267 matching studies

Sponsor Condition of Interest
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

open study

Maternal Morbidity and Mortality During the COVID-19 Pandemic
The George Washington University Biostatistics Center COVID-19 Pregnancy Complications
A cohort study of women who deliver at select sites on randomly selected days in 2019 and 2020, and all confirmed COVID-19 infections among pregnant or immediately postpartum women in 2020. The study population includes approximately 24,400 deliveries on randomly selected days... expand

A cohort study of women who deliver at select sites on randomly selected days in 2019 and 2020, and all confirmed COVID-19 infections among pregnant or immediately postpartum women in 2020. The study population includes approximately 24,400 deliveries on randomly selected days in 2019 and 2020, and an additional 1000-2100 confirmed COVID-19 infections among pregnant women or immediately postpartum.

Type: Observational

Start Date: Jun 2020

open study

FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study
Abbott Medical Devices Ventricular Tachycardia
This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs... expand

This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

Type: Interventional

Start Date: Jun 2018

open study

Ribociclib and Letrozole Treatment in Ovarian Cancer
Gynecologic Oncology Group Low Grade Serous Carcinoma
The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum. expand

The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.

Type: Interventional

Start Date: Dec 2018

open study

Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I...
Gynecologic Oncology Group Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Lymphedema Stage IA1 Cervical Cancer AJCC v6 and v7
This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects... expand

This clinical trial studies the physical function and quality-of-life before and after surgery in patients with stage I cervical cancer. Studying quality-of-life in patients undergoing surgery for cervical cancer may help determine the intermediate-term and long-term effects of surgery.

Type: Interventional

Start Date: Oct 2012

open study

Safety and Efficacy Study of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy
Ra Pharmaceuticals Immune Mediated Necrotizing Myopathy
The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks. expand

The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.

Type: Interventional

Start Date: Dec 2019

open study

CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
NYU Langone Health COVID-19 Coronavirus Coronavirus Infection
This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation. expand

This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms requiring oxygen supplementation.

Type: Interventional

Start Date: Apr 2020

open study

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

open study

Early Advanced Weight Bearing for Peri-articular Knee and Pilon Injuries
Major Extremity Trauma Research Consortium Distal Femur Fracture Tibial Plateau Fracture Distal Tibia Fracture Pilon Fracture
The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries. expand

The overall objective of this study is to compare outcomes following early advanced weight bearing (EAWB) using the AlterG antigravity treadmill versus standard of care physical therapy for adult patients with lower extremity periarticular injuries.

Type: Interventional

Start Date: Feb 2019

open study

BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit
Memorial Hermann Health System Acute Ischemic Stroke
The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management,... expand

The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).

Type: Interventional

Start Date: Aug 2014

open study

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

open study

Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
The University of Texas Health Science Center, Houston Neuropathic Pain SCI - Spinal Cord Injury
The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients. expand

The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury patients.

Type: Interventional

Start Date: Jul 2020

open study

SEdation Versus General Anesthesia for Endovascular Therapy in Acute Ischemic Stroke
The University of Texas Health Science Center, Houston Stroke
Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence... expand

Objectives: This study aims to estimate overall treatment benefit (improvement in disability) among acute ischemic stroke patients that are randomized to General Anesthesia (GA) compared with Sedation (CS) during endovascular therapy. Assess safety (as measured by incidence of symptomatic intracranial hemorrhage); rates of Endovascular therapy (EVT) procedural complications, reperfusion; and quality of life. Hypothesis: GA during EVT for acute ischemic stroke improves functional outcomes at 90 days compared to sedation.

Type: Interventional

Start Date: Jul 2018

open study

SynCardia 70cc TAH-t for Destination Therapy (DT)
SynCardia Systems. LLC Life-threatening Biventricular Heart Failure Ineligible for Cardiac Transplant
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happen) death from irreversible biventricular heart failure. The purpose of... expand

The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent (about to happen) death from irreversible biventricular heart failure. The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation. The TAH-t, when used for patients who are not eligible for transplant, is considered to be an investigational (not approved by FDA) use. This use is called destination therapy (DT). Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that are experienced by the enrolled subjects and comparing them to previous experience of TAH-t patients who were waiting for a heart transplant. Since approximately 74% of patients with this condition would not be expected to live beyond six months, the benefit of the TAH-t for DT will be confirmed based on survival to six months without experiencing permanent disabling stroke-related deficits. After the six month follow-up visit, patients will continue to be followed under the study for up to five (5) years postTAH-t implant [every six months for up to two years while supported with the TAH-t implant and then annually for another three years]. Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be the same for patients enrolled in both arms of the study.

