248 matching studies

Sponsor Condition of Interest
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions...
W.L.Gore & Associates Aortic Aneurysm, Thoracic Aorta, Lesion
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta. expand

The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.

Type: Interventional

Start Date: Aug 2016

open study

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
The George Washington University Biostatistics Center Obstetrical Complications Hemorrhage Labor and Delivery
A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery. expand

A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.

Type: Interventional

Start Date: Mar 2018

open study

Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post--‐Anesthesia Care Unit
The University of Texas Health Science Center, Houston Neuromuscular Blockade Respiratory Insufficiency
The Primary objective of this study is to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory... expand

The Primary objective of this study is to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression (which can precede critical respiratory events, CRE). The Secondary objectives are to: a) determine whether patients receiving sugammadex will have a normal TOF ratio (>0.90) indicative of full neuromuscular recovery in the PACU; and b) to improve patient safety by documenting whether postoperative respiratory depression (decreased MV below 80% and 40% of predicted MV as assessed by a Respiratory Volume Monitor) is due to opioid administration vs. postoperative residual neuromuscular block (by comparing postoperative VAS scores and total opioid administered).

Type: Interventional

Start Date: Feb 2017

open study

A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following...
Clovis Oncology, Inc. Epithelial Ovarian Cancer Primary Peritoneal Fallopian Tube Cancer Newly Diagnosed FIGO Stage III-IV
This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed... expand

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Type: Interventional

Start Date: May 2018

open study

Impact of Fever Prevention in Brain Injured Patients
C. R. Bard Fever Ischemic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated... expand

This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop.

Type: Interventional

Start Date: Jan 2017

open study

Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
The University of Texas Health Science Center, Houston Major Depressive Disorder
The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed and... expand

The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed and no symptoms of depression in the past 6 months).

Type: Interventional

Start Date: Feb 2018

open study

Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic...
Basilea Pharmaceutica Bacterial Infections
The primary objective is to characterize the pharmacokinetics of single doses of ceftobiprole in neonates and infants aged ≤3 months. The secondary objective is to evaluate safety and tolerability of ceftobiprole in neonates and infants aged ≤3 months. expand

The primary objective is to characterize the pharmacokinetics of single doses of ceftobiprole in neonates and infants aged ≤3 months. The secondary objective is to evaluate safety and tolerability of ceftobiprole in neonates and infants aged ≤3 months.

Type: Interventional

Start Date: Nov 2016

open study

Methotrexate and Etoposide Infusions Into the Fourth Ventricle in Children With Recurrent Posterior Fossa...
The University of Texas Health Science Center, Houston Brain Tumor Recurrent
The goal of this clinical research study is to establish the safety of simultaneous infusions of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in patients with recurrent malignant posterior fossa brain tumors. These tumors include medulloblastoma,... expand

The goal of this clinical research study is to establish the safety of simultaneous infusions of methotrexate and etoposide into the fourth ventricle of the brain or resection cavity in patients with recurrent malignant posterior fossa brain tumors. These tumors include medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor or other malignant brain tumor with recurrence or progression involving anywhere in the brain and/or spine. Patients' disease must have originated in the posterior fossa of the brain.

Type: Interventional

Start Date: Oct 2016

open study

Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc. Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries—REGISTRY in Europe, and COHORT in North America and Australasia—while also expanding to include sites in Latin America. More than 20,000 participants... expand

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries—REGISTRY in Europe, and COHORT in North America and Australasia—while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Type: Observational [Patient Registry]

Start Date: Jul 2012

open study

Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma
Privo Technologies Oral Squamous Cell Carcinoma
Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3 or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled... expand

Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3 or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled to occur during the 3 weeks prior to the standard of care tumor resection.

Type: Interventional

Start Date: Jun 2018

open study

Generic Database of Very Low Birth Weight Infants
NICHD Neonatal Research Network Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information... expand

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Type: Observational

Start Date: Jan 1987

open study

DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer
M.D. Anderson Cancer Center Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Triple-Negative Breast Carcinoma
This early phase I trial studies how well dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and technetium-Tc99m sestamibi molecular breast imaging (MBI) work in assessing tumor response to chemotherapy in patients with triple negative breast cancer (TNBC) who are... expand

This early phase I trial studies how well dynamic contrast enhanced molecular resonance imaging (DCE-MRI) and technetium-Tc99m sestamibi molecular breast imaging (MBI) work in assessing tumor response to chemotherapy in patients with triple negative breast cancer (TNBC) who are undergoing chemotherapy. Investigational imaging scans such as MBI and DCE-MRI may help researchers predict which patients may respond to treatment.

Type: Interventional

Start Date: Nov 2016

open study

Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove®...
MyndTec Inc. Spinal Cord Injuries Trauma, Nervous System
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms... expand

A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, sub-acute, traumatic spinal cord injury.

