 113 weeks.
This
includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug
Holiday
(#1), an up to 12 month Single Blind (investigator open, sponsor open and subject
blind)
Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension
Period and a 4 week Follow up Period.
View Study Details
Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years
and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment
in Flaring Subjects
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and
over
with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis.
Subjects
responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg)
taken
orally once daily (QD) will be identified and randomized in a double-blind manner
to receive
200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of
2 doses
of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing
significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks
rescue
treatment and receive 200 mg PF-04965842 together with a marketed topical medicine.
Eligible
patients will have the option to enter a long-term extension study after completing
the
initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
View Study Details
Studying Infant Nutrition and Blood Sugar in Breastfed Infants
Lead Researcher: Bridget Young
This study is for pregnant women who plan on breastfeeding their baby for at least
5 months. You and your baby will have two study visits over the first 6 months of
your baby's life at the University of Rochester Medical Center. We will ask for some
blood and some breast milk from you. We will ask for some urine and stool, and a heel
prick from your baby.
View Study Details
Suicide Prevention Training for PC Providers-in-training
This randomized control study responds to the need for effective suicide prevention
education/training that is grounded in adult learning theory and advances in education,
in
the context of a changing health care landscape where primary care providers are likely
to
encounter suicidal individuals. The study will test the effectiveness of suicide prevention
education for providers-in-training by comparing two conditions: 1) A Control learning
group:
includes suicide prevention didactics (Commitment to Living: Primary Care) delivered
online
via brief videos, and 2) An Experimental learning group: includes didactics plus two
standardized patient (SP) interactions. One Experimental learning group SP interaction
will
be in person and the other will be conducted remotely using a secure webcam service
(OoVoo).
All SP interactions will be recorded. Both groups will be compared in terms of their
suicide
prevention skills using an SP 'test case' at 6-month follow up. The primary research
question
is to learn about the impact of practice (though SP simulation) over and above didactics
alone.
View Study Details
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed
or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders
(The Pediatric MATCH Screening Trial)
This Pediatric MATCH screening and multi-sub-study phase II trial studies how well
treatment
that is directed by genetic testing works in pediatric patients with solid tumors,
non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at
least one
line of standard systemic therapy and/or for which no standard treatment exists that
has been
shown to prolong survival. Genetic tests look at the unique genetic material (genes)
of
patients' tumor cells. Patients with genetic changes or abnormalities (mutations)
may benefit
more from treatment which targets their tumor's particular genetic mutation, and may
help
doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.
View Study Details
The EPIC Observational Study
The purpose of this study is to better define risk factors preceding first isolation
of
Pseudomonas aeruginosa (Pa) from respiratory cultures in cystic fibrosis (CF) lung
disease
and to better define clinical outcomes associated with acquisition of Pa. This study
will
also collect and bank DNA samples for current and future studies designed to enhance
the
understanding of the pathogenesis of CF.
View Study Details
The INSYTE (Management of Parkinson's Disease Psychosis in Actual Practice) Study
To examine the current disease progression of PDP, the clinical, economic, and humanistic
impact of anti-psychotic therapy in the management of the condition in real-world
settings,
and the burden of the condition on patients and their caregivers
View Study Details
The LGBTQI parental experience with newborn nutrition
Lead Researcher: Rita Dadiz
Eligible participants include parents of a newborn child born within the past 1 year
from time of recruitment. Parents must have identified as LGBTQI during the birthing
and initial newborn hospitalization period. Adopted parents are eligible if they were
involved in the birthing process. Parents must be at least 18 years old.
The study includes two brief surveys which can be done online or on paper and a 60-90
minute interview done either in person or through video conferencing.
View Study Details
The Role of Microparticles as a Biomarker
The investigators propose to characterize MPs in aHUS and TTP both at the onset and
throughout treatment. The investigators believe that the number, size, and cell origin
of MPs
will differ between these two diseases. The hypothesis is that endothelial derived
MPs will
be higher in number and comprise a larger portion of the MP population in aHUS and
that
platelet MPs will comprise a larger number and greater proportion of MPs in TTP. The
investigators believe that MP identity and number can be used to reliably differentiate
between aHUS and TTP at disease onset.
