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Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol
University of Southern California
Mild Cognitive Impairment (MCI)
Alzheimer's Disease (AD)
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging
Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD.
ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been
combined... expand
Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research. Type: Observational Start Date: Oct 2016 |
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)
Boehringer Ingelheim
Chronic Kidney Disease
The primary aim of the study is to investigate the effect of empagliflozin on kidney disease
progression or cardiovascular death versus placebo on top of standard of care in patients
with pre-existing chronic kidney disease
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The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease Type: Interventional Start Date: Jan 2019 |
Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD
Massachusetts General Hospital
Treatment Resistant Major Depressive Disorder
This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment
arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing,
stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a
therapeutically... expand
This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine. Type: Interventional Start Date: May 2017 |
A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
University of Florida
Prostate Cancer
This study is a large, prospective, pragmatic, controlled comparison of patient-centric
outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of
men with prostate cancer treated simultaneously at proton therapy facilities and at
geographically... expand
This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes [quality of life (QOL), toxicity, and disease control] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques. Type: Interventional Start Date: Jul 2018 |
ACTIV-2: A Study for Outpatients With COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)
Coronavirus
Covid19
Drug studies often look at the effect one or two drugs have on a medical condition, and
involve one company. There is currently an urgent need for one study to efficiently test
multiple drugs from more than one company, in people who have tested positive for COVID-19
but who... expand
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. Participants in the study will be treated with either a study drug or with placebo. Type: Interventional Start Date: Aug 2020 |
A Study to Evaluate Ibrutinib Combination Therapy in Patients With Selected Gastrointestinal and Genitourinary...
Pharmacyclics LLC.
Metastatic Renal Cell Carcinoma
Advanced Urothelial Carcinoma
Advanced Gastric Adenocarcinoma
Metastatic Colorectal Adenocarcinoma
The purpose of this study is to evaluate the safety, tolerability, and efficacy of single
agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel,
docetaxel, pembrolizumab or cetuximab in selected advanced gastrointestinal and genitourinary
tumors.... expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab or cetuximab in selected advanced gastrointestinal and genitourinary tumors. Type: Interventional Start Date: Nov 2015 |
Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors...
University of Kansas Medical Center
End Stage Renal Disease
The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve
cognitive function by having less effect on brain blood flow.
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The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow. Type: Observational Start Date: Feb 2018 |
Hepcidin Mimetic in Patients With Polycythemia Vera
Protagonist Therapeutics, Inc.
Polycythemia Vera
This is a Phase 2 study with an open-label dose escalation phase followed by a blinded
withdrawal phase and an open label extension. The study is designed to monitor the PTG-300
safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of
phlebotomy-requiring... expand
This is a Phase 2 study with an open-label dose escalation phase followed by a blinded withdrawal phase and an open label extension. The study is designed to monitor the PTG-300 safety profile and to obtain preliminary evidence of efficacy of PTG-300 for the treatment of phlebotomy-requiring polycythemia vera. Type: Interventional Start Date: Oct 2019 |
Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD)
University of Kansas Medical Center
FSHD
The primary goal of this proposal is to collect motor and functional outcomes specific to
FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level
of clinical care is being provided. Also, the hope is to speed up drug development by gaining... expand
The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD. Type: Observational Start Date: Nov 2020 |
LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109...
Santen Inc.
Non Infectious Uveitis
This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months
in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).
There is a 6-month, single-arm, open-label period after completion of the 6-month double-... expand
This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control. Type: Interventional Start Date: Nov 2018 |
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc.
Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary
surgical and minimally invasive intervention post index procedure, as well as harms
associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a
control... expand
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor. Type: Observational Start Date: Mar 2017 |
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal...
Alliance for Clinical Trials in Oncology
Stage II Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
This phase II/III trial studies the best dose of duloxetine and how well it works in
preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with
oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount
of certain... expand
This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy. Type: Interventional Start Date: May 2020 |
A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis,...
CTI BioPharma
Primary Myelofibrosis
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID
of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe
thrombocytopenia (platelet count <50,000/μL). Approximately 348 patients in total will be... expand
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 348 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 232 patients) or to P/C therapy (approximately 116 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib Type: Interventional Start Date: Jun 2017 |
Phase 3 Clinical Effect Durability of TD-9855 for Treating Symptomatic nOH in Subjects With Primary Autonomic...
Theravance Biopharma
Symptomatic Neurogenic Orthostatic Hypotension
A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating
Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
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A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of ampreloxetine in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure Type: Interventional Start Date: Feb 2019 |
Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic...
NovoCure Ltd.
Pancreas Adenocarcinoma
Brief Summary:
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy
and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and
nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The... expand
Brief Summary: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. Type: Interventional Start Date: May 2018 |
Rucaparib Plus Ramucirumab With or Without Nivolumab in Advanced Gastric and Esophageal Adenocarcinoma
Anwaar Saeed
Esophagus Cancer, Adenocarcinoma
Stomach Cancer, Adenocarcinoma
The study population is advanced gastric, gastroesophageal, and esophageal adenocarcinoma
participants who have failed upfront standard of care chemotherapy. The goal is to
demonstrate that Rucaparib plus Ramucirumab with or without Nivolumab has a higher response
rate than... expand
The study population is advanced gastric, gastroesophageal, and esophageal adenocarcinoma participants who have failed upfront standard of care chemotherapy. The goal is to demonstrate that Rucaparib plus Ramucirumab with or without Nivolumab has a higher response rate than what has been reported for Ramucirumab in previously treated patients. Trial will be a phase 1/2 trial. The Phase 1 portion will determine the recommended Phase 2 treatment dose for the combination of Rucaparib plus Ramucirumab and Nivolumab and enroll approximately 6-9 participants. The Phase 2 portion of the study will involve 52 participants allocated between two treatment groups comparing Rucaparib plus Ramucirumab with or without Nivolumab. The participants will be selected based on the results of a screening HRD gene panel. Type: Interventional Start Date: Jan 2020 |
Multicenter Study Of Natalizumab Plus Standard Steroid Treatment For High Risk Acute Graft-Versus-Host...
