451 matching studies

Sponsor Condition of Interest
Low-Dose Atropine for Treatment of Myopia
Jaeb Center for Health Research Myopia
Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment).... expand

Study Objectives The objectives for this randomized trial are: 1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years (Primary Outcome On-Treatment). 2. To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment). Synopsis of Study Design The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Type: Interventional

Start Date: Jun 2018

open study

Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
Xeris Pharmaceuticals Hypoglycemia Unawareness Diabetes Mellitus, Type 1
This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects... expand

This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects will receive blinded study drug for 4 weeks, and they will be followed for an additional 26 weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.

Type: Interventional

Start Date: Mar 2018

open study

Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
Johns Hopkins University Multiple Sclerosis, Relapsing-Remitting
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing... expand

FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.

Type: Interventional

Start Date: May 2018

open study

A Study of Brentuximab Vedotin in Adults Age 60 and Above With Hodgkin Lymphoma (HL) and CD30-expressing...
Seattle Genetics, Inc. Hodgkin Disease Peripheral T Cell Lymphoma
This trial will study brentuximab vedotin to find out whether it is an effective treatment in patients 60 years or older for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). The study will look at brentuximab vedotin alone and combined with other drugs. expand

This trial will study brentuximab vedotin to find out whether it is an effective treatment in patients 60 years or older for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). The study will look at brentuximab vedotin alone and combined with other drugs.

Type: Interventional

Start Date: Oct 2012

open study

Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic...
Seattle Genetics, Inc. Breast Neoplasms
This trial studies SGN-LIV1A in combination with pembrolizumab to find out what their side effects are and if they work for patients with triple-negative breast cancer that has spread to other parts of the body. Patients will be given both experimental drugs every 3 weeks. expand

This trial studies SGN-LIV1A in combination with pembrolizumab to find out what their side effects are and if they work for patients with triple-negative breast cancer that has spread to other parts of the body. Patients will be given both experimental drugs every 3 weeks.

Type: Interventional

Start Date: Feb 2018

open study

A Safety Study of SGN-LIV1A in Breast Cancer Patients
Seattle Genetics, Inc. Breast Cancer
This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab. expand

This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.

Type: Interventional

Start Date: Oct 2013

open study

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Thomas G. Brott, M.D. Carotid Stenosis
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis.... expand

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

Type: Interventional

Start Date: Dec 2014

open study

Transthyretin-Associated Amyloidoses Outcome Survey (THAOS)
Pfizer Transthyretin Mutations Transthyretin Amyloidosis
THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years.... expand

THAOS is a global, multi-center, longitudinal observational survey open to all patients with transthyretin-associated amyloidoses (ATTR), including ATTR-PN (polyneuropathy), ATTR-CM (cardiomyopathy) and wild-type ATTR-CM. It is open-ended with a minimum duration of 10 years. Patients will be followed as long as they are able to participate. The principal aims of this outcome survey are to better understand and characterize the natural history of the disease by studying a large and heterogenous patient population. Survey data may be used to develop new treatment guidelines and recommendations, and to inform and educate clinicians about the management of this disease.

Type: Observational

Start Date: Jul 2007

open study

A Study of Parsaclisib in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without...
Incyte Corporation Lymphoma
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.... expand

This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in subjects with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

Type: Interventional

Start Date: Oct 2017

open study

Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory...
National Cancer Institute (NCI) Recurrent Classic Hodgkin Lymphoma Refractory Classic Hodgkin Lymphoma
This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous... expand

This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.

Type: Interventional

Start Date: Jan 2014

open study

Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer
National Cancer Institute (NCI) Early-Stage Breast Carcinoma Invasive Breast Carcinoma
This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development... expand

This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a necessary feature of agents under development for cancer prevention.

Type: Interventional

Start Date: Mar 2018

open study

Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed...
Basilea Pharmaceutica Glioblastoma MGMT-Unmethylated Glioblastoma
This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work... expand

This phase I trial studies the side effects and best dose of microtubule-targeted agent BAL101553 when given together with radiation therapy in treating patients with newly diagnosed glioblastoma. Drugs used in chemotherapy, such as microtubule-targeted agent BAL101553, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving microtubule-targeted agent BAL101553 and radiation therapy may work better in treating patients with glioblastoma.

