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Laparoscopic Incision Closure s in Obese Patients
The University of Texas Health Science Center, Houston
Obesity
Incision, Surgical
Several methods for closure of trocar wounds are known in laparoscopic surgery including
mostly transcutaneous or subcuticular suture or adhesive paper tape. Studies comparing
laparoscopic incision closure in bariatric population are limited .This is a prospective
study that will be conducted in a... expand
Several methods for closure of trocar wounds are known in laparoscopic surgery including mostly transcutaneous or subcuticular suture or adhesive paper tape. Studies comparing laparoscopic incision closure in bariatric population are limited .This is a prospective study that will be conducted in a single tertiary medical center. s obese population comprise most of our surgical candidates, and due to the aforementioned, the aim of our study is to compare the outcomes of both techniques in obese women. Type: Interventional Start Date: Dec 2023 |
Discovery and Analytical Validation of Inflammatory Bio-signatures of the Human Pain Experience
Alan Prossin
Pain
The first objective of the study is to evaluate whether a novel bio-signature (derived
from a wide range of pro- and anti-nociceptive IL-1 family cytokine activity) will
predict pain experienced and also release of underlying endogenous opioid
neurotransmitters during an experimental nociceptive pain... expand
The first objective of the study is to evaluate whether a novel bio-signature (derived from a wide range of pro- and anti-nociceptive IL-1 family cytokine activity) will predict pain experienced and also release of underlying endogenous opioid neurotransmitters during an experimental nociceptive pain challenge, which will be performed while simultaneously quantifying mu-opioid receptor activity in the brain via [11C]-carfentanil PET neuroimaging in healthy subjects. Another objective is to evaluate whether an anti-inflammatory drug that reduces activation of IL-1b (minocycline) will perturb the balance between pro- and anti-nociceptive IL-1 cytokines and effect a reduction in pain experienced (and endogenous opioids released) during the experimental, nociceptive pain challenge. A final objective is to evaluate performance characteristics (sensitivity, accuracy, dynamic range) of the biosignature for the purpose of predicting post-operative pain. Type: Interventional Start Date: Jul 2021 |
Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
Johns Hopkins University
Intracerebral Hemorrhage
This first-in-patient phase 2a pilot study will assess the safety and tolerability of
MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). expand
This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH). Type: Interventional Start Date: Oct 2022 |
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 will also explore... 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 or [11C]ER176. Type: Interventional Start Date: May 2017 |
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 is to have a consolidated... 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 |
Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic...
The University of Texas Health Science Center, Houston
Traumatic Brain Injury
The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before
Endotracheal suctioning (ETS) compared to instilled lidocaine and the effectiveness of
aerosolized lidocaine versus instilled normal saline before ETS in attenuating the
increase of intracranial pressure (ICP)... expand
The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before Endotracheal suctioning (ETS) compared to instilled lidocaine and the effectiveness of aerosolized lidocaine versus instilled normal saline before ETS in attenuating the increase of intracranial pressure (ICP) in severe head injured children and to evaluate the feasibility of a trial involving instilled lidocaine and aerosolized lidocaine for the management of ETS and to evaluate the safety of nebulized lidocaine in traumatic brain injury (TBI) compared to instilled lidocaine and instilled sodium chloride (NS). Type: Interventional Start Date: Nov 2021 |
Autism Spectrum Disorder (ASD) and Intellectual Disability (ID) Determinants in Tuberous Sclerosis Complex...
