Clinical Research & Trials

Study of Abaloparatide and Bevacizumab in Myelodysplastic Syndromes

Lead Researcher: Jason Mendler

The primary objective of this study is to determine the safety and tolerability of combined abaloparatide and bevacizumab in patients with Myelodysplastic Syndromes (MDS). A secondary objective is to determine the response to treatment (based on bone marrow and peripheral blood findings). A tertiary objective is to determine the impact of therapy on health-related quality of life (HRQOL) and patient-reported outcomes (PRO). A quaternary (scientific) objective is to determine the impact of treatment on both hematopoietic and stromal cell populations within the bone marrow of MDS patients.

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Study of infusion treatment, axicabtagene ciloleucel, for patients with Indolent Non-Hodgkin Lymphoma

Lead Researcher: Carla Casulo

Axicabtagene ciloleucel is an experimental product made from the subject's own white blood cells which are genetically modified and grown to fight cancer. Patients will be infused with axicabtagene ciloleucel to see if their disease responds and if this product is safe. This study will enroll approximately 160 adult subjects who have relapsed or refractory Indolent Non-Hodgkin Lymphoma.

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A Drug Study of Ibrutinib + Obinutuzumab in Patients with Chronic Lymphocytic Leukemia (CLL)

Lead Researcher: Paul Barr

This research study is evaluating a combination of two drugs, ibrutinib and obinutuzumab, as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Lead Researcher: Jane Liesveld

Cord blood is blood from the umbilical cord of a newborn baby. This blood contains high concentrations of stem cells (cells from which all blood cells develop). This study is a protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with blood cancers.

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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.

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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).

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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).

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A study evaluating KTE-X19, a cell therapy infusion for leukemia

Lead Researcher: Kristen O'Dwyer

The primary objectives of this study are to determine the safety and effectiveness of KTE-X19, a cell therapy (infusion) for adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

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A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata

Lead Researcher: Mary Gail Mercurio

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.

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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)

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A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

Lead Researcher: Marcus Noel

This study will evaluate the safety profile, tolerability, and effectiveness of the drug BMS-813160 in patients with metastatic colorectal and pancreatic cancers.

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A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma

Lead Researcher: Jonathan Friedberg

This is an open-label clinical trial designed to evaluate the effectiveness and safety of brentuximab vedotin, a chemotherapy drug, as front-line therapy of Hodgkin Lymphoma in adults age 60 and above. It will be given as a single treatment (Part A) or in combination with dacarbazine (Part B), or in combination with bendamustine (Part C), or in combination with nivolumab (Part D).

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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.

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A study of Duvelisib, an oral medicine to treat Peripheral T Cell Lymphoma (PTCL)

Lead Researcher: Carla Casulo

This is a multi-center, open-label study of duvelisib (brand name Copiktra), an oral medicine to treat patients with relapsed or refractory Peripheral T cell Lymphoma (PTCL).

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A Study of Elotuzumab With Pomalidomide, Bortezomib, and Dexamethasone in Relapsed Multiple Myeloma

Lead Researcher: Brea Lipe

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.

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A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

Lead Researcher: Lawrence Saubermann

The purpose of this program is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

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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)

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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.

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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.

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A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

Lead Researcher: Ajay Kuriyan

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).

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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.

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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.

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A Study to Test Radium-223 Therapy With Docetaxel Chemotherapy in Patients With Prostate Cancer

Lead Researcher: Chunkit Fung

The purpose of this study is to compare any good and bad effects of using radium-223 therapy along with docetaxel chemotherapy treatment versus using docetaxel alone.

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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.

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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.

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Acute Myeloid Leukemia (AML): Crenolanib Versus Midostaurin in Newly Diagnosed Subjects With FLT3 Mutated AML

Lead Researcher: Jane Liesveld

This purpose of this study is to compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on event-free survival in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation.

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Acute Myeloid Leukemia (AML): Intensive Chemotherapy with or without Glasdegib or AZA with or without Glasdegib

Lead Researcher: Jane Liesveld

The purpose of this study is to determine if glasdegib is superior to placebo in combination with azacitidine or cytarabine and daunorubicin in prolonging overall survival in subjects with untreated AML.

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Acute Myeloid Leukemia (AML): Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML

Lead Researcher: Jane Liesveld

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

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Acute Myeloid Leukemia (AML): Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory AML

Lead Researcher: Jane Liesveld

The purpose of this trial is to compare overall survival achieved with uproleselan administered with chemotherapy versus chemotherapy alone.

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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.

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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.

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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)

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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.

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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.

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Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

Lead Researcher: Yuhchyau Chen

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.

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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.

