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A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)
AC Immune SA
Alzheimer's Disease
Prodromal Alzheimer's Disease
Amyloid Plaque
Beta-Amyloid
Alzheimer's Disease in Down Syndrome
The purpose of this study is to assess the safety, tolerability, immunogenicity and
pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and
in non-demented adults with Down syndrome. expand
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome. Type: Interventional Start Date: Jun 2022 |
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
Bristol-Myers Squibb
Carcinoma, Hepatocellular
The purpose of this study is to evaluate the safety and effectiveness of triplet therapy
of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants
with untreated advanced/metastatic hepatocellular carcinoma (HCC). expand
The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC). Type: Interventional Start Date: May 2022 |
Home-based Brain Stimulation Treatment for Post-acute Sequelae of COVID-19 (PASC)
Massachusetts General Hospital
Dysexecutive Syndrome
Post-Acute Sequelae of COVID-19
The main goal of this study is to improve dysexecutive symptoms (e.g., sustained
attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19
(PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive
method that uses low intensity electric currents... expand
The main goal of this study is to improve dysexecutive symptoms (e.g., sustained attention, processing speed) in patients exhibiting post-acute sequelae of COVID-19 (PASC) through home-based transcranial direct current stimulation (tDCS), a noninvasive method that uses low intensity electric currents delivered to the brain through stimulation electrodes on the scalp. Type: Interventional Start Date: Jun 2022 |
ML-004 in Adolescents and Adults with Autism Spectrum Disorders (ASD)
MapLight Therapeutics
Autism Spectrum Disorder
ML-004-002 is a multi-center, randomized, double-blind, parallel-group,
placebo-controlled study that will enroll approximately 150 adolescent and adult subjects
with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with
placebo in the improvement of social communication deficits... expand
ML-004-002 is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study that will enroll approximately 150 adolescent and adult subjects with ASD. The primary objective is to evaluate the efficacy of ML-004 compared with placebo in the improvement of social communication deficits in subjects with ASD. Type: Interventional Start Date: Sep 2022 |
Parkinson's Foundation PD GENEration Genetic Registry
Parkinson's Foundation
Parkinson's Disease
Development of a central repository for PD-related genomic data for future research. expand
Development of a central repository for PD-related genomic data for future research. Type: Observational [Patient Registry] Start Date: Dec 2020 |
Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 or mNF2...
Vivace Therapeutics, Inc
Solid Tumor, Adult
Mesothelioma
This is an open-label, dose escalation and expansion study to evaluate the safety,
tolerability, PK, and biological activity of VT3989 administered once daily in 3- or
4-week cycles in patients with mesothelioma and/or metastatic solid tumors that are
resistant or refractory to standard therapy or... expand
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered once daily in 3- or 4-week cycles in patients with mesothelioma and/or metastatic solid tumors that are resistant or refractory to standard therapy or for which no effective standard therapy is available. Type: Interventional Start Date: Mar 2021 |
IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact
Medstar Health Research Institute
Atherosclerosis
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been
shown in clinical trials, registries, and meta-analyses to reduce recurrent events after
PCI. This is accomplished by improving the angiographic result with lesion and vessel
assessment to guide stent selection... expand
Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent events after PCI. This is accomplished by improving the angiographic result with lesion and vessel assessment to guide stent selection and implantation and intravascular imaging following stent implantation to ensure an adequate treatment endpoint has been achieved. Despite extensive literature supporting the use of IVUS in PCI, utilization remains low in the United States. An increasing number of high-risk or complex lesions are being treated with PCI and we hypothesize that the impact of IVUS in these complex lesions will be of increased importance in reducing clinical adverse events while remaining cost effective. Type: Interventional Start Date: Oct 2020 |
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke...
W.L.Gore & Associates
Stroke
PFO - Patent Foramen Ovale
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder
in a post approval setting and evaluate the quality of operator education and training
and transferability of trial experience to a post-market setting. expand
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting. Type: Interventional Start Date: Jul 2019 |
Venetoclax and Chemotherapy as Frontline Therapy in Older Patients and Patients With Relapsed/Refractory...
