88 matching studies

Sponsor Condition of Interest
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
The George Washington University Biostatistics Center Short Cervical Length
This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. expand

This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.

Type: Interventional

Start Date: Nov 2015

open study

Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer...
Alliance for Clinical Trials in Oncology Node Positive HER2 Negative Breast Cancer
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces... expand

This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.

Type: Interventional

Start Date: Dec 2016

open study

Longitudinal Study of the Porphyrias
Icahn School of Medicine at Mount Sinai Acute Porphyrias Cutaneous Porphyrias
The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders. expand

The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders.

Type: Observational

Start Date: Nov 2010

open study

Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically...
Exact Sciences Corporation Lung Cancer (Diagnosis)
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule... expand

The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm.

Type: Observational

Start Date: Apr 2016

open study

Use of Sildenafil for Treatment of Urinary Incontinence
The University of Texas Medical Branch, Galveston Urinary Incontinence
The investigators goal is to develop medical treatments for stress/mixed urinary incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and strength and to decrease muscle fatigue. The investigators believe that it will improve muscular atrophy in... expand

The investigators goal is to develop medical treatments for stress/mixed urinary incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and strength and to decrease muscle fatigue. The investigators believe that it will improve muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related to pelvic floor dysfunction.

Type: Interventional

Start Date: Mar 2017

open study

Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
The George Washington University Biostatistics Center Obstructive Sleep Apnea of Adult Preeclampsia Obstetrical Complications
A randomized controlled trial of 2,700 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy. expand

A randomized controlled trial of 2,700 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.

Type: Interventional

Start Date: Jul 2018

open study

Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive...
Alliance for Clinical Trials in Oncology Stage II Breast Cancer Stage IIIA Breast Cancer
This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove... expand

This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

Type: Interventional

Start Date: Feb 2014

open study

Oral Iron for Erythropoietic Protoporphyrias
Icahn School of Medicine at Mount Sinai Erythropoietic Protoporphyria EPP X-linked Protoporphyria XLP
In the medical literature there are conflicting reports on whether iron improves symptoms in patients with EPP and XLP. Giving iron to people who are iron deficient is thought to improve EPP symptoms. However, this has never been systematically tested. Therefore, the purpose of... expand

In the medical literature there are conflicting reports on whether iron improves symptoms in patients with EPP and XLP. Giving iron to people who are iron deficient is thought to improve EPP symptoms. However, this has never been systematically tested. Therefore, the purpose of this study is to determine the effect of oral iron for EPP and XLP patients.

Type: Interventional

Start Date: Dec 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

Validation of a Novel Screening Test for Maternal Insulin Resistance
The University of Texas Medical Branch, Galveston Insulin Resistance, Diabetes
This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the results of this initial trial, investigators plan to perform a larger trial at UTMB. Quantose... expand

This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the results of this initial trial, investigators plan to perform a larger trial at UTMB. Quantose IR is a fasting blood test for insulin resistance and prediabetes, and is clinically validated in non-pregnant individuals. The Quantose IR Score is based on three novel nonglycemic biomarkers, as well as insulin, and provides a comprehensive measure of insulin resistance. These analytes include: - α-HB (α-hydroxybutyrate): positively correlated with insulin resistance and indicative of early β-cell dysfunction. - L-GPC (linoleoyl-glycerophosphocholine): negatively correlated with insulin resistance and impaired glucose tolerance. - Oleic Acid: positively correlated with increasing lipolysis and insulin resistance. - Insulin: increased insulin is characteristic of insulin resistance and is an independent risk factor for type 2 diabetes and cardiovascular disease. Quantose IGT is designed to estimate the risk of being IGT. It is calculated from a multiple logistic regression model based on the fasting plasma levels of: - Glucose. - α−HB. - β−HB. - 4-methyl-2-oxopentanoic acid. - LGPC. - Oleic acid. - Serine. - Vitamin B5. Participants in the study will be consenting to data collection and two visits for lab draw. The investigators will then evaluate the performance of the Quantose IR and Quantose IGT in the study population.

Type: Observational

Start Date: Dec 2017

open study

A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix
The George Washington University Biostatistics Center Short Cervix Preterm Delivery
The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix. expand

The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix.

Type: Interventional

Start Date: Feb 2017

open study

Pravastatin for Prevention of Preeclampsia
The University of Texas Medical Branch, Galveston Preeclampsia
The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia. expand

The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia.

Type: Interventional

Start Date: Aug 2012

open study

Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
The University of Texas Medical Branch, Galveston Pre-Eclampsia Gestational Hypertension Superimposed Pre-Eclampsia Hypertension, Pregnancy-Induced Postpartum Pregnancy-Induced Hypertension
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension. expand

Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension.

Type: Interventional

Start Date: Nov 2017

open study

Antibacterial-coated Sutures at Time of Cesarean
The University of Texas Medical Branch, Galveston Surgical Site Infection Surgical Wound Infection Cesarean Section; Infection Cesarean Section Complications
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical... expand

Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery.