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ASPIRE: Treating Children With Atopic Dermatitis (Eczema)

Lead Researcher: Julie Wolf

This study will monitor the effects of ointments, crisaborole and tacrolimus 0.03%, on patient-reported outcomes (PROs) and caregiver burden in children (ages 5 to 15 years) with atopic dermatitis over a 12 week period of time. The goal of this study is to detect changes in PROs and caregiver burden during treatment for atopic dermatitis of moderate or less severity. The study design will allow us to correlate PROs and caregiver burden with treatment response and disease improvement in children.

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Aspirin in Preventing Recurrence of Breast Cancer

Lead Researcher: Kristin Skinner

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

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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.

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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.

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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.

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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.

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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).

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Bladder Cancer: Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer S1605

Lead Researcher: Deepak Sahasrabudhe

The purpose of this study is to estimate complete response at 25 weeks after registration.

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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.

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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.

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Blood Cancer: A Study of APTO-253 in Patients With Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrom (MDS)

Lead Researcher: Kristen O'Dwyer

This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

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Blood Cancer: Denosumab for Smoldering Multiple Myeloma

Lead Researcher: Brea Lipe

This is a trial of denosumab 120mg subcutaneous (under the skin) for patients with smoldering multiple myeloma (SMM). SMM is a plasma cell disorder has a high risk of progressing to multiple myeloma (MM). Participants will be recruited from the James P. Wilmot Cancer Center, University of Rochester in Rochester, New York. Patients seen in the inpatient or outpatient setting with histologically confirmed SMM will be evaluated for this study. 20 patients will be treated with a dose of denosumab every 4 weeks over the course of a year. Patients will be followed after completion of the study for an additional 2 years. All patients will take daily vitamin D and calcium supplements.

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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.

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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.

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Breast Cancer WEight Loss Study (BWEL Study)

Lead Researcher: Kristin Skinner

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

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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.

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Breast Cancer: Exemestane With or Without Entinostat in Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

Lead Researcher: Michelle Shayne

If you choose to be in this study, you will be "randomized" into one of the study groups described below. *If you are in group A, you will take entinostat (5 mg) once per week in addition to your exemestane once per day. If your doctor decides it is best for you to change your study drug dosing during the study, you will take your doses as instructed by your doctor. *If you are in group B, you will take an inactive substance (called a “placebo”) once per week in addition to your exemestane once per day. If your doctor decides to change your study drug dosing during the study, you will take your doses as instructed by your doctor.

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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.

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Breast Cancer: MK-3475 as Adjuvant therapy for Triple Receptor-Negative Breast Cancer or Positive Lymph Nodes After Neoadjuvant Chemotherapy - S1418

Lead Researcher: Alissa Huston

The purpose of this study is to compare treated subjects' invasive disease-free survival of patients with triple-negative breast cancer after neoadjuvant chemotherapy.

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Breast Cancer: Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA)

Lead Researcher: Alissa Huston

The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for your type of cancer. If your cancer is sensitive to hormone treatment, you may receive hormone drugs as part of usual care. In this study, you will get either olaparib or placebo, a pill that looks like the study drug but contains no medication. The use of olaparib could reduce the risk of your cancer coming back but it could also cause side effects.

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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.

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Breast Cancer: Radiation Therapy with the Oral Drug Olaparib

Lead Researcher: Ajay Dhakal

This phase II trial studies how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer.

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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.

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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.

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Cardiac Surgery Peer Recovery Support Program

Lead Researcher: Barbara Olesko

The purpose of the study is to develop and implement an addiction recovery support program for cardiac surgery patients admitted with a diagnosis of infective endocarditis and IV drug addiction. Patients admitted to Strong Memorial Hospital will be enrolled. We will test whether the recovery support model of care improves a person's readiness to start addiction treatment.

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Cellular Dynamics at the Synovium Bone Interface in RA

Lead Researcher: Jennifer Anolik

You will be asked to have an ultrasound and a biopsy of your inflamed synovial tissue done. Synovial tissue is found in joints, like your knees, wrists and fingers, and creates synovial fluid, which helps lubricate your joint. Rheumatoid Arthritis (RA) causes the thin synovial tissue to become inflamed, leading to an accumulation of synovial fluid which causes swelling and pain.

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Chemotherapy study for acute myeloid leukemia (AML)

Lead Researcher: Jane Liesveld

To evaluate the response to chemotherapy with the drug decitabine combined with rapamycin in the treatment of relapsed or refractory acute myeloid leukemia in patients of all ages, and in the treatment of newly diagnosed leukemia in those who are older than 65 when diagnosed.

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CLEAR: A Study comparing an injection of the drug SP-102 to placebo for low back pain

Lead Researcher: John Markman

This is a double-blind, placebo-controlled research study to compare the level of pain relief after an injection of SP-102 or placebo in the treatment of a form of lower back pain, called sciatica.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Lead Researcher: Jane Liesveld

This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, 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. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

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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.

