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Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe...
Medtronic Cardiovascular
Mitral Valve Regurgitation
Multi-center, global, prospective, non-randomize, interventional, pre-market trial. All
subjects enrolled with receive the study device
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Multi-center, global, prospective, non-randomize, interventional, pre-market trial. All subjects enrolled with receive the study device Type: Interventional Start Date: Oct 2017 |
Impact of Fever Prevention in Brain Injured Patients
C. R. Bard
Fever
Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
This study will assess the impact of fever prevention on fever burden and short- and
long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo
fever prevention using a targeted temperature management system and half of the subjects will
be... expand
This study will assess the impact of fever prevention on fever burden and short- and long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo fever prevention using a targeted temperature management system and half of the subjects will be treated for fever should it develop. Type: Interventional Start Date: Jan 2017 |
The Will Erwin Headache Research Center - Cluster Headache Study
The University of Texas Health Science Center, Houston
Cluster Headache
Cluster Headaches and Other Trigeminal Autonomic Cephalgias
Paroxysmal Hemicrania
SUNCT
Hemicrania Continua
The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is
a prospective, multicenter, observational research network for subjects with Cluster Headache
and/or Trigeminal Neuralgia.
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The Will Erwin Headache Research Center Study of Cluster Headache and Trigeminal Neuralgia is a prospective, multicenter, observational research network for subjects with Cluster Headache and/or Trigeminal Neuralgia. Type: Observational Start Date: May 2016 |
Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis
The University of Texas Health Science Center, Houston
Sepsis
Severe Sepsis
Septic Shock
Multi-organ Failure
This is an observational study to understand the changes in alveolar dead space in medical
critically ill patients with severe infection (severe sepsis) requiring mechanical
ventilation and the possibility to predict multi-organ failure.
The measurement of alveolar dead... expand
This is an observational study to understand the changes in alveolar dead space in medical critically ill patients with severe infection (severe sepsis) requiring mechanical ventilation and the possibility to predict multi-organ failure. The measurement of alveolar dead space used to require sophisticated equipment and time. New ventilators have microprocessors that allow rapid mathematical calculation with minimal intervention. Type: Observational Start Date: Dec 2016 |
Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults
The University of Texas Health Science Center, Houston
Frailty
The purpose of this study is to implement a home-based exercise program, administered through
Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on
frailty status and nutritional markers in homebound older adults.
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The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults. Type: Interventional Start Date: Sep 2019 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
TIA
Stroke
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)
with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA
(1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
N-of-1 Trials In Children With Hypertension
The University of Texas Health Science Center, Houston
Pediatric Hypertension
The single patient (n-of-1) randomized trial is an underused approach to resolving
therapeutic uncertainty by using a patient's own data to inform an individualized treatment
plan. The proposed research is designed to assess whether the n-of-1 trial approach improves
blood... expand
The single patient (n-of-1) randomized trial is an underused approach to resolving therapeutic uncertainty by using a patient's own data to inform an individualized treatment plan. The proposed research is designed to assess whether the n-of-1 trial approach improves blood pressure control. This trial will advance learning about not only the treatment of pediatric hypertension but also the use of a neglected type of randomized trial to optimize the care of each patient. Type: Interventional Start Date: Apr 2018 |
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions...
W.L.Gore & Associates
Aortic Aneurysm, Thoracic
Aorta, Lesion
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch
Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending
thoracic aorta.
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The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta. Type: Interventional Start Date: Aug 2016 |
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors,...
National Cancer Institute (NCI)
Advanced Malignant Solid Neoplasm
Bladder Carcinoma
Breast Carcinoma
Cervical Carcinoma
Colon Carcinoma
This phase II MATCH trial studies how well treatment that is directed by genetic testing
works in patients with solid tumors or lymphomas that have progressed following at least one
line of standard treatment or for which no agreed upon treatment approach exists. Genetic
tests... expand
This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma. Type: Interventional Start Date: Aug 2015 |
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are...
Scynexis, Inc.
Invasive Candidiasis
Mucocutaneous Candidiasis
Coccidioidomycosis
Histoplasmosis
Blastomycosis
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy
and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal
disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal... expand
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Type: Interventional Start Date: Apr 2017 |
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic...
Edwards Lifesciences
Aortic Stenosis
Heart Diseases
This clinical trial is a prospective, randomized, controlled, multi-center study. Patients
will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with
the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be
stratified... expand
This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable. Type: Interventional Start Date: Jul 2017 |
Anesthesia in Patients With Mitochondrial Disease
The University of Texas Health Science Center, Houston
Mitochondrial Diseases
This pilot study is a prospective, randomized clinical trial to evaluate the effect of
anesthesia in the mitochondrial dysfunction patient.
