244 matching studies

Sponsor Condition of Interest
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

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

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

Identifying Correlates of Brain Microglial Activation in Neuropsychiatric Syndromes: A Dimensional Approach
The University of Texas Health Science Center, Houston Neuropsychiatric Syndromes
The purpose of this research is to determine whether there is more extensive inflammation in the brain of people with clinical evidence of neuropsychiatric syndromes, such as mood disorder, chronic pain syndrome, dementia, traumatic brain injury, or substance abuse. The research... expand

The purpose of this research is to determine whether there is more extensive inflammation in the brain of people with clinical evidence of neuropsychiatric syndromes, such as mood disorder, chronic pain syndrome, dementia, traumatic brain injury, or substance abuse. The research will also explore whether there is more inflammation in patients with more neuropsychiatric symptoms. Inflammation in the brain will identified by using Positron Emission Tomography (PET) with the radiotracer [11C]PBR-28.

Type: Interventional

Start Date: May 2017

open study

Substance Abuse Pre-Treatment Screening Study
The University of Texas Health Science Center, Houston Cocaine Abuse Cocaine Dependence Opiate Dependence Alcohol Dependence Substance Abuse
The overarching goal of this project is to have a consolidated consent and evaluation procedure that will lead potential subjects to the most appropriate clinical trial or human laboratory study (and its consent process) for their presenting concerns or interests. A second purpose... expand

The overarching goal of this project is to have a consolidated consent and evaluation procedure that will lead potential subjects to the most appropriate clinical trial or human laboratory study (and its consent process) for their presenting concerns or interests. A second purpose is to have a consolidated intake data base on which secondary analyses can be conducted.

Type: Observational

Start Date: Oct 2005

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

Are NSAIDs Effective Enough for Postoperative Pain Control After Functional Endoscopic Sinus Surgery...
The University of Texas Health Science Center, Houston Pain Control After Functional Endoscopic Sinus Surgery and Septoplasty
The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty. expand

The purpose of this study is to compare the level of pain control in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs) to those receiving opioids in the postoperative period after endoscopic sinus surgery (ESS) and/or septoplasty.

Type: Interventional

Start Date: Aug 2018

open study

Management of Sub-Clinical Bacteriuria in Pregnancy
The University of Texas Health Science Center, Houston Cystitis Cystitis;Puerperium Pyelonephritis
The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes. expand

The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.

Type: Interventional

Start Date: Sep 2017

open study

Reclaim™ Deep Brain Stimulation (DBS) Therapy for Obsessive-Compulsive Disorder (OCD)
The University of Texas Health Science Center, Houston Obsessive-Compulsive Disorder (OCD)
There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the alternative approach or a combination of the two. A rarely used third therapy approach, appropriate... expand

There are two primary approaches to the treatment of OCD, pharmacotherapy and cognitive behavior therapy (CBT). Lack of therapeutic success with one approach leads to trials of the alternative approach or a combination of the two. A rarely used third therapy approach, appropriate for only the most severely afflicted and treatment resistant patients, is neurosurgical ablation of certain brain regions involved in mood and anxiety. The neurosurgical ablation procedures are irreversible in nature, and involve the destruction of specific volumes of brain tissue through various controlled means. Surgical procedures include cingulotomy, subcaudate tractotomy, limbic leucotomy which is a combination of the first two procedures and capsulotomy. DBS therapy is an alternative to neurosurgical procedures, specifically anterior capsulotomy, for patients with chronic, severe OCD which has proven resistant to primary pharmacological and/or behavior therapy options. Results from 26 severe, treatment-resistant OCD patients treated with DBS at four collaborating centers, three in the US, and one in Europe are summarized in great detail in pages 12-22 of the provided/attached "Reclaim Summary of Safety and Probable Benefit."

Type: Interventional

Start Date: Nov 2018

open study

BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit
Memorial Hermann Health System Acute Ischemic Stroke
The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management,... expand

The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).

Type: Observational

Start Date: Aug 2014

open study

A Prospective Study To Identify Predictive Biological Markers In Blood And Cyst Fluid Aspirates From...
The University of Texas Health Science Center, Houston Pancreatic Cystic Lesions
The purpose To determine the diagnostic potential of various biological markers in blood and cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs). Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository study enrolling all... expand

The purpose To determine the diagnostic potential of various biological markers in blood and cyst fluid aspirates from patients with Pancreatic Cystic Lesions (PCLs). Research design This is a 10-year prospective cohort and pancreatic cyst fluid repository study enrolling all patients diagnosed with pancreatic cyst and undergoing the cyst aspiration. Procedures to be used Blood Sample Cyst Fluid Sample Data Collection: Medical Record Number Demographics (age, sex, gender, race) Contact information History of alcohol use and IV and other recreational drugs and narcotics use/abuse Medication history Past hospitalizations, diagnoses, and treatment Physical examination findings Imaging data of abdominal and chest regions, including and not limited to ultrasonography, magnetic resonance imaging (MRI), computed tomography (CT) Future admissions, diagnoses, treatment including histopathological findings of resected specimens and blood reports End of study data: clinical progression of disease, cyst size, wall thickening, calcification, communication with pancreatic duct, string sign, cytology, immunohistochemical findings, assay levels of lipase, amylase CEA (carcinoembryonic antigen), carbohydrate antigen19-9 (CA 19-9), and other biomarkers. Risks and potential benefits The risks associated with this study are slight discomfort or bruising from the blood sampling and the possible loss of confidentiality if the patient data or information is inadvertently disclosed outside of this study. The patient will not receive any additional benefit from the study aside from those received as part of routine standard of care. Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may benefit other patients with Pancreatic Cyst Lesions in the future.

Type: Observational [Patient Registry]

Start Date: May 2015

open study

Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
The University of Texas Health Science Center, Houston Dental Implant Immediate Dental Implant Soft Tissue Augmentation
The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone. expand

The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone.

Type: Interventional

Start Date: Oct 2016

open study

Effect of D-amphetamine on Reward Functioning
The University of Texas Health Science Center, Houston Anhedonia
The purpose of this study is to establish the dose-response curve for therapeutic doses of d-amphetamine on tasks of motivation and reward learning in the same participants and to use d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in reward-related... expand

The purpose of this study is to establish the dose-response curve for therapeutic doses of d-amphetamine on tasks of motivation and reward learning in the same participants and to use d-amphetamine as a dopaminergic probe to test newer theories about the role of dopamine in reward-related decision-making.

Type: Interventional

Start Date: Jan 2018

open study

Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury
The University of Texas Health Science Center, Houston Acquired Brain Injury
This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal... expand

This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal direct current stimulation (tsDCS) over cervical spine combined with high intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.

Type: Interventional

Start Date: May 2016

open study

Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries
The University of Texas Health Science Center, Houston Cervical Spinal Cord Injury Spinal Cord Injuries Traumatic Spinal Cord Compression
The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury. expand

The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.

Type: Interventional

Start Date: Apr 2018

open study