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NCT ID: NCT03859648 Terminated - Clinical trials for Hearing Loss, Conductive

BONEBRIDGE Bone Conduction Implant in Adults

Start date: August 26, 2019
Phase: N/A
Study type: Interventional

Approximately thirty subjects with mixed or conductive hearing loss, meeting FDA-cleared candidacy criteria for the BONEBRIDGE, will be implanted and followed for three (3) months post-activation to assess safety and effectiveness of the BONEBRIDGE implant.

NCT ID: NCT03859167 Terminated - Blood Pressure Clinical Trials

Study of the Loss of AV Synchrony at Maximum Exercise

SLAVSME
Start date: September 10, 2019
Phase:
Study type: Observational

Investigators will identify a group of patients with complete heart block and a dual chamber pacemaker who will be expected to be able to exercise on a treadmill. Investigators will utilize symptom logs, cuff and continuous blood pressure monitoring. It is planned to study the symptomatic impact of loss of AV synchrony at significant levels of exercise.

NCT ID: NCT03858972 Terminated - Breast Cancer Clinical Trials

Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

CONTESSA 2
Start date: February 5, 2019
Phase: Phase 2
Study type: Interventional

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane. The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). 152 patients were enrolled.

NCT ID: NCT03858933 Terminated - Clinical trials for Stress Disorders, Post-Traumatic

Train Your Brain: Neurofeedback Intervention for PTSD

Start date: April 19, 2018
Phase: N/A
Study type: Interventional

The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.

NCT ID: NCT03858647 Terminated - Clinical trials for Sensorineural Hearing Loss

Electrode Placement and Audiologic Outcomes With the Advanced Bionics HiFocus L23 Electrode

Start date: February 21, 2019
Phase:
Study type: Observational

The goal of this study is to measure patient performance after cochlear implantation with the Food and Drug Administration (FDA) approved Advanced Bionics HiFocus L23 device. The specific aims of the project are as follows: 1. To measure implant audiologic performance as defined by speech performance in standard cochlear implant speech test batteries. 2. To determine scalar location after insertion through either intraoperative or postoperative imaging and correlate this with audiologic outcomes. 3. To assess the rates of preservation of residual acoustic hearing and correlate those with scalar location as determined in specific aim 2 and audiologic performance as determined in specific aim 1. 4. To correlate speech outcomes with quality of life measures, as defined by validated questionnaires including the Tinnitus Handicap Index (THI), Speech and Spatial Qualities (SSQ) Questionnaire, and Nijmegen Questionnaire. 5. To evaluate intraoperative ease of insertion from the surgeon's perspective and correlate this with postoperative electrode location and audiologic performance.

NCT ID: NCT03858517 Terminated - Clinical trials for Shoulder Arthroplasty

A Post-Market Clinical Evaluation of the ReUnion TSA System

Start date: June 25, 2019
Phase:
Study type: Observational

This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty subjects, which entails clinical evaluation on a regular ongoing basis, or as needed should the subject become symptomatic in the treated joint.

NCT ID: NCT03858361 Terminated - Data Collection Clinical Trials

Patient Specific Optimized Therapy (PSOT)

PSOT
Start date: September 13, 2019
Phase:
Study type: Observational [Patient Registry]

Data collection from atrial flutter patients before, during and after undergoing catheter-based electrophysiological (EP) intervention in order to develop a patient specific optimized therapy (PSOT) to improve specific patient's arrhythmia treatment for Atrial Flutter.

NCT ID: NCT03857867 Terminated - Parkinson Disease Clinical Trials

Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.

NCT ID: NCT03857841 Terminated - Clinical trials for Bronchopulmonary Dysplasia

A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD

Start date: October 9, 2019
Phase: Phase 1
Study type: Interventional

A multicenter, placebo-controlled, randomized, dose escalation, safety, and tolerability study of UNEX-42 in infants born at <27 weeks of gestational age (GA) at high risk for bronchopulmonary dysplasia (BPD).

NCT ID: NCT03857659 Terminated - Clinical trials for Fetal Growth Abnormality

Serial Third Trimester Abdominal Circumference and Amniotic Fluid Measurements Versus Routine Care

STAR
Start date: April 5, 2019
Phase: N/A
Study type: Interventional

The purpose of this study us to compare the rate of prenatal identification of abnormal fetal growth or amniotic fluid between clinical evaluation of uterine size by symphysis fundal height (SFH) measurements versus point-of-care ultrasound (POC-US) evaluation of abdominal circumference (AC) and maximum vertical pocket (MVP).