772 matching studies

Sponsor Condition of Interest
Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects
Mayo Clinic Familial Frontotemporal Dementia
This study is being done to learn more about normal thinking and behavior, mild thinking and behavior problems, Frontotemporal Dementia and other forms of dementia in families in which one or more relatives have a mutation associated with Frontotemporal Dementia. expand

This study is being done to learn more about normal thinking and behavior, mild thinking and behavior problems, Frontotemporal Dementia and other forms of dementia in families in which one or more relatives have a mutation associated with Frontotemporal Dementia.

Type: Observational

Start Date: Apr 2015

open study

A Trial of Integrating SBRT With Targeted Therapy in Stage IV Oncogene-driven NSCLC
Massachusetts General Hospital Non-small Cell Lung Cancer Metastatic Targetable Oncogenes (EGFR, ALK, ROS1)
This research study is studying a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) as a possible treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) or or displaced anaplastic lymphoma... expand

This research study is studying a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) as a possible treatment for stage IV non-small cell lung cancer (NSCLC) that has a mutated epidermal growth factor receptor (EGFR) or or displaced anaplastic lymphoma receptor tyrosine kinase (ALK) or ROS proto-oncogene 1 (ROS1) gene (= oncogene-driven NSCLC) and for which the subject has been receiving treatment with a targeted biological agent such as erlotinib, crizotinib, or other drugs.

Type: Interventional

Start Date: Dec 2014

open study

Natural History Evaluation of Charcot Marie Tooth Disease (CMT) Types CMT1B, CMT2A, CMT4A, CMT4C, and...
Michael Shy Charcot Marie Tooth Disease
This is an observational longitudinal study to determine the natural history and genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C). The investigators will also be determine... expand

This is an observational longitudinal study to determine the natural history and genotype-phenotype correlations of disease causing mutations in Charcot Marie Tooth disease (CMT) type 1B (CMT1B), 2A (CMT2A), 4A (CMT4A), and 4C (CMT4C). The investigators will also be determine the capability of the newly developed CMT Pediatric Scale (CMT Peds scale) and the Minimal Dataset to measure impairment and perform longitudinal measurements in patients with multiple forms of CMT over a five year window

Type: Observational

Start Date: Apr 2010

open study

A Phase 2 Study of LY3023414 and Abemaciclib With or Without Letrozole in Endometrial Cancer
Dana-Farber Cancer Institute Endometrial Cancer
This research study is studying a combination of targeted therapies as a possible treatment for endometrial cancer. The drugs involved in this study are: - Abemaciclib (also known as Verzenio™) - LY3023414 - Letrozole (also known as Femara®) expand

This research study is studying a combination of targeted therapies as a possible treatment for endometrial cancer. The drugs involved in this study are: - Abemaciclib (also known as Verzenio™) - LY3023414 - Letrozole (also known as Femara®)

Type: Interventional

Start Date: Dec 2018

open study

Comparative Antiresorptive Efficacy Discontinuation of Denosumab
Massachusetts General Hospital Osteoporosis, Postmenopausal Osteoporosis
Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to... expand

Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene. Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued. The proposed study will help us determine the relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.

Type: Interventional

Start Date: Nov 2018

open study

ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer
Dana-Farber Cancer Institute Breast Cancer
This research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab... expand

This research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)

Type: Interventional

Start Date: Aug 2018

open study

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors,...
National Cancer Institute (NCI) Advanced Malignant Solid Neoplasm Bladder Carcinoma Breast Carcinoma Cervical Carcinoma Colon Carcinoma
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests... expand

This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.

Type: Interventional

Start Date: Aug 2015

open study

HIV-1-Gag Conserved-Element DNA Vaccine as Therapeutic Vaccination in HIV-Infected Persons With Viral...
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections
This study will evaluate the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who are on antiretroviral therapy (ART). The... expand

This study will evaluate the safety, immunogenicity, and preliminary assessment of efficacy of a novel vaccine encoding conserved elements (CE) of the HIV-1 Gag core protein, p24Gag, as a therapeutic vaccine in HIV-1 infected persons who are on antiretroviral therapy (ART). The study aims to induce potent virus-specific cytotoxic T lymphocytes (CTL) responses.

