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AWARE: Management of ADHD in Autism Spectrum Disorder
Daniel Coury
ADHD
Autism Spectrum Disorder
This study is a pragmatic clinical trial examining the comparative effectiveness of two
stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in
children and adolescents with autism. Using a sequential, multiple assignment
randomization trial (SMART) design the study will... expand
This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care. Type: Interventional Start Date: Oct 2023 |
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 healthy
adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort
(TRC), and up to 450 participants in total including co-enrolled in the Alzheimer
Biomarkers Consortium - Down Syndrome (ABC-DS)... expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 450 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. 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 eating disorder characterized... 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 |
Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD)
NYU Langone Health
Mild Cognitive Impairment
Alzheimer Disease
This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM
in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of
0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham.
At baseline, all subjects will complete... expand
This multi-site study will be the first to evaluate the dose-dependent effects of t-PBM in amnestic Mild Cognitive Impairment (aMCI) and early Alzheimer's Disease (AD) (CDR of 0.5-1, FAST 1-4; age 65-85) in a randomized clinical trial of 8 weeks of t-PBM vs. sham. At baseline, 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). After undergoing target engagement testing (t-PBM session performed during fMRI to detect BOLD changes with active t-PBM), subjects will then be randomized to t-PBM/sham and complete 24 t-PBM/sham treatments, ~11 min per day, 3 days per week, for 8 weeks. t-PBM will be administered via continuous, 808 nm wavelength laser delivery to the forehead bilaterally (at standard EEG electrode positions F4, F3). Type: Interventional Start Date: Apr 2021 |
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) protocol to reduce anxiety... 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 |
FUSION: A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of ION363 in...
Ionis Pharmaceuticals, Inc.
Amyotrophic Lateral Sclerosis
The primary purpose of this study is to evaluate the 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 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 |
A Study of TCD601 in de Novo Renal Transplant Recipients
ITB-Med LLC
Renal Transplantation
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination
with Belatacept when compared to standard of care immunosuppression therapy in de novo
renal transplant patients. expand
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients. Type: Interventional Start Date: Dec 2023 |
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 behavioral intervention... 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 |
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33
NYU Langone Health
Major Depressive Disorder
The purpose of this research study is to determine if application of near infrared energy
to the forehead can change blood flow in the brains of people with depression. Near
infrared energy is like light but is not visible to the human eye. expand
The purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. Near infrared energy is like light but is not visible to the human eye. Type: Interventional Start Date: Apr 2023 |
Systems Biology of Early Atopy
National Institute of Allergy and Infectious Diseases (NIAID)
Allergic Diseases
Food Allergy
Atopic Dermatitis
The goal of this study is to establish a birth cohort that collects prenatal and early
life biosamples and environmental samples and rigorously phenotypes young children for
food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of
high risk for food allergy and AD, as... expand
The goal of this study is to establish a birth cohort that collects prenatal and early life biosamples and environmental samples and rigorously phenotypes young children for food allergy and Atopic Dermatitis (AD) to identify prenatal and early life markers of high risk for food allergy and AD, as well as biological pathways (endotypes) that result in these conditions. Primary Objectives: - To study the role and interrelationships of established and novel clinical, environmental, biological, and genetic prenatal and early-life factors in the development of allergic diseases through age 3 years, with an emphasis on atopic dermatitis and food allergy - To apply systems biology to identify mechanisms and biomarkers underlying the development of food allergy, atopic dermatitis, and their endotypes - To collect, process, and assay or store environmental and biological samples for current and future use in the study of allergic disease development Type: Observational Start Date: Mar 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 |
Expanding First-line Options for Depression and Matching Treatments to Patients: Hatha Yoga vs. Behavioral...
Massachusetts General Hospital
Depression
This is a parallel group study design. The investigators propose to compare an online,
synchronous group-based yoga intervention developed for individuals with depression to an
online, synchronous individualized, evidence-based behavioral therapy for depression, or
Brief Behavioral Activation Treatment... expand
This is a parallel group study design. The investigators propose to compare an online, synchronous group-based yoga intervention developed for individuals with depression to an online, synchronous individualized, evidence-based behavioral therapy for depression, or Brief Behavioral Activation Treatment for Depression (BA). This study is a multi-site randomized trial of adults with clinically significant depressive symptoms. Participants (N=518) will be randomized in an equal allocation ratio (i.e., 1:1) across two intervention groups: yoga and BA. Interventions will be provided over a 12-week period and assessments will occur at baseline (week 0), week 6, week 12, week 18, and week 24. Type: Interventional Start Date: Feb 2023 |
Supporting Our Caregivers In ADRD Learning (SOCIAL)
Massachusetts General Hospital
Alzheimer's Disease and Related Dementias
Quality of Life
Caregiver Stress
Building on limitations of prior research, the investigators developed the Mindful and
Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer
Disease and Related Dementias (ADRD) manage stress associated with the general caregiver
experience including stress stemming from... expand
Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks. The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial. Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention. Type: Interventional Start Date: Mar 2024 |
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Edwards Lifesciences
Aortic Stenosis, Calcific
Aortic Valve Stenosis
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3
/ SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects
with moderate, calcific aortic stenosis.
