248 matching studies

Sponsor Condition of Interest
Breast/Evaluation of Cryotherapy and TRPA1 Receptors in Chemotherapy Induced Neuropathy
The University of Texas Health Science Center at San Antonio Peripheral Neuropathies
To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities expand

To determine rate and severity of chemotherapy induced neuropathy in extremities treated with cold gloves and socks versus control extremities

Type: Interventional

Start Date: Nov 2017

open study

Safety and Effectiveness of the Jada System in Treating Primary Postpartum Hemorrhage
Alydia Health Postpartum Hemorrhage
The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage. expand

The purpose of this study is to evaluate the safety and effectiveness of the Jada System in the control and reduction of primary postpartum hemorrhage.

Type: Interventional

Start Date: Sep 2017

open study

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
The University of Texas Health Science Center, Houston Stroke
Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence... expand

Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life. Hypothesis: GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.

Type: Interventional

Start Date: Jul 2018

open study

International Bicuspid Aortic Valve Consortium (BAVCon)
Beth Israel Deaconess Medical Center Bicuspid Aortic Valve Disease Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve
Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30%... expand

Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability. The Specific Aims of this study are: 1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease. 2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease. To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.

Type: Observational [Patient Registry]

Start Date: Nov 2013

open study

Topical Antibiotic Irrigation (Bacitracin) in Prophylaxis of Midfacial Fracture Surgical Wounds
The University of Texas Health Science Center, Houston Surgical Site Infection
The purpose of this study is to evaluate the use of topical antibiotic irrigation (bacitracin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). expand

The purpose of this study is to evaluate the use of topical antibiotic irrigation (bacitracin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).

Type: Interventional

Start Date: Oct 2018

open study

Pulmonary Fibrosis Foundation Patient Registry
University of Michigan Interstitial Lung Disease (ILD) Idiopathic Pulmonary Fibrosis (IPF)
The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic... expand

The Pulmonary Fibrosis Foundation Patient Registry will collect data on at least 2,000 patients with interstitial lung disease (ILD) at approximately 40 clinical sites in the US. The Registry is targeting enrollment of approximately 60% of the 2,000 ILD participants to have idiopathic pulmonary fibrosis (IPF). The aim of the Registry is to create a cohort of well-characterized patients with interstitial lung disease (ILD) for participation in retrospective and prospective research

Type: Observational [Patient Registry]

Start Date: Mar 2016

open study

The PARTNER 3 - AVIV Trial
Edwards Lifesciences Aortic Stenosis Cardiomyopathy, Hypertrophic
To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve. expand

To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

Type: Interventional

Start Date: Jan 2017

open study

Nanovectors to Prevent Placental Passage of Tocolytic Agents
The University of Texas Health Science Center, Houston Preterm Labor
The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions... expand

The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.

Type: Observational

Start Date: Jul 2014

open study

Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes
University of Texas Southwestern Medical Center Peripheral Arterial Disease
XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software,... expand

XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to: 1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint) Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient.

Type: Observational [Patient Registry]

Start Date: Jan 2013

open study

Anesthesia in Patients With Mitochondrial Disease
The University of Texas Health Science Center, Houston Mitochondrial Diseases
This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient. expand

This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient.

Type: Interventional

Start Date: Jan 2014

open study

IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women
The University of Texas Health Science Center, Houston Pain Management in Pregnant Women
Purpose: To determine if IV acetaminophen can 1) decrease pain in pregnancy women, 2)reduce the amount of opioid use in pregnant women who encounter pain, 3) reduce maternal and fetal adverse effects compared to opioids. Design: This is a comparative effective trial that is... expand

Purpose: To determine if IV acetaminophen can 1) decrease pain in pregnancy women, 2)reduce the amount of opioid use in pregnant women who encounter pain, 3) reduce maternal and fetal adverse effects compared to opioids. Design: This is a comparative effective trial that is a randomized, controlled trial of IV acetaminophen vs. IV morphine in pregnant women. Procedures: Women meeting inclusion/exclusion criteria will be randomized to IV acetaminophen or IV morphine. The IV acetaminophen group will get up to four standard doses of IV acetaminophen during their stay at the hospital. The second group will get up to six standard doses of morphine. Subjects will complete a pain scale after medication administration and will be asked about any side effects.

