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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 |
Pulsed Field Ablation (PFA) Vs Anti-Arrhythmic Drug (AAD) Therapy As a First Line Treatment for Persistent...
Boston Scientific Corporation
Persistent Atrial Fibrillation
The purpose of this study is to establish the safety and effectiveness of pulsed field
ablation as a first-line ablation treatment for subjects with persistent atrial
fibrillation as compared to subjects who received an initial treatment with
anti-arrhythmic drugs. expand
The purpose of this study is to establish the safety and effectiveness of pulsed field ablation as a first-line ablation treatment for subjects with persistent atrial fibrillation as compared to subjects who received an initial treatment with anti-arrhythmic drugs. Type: Interventional Start Date: Dec 2023 |
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus...
Genentech, Inc.
Adenocarcinoma, Pancreatic Ductal
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene
cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan,
and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected
pancreatic ductal adenocarcinoma (PDAC)... expand
The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery. Type: Interventional Start Date: Oct 2023 |
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 |
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active...
Pfizer
Stable Nonsegmental Vitiligo
Active Nonsegmental Vitiligo
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental
Vitiligo (Active and Stable) Tranquillo expand
A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Nonsegmental Vitiligo (Active and Stable) Tranquillo Type: Interventional Start Date: Dec 2022 |
A Study to Investigate LYL845 in Adults With Solid Tumors
Lyell Immunopharma, Inc.
Melanoma
Non-small Cell Lung Cancer
Colorectal Cancer
This is an open-label, multi-center, dose-escalation study with expansion cohorts,
designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically
reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed
or refractory (R/R) metastatic or locally... expand
This is an open-label, multi-center, dose-escalation study with expansion cohorts, designed to evaluate the safety and anti-tumor activity of LYL845, an epigenetically reprogrammed tumor infiltrating lymphocyte (TIL) therapy, in participants with relapsed or refractory (R/R) metastatic or locally advanced melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). Type: Interventional Start Date: Dec 2022 |
A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid Tumors
Seagen Inc.
Cutaneous Melanoma
Non-small Cell Lung Cancer
Colorectal Neoplasms
Pancreatic Neoplasms
Mesothelioma
This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants
with melanoma and other solid tumors that are hard to treat or have spread through the
body. It will also study the side effects of this drug. A side effect is anything a drug
does to the body besides treating the... expand
This study will test the safety of a drug called PF-08046049/SGN-BB228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have 3 parts. Parts A and B of the study will find out how much PF-08046049/SGN-BB228 should be given to participants. Part C will use the information from Parts A and B to see if PF-08046049/SGN-BB228 is safe and if it works to treat solid tumor cancers. Type: Interventional Start Date: Jan 2023 |
A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe...
Eli Lilly and Company
Atopic Dermatitis
Eczema
The main purpose of this study is to measure the effect, safety and how well the body
absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with
moderate-to-severe atopic dermatitis (AD). expand
The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD). Type: Interventional Start Date: Oct 2022 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients...
Hoffmann-La Roche
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)
The main objective of the study is to evaluate the efficacy of satralizumab compared with
placebo based on time from randomization to the first occurrence of an adjudicated MOGAD
relapse in the double-blind (DB) treatment period expand
The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period Type: Interventional Start Date: Aug 2022 |
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 |
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu...
Greenwich LifeSciences, Inc.
Breast Cancer
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center,
Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive
subjects who are at high risk for disease recurrence and have completed both neoadjuvant
and postoperative adjuvant standard of care... expand
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects. Type: Interventional Start Date: Aug 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 |
Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
Boston Scientific Corporation
Pulmonary Embolism
There are many available treatments for pulmonary embolism (PE), but the best treatment
for this condition is not known. The HI-PEITHO study will compare two treatment options
that are both available on the market for the treatment of PE.
Patients will be randomized 1:1 to receive either blood thinners... expand
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems. Type: Interventional Start Date: Aug 2021 |
PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
Michael J. Fox Foundation for Parkinson's Research
Parkinson Disease
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational,
multi-center natural history study to assess progression of clinical features, digital
outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD)
progression in study participants with manifest... expand
The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability. Type: Observational Start Date: Jul 2020 |
Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy
Impulse Dynamics
Heart Failure
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized,
single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of
care. Patients to be included will have NYHA functional class III symptoms and a left
ventricular ejection fraction of 25-45% expand
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45% Type: Observational [Patient Registry] Start Date: Jan 2020 |
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic...
Juno Therapeutics, a Subsidiary of Celgene
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Small Lymphocytic
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety
of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will
include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in
subjects with relapsed or refractory CLL or... expand
This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated. Type: Interventional Start Date: Nov 2017 |
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