Type: Interventional

Start Date: Feb 2016

open study

Effect of Systemic Inflammation on Emotion and Cognition in Patients With Mood Disorder - A Vaccine Study
The University of Texas Health Science Center, Houston Major Depressive Disorder
The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed... expand

The purpose of this pilot study is to investigate and compare the effect of a mild inflammatory stimulus (typhoid vaccine) on immune response, mood and cognition in healthy volunteers compared to patients with history Major Depressive Disorder (MDD) (not currently depressed and no symptoms of depression in the past 6 months).

Type: Interventional

Start Date: Feb 2018

open study

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. expand

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

open study

Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to...
National Cancer Institute (NCI) Gliosarcoma MGMT-Unmethylated Glioblastoma
This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy plus immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons... expand

This phase II/III trial compares the usual treatment with radiation therapy and temozolomide to radiation therapy plus immunotherapy with ipilimumab and nivolumab in treating patients with newly diagnosed MGMT unmethylated glioblastoma. Radiation therapy uses high energy photons to kill tumor and shrink tumors. Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving radiation therapy with ipilimumab and nivolumab lengthen the time without brain tumor from returning or growing and extend patients life compared to usual treatment of radiation therapy and chemotherapy.

Type: Interventional

Start Date: Aug 2020

open study

ILUMIEN IV: OPTIMAL PCI
Abbott Medical Devices Coronary Artery Disease Coronary Stenosis Atherosclerosis STEMI STEMI - ST Elevation Myocardial Infarction
The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving... expand

The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

Type: Interventional

Start Date: Mar 2018

open study

Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer
National Cancer Institute (NCI) Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive... expand

This phase II/III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.

Type: Interventional

Start Date: Jun 2019

open study

Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin)...
National Cancer Institute (NCI) Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Stage IB2 Cervical Cancer AJCC v6 and v7 Stage II Cervical Cancer AJCC v7
This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA... expand

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether radiation therapy and cisplatin are more effective with triapine in treating cervical or vaginal cancer.

Type: Interventional

Start Date: Jan 2016

open study

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

open study

Adavosertib Before Surgery in Treating Patients With Advanced High Grade Ovarian, Fallopian Tube, or...
M.D. Anderson Cancer Center Advanced Fallopian Tube Carcinoma Advanced Ovarian Carcinoma Advanced Primary Peritoneal Carcinoma Carcinomatosis High Grade Fallopian Tube Serous Adenocarcinoma
This pilot early phase I trial studies how adavosertib affects the tumor deoxyribonucleic acid (DNA) of patients undergoing surgery for high grade (fast growing or aggressive) ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body... expand

This pilot early phase I trial studies how adavosertib affects the tumor deoxyribonucleic acid (DNA) of patients undergoing surgery for high grade (fast growing or aggressive) ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body (advanced). Certain characteristics in the DNA of these patients may affect how well they respond to treatment. Learning how adavosertib affects DNA in tumor cells may help doctors plan effective treatment.

Type: Interventional

Start Date: Feb 2016

open study

Safety and Efficacy Study of PRV111 in Subjects With Oral Squamous Cell Carcinoma
Privo Technologies Oral Squamous Cell Carcinoma
Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3, or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled... expand

Up to 31 subjects diagnosed with oral squamous cell carcinoma will receive one application of a permeation enhancer and 2, 3, or 5 treatment applications of a Cisplatin drug-loaded patch to the tumor site at each of 4 treatment visits. These 4 treatment visits will be scheduled to occur during the 3 weeks prior to the standard of care tumor resection. Funding Source: FDA OOPD

Type: Interventional

Start Date: Jun 2018

open study

Web Based Orthopaedic Sports Medicine Registry
Arthrex, Inc. Degenerative and Traumatic Pathology of the Knee Degenerative and Traumatic Pathology of the Shoulder and Elbow Degenerative and Traumatic Pathology of the Foot and Ankle Degenerative and Traumatic Pathology of the Hand and Wrist Degenerative and Traumatic Pathology of the Hip
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated... expand

The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with the surgical procedures and nonoperative treatments.

Type: Observational [Patient Registry]

Start Date: Sep 2010

open study

A Phase 1, Multi-Center, Safety, Dose Escalation, Pharmacokinetics of INV-1120 in Adult Patients Advanced...
Shenzhen Ionova Life Sciences Co., Ltd. Cancer Solid Tumor, Adult Cancer Metastatic Solid Carcinoma Solid Tumor, Unspecified, Adult
Phase 1, first-in-human, open-label dose-escalation study to determine the MTD and RP2D, and to assess the DLT of INV-1120 (also referred to as investigational product or IP). The safety, tolerability, and PK of INV-1120 will be assessed in adult patients with advanced solid... expand

Phase 1, first-in-human, open-label dose-escalation study to determine the MTD and RP2D, and to assess the DLT of INV-1120 (also referred to as investigational product or IP). The safety, tolerability, and PK of INV-1120 will be assessed in adult patients with advanced solid tumors.

Type: Interventional

Start Date: Jun 2020

open study