66 matching studies

Sponsor Condition of Interest
Adaptive COVID-19 Treatment Trial (ACTT)
National Institute of Allergy and Infectious Diseases (NIAID) COVID-19
This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites... expand

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

Type: Interventional

Start Date: Feb 2020

open study

Adaptive COVID-19 Treatment Trial 2 (ACTT-II)
National Institute of Allergy and Infectious Diseases (NIAID) COVID-19
ACTT-II will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects,... expand

ACTT-II will evaluate the combination of baricitinib and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.

Type: Interventional

Start Date: May 2020

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

D-CARE - The Dementia Care Study: A Pragmatic Clinical Trial of Health System-Based Versus Community-Based...
University of California, Los Angeles Dementia
D-CARE: The Dementia Care Study This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the United States, will compare the effectiveness and cost-effectiveness of 18 months of health systems-based... expand

D-CARE: The Dementia Care Study This pragmatic randomized clinical trial of 2150 persons with dementia and their caregivers, at four diverse clinical trial sites in the United States, will compare the effectiveness and cost-effectiveness of 18 months of health systems-based dementia care provided by a Dementia Care Specialist (nurse practitioner or physician assistant) who works within the heath system versus community-based dementia care provided by a Care Consultant (social worker or nurse) who works at a Community-Based Organization (CBO). The trial will also compare the effectiveness and cost-effectiveness of both models versus enhanced usual care.

Type: Interventional

Start Date: Jun 2019

open study

Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus...
ModernaTX, Inc. Human Metapneumovirus and Human Parainfluenza Infection
This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18-49 years of age) and 3 dose levels in children (12-36 months of age) with serologic... expand

This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18-49 years of age) and 3 dose levels in children (12-36 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.

Type: Interventional

Start Date: Nov 2019

open study

Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus...
National Institute of Allergy and Infectious Diseases (NIAID) Respiratory Syncytial Virus (RSV)
The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.... expand

The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.

Type: Interventional

Start Date: May 2019

open study

Easy Stretch Toolkit: A Pilot Study
The University of Texas Medical Branch, Galveston Facial Injuries
To research the use of a novel set of intraoral tools called the Easy Stretch Toolkit for the therapeutic management of facial burns and other facial disorders. expand

To research the use of a novel set of intraoral tools called the Easy Stretch Toolkit for the therapeutic management of facial burns and other facial disorders.

Type: Interventional

Start Date: Feb 2019

open study

PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)
Oak Crest Institute of Science HIV Prevention
Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products.... expand

Participants will have a 28-day pre-ring baseline assessment period (Stage 1) followed by randomization to order with 5 participants per study arm. All participants will sequentially receive both study products for 28-days with at least a 2-week washout period between products. Arm 1 will receive the TDF-FTC pod-IVR for Stage 2 followed by the placebo pod-IVR during Stage 3. Arm 2 will receive the placebo pod-IVR for Stage 2 followed by the TDF-FTC pod-IVR during Stage 3. During Stages 2 & 3 participants will also complete brief phone surveys (<3 min), computer-assisted self-interviews (CASIs), and in-depth interviews (IDIs) regarding perceptibility and acceptability. If willing, participants' male sexual partners will be invited to complete IDIs as well.

Type: Interventional

Start Date: Sep 2018

open study

The Effects of Video Game Warm-up on EyeSi Surgical Simulator Performance
The University of Texas Medical Branch, Galveston Training Effects of Bimanual Dexterity Activities of Video Games on Eyesi Tested Surgical Skills
This study will examine the history of video game use an activities of manual dexterity with the scored skills used in the Eyesi surgical simulator. Subjects will be asked to participate in video games or no video games prior to testing skills in Eyesi to examine training effects... expand

This study will examine the history of video game use an activities of manual dexterity with the scored skills used in the Eyesi surgical simulator. Subjects will be asked to participate in video games or no video games prior to testing skills in Eyesi to examine training effects of video game participation and changes in manual dexterity.

Type: Interventional

Start Date: May 2020

open study

A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT...
Pfizer Respiratory Tract Infection
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics... expand

This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.

Type: Interventional

Start Date: Aug 2019

open study

Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss
The University of Texas Medical Branch, Galveston Obesity
This study tests the feasibility and acceptability of a numberless behavioral digital scale (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes to promote weight loss in adolescents who are obese. Half of the participants will receive this... expand

This study tests the feasibility and acceptability of a numberless behavioral digital scale (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes to promote weight loss in adolescents who are obese. Half of the participants will receive this intervention, while the other half will use a digital scale along with the standard adolescent weight loss program.