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This pilot study is a prospective, randomized clinical trial to evaluate the effect of anesthesia in the mitochondrial dysfunction patient. Type: Interventional Start Date: Jan 2014 |
Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
The University of Texas Health Science Center, Houston
Cocaine-Related Disorders
First, the investigators will determine whether Acceptance and Commitment Therapy in
combination with Contingency Management increases initial treatment response rates.
Second, for patients who do not respond to initial treatment, the investigators will examine
whether dopamine-targeted... expand
First, the investigators will determine whether Acceptance and Commitment Therapy in combination with Contingency Management increases initial treatment response rates. Second, for patients who do not respond to initial treatment, the investigators will examine whether dopamine-targeted pharmacotherapy is an effective augmentation strategy. Third, for patients who respond to initial treatment, the investigators will assess the relative benefit of continued treatment with Acceptance and Commitment Therapy in combination with Contingency Management, as compared to Drug Counseling in combination with Contingency Management, to prevent relapse. Type: Interventional Start Date: Nov 2016 |
Esthetic Outcomes Following Immediate Implant Combine With Soft Tissue Augmentation
The University of Texas Health Science Center, Houston
Dental Implant
Immediate Dental Implant
Soft Tissue Augmentation
The purpose of this study is to evaluate the esthetic outcomes following immediate implant
combined with the autogenous tissue graft or acellular dermal matrix compared to immediate
implant alone.
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The purpose of this study is to evaluate the esthetic outcomes following immediate implant combined with the autogenous tissue graft or acellular dermal matrix compared to immediate implant alone. Type: Interventional Start Date: Oct 2016 |
The Intra-arterial Vasospasm Trial
The University of Texas Health Science Center, Houston
Cerebral Vasospasm
The primary objective of the study is to determine the optimal intra-arterial drug treatment
regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal
subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days
post... expand
The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration post cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome at 90 days post discharge following optimal intra-arterial drug treatment for cerebral vasospasm. We hypothesize that Intra-arterial (IA) infusion of a combination of multiple vasodilators is more efficacious than single agent treatment cerebral vasospasm therapy. All procedures done as a part of this study are standard hospital care procedures done to treat cerebral vasospasm and all drugs to be used are FDA approved. Type: Interventional Start Date: Aug 2016 |
The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.
The University of Texas Health Science Center, Houston
Primary Ciliary Dyskinesia
The purpose of this study is to determine the effect of a dietary supplement rich in nitric
oxide (NO) on nasal nitric oxide and fractional exhaled nitric oxide (FeNO),on ciliary beat
frequency assessed by high-speed digital video microscopy and on lung function assessed by... expand
The purpose of this study is to determine the effect of a dietary supplement rich in nitric oxide (NO) on nasal nitric oxide and fractional exhaled nitric oxide (FeNO),on ciliary beat frequency assessed by high-speed digital video microscopy and on lung function assessed by spirometry in normal patients and patients with Primary ciliary dyskinesia (PCD). Type: Interventional Start Date: Jul 2019 |
Endpoint Determination Study Protocol
Biomerica
Irritable Bowel Syndrome
This study is designed to evaluate the most applicable endpoints for evaluation of the
Biomerica InFoods® IBS product.
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This study is designed to evaluate the most applicable endpoints for evaluation of the Biomerica InFoods® IBS product. Type: Interventional Start Date: Jun 2018 |
Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
CHDI Foundation, Inc.
Huntington's Disease
Enroll-HD is a longitudinal, observational, multinational study that integrates two former
Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and
Australasia-while also expanding to include sites in Latin America. More than 20,000
participants... expand
Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more. Type: Observational [Patient Registry] Start Date: Jul 2012 |
Early Feasibility Study: Fetoscopic NEOX Cord 1K® Myelomeningocele (MMC) Repair
The University of Texas Health Science Center, Houston
Spina Bifida
Fetus Risk
Myelomeningocele
The purpose of this study is to test the feasibility of surgically covering myelomeningocele
spina bifida spinal cord developmental defects using Neox Cord 1K, cryopreserved human
umbilical cords, via a laparotomy-fetoscopic surgical approach. Intact repair of the defect,... expand
The purpose of this study is to test the feasibility of surgically covering myelomeningocele spina bifida spinal cord developmental defects using Neox Cord 1K, cryopreserved human umbilical cords, via a laparotomy-fetoscopic surgical approach. Intact repair of the defect, prevention of cerebral spinal fluid leakage and wound dehiscence will be assessed at birth and at 12 months of age. Type: Interventional Start Date: Feb 2020 |
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
PolyPid Ltd.
