267 matching studies

Sponsor Condition of Interest
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Heron Therapeutics COVID-19
The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19. expand

The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.

Type: Interventional

Start Date: Jul 2020

open study

Home-based Transcranial Direct Current Stimulation (tDCS) for Pain Management in Persons With Alzheimer's...
The University of Texas Health Science Center, Houston Alzheimer's Disease and Related Dementias
The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's... expand

The purpose of this project is to evaluate the preliminary effects of home-based M1-SO applied tDCS (that is, tDCS with the anode over the primary motor cortex and the cathode over the contralateral supraorbital area) on clinical pain in persons with early-stage Alzheimer's disease and Related Dementias (ADRD), to evaluate the preliminary effects of home-based M1-SO applied tDCS on pain-related cortical response in persons with early-stage ADRD, and to evaluate the feasibility and acceptability of home-based M1-SO applied tDCS for pain management in persons with early-stage AD.

Type: Interventional

Start Date: Sep 2020

open study

Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal...
Destiny Pharma Plc Staphylococcal Infections Surgical Site Infection
This study looks at the difference between XF-73 and placebo in reducing the carriage of a bacteria S. aureus in the nose before, during and after heart surgery. Only people who normally have S.aureus in their nose will be enrolled onto the study. This will be confirmed by... expand

This study looks at the difference between XF-73 and placebo in reducing the carriage of a bacteria S. aureus in the nose before, during and after heart surgery. Only people who normally have S.aureus in their nose will be enrolled onto the study. This will be confirmed by analysis of a nasal swab (a cotton bud placed in the nose) before entering the study. It is expected 125 people will participate in this study. Participation will be confirmed by analysis of a nasal swab (a cotton bud placed in the nose) before entering the study. XF-73 or placebo will be given 5 times, with an equal chance of participants receiving either XF-73 or placebo. During the hospital stay more nasal swabs will be taken to determine the amount of S.aureus present in the participant's nose. Other tests such as blood samples, blood pressure and an examination of the nose and sense of smell will be performed as part of the safety assessment. After the hospital stay participants will be followed up for 30 days or if a device has been inserted into the body as part of the surgery for 90 days to look at the rates of post-operative infection between the placebo and XF-73 groups. The study will run for about 18 months. During this period, an independent data monitoring committee will review the study to make sure that the balance of benefits and risks of participating in the study does not change.

Type: Interventional

Start Date: Jun 2019

open study

Houston Emergency Opioid Engagement System
The University of Texas Health Science Center, Houston Opioid Dependence
The Houston Emergency Response Opioid Engagement System (HEROES) is a community-based research program integrating assertive outreach, medication-assisted treatment, behavioral counseling, peer recovery support, and paramedic follow-up in Houston Texas. The objective is to... expand

The Houston Emergency Response Opioid Engagement System (HEROES) is a community-based research program integrating assertive outreach, medication-assisted treatment, behavioral counseling, peer recovery support, and paramedic follow-up in Houston Texas. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder.

Type: Interventional

Start Date: Apr 2018

open study

Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
The University of Texas Health Science Center, Houston Autism Spectrum Disorder Gastrointestinal Symptoms
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in... expand

This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. The study is being conducted in order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted at the University of Texas Health Science Center at Houston and Memorial Hermann. Biomarker identification includes Integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular Virology & Microbiology of Baylor College of Medicine.

Type: Interventional

Start Date: May 2016

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... 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

DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants
The University of Texas Health Science Center, Houston Cleft Lip and Palate
The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families. expand

The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft tissues of infants with unilateral incomplete cleft lip and to assess influences on quality of life for infants who underwent DynaCleft® and that of their families.

Type: Interventional

Start Date: Sep 2020

open study

MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Vertos Medical, Inc. Lumbar Spinal Stenosis
This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control... expand

This prospective longitudinal study will compare incidence rates of Medicare beneficiary surgical and minimally invasive intervention post index procedure, as well as harms associated with the MILD procedure, at 24 months post-treatment with MILD, tested against a control group of similar patients that have had a comparable procedure. This study will start with patients treated with a study procedure having an index date on or after January 1, 2017, and enrollment will continue until stopped by the sponsor.

Type: Observational

Start Date: Mar 2017

open study

Caterpillar™ Arterial Embolization Device Post-Market Study
C. R. Bard Embolization, Therapeutic
The primary objective of this study is to evaluate the performance and safety of the Caterpillar™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature in a real world, on-label application. expand

The primary objective of this study is to evaluate the performance and safety of the Caterpillar™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature in a real world, on-label application.

Type: Interventional

Start Date: Apr 2020

open study

MitraClip REPAIR MR Study
Abbott Medical Devices Mitral Valve Regurgitation
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction... expand

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.

Type: Interventional

Start Date: Jul 2020

open study

The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures
The University of Texas Health Science Center, Houston Jaw Fractures Infection
The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems expand

The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems

Type: Interventional

Start Date: Oct 2020

open study

Patient-Specific Precision Injury Signatures in Multiply Injured Orthopaedic Patients
Major Extremity Trauma Research Consortium Pelvic, Acetabular, Femur, or Diaphyseal Tibial Operative Orthopaedic Injuries
The purpose of this study is to evaluate the use of precision methods that quantify injury and response to injury to predict how short-term clinical outcomes are affected by initial and staged orthopaedic interventions in multiply injured patients (MIPs) who sustain major... expand

The purpose of this study is to evaluate the use of precision methods that quantify injury and response to injury to predict how short-term clinical outcomes are affected by initial and staged orthopaedic interventions in multiply injured patients (MIPs) who sustain major orthopaedic trauma.