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Developmental Impact of NICU Exposures (DINE)

Lead Researcher: Gloria Pryhuber

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.

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Diffuse Large B Cell Lymphoma: A Study of PET Scan Adapted Therapy and Non-Invasive Monitoring

Lead Researcher: Carla Casulo

Measuring levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

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DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

Lead Researcher: Deepinder Singh

This study is for people with squamous cell carcinoma (skin cancer) and mucositis. Mucositis is the painful inflammation and ulceration of the mucous membranes lining the digestive tract, usually as an adverse effect of chemotherapy and radiotherapy treatment for cancer. This study will assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

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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.

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Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients and Non-Cancer Control Participants With an Optional Sub-Study: Research Brain MRI

Lead Researcher: Michelle Janelsins-Benton

Study is enrolling newly diagnosed breast cancer patients about to start chemotherapy and age-matched control participants. The investigator is trying to better understand the prevalence of cognitive difficulties in cancer patients receiving chemotherapy compared to the general population as well as what biological mechanisms may play a role in the development of these difficulties. Patients will be asked to complete six assessments over the course of approximately 5 months. Assessments 1,3, 4.5 and 5 include computerized and paper and pencil cognitive testing as well as blood draws. Assessments 2 and 4 only involve the collection of a blood sample. An optional sub study is offered after Assessment 1. It involves a research brain MRI at Assessment 4.5 and cognitive testing and another research brain MRI at Assessment 6.

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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.

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Efficacy and safety of AbGn-168H in patients with moderate to severe active ulcerative colitis

Lead Researcher: Lawrence Saubermann

The purpose of this study is to evaluate the safety and effectiveness of the drug AbGn-168H in patients who have moderate to severe Ulcerative Colitis. The study will test use of the drug AbGn-168H for 26 weeks. To determine if the drug is safe and effective, patients will come to the clinic regularly to meet with the study team, complete questionnaires, and have blood work completed.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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First-Line Treatment Study for Leukemia: Evaluating the combination of Pevonedistat and Azacitidine Vs. Azacitidine alone

Lead Researcher: Jane Liesveld

The purpose of this study is to determine whether the combination of pevonedistat and azacitidine improves event-free survival (EFS) when compared with azacitidine alone. This study is for patients with Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Low-Blast Acute Myelogenous Leukemia.

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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.

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Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

Lead Researcher: Kristin Skinner

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.

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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.

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Gastric Cancer: Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Lead Researcher: Mohamedtaki Tejani

A small number of esophagus cancers have too much of the HER2 protein on the surface of their cells, which can help cancer cells to grow. Having too much of this protein is caused by having too many copies of the HER2 gene. If you have esophageal cancer and can’t have surgery, your doctor may have your tumor biopsy samples tested for the HER2 protein or gene. The study will compare drugs that target HER2-positive cancers.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Gynecologic Cancer (Ovary, Peritoneal): Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer

Lead Researcher: Richard Moore

In this study, you will get either the trametinib or one of the standard treatments available. You will not get both at the same time.

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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.

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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.

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Hearing Study: Sensitivity to Features of Speech Sounds

Lead Researcher: Laurel Carney

The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear. We are recruiting listeners age 18 to 80, with either normal hearing or hearing loss. Listeners with hearing loss must similar hearing loss in both ears that is sensorineural in nature and mild or moderate in severity. All listeners will have their hearing tested at the beginning of the study.

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Herpes Zoster Vaccine in Patients with Chronic Lymphocytic Leukemia and Waldenström Macroglobulinemia

Lead Researcher: Jonathan Friedberg

The purpose of this study is to measure humoral response 4 weeks after vaccination with the Shingrix herpes zoster vaccine in patients with CLL and WM undergoing first-line treatment with BTK inhibitors.

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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.

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Hydrocortisone for premature babies

Lead Researcher: Carl D'Angio

The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10 days improves survival for premature infants who have a breathing tube. Infants will either receive hydrocortisone or placebo.

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Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Lead Researcher: Paul Barr

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating older patients with untreated chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as venetoclax 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 ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.

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Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia

Lead Researcher: Paul Barr

This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, 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 ibrutinib, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.

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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.

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Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

Lead Researcher: Deepak Sahasrabudhe

Immunotherapy + Radiation in Resectable Soft Tissue Sarcoma

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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.

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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.

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Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash

Lead Researcher: Richard Dunne

Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash. Epidermal growth factor receptor (EGFR) inhibitors have been used to treat a variety of cancers, including head and neck cancer, non–small-cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer. Examples of drugs that make up this class of targeted medications include cetuximab, panitumumab, necitum­umab, erlotinib, gefitinib, osimertinib, and afatinib. One of the most common side effects of these drugs is skin reactions such as papulopustular (acneiform) rash. This study is for people with EGFR inhibitor-induced rashes.

