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NCT ID: NCT03450733 Completed - Osteoarthritis, Hip Clinical Trials

Wright Medical Technology Metal-on-Metal 522 Post-Market Surveillance Study

Start date: April 11, 2018
Phase:
Study type: Observational

This study is in response to the Food and Drug Administration (FDA) call to all manufacturers with 510(k) clearance for metal-on-metal (MoM) total hip arthroplasty (THA) devices to conduct postmarket surveillance studies. MicroPort has various acetabular shells, acetabular liners, fixation screws, femoral heads, femoral stems, modular necks, and proximal bodies currently cleared for MoM indications. Together these components comprise the Wright Medical Technology (WMT) MoM THA System. The primary objective of the study is to determine the incidence of adverse local tissue reactions (ALTR) in each THA implanted with the WMT MoM THA System overall and to create cross-sectional epochs of ≤ 8 years and > 8 years, since implantation.

NCT ID: NCT03456414 Completed - Clinical trials for End Stage Renal Disease

Virtual Reality During Hemodialysis

VRHD
Start date: April 11, 2018
Phase: N/A
Study type: Interventional

The main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis VR in physical activity level, health related quality of life and in cognitive function.

NCT ID: NCT03467425 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

INTREPID: Investigation of TRELEGY Effectiveness: Usual Practice Design

Start date: April 11, 2018
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA relative to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary Disease (COPD) control within the usual clinical practice setting. The study will be conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be conducted and is available commercially. This is a randomized, open-label, effectiveness, phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone furoate [FF]/vilanterol [VI]/umeclidinium bromide [UMEC]: 100 microgram [mcg]/62.5 mcg/25 mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of companies. The study will enroll approximately 3000 subjects.

NCT ID: NCT03470493 Completed - Clinical trials for Sleep-disordered Breathing

ApneaLink Air Home Sleep Testing (HST) Device Validation Study

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.

NCT ID: NCT03475667 Completed - Septic Shock Clinical Trials

Comparison of Radial and Femoral Artery Site Invasive Blood Pressure Measurement in Septic Shock Patients

Start date: April 11, 2018
Phase:
Study type: Observational [Patient Registry]

Inaccurate monitoring of mean arterial pressure (MAP) could lead to improper treatment in the form of excessive fluid infusion or unnecessary vasopressor therapy; therefore, accurate hemodynamic monitoring is crucial in treatment of septic shock. In critically ill septic patients treated with vasoactive drugs, many studies reported that radial arterial pressure monitoring significantly underestimates central arterial pressure. Insertion of a femoral line allowed a substantial reduction of the infusion rate of vasoactive drugs in these patients. These findings might imply that femoral placement of arterial lines is the gold standard for invasive arterial blood pressure monitoring in shock patient. Our study aimed to determine the difference between radial (peripheral) and femoral (central) arterial pressures measured simultaneously in a group of critically ill patients receiving high dose noradrenaline therapy (≥ 0.1 mcg/kg/min).

NCT ID: NCT03481972 Completed - Clinical trials for TTR Cardiac Amyloidosis

A Study of Doxycycline and Tauroursodeoxycholic Acid (Doxy/TUDCA) Plus Standard Supportive Therapy Versus Standard Supportive Therapy Alone in Cardiac Amyloidosis Caused by Transthyretin

Start date: April 11, 2018
Phase: Phase 3
Study type: Interventional

Cardiac amyloidosis caused by transthyretin either mutated (in ATTRm amyloidosis) or wildtype (in ATTRwt, formerly senile, amyloidosis) is a rare disease but is diagnosed with increasing frequency thanks to the availability of non-invasive scintigraphy-based means. Cardiac ATTR amyloidosis is characterized by progressive heart failure with a median survival of less than 4 years, and there is no standard treatment for this disease. It was proved that the marketed antibiotic doxycycline (Doxy) disrupts amyloid fibrils in vitro and in animal models synergistically with tauroursodeoxycholic acid (TUDCA). Based on these pre-clinical data, a clinical trial of Doxy/TUDCA in ATTR Amyloidosis (NCT01171859) was conducted. Treatment was well tolerated and was able to prevent progression of cardiac dysfunction.

NCT ID: NCT03483428 Completed - Hearing Loss Clinical Trials

Adaptation and Pilot Testing of a Behavioral Parent Training Program for Parents of Deaf and Hard of Hearing Children

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

Despite being more likely than typical hearing children to experience disruptive behavior problems, children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This pilot project will systematically adapt an evidence-based behavioral parent training (BPT) intervention to increase its acceptability and relevance for parents of young DHH children. Two parents of DHH children will be trained in the adapted BPT for DHH children. They will each deliver the intervention to five families with DHH preschool-aged children.

NCT ID: NCT03489980 Completed - Anxiety Clinical Trials

Influence of the Coloring of a Complex Form on Anxiety Associated With Care.

COLORI
Start date: April 11, 2018
Phase:
Study type: Observational

Evaluate the contribution of a coloring-type artistic task of a complex form in the reduction of anxiety related to care and pathology by a self-questionnaire "State-Trait anxiety inventory" and a self-questionnaire on the experience of the activity, in 3 different medical situations: in day hospitalization service in psychiatry, in hemodialysis service and in an ambulatory consultation waiting room.

NCT ID: NCT03494777 Completed - HIV/AIDS Clinical Trials

Behavioral Economics Incentives to Support HIV Treatment Adherence in Sub-Saharan Africa

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

This study will implement an intervention in a two-year randomized controlled trial (RCT) to establish efficacy on viral suppression as a biological endpoint, compare the effectiveness of two different modes of implementation (including one entirely based on readily available clinic data), and investigate cost-effectiveness. Participants in the first intervention group (T1, n=110) will be eligible for small lottery prizes based on timely clinic visits, and qualify for an annual lottery conditional if demonstrating viral suppression; those in the second group (T2, n=110) will draw prizes conditional on electronically measured adherence at each clinic visit, and also participate in an annual lottery that is conditional on high adherence throughout the year. The control group (n=110) will receive the usual standard of care. Assessments will be conducted at baseline and then every six months. Primary outcomes are undetectable viral load and electronically measured adherence.

NCT ID: NCT03499067 Completed - Myopia Clinical Trials

A Dispensing Clinical Trial of Test Contact Lens Against Marketed Contact Lens

Start date: April 11, 2018
Phase:
Study type: Interventional

Evaluation of the clinical performance of an investigational silicone-hydrogel contact lens (test) compared to a marketed lens (control), when worn on a daily basis for 1 month.