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Sponsor Condition of Interest |
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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 |
RECOVER-SLEEP: Platform Protocol
Duke University
Long COVID
Long COVID-19
Hypersomnia
Sleep Disturbance
The platform protocol is designed to be flexible so that it is suitable for a range of
study settings and intervention types. Therefore, the platform protocol provides a
general protocol structure that can be shared by multiple interventions and allows
comparative analysis across the interventions.... expand
The platform protocol is designed to be flexible so that it is suitable for a range of study settings and intervention types. Therefore, the platform protocol provides a general protocol structure that can be shared by multiple interventions and allows comparative analysis across the interventions. For example, objectives, measures, and endpoints are generalized in the platform protocol, but intervention-specific features are detailed in separate appendices. This platform protocol is a prospective, multi-center, multi-arm, randomized controlled platform trial evaluating potential interventions for PASC-mediated sleep disturbances. The hypothesis is that symptoms of sleep and circadian disorders that emerge in patients with PASC can be improved by phenotype-targeted interventions. Specific sleep and circadian disorders addressed in this protocol include sleep-related daytime impairment (referred to as hypersomnia) and complex PASC-related sleep disturbance (reflecting symptoms of insomnia and sleep-wake rhythm disturbance). Type: Interventional Start Date: Jul 2024 |
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 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic...
Bristol-Myers Squibb
Idiopathic Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of
BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. Type: Interventional Start Date: Sep 2023 |
Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Stryker Trauma and Extremities
Rotator Cuff Tears
Rheumatoid Arthritis Shoulder
Osteoarthritis Shoulder
Avascular Necrosis of the Head of Humerus
Fracture, Humeral
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to
collect safety and performance data on the commercially available Shoulder iD™ Primary
Reversed Glenoid device. The study will learn about standard device use in adult patients
who have a functional deltoid muscle... expand
The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are: - What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and - What is the rate of surgical revisions needed over a 10 year period Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes. Type: Observational Start Date: Oct 2023 |
ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)
Chimerix
H3 K27M
Glioma
This is a randomized, double-blind, placebo-controlled, parallel-group, international,
Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess
whether treatment with ONC201 following frontline radiotherapy will extend overall
survival and progression-free survival in... expand
This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy. Type: Interventional Start Date: Jan 2023 |
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 |
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants...
Biogen
Subacute Cutaneous Lupus Erythematosus
Chronic Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab
(BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus
on participants who have either active subacute CLE or chronic CLE, or both. They may
also have systemic lupus erythematosus (SLE).... expand
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). The main questions researchers want to answer are: - How many participants have a score of 0 or 1 on the CLA-IGA-R looking at skin redness after treatment? - How many participants have their skin disease activity go down by at least 70%? Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and CLE have on the quality of life of participants using a group of questionnaires. The study will be split into 2 parts - Part A and Part B. Both parts will be done as follows: - After screening, participants will be randomized to receive either litifilimab or placebo for the 1st treatment period. A placebo looks like the study drug but contains no real medicine. - Participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. - The 1st treatment period will be double blinded which means neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - This double blinded treatment period will last 24 weeks, after which the 2nd treatment period will begin. - During the 2nd treatment period, all participants will receive litifilimab for 28 weeks. - After completing treatment in this study, participants that qualify will be given the choice to join the Long-Term Extension study, 230LE305. If they do not, they will move into a follow-up safety period that will last up to 24 weeks. - The total study duration for participants will be up to 80 weeks Type: Interventional Start Date: Sep 2022 |
Study to Assess Adverse Events and Disease Activity of Oral Ubrogepant Tablets for the Acute Treatment...
AbbVie
Migraine
Migraine is a common neurological disorder typically characterized by attacks of
throbbing, moderate to severe headache, often associated with nausea, vomiting, and
sensitivity to light and sound. Migraine is extremely common and disabling in children.
The purpose of this study is to evaluate how... expand
Migraine is a common neurological disorder typically characterized by attacks of throbbing, moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light and sound. Migraine is extremely common and disabling in children. The purpose of this study is to evaluate how safe and effective ubrogepant is in the acute treatment of migraine in children and adolescents. Ubrogepant is a drug approved for the acute treatment of migraine in adults. Children and adolescents (aged 6-17 years) with a history of migraine will be enrolled. The study will include 2 cohorts of participants - PK Cohort and Main Study (non-PK cohort). Participants aged 6-11 years in the PK Cohort will receive Dose A or Dose B of Ubrogepant for PK analysis to determine dose selection for the main study. In the main study, after dose selection, children aged 6-11 years will be randomized to receive either low or high dose of Ubrogepant or placebo. There is a 1 in 3 chance that a participant will be assigned to placebo. Adolescents aged 12-17 years will be randomized to receive either low or high dose of Ubrogepant or placebo with a 1 in 3 chance of placebo assignment. For qualifying migraine attacks, participants will receive oral tablets of the double-blind study intervention. There will be an option to take a second dose of double-blind study intervention (identical to initial dose), or rescue medication, at least 2 hours after the initial dose, for headache of moderate/severe intensity. Around 1059 participants will be enrolled in the study in approximately 120 sites in the United States. The study duration will be up to 6 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Jan 2022 |
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome (HLHS): A Phase IIb...
Longeveron Inc.
Hypoplastic Left Heart Syndrome
The purpose of this study is to test whether Lomecel-B™ works in treating patients with
hypoplastic left heart syndrome (HLHS) and to gather additional information about the
safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active
ingredient. MSCs are special cells... expand
The purpose of this study is to test whether Lomecel-B™ works in treating patients with hypoplastic left heart syndrome (HLHS) and to gather additional information about the safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient. MSCs are special cells in the body that are able to change into other types of cells, such as heart, blood, and muscle cells. MSCs are found in various tissues of the body, such as the bone marrow, which is the spongy tissue inside of your bones. Lomecel-B uses MSCs from bone marrow of unrelated young healthy donors. These are called "allogeneic", and do not require donor matching to the patient. Type: Interventional Start Date: Jun 2021 |
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