Surgical Site Infection
Sternal Infection
Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single
Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the
Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of
Post-Cardiac... expand
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections. Study to assess D-PLEX efficacy and safety in preventing sternal infections over a period of 90 days (3 months) post cardiac surgery with median sternotomy, in patients with high risk for infection compared to the control arm. Type: Interventional Start Date: Dec 2019 |
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
ECOG-ACRIN Cancer Research Group
Breast Screening
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer screening
and may... expand
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment. Type: Interventional Start Date: Jul 2017 |
Milrinone in Congenital Diaphragmatic Hernia
NICHD Neonatal Research Network
Congenital Diaphragmatic Hernia
Persistent Pulmonary Hypertension of the Newborn
Hypoxemic Respiratory Failure
Pulmonary Hypoplasia
Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and
persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory
failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to
conventional... expand
Infants with congenital diaphragmatic hernia (CDH) usually have pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN) leading to hypoxemic respiratory failure (HRF). Pulmonary hypertension associated with CDH is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO). Increased pulmonary vascular resistance (PVR) can lead to right ventricular overload and dysfunction. In patients with CDH, left ventricular dysfunction, either caused by right ventricular overload or a relative underdevelopment of the left ventricle, is associated with poor prognosis. Milrinone is an intravenous inotrope and lusitrope (enhances cardiac systolic contraction and diastolic relaxation respectively) with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PPHN. Milrinone is commonly used during the management of CDH although no randomized trials have been performed to test its efficacy. Thirty percent of infants with CDH in the Children's Hospital Neonatal Database (CHND) and 22% of late-preterm and term infants with CDH in the Pediatrix database received milrinone. In the recently published VICI trial, 84% of patients with CDH received a vasoactive medication. In the current pilot trial, neonates with an antenatal or postnatal diagnosis of CDH will be randomized to receive milrinone or placebo to establish safety of this medication in CDH and test its efficacy in improving oxygenation. Type: Interventional Start Date: Aug 2017 |
A Study to Evaluate LB1148 for Return of Gastrointestinal Function and Adhesions in Subjects Undergoing...
Leading BioSciences, Inc
Ileus
Post-Operative Adhesions
The purpose of this study is to establish preliminary evidence of the efficacy, safety, and
tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal
adhesions in subjects undergoing elective bowel resection.
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The purpose of this study is to establish preliminary evidence of the efficacy, safety, and tolerability of LB1148 for the treatment of post-operative ileus and intra-abdominal adhesions in subjects undergoing elective bowel resection. Type: Interventional Start Date: Oct 2019 |
Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes
University of Texas Southwestern Medical Center
Peripheral Arterial Disease
XLPAD is an observational study designed to evaluate the effectiveness and use of stent and
non-stent based therapies among PAD patients. The study will create a registry that will
include entry of procedural and clinical follow-up information into an online data collection... expand
XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until 14,000 patients have been included. The primary objectives of this observational registry study are to: 1. Compare stent and non-stent based outcomes defined as a composite of symptom driven target vessel revascularization (TVR), unplanned surgical revascularization of the target limb and need for target limb amputation through 12 months post-index procedure (Primary efficacy endpoint) 2. Compare stent and non-stent based outcomes defined as a composite of causes such as: death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel revascularization (TVR) and unplanned surgical revascularization/amputation of the target limb through 12 months (Primary safety endpoint) 3. Compare stent and non-stent based change in walking distance, Rutherford category and/or ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical improvement endpoint) Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment in the observational study will be monitored in an effort to achieve at least 20% (and no more than 80%) of the population receiving stents as the initial treatment strategy. Follow-up visits by sites will be reported at 6 and 12 months after index procedure to collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures are not mandated by the registry protocol. Each site will be encouraged to enter follow-up information derived from clinically indicated follow-up visits. All events post-index procedure till the 7th month will be reported under the 6 month follow-up form and subsequent follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form. Patient management and treatment decisions are at the discretion of the care team per routine clinical practice. The procedural aspects (including selection of stent type or non-stent based treatments) and follow-up are not mandated by the registry and will be up to the discretion of the operator and/or based upon the practice dictated by the clinical care of the patient. Therefore the study poses minimal risk to the patient. Type: Observational [Patient Registry] Start Date: Jan 2013 |
Registry for Participants With Short Bowel Syndrome
Shire
Short Bowel Syndrome
This is a global prospective, observational, multi-center registry to evaluate the long-term
safety profile for participants with short bowel syndrome (SBS) who are treated with
teduglutide in a routine clinical setting. The registry will also evaluate the long-term
clinical... expand
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled. Type: Observational [Patient Registry] Start Date: Jun 2014 |