799 matching studies

Sponsor Condition of Interest
The Effect of RNS60 on ALS Biomarkers
Mario Negri Institute for Pharmacological Research Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This prompts new treatments of ALS. RNS60 is an experimental drug with favorable effects in preclinical... expand

Amyotrophic Lateral Sclerosis (ALS) is a rare lethal neurodegenerative disease involving inflammation. Riluzole, the only drug for ALS, improves median survival by 3 months. This prompts new treatments of ALS. RNS60 is an experimental drug with favorable effects in preclinical studies of neuroinflammation and neurodegeneration. Based on significant efficacy demonstrated in preclinical studies and its excellent clinical safety profile, RNS60 is a promising candidate for a drug to treat ALS. Developing a pharmacodynamic marker will be a first and important step for dose finding and exploration of the mechanism of action in human, and pave the way to trials measuring drug efficacy. The Investigator propose a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase II trial. The study centers will be located in Italy and at Massachusetts General Hospital (MGH) in Boston. A total of 142 ALS patients will be randomly assigned to RNS60 or placebo (administered by intravenous infusion once/week and inhaled via nebulization every morning for 24 weeks). All participants will also take riluzole (50-mg tablet twice/day). Blood samples for biomarker analysis (protein, RNA) will be collected in the screening period, on day 1, week 4,12 and 24. Both safety and potential therapeutic effects of RNS60 will be also assessed.

Type: Interventional

Start Date: Nov 2016

open study

Stroke Motor Rehabilitation and Recovery Study
Massachusetts General Hospital Stroke, Ischemic
SMaHRT (Stroke Motor reHabilitation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic stroke. expand

SMaHRT (Stroke Motor reHabilitation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic stroke.

Type: Observational

Start Date: Jun 2017

open study

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia
Leigh R. Hochberg, MD, PhD. Tetraplegia Spinal Cord Injuries Amyotrophic Lateral Sclerosis Brain Stem Infarctions Locked in Syndrome
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts. expand

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility of efficacy) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

Type: Interventional

Start Date: May 2009

open study

Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Massachusetts General Hospital Sleep-Related Eating Disorder
The purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating Sleep-Related Eating Disorder (SRED). expand

The purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).

Type: Interventional

Start Date: Jan 2008

open study

Advanced MRI Applications Development
Massachusetts General Hospital Brain Tumors
The goals of this study are to: 1. To improve upon and develop new innovative magnetic resonance imaging techniques that refine image quality and enhance performance. Improvements in these areas will have positive implications for medical diagnosis and treatment.... expand

The goals of this study are to: 1. To improve upon and develop new innovative magnetic resonance imaging techniques that refine image quality and enhance performance. Improvements in these areas will have positive implications for medical diagnosis and treatment. 2. To correlate MRI images with underlying disease pathophysiology in order to ensure that imaging accurately reflects the disease process.

Type: Observational

Start Date: Jan 2014

open study

Kidney Information Network for Disease Research and Education
Massachusetts General Hospital ESRD Fabry Disease Rare Diseases Kidney Diseases End Stage Renal Disease
In this study, Investigators will conduct a prospective cohort study of dialysis patients by collecting research-quality information on patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic... expand

In this study, Investigators will conduct a prospective cohort study of dialysis patients by collecting research-quality information on patient characteristics, comorbid diseases and laboratory markers used in routine practice, as well as novel biochemical markers and genetic data. Investigators will utilize data from the cohort to test the independent relationship between biochemical and genetic markers and Fabry disease and other rare diseases.

Type: Observational [Patient Registry]

Start Date: Jan 2018

open study

Neurobiological Underpinnings of Placebo Response in Depression
Massachusetts General Hospital Depression
In summary, the proposed research is novel with respect to design, technology, and its multi-level integration probing psychological and neurobiological constructs assumed to be crucially implicated in placebo response and has significant clinical and research implications for... expand

In summary, the proposed research is novel with respect to design, technology, and its multi-level integration probing psychological and neurobiological constructs assumed to be crucially implicated in placebo response and has significant clinical and research implications for the future. Specifically, the future implications include: 1) identification of biomarkers and biosignatures of placebo responders, 2) new possibilities to understanding and manipulating the system, 3) possibly decreasing or eliminating a major confounder in clinical trials and drug development, and 4) refining treatments with novel drugs that decrease (in clinical trial) or increase (in clinical practice) the placebo response.