Type: Interventional

Start Date: Jan 2019

open study

Assisted Fluid Management IDE Study
Edwards Lifesciences Non-Cardiac/ Non-Thoracic Surgery Abdominal Surgery Pelvic Surgery Major Peripheral Vascular Surgery
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness. expand

The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.

Type: Interventional

Start Date: Apr 2018

open study

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With...
Enanta Pharmaceuticals Primary Biliary Cholangitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis expand

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis

Type: Interventional

Start Date: Dec 2017

open study

Treatments Against RA and Effect on FDG-PET/CT
Brigham and Women's Hospital Arthritis, Rheumatoid
In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders... expand

In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening).

Type: Interventional

Start Date: Jul 2016

open study

Oral TRK Inhibitor LOXO-101 for Treatment of Advanced Adult Solid Tumors
Bayer Unspecified Adult Solid Tumor, Protocol Specific
This is a multicenter, open-label, Phase 1 study of orally administered larotrectinib in adult subjects with advanced solid tumors and a NTRK1, NTRK2, or NTRK3 gene fusion that have progressed or are non responsive to available therapies and for which no standard or available... expand

This is a multicenter, open-label, Phase 1 study of orally administered larotrectinib in adult subjects with advanced solid tumors and a NTRK1, NTRK2, or NTRK3 gene fusion that have progressed or are non responsive to available therapies and for which no standard or available curative therapy exists.

Type: Interventional

Start Date: May 2014

open study

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
Orion Corporation, Orion Pharma Amyotrophic Lateral Sclerosis
This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter... expand

This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

Type: Interventional

Start Date: Jun 2018

open study

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis...
AbbVie Atopic Dermatitis
The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe Atopic Dermatitis (AD) who are candidates for systemic therapy. expand

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe Atopic Dermatitis (AD) who are candidates for systemic therapy.

Type: Interventional

Start Date: Aug 2018

open study

OPTIMIZE IDE for the Treatment of ACS
Svelte Medical Systems, Inc. Acute Coronary Syndrome
Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than... expand

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm

Type: Interventional

Start Date: Jan 2018

open study

Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function
Protalix Fabry Disease
This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients treated for approximately 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then... expand

This is a randomized, double blind, active control study of PRX-102 (pegunigalsidase alfa) in Fabry disease patients with impaired renal function. Patients treated for approximately 1 year with agalsidase beta and on a stable dose for at least 6 months will be screened and then randomized to continue treatment with 1mg/kg agalsidase beta or to treatment with 1 mg/kg of PRX-102. The identity of the enzyme will be blinded to the patient and the investigator. Patients will receive intravenous infusions every two weeks. Patients will be randomized in a 2:1 ratio of PRX-102 to agalsidase beta. Randomization will be stratified by urinary protein to creatinine ratio (UPCR) of < or ≥ 1 g/g by spot urine sample. No more than 50% of the patients will be female.

Type: Interventional

Start Date: Jun 2016

open study

MAGE A10ᶜ⁷⁹⁶T for Advanced NSCLC
Adaptimmune Non-Small Cell Lung Cancer Carcinoma
This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and... expand

This first time in human study is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*02:01 and/or HLA-A*02:06 and a tumor test positive for MAGE A10 protein expression (protein or gene). This trial is a dose escalation trial that will evaluate 3 doses of transduced cells administered after a lymphodepleting chemotherapy regimen using a 3+3 dose escalation design .The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. When the MAGE A10ᶜ⁷⁹⁶T cells are available, subjects will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by the T cell infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with lung cancer. The study will evaluate three different cell dose levels in order to find out the target cell dose. Once the target cell dose is determined, additional subjects will be enrolled to further test the safety and effects at this cell dose. Subjects will be seen frequently by the Study Physician right after receiving their T cells back and up to first 6 months. After that, subjects will be seen every three months. Subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion. If the T cells are found in the blood at five years, then the subjects will continue to be seen once a year until the T cells are no longer found in the blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the subject will be contacted by the Study Physician for the next 10 years. Subjects who have a confirmed response (or have stable disease for >4 months) but subsequent disease progression following the initial infusion and whose tumor continues to express the appropriate antigen target may be eligible for a second infusion. All subjects, completing or withdrawing from the Interventional Phase of the study, will enter a 15-year long-term follow-up phase for observation of delayed adverse events, All subjects will continue to be followed for overall survival during the long-term follow-up phase.