Type: Observational

Start Date: Mar 2019

open study

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Virginia Polytechnic Institute and State University Perinatal Stroke Hemiparesis
This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS). expand

This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).

Type: Interventional

Start Date: Oct 2019

open study

MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Athersys, Inc Trauma Adult Stem Cells
Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation. expand

Single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.

Type: Interventional

Start Date: Nov 2020

open study

Losmapimod Safety and Efficacy in COVID-19
Fulcrum Therapeutics COVID-19
The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study... expand

The therapeutic hypothesis for the use of losmapimod in COVID-19 disease is that increased mortality and severe disease is caused by p38 mitogen-activated protein kinase (MAPK)-mediated exaggerated acute inflammatory response resulting from SARS-CoV-2 infection. The study Sponsor hypothesize's that the early initiation of p38α/β inhibitor therapy in patients hospitalized with moderate COVID-19 who are at increased risk of a poor prognosis based on older age and elevated systemic inflammation will reduce clinical deterioration including progression to respiratory failure and death. To address this hypothesis, Fulcrum Therapeutics is conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of losmapimod versus placebo in subjects 50 and older who are hospitalized with moderate COVID-19 disease.

Type: Interventional

Start Date: Aug 2020

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... 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

Management of Chronic Pain and PTSD in Gulf War Veterans With tDCS+Prolonged Exposure
The University of Texas Health Science Center, Houston Chronic Pain PTSD
Gulf War Veterans (a DoD/VA defined service era corresponding to the first Gulf War under operations Desert Storm and Desert Shield 1990-1991), especially those who present with Post-Traumatic Stress Disorder (PTSD), are particularly likely to experience chronic pain. Veterans... expand

Gulf War Veterans (a DoD/VA defined service era corresponding to the first Gulf War under operations Desert Storm and Desert Shield 1990-1991), especially those who present with Post-Traumatic Stress Disorder (PTSD), are particularly likely to experience chronic pain. Veterans with co-morbid chronic pain and PTSD utilize healthcare services at a higher rate than those with pain or PTSD alone. Unfortunately, there are no integrated treatments for Pain and PTSD. Moreover, non-pharmacological treatments for pain such as Cognitive Behavioral Therapy are useful in only about 50% of cases. Transcranial direct current stimulation (tDCS) may be an effective treatment for pain, and has been recently used to ameliorate PTSD symptoms. Prolonged Exposure Therapy (PE) is highly effective in treating PTSD symptoms. Therefore, we propose to (a) integrate & (b) gather feasibility data for home-based tDCS + PE for Pain and PTSD with 15 Gulf War Veterans. The Overall Aim of the present proposal is to integrate, refine and investigate the feasibility (e.g., pilot testing, recruitment, attrition, assessment) of tDCS for treating chronic pain with a best practices evidence-based treatment for PTSD (i.e., Prolonged Exposure: PE) in 15 Gulf War veterans, a group for which both pain (fibromyalgia) and PTSD are particularly problematic.

Type: Interventional

Start Date: Jan 2020

open study

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic...
Astellas Pharma Global Development, Inc. Urothelial Cancer
This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in... expand

This study is being done to see how well two drugs (enfortumab vedotin and pembrolizumab) work together to treat patients with urothelial cancer. The study will compare these drugs to other drugs that are usually used to treat this cancer (standard of care). The patients in this study will have cancer that has spread from their urinary system to other parts of their body.

Type: Interventional

Start Date: Mar 2020

open study

Topical Antibiotic Irrigation (Bacitracin) in Prophylaxis of Midfacial Fracture Surgical Wounds New Title...
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 (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). In April of 2020 a petition was made to add gentamycin... expand

The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS). In April of 2020 a petition was made to add gentamycin and remove bacitracin after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted has removed bacitracin from its formulary. The modification was approved.

Type: Interventional

Start Date: Oct 2018

open study

Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial
NICHD Neonatal Research Network Apnea of Prematurity
The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization. expand

The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

Type: Interventional

Start Date: Feb 2019

open study

Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
The University of Texas Health Science Center, Houston Suicidal Ideation Depression Alcohol Abuse
This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse... expand

This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse of alcohol.

Type: Interventional

Start Date: May 2018

open study

Evaluation of Hemostasis in Bleeding and Thrombotic Disorders
The University of Texas Health Science Center, Houston Blood Coagulation Disorders, Inherited Thrombotic Disorder
The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay. expand

The objective of this study will be to assess the coagulation system in-vitro in a variety of bleeding and clotting disorders using the ROTEG analyzer and the thrombin generation assay.

Type: Observational

Start Date: Oct 2002

open study

A Prospective Clinical Study of Phenylketonuria (PKU)
BioMarin Pharmaceutical Phenylketonurias
This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study. expand

This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study.

Type: Observational

Start Date: Oct 2019

open study

Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
Novartis Pharmaceuticals Sickle Cell Disease (SCD)
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit. expand

The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

Type: Interventional

Start Date: Jul 2019

open study

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for...
Abbott Medical Devices Mitral Regurgitation Mitral Insufficiency Mitral Valve Insufficiency Cardiovascular Diseases Valve Disease, Heart
Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects... expand

Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-Randomized and MAC cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-randomized cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Type: Interventional

Start Date: Jun 2018

open study