View Study Details
The Treatment of Progressive Early Onset Spinal Deformities: A Multi-Center Outcome
Study
The purpose of this study is to examine the treatment, both surgical and non-surgical,
of
patients with any form of early onset scoliosis. Such treatment may include the use
of growth
friendly devices that are surgically or magnetically lengthened; or the use of serial
body
casting or bracing, or observation. Outcomes examined will be what can be seen physically
on
the patient and on x-ray, as well as parent perception of how the treatment effects
their
child with the use of a health-related quality of life (HRQOL) questionnaire.
View Study Details
Therapy for Moderate to Severe Ulcerative Colitis (UC)
Lead Researcher: Lawrence Saubermann
Participation will last just under 1 year. Subjects will be randomized to either receive
a dose of either the PF1600 or PF841 study drug or placebo pill for the first 8 weeks,
and then they will be re-randomized to take one set dose of either study drug or placebo
pill for the remaining 24 weeks. Subjects will need to visit the clinic for study
related procedures at least 10 times. Colonoscopies are required.
View Study Details
To determine how flu causes symptoms and how the immune system responds to flu infection
Lead Researcher: Angela Branche
THIS STUDY IS BEING DONE TO DETERMINE HOW IMMUNE SYSTEM RESPONDS IN PEOPLE AND IS
THE IMMUNE RESPONSE DIFFERENT IN ADULTS AS COMPARED TO CHILDREN
View Study Details
Trametinib and Docetaxel in Treating Patients With Recurrent or Stage IV KRAS Mutation
Positive Non-small Cell Lung Cancer
This phase II trial studies how well trametinib and docetaxel work in treating patients
with
stage IV KRAS mutation positive non-small cell lung cancer or cancer that has come
back.
Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell
growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop
the
growth of tumor cells, either by killing the cells, by stopping them from dividing,
or by
stopping them from spreading. Giving trametinib with docetaxel may work better in
treating
non-small cell lung cancer.
View Study Details
Transfusion of Prematures Trial
The objective of the TOP trial is to determine whether higher hemoglobin thresholds
for
transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement
in the
primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26
months
of age, using standardized assessments by Bayley.
View Study Details
Treatment Alternatives in iSGS (NoAAC PR-02 Study)
The study is aimed at answering the questions; (1) How well do the most commonly used
treatments in iSGS work? and (2) What quality-of-life trade-offs are associated with
each
approach?
With the results of this trial, the investigators hope to provide information to iSGS
patients: (1) Given my personal characteristics, conditions, and preferences, what
should I
expect will happen to me? and (2) What are my options, and what are the potential
benefits
and harms of these options?
View Study Details
Treatment of Acute Lymphoblastic Leukemia in Children
RATIONALE: L-asparaginase is an important component of treatment for childhood acute
lymphoblastic leukemia, but is also associated with notable side-effects, including
hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients
with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued
because of
intolerable side-effects had survival outcomes that were inferior to those who received
all
or nearly all of their intended doses. Two bacterial sources of asparaginase exist:
Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived
enzyme has been used as front-line therapy and the Erwinia-derived preparation has
been
reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase
(PEG-asparaginase) has a longer half-life and is potentially less immunogenic than
native E
coli L-asparaginase, and has been used as the initial asparaginase preparation in
some
pediatric acute lymphoblastic leukemia treatment regimens.
PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations:
intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase
(IM-EC)
have been well characterized, their relative efficacy and toxicity have not been studied
extensively.
View Study Details
Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic
Leukemia
This phase III trial studies tretinoin and arsenic trioxide in treating patients with
newly
diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic
leukemia
involves high doses of a common class of chemotherapy drugs called anthracyclines,
which are
known to cause long-term side effects, especially to the heart. Tretinoin may stop
the growth
of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide
may
stop the growth of cancer cells by either killing the cells, by stopping them from
dividing,
or by stopping them from spreading. Completely removing or reducing the amount of
anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may
be an
effective treatment for acute promyelocytic leukemia and may reduce some of the long-term
side effects.
View Study Details
Trial in Adult Subjects With Spinocerebellar Ataxia
The primary purpose of this study is to compare the efficacy of BHV-4157 versus placebo
after
8 weeks of treatment on ataxia symptoms in subjects with spinocerebellar ataxia (SCA).