Type: Interventional

Start Date: Feb 2020

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

Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
The University of Texas Medical Branch, Galveston Post Partum Hemorrhage Blood Loss Vaginal Bleeding Vaginal Delivery
This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators.... expand

This study will be a prospective cohort study. Patients who meet criteria for inclusion in the study will be approached for participation at same day of admission. Written informed consent will be obtained from the patients by the Co-principal investigator and by the study collaborators. If patients agree to participate, a CBC (complete blood count) will be obtained via venous puncture routine in our facility as part of the admission labs which will be around 10 cc of blood. The device will be used during the delivery in laboring room. The device will be used to assess QBL (quantitative blood loss) by the research staff only and results/ QBL assessment will be masked to the clinical team. Unmasking will only occur following study completion with purpose to perform data analysis. Patient management will be according to the clinical team without the knowledge of the QBL. All patients undergo a CBC postpartum as part of post-partum evaluation, this will also be performed by venipuncture where 10 cc of blood will be collected. The drop in Hgb (hemoglobin) between the pre and post partum CBCs will be calculated for each patient. The post-partum CBC will be collected approximately 24-30 hours from delivery as standard in our unit. The blood will be collected from each patient by the nursing staff who are experienced in withdrawing blood. Patients will be divided into quartiles of Hgb. Cases will be those patients whose Hgb is in the upper quartile, while controls will be those patients whose Hgb is in the lower 3 quartiles. We will be comparing visual EBL (estimated blood loss) by standard clinical assessment versus the QBL result from the device between cases and controls. The Triton L&D (labor and delivery) system which comprises of the device, software analysis and staff training will be supplied by the manufacturer free of charge. Research staff will be trained by the manufacturer. We will be offering our skills, fellows, midwifes and residents, who will be collecting data and we will be performing the data analysis. Results will be available to the manufacturer after results are completed. The results of this study will be presented in conferences or published in a peer-review journal. Demographic information will be obtained from the electronic medical record. The data will be kept on a password secured University of Texas Medical Branch (UTMB) computer. An encrypted USB flash drive will be used to transfer data. The data will be identified and linked to the patient using the medical record number. During data analysis, all patient identifiers will be deleted.

Type: Interventional

Start Date: May 2020

open study

Pink Warrior 2: Teleconference-based Gaming Support
The University of Texas Medical Branch, Galveston Breast Cancer Physical Activity
Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity—speeding recovery time and reduced cancer... expand

Breast cancer survivors, from diagnosis until the end of life, go through many transitions. One major transition is the significant decrease of physical activity immediately after diagnosis. Despite the known benefits of physical activity—speeding recovery time and reduced cancer recurrence risk—only 1 in 3 survivors met physical activity recommendations of 150 minutes of moderate-intensity activity per week. Physical activity interventions have shown effectiveness in helping breast cancer survivors increase physical activity during treatment, but limited evidence-based physical activity interventions have been incorporated into the clinic and community. To address this limitation, the investigators are partnering with the UTMB breast cancer support group to conduct a 12-week physical activity intervention, Pink Warrior. The goal of this study is to compare an intervention that uses active games versus an intervention uses pedometer to encourage physical activity such as walking within breast cancer survivors in active cancer treatment. The study will include breast cancer survivor between the ages of 18 - 70 whom currently gets less than 150 minutes of planned physical activity per week and received a breast cancer diagnosis within 0 to 6 months. Participants will be randomized to participate in the support group using the active video game-based physical activity intervention (Wii and Xbox active games) or to participate in the existing UTMB breast cancer support group with pedometers (Digi-Walker CW-700/701). The investigators hypothesize that by engaging in active video gaming, breast cancer survivors will be motivated to initiate and maintain physical activity during treatment. This will ultimately increase functional capacity and prevent functional disability in breast cancer survivors.

Type: Interventional

Start Date: May 2020

open study

A Social Media Game to Increase Physical Activity Among Older Adult Women
The University of Texas Medical Branch, Galveston Aging
This study will test the effects of a social media game on the physical activity of older adult women. The game will consist of playful weekly challenges that require sharing photographs on a private social media group and also wearing an activity monitor to track steps. Participants... expand

This study will test the effects of a social media game on the physical activity of older adult women. The game will consist of playful weekly challenges that require sharing photographs on a private social media group and also wearing an activity monitor to track steps. Participants will be randomized to this game group or to receive the activity monitor only.