Dana-Farber Cancer Institute
Leukemia
This research study is studying a medication called Venetoclax and a chemotherapy regimen
as a possible treatment for Acute Lymphoblastic Leukemia.
The drugs involved in this study are:
- Venetoclax
- Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin,... expand
This research study is studying a medication called Venetoclax and a chemotherapy regimen as a possible treatment for Acute Lymphoblastic Leukemia. The drugs involved in this study are: - Venetoclax - Standard Chemotherapy (which includes cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, 6-mercaptopurine, etoposide, and cytarabine Type: Interventional Start Date: Oct 2017 |
Mobile Mental Health Stigma Reduction Intervention Among Black Adults
Massachusetts General Hospital
Anxiety
Depression
Health Knowledge, Attitudes, Practice
Stigmatization
Mobile Phone Use
Major depressive and anxiety disorders are highly prevalent in the general population and
are a leading cause of disability. Black adults have a high burden of depression and
anxiety. This study aims to assess a self- administered video-based intervention to
reduce mental illness stigma and medical... expand
Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety. Type: Interventional Start Date: Mar 2024 |
GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH
Massachusetts General Hospital
Genetic Predisposition
Metabolic Diseases
Type 2 Diabetes
The goal of this research study is to evaluate the pathophysiologic mechanisms by which
genetic variation impacts response to an FDA-approved medication commonly used to treat
type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological
response to a mixed meal tolerance... expand
The goal of this research study is to evaluate the pathophysiologic mechanisms by which genetic variation impacts response to an FDA-approved medication commonly used to treat type 2 diabetes called oral semaglutide (Rybelsus) and to characterize the physiological response to a mixed meal tolerance test (MMTT) before and after a 14-day treatment with oral semaglutide. The investigators will do this by measuring factors in the blood, such as sugars, fats, metabolites, and proteins, after eating a standardized breakfast meal at the first visit and after taking 14 doses of oral semaglutide over two weeks before the second study visit. The food (mixed meal breakfast) we will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat. The investigators hypothesize that understanding how the acute biochemical response to oral semaglutide differs by genetic variation will generate insight into drug mechanisms and type 2 diabetes pathophysiology. Type: Interventional Start Date: Mar 2024 |
Boosting Emotional Well-being and Happiness in Outpatients Living With Diabetes
Massachusetts General Hospital
Diabetes Mellitus, Type 2
The focus of this study is to test the efficacy of an 8-week, remotely delivered,
positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice
weekly text messages for a total of 16 weeks (with interactive, algorithm-driven,
goal-focused text messages in the final 8 weeks),... expand
The focus of this study is to test the efficacy of an 8-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 16 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 8 weeks), compared to MI-alone, in a randomized trial of 280 individuals with type 2 diabetes and low baseline physical activity. Type: Interventional Start Date: Oct 2022 |
Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy
Massachusetts General Hospital
Adrenoleukodystrophy
Restless Legs Syndrome
The investigators recently observed that up to 25% of women with X-linked
adrenoleukodystrophy (ALD) have moderate to severe Restless Leg Syndrome (RLS). In this
study, the investigators aim to estimate the prevalence of RLS among women with ALD and
to assess whether pramipexole improves RLS symptoms... expand
The investigators recently observed that up to 25% of women with X-linked adrenoleukodystrophy (ALD) have moderate to severe Restless Leg Syndrome (RLS). In this study, the investigators aim to estimate the prevalence of RLS among women with ALD and to assess whether pramipexole improves RLS symptoms as well as sleep and gait measures in women with ALD. Type: Interventional Start Date: Apr 2023 |
Impact of Transcutaneous Vagal Nerve Stimulation on Stress Response in Major Depression
Massachusetts General Hospital
Major Depressive Disorder
This study will identify the sex-dependent impact of expiratory-gated transcutaneous
vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry and
associated physiology in major depressive disorder (MDD). We will evaluate a sample of 80
adults with recurrent MDD randomized... expand
This study will identify the sex-dependent impact of expiratory-gated transcutaneous vagus nerve stimulation (tVNS) on the modulation of the stress response circuitry and associated physiology in major depressive disorder (MDD). We will evaluate a sample of 80 adults with recurrent MDD randomized to receive active or sham expiratory-gated tVNS during a functional magnetic resonance imaging (fMRI) session, with simultaneous mood and physiological assessments. We hypothesize that expiratory-gated tVNS will effectively modulate, in a sex-dependent manner, specific brainstem-cortical pathways of the stress circuitry and attenuate physiological deficits in MDD. Type: Interventional Start Date: Jan 2021 |
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Memorial Sloan Kettering Cancer Center
Metastatic Non-small Cell Lung Cancer
This study will compare the effectiveness of osimertinib alone with the combination of
osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung
cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual
treatment for metastatic EGFR-mutant... expand
This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. Researchers think adding chemotherapy to osimertinib could possibly add to the anticancer effects of the usual treatment and help stop cancer from growing or spreading. Type: Interventional Start Date: May 2020 |
Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed...