Type: Interventional

Start Date: Aug 2016

open study

Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia
New England Research Institutes Critical Limb Ischemia
This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options. expand

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Type: Interventional

Start Date: Aug 2014

open study

Depression and Body Image Distress Following Mastectomy With Reconstruction
Massachusetts General Hospital Breast Cancer BRCA1 Mutation BRCA2 Mutation
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial... expand

Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.

Type: Observational

Start Date: Oct 2017

open study

INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
Dana-Farber Cancer Institute Glioblastoma
This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115 expand

This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115

Type: Interventional

Start Date: Feb 2017

open study

Resiliency Training for Adults With Neurofibromatosis Via Live Videoconferencing
Massachusetts General Hospital Neurofibromatoses Neurofibromatosis 1 Neurofibromatosis 2 Schwannomatosis
The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning. expand

The aims of this study are to compare the effect and durability of two stress and symptom management programs tailored for patients with neurofibromatosis on quality of life and psychosocial functioning.

Type: Interventional

Start Date: Oct 2017

open study

GVAX for Colorectal Cancer
Massachusetts General Hospital Colorectal Cancer
This study is a Pilot clinical trial. Pilot clinical trials test the safety of an investigational combination of drugs. Pilot studies provide information on what effects, both good and bad, the Investigational agent might have on your disease. "Investigational" means that the... expand

This study is a Pilot clinical trial. Pilot clinical trials test the safety of an investigational combination of drugs. Pilot studies provide information on what effects, both good and bad, the Investigational agent might have on your disease. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved the treatment for your type of cancer. The main purposes of this study are to determine: - The amount of vaccine that can be made for your colorectal tumor cells - If the vaccine can be given safely - What the effects of the vaccine are, both good and bad - How the vaccine affects your immune system - Whether this vaccine might have any effect on the return of your cancer in the liver after surgical removal This study is being done because there are currently no treatments which have demonstrated to cure diseae which has progressed, or moved beyond the site of the primary site of disease (colon or rectum). These vaccinations will be given after you have completed the standard of care treatment as determined by your doctor. Laboratory research has made vaccines from cancer cells by inserting genetic material from a protein called granulocyte-macrophage colony stimulating factor (GM-CSF) into the cancer cell. Once complete, the cancer cells are able to produce large amounts of GM-CSF. The vaccine made form these cells has a greater anti-tumor effect than cancer cells without GM-CSF. The purpose of this research study is to determine the safety of an investigational vaccine that will be made using your own colorectal cancer cells in the manner described above. This vaccine has been used in several other research studies for treatment for other cancers (skin, lung, ovarian, sarcoma and leukemia.) Information from these other research studies suggests that this vaccine may help to reduce the risk of your colorectal cancer returning after you have your colorectal cancer surgery. Due to these results in melanoma and several other tumors we are encouraged to use this vaccine approach in patients with liver metastases from colorectal cancer, after the cancer in the liver has been removed by surgery.

Type: Interventional

Start Date: Jul 2013

open study

Struvite Stones Antibiotic Study
University of British Columbia Kidney Stones
The aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones). expand

The aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones).

Type: Interventional

Start Date: Mar 2015

open study

Study CB-839 in Combination With Nivolumab in Patients With Melanoma, ccRCC and NSCLC
Calithera Biosciences, Inc Clear Cell Renal Cell Carcinoma Melanoma Non-small Cell Lung Cancer
This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer. expand

This study is an open-label Phase 1/ 2 evaluation of CB-839 in combination with nivolumab in patients with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.

Type: Interventional

Start Date: Aug 2016

open study

Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
Massachusetts General Hospital Insomnia
The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans. expand

The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.

Type: Interventional

Start Date: Jan 2015

open study

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Lumicell, Inc. Colorectal Cancer Pancreatic Cancer Esophageal Cancer
The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM 2.6 Imaging Device. expand

The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM 2.6 Imaging Device.

Type: Interventional

Start Date: May 2016

open study

Chromatic Pupillometry to Assess the Melanopsin-Light Pathway in Progressive Supranuclear Palsy
Massachusetts General Hospital PSP - Progressive Supranuclear Palsy PD - Parkinson's Disease AD - Alzheimer's Disease ALS (Amyotrophic Lateral Sclerosis)
The specific aim of this study is to investigate rod, cone and melanopsin driven pupillary light response in individuals with progressive supranuclear palsy (PSP), age-matched healthy controls and individuals with other neurodegenerative diseases using chromatic pupillometry,... expand