Type: Interventional

Start Date: Jun 2017

open study

Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Pfizer Transthyretin (TTR) Amyloid Cardiomyopathy
Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy expand

Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

Type: Interventional

Start Date: Jun 2016

open study

Improving Thinking in Everyday Life: Pilot Study A
University of Alabama at Birmingham Cognitive Impairment
This is a pilot study at the University of Alabama at Birmingham. The purpose of this initial study is to test how effective a new therapy is for improving participants ability to think, particularly how rapidly they process information that they receive from their senses, e.g.,... expand

This is a pilot study at the University of Alabama at Birmingham. The purpose of this initial study is to test how effective a new therapy is for improving participants ability to think, particularly how rapidly they process information that they receive from their senses, e.g., sight, hearing,… . The study will also test whether the new therapy improves how often and how well they are able to carry out tasks that rely on thinking in their daily life. The therapy will combine a computer game that ask participants to identify targets on the screen as rapidly as possible with a set of psychological techniques that will help to apply the improvements that are made in how rapidly participants process information as a result of the game to carrying out tasks that rely on thinking in your daily life.

Type: Interventional

Start Date: Mar 2019

open study

An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently...
Bristol-Myers Squibb Psoriasis
The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis. expand

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.

Type: Interventional

Start Date: Jul 2018

open study

Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study
University of Alabama at Birmingham Spinal Cord Injuries Traumatic Brain Injury Spina Bifida Cerebral Palsy Stroke
The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be... expand

The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested.

Type: Interventional

Start Date: Jun 2019

open study

Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive...
Janssen Research & Development, LLC Depressive Disorder, Major
The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and previously validated examiner‑administered cognitive tests.... expand

The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and previously validated examiner‑administered cognitive tests.

Type: Observational

Start Date: Oct 2016

open study

Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in HIV-1-infected Participants...
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections
The purpose of this study is to evaluate the safety and immunotherapeutic activity of an anti-PD-1 antibody (cemiplimab) in HIV-1-infected participants on suppressive combination antiretroviral therapy (cART). expand

The purpose of this study is to evaluate the safety and immunotherapeutic activity of an anti-PD-1 antibody (cemiplimab) in HIV-1-infected participants on suppressive combination antiretroviral therapy (cART).

Type: Interventional

Start Date: Apr 2019

open study

Radiosurgery Plus NovoTTF-200A for Metastatic Small Cell Lung Cancer to the Brain
Drexell Hunter Boggs Brain Metastases Small Cell Lung Cancer
This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC). expand

This study is a prospective single arm trial designed to study the safety and effectiveness of a medical device, NovoTTF-200A, used with stereotactic radiosurgery (SRS) in subjects with brain metastases from small cell lung cancer (SCLC).

Type: Interventional

Start Date: Jun 2019

open study

Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress...
Renovia, Inc. Stress Urinary Incontinence Mixed Urinary Incontinence
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes... expand

A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.

Type: Interventional

Start Date: Oct 2018

open study

Diastolic Dysfunction and Pauci-inflammatory Acute Exacerbations of COPD
University of Alabama at Birmingham Chronic Obstructive Pulmonary Disease Diastolic Dysfunction
This is a prospective study to determine the relationships between pauci-inflammatory exacerbations and diastolic dysfunction, and their implications in hospitalized patients with acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a number... expand

This is a prospective study to determine the relationships between pauci-inflammatory exacerbations and diastolic dysfunction, and their implications in hospitalized patients with acute exacerbations of COPD. To assess changes within subjects from stable to acute phase, a number of comparisons will be made in subjects enrolled during acute exacerbation with similar measurements made in the stable phase after recovery from exacerbation after at least 35 days from index hospitalization or prior exacerbation.

Type: Observational

Start Date: Nov 2013

open study

A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant)...
Idorsia Pharmaceuticals Ltd. Resistant Hypertension
The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept... expand

The purpose of the study is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.

Type: Interventional

Start Date: Jun 2018

open study

Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due...
Intercept Pharmaceuticals Compensated Cirrhosis Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH. expand

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Type: Interventional

Start Date: Aug 2017

open study

A Study of Baricitinib (LY3009104) in Adult Participants With Moderate to Severe Atopic Dermatitis
Eli Lilly and Company Atopic Dermatitis
The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis. expand

The purpose of this study is to evaluate the efficacy and safety of baricitinib in adult participants with moderate to severe atopic dermatitis.

Type: Interventional

Start Date: Feb 2018

open study

HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+...
Johns Hopkins University Hiv
The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications. expand

The primary objective of this study is to determine if an HIV-infected deceased kidney donor (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications.

Type: Interventional

Start Date: Apr 2018

open study