Search Clinical Trials
Sponsor Condition of Interest |
---|
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 |
Glecaprevir/Pibrentasvir Fixed-dose Combination Treatment for Acute Hepatitis C Virus Infection
AIDS Clinical Trials Group
Hepatitis C Infection
HIV Infection
The purpose of this study is to assess the efficacy of a fixed dose combination (FDC) of
glecaprevir/pibrentasvir (G/P) given for 4 weeks in acute hepatitis C (HCV)-infected
participants, with or without HIV-1 coinfection.
expand
The purpose of this study is to assess the efficacy of a fixed dose combination (FDC) of glecaprevir/pibrentasvir (G/P) given for 4 weeks in acute hepatitis C (HCV)-infected participants, with or without HIV-1 coinfection. Type: Interventional Start Date: Nov 2019 |
A Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Knee Osteoarthritis Pain.
Maurizio Fava, MD
Knee Osteoarthritis
The primary objective of this study is to evaluate the safety and efficacy of two doses of
CNTX-6970 for the treatment of pain related to OA of the knee compared to placebo. CNTX-6970
is being developed as a new treatment for chronic pain, including painful osteoarthritis of... expand
The primary objective of this study is to evaluate the safety and efficacy of two doses of CNTX-6970 for the treatment of pain related to OA of the knee compared to placebo. CNTX-6970 is being developed as a new treatment for chronic pain, including painful osteoarthritis of the knee. Type: Interventional Start Date: Oct 2021 |
Trial-Ready Cohort-Down Syndrome (TRC-DS)
University of Southern California
Down Syndrome
Alzheimer Disease
Dementia
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 non-demented
adults (ages 35-55) with Down syndrome (DS) into a trial ready cohort (TRC). Participants
enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic... expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 non-demented adults (ages 35-55) with Down syndrome (DS) into a trial ready cohort (TRC). Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Type: Observational Start Date: Jun 2021 |
The Role of Estrogen in the Neurobiology of Eating Disorders
Massachusetts General Hospital
Eating Disorders
Hypoestrogenemia
This is a randomized, double blind, placebo-controlled study of the effects of transdermal
estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder
pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an... expand
This is a randomized, double blind, placebo-controlled study of the effects of transdermal estradiol versus placebo on cognitive flexibility, reward processing, and eating disorder pathology in hypoestrogenemic female adolescents and young adults (ages 14-35 years) with an eating disorder characterized by extreme dietary restriction and/or excessive exercise. Subjects will be randomized 1:1 to 12 weeks of transdermal estradiol with cyclic progesterone or placebo patches and cyclic placebo pills. Study visits include a screening visit to determine eligibility and visits at baseline, 8 weeks, and 12 weeks. Study procedures comprise behavioral, neuroimaging, and endocrine assessments. Type: Interventional Start Date: Jun 2019 |
Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person...
University of Colorado, Denver
Diabetes Mellitus, Type 1
Type 1 Diabetes
Diabetes, Autoimmune
Diabetes type1
Autoimmune Diabetes
This is a study assessing the feasibility of using the insulin-only configuration of the iLet
bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care
practice with either in-person training and follow-up (PC-IP) or with training and follow-up... expand
This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). As a comparison, the iLet will be initiated by an academic endocrinology practice with either in-person training and follow-up (EN-IP) or with training and follow-up via telehealth (EN-TH). Type: Interventional Start Date: Mar 2022 |
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Massachusetts General Hospital
Anxiety Disorder of Childhood
Fear
Shyness
The purpose of this study is to test the feasibility and efficacy of intervening with
2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children
with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy
(CBT)... expand
The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety and their parents, using a parent-child Cognitive Behavioral Therapy (CBT) protocol to reduce anxiety disorders and maintain reduced anxiety at one-year follow-up. Before the COVID-19 pandemic, study visits and treatment sessions were conducted in office. Now all visits and treatment sessions are conducted remotely. Type: Interventional Start Date: Sep 2019 |
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
NYU Langone Health
Mild Cognitive Impairment
Alzheimer Disease
This study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild
Cognitive Impairment (aMCI) (CDR of 0.5-1, FAST 1-3; age 65-85) in a randomized clinical
trial of 8 weeks of t-PBM vs. sham. At screening, all subjects will complete initial
neuropsychological... expand
This study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) (CDR of 0.5-1, FAST 1-3; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At screening, all subjects will complete initial neuropsychological testing. To elucidate mechanisms of action of t-PBM, prior to treatment, subjects will undergo neuroimaging related to critical features of AD: tau 18F MK-6240 load (PET), measures of brain bioenergetics (31P-MRS), and functional connectivity (rs-fMRI). Subjects will also undergo an open label t-PBM session performed during fMRI to detect BOLD changes with t-PBM. Subjects will then be randomized to t-PBM/sham and complete treatments in two participating centers (NYU/NKI acting as a single center, and MGH), ~10 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via pulsed, 808nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3). Type: Interventional Start Date: Apr 2021 |
Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)
Massachusetts General Hospital
Major Depressive Disorder
This study will evaluate the short term effects of respiratory-gated transcutaneous vagus
nerve stimulation on the regulation of cardiovagal activity, depressive symptomatology and
immune function in subjects with major depression and determine the optimal stimulation
frequency... expand
This study will evaluate the short term effects of respiratory-gated transcutaneous vagus nerve stimulation on the regulation of cardiovagal activity, depressive symptomatology and immune function in subjects with major depression and determine the optimal stimulation frequency for this population. Type: Interventional Start Date: Nov 2020 |
Doravirine for Persons With Excessive Weight Gain on Integrase Inhibitors and Tenofovir Alafenamide
AIDS Clinical Trials Group
HIV Infections
The primary purpose of this study is to see if people with HIV who had a significant weight
gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir
alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of
weight gain... expand
The primary purpose of this study is to see if people with HIV who had a significant weight gain after starting INSTI (integrase strand transfer inhibitor)+TAF/FTC (tenofovir alafenamide/emtricitabine) (TAF/3TC (lamivudine)) regimen could either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication). The study will also try to see if participants changing from TAF/FTC (or TAF/3TC) to TDF/FTC (or TDF/3TC) will experience less additional weight gain or a reduction in overall body weight at 48 weeks compared to persons continued on an INSTI + TAF/FTC (or TAF/3TC) combination. INSTINs assessed in A5391 include bictegravir (BIC), dolutegravir (DTG), or raltegravir (RAL). Additionally, the study will see whether a change in ART can affect things like waist circumference, metabolic and cardiovascular health, fat and lean mass body composition, bone health, and maintenance of virologic suppression. Finally, the study will look at the safety and tolerability of DOR plus either TAF/FTC (or TAF/3TC) versus TDF/FTC (or TDF/3TC). Type: Interventional Start Date: May 2021 |
A Pilot Study of Ambulatory Heart Rate Variability Biofeedback for Substance Use Disorder
Massachusetts General Hospital
Substance Use Disorders
Heart rate variability biofeedback (HRVB) is an biobehavioral intervention involving rhythmic
breathing at resonance frequency that stimulates cardiovascular regulatory systems to help
individuals better regulate affect and bolster cognitive control. This intervention has... expand
Heart rate variability biofeedback (HRVB) is an biobehavioral intervention involving rhythmic breathing at resonance frequency that stimulates cardiovascular regulatory systems to help individuals better regulate affect and bolster cognitive control. This intervention has already shown its potential as a substance use disorder (SUD) treatment tool, but practical limitations of its accessibility, labor intensiveness, and cost have previously prevented this intervention from going to scale. Second-generation, ambulatory HRVB technology, however, has overcome these limitations and now allows patients to practice HRVB in-the-moment when its needed most. This study is testing the efficacy of second-generation, ambulatory HRVB for the first time with individuals with SUD. Type: Interventional Start Date: Dec 2022 |
A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy
Astellas Pharma Inc
Primary Mitochondrial Myopathy
The purpose of the phase 2 portion of this study is to select a biologically-active ASP0367
dose level by pharmacokinetic (PK) and pharmacodynamic (PD) evaluation. The phase 2 portion
of this study will also assess the safety and tolerability of ASP0367.
The purpose of the... expand
The purpose of the phase 2 portion of this study is to select a biologically-active ASP0367 dose level by pharmacokinetic (PK) and pharmacodynamic (PD) evaluation. The phase 2 portion of this study will also assess the safety and tolerability of ASP0367. The purpose of the phase 3 portion of this study is to assess the effect of ASP0367 on functional improvement relative to placebo and will also assess the safety and tolerability of ASP0367 relative to placebo. The phase 3 portion of this study will also assess the effect of ASP0367 on functional improvement and fatigue relative to placebo and will assess the effect of ASP0367 in overall participant functioning relative to placebo. Type: Interventional Start Date: May 2021 |
Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
Spaulding Rehabilitation Hospital
Fibromyalgia
This trial aims at understanding the mechanisms of optimized transcranial direct current
stimulation (tDCS) (16 tDCS sessions combined with exercise)] on pain control. Optimized tDCS
can lead to stronger engagement of the endogenous pain regulatory system that will ultimately... expand
This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial [tDCS (active and sham) and aerobic exercise (AE) (active and control)] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention. Type: Interventional Start Date: May 2019 |
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 |
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 |
Evaluation of Medical Cannabis and Prescription Opioid Taper Support for Reduction of Pain and Opioid...