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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.

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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.

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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.

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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.

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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.

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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.

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Leukemia Treatment: Adding an Antibody to Front-Line Chemotherapy

Lead Researcher: Kristen O'Dwyer

Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. 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 inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia. This trial studies the side effects of inotuzumab ozogamicin and how well it works when given with front-line chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia.

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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.

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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.

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Leukemia: Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

Studies are being done in ALL and other blood cancers with blinatumomab. It is hoped that blinatumomab will target your B-cell ALL and destroy these specific cells, but it has not yet been proven.

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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.

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Liver Cancer: Safety and Efficacy of Lenvatinib in Combination with Pembras as First-Line Treatment

Lead Researcher: Richard Dunne

The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypothesis of this study is that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).

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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.

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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.

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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.

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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.

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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.

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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."

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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.

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Lung Cancer: First-Line Treatment of M7824 Versus Pembrolizumab

Lead Researcher: Deborah Mulford

The study will evaluate M7824 monotherapy versus pembrolizumab as first-line treatment for participants with advanced non-small-cell lung carcinoma (NSCLC) with high PD-L1-tumor expression (PD-L1 stand for Programmed Death-Ligand 1).

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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.

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Lung-MAP Screening Study

Lead Researcher: Megan Baumgart

The purpose of this study is to find out if a targeted or immunotherapy treatment will have an effect on specific genes and proteins in a tumor.

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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.

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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.

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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.

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Lymphoma (DLBCL): Impact of CD34+ Cell Dose on Progression-free Survival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Lead Researcher: Michael Becker

Autologous transplant is the standard treatment for relapsed DLBCL or DLBCL that did not respond to initial chemotherapy. This is a randomized study, a computer program will assign subjects to either the experimental or standard arm. Neither you nor your study doctor will know what group you will be in.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Management of the PDA Trial

Patent ductus arteriosus (PDA) is an extra blood vessel found in babies before birth and just after birth. In most babies who have an otherwise normal heart, the PDA will shrink and close on its own in the first few days of life. If it stays open longer, it may cause extra blood to flow to the lungs. This study estimates the risks and benefits of active treatment versus expectant management of premature babies with patent ductus arteriosus.

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Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Lead Researcher: Michal Lada

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.

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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. 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.

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Melanoma: Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

Lead Researcher: Deepak Sahasrabudhe

The BRAF inhibitor component will include two drugs dabrafenib and trametinib that each have been approved by the FDA for the treatment of this patient population and have also been approved for use in combination due to superior effects relative to the single agent treatments. In addition, the study will involve the addition of the FDA approved agent nivolumab to the standard FDA approved ipilimumab immunotherapy in the hopes that it might further improve the good effects of the immunotherapy component of the treatment sequence.

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Melanoma: Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAF Mutant Melanoma That Cannot Be Removed by Surgery

Lead Researcher: Deepak Sahasrabudhe

This study will allow the researchers to know whether a break in treatment is better, the same, or worse than continuous treatment of dabrafenib and trametinib. To be better, the break in treatment approach should extend the time before cancer gets worse by about 4 to 6 months compared to the continuous treatment approach.

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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.

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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).

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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.

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Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

Apnea of prematurity (AOP) is a condition in which premature infants stop breathing for 15 to 20 seconds during sleep. 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.

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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.

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MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

Lead Researcher: Kristin Skinner

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.

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MS PATHS Normative Sub-Study

Lead Researcher: Megan Hyland

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.

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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.

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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.

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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.

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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.

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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.

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Muscle-Invasive Bladder Cancer: Durvalumab in combination with Gemcitabine and Cisplatin (Given Before the Primary Treatment) and Durvalumab Alone (Given After the Primary Treatment)

Lead Researcher: Chunkit Fung

A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment (given before the primary treatment) and Durvalumab Alone for Adjuvant Treatment (given after the primary treatment) in Patients with Muscle-Invasive Bladder Cancer

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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.

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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.

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Myotonic Dystrophy and Facioscapulohumeral Muscular Dystrophy Registry

Lead Researcher: Al-rabi Tawil

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.

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Nasal and Paranasal Sinus Cancer: a study comparing chemotherapy before surgery & radiation therapy Vs. surgery & radiation therapy alone

Lead Researcher: Ronald Maggiore

Drugs used in chemotherapy, such as docetaxel, cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy before surgery and radiation therapy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and treated with radiation. This trial studies how well chemotherapy before surgery and radiation therapy works compared to surgery and radiation therapy alone in treating patients with nasal and paranasal sinus cancer.