Type: Interventional

Start Date: Nov 2015

open study

Anti-Cytokine Therapy for Hemodialysis InflammatION
University of Pennsylvania End-Stage Renal Disease
Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis. expand

Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis.

Type: Interventional

Start Date: Dec 2017

open study

Safety and Efficacy of MAGE-A3/A6 T Cell Receptor Engineered T Cells (KITE-718) in HLA-DPB1*04:01 Positive...
Kite, A Gilead Company Solid Tumor
The primary objectives of Phase 1A are to evaluate the safety of KITE-718, determine a recommended Phase 1B dose, and to evaluate the efficacy of KITE-718 in Phase 1B. expand

The primary objectives of Phase 1A are to evaluate the safety of KITE-718, determine a recommended Phase 1B dose, and to evaluate the efficacy of KITE-718 in Phase 1B.

Type: Interventional

Start Date: May 2017

open study

Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or...
National Cancer Institute (NCI) Metastatic Transitional Cell Carcinoma Metastatic Urothelial Carcinoma Recurrent Bladder Carcinoma Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage IV Bladder Urothelial Carcinoma AJCC v7
This pilot phase II trial studies how well sapanisertib works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and/or TSC2... expand

This pilot phase II trial studies how well sapanisertib works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and/or TSC2 mutations (changes in deoxyribonucleic acid [DNA]). Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Type: Interventional

Start Date: Dec 2016

open study

Genetics of Charcot Marie Tooth (CMT) - Modifiers of CMT1A, New Causes of CMT2
University of Iowa Charcot-Marie-Tooth Disease, Type Ia (Disorder) HMSN
This project includes two projects. One is looking for new genes that cause Charcot Marie Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the symptoms a person has. expand

This project includes two projects. One is looking for new genes that cause Charcot Marie Tooth disease (CMT). The other is looking for genes that do not cause CMT, but may modify the symptoms a person has.

Type: Observational

Start Date: Apr 2010

open study

Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX
Massachusetts General Hospital Pancreas Cancer
The goal of this research is to study an intervention, which the investigators call "Supportive Oncology Care at Home," that entails both remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs, and body weight) and a Medically Home care model (e.g.... expand

The goal of this research is to study an intervention, which the investigators call "Supportive Oncology Care at Home," that entails both remote patient monitoring (e.g. patient-reported symptoms, home monitored vital signs, and body weight) and a Medically Home care model (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified). Specifically, the investigators will conduct a single arm pilot study (N=20) in patients with pancreatic cancer who sign consent for parent trial of neoadjuvant FOLFIRINOX (18-179) receiving preoperative FOLFIRINOX to assess the feasibility and acceptability of Supportive Oncology Care at Home.

Type: Interventional

Start Date: Jan 2019

open study

A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin...
Bioverativ Therapeutics Inc. Agglutinin Disease, Cold
The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a... expand

The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAD) without a recent history of blood transfusion. The purpose of Part B is to evaluate the long-term safety and tolerability of sutimlimab in participants with primary CAD.

Type: Interventional

Start Date: Nov 2017

open study

Breast Cancer WEight Loss Study (BWEL Study)
Alliance for Clinical Trials in Oncology Breast Carcinoma
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk... expand

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

Type: Interventional

Start Date: Aug 2016

open study

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole...
Pfizer Breast Cancer
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion... expand

This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.

Type: Interventional

Start Date: Jun 2016

open study