Type: Interventional

Start Date: Jan 2014

open study

Transforming Research and Clinical Knowledge in Traumatic Brain Injury
University of California, San Francisco Traumatic Brain Injury
The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI from concussion... expand

The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical trials, advance diagnostic and prognostic models for TBI and improve clinical trial design. We are enrolling patients within 24 hours of injury who present to a TRACK-TBI site with a brain injury that meets ACRM criteria and receives a clinically indicated head CT.

Type: Observational

Start Date: Feb 2014

open study

Extracorporeal CO2 Removal With the Hemolung RAS for Mechanical Ventilation Avoidance During Acute Exacerbation...
Alung Technologies Acute Exacerbation of COPD
This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation... expand

This study evaluates the safety and efficacy of using the Hemolung RAS to provide low-flow extracorporeal carbon dioxide removal (ECCO2R) as an alternative or adjunct to invasive mechanical ventilation for patients who require respiratory support due to an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). It is hypothesized that the Hemolung RAS can be safely used to avoid or reduce time on invasive mechanical ventilation compared to COPD patients treated with standard-of-care mechanical ventilation alone. Eligible patients will be randomized to receive lung support with either the Hemolung RAS plus standard-of-care mechanical ventilation, or standard-of-care mechanical ventilation alone.

Type: Interventional

Start Date: Feb 2018

open study

Self Transcranial Direct Current Stimulation for Pain in Older Adults With Knee Osteoarthritis
The University of Texas Health Science Center, Houston Knee Osteoarthritis Chronic Pain
The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA). expand

The purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self Transcranial Direct Current Stimulation (tDCS) for pain in older patients with knee osteoarthritis (OA).

Type: Interventional

Start Date: Mar 2018

open study

Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor
The University of Texas Health Science Center, Houston Preterm Labor
Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus... expand

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Type: Interventional

Start Date: May 2015

open study

CytID Analysis of Oral Lesions
The University of Texas Health Science Center, Houston Oral Cavity Cancer Oropharyngeal Cancer
The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment... expand

The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. The study-related data gathering will not influence the treatment decisions of the clinician.

Type: Observational

Start Date: May 2018

open study

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
The University of Texas Health Science Center, Houston Lymphedema
The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease that... expand

The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly chemotherapy in genetically susceptible patients.

Type: Interventional

Start Date: Apr 2017

open study

Clinical Outcome Following Arthroscopic Knee Surgery
The University of Texas Health Science Center, Houston Anterior Cruciate Ligament Injury
Purpose: There are no existing data available to guide clinicians in the appropriate rehabilitation progression of patients who have undergone knee arthroscopy. The investigator intends to fill this void by establishing normative recovery curves for patients undergoing knee arthroscopy.... expand

Purpose: There are no existing data available to guide clinicians in the appropriate rehabilitation progression of patients who have undergone knee arthroscopy. The investigator intends to fill this void by establishing normative recovery curves for patients undergoing knee arthroscopy. Research Design: Prospective Observational Design Procedures: Patients 10-70 years old will be screened for "standard of care" clinical and functional outcomes to occur at standardized time-points (post-op weeks 1-4, 8, 12, 16, 20 and return to sport/activity) following arthroscopic knee surgery. Recovery curves will be plotted for all outcome variables of interest including; (1) International knee Disability Committee (IKDC) survey, (2) Tampa Kinesiophobia scale, (3) Tegner activity scale, (4) Marx activity scale, (5) Passive knee range of motion/heel-height difference, (6) Balance Error Scoring System (BESS), (7) Quad/Hamstring strength ratios, (8) Y-Balance, (9) Functional Movement Screening, (10) Vail-Sport Test, (11) Landing Error Scoring System (LESS), (12) Hop Testing, and the (13) Sports Metrics Test. Polynomial lines-of-best-fit and 95% confidence intervals will be plotted to provide objective recovery curves for clinical utilization and stratification of patient recovery. Risks: There are no additional risks to "standard physical therapy practice" for post-surgical patients participating in this study. The investigator will not be using invasive procedures or testing modalities that emit radiation. Benefits & Clinical Relevance: This information may offer valuable information to clinicians treating patients following knee arthroscopy by providing objective data for each phase of post-operative recovery. Identifying key landmarks and functional milestones may allow the ability to identify patients who are not meeting clinical expectations and subsequently tailor rehabilitation programs to improve recovery trajectories.