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Neoadjuvant FOLFOX therapy and active surveillance without use of radiation in locally advanced rectal cancer

Lead Researcher: Marcus Noel

The purpose of this study is to evaluate the treatment of patients with locally advanced rectal cancer for complete response to neoadjuvant chemotherapy without the use of radiation and surgery. These patients will be evaluated for complete clinical response (cCR) after completing up to 10 cycles of modified FOLFOX (mFOLFOX) (fluorouracil, leucovorin, oxaliplatin) chemotherapy, with interval analysis after six cycles. Patients who have stable or progressive disease will be removed from study and treated per discretion of the treating physician. Those determined to have partial or complete response will complete full neoadjuvant treatment and undergo close surveillance with watchful waiting for local recurrence without immediate surgery. The primary endpoint of this study will be the rate of cCR, which is to include complete and near complete clinical response, with secondary endpoints of disease-free survival (DFS), overall survival (OS), quality of life (QOL), as well as evaluation of safety and toxicity.

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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.

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NIR Fluorescence Imaging of Lymphatic Transport Using ICG

Lead Researcher: Christopher Ritchlin

Healthy volunteers and patients with Rheumatoid Arthritis (RA) in the developmental arm will have a minimum of two study visits to determine the optimal conditions for visualizing lymphatic transport in the upper extremities. Concentrations of 0.1 mg/ml of Indocyanine Green (ICG) will be injected intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). An ultrasound of the upper extremities may be performed after the ICG fluorescence is observed. The exam will help identify the location of the lymphatic vessels and nodes in the areas fluoresced.

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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.

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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.

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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.

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OPN-375 Efficacy and Safety in Adolescents With Bilateral Nasal Polyps

Lead Researcher: Li-Xing Man

This is a 16-Week Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adolescents with Bilateral Nasal Polyps followed by a 12-Week Open-Label Treatment Phase. The total planned number of subjects is approximately 120 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 2:1 ratio (OPN-375 186 μg: Placebo). For the PK sub-study, up to 14 subjects will be enrolled to obtain 10 completers.

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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: Efficacy and Safety Study of Cediranib in Combination With Olaparib in Patients With Recurrent Platinum-Resistant Ovarian Cancer (CONCERTO)

Lead Researcher: Richard Moore

The purpose of the study is to see if the combination of two drugs, cediranib and olaparib, is effective and tolerable in patients with ovarian cancer who have received at least 3 prior chemotherapy treatments, including treatment that included either carboplatin or cisplatin, and their disease came back within 6 months of the last dose of chemotherapy that included either cisplatin or carboplatin.

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Ovarian Cancer: Evaluation of a blood test that could help determine if a pelvic mass is cancerous or non-cancerous

Lead Researcher: Richard Moore

The purpose of this study is to validate and refine a technology that can help physicians determine whether an abnormal pelvic mass in women is benign (non-cancerous) or malignant (cancerous) using a blood test. The specific technology is called ParsortixTM PC1 system, a semi-automated system capable of capturing and harvesting rare cells for subsequent analysis from blood based on the size and deformability (i.e.compressibility) of the cells.

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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: Tesaro-FIRST

Lead Researcher: Richard Moore

The purpose of this study is to compare the progression-free survival of patients with Stage III or IV non-mucinous epithelial ovarian cancer treated with platinum-based therapy, TSR-042, and niraparib to standard-of-care (SOC) platinum-based therapy.

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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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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.

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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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Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Lead Researcher: Mohamedtaki Tejani

The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants. The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS), and progression-free survival (PFS).

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Pembrolizumab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Lead Researcher: Carla Casulo

The purpose of this research study is to evaluate a new drug Pembrolizumab in combination with chemotherapy, for Relapsed/Refractory Hodgkin Lymphoma. The chemotherapy regimen is called "ICE" and includes three drugs: ifosfamide, carboplatin, and etoposide. Pembrolizumab is currently Food and Drug Administration (FDA) approved for the treatment of some patients with melanoma, lung cancer and head and neck cancer, but has not yet been approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma. The 'ICE' regimen of chemotherapy is currently FDA approved for the treatment of Relapsed/Refractory Hodgkin Lymphoma, but has not yet been investigated in combination with pembrolizumab for this disease. For patients who have a relapse of their Hodgkin's lymphoma, retreatment with chemotherapy followed by a stem cell transplant is recommended. We know that obtaining a complete remission (not able to detect any disease on scans) is very important prior to proceeding to the stem cell transplant. Patients with negative scans have a lower chance of the disease coming back and a higher chance of achieving a long-term cure.

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Pevonedistat and Azacitidine in MDS or MDS/MPN Patients

Lead Researcher: Jason Mendler

The purpose of this study is to compare survival of patients treated with a combination of pevonedistat and azacitidine after failure of DNA methyltransferase inhibitors to historical survival for patients with relapsed/refractory myelodysplastic syndrome or myelodysplastic/ myeloproliferative overlap syndromes who are ineligible for hematopoietic stem cell transplant.