John Levine
Acute Graft Versus Host Disease
This research trial is designed to study the safety and effectiveness of combining the study
drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new
treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious... expand
This research trial is designed to study the safety and effectiveness of combining the study drug, Natalizumab (Tysabri®) with the standard treatment, the use of steroids, as a new treatment for acute graft versus host disease (acute GVHD). GVHD is the most common serious complication, after bone marrow transplant. GVHD occurs when the donor cells (the graft), treat the recipient's body as "foreign" and attack the cells in the recipient's body. During this immune system response, donor cells damage body tissues, such as the skin, liver, stomach, and/or intestines. Acute GVHD can be severe and if severe, potentially fatal to the transplant recipient. Acute GVHD usually happens within the first several months after transplant. The goal of this research is to develop a safer and more effective treatment for acute GVHD, and particularly for acute GVHD that affects the gastrointestinal (or GI) tract, with the ultimate goal being safer and more effective transplant therapies for blood cancers such as leukemia, lymphoma, and multiple myeloma. Type: Interventional Start Date: Aug 2016 |
Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery...
Merck Sharp & Dohme Corp.
Head and Neck Neoplasms
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given
prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or
without cisplatin), as post-surgical therapy in treatment naïve participants with newly
diagnosed... expand
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves major pathological response and event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone. Type: Interventional Start Date: Dec 2018 |
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
Jun Zhang, MD, PhD
NSCLC Stage IV
NSCLC, Recurrent
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung
cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy
treatment as well as determine ahead of time adverse events and their severity. In addition,... expand
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers. Type: Observational Start Date: Jul 2020 |
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Eli Lilly and Company
Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as
maintenance therapy in participants who completed prior 12-week induction study AMAN
(NCT03518086).
expand
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086). Type: Interventional Start Date: Oct 2018 |
S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer
Southwest Oncology Group
Cardiotoxicity
HER2/Neu Positive
Metastatic Malignant Neoplasm in the Brain
Recurrent Breast Carcinoma
Stage IV Breast Cancer AJCC v6 and v7
This phase III trial studies how well carvedilol works in preventing cardiac toxicity in
patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has
spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat
heart... expand
This phase III trial studies how well carvedilol works in preventing cardiac toxicity in patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. A beta-blocker, such as carvedilol, is used to treat heart failure and high blood pressure, and it may prevent the heart from side effects of chemotherapy. Type: Interventional Start Date: Sep 2017 |
A Study of TheraT® Vector(s) Expressing HPV 16+ in Patients With HPV 16+ Confirmed Cancers
Hookipa Biotech GmbH
HPV-Related Squamous Cell Carcinoma
This is an First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of
HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+
confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.... expand
This is an First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion. Type: Interventional Start Date: Dec 2019 |
Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer
National Cancer Institute (NCI)
Limited Stage Lung Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage IA1 Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8
This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation)
with or without atezolizumab works in treating patients with limited stage small cell lung
cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in... expand
This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, 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. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer. Type: Interventional Start Date: May 2019 |
NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
National Institute of Allergy and Infectious Diseases (NIAID)
Gastroenteritis Norovirus
This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and
safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell
transplant recipients with symptomatic diarrhea due to Norovirus. The study involves a total
of 160... expand
This is a phase 2 multi-center, double-blind, placebo-controlled study of the efficacy and safety of nitazoxanide for the treatment of solid organ and hematopoietic stem cell transplant recipients with symptomatic diarrhea due to Norovirus. The study involves a total of 160 Hematopoietic Stem Cell or Solid Organ transplant recipients, equal to or greater than 12 years of age with diagnosis of Norovirus who will be selected and randomly assigned (1:1) to nitazoxanide or placebo group. The study duration is 60 months and subject participation duration is 6 months. Given the safety of prolonged therapy with nitazoxanide, lack of interactions with common post-transplant medications, putative antiviral activity and prolonged duration of viral shedding we are assessing 56 doses of therapy. The longitudinal monitoring phase will provide useful information on the course of host and viral responses in subjects with chronic Norovirus infection with and without treatment. Randomization will be stratified by age group (pediatric (12 through 17 years) vs. adult (greater than or equal to 18 years)), chronicity of Norovirus-associated symptoms (acute (less than 14 days) vs. chronic (greater than or equal to 14 days)) and transplant type (solid organ (SOT)) vs. hematopoietic stem cell transplant (HSCT)). Enrolled subjects will participate in 2 phases of the study: Treatment Phase, which will include dosing with the assigned study agent for 28 days. Longitudinal Monitoring Phase which will include telephone call on Days 35, 53, 113, 173. Primary objective is 1) to assess the clinical efficacy of nitazoxanide for the management of acute and chronic Norovirus in transplant recipients. Type: Interventional Start Date: Oct 2018 |
Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer
Southwest Oncology Group
Previously Treated Non-Small Cell Lung Cancer
This screening and multi-sub-study randomized phase II/III trial will establish a method for
genomic screening of similar large cancer populations followed by assigning and accruing
simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer
trait... expand
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies. Type: Interventional Start Date: Jan 2019 |