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NCT ID: NCT03954041 Terminated - Brain Contusion Clinical Trials

A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion

ASTRAL
Start date: October 6, 2019
Phase: Phase 2
Study type: Interventional

The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

NCT ID: NCT03953326 Terminated - Breast Cancer Clinical Trials

HeartPhone Cancer Survivors Trial 2019

Start date: April 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a behavioral study that will examine changes in physical activity and vascular health in response to a digital tool (app) that will appear on participant's lock screen of their Android phone. Participants will be asked to use this app for 3 months and to wear a Fitbit device continuously throughout the study. Participants will be asked to complete questionnaires, participate in fitness testing and measures of cardiovascular health at 3 months and 6 months after baseline assessments. The hypothesis is that exposure to the app will lead to increased physical activity volume and improved microvessel function.

NCT ID: NCT03953261 Terminated - Clinical trials for Systemic Lupus Erythematosus

Effect of Curcumin on Systemic Lupus Erythematosus

Start date: September 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this investigator initiated study is to determine the efficacy of curcumin on disease activity of subjects with systemic lupus erythematous. Curcumin has been found to have anti-inflammatory effects and has been found to improve disease activity in lupus patients. In addition, subjects with rheumatoid arthritis as well as osteoarthritis have also found benefit for their disease activity.

NCT ID: NCT03952325 Terminated - Breast Cancer Clinical Trials

Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC

CONTESSA TRIO
Start date: July 9, 2019
Phase: Phase 2
Study type: Interventional

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1) positive status. In Cohort 2, approximately 60 elderly patients with human epidermal growth factor receptor 2 (HER2) negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor (HR)-positive, HER2-negative disease. In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy. The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive, HER2-negative disease.

NCT ID: NCT03952182 Terminated - Lumbar Fracture Clinical Trials

Effect of Bracing Versus No Bracing in Stable Thoracolumbar Compression and Burst Fractures

Start date: January 5, 2020
Phase: N/A
Study type: Interventional

Spinal orthoses have been used in the treatment of non-operative thoracic and lumbar fractures with much success. However, there has been increasing questioning as to wether or not the orthotics are necessary to have a good overall outcome. Being fitted for and acquiring braces are associated with great expense and increased hospital stays. The purpose of this study is to determine wether or not braces are required for good outcome post thoracic or lumbar fracture.

NCT ID: NCT03952156 Terminated - Phenylketonurias Clinical Trials

Gene Therapy Clinical Study in Adult PKU

pheNIX
Start date: June 10, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, randomized, concurrently-controlled, dose escalation study to evaluate the safety and efficacy of HMI-102 in adult PKU subjects with PAH deficiency. Participants will receive a single administration of HMI-102 and will be followed for safety and efficacy for 1 year.

NCT ID: NCT03951363 Terminated - Clinical trials for Chronic Kidney Diseases

iControl Chronic Kidney Disease

iControl CKD
Start date: May 13, 2019
Phase: N/A
Study type: Interventional

The proposed study is responsive to the call for obtaining enhanced preliminary data for an external grant resubmission. The goal is to demonstrate a novel approach using digital health tools to help preserve kidney function. The investigators aim to adapt a previous behavioral intervention and conduct formative testing among patients with CKD. Specifically, the investigators will: Aim 1: Modify an existing technology platform to build the iControl CKD system and adapt intervention content to reflect behavioral guidelines for patients with mild to moderate CKD. Aim 2: Conduct qualitative interviews and user testing among patients with CKD to obtain feedback on the design of the intervention. Aim 3: Conduct a prospective cohort feasibility trial to assess the feasibility and initial acceptability of the iControl CKD intervention.

NCT ID: NCT03951064 Terminated - Respiratory Failure Clinical Trials

Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

PROP OPEN
Start date: March 31, 2021
Phase: N/A
Study type: Interventional

This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator. Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.

NCT ID: NCT03951012 Terminated - Clinical trials for Non Small Cell Lung Cancer

Use Peripheral Blood Proteomics to Predict the Treatment Response and Toxicities in NSCLC Immunotherapy

Start date: April 15, 2019
Phase:
Study type: Observational

Peripheral blood contains enormous quantity of biological information that can improve our patient care. Investigators plan to use proteomics from serum to study its value in predicting the therapeutic response and toxicities of immunotherapy in non-small cell lung cancer (NSCLC).

NCT ID: NCT03950414 Terminated - Clinical trials for Cytomegalovirus Infections

A Dose-Escalation Study Evaluating Safety and Tolerability of Viral-Specific T Cells Against CMV in Adult Solid Organ Transplant Recipients

Start date: September 27, 2019
Phase: Phase 1
Study type: Interventional

This study measures the tolerability of viral-specific T cells against Cytomegalovirus (CMV) in adult solid organ transplant (SOT) recipients. Participants are expected to be on study for 52 +/- 3 weeks.