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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.

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Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC PB1046 in Subjects With Symptomatic PAH

Pulmonary arterial hypertension (PAH) is one form of a broader condition known as pulmonary hypertension, which means high blood pressure in the lungs. This is a multi-center, randomized, double-blind, controlled, Phase 2 study to assess the safety, tolerability, and efficacy of PB1046 in patients with pulmonary arterial hypertension.

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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).

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Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC) formerly known as primary biliary cirrhosis 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) helps prevent liver damage and improves liver function. 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

Lead Researcher: Yuhchyau Chen

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.

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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.

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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

Lead Researcher: Carl D'Angio

Encephalopathy is a general term that means brain disease, damage, or malfunction. 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.

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PRISM: Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma

Lead Researcher: Patrick Reagan

This is a Phase 1 platform protocol designed to evaluate various targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's lymphoma (NHL). Each study arm will be conducted in a predefined disease subset. All study arms are open label and allocation to each study arm will not be randomized. As this master platform protocol has multiple study arms, subjects can be screened for several study arms at once. Likewise, a subject who ends participation in one study arm may be re-screened for participation in another (separate) study arm. The primary objective of the study is to evaluate the safety of targeted agents for the treatment of relapsed/refractory aggressive Non-Hodgkin's Lymphoma (NHL). This protocol has a modular design, with the potential for future treatment arms to be added via protocol amendment.

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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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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.

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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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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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Rare Diseases Clinical Research Network: Neurophysiological Correlates

A biomarker, or biological marker is a measurable indicator of some biological state or condition. 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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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.

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Rectal Cancer: Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management

Lead Researcher: Mohamedtaki Tejani

Patients with rectal cancer are given chemotherapy and radiation therapy, and then they have surgery to remove the rectum. Chemotherapy and radiation therapy are given at the same time. This is called chemoradiation. Sometimes after surgery, patients will have extra chemotherapy without radiation. The extra chemotherapy is given to help make sure the tumor does not come back and to try and cure patients of their cancer. The purpose of this study is to increase the number of patients cured from their rectal cancer by giving the extra chemotherapy before surgery instead of after surgery. We also want to find out what effects, good and/or bad, having chemotherapy before surgery has on you and your rectal cancer. We believe that it will be better for you to have chemotherapy before surgery, but we are not sure if it is better to give the chemotherapy before or after the chemoradiation. Another important purpose of this study is to try and avoid surgery in patients with rectal tumors that have disappeared in response to the chemoradiation and the chemotherapy given before surgery. We believe that having additional chemotherapy before surgery may improve the chances that your tumor will disappear and we will be able to save your rectum.

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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.

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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.

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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.

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S-CitAD - Escitalopram for Agitation in Alzheimer's Disease

Lead Researcher: Anton Porsteinsson

Individuals with a diagnosis of Alzheimer's disease and clinically significant agitation/aggression as assessed by the Neuropsychiatric Inventory (NPI), and not residing in a skilled nursing or long-term acute care facility may be eligible to participate. Enrolled participants will receive 3 weeks of psychosocial intervention (counseling). Those responding to counseling will be monitored on usual care. Those not responding to 3 weeks of counseling will randomly be assigned to receive daily escitalopram or placebo (a pill with no active ingredients) while continuing to receive counseling. These 2 groups will be compared to the group responding to counseling alone.

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Safety and Effectiveness of KD025 in Subjects With Chronic Graft Versus Host Disease

Lead Researcher: Jane Liesveld

Approximately 126 subjects with active Chronic Graft Versus Host Disease (cGVHD) will receive treatment with one of two KD025 regimens: Arm A: KD025 200mg QD (once a day) Arm B: KD025 200mg BID (two times a day) Subjects may receive treatment in 28-day treatment cycles until progression of cGVHD. Subjects who have not achieved a response after 12 cycles of KD025 should be withdrawn if in the Investigator's judgment there is no evidence of clinical benefit.

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Safety and Efficacy of Chlorthalidone in Type 1 Diabetes

Lead Researcher: David Weber

Chlorthalidone is a prescription drug used to treat high blood pressure (hypertension). This open-label study will determine if chlorthalidone is safe and effective for the use of reducing the amount of calcium in urine over 4 weeks in patients with type 1 diabetes.

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Safety and efficacy of obeticholic acid in patients with compensated NASH

Lead Researcher: Jonathan Huang

This study will last 2 years and 3 months with the participant visiting the clinic 22 times. This consists of a 1 year double blind period and an optional 1 year open label period. After the screening period, participants will be randomized into groups of Placebo medication, 10 mg of OCA, or 10-25 mg of OCA. A liver biopsy is required for this study at the screening visit if one has not been completed within 12 months of day 1. This study will also include questionnaires, an EKG of your heart, fasting blood work, vital signs, and physical examinations. All study medication and protocol required procedures are covered by the clinical trial sponsor.