Type: Observational

Start Date: Oct 2014

open study

Trial of the Effect of Timing of Cholecystectomy During Initial Admission for Mild Gallstone Pancreatitis
The University of Texas Health Science Center, Houston Pancreatitis
Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis. expand

Randomized trial of laparoscopic cholecystectomy with cholangiogram on admission versus after resolution of pain for mild gallstone pancreatitis.

Type: Interventional

Start Date: Jun 2016

open study

Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
The University of Texas Health Science Center, Houston Diabetes Mellitus, Type 2
To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM). expand

To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM).

Type: Interventional

Start Date: Sep 2018

open study

Effects of Transcutaneous Spinal Direct Current Stimulation in Incomplete Spinal Cord Injury
The University of Texas Health Science Center, Houston Incomplete Spinal Cord Injury
The purpose of the study is to investigate the effects of a novel therapeutic approach with transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and spasticity in chronic spinal cord injury (SCI). expand

The purpose of the study is to investigate the effects of a novel therapeutic approach with transcutaneous spinal direct current stimulation (tsDCS) to promote functional recovery and spasticity in chronic spinal cord injury (SCI).

Type: Interventional

Start Date: Aug 2017

open study

N-of-1 Trials In Children With Hypertension
The University of Texas Health Science Center, Houston Pediatric Hypertension
The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure... expand

The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure control. This trial will advance learning about not only the treatment of pediatric hypertension but also the use of a neglected type of randomized trial to optimize the care of each patient.

Type: Interventional

Start Date: Apr 2018

open study

Extended Criteria For Fetal Myelomeningocele Repair
The University of Texas Health Science Center, Houston Obesity Myelomeningocele Pregnancy Diabetes Mellitus in Pregnancy Fetal Anomaly
The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with one of the former surgery exclusion factors - A BMI of 35-40 kg/m2 - Diabetes; patients will require good glycemic control - History a previous preterm... expand

The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with one of the former surgery exclusion factors - A BMI of 35-40 kg/m2 - Diabetes; patients will require good glycemic control - History a previous preterm birth, as long as it was followed by a full term birth - Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis. - Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E < 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis. We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including these factors. Prenatal clinical and outcome information will be collected; safety and efficacy will be evaluated

Type: Interventional

Start Date: Dec 2015

open study

The Leigh Syndrome Registry
The University of Texas Health Science Center, Houston Leigh Syndrome Leigh Disease Leigh's Necrotizing Encephalopathy Subacute Necrotizing Encephalomyopathy Subacute Necrotizing Encephalomyelopathy
The purpose of this study is to develop a database containing clinical and laboratory information for patients with Leigh syndrome. The goal is to provide a greater understanding of Leigh syndrome allowing further characterization of this disease. expand

The purpose of this study is to develop a database containing clinical and laboratory information for patients with Leigh syndrome. The goal is to provide a greater understanding of Leigh syndrome allowing further characterization of this disease.

Type: Observational [Patient Registry]

Start Date: Jun 2015

open study

Damage Control Laparotomy
The University of Texas Health Science Center, Houston Other Injury of Other Intra-abdominal Organs, Initial Encounter
Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize. expand

Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.

Type: Interventional

Start Date: Jun 2016

open study