National Cancer Institute (NCI)
Anaplastic Astrocytoma
Anaplastic Astrocytoma, Not Otherwise Specified
Anaplastic Ganglioglioma
Anaplastic Pleomorphic Xanthoastrocytoma
Glioblastoma
This phase II trial studies how well the combination of dabrafenib and trametinib works
after radiation therapy in children and young adults with high grade glioma who have a
genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill
tumor cells and reduce the size of... expand
This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma. Type: Interventional Start Date: Feb 2020 |
Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17
St. Jude Children's Research Hospital
Hodgkin Lymphoma
This is a phase II study using risk and response-adapted therapy for low, intermediate
and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk
group assignment. Low-risk and intermediate- risk patients will be treated with
bendamustine, etoposide, Adriamycin® (doxorubicin),... expand
This is a phase II study using risk and response-adapted therapy for low, intermediate and high risk classical Hodgkin lymphoma. Chemotherapy regimens will be based on risk group assignment. Low-risk and intermediate- risk patients will be treated with bendamustine, etoposide, Adriamycin® (doxorubicin), bleomycin, Oncovin® (vincristine), vinblastine, and prednisone (BEABOVP) chemotherapy. High-risk patients will receive Adcetris® (brentuximab vedotin), etoposide, prednisone and Adriamycin® (doxorubicin) (AEPA) and cyclophosphamide, Adcetris® (brentuximab vedotin), prednisone and Dacarbazine® (DTIC) (CAPDac) chemotherapy. Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an adequate response (AR) after 2 cycles of therapy for all risk groups. Type: Interventional Start Date: Dec 2018 |
OCS™ Lung TOP Registry For Donor Lungs for Transplantation
TransMedics
Lung Transplantation
Single-arm, prospective, multi-center, post-approval U.S. registry expand
Single-arm, prospective, multi-center, post-approval U.S. registry Type: Observational [Patient Registry] Start Date: Dec 2018 |
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ottawa Heart Institute Research Corporation
Ascending Aortic Aneurysm Enlargement
Ascending Aorta Aneurysm
The ascending aorta conducts blood from the heart to the rest of the body. The ascending
aorta can become enlarged, and the risk of tearing and rupturing becomes higher with
larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if
surgery is done as soon as possible.... expand
The ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand, surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there is currently no great support for either approach for patients with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will undergo replacement of aorta, or the surveillance group, in which they will be closely monitored. The chance of dying or suffer tearing or rupture of aorta between the two groups will be compared. The result of the trial will guide future practice for patients with enlarged ascending aorta. This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations. Type: Interventional Start Date: Sep 2018 |
Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid...