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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.

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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).

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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).

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Safety of Sildenafil in Premature Infants

Bronchopulmonary dysplasia (BPD) is a form of chronic lung disease that affects newborns (mostly premature) and infants. It results from damage to the lungs caused by mechanical ventilation (respirator) and long-term use of oxygen. Most infants recover from BPD, but some may have long-term breathing difficulty. This study will look at 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.

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Sarcoma: Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma

Lead Researcher: Deepak Sahasrabudhe

You will receive the MLN0128 for as long as the drug is preventing your cancer from growing and the side effects are reasonable. After you finish taking MLN0128, your doctor will continue to watch you for side effects and follow your condition for at least 30 days. Your doctor will continue to watch you for up to 2 years after you begin treatment.

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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.

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Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

Lead Researcher: Alissa Huston

This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.

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Skin Cancer: Safety and Efficacy of Pembrolizumab (trade name Keytruda) Compared to Placebo

Lead Researcher: Deepak Sahasrabudhe

Pembrolizumab is an antibody that blocks a protective mechanism of cancer cells and thereby allows the immune system to destroy them. This study will evaluate pembrolizumab compared to placebo in participants after the surgical removal of stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Part 2 is an open-label design for participants who receive placebo in Part 1 or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1. They may be eligible to receive up to 35 additional cycles of pembrolizumab in Part 2.

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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.

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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.

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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.

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Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

Stereotactic radiosurgery (SRS) is a non-surgical radiation therapy used to treat functional abnormalities and small tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue. 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.

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Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer

Lead Researcher: Chunkit Fung

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

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Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202)

Lead Researcher: Jessica Mackowiak

This study will assess the efficacy and safety of BL-8040 in combination with pembrolizumab (Keytruda®) and BL8040/Pembrolizumab in combination with liposomal irinotecan (Onivyde®)/5-fluorouracil/leucovorin (5-FU/LV) in subjects with metastatic pancreatic adenocarcinoma.

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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.

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Study of BHV-4157 in Alzheimer's Disease

Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect patients 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.

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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.

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Study of Oxygen Therapy in Improving Stem Cell Transplant

Lead Researcher: Omar Aljitawi

Umbilical Cord Blood (UCB) as a graft source for a bone marrow transplant has drawbacks related to the limited cell dose available for transplant and defects in homing. Homing is the process of UCB stem cell lodging in the bone marrow. If the homing is not efficient it could delay the re-population of the stem cells (or engraftment), possibly lead to engraftment failure, and delay the rebuilding of the immune system after transplant. This could, in turn, provide a higher risk to infection after the UCB transplant. This research study is aimed at investigating the use of hyperbaric oxygen (HBO) therapy prior to the UCB transplant to find out if it will improve the stem cell homing, and subsequently, the engraftment. HBO therapy involves breathing 100% pure oxygen while in a sealed chamber that has been pressurized at 2 ½ times the normal atmospheric pressure. There is a specific hormone which tells stem cells in the bone marrow to make more red blood cells. This hormone (called EPO) is increased when blood oxygen levels are low. When the EPO is increased, it might impair the bone marrow homing process of your transplant. Therefore, the researchers conducting this study hope to determine if providing 100% pure oxygen to you prior to your UCB transplant will decrease this hormone, and in turn, improve the homing process after your transplant.

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Study of Peptide Vaccine in Treating Patients with Newly Diagnosed Plasma Cell Leukemia

Lead Researcher: Brea Lipe

This study looks at treating patients with newly diagnosed multiple myeloma (plasma cell leukemia) who are receiving lenalidomide maintenance therapy, a kind of maintenance chemotherapy. Specifically, this study will look at the safety of SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant together with sargramostim. This peptide vaccine may help the body build an effective immune response to kill certain cancer cells. Incomplete Freund's adjuvant may help stimulate the body's immune response to the vaccine treatment. Sargramosti may increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide maintenance therapy may be a better treatment for multiple myeloma.

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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.

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Study of the drug acalabrutinib and rituximab in patients with CLL/SLL

Lead Researcher: Paul Barr

Despite an array of available therapies, chronic lymphocytic leukemia (CLL) remains an incurable disease. The development of an improved therapy would be a major contribution to the management of CLL and other B cell malignancies. The investigator proposes that the drug acalabrutinib will work better with an antibody treatment, rituximab, in the treatment of CLL.

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Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative colitis is an inflammatory bowel disease (IBD) that causes long-lasting inflammation and ulcers (sores) in your digestive tract. Ulcerative colitis affects the innermost lining of your large intestine (colon) and rectum. The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

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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

Lead Researcher: Lisa Beck

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.