Boston Children's Hospital
Tuberous Sclerosis
Autism Disorder
Intellectual Disability
The purpose of this study is to characterize the developmental phenotype of ASD and ID
and to identify biomarkers using advanced MRI methodology and electrophysiological
biomarkers of synaptic function and connectivity predictive of ASD and ID presence and
severity in patients with TSC. In addition,... expand
The purpose of this study is to characterize the developmental phenotype of ASD and ID and to identify biomarkers using advanced MRI methodology and electrophysiological biomarkers of synaptic function and connectivity predictive of ASD and ID presence and severity in patients with TSC. In addition, this study will be establishing infrastructure for the collection and storage of human bio-specimens, including genetic material, from TSC patients and their family members with ASD. Type: Observational Start Date: May 2015 |
Modernizing Perinatal Syphilis Testing
The University of Texas Health Science Center, Houston
Syphilis
Treponema pallidum is a bacterium that causes the disease syphilis. The primary objective
of the study is to evaluate the testing performance of two diagnostic molecular
techniques [quantitative polymerase chain reaction (qPCR) and transcription-mediated
amplification (TMA)] for the detection of Treponema... expand
Treponema pallidum is a bacterium that causes the disease syphilis. The primary objective of the study is to evaluate the testing performance of two diagnostic molecular techniques [quantitative polymerase chain reaction (qPCR) and transcription-mediated amplification (TMA)] for the detection of Treponema pallidum in maternal and neonatal specimens from participants with the diagnosis of syphilis using the Centers for Disease Control's (CDC's) Sexually Transmitted Infections (STI) Treatment Guidelines for adult and congenital syphilis. Type: Interventional Start Date: May 2023 |
Young Houston Emergency Opioid Engagement System
The University of Texas Health Science Center, Houston
Opioid-use Disorder
Opioid Dependence
Opioid Overdose
Opioid Use
Substance Use Disorders
The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young
HEROES) is a community-based research program integrating assertive outreach, medication
for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The
objective is to compare differences... expand
The Houston Emergency Response Opioid Engagement System for Youths and Adolescents (Young HEROES) is a community-based research program integrating assertive outreach, medication for opioid use disorder (MOUD), behavioral counseling, and peer recovery support. The objective is to compare differences in engagement and retention in treatment for individuals with opioid use disorder. The investigators also intend to understand the prevalence of opioid overdoses and OUD among youth in Houston. Type: Interventional Start Date: Apr 2021 |
XG005 for Pain Control in Subjects Undergoing Bunionectomy
Xgene Pharmaceutical Group
Acute Pain
This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose
(1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy.
Subjects will be confined in the clinic from check-in through 72 hours post-surgery to
monitor subject safety. expand
This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy. Subjects will be confined in the clinic from check-in through 72 hours post-surgery to monitor subject safety. Type: Interventional Start Date: Aug 2023 |
An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical...
The University of Texas Health Science Center, Houston
Chronic Diseases in Children
The purpose of this study is to assess if the benefits for children with medical
complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be
further improved by enhanced telemedicine program (ETM) provided during clinic hours
using mobile devices to measure temperature& oxygen... expand
The purpose of this study is to assess if the benefits for children with medical complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be further improved by enhanced telemedicine program (ETM) provided during clinic hours using mobile devices to measure temperature& oxygen saturation, auscultate the heart & lungs, and view the skin, throat, & tympanic membranes in the home. Type: Interventional Start Date: Jul 2022 |
The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy...
The University of Texas Health Science Center, Houston
Non-allergic Rhinitis
The purpose of this study to determine the therapeutic response of non-allergic rhinitis
patients that have been subtyped as non-allergic rhinitis with local IgE elevation or
non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical
rhinometry, to determine the prevalence... expand
The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment. Type: Interventional Start Date: Sep 2019 |
Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease
The University of Texas Health Science Center, Houston
Aortic Aneurysm
Aortic Dissection
Aortic Diseases
The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large
cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD)
genes, define the phenotype associated with these genes, and determine genetic and
environmental modifiers of H-TAD. expand
The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD. Type: Observational [Patient Registry] Start Date: Apr 2016 |
Patient-centered Outcomes After Permanent Female Sterilization Procedure(POPS Trial)
The University of Texas Health Science Center, Houston
Sterility, Female
The purpose of this study is to compare and capture key elements of the patient
experience, quality of recovery, preferences and satisfaction after laparoscopic
salpingectomy done via 3 different routes. expand
The purpose of this study is to compare and capture key elements of the patient experience, quality of recovery, preferences and satisfaction after laparoscopic salpingectomy done via 3 different routes. Type: Interventional Start Date: Nov 2022 |
The Establishment of a Registry and a Biorepository of Patients With Suspected Amniotic Fluid Embolism...
