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NCT ID: NCT04531189 Completed - Wilson Disease Clinical Trials

Clinical Evaluation and Assessment of Instruments and Biomarkers in Subjects With Wilson Disease

Start date: December 11, 2020
Phase:
Study type: Observational

The primary objective of the study is to determine the relevance and appropriateness of outcome assessments, including biomarkers, within the Wilson disease population to inform study design and endpoint selection for future clinical studies.

NCT ID: NCT04530344 Completed - Vitiligo Clinical Trials

Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

NCT ID: NCT04529850 Completed - Clinical trials for Head and Neck Cancer

Ph 2 Open Label Study of GC4419 to Reduce SOM Associated With Chemoradiotherapy for Head and Neck Cancer

Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

GTI-4419-202 is a Phase 2 open-label study of the effects of GC4419 (IV) when administered in combination with IMRT and cisplatin to up to subjects with head and neck cancer, who are at high risk for Severe Oral Mucositis (SOM)

NCT ID: NCT04528537 Completed - Clinical trials for Postoperative Quality of Recovery in the Postanesthesia Care Unit

Validation of the Quality of Recovery Questionnaire for the Postanesthesia Care Unit (QoR-PACU)

Start date: August 10, 2020
Phase:
Study type: Observational

Quality of recovery after surgery and anesthesia is an important endpoint in perioperative medicine. Several questionnaires have been developed that assess the patient's perception on postoperative recovery at 24 h after surgery. This study aims to adapt validate the Quality of Recovery 15-questionnaire for application in the postanesthesia care unit.

NCT ID: NCT04528524 Completed - Clinical trials for Postoperative Quality of Recovery

Validation of the German Quality of Recovery-15 Questionnaire

Start date: August 17, 2020
Phase:
Study type: Observational

The Quality of Recovery 15-questionnaire (QoR-15) is used to assess postoperative quality of recovery after surgery and anesthesia from the patient's perspective. It evaluates five dimensions including pain, physical comfort, physical independence, psychological support, and emotional state. The aim of this study is to validate a German version of the QoR-15 scale (QoR-15Dt) to measure postoperative recovery in German-speaking patients.

NCT ID: NCT04527731 Completed - Physical Activity Clinical Trials

Physical Activity Level During Pregnancy

Fit4Two
Start date: February 25, 2020
Phase:
Study type: Observational

This study examines (1) the extent and intensity of physical activity among women in different phases of their pregnancy and (2) the relationship between patterns of physical activity in pregnancy and well-being.

NCT ID: NCT04527497 Completed - COVID-19 Clinical Trials

Clinical Course and Treatment of COVID-19 Inpatients in Hospital

Start date: August 1, 2020
Phase:
Study type: Observational

The study is an epidemiological observational study. It serves to collect data from patients with positive COVID-19 test results who are hospitalized. All data describing the course of the inpatient stay are recorded (Length of stay, course of therapy, medication, X-ray and CT results,ventilation mode and duration, laboratory). Furthermore, anthropometric data and information on COVID-19 symptoms is recorded.

NCT ID: NCT04527107 Completed - Diabetes Mellitus Clinical Trials

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

KALAHARI
Start date: July 31, 2020
Phase: Phase 2
Study type: Interventional

Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

NCT ID: NCT04526964 Completed - Self-management Clinical Trials

Improved Self-management for Patients on Ventricular Assist Device (VAD) Support - Phase 3

SELMA
Start date: September 7, 2020
Phase: N/A
Study type: Interventional

The number of patients suffering from end-stage heart disease challenges healthcare services in the western world, where an estimated 1-2% of the population suffer from this chronic condition. Ventricular assist device (VAD) implantations have become a common therapeutic strategy for those affected. Live with a VAD, however, is far from normal and does expose patients to multiple challenges and the need to adjust to a complex self-management. Inadequate self-management can lead to serious complications, specifically neuro-cognitive events, bleeding, and exit-site related wound infections may impair the outcome following the VAD implantation procedure. Based on systematized literature review and a previous prevalence assessment study (ClinicalTrials.gov Identifier: NCT04234230), a modular evidence-based curriculum has been developed by a multiprofessional group of experts. This curriculum aims at improving knowledge, skills, and competencies for those affected to empower VAD patients to better self-manage their everyday life with the VAD, and to regain quality of life. This study focuses on a multi-center implementation and evaluation of the curriculum using a fully powered randomized-controlled study (RCT) design. This RCT will be conducted at four established cardiac centers throughout Germany. Participants will be assigned to either intervention or control using a 1: 1 randomization scheme. Block-randomization will be performed by a professional from the study coordinating center not being involved into the clinical care for patients. At the participating sites, the group assignment is non-blinded to the professionals involved in order to enable the intervention so be carried out adequately. Participants in the control group (CGr) receive the standard follow-up procedures (care as usual). Participants in the intervention group (IGr) receive self-management support and skills training based on the modular self-management curriculum post-implant, and during regular outpatient follow-up. The intervention lasts for 3 months followed by a 9-month follow-up per participant. Based on the power calculations the inclusion of 142 patients is anticipated.

NCT ID: NCT04525794 Completed - Clinical trials for Peripheral Artery Disease

BRight DCB First-in-Human Study

Start date: February 4, 2021
Phase: N/A
Study type: Interventional

The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD). The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months.