View Study Details
trūFreeze® Spray Cryotherapy Patient Registry
To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy
for
the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
View Study Details
Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With
Low Ejection Fraction
This study assesses the 18-month incidence of inappropriate shocks in subjects implanted
with
the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of
sudden
cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp
in order
to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The
incidence
of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks
observed in the MADIT RIT study.
View Study Details
Urinary tract cancer: Chemotherapy Before Surgery in Treating Patients With High Grade
Upper Urinary Tract Cancer
Lead Researcher: Elizabeth Guancial
This research study has two study groups.
Groups 1 and 2 will both receive chemotherapy followed by surgery. The type of chemotherapy
will depend on your kidney function, which will be determined by blood and urine tests.
Patients with normal or near normal kidney function (Group 1) will be given methotrexate,
vinblastine, doxorubicin, cisplatin and pegfilgrastim (AMVAC) on the first day of
every cycle (which is 14 days) for 4 total cycles. 21 to 60 days after finishing the
chemotherapy, you will have surgery to remove your tumor.
Patients with decreased kidney function (Group 2) will be given gemcitabine and carboplatin
(GC) for four cycles, the cycles are 21 days. Gemcitabine will be given on day 1
and day 8 of each cycle. Carboplatin will be given on day 1 of each cycle. 21 to
60 days after finishing the chemotherapy, you will have surgery to remove your tumor.
View Study Details
Using An Investigational Drug to Treat Non-Diabetic Nerve Pain ("TopCSPN")
Lead Researcher: David Herrmann
Many people experience nerve pain and tingling in their hands and feet that has a
known cause, such as diabetes. When there is no identifiable medical reason for the
nerve pain (‘neuropathy’) you are experiencing, it is called Cryptogenic Sensory Peripheral
Neuropathy, “CSPN,” for short. This study is a double blind, randomized placebo-controlled
trial of topiramate at a target dose of 100 mg daily for 96 weeks as a potential therapy
for the nerve pain of CSPN. Topiramate is the Investigational Drug in this study.
Topiramate is approved by the US Food and Drug Administration for prevention of migraines
and seizures, but not for the treatment of nerve pain. Study participants will be
randomized 1:1 to topiramate or placebo (sugar pill). Neither participants nor the
Study Team will know which group participants are in. All participants will return
to the clinic for follow up visits once every 16 weeks for evaluation. Evaluations
will include assessments and questionnaires to determine if topiramate improves symptoms
of CSPN and makes your life better.
View Study Details
Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing
Loss
This is an international, multi-center, double-blind, placebo-controlled evaluation
valganciclovir treatment for up to 54 children (up to 4 years of age) with
virologically-confirmed congenital CMV infection and hearing loss. Subject participation
will
be over a six-month period and study subjects will be stratified according to age.
The
primary objective is to assess whether a six-week course of oral valganciclovir can
stabilize
the hearing of children with congenital CMV infection who present with hearing loss.
View Study Details
Validation of Brain Function Assessment Algorithm for mTBI From Initial Injury to
Rehabilitation
Lead Researcher: Kian Merchant-Borna
This study is a validation of prior algorithms applied to the 13-25 year old population.
View Study Details
Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation
in College Athletes
This study is designed to validate the performance of the algorithms to be used in
future
commercial device.
View Study Details
Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation
This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal
cord
stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters
delivered to neural targets identified during current commercial trial stimulation
procedures. The study will evaluate changes in back and leg pain from baseline to
3, 6, and
12 months.
View Study Details
Veliparib, Pembrolizumab, and Combination Chemotherapy in Treating Patient With Locally
Advanced Rectal Cancer
This randomized phase II trial studies how well veliparib or pembrolizumab work with
combination chemotherapy and radiation therapy in treating patients with rectal cancer
that
has spread from where it started to nearby tissue or lymph nodes (locally advanced).
Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed
for cell
growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability
of tumor
cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6
regimen,
work in different ways to stop the growth of tumor cells, either by killing the cells,
by
stopping them from dividing, or by stopping them from spreading. Radiation therapy
uses
high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib or pembrolizumab
with combination chemotherapy and radiation therapy may kill more tumor cells, make
the tumor
smaller, and reduce the amount of normal tissue that needs to be removed.
View Study Details
Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors,
Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric
MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well vemurafenib works in treating
patients
with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations
that have spread to other places in the body and have come back or do not respond
to
treatment. Vemurafenib may stop the growth of tumor cells by blocking some of the
enzymes
needed for cell growth.