The University of Texas Health Science Center, Houston
Amniotic Fluid Embolism
To establish a clinical registry of suspected cases of AFE. The existing registry will be
migrated to a new platform, expand
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform, Type: Observational [Patient Registry] Start Date: Jul 2022 |
Follow-up Visit of High Risk Infants
NICHD Neonatal Research Network
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which
surviving extremely low birth-weight infants born in participating network centers
receive neurodevelopmental, neurosensory and functional assessments at 22-26 months
corrected age (Infants born prior to July 1,... expand
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment. Type: Observational Start Date: Jan 1993 |
Perioperative Warming Measures in Cesarean Delivery
The University of Texas Health Science Center, Houston
Hypothermia; Anesthesia
Hypothermia, Newborn
Hypothermia, Sequela
The purpose of this study is to evaluate the best method for keeping patients warm during
cesarean deliveries and the effect of temperature change on the patient and baby expand
The purpose of this study is to evaluate the best method for keeping patients warm during cesarean deliveries and the effect of temperature change on the patient and baby Type: Interventional Start Date: Aug 2021 |
Network Effects of Therapeutic Deep Brain Stimulation
The University of Texas Health Science Center, Houston
Intractable Epilepsy
The purpose of this study is to map the acute, short-term cortical evoked responses to
thalamic electrical stimulation in persons with intractable epilepsy expand
The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy Type: Interventional Start Date: Aug 2022 |
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 patients diagnosed... 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 |
ACute Uncomplicated Type b Aortic Dissection: Endovascular Repair vs. Best Medical Therapy
The University of Texas Health Science Center, Houston
Distal Aortic Dissection
Dissection, Aortic Acute
Acute Type B Aortic Dissection (Uncomplicated)
The purpose of the study is to conduct a randomized controlled trial comparing best
medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR)
for uncomplicated acute type B aortic dissection. expand
The purpose of the study is to conduct a randomized controlled trial comparing best medical therapy (BMT) alone to BMT with thoracic endovascular aortic repair (BMT+TEVAR) for uncomplicated acute type B aortic dissection. Type: Interventional Start Date: Oct 2018 |
A Randomized Control Trial of a Responsive Parenting Intervention to Support Healthy Brain Development...
The University of Texas Health Science Center, Houston
Premature Birth
The purpose of this study is to determine whether participation in the Play and Learning
Strategies (PALS) parenting intervention results in increased caregiver responsiveness
behaviors and to test if participation in PALS results in increases in toddler skills
and/or toddler neurological development. expand
The purpose of this study is to determine whether participation in the Play and Learning Strategies (PALS) parenting intervention results in increased caregiver responsiveness behaviors and to test if participation in PALS results in increases in toddler skills and/or toddler neurological development. Type: Interventional Start Date: Aug 2020 |
Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra...
The University of Texas Health Science Center, Houston
Gastric Antral Vascular Ectasia
The purpose: To determine the safety and efficacy of Radiofrequency Ablation (RFA) HALO
Ultra system in patients with Gastric Antral Vascular Ectasia patient cohort (GAVE).
Research design: This is a prospective observational study. Procedure Used:
Radiofrequency Ablation
Risks and potential... expand
The purpose: To determine the safety and efficacy of Radiofrequency Ablation (RFA) HALO Ultra system in patients with Gastric Antral Vascular Ectasia patient cohort (GAVE). Research design: This is a prospective observational study. Procedure Used: Radiofrequency Ablation Risks and potential benefits: There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future. Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to other patients in the future. Type: Observational [Patient Registry] Start Date: Aug 2015 |
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Biohaven Therapeutics Ltd.
Focal Epilepsy
The purpose of this study is to determine whether BHV-7000 is effective in the treatment
of refractory focal epilepsy. expand
The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy. Type: Interventional Start Date: May 2024 |
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to...
Merck Sharp & Dohme LLC
Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in
participants with moderately to severely active ulcerative colitis. Study 1's primary
hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the
proportion of participants achieving clinical... expand
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12. Type: Interventional Start Date: Oct 2023 |
A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's...
Emalex Biosciences Inc.
Tourette Syndrome
The primary objective of this study is to evaluate the long-term safety and tolerability
of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12
years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age)
with Tourette's Syndrome (TS). expand
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS). Type: Interventional Start Date: Aug 2023 |
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