Randomized Double-Blind Placebo-controlled Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2-GDNF) in Multiple System Atrophy
In this clinical trial, we are testing a drug called glial cell line-derived neurotrophic factor (GDNF) gene transfer to see if it helps people with Multiple System Atrophy (MSA). GDNF gene is delivered to a part of the brain involved in MSA. This study will evaluate the safety of this study drug, and see whether it can improve the course of MSA.
Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy (REBIRTH) for Peripartum Cardiomyopathy
The purpose of the study is to test the use of a drug called bromocriptine for women who have a condition called “Peripartum cardiomyopathy” or PPCM. PPCM means you have heart failure at the end of pregnancy or after giving birth. The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill.
Randomized multicenter open-label phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRa-positive recurrent platinum-sensitive epithelial ovarian fallopian tube or primary peritoneal cancers who have not progressed after second line platinum-based chemotherapy plus bevacizumab(GOG 3078)
The purposes of this study are: • To determine if mirvetuximab soravtansine (MIRV) plus BEV is effective at managing subjects' type of cancer in a maintenance setting, meaning to assess if it helps to prevent their cancer from returning or delaying their cancer’s return. • To determine if mirvetuximab soravtansine (MIRV) plus BEV is more effective at managing subjects' type of cancer in a maintenance setting than treatment with BEV alone.• To find out what effects, both good and/or bad, MIRV plus BEV may have on subjects and their type of cancer. • To assess if taking MIRV and BEV affects quality of life, both good and/or bad.
Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib Alone as Maintenance Therapy in Metastatic Pancreatic Cancer Patients with Germline BRCA1 or BRCA2 Mutations
chemotherapy. The goals of the study are to check how safe and well-tolerated both treatments are, how long people stay without their cancer getting worse, and how long the treatments help people improve. The study will also look at overall survival, how well the cancer responds to the treatment, and how long the positive effects last. Patients will be randomly assigned to either the combination treatment or olaparib alone after they’ve finished chemotherapy. The study will also collect tissue and blood samples for future research. This study is testing whether combining two treatments—one that damages cancer cells (olaparib) and one that boosts the immune system (pembrolizumab)—can help improve survival for people with this dangerous cancer.
Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS = 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)
A randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab versus Paclitaxel + Ramucirumab in Patients with PD-L1 CPS = 1 Advanced Gastric and Esophageal Adenocarcinoma
Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck
This study will therefore address the question whether docetaxel alone is as active as docetaxel and cetuximab combination and whether either taxane-based regimen is better than cisplatin monotherapy given to this high-risk group of patients with concurrent radiation. The less toxic weekly cisplatin regimen is selected to enhance compliance in the control arm and to parallel to weekly regimen proposed for the 2 experimental arms. If positive, this study will provide a new standard of care with a non-cisplatin regimen for patients with high-risk head and neck squamous cell carcinoma in the postop setting.
Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma
This study is testing whether receiving medicine called cemiplimab (PD-L1 antibody), before surgery (neoadjuvant immunotherapy), is more effective than standard surgery for patients with resectable stage III/IV cutaneous squamous cell carcinoma. Patients will be divided into two groups. The first group will receive standard surgery followed by radiation. The second group will receive an immunotherapy medicine called cemiplimab before the surgery, followed by radiation. The study team will take blood samples from all patients to see if the blood counts are within acceptable ranges and the patients are doing well. Patients will have special scans taken at different times during the study to see how the study medicine is changing their tumor size. All patients will be closely monitored for side effects and discomfort throughout the study. Patients will be followed up to 2 years after the end of treatment.
Randomized placebo controlled trial to determine the biological signature of cannabidiol as a treatment for social anxiety disorder
The goals of these two phased studies (“R61” followed by “R33”) are to establish a biological signature of CBD’s putative therapeutic effects in SAD and its link to core SAD symptoms, to provide estimates of clinical effect sizes, and to provide safety and feasibility data to guide a future definitive RCT of CBD for SAD.
Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition
A dose-escalation phase (phase I) is added to determine RP2D. In phase I, 3 mg/kg dose were added in the dose escalation phase, including 6 patients to receive study drug at 3 mg/kg and Lu 177 vipivotide and 3 patients to receive Lu 177 vipivotide alone. Optional intermediate doses of 6 mg/kg and 1 mg/kg was proposed in case either 3 mg/kg or 10 mg/kg was found to have excess toxicity.DLT observation period updated to 28 days.Added Exploratory Objectives.Trial design has been updated to include dose escalation phase (phase I) and dose expansion phase (phase II).
Rapid Motion-Robust and Easy-to-Use Dynamic Contrast-Enhanced MRI for Liver Perfusion Quantification (Non-treatment cohort)
We propose to develop new rapid MRI techniques combining novel motion-robust sampling strategies and advanced reconstruction models to address these challenges.