Massachusetts General Hospital
Opioid Use
Pain
Marijuana Use
This study will use a randomized controlled design to test whether medical marijuana use by
adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated
with reduced opioid dose and improved pain intensity and interference when added to a 24-week... expand
This study will use a randomized controlled design to test whether medical marijuana use by adults on high-dose chronic opioid therapy (COT) for chronic non-cancer pain is associated with reduced opioid dose and improved pain intensity and interference when added to a 24-week behavioral intervention (POTS). Type: Interventional Start Date: Aug 2021 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in Amyotrophic...
Ionis Pharmaceuticals, Inc.
Amyotrophic Lateral Sclerosis
The primary purpose of this study is to evaluate the clinical efficacy of ION363 on clinical
function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral
sclerosis (FUS-ALS).
expand
The primary purpose of this study is to evaluate the clinical efficacy of ION363 on clinical function and survival in carriers of fused in sarcoma mutations with amyotrophic lateral sclerosis (FUS-ALS). Type: Interventional Start Date: Jun 2021 |
Medication Treatment for Opioid Use Disorder in Expectant Mothers
T. John 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 |
Study Evaluating MyoRegulator® Treatment in Post-Stroke Upper Limb Spasticity
PathMaker Neurosystems Inc.
Muscle Spasticity
Stroke
This is a multi-center, randomized, double-blind (patient and evaluator), sham-controlled
study to be conducted in stroke patients with upper-extremity spasticity. The main objectives
of this study are to evaluate the performance and safety of the MyoRegulator® device in
active-... expand
This is a multi-center, randomized, double-blind (patient and evaluator), sham-controlled study to be conducted in stroke patients with upper-extremity spasticity. The main objectives of this study are to evaluate the performance and safety of the MyoRegulator® device in active- versus sham-treated patients after 5 consecutive days of treatment. The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation for the treatment of muscle spasticity. Type: Interventional Start Date: Mar 2022 |
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.
expand
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 |
Fabry Disease Registry & Pregnancy Sub-registry
Genzyme, a Sanofi Company
Fabry Disease
The Fabry Registry is an ongoing, international multi-center, strictly observational program
that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of
treatment status. No experimental intervention is involved; patients in the Registry undergo... expand
The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician. The primary objectives of the Registry are: - To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease; - To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care; - To characterize and describe the Fabry population as a whole; - To evaluate the long-term safety and effectiveness of Fabrazyme® Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected. Type: Observational [Patient Registry] Start Date: Jul 2001 |
Mucopolysaccharidosis I (MPS I) Registry
Genzyme, a Sanofi Company
Mucopolysaccharidosis I (MPS I)
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that
tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will
provide information to better characterize the natural history and progression of MPS I as
well... expand
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: - To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) - To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I - To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care Type: Observational Start Date: Nov 2003 |
Psychosocial Mobile App for Chronic Graft-Versus-Host Disease
Massachusetts General Hospital
Chronic Graft-Versus-Host Disease
Allogeneic Stem Cell Transplant
The purpose of this research study is to see whether a psychosocial mobile app called
Horizons is effective at improving quality of life, symptom burden, psychological distress,
and coping in patients living with chronic graft-versus host disease (GVHD)
expand
The purpose of this research study is to see whether a psychosocial mobile app called Horizons is effective at improving quality of life, symptom burden, psychological distress, and coping in patients living with chronic graft-versus host disease (GVHD) Type: Interventional Start Date: Jan 2023 |
A Phase 3 Study of Obexelimab in Patients With IgG4-Related Disease
Zenas BioPharma (USA), LLC
IgG4 Related Disease
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare
of IgG4-related disease (IgG4-RD)
expand
This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD) Type: Interventional Start Date: Sep 2022 |
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602...
Marengo Therapeutics, Inc.
Advanced Solid Tumor
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and
preliminary clinical activity of STAR0602 as a single agent administered intravenously in
participants with advanced solid tumors that are antigen-rich.
expand
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich. Type: Interventional Start Date: Jan 2023 |