Type: Interventional

Start Date: Jan 2018

open study

Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer
National Cancer Institute (NCI) Recurrent Bladder Urothelial Carcinoma Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7 Stage 0is Bladder Urothelial Carcinoma AJCC v6 and v7 Stage I Bladder Urothelial Carcinoma AJCC v6 and v7
This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back and has not responded to treatment with Bacillus Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may... expand

This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back and has not responded to treatment with Bacillus Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Type: Interventional

Start Date: Feb 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 InPress Device in the control and reduction of primary postpartum hemorrhage. expand

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

Type: Interventional

Start Date: Sep 2017

open study

Study to Evaluate Efficacy, Safety, and Tolerability of MT‑7117 in Subjects With Erythropoietic Protoporphyria
Mitsubishi Tanabe Pharma Development America, Inc. Erythropoietic Protoporphyria (EPP)
The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight exposure duration without symptoms and tolerance in subjects with EPP. expand

The purpose of this study is to investigate the efficacy and safety of MT-7117 on sunlight exposure duration without symptoms and tolerance in subjects with EPP.

Type: Interventional

Start Date: Jul 2018

open study

Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?
The University of Texas Medical Branch, Galveston PPROM Respiratory Distress Syndrome in Premature Infants
The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated... expand

The purpose of this study is to determine if a repeat course of betamethasone given to pregnant women with preterm premature rupture of membranes (PPROM) will decrease the infant's length of stay in the neonatal intensive care unit (NICU) and the overall neonatal morbidity associated with this condition.

Type: Interventional

Start Date: Nov 2016

open study

Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients
The University of Texas Medical Branch, Galveston Muscle Weakness Late Effect of Burn Muscle; Fatigue, Heart Burn Rehabilitation
This study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried... expand

This study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation).

Type: Interventional

Start Date: Jul 2015

open study

Prevalence of Malnutrition and/or Sarcopenia at Hospital Admission
The University of Texas Medical Branch, Galveston Malnutrition Sarcopenia
The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at admission to the hospital in older adults. expand

The purpose of this study is to determine the prevalence of malnutrition and/or sarcopenia at admission to the hospital in older adults.

Type: Observational

Start Date: Feb 2015

open study

Collection of Samples From Pregnant Women for the Evaluation of Preeclampsia (Pre-E) Biomarkers
Progenity, Inc. Preeclampsia Hypertension Proteinuria Thrombocytopenia Renal Insufficiency
Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic... expand

Preeclampsia (Pre-E) is a hypertensive disease of pregnancy with multi-system involvement that usually occurs in the second half of pregnancy. Pre-E occurs in 5% to 7% of U.S. pregnancies, and is the third-leading cause of U.S. maternal death. Improvements to the current diagnostic paradigm have been evaluated. However, no stand-alone diagnostic method has emerged that more accurately identifies women at risk for preeclampsia, warranting improvements in diagnosing Pre-E. This sample collection study will obtain serum and urine samples from pregnant women who present with clinical signs, symptoms, or conditions contributing to the suspicion of Pre-E. Samples will be used to evaluate and validate the performance of an assay intended to aid in assessing the risk of Pre-E.

Type: Observational

Start Date: Jan 2016

open study

Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth
Steve N. Caritis, MD Preterm Birth
The study plans to determine the relationship between plasma concentrations of 17-OHPC (hydroxyprogesterone caproate) and the rate of preterm birth. The study is a randomized, open label study of pregnant women with one or more prior spontaneous preterm births. Subjects are randomized... expand

The study plans to determine the relationship between plasma concentrations of 17-OHPC (hydroxyprogesterone caproate) and the rate of preterm birth. The study is a randomized, open label study of pregnant women with one or more prior spontaneous preterm births. Subjects are randomized to a weekly single injection of either 250 or 500mg 17-OHPC (hydroxyprogesterone caproate).

Type: Interventional

Start Date: Feb 2018

open study

Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
Intact Vascular Peripheral Arterial Disease
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous... expand

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

Type: Interventional

Start Date: Feb 2017

open study

Environment Analysis Inside an Investigational Prescription Bottle
The University of Texas Medical Branch, Galveston Chronic Pain
The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. expand

The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.

Type: Interventional

Start Date: Dec 2018

open study

Identifying Therapeutic Targets of Accelerated Sarcopenia
The University of Texas Medical Branch, Galveston Sarcopenia Diabetes Mellitus Aging
The proposed research is designed to identify the mechanisms that can accelerate loss of muscle size, strength and physical function in type 2 diabetes and with hospitalization in older persons. About ⅓ of older Americans have type 2 diabetes, and about ⅓ of the hospitalizations... expand

The proposed research is designed to identify the mechanisms that can accelerate loss of muscle size, strength and physical function in type 2 diabetes and with hospitalization in older persons. About ⅓ of older Americans have type 2 diabetes, and about ⅓ of the hospitalizations in the USA involve persons older than 65 year of age. The proposed research is relevant to the part of NIH's mission that pertains to development of the fundamental knowledge that will improve health and reduce the burdens of disability, because this work will provide the fundamental evidence to identify new targets for the development of innovative treatments to slow down muscle loss and disability in our aging society.

Type: Interventional

Start Date: May 2017

open study