PharmaMar
Advanced Solid Tumors
Glioblastoma
Soft Tissue Sarcoma (Excluding GIST)
Endometrial Carcinoma
Epithelial Ovarian Carcinoma
Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in
combination with irinotecan. The study will be divided into two stages: a Phase I dose
escalation stage and a Phase II expansion stage. expand
Prospective, open-label, dose-ranging, uncontrolled phase I/II study of Lurbinectedin in combination with irinotecan. The study will be divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage. Type: Interventional Start Date: May 2016 |
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 clinical assessments... 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 |
Use of Serial Plasma NGS as a New Efficacy Metric to Guide Immunotherapy Treatment Discontinuation
Massachusetts General Hospital
Melanoma
Non-small Cell Lung Cancer
The goal of this prospective study to investigate the use of circulating tumor DNA
(ctDNA) to guide end of therapy decisions in patients with melanoma or non-small-cell
lung cancer.
The main question it aims to answer is:
• Do patients with metastatic melanoma or non-small-cell lung cancer, who... expand
The goal of this prospective study to investigate the use of circulating tumor DNA (ctDNA) to guide end of therapy decisions in patients with melanoma or non-small-cell lung cancer. The main question it aims to answer is: • Do patients with metastatic melanoma or non-small-cell lung cancer, who have received at least 12 months of immune checkpoint inhibition (monotherapy or in combination) with evidence of disease response/control on imaging and have no evidence of circulating tumor DNA, have an increased 12-month disease free survival in comparison to historical controls? Type: Interventional Start Date: Jan 2024 |
PET Imaging Evaluation of [11C]SY08
Massachusetts General Hospital
Parkinson's Disease
Multiple System Atrophy
Dementia With Lewy Bodies
Healthy Controls
The overall goal of the proposed research is to evaluate the use of [11C]SY08 as a PET
radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease
(PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy
controls.
The purpose of this study is... expand
The overall goal of the proposed research is to evaluate the use of [11C]SY08 as a PET radiotracer for aggregated alpha synuclein (αS) in individuals with Parkinson's disease (PD), Multiple system atrophy (MSA), Dementia with Lewy Bodies (DLB) and healthy controls. The purpose of this study is to evaluate the use of [11C]SY08 as a PET radiotracer for αS fibrils in individuals with PD, MSA, DLB and healthy controls. The specific aims of the current study are: 1. To determine brain uptake, distribution, and kinetics of [11C]SY08 in healthy individuals. 2. To determine brain uptake, distribution, and kinetics of [11C]SY08 in patients with alpha synuclein aggregates in the brain, including PD, DLB and MSA. 3. To determine human dosimetry of [11C]SY08 in healthy individuals An intravenous bolus injection of [11C]SY08 will be administered per subject for brain PET imaging. Type: Interventional Start Date: May 2024 |
Esophageal Cancer Multimodal Prehabilitation Study
Massachusetts General Hospital
Esophageal Cancer
Esophageal Neoplasms
The goal of this research study is to investigate the feasibility of implementing a
prehabilitation program that aims to improve a patient's physical, nutritional, and sleep
health before surgery in an older, at-risk group with esophageal cancer. expand
The goal of this research study is to investigate the feasibility of implementing a prehabilitation program that aims to improve a patient's physical, nutritional, and sleep health before surgery in an older, at-risk group with esophageal cancer. Type: Interventional Start Date: Dec 2023 |
Cryoablation+Ipilimumab+Nivolumab in Melanoma
Massachusetts General Hospital
Metastatic Melanoma
Skin Cancer
The aim of this study is to find out whether the combination of two approved drugs,
ipilimumab and nivolumab, in combination with cryoablation are safe and effective for
participants who have an unresectable melanoma that is resistant, or is growing, after
receiving immunotherapy with a PD-1 inhibitor.
The... expand
The aim of this study is to find out whether the combination of two approved drugs, ipilimumab and nivolumab, in combination with cryoablation are safe and effective for participants who have an unresectable melanoma that is resistant, or is growing, after receiving immunotherapy with a PD-1 inhibitor. The names of the study interventions involved in this study are: - Cryoablation (an interventional radiology procedure that freezes part of a tumor) - Ipilimumab (an immunotherapy) - Nivolumab (an immunotherapy) Type: Interventional Start Date: Sep 2023 |
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