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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 |
Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes
University of Alabama at Birmingham
Diabetes Mellitus, Type 2
Preterm Birth
Pregnancy, High Risk
Diabetes, Gestational
There is a fundamental gap in understanding the maternal and neonatal effects of
antenatal corticosteroid (ACS) administration in women with threatened preterm birth
(PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972,
more than 40 randomized controlled trials... expand
There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM, and there is limited data among women with gestational diabetes. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with diabetes. Before neonatal benefit of ACS can be evaluated in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. Our long-term goal is to improve maternal and child health among women with diabetes as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims will determine the optimal strategy to achieve maternal glycemic control after ACS and inform a larger, multicenter trial to improve neonatal outcomes among women with diabetes and threatened PTB. Type: Interventional Start Date: Feb 2022 |
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 |
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care...
The University of Texas Health Science Center, Houston
Anemia
The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to
reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit
(IMU) patients with low hemoglobin compared with standard size tubes, to compare the
intervention and the control groups in... expand
The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit (IMU) patients with low hemoglobin compared with standard size tubes, to compare the intervention and the control groups in regards to: ICU length of stay (LOS), ICU mortality, hospital LOS, and hospital mortality and to assess the acceptability of small phlebotomy tubes in adult ICU and IMU patients. Type: Interventional Start Date: Jul 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 in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung...
Boehringer Ingelheim
Scleroderma, Systemic
This study is open to adults aged 18 and older or above legal age who have systemic
sclerosis. People can participate if they have a specific subtype called diffuse
cutaneous systemic sclerosis. People with another subtype called limited cutaneous
systemic sclerosis can also participate if they are... expand
This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects. Type: Interventional Start Date: Nov 2022 |
Type O Whole Blood and Assessment of Age During Prehospital Resuscitation Trial
Jason Sperry
Hemorrhagic Shock
Traumatic Injury
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma
centers designed to determine the efficacy and safety of low titer whole blood
resuscitation as compared to standard of care resuscitation in patients at risk of
hemorrhagic shock and to appropriately characterize... expand
Open label, multi-center, pre-hospital randomized trial utilizing 10 level-1 trauma centers designed to determine the efficacy and safety of low titer whole blood resuscitation as compared to standard of care resuscitation in patients at risk of hemorrhagic shock and to appropriately characterize the hemostatic competency of whole blood relative to its age. Type: Interventional Start Date: Apr 2022 |
Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents...
The University of Texas Health Science Center, Houston
Child Obesity
Cardiometabolic Health
The purpose of this study is to examine the effects of the (Brighter Bites (BB)
intervention compared to a wait-list control group 9 months after the intervention on
changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary
outcomes (household food security status, parent... expand
The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes. Type: Interventional Start Date: Aug 2024 |
Evaluate the Neurological Effects of EryDex on Subjects With A-T
Quince Therapeutics S.p.A.
Ataxia Telangiectasia
This is an international, multi-center, randomized, prospective, double-blind,
placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone
sodium phosphate [DSP] in autologous erythrocytes), administered by intravenous (IV)
infusion once every 28 days, on neurological... expand
This is an international, multi-center, randomized, prospective, double-blind, placebo-controlled, Phase 3 study, designed to assess the effect of EryDex (dexamethasone sodium phosphate [DSP] in autologous erythrocytes), administered by intravenous (IV) infusion once every 28 days, on neurological symptoms of patients with Ataxia Telangectasia (A-T). Type: Interventional Start Date: Jun 2024 |
Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women With Substance Use Disorders
The University of Texas Health Science Center, Houston
Substance Use
The goal of this clinical trial is to test an addiction-clinic based behavioral
intervention for increasing PrEP uptake and adherence among women who engage in high-risk
sexual behaviors and problematic substance use. The main question it aims to answer is:
• If the integrated intervention increase... expand
The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is: • If the integrated intervention increase PrEP uptake and adherence compared to standard treatment Participants will - receive provision of PrEP information through 4 counseling sessions - prevention navigation - receive nurse practitioner prescribed PrEP in an addiction treatment setting Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence Type: Interventional Start Date: Jun 2022 |
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