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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 |
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 |
Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance
Massachusetts General Hospital
Chronic Pain
Dual medication (guanfacine and morphine) as a standard treatment for chronic pain.
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Dual medication (guanfacine and morphine) as a standard treatment for chronic pain. Type: Interventional Start Date: Nov 2013 |
Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers
Massachusetts General Hospital
Obsessive Compulsive Disorder
The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic
stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive
compulsive disorder. Additionally, this study aims to identify the mechanisms of action of
TMS and... expand
The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive compulsive disorder. Additionally, this study aims to identify the mechanisms of action of TMS and potential biomarkers and predictors of treatment response. Type: Interventional Start Date: May 2015 |
Effect of Guanfacine on the Reversal of Opioid-induced Hyperalgesia (OIH)
Massachusetts General Hospital
Chronic Pain
Combination of guanfacine with opioid medication as a standard treatment for chronic pain.
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Combination of guanfacine with opioid medication as a standard treatment for chronic pain. Type: Interventional Start Date: Sep 2014 |
Cardiometabolic Disease and Pulmonary Hypertension
Massachusetts General Hospital
Obesity
This study will investigate if metformin can help people with obesity and high pressures
inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug
Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat
pulmonary hypertension.... expand
This study will investigate if metformin can help people with obesity and high pressures inside their lung blood vessels. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat diabetes, but metformin is not approved by the FDA to treat pulmonary hypertension. This study will examine whether Metformin will improve the high pressure inside lung blood vessels in people who are obese. The study will help understand the effect of metformin on pressures inside lung blood vessels. Type: Interventional Start Date: Nov 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 |
Shift Work, Heredity, Insulin, and Food Timing Study
Massachusetts General Hospital
Shift Work Type Circadian Rhythm Sleep Disorder
Diabetes Mellitus, Type 2
Circadian Rhythm Sleep Disorder, Shift Work Type
Insulin Resistance
The purpose of this study is to determine whether night time eating that coincides with
elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the
MTNR1B risk allele.
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The purpose of this study is to determine whether night time eating that coincides with elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the MTNR1B risk allele. Type: Observational Start Date: Jan 2017 |
Medication Treatment for Opioid Use Disorder in Expectant Mothers
Theresa Winhusen, PhD
Opioid-Related Disorders
Drug Addiction
Pregnancy Related
Substance Abuse
Drug Abuse
The primary objective of this study is to evaluate the impact of treating opioid use disorder
(OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual
buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the... expand
The primary objective of this study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release buprenorphine (BUP-XR), compared to sublingual buprenorphine (BUP-SL), on mother and infant outcomes. The primary hypothesis is that the BUP-XR group will not have greater illicit opioid use than the BUP-SL group during pregnancy (non-inferiority). Type: Interventional Start Date: Jul 2020 |
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric...
Massachusetts General Hospital
Traumatic Brain Injury
Major Depressive Disorder
Bipolar Disorder
Schizophrenia
Attention Deficit Hyperactivity Disorder
In the current study, the investigators aim to understand the role of transcranial direct
current stimulation (tDCS) in improving executive function across neuropsychiatric
populations known to have deficits in this cognitive domain.
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In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain. Type: Interventional Start Date: Sep 2014 |
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
ReCor Medical, Inc.
Hypertension
Vascular Diseases
Cardiovascular Diseases
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety
of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time
of consent. Prior to randomization, subjects will be hypertensive in the absence of
hypertension... expand
The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication. Type: Interventional Start Date: Dec 2018 |
Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants
National Institute of Allergy and Infectious Diseases (NIAID)
Peanut Allergy
Multi-food Allergy
This study is a multi-center, randomized, double-blind, placebo-controlled study in
participants 1 to less than 56 years of age who are allergic to peanut and at least two other
foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may
be... expand
This study is a multi-center, randomized, double-blind, placebo-controlled study in participants 1 to less than 56 years of age who are allergic to peanut and at least two other foods (including milk, egg, wheat, cashew, hazelnut, or walnut). While each participant may be allergic to more than two other foods, the primary endpoint/outcome in this study will only be assessed in peanut and two other foods for each participant. The primary objective of the study is to compare the ability to consume foods without dose-limiting symptoms during a double-blind placebo-controlled food challenge (DBPCFC), after treatment with either omalizumab or placebo for omalizumab. Type: Interventional Start Date: Jul 2019 |
Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)
Massachusetts General Hospital
HIV
HIV-infected individuals treated with antiretroviral medications are living longer, but have
an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone
called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV... expand
HIV-infected individuals treated with antiretroviral medications are living longer, but have an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV population in association with with increased belly fat and altered glucose metabolism. Elevations in aldosterone hormone may also be associated with abnormal blood flow, inflammation, and coronary plaque in the heart. This study is being conducted to evaluate whether therapies to reduce the actions of aldosterone may decrease the burden and progression of heart disease in the HIV population. Type: Interventional Start Date: Jan 2017 |
HIV Exposure In Utero and Metabolic Disease Risk in HIV-Negative Young Adults
