499 matching studies

Sponsor Condition of Interest
Standard or Comprehensive Radiation Therapy in Treating Patients With Early-Stage Breast Cancer Previously...
NSABP Foundation Inc Stage IB Breast Cancer Stage II Breast Cancer
This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation... expand

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Type: Interventional

Start Date: Aug 2013

open study

Palbociclib in Real World Practice
Pfizer Advanced Breast Cancer Metastatic Breast Cancer
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer. expand

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.

Type: Observational

Start Date: Jan 2017

open study

Psilocybin-facilitated Treatment for Cocaine Use
University of Alabama at Birmingham Cocaine-Related Disorders
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement... expand

The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement (e.g., criminal involvement). MRI assessment is a unique aspect of this study. As a potential biological mechanism of psilocybin's effect includes changes in default mode network functional connectivity (Carhart-Harris et al., 2012), we will determine if psilocybin's therapeutic effects are mediated by such changes. Moreover, as Glx (a brain metabolite that reflects glutamate) abnormalities have been shown to play a role in cocaine addiction, we will determine if psilocybin impacts Glx in the anterior cingulate cortex and hippocampus.

Type: Interventional

Start Date: May 2015

open study

Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions
University of Alabama at Birmingham Gout
Bone erosions are a common manifestation and feature of structural damage in severe/chronic tophaceous gout. Management of this destructive and often debilitating gout complication has focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but... expand

Bone erosions are a common manifestation and feature of structural damage in severe/chronic tophaceous gout. Management of this destructive and often debilitating gout complication has focused exclusively on urate-lowering therapy (ULT) to reduce frequency of gout attacks, but little attention has been given to prevention or reversal of gout related bone erosions and other structural damage to bone caused by gout. Since there is no known effective treatment to attenuate or improve structural damage caused by gout, we propose a pilot, controlled, proof-of-concept study in which denosumab, an FDA approved medication for the treatment of bone loss, will be added to standard ULT in 20 patients with erosive gout.

Type: Interventional

Start Date: Feb 2017

open study

Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
University of Alabama at Birmingham Ventilator-Induced Lung Injury Respiratory Distress Syndrome Bronchopulmonary Dysplasia Preterm Infant
The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard... expand

The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard frequency ventilation strategy using ventilator rates of ≥ 20 to < 60 per minute will increase the number of alive ventilator-free days after randomization and reduce the risk of ventilator induced lung injury.

Type: Interventional

Start Date: Aug 2017

open study

Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
University of Maryland, Baltimore Transplant Glomerulopathy
This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR. expand

This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (2 g/Kg), and/or Rituximab, in patients with CAMR.

Type: Interventional

Start Date: Aug 2016

open study

DCM Precision Medicine Study
Ray Hershberger Idiopathic Dilated Cardiomyopathy
The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening. expand

The aims of the DCM Precision Medicine Study are to test the hypothesis that DCM has substantial genetic basis and to evaluate the effectiveness of a family communication intervention in improving the uptake and impact of family member clinical screening.

Type: Interventional

Start Date: Jun 2016

open study

P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
CeraPedics, Inc Degenerative Disc Disease
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody... expand

The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied in instrumented transforaminal lumbar interbody fusion (TLIF) in subjects with degenerative disc disease (DDD). In addition to the general overall objective, a sub-group analysis will be performed on the high-risk subject population (tobacco use, obesity, diabetes), as previous studies have shown negative effects of smoking, obesity and diabetes on fusion and bone healing, increased peri/postoperative complications, and lower patient-reported outcome scores.

Type: Interventional

Start Date: Apr 2018

open study

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Boston Scientific Corporation Heart Failure Defibrillators, Implantable Monitoring, Physiologic Cardiac Resynchronization Therapy Cardiovascular Disease
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization... expand

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

Type: Observational

Start Date: Jun 2018

open study

Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer
Massachusetts General Hospital Lung Cancer
This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families. expand

This research study is evaluating ways to provide palliative care to patients who have recently been diagnosed with lung cancer and their families.

Type: Interventional

Start Date: Jun 2018

open study

Neuroimaging Biomarker for Seizures
Providence VA Medical Center Seizure Disorder Seizure Disorder, Post Traumatic Traumatic Brain Injury Non-Epileptic Seizure Conversion Disorder
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using... expand

This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.

Type: Interventional

Start Date: Sep 2017

open study

Impact of CCR5 Blockade in HIV+ Kidney Transplant Recipients
National Institute of Allergy and Infectious Diseases (NIAID) HIV Infections Kidney Diseases
Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant. expand

Maraviroc (MVC) is a type of HIV medicine called a CCR5 inhibitor. This study will evaluate the safety and tolerability of MVC in HIV-infected adults receiving a kidney transplant.

Type: Interventional

Start Date: Jan 2017

open study

A Study Investigating the Efficacy, Safety, and PK Profile of ANB020 Administered to Adult Subjects With...
AnaptysBio, Inc. Atopic Dermatitis
This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of ANB020 in subjects with atopic dermatitis (AD). expand

This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of ANB020 in subjects with atopic dermatitis (AD).

