266 matching studies

Sponsor Condition of Interest
MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression...
Agendia Breast Cancer
The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry,... expand

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

Type: Observational [Patient Registry]

Start Date: Apr 2017

open study

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

open study

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... 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

open study

Tissue Reinforcement of Incisional Closure Among High Risk Patients
The University of Texas Health Science Center, Houston Wound Complication
Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal surgery, 30% of patients will suffer a major chronic complication with their wound closure in the first post-operative year. This may include significant wound infections, open wounds,... expand

Half of all individuals will undergo abdominal surgery in their lifetime. Following abdominal surgery, 30% of patients will suffer a major chronic complication with their wound closure in the first post-operative year. This may include significant wound infections, open wounds, fluid collections, fascial dehiscence, or incisional hernia. These complications not only have a substantial impact on the health care system (cost and chronic disease) and the hospital (cost and space), but most importantly have a substantial impact on the patient. Major chronic wound complications adversely impact patient quality of life and function. Potential methods to reduce major wound complications include utilizing specific suturing techniques or reinforcing the incision line. Suturing technique of small-bites (0.5x0.5 cm bites) as opposed to large bites (1.0x1.0 cm bites) has been shown to be efficacious in European populations with a typical body mass index of 20-25 kg/m2. Tissue reinforcement has been shown to decrease rates of major wound complications in small randomized controlled trials. However, the lack of widespread adoption of these practices may be due to issues of generalizability including strict inclusion criteria, careful patient selection, and small study size. For example, the generalizability of small bites to an overweight population (mean BMI in the United States is 28 kg/m2) as opposed to a normal-weight population are unclear. The use of synthetic materials in comorbid patients or complex settings may risk major wound complications such as prosthetic infection. Biologic materials have been shown to be effective in decreasing major wound complications but in different settings. This study is being done to assess the effectiveness of different efficacious strategies to decrease the rate of major wound complications following abdominal surgery among high-risk individuals The researchers hypothesize: 1. Among high-risk patients undergoing abdominal surgery, the use of "small-bites" closure as opposed to "large-bites" closure will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative. 2. Among high-risk patients undergoing abdominal surgery, the biologic tissue reinforcement of the suture line as opposed to no reinforcement will increase the proportion of patients who are free of major, chronic wound complications at 1-year post-operative.

Type: Interventional

Start Date: Sep 2017

open study

Papaverine vs Heparin for Peripheral Arterial Catheter Patency in Pediatric Patients
The University of Texas Health Science Center, Houston Pediatrics Anesthesia Vasospasm
Periodic small volume boluses of diluted papaverine in peripheral arterial catheters of pediatric patients will prevent arterial spasm and help maintain patency of arterial catheters during general anesthesia. expand

Periodic small volume boluses of diluted papaverine in peripheral arterial catheters of pediatric patients will prevent arterial spasm and help maintain patency of arterial catheters during general anesthesia.

Type: Interventional

Start Date: Apr 2019

open study

Cardiovascular Manifestations of COVID-19
Memorial Hermann Health System Cardiovascular Diseases COVID
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the novel coronavirus disease 2019 (COVID-19). The first reports of COVID-19 came from Wuhan, China in December of 2019. Since then, the disease has spread rapidly around the globe,... expand

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the novel coronavirus disease 2019 (COVID-19). The first reports of COVID-19 came from Wuhan, China in December of 2019. Since then, the disease has spread rapidly around the globe, accounting for thousands of deaths in multiple countries. On March 11th, 2020, the World Health Organization declared COVID-19 as a pandemic. Although COVID-19 manifests primarily as a respiratory illness, several cardiovascular implications have been reported related to its natural course and treatment. Its exact effect on the cardiovascular system though is currently unknown. Therefore, we propose a retrospective, observational, case-control study looking for cardiovascular manifestations of COVID-19, including laboratory evidence of myocardial injury, electrocardiographic changes, arrhythmias and echocardiographic abnormalities. Hospitalized patients admitted with fever, cough, sore throat, and/or dyspnea who were tested positive for SARS-CoV-2 will be included in our study and will be matched based on their age and gender with patients admitted with similar symptoms who tested negative for SARS-CoV-2. The electronic medical charts of the study subjects will be reviewed and relevant demographic, clinical, laboratory and imaging findings will be deidentified and recorded. Since our study will be a retrospective chart review study it carries minimal risk for the patients and the investigators. Cardiovascular disease associated with COVID-19 might be contributing to the high mortality rates and its recognition will allow for prevention, early diagnosis and appropriate treatment. This will be the first, large, case-control study assessing cardiovascular involvement of COVID-19 in a well-defined cohort of patients.

Type: Observational

Start Date: Mar 2020

open study

Mesh Type in Ventral Hernia Repair
The University of Texas Health Science Center, Houston Ventral Hernia
Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators... expand

Ventral hernias are common following abdominal surgery. Currently, there is no equipoise on when synthetic and biologic meshes should be used. Among open ventral hernia repairs, half are repaired using biologic mesh while half are repaired using synthetic mesh. The investigators hypothesize that biologic mesh as opposed to synthetic mesh repair of open ventral hernia repair is associated with decreased risk of major complications one year after surgery.

Type: Interventional

Start Date: Mar 2017

open study

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... 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

open study

Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications
The University of Texas Health Science Center, Houston Intubation Complication
The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration,... expand

The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.

Type: Interventional

Start Date: Feb 2020

open study

Profiling Biospecimens From Cancer Patients to Screen for Molecular Alterations Related to Treatment...
Strata Oncology Cancer Adult Solid Tumor Lymphoma
Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial (STR-001-001) with the... expand

Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. Strata Oncology is initiating the Strata Trial (STR-001-001) with the primary goal of understanding the proportion of subjects available for clinical trials and approved targeted therapies in advanced cancer while assessing the feasibility of using a large-scale NGS screening program to match subjects for eligibility assessments in clinical trials and/or for approved targeted therapies. The Strata Trial does not require additional procedures but rather uses surplus, or leftover tumor specimens for molecular profiling.