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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.

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Targeted Lung Cancer Treatment Study (Lung-MAP Study)

Lead Researcher: Megan Baumgart

This study is being done to answer the following question: Can we lower the chance of your lung cancer growing or spreading by using a drug that targets a biomarker (biological marker) present in your tumor? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your lung cancer. The usual approach is defined as care most people get for their lung cancer.

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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.

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Teriparatide as a Regenerative Therapy in Knee Osteoarthritis

Lead Researcher: Christopher Ritchlin

If you decide to take part in this study, you will be asked to complete UP TO 16 study visits over the course of the next two and a half years. This study will determine if the drug Teriparatide (Forteo)improves arthritis in knee joints. If you have osteoarthritis in your knee you may be eligible to enroll. You will be assigned by chance (like flipping a coin) to one of two groups. Group 1 will receive the study drug (teriparatide) and Group 2 will receive a placebo (saline). There is an equal chance that you will be assigned to either group. Study Staff members will not know which group you have been assigned to. You will be asked to inject yourself with the study injection pen every day for 24 weeks. A nurse will teach you how to administer the injection. As a part of these visits study staff will ask you to rate your pain and test your physical function. They will also collect height, weight, blood pressure, pulse, collect blood and urine samples and pain surveys. You will have x rays and MRIs of your knee.

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The Couples Sexual Health Study

Lead Researcher: Natalie Leblanc

The Sexual Health HIV Prevention Toolkit originally designed for gay couples is a guide for couples to think about their relationship and sexual health. The purpose of this study is to learn if an online Sexual Health Toolkit originally designed for gay couples to use together would be acceptable by Black Heterosexual couples. You do not need to be HIV infected or at risk for HIV to participate in this study. Couples who are either aware or not aware of their HIV status are invited to participate. Both you and you partner have to agree to participate. The study has two phases: an online survey with consent, and an in-person interview phase. HIV testing is not provided as part of the study. We will pay you for your time and travel.

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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.

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The REPLACE Registry-for people who take Cholbam/Kolbam (Cholic Acid)

Lead Researcher: Nanda Kerkar

This is a study for people who take Cholbam/Kolbam also known as Cholic acid. You will be in this study for 10 years and we will collect information about your health.

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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.

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The social brain study

Lead Researcher: David Dodell-feder

The purpose of this study is to learn how people with schizophrenia think about other people when in social situations. The study involves three parts, which will be completed on separate days: 1. Clinical interviews, questionnaires, paper-and-pencil and computerized assessments of cognition (4-6 hours, which can be completed in multiple sessions) 2. Magnetic resonance imaging (MRI) scan (2 hours) 3. Daily diary questionnaire (7 days, 5 minutes/day)

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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.

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Tissue Bank Study for Thrombotic Thrombocytopenic Purpua

Lead Researcher: Frank Akwaa

Thrombotic Thrombocytopenic Purpura (TTP) is a rare blood disease that can affect some people once, but it can be a recurrent problem with chronic issues for others. This study will help us understand why this is the case. Blood samples and data will be stored and used in the future to learn more about this condition.

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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.

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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.

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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?

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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.

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trūFreeze® Palliative Esophageal Cancer

Lead Researcher: Vivek Kaul

Prospective, open label, non-controlled single arm, multi-center study. The primary objective is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.

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Umbilical Cord Blood Transplantation from Unrelated Donors

Lead Researcher: Jane Liesveld

This study is a single-center treatment protocol with four possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution. Enrolled patients will receive chemotherapy +/-total body radiation as a pre-transplant conditioning regimen. Patients will then receive cord blood stem cells followed by GvHD prophylaxis that will include Tacrolimus and Mycophenolate Mofetil, or Cyclosporin A and Methylprednisolone. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

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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.

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URMC Related Haplo-identical Donor BMT (HaploOnly)

Lead Researcher: Jeffrey Andolina

This study will be a single-center treatment protocol with five possible preparative regimens, designed to validate the process of related donor haploidentical-SCT at the Wilmot Cancer Institute Blood and Marrow Transplant Unit. Enrolled patients will receive chemotherapy +/- radiation as a pre-transplant conditioning regimen. Patients will then receive haploidentical stem cells, either bone marrow or mobilized peripheral blood, followed by GvHD prophylaxis that will include cyclophosphamide. Multiple data points will be collected prior to, during, and following transplantation to ensure safety of the process and to evaluate the stated objectives.

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Using An Investigational Drug to Treat Non-Diabetic Nerve Pain ("TopCSPN")

Lead Researcher: Peter Creigh

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.

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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.

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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.

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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.

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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.

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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.

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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.

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Whole-Food, Plant-Based Nutrition Among Women with 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.

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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.

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