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mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or...
Alliance for Clinical Trials in Oncology
Advanced Esophageal Adenocarcinoma
Advanced Gastric Adenocarcinoma
Advanced Gastroesophageal Junction Adenocarcinoma
Clinical Stage III Esophageal Adenocarcinoma AJCC v8
Clinical Stage III Gastric Cancer AJCC v8
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium,
oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium,
and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2
negative esophageal, gastroesophageal... expand
This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers. Type: Interventional Start Date: Jan 2023 |
Longitudinal Spatial Frequency Domain Imaging Study
Boston University
Systemic Scleroderma
Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen
deposition) of the skin and internal organs. The extent of skin fibrosis is an important
predictor of internal organ complications and increased mortality. Currently imprecise
and subjective methods that varies amongst... expand
Scleroderma (SSc) is an autoimmune disease characterized by fibrosis (or collagen deposition) of the skin and internal organs. The extent of skin fibrosis is an important predictor of internal organ complications and increased mortality. Currently imprecise and subjective methods that varies amongst different doctors for the same patient are available to quantify skin fibrosis in patients, by "pinching" their skin and assessing how thick it is; this is the method used to determine the modified Rodnan skin score (mRSS). Skin thickness and the amount of fibrosis can change over time due to disease progression or in response to therapy. In this research, longitudinal measurements will be taken to determine if spatial frequency domain imaging (SFDI) can detect changes in skin thickness that occur over time in response to therapy or from disease progression in scleroderma patients. This study will compare SFDI with other clinical outcome assessments of skin thickness and fibrosis in scleroderma patients including mRSS, skin biopsy histology, scleroderma skin patient reported outcome (SSPRO), ultrasound, and durometry (durometer measures skin hardness). SFDI information will also be compared with capillaroscopy (allows for non-invasive imaging of the nailfold capillaries) if available from the electronic medical record. If SFDI correlates well with other clinical outcome assessments, it may be used in the future as a rapid, non-invasive tool for monitoring disease activity in scleroderma patients. Type: Interventional Start Date: Feb 2023 |
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune...
Novartis Pharmaceuticals
Primary Immune Thrombocytopenia
The purpose of this study is to evaluate the effect of two different doses of ianalumab
added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary
ITP who failed previous first-line treatment with steroids. expand
The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids. Type: Interventional Start Date: Feb 2023 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Alliance for Clinical Trials in Oncology
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after
long-course chemoradiation in patients with stage II-III rectal cancer. Combination
chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and
oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
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 in Part 1
and to further characterize safety and efficacy of an alternative dosing for teclistamab
in Part 2 in participants with relapsed or refractory multiple myeloma. expand
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma. 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 |
Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Jaeb Center for Health Research
Intermittent Exotropia
Determine whether full-time patching is more effective than observation for improving
distance control of IXT after 3 months of treatment (on-treatment outcome). expand
Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome). Type: Interventional Start Date: Nov 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 Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and...
Theratechnologies
HIV Infections
Multi-Antiviral Resistance
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical
trials. This study will expand ibalizumab's clinical data set and allow a better
understanding of the virologic response durability on ARV regimens with or without
ibalizumab in a heterogeneous real-world patient... expand
The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end. Primary Objective: To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab. Secondary Objective: To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment. To assess the long-term safety and tolerability of ibalizumab. Other Objectives: To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll. Type: Observational Start Date: Mar 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 |
Aspiration in Acute Respiratory Failure Survivors 2
University of Colorado, Denver
Dysphagia
Aspiration
The purpose of this study is to learn more about problems with swallowing that could
develop in patients who are very sick and need a machine to help them breathe. expand
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. 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 |
Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Pulmonary Arterial Hypertension
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly
called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy)
versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in
participants who are newly diagnosed... expand
The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression. Type: Interventional Start Date: Mar 2022 |
PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD)
progression in study participants with manifest... expand
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Jaeb Center for Health Research
Amblyopia
A randomized trial to determine whether simultaneous treatment with spectacles and
patching has an equivalent VA outcome compared with sequential treatment, first with
spectacles alone followed by patching (if needed), for previously untreated amblyopia in
children 3 to <13 years of age. expand
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to <13 years of age. Type: Interventional Start Date: Dec 2020 |
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 |
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