Type: Interventional

Start Date: Dec 2019

open study

Narrative Visualization for Breast Cancer Survivors' Physical Activity
The University of Texas Medical Branch, Galveston Breast Cancer
This study tests the feasibility and acceptability of a physical activity intervention that combines use of a wearable activity monitor with a scrapbook. Half of the participants will receive this enhanced intervention, while the other half will receive a wearable activity monitor... expand

This study tests the feasibility and acceptability of a physical activity intervention that combines use of a wearable activity monitor with a scrapbook. Half of the participants will receive this enhanced intervention, while the other half will receive a wearable activity monitor with a standard step log.

Type: Interventional

Start Date: Sep 2018

open study

Optimizing Medication Management for Mothers With Depression
Northwestern University Depression Pregnancy
The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the blood changes due to the physiological changes in the body (i.e., changes in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of genetic... expand

The purpose of this study is to explore the way the antidepressant concentration (amount of medication) in the blood changes due to the physiological changes in the body (i.e., changes in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of genetic factors on the degree of these changes. Changes in antidepressant concentration are important to monitor, as decreases in antidepressant concentration may lead to less than therapeutic drug levels, which may cause an increase in mood symptoms or recurrence of depressive episodes. Increases in antidepressant concentration have the potential to lead to increased side effects. The study team is hoping to better understand the course of these changes across pregnancy and postpartum and how an individual's genetic makeup impacts these changes with the goal of developing guidelines to optimize antidepressant treatment of pregnant women.

Type: Observational

Start Date: Aug 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

S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer
Southwest Oncology Group Stage 0 Bladder Urothelial Carcinoma Stage 0is Bladder Urothelial Carcinoma Stage I Bladder Urothelial Carcinoma
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle.... expand

This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.

Type: Interventional

Start Date: Feb 2017

open study

A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth
The University of Texas Medical Branch, Galveston Obesity Postpartum Weight Retention Insulin Sensitivity
The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women. expand

The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women.

Type: Interventional

Start Date: Dec 2019

open study

Panhematin for Prevention of Acute Attacks of Porphyria
The University of Texas Medical Branch, Galveston Acute Intermittent Porphyria Hereditary Coproporphyria Variegate Porphyria
The purpose of this study is to determine if Panhematin is safe and effective for prevention of acute attacks of porphyria. The study aims to provide high quality evidence for the use on hemin for prevention of acute attacks of porphyria. High quality studies have not been done... expand

The purpose of this study is to determine if Panhematin is safe and effective for prevention of acute attacks of porphyria. The study aims to provide high quality evidence for the use on hemin for prevention of acute attacks of porphyria. High quality studies have not been done previously for treating or preventing acute attacks with hemin. The lack of strong evidence for efficacy of hemin for treatment and prevention of attacks limits its availability for patients with acute porphyrias. Funding source: FDA Office of Orphan Product Development (FDA OOPD) FD-R-03720

Type: Interventional

Start Date: Oct 2015

open study

Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe...
AMAG Pharmaceuticals, Inc. Severe Preeclampsia
This study evaluates the use of AMAG-423 (Digoxin Immune Fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo. expand

This study evaluates the use of AMAG-423 (Digoxin Immune Fab) in addition to expectant management in the treatment of severe preeclampsia as compared to placebo.

Type: Interventional

Start Date: Apr 2017

open study

Feasibility of a Stroke Specific Self-management Program
The University of Texas Medical Branch, Galveston Stroke Chronic Conditions
Stroke is a leading cause of disability, institutionalization, readmission and death. This research is being completed to accelerate the adoption of evidence-based therapy practices that improve overall stroke care and outcomes. We will implement a feasibility randomized controlled... expand

Stroke is a leading cause of disability, institutionalization, readmission and death. This research is being completed to accelerate the adoption of evidence-based therapy practices that improve overall stroke care and outcomes. We will implement a feasibility randomized controlled trial (RCT) studying the implementation of a stroke specific chronic disease self-management program. Specifically, if the person is identified to have a chronic vision impairment identified on the vision screen, a specific low vision self-management program will be used. Otherwise the program that will be used is the generic chronic disease self-management program.

Type: Interventional

Start Date: Sep 2019

open study

Use of a Dynamic Compression Intramedullary Nail for Tibiotalocalcaneal Arthrodesis
MedShape, Inc Ankle Arthritis Foot Arthritis
The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis. expand

The purpose of this study is to determine the clinical efficacy of a novel dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis.

Type: Observational

Start Date: May 2019

open study

Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
The University of Texas Medical Branch, Galveston Bacterial Vaginoses
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces... expand

Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities

Type: Interventional

Start Date: Oct 2019

open study