Following completion of enrollment, subjects will be eligible for enrollment... expand
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial. Type: Interventional Start Date: Oct 2021 |
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
Joseph Broderick, MD
Intracerebral Hemorrhage
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time
(FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral
hemorrhage (ICH) within a time window and subgroup of patients that is most likely to
benefit. The central hypothesis is that... expand
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. Type: Interventional Start Date: Dec 2021 |
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With...
NRG Oncology
Metastatic Malignant Neoplasm in the Bone
Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
This phase III trial compares less intense hormone therapy and radiation therapy to usual
hormone therapy and radiation therapy in treating patients with high risk prostate cancer
and low gene risk score. This trial also compares more intense hormone therapy and
radiation therapy to usual hormone... expand
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score. Type: Interventional Start Date: Dec 2020 |
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 already shown its potential... 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 |
Myocardial Mechanisms in Heart Failure With Preserved Ejection Fraction
Northwestern University
Heart Failure
Heart Failure With Preserved Ejection Fraction
The purpose of this study is to identify changes in heart tissue structure and biological
function in patients with heart failure by performing an endomyocardial biopsy (EMB or
heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use
this information to develop new treatments... expand
The purpose of this study is to identify changes in heart tissue structure and biological function in patients with heart failure by performing an endomyocardial biopsy (EMB or heart biopsy) during a right heart catheterization (RHC). The ultimate goal is to use this information to develop new treatments for heart failure. Type: Observational [Patient Registry] Start Date: Oct 2024 |
The Effects of Auditory Stimulation During Sleep on Brain Networks in Schizophrenia
Massachusetts General Hospital
Schizophrenia
In this research study the investigators will use sleep headbands to measure brain
rhythms and to improve their coordination across brain regions. The headbands will be
worn at home for multiple nights. On some nights the headbands will play soft sounds at
specific times during sleep. The investigators... expand
In this research study the investigators will use sleep headbands to measure brain rhythms and to improve their coordination across brain regions. The headbands will be worn at home for multiple nights. On some nights the headbands will play soft sounds at specific times during sleep. The investigators are interested in learning whether this timed auditory stimulation may be a strategy to improve the coordination of sleep rhythms across brain regions, improve network communication, and as a result, improve memory. The investigators will study 30 adults aged 18-45 with schizophrenia and 30 demographically matched healthy controls. Participants will first have a daytime MRI scan, during which they will complete a finger tapping motor sequence task (MST), followed by a week of sleep at home with a sleep headband. They will also do the MST at home on two of the nights. On the final day of the study, participants will return for a second MRI scan. Type: Interventional Start Date: Oct 2024 |
A Clinical Study of V940 Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)
Merck Sharp & Dohme LLC
Melanoma
The purpose of this study is to learn if V940 which is an individualized neoantigen
therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab
(MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma.
Researchers want to know if V940 with... expand
The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning. Type: Interventional Start Date: Jul 2023 |
A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent...
AbbVie
Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions
in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This
study will assess how safe and effective upadacitinib is in treating adult and adolescent
participants with moderate to severe... expand
Hidradenitis suppurativa (HS) is an inflammatory skin disease that causes painful lesions in the axilla (underarm), inguinal (groin) and anogenital (anal/genital) regions. This study will assess how safe and effective upadacitinib is in treating adult and adolescent participants with moderate to severe HS who have failed to respond to or are intolerant of anti-tumor necrosis factor (TNF) therapy. Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for ulcerative colitis, atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of HS. This study is "double-blinded", meaning that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo. This study is comprised of 3 periods. In Period 1, participants are randomized into 2 groups called treatment arms where each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. In Period 2, participants are placed into 6 different groups depending on their placement and results in Period 1. Period 3 is the long-term extension period where participants will continue treatment from Period 2. Approximately 1328 adult and adolescent participants diagnosed with HS will be enrolled in approximately 275 sites worldwide. Participants will receive oral tablets of upadacitinib or placebo once daily for 36 weeks in Period 1 and Period 2. Eligible participants from Period 1 and Period 2 will enter Period 3 and receive oral tablets of upadacitinib or placebo once daily for 68 weeks. Participants will be followed up for approximately 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular outpatient visits during the study. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jun 2023 |
A Safety, Tolerability, and Efficacy Study of VX-264 in Participants With Type 1 Diabetes
Vertex Pharmaceuticals Incorporated
Type 1 Diabetes
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264
in participants with type 1 diabetes (T1D). expand
The purpose of the study is to evaluate the safety, tolerability, and efficacy of VX-264 in participants with type 1 diabetes (T1D). Type: Interventional Start Date: May 2023 |
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis...
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Diffuse Cutaneous Systemic Sclerosis
Interstitial Lung Disease
The purpose of this study is to assess the safety and efficacy of tulisokibart in
participants with SSc-ILD. expand
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD. Type: Interventional Start Date: Jul 2022 |
A 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 |
Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine...
Merck Sharp & Dohme LLC
Pheochromocytoma/Paraganglioma
Pancreatic Neuroendocrine Tumor
Von Hippel-Lindau Disease
Advanced Gastrointestinal Stromal Tumor
HIF-2α Mutated Cancers
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in
participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic
neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced
Gastrointestinal Stromal Tumor (wt GIST), or Advanced... expand
This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Type: Interventional Start Date: Aug 2021 |