Type: Interventional

Start Date: May 2018

open study

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease
Texas Scottish Rite Hospital for Children Legg Calve Perthes Disease
Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective... expand

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, >11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician preference. Physicians pick an intervention for each age group and treat each patient with the same intervention.

Type: Observational

Start Date: Aug 2012

open study

Dyslipidemia and Diabetic Retinopathy
University of Alabama at Birmingham Diabetic Retinopathy Dyslipidemia
The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes. expand

The purpose of this study is to determine if the reparative cells of blood vessels called endothelial progenitor cells(EPC) are defective in people with diabetes.

Type: Observational

Start Date: Jan 2014

open study

Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation
Ohio State University Stroke Hemiparesis
The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group... expand

The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 4 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy. After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).

Type: Interventional

Start Date: Nov 2015

open study

Patients Treated for SCID (1968-Present)
National Institute of Allergy and Infectious Diseases (NIAID) SCID ADA-SCID XSCID Leaky SCID Omenn Syndrome
People with Primary Immune Deficiency (PID) may develop severe, life-threatening infections as a result of inherited defects in the genes that normally instruct blood-forming cells to develop and to fight infections. PID diseases include Severe Combined Immune Deficiency (SCID),... expand

People with Primary Immune Deficiency (PID) may develop severe, life-threatening infections as a result of inherited defects in the genes that normally instruct blood-forming cells to develop and to fight infections. PID diseases include Severe Combined Immune Deficiency (SCID), leaky SCID, Omenn syndrome (OS), and Reticular Dysgenesis (RD). PIDs may be treated by transplantation of bone marrow stem cells from a healthy person or, in some cases, by enzyme replacement or by gene therapy. Patients with SCID were among the first to receive bone marrow stem cell (also called hematopoietic cells) transplantation (HCT) more than 40 years ago, and HCT is the standard treatment today for this group of diseases. Since PID diseases are rare, there are not enough patients at any single center to determine the full range of causes, natural history, or best methods of treatment. For this research study many PID centers across North America have organized into the Primary Immune Deficiency Treatment Consortium (PIDTC) to pool their experience and study PIDs together. Researchers will collect information on your general health, psychological and developmental health, and the current status of your immune system to help better define future approaches to PID treatments.

Type: Observational

Start Date: May 2011

open study

Patients Treated for Chronic Granulomatous Disease (CGD) Since 1995
National Institute of Allergy and Infectious Diseases (NIAID) Granulomatous Disease, Chronic
Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation (BMT) has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. This... expand

Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation (BMT) has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. This study will determine the long term medical condition and daily functioning of participants with CGD after a transplant and if possible, compare these results to participants who do not undergo a transplant.

Type: Observational

Start Date: Jun 2014

open study

Cerebrotendinous Xanthomatosis (CTX) Prevalence Study
Retrophin, Inc. Cerebrotendinous Xanthomatosis (CTX)
This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through... expand

This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.

Type: Observational

Start Date: Sep 2015

open study

Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and...
Tornier, Inc. Shoulder Arthroplasty and Fracture Repair
The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications... expand

The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products. In addition, this study will provide performance data for use in education, marketing materials, peer-reviewed publications and support research and development of future products.

Type: Observational [Patient Registry]

Start Date: Mar 2014

open study

Radiation Therapy With or Without Chemotherapy in Treating Patients With High-Risk Malignant Salivary...
Radiation Therapy Oncology Group Head and Neck Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation... expand

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with chemotherapy or alone after surgery in treating salivary gland tumors. PURPOSE: This randomized phase II/III trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.

Type: Interventional

Start Date: Jan 2011

open study

Interactive Telehealth for Pressure Ulcer Prevention After SCI
Rancho Research Institute, Inc. Spinal Cord Injuries Pressure Ulcer
The goal of this module project is to establish the efficacy of a portable sensor and app-based biofeedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. In collaboration with the participating... expand

The goal of this module project is to establish the efficacy of a portable sensor and app-based biofeedback technology system for promoting effective pressure relief behaviors and reducing risk of pressure ulcer development among wheelchair users. In collaboration with the participating SCIMS centers, the investigators will conduct a randomized clinical trial of education and goal setting alone compared to education and goal setting combined with the biofeedback system (SENSIMAT®) that is commercially available.

Type: Interventional

Start Date: May 2018

open study

Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With...
Gynecologic Oncology Group Fallopian Tube Clear Cell Adenocarcinoma Fallopian Tube Endometrioid Adenocarcinoma Fallopian Tube Mucinous Adenocarcinoma Fallopian Tube Serous Adenocarcinoma Fallopian Tube Transitional Cell Carcinoma
This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian... expand

This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

Type: Interventional

Start Date: Jun 2012

open study

American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) Registry
University of Louisville Pancreatic Cancer
The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical... expand

The purpose of this study is to create a registry to provide insight into treatment selection and treatment outcome of pancreatic IRE in order to develop an evidence base such that physicians can provide the best possible care to patients with pancreatic cancer requiring surgical interventions. The investigators seek a better understanding of the uses of ablation in the treatment of unresectable soft tissue pancreatic tumors and the limitations, concerns and complications that earlier users have.

Type: Observational [Patient Registry]

Start Date: Jan 2016

open study