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 |
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. 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 (CNCP) is
associated with reduced opioid dose and improved pain intensity and interference when added
to... 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 (CNCP) 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 |
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 |
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 |
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 |
A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute...
Ocelot Bio, Inc
Cirrhosis
Ascites
Hepatorenal Syndrome
Acute Kidney Injury
OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute
Kidney Injury as a complication of cirrhosis with ascites.
The study aims are to evaluate the safety and efficacy of OCE-205 at various doses.
Participants will receive treatment... expand
OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute Kidney Injury as a complication of cirrhosis with ascites. The study aims are to evaluate the safety and efficacy of OCE-205 at various doses. Participants will receive treatment by intravenous infusion. Participants will continue with this treatment until participants meets primary endpoint or any discontinuation criteria. Type: Interventional Start Date: Apr 2022 |
A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel
Janssen Research & Development, LLC
Multiple Myeloma
The purpose of this study is to collect long-term follow-up data on delayed adverse events
after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and
understand the long-term safety profile of cilta-cel.
expand
The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel. Type: Interventional Start Date: Mar 2022 |
Efficacy and Safety of REC-2282 in Patients With Progressive Neurofibromatosis Type 2 (NF2) Mutated Meningiomas
Recursion Pharmaceuticals Inc.
Neurofibromatosis Type 2
This is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study to
investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated
meningiomas.
expand
This is a parallel-group, two-staged, Phase 2/3, randomized, multi-center study to investigate the efficacy and safety of REC-2282 in patients with progressive NF2 mutated meningiomas. Type: Interventional Start Date: Jun 2022 |
Novel Experimental COVID-19 Therapies Affecting Host Response
Sean Collins
COVID-19
SARS-CoV-2 Infection
Coronavirus Infection
The overarching goal of the Master Protocol is to find effective strategies for inpatient
management of patients with COVID-19. Therapeutic goals for patients hospitalized for
COVID-19 include hastening recovery and preventing progression to critical illness,
multiorgan failure,... expand
The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19. Type: Interventional Start Date: Jul 2021 |
Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change...
AbbVie
Crohn's Disease (CD)
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any
part of the gut. This study will evaluate how well risankizumab works compared to
ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI).
Risankizumab is... expand
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Sep 2020 |
QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
Massachusetts General Hospital
Kidney Failure
Hepatitis C
Kidney Disease, Chronic
This is a single center study characterizing the experience of administration of 4 weeks of
pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis
C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
expand
This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient. Type: Interventional Start Date: May 2021 |
Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
BioMed Valley Discoveries, Inc
Advanced Solid Tumor
BRAF Gene Mutation
BRAF Gene Alteration
MEK Mutation
MEK Alteration
This BVD-523-ABC study builds on the safety and clinical activity experience of previous
studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of
patients with specific genetic alterations and tumor histologies that result in aberrant MAPK... expand
This BVD-523-ABC study builds on the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling. Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional development is warranted. Type: Interventional Start Date: Nov 2020 |
Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic...
Mitsubishi Tanabe Pharma Development America, Inc.
Diffuse Cutaneous Systemic Sclerosis
To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic
sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in
Diffuse Systemic Sclerosis (ACR CRISS) at Week 52
expand
To evaluate the efficacy of MT-7117 treatment in subjects with diffuse cutaneous systemic sclerosis (dcSSc) using the American College of Rheumatology Composite Response Index in Diffuse Systemic Sclerosis (ACR CRISS) at Week 52 Type: Interventional Start Date: Feb 2021 |