Type: Observational [Patient Registry]

Start Date: Nov 2016

open study

Brain Oxygen Optimization in Severe TBI, Phase 3
University of Michigan Brain Injuries, Traumatic
BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided... expand

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.

Type: Interventional

Start Date: Aug 2019

open study

Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
University of Tennessee Health Science Center Ischemic Stroke
Placing the head of bed (HOB) at 0-degrees has been shown in small studies to improve blood flow to the brain in patients with ischemic stroke caused by large artery occlusions, thereby reducing stroke symptom worsening. This simple yet potentially impactful intervention has yet... expand

Placing the head of bed (HOB) at 0-degrees has been shown in small studies to improve blood flow to the brain in patients with ischemic stroke caused by large artery occlusions, thereby reducing stroke symptom worsening. This simple yet potentially impactful intervention has yet to be tested in a large clinical trial in hyperacute large artery ischemic stroke patients, but may provide nurses with a powerful contribution to acute stroke care that is capable of preventing worsening of stroke symptoms and promoting stabilization. Because stroke is the leading cause of preventable long-term disability in adults, this study may show that simple methods such as 0-degree HOB positioning should be considered one of the very first actions taken in the emergent management of acute ischemic stroke patients.

Type: Interventional

Start Date: Sep 2018

open study

VITORA: Clinical Study to Evaluate the Effect of KB109 on the Gut Microbiome in Subjects Whose Gastrointestinal...
Kaleido Biosciences Vancomycin-Resistant Enterococcus, Extended-Spectrum Beta Lactamase-Producing Enterobacteriaceae, or Carbapenem-Resistant Enterobacteriaceae Colonized Subjects
This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized with multiple drug-resistant organisms. expand

This randomized, open-label, clinical study aims to explore the safety and tolerability of KB109, a novel glycan, versus an observational control group on the gut microbiome in subjects whose gastrointestinal tracts are colonized with multiple drug-resistant organisms.

Type: Interventional

Start Date: Jun 2019

open study

Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS
The Cleveland Clinic Multiple Sclerosis, Relapsing-Remitting
The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study... expand

The DELIVER-MS study seeks to answer the question: Does early treatment with highly effective DMT improve the prognosis for people with MS? This is an area of significant controversy and no data currently exist to guide treatment choices for patients and clinicians. The study results will help guide overall treatment philosophy and will be applicable not only to a wide range of existing therapies but also to new therapies, meeting a significant unmet need in patient decision making and aiding the decision for medication approval by third parties.

Type: Interventional

Start Date: Jan 2019

open study

On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
On-X Life Technologies, Inc. Thrombotic and Bleeding Events
The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up... expand

The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The objective will be to compare adverse event rates for patients in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to rates from the previous IDE trial (G050208).

Type: Observational [Patient Registry]

Start Date: Nov 2015

open study

A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
Annexon, Inc. Guillain-Barré Syndrome
This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS. expand

This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.

Type: Interventional

Start Date: Jan 2020

open study

An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy...
Nanospectra Biosciences, Inc. Neoplasms of the Prostate
To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation. expand

To determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser irradiation.

Type: Interventional

Start Date: Jan 2020

open study

A Study of NCS-01 in Patients With Acute Ischemic Stroke
NC Medial Research Inc Ischemic Stroke
This is an initial Phase1/2 dose-finding, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 24 hours of stroke onset. This study will be conducted... expand

This is an initial Phase1/2 dose-finding, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of NCS-01 in patients with acute ischemic stroke. All patients will be randomized within 24 hours of stroke onset. This study will be conducted in 2 stages.

Type: Interventional

Start Date: Feb 2020

open study

The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
Mercy Health Ohio Ischemic Stroke
The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility.... expand

The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.

Type: Interventional

Start Date: Jul 2019

open study

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem...
Hope Biosciences Traumatic Brain Injury
This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults. expand

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

Type: Interventional

Start Date: Jan 2020

open study

Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia...
Innocoll Inguinal Hernia Postoperative Pain
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a... expand

A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a step-wise fashion until appropriate doses are established for all 3 pediatric age groups (12 to <17 years, 6 to <12 years, 2 to <6 years).

Type: Interventional

Start Date: Jun 2017

open study

Blood and Stool Sample Collection in Subjects With a Diagnosis of Colorectal Cancer or Colorectal Lesion:...
Exact Sciences Corporation Colorectal Cancer
The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC). expand

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for the detection of colorectal cancer (CRC).

Type: Observational

Start Date: Dec 2018

open study

Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury
The University of Texas Health Science Center, Houston Acquired Brain Injury
This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal... expand

This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal direct current stimulation (tsDCS) over cervical spine combined with high intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.

Type: Interventional

Start Date: May 2016

open study

Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
The University of Texas Health Science Center, Houston Pseudoachondroplasia
The purpose of this study is to determine if self-administered oral resveratrol can dampen joint pain for individuals with pseudoachondroplasia compared to placebo. expand

The purpose of this study is to determine if self-administered oral resveratrol can dampen joint pain for individuals with pseudoachondroplasia compared to placebo.

Type: Interventional

Start Date: Jun 2019

open study

Hemodynamic-GUIDEd Management of Heart Failure
Abbott Medical Devices Heart Failure Heart Failure, Systolic Heart Failure, Diastolic Heart Failure NYHA Class II Heart Failure NYHA Class III
The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality. expand

The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality.

Type: Interventional

Start Date: Mar 2018

open study