Type: Interventional

Start Date: Jun 2019

open study

Homeless Care Management App
University of Oklahoma Substance Use Disorders Mental Health Impairment Health Behavior Adherence, Patient
There is a significant revolving door of incarceration among homeless adults, a population with substantial health disparities. Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from... expand

There is a significant revolving door of incarceration among homeless adults, a population with substantial health disparities. Homeless adults who receive the professional coordination of individualized care (i.e., case management) during the period following their release from jail experience fewer mental health and substance use problems, are more likely to obtain stable housing, and are less likely to be re-incarcerated. The proposed study will use mobile technology to address these barriers and fill gaps in the understanding of the causes of the revolving door of homeless incarceration. This research represents a step toward integrated service connection and healthcare service provision for one of the most underserved, high need, and understudied populations in the United States. Smart phone apps that increase the use of available healthcare services and identify predictors of key outcomes (e.g., homelessness, re-arrest, medication compliance) could be used to reach hard to reach populations with histories of significant and persistent health disparities (e.g., homeless adults).

Type: Interventional

Start Date: Apr 2018

open study

UTHealth Turner Syndrome Research Registry
The University of Texas Health Science Center, Houston Turner Syndrome
The investigators will conduct genetic comparisons between Turner Syndrome (TS) patients with and without Bicuspid Aortic Valve (BAV) to identify causative agents of BAV in people with TS. The investigators will correlate the patterns and prevalence of structural heart defects... expand

The investigators will conduct genetic comparisons between Turner Syndrome (TS) patients with and without Bicuspid Aortic Valve (BAV) to identify causative agents of BAV in people with TS. The investigators will correlate the patterns and prevalence of structural heart defects in TS women with emerging molecular data to identify patients who are at high risk for cardiovascular complications

Type: Observational [Patient Registry]

Start Date: Aug 2015

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

Effectiveness of Higher Aspirin Dosing for Prevention of Preeclampsia in High Risk Obese Gravida
The University of Texas Health Science Center, Houston Pre-Eclampsia Hypertension in Pregnancy Obesity
To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day... expand

To compare the incidence of preeclampsia in obese pregnant women (BMI greater than 30) with a singleton gestation at less than 20 weeks and either a history of preeclampsia in a prior pregnancy or stage I hypertension or pre-gestational diabetes who are randomized to either 81mg/day aspirin or 162mg/day aspirin.

Type: Interventional

Start Date: May 2019

open study

Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by...
ECOG-ACRIN Cancer Research Group ALK Gene Rearrangement ALK Gene Translocation ALK Positive Stage IB Non-Small Cell Lung Carcinoma AJCC v7 Stage II Non-Small Cell Lung Cancer AJCC v7
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make... expand

This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Type: Interventional

Start Date: Aug 2014

open study

Assessing the Ability of the T-SPOT®.TB Test (IQ)
Oxford Immunotec Tuberculosis
The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified... expand

The primary objective of this clinical research study is to demonstrate performance of the normalized TB specific lymphocyte response (NTBSLR) in identifying patients with active TB disease. The secondary exploratory objective is to demonstrate that active TB cannot be identified using an antigen-to-mitogen ratio derived from an ELISA-based IGRA.

Type: Observational

Start Date: Sep 2019

open study

Promoting the Psychological Health of Women With SCI: A Virtual World Intervention
The University of Texas Health Science Center, Houston Spinal Cord Injuries
The purpose of this project is to test the efficacy of an internet-based psychological health enhancement program for women with spinal cord injury. The intervention will occur in Second Life (SL), which is an online virtual word simulator with a group of women with spinal cord... expand

The purpose of this project is to test the efficacy of an internet-based psychological health enhancement program for women with spinal cord injury. The intervention will occur in Second Life (SL), which is an online virtual word simulator with a group of women with spinal cord injury.

Type: Interventional

Start Date: Aug 2018

open study

The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury
Daren K. Heyland Burns
The purpose of this study is to test the following hypotheses: 1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries. 2. Enteral glutamine administration decreases hospital-acquired blood stream infections... expand

The purpose of this study is to test the following hypotheses: 1. Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries. 2. Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries. 3. Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care. The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 1200 patients in 80 sites: 1. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital 2. In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?

Type: Interventional

Start Date: Dec 2010

open study

The Impact of a Technology-enabled Decision Aid, for Patients With Hip and Knee Osteoarthritis on Decision...
University of Texas at Austin Osteoarthritis, Knee
This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question & answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level... expand

This study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question & answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to joint stiffness, joint pain and quality of life. The study will be performed in the setting of an integrated care system providing patient-centered care for hip and knee osteoarthritis over the full cycle of care. The impact of a technology-enabled decision aid incorporating predictive analytics with machine learning capabilities on decision quality, activation, experience & limitations of patients in this setting is relatively unknown.

Type: Interventional

Start Date: Mar 2019

open study

Postmenopausal Pessary Users: Estrogen Versus Trimosan
The University of Texas Health Science Center, Houston Vaginosis Vaginosis, Bacterial Vaginal Discharge
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users. expand

The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.

Type: Interventional

Start Date: May 2019

open study

Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder...
Abbott Medical Devices Ventricular Septal Defects
The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder. expand

The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.

Type: Interventional

Start Date: Mar 2008

open study

Self Transcranial Direct Current Stimulation and Mindfulness-based Meditation for Pain in Older Adults...
The University of Texas Health Science Center, Houston Knee Osteoarthritis
The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis. expand

The purpose of this study is to determine the feasibility and preliminary efficacy of a two-week self tDCS and mindfulness-based meditation for pain in older adults with knee osteoarthritis.

Type: Interventional

Start Date: Nov 2018

open study