View Study Details
Vision-based Speed of Processing Cognitive Training and Mild Cognitive Impairment
This project seeks to identify neural changes that occur in adults with mild cognitive
impairment (MCI) after engagement in computerized cognitive training. In addition,
this
project aims to identify physiological factors that may bolster effects of the training
on
cognitive function. Individuals with MCI are at high risk for Alzheimer's disease
(AD).
Understanding how cognitive training protects cognitive function in MCI can contribute
to
development of effective interventions to slow progression to AD in individuals at
risk,
thereby reducing the significant morbidity and health care costs associated with AD.
View Study Details
Vitamin D Dynamics in Women
The goal of this pilot project is to utilize stable isotopically labeled vitamin D3
and state
of the art mass spectrometric methodology to assess vitamin D dynamics during pregnancy
in
relation to calcitropic hormone status at this key life stage. At the conclusion of
this
study, the investigators will have obtained novel information on the absorption and
utilization of vitamin D in women and determined if maternal vitamin D3 or maternal
25(OH)D3,
or both, can be transferred across the placenta to the fetus. The long-term goal is
to better
understand the unique metabolism of vitamin D during pregnancy.
View Study Details
Vitamin D Supplementation in Multiple Sclerosis
Low vitamin D levels have been shown to increase a person's risk of developing multiple
sclerosis (MS), and patients with MS who have lower vitamin D levels are at increased
risk of
having attacks. However, it is not known if giving supplemental vitamin D to those
with MS
reduces the risk of attacks, and some research suggests that vitamin D could even
be harmful
to people with MS.
In this clinical trial, patients with relapsing-remitting MS will receive high-dose
or
low-dose oral vitamin D in addition to an approved therapy for MS, glatiramer acetate.
Patients will be evaluated for two years, and the effect of high-dose vitamin D
supplementation on the rate of MS attacks and on the number of new lesions and change
in
brain volume on MRI will be determined. Establishing this association will have major
implications for the treatment of individuals with MS throughout the world.
View Study Details
VX15/2503 Treatment for Huntington's Disease
The purpose of this study is to evaluate the safety, tolerability, PK, and efficacy
of
VX15/2503 in subjects with late prodromal and early manifest Huntington's disease.
View Study Details
Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib
Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic
radiosurgery with or without lapatinib ditosylate works in treating patients with
breast
cancer that has too many of a protein called human epidermal growth factor receptor
2 (HER2)
on its cells and has spread to the brain. Radiation therapy uses high energy x rays
to kill
tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation
therapy
that delivers a single, high dose of radiation directly to the tumor and may kill
more tumor
cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth
of
tumor cells by blocking some of the enzymes needed for cell growth. It is not yet
known
whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib
ditosylate is an effective treatment for brain metastasis from breast cancer.
View Study Details
Whole-Brain Radiation Therapy With or Without Hippocampal Avoidance in Treating Patients
With Limited Stage or Extensive Stage Small Cell Lung Cancer
This randomized phase II/III trial studies how well whole-brain radiation therapy
works and
compares it with or without hippocampal avoidance in treating patients with small
cell lung
cancer that is found in one lung, the tissues between the lungs, and nearby lymph
nodes only
(limited stage) or has spread outside of the lung in which it began or to other parts
of the
body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells
and
shrink tumors. The hippocampus is part of the brain that is important for memory.
Avoiding
the hippocampus during whole-brain radiation could decrease the chance of side effects
on
memory and thinking. It is not yet known whether giving whole-brain radiation therapy
is more
effective with or without hippocampal avoidance in treating patients with small cell
lung
cancer.
View Study Details
Whole-Food, Plant-Based Nutrition Among Women wiith Metastatic Breast Cancer
Lead Researcher: Thomas Campbell
Women will be given free, prepared food for 8 weeks, along with a multivitamin, and
will attend weekly office visits. Women will be assessed at the beginning of the study
and after eating the food for 8 weeks, in addition to a blood test after 3 weeks.
There will also be a Control Group of women that will eat their regular diet and take
a provided multivitamin.
View Study Details
Zenith® Low Profile AAA Endovascular Graft
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial
to study
the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used
in
conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic,
aortoiliac, and iliac aneurysms.
View Study Details