The specific aim of this study is to investigate rod, cone and melanopsin driven pupillary light response in individuals with progressive supranuclear palsy (PSP), age-matched healthy controls and individuals with other neurodegenerative diseases using chromatic pupillometry, with special interest in assessing melanopsin-driven post-illumination pupil response (PIPR) as an identifier for PSP. The study addresses the following hypotheses: 1. Chromatic pupil responses, including rod/cone-driven rapid phase constriction and melanopsin-driven PIPR, are reduced in subjects with PSP compared to age-matched normal healthy control subjects, 2. Pupil parameters of the melanopsin-driven PIPR are abnormal in PSP subjects without supranuclear palsy, which is indicative of a subclinical physiological deficit of the OPN in the early stages of PSP. If these hypotheses are upheld, chromatic pupillometry to measure the PIPR promises to be a reliable in vivo, non-invasive, convenient and inexpensive technique to detect asymptomatic pupillomotor impairment in advance of diagnostic oculomotor signs and deterioration of cognitive function.

Type: Observational

Start Date: Nov 2017

open study

Project: Every Child for Younger Patients With Cancer
Children's Oncology Group Central Nervous System Neoplasm Childhood Immature Teratoma Childhood Langerhans Cell Histiocytosis Childhood Malignant Neoplasm Childhood Mature Teratoma
This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care. expand

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Type: Observational

Start Date: Oct 2015

open study

Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia
Kura Oncology, Inc. Leukemia, Myelomonocytic, Chronic
A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR) of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21)... expand

A Phase 2 study to investigate the antitumor activity in terms of overall response rate (ORR) of tipifarnib in approximately 20 eligible subjects with CMML. Subjects will receive tipifarnib administered orally, twice a day (bid) for 7 days in alternating weeks (Days 1-7 and 15-21) in 28 day cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment until disease progression. If a complete response is observed, therapy with tipifarnib will be maintained for at least 6 months beyond the start of response.

Type: Interventional

Start Date: Oct 2016

open study

Effects of Botox in Obstructed Defecation Syndrome
Massachusetts General Hospital Obstructed Defecation Syndrome (ODS)
The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve symptoms of constipation in obstructed defecation syndrome (ODS). expand

The purpose of this study is to determine if Botulinum Toxin-A (Botox) injection will improve symptoms of constipation in obstructed defecation syndrome (ODS).

Type: Interventional

Start Date: Feb 2016

open study

Effects of tDCS and TUS on the Perception of Pain and Functional Limitations Due to Non-Specific Chronic...
Spaulding Rehabilitation Hospital Chronic Pain Chronic Low Back Pain
The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to... expand

The purpose of this study is to assess the effects of tDCS in combination with TUS for the treatment of pain and functional limitations in subjects with NSCLBP. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation.

Type: Interventional

Start Date: Nov 2016

open study

Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
Massachusetts General Hospital Stress
This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with ASD, this study aims to identify the psychosocial needs of parents of children with ASD, specifically a) the types of concerns... expand

This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with ASD, this study aims to identify the psychosocial needs of parents of children with ASD, specifically a) the types of concerns that parents find most difficult and stressful b) areas of concern that lack support and resources, and c) areas of need for education and skill training. This study also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP). Phase II: Informed by Phase I findings, this study aims to develop and determine the feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP) program for parents of children with ASD. Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial, establishing efficacy of a virtual resiliency program.

Type: Interventional

Start Date: Dec 2016

open study

Comparative Effectiveness of Bariatric Surgery With PROMs
Massachusetts General Hospital Bariatric Surgery Metabolic Surgery Weight Reduction
This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of... expand

This long-term, nationwide observational data collection repository will obtain patient-reported outcomes from metabolic and bariatric surgery patients. The data will be used in conjunction with clinical outcomes to determine quality, safety, and comparative effectiveness of various metabolic and bariatric procedures.

Type: Interventional

Start Date: Mar 2016

open study

Pharmacokinetics, Pharmacodynamics and Safety of Basis in Acute Kidney Injury Study
Massachusetts General Hospital Acute Kidney Injury
This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating doses of Basis following twice daily oral administration in patients with acute kidney injury (AKI). Basis is a commercially available nutritional supplement consisting of nicotinamide riboside... expand

This study will determine the pharmacokinetics, pharmacodynamics and safety of escalating doses of Basis following twice daily oral administration in patients with acute kidney injury (AKI). Basis is a commercially available nutritional supplement consisting of nicotinamide riboside (NR) and pterostilbene that acts to increase sirtuin activity.

Type: Interventional

Start Date: Nov 2017

open study

DNA Analysis of Blood and Tissue From Patients With Lung Cancer
Massachusetts General Hospital Lung Cancer
RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This clinical trial... expand

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future. PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

Type: Observational

Start Date: Sep 2005

open study