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RECOVER-VITAL: Platform Protocol to Measure the Effects of Antiviral Therapies on Long COVID Symptoms
Kanecia Obie Zimmerman
Long COVID
Long Covid19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a
prospective, multi-center, multi-arm,... expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, double-blind, randomized, controlled platform trial with different interventions organized as appendices to the protocol. Each appendix (or sub-study) evaluates potential mechanisms of action, efficacy, and safety of antivirals and other therapeutics in individuals with PASC, according to the platform protocol objectives. The hypothesis is that persistent viral infection, viral reactivation, and/or overactive/chronic immune response and inflammation are underlying contributors to PASC and that antiviral and other applicable therapies may result in viral clearance or decreased inflammation and improvement in PASC symptoms. Type: Interventional Start Date: Jul 2023 |
A Study of LY3540378 in Participants With Worsening Chronic Heart Failure With Preserved Ejection Fraction...
Eli Lilly and Company
Heart Failure
Heart Failure With Preserved Ejection Fraction
The main purpose of this study is to assess the efficacy and safety of LY3540378 in
adults with worsening heart failure with preserved ejection fraction expand
The main purpose of this study is to assess the efficacy and safety of LY3540378 in adults with worsening heart failure with preserved ejection fraction Type: Interventional Start Date: Feb 2023 |
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib,...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. expand
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd. Type: Interventional Start Date: Mar 2023 |
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth...
Janssen Research & Development, LLC
Carcinoma, Non-small-Cell Lung
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab
which will be administered as a co-formulation with recombinant human hyaluronidase PH20
(rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts
except Cohort 4) and to characterize... expand
The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation [SC-CF]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4). Type: Interventional Start Date: Nov 2022 |
Perception in Parkinson's Disease
Boston University Charles River Campus
Parkinson's Disease
Perception
Visual Hallucination
The investigators plan to examine the relation of perceptual variables-basic vision,
unusual perceptual experiences(including but not limited to visual hallucinations)-to
relevant functional variables such as cognition, mood, and alertness/sleepiness in an
online sample of persons with Parkinson's... expand
The investigators plan to examine the relation of perceptual variables-basic vision, unusual perceptual experiences(including but not limited to visual hallucinations)-to relevant functional variables such as cognition, mood, and alertness/sleepiness in an online sample of persons with Parkinson's disease (PwPD). It is hypothesized that unusual perceptual experiences will relate significantly to the selected variables. Participants do not need to experience visual hallucinations to be able to participate in this study. This is an observational study only, and not an interventional study. Type: Observational Start Date: Sep 2022 |
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and...
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC)
in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in
combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination
with pomalidomide and dexamethasone... expand
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Type: Interventional Start Date: Oct 2022 |
A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's...
Biogen
Parkinson Disease
In this study, researchers will learn more about a study drug called BIIB122 in
participants with early-stage Parkinson's disease (PD). In this study:
- Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by
mouth. A placebo looks like the study drug but has no... expand
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study: - Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it. - Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks. - Certain medications for PD will be allowed at enrollment for a subset of participants. - Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122. Type: Interventional Start Date: Apr 2022 |
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed...
Merck Sharp & Dohme LLC
Carcinoma, Non-Small-Cell Lung
Researchers are looking for new ways to treat people with locally advanced non-small cell
lung cancer (NSCLC). The goal of this study is to learn if people who receive the
combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer
getting worse and live longer overall... expand
Researchers are looking for new ways to treat people with locally advanced non-small cell lung cancer (NSCLC). The goal of this study is to learn if people who receive the combination of vibostolimab and pembrolizumab (MK-7684A) live longer without the cancer getting worse and live longer overall than people who receive durvalumab. Type: Interventional Start Date: May 2022 |
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis...
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with SSc-ILD. expand
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD. Type: Interventional Start Date: Jul 2022 |
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene...
Stichting European Myeloma Network
Multiple Myeloma
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib,
Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus
Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous
Stem Cell Transplant (ASCT) in newly diagnosed multiple... expand
The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients. Type: Interventional Start Date: Oct 2023 |
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
Janssen Research & Development, LLC
Amyloidosis
The purpose of this study is to characterize cardiac safety of Daratumumab,
Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A:
daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly
diagnosed systemic amyloid light chain (AL) amyloidosis... expand
The purpose of this study is to characterize cardiac safety of Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone (D-VCd) treatment regimens (Arm A: daratumumab + immediate VCd treatment and Arm B: daratumumab + deferred VCd) in newly diagnosed systemic amyloid light chain (AL) amyloidosis with cardiac involvement and to identify potential mitigation strategies for cardiac toxicity (cohort 1); to characterize the pharmacokinetics of subcutaneous (SC) daratumumab, among racial and ethnic minorities, including Black or African American, with newly diagnosed AL amyloidosis treated with D-VCd (cohort 2). Type: Interventional Start Date: Mar 2022 |
Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced...
Alliance for Clinical Trials in Oncology
Metastatic Pancreatic Neuroendocrine Tumor
Unresectable Pancreatic Neuroendocrine Carcinoma
This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate
for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of
the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy
drugs, such as capecitabine and... expand
This phase II trial compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors. Type: Interventional Start Date: Mar 2022 |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FTX-6058
Fulcrum Therapeutics
Sickle Cell Disease
Sickle Cell Anemia
This is a study to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of FTX-6058 in participants with sickle cell disease. expand
This is a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of FTX-6058 in participants with sickle cell disease. Type: Interventional Start Date: Dec 2021 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease...