Massachusetts General Hospital
HIV-exposed Uninfected
Globally, over 1 million babies are born to mothers with HIV each year. With the advent of
prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected
(HEU). A growing literature suggests that in utero HIV exposure - even in the absence of... expand
Globally, over 1 million babies are born to mothers with HIV each year. With the advent of prenatal antiretroviral therapy, up to 98% of these individuals may be HIV-exposed uninfected (HEU). A growing literature suggests that in utero HIV exposure - even in the absence of subsequent infection - may be associated with adverse health outcomes in infancy and childhood. However, there is little information about the long-term health implications of in utero HIV exposure later in life, such as into adulthood. In this study, for the first time, we seek to prospectively evaluate metabolic and immune indices among HEU young adults as compared to well-matched HIV-unexposed uninfected controls. This study serves as a necessary first step toward optimizing clinical care for this expanding and aging HEU population, including the implementation of novel screening and prevention strategies. Type: Observational Start Date: Oct 2019 |
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Massachusetts General Hospital
Genetic Testing
An electronic decision aid will be used to assist individuals in choosing a multi-gene panel
with their medical oncologist instead of a genetic counselor. A decision aid may facilitate
quality decisions around the selection of a specific multi-gene panel without a genetic... expand
An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid. Type: Interventional Start Date: Nov 2020 |
A Phase 3 Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe...
Concert Pharmaceuticals
Alopecia Areata
This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an
investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or
greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering
the... expand
This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo. Type: Interventional Start Date: Nov 2020 |
A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal...
Leap Therapeutics, Inc.
Gastric Cancer
Gastric Adenocarcinoma
GastroEsophageal Cancer
A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ±
Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally
Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
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A Phase 2a, Multicenter, Open-Label Study of DKN-01 in Combination with Tislelizumab ± Chemotherapy as First-Line or Second-Line Therapy in Adult Patients with Inoperable, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Type: Interventional Start Date: Jul 2020 |
A Study of Selpercatinib (LY3527723) in Participants With RET-Mutant Medullary Thyroid Cancer
Eli Lilly and Company
Medullary Thyroid Cancer
The reason for this study is to see if the study drug selpercatinib is safe and more
effective compared to a standard treatment in participants with rearranged during
transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or
has spread to... expand
The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib. Type: Interventional Start Date: Feb 2020 |
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
Alexion Pharmaceuticals
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for
the treatment of adult participants with NMOSD.
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The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD. Type: Interventional Start Date: Dec 2019 |
Combination Margetuximab, INCMGA00012, MGD013, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ...
MacroGenics
Gastric Cancer
Gastroesophageal Junction Cancer
HER2-positive Gastric Cancer
This is a Phase 2/3, randomized, open-label study for the treatment of patients with
HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the
efficacy of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and
margetuximab... expand
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer to determine the efficacy of margetuximab combined with INCMGA00012 (also known as MGA012) (Cohort A) and margetuximab combined with INCMGA00012 or MGD013 and chemotherapy compared to trastuzumab combined with chemotherapy (Cohort B). Type: Interventional Start Date: Sep 2019 |
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
Alliance for Clinical Trials in Oncology
CDK Gene Mutation
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
NTRK Family Gene Mutation
PI3K Gene Mutation
This phase II trial studies how well genetic testing works in guiding treatment for patients
with solid tumors that have spread to the brain. Several genes have been found to be altered
or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these... expand
This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation. Type: Interventional Start Date: Aug 2019 |
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed...
National Cancer Institute (NCI)
Anaplastic Astrocytoma
Anaplastic Ganglioglioma
Anaplastic Pleomorphic Xanthoastrocytoma
Glioblastoma
Malignant Glioma
This phase II trial studies how well the combination of dabrafenib and trametinib works after
radiation therapy in children and young adults with high grade glioma who have a genetic
change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells... expand
This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma. Type: Interventional Start Date: Oct 2019 |
Medtronic Deep Brain Stimulation (DBS) Therapy for Epilepsy Post-Approval Study (EPAS)
MedtronicNeuro
Epilepsy
The purpose of this post-approval study is to further evaluate the long-term safety and
effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted
participants through 3 years of follow-up in different geographic populations.
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The purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted participants through 3 years of follow-up in different geographic populations. Type: Interventional Start Date: Mar 2020 |
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke...
W.L.Gore & Associates
Stroke
PFO - Patent Foramen Ovale
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a
post approval setting and evaluate the quality of operator education and training and
transferability of trial experience to a post-market setting.
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This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting. Type: Interventional Start Date: Jul 2019 |
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
Medtronic Endovascular
Venous Reflux
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™
Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of
Early and Advanced Stage Superficial Venous Disease
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Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease Type: Interventional Start Date: Feb 2020 |