Agios Pharmaceuticals, Inc.
Sickle Cell Disease
This clinical trial is a Phase 2/3 study that will determine the recommended dose of
mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by
testing how well mitapivat works compared to placebo to increase the amount of hemoglobin
in the blood and to reduce or prevent... expand
This clinical trial is a Phase 2/3 study that will determine the recommended dose of mitapivat and evaluate the efficacy and safety of mitapivat in sickle cell disease by testing how well mitapivat works compared to placebo to increase the amount of hemoglobin in the blood and to reduce or prevent the occurrence of sickle cell pain crises. In addition, the long-term effect of mitapivat on efficacy and safety will be explored in an open-label extension portion. Type: Interventional Start Date: Feb 2022 |
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
Prothena Biosciences Ltd.
Light Chain (AL) Amyloidosis
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis. expand
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis. Type: Interventional Start Date: Aug 2021 |
Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals...
Pfizer
Sickle Cell Disease
This registry is an observational study designed to evaluate the effect of Oxbryta in
individuals with SCD in a real-world setting. expand
This registry is an observational study designed to evaluate the effect of Oxbryta in individuals with SCD in a real-world setting. Type: Observational [Patient Registry] Start Date: Feb 2022 |
Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)
Novo Nordisk A/S
Non-alcoholic Steatohepatitis
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known
medicine, which is already used by doctors to treat type 2 diabetes in many countries.
Participants will either get semaglutide or a dummy medicine - which treatment
participants get is decided by chance.
Participants... expand
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period. Type: Interventional Start Date: Apr 2021 |
Fenofibrate for Prevention of DR Worsening
Jaeb Center for Health Research
Diabetic Retinopathy
This randomized trial will evaluate the effect of fenofibrate compared with placebo for
prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes
with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline.
In addition to evaluating efficacy,... expand
This randomized trial will evaluate the effect of fenofibrate compared with placebo for prevention of diabetic retinopathy (DR) worsening through 6 years of follow-up in eyes with mild to moderately severe non-proliferative DR (NPDR) and no CI-DME at baseline. In addition to evaluating efficacy, this study aims to evaluate the feasibility of a model for ophthalmologists to prescribe or collaborate with a primary care provider such as an internist/endocrinologist to prescribe and monitor the drug safely. If this study demonstrates that fenofibrate is effective for reducing the onset of proliferative diabetic retinopathy (PDR) or and the results are adopted by the community of retina specialists, a new strategy to prevent vision threatening complications of diabetes could be widely adopted. Widespread use of an oral agent effective at reducing worsening of DR would decrease the numbers of patients who undergo more invasive and much more expensive treatment for DR and who are consequently at risk for side effects that adversely affect visual function. This study will also assess the relationship of glycemic variability, as measured by continuous glucose monitoring with DR outcomes. Ancillary studies will characterize functional and structural outcomes in this cohort. Type: Interventional Start Date: Mar 2021 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive...
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Trastuzumab... expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
Alliance for Clinical Trials in Oncology
Pancreatic Adenosquamous Carcinoma
Resectable Pancreatic Adenocarcinoma
Pancreatic Cancer
This phase III trial compares perioperative chemotherapy (given before and after surgery)
versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer
that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as
fluorouracil, irinotecan, leucovorin,... expand
This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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 chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly). Type: Interventional Start Date: Jul 2020 |
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study
ECOG-ACRIN Cancer Research Group
Anal Basaloid Carcinoma
Anal Canal Cloacogenic Carcinoma
Anal Canal Squamous Cell Carcinoma
Anal Margin Squamous Cell Carcinoma
Stage I Anal Cancer AJCC v8
This phase II trial studies how well lower-dose chemotherapy plus radiation
(chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating
patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin,
fluorouracil, and capecitabine, work in different... expand
This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, 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 with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type. Type: Interventional Start Date: Jan 2020 |
S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration
SWOG Cancer Research Network
Multiple Myeloma
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg
Step 2. Patients are followed until they will begin Maintenance and then registered to
Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2
years and Lenalidomide + Daratumumab/rHuPH20.... expand
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years. Type: Interventional Start Date: Aug 2019 |
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
Icahn School of Medicine at Mount Sinai
Atrial Fibrillation
Stroke
Bleeding
The primary objective of this study is to evaluate the effectiveness (prevention of
thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC)
to background antiplatelet therapy in patients who develop new-onset post-operative
atrial fibrillation (POAF) after isolated... expand
The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey. Type: Interventional Start Date: Dec 2019 |
Trial of Parkinson's And Zoledronic Acid
California Pacific Medical Center Research Institute
Parkinson Disease
Osteoporosis
Parkinsonism
Parkinson's Disease and Parkinsonism
Atypical Parkinsonism
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion
of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60
years and older with Parkinson's disease and parkinsonism with at least 2 years of
follow-up. A total of 3500 participants... expand
This home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging. Type: Interventional Start Date: Nov 2019 |
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