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NCT ID: NCT04846543 Recruiting - Forearm Fracture Clinical Trials

Bioresorbable Intramedullary Nailing of Forearm Fractures

BRINFF
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The Activa IM-Nail™ is used in the fixation of forearm fractures with cast to achieve a level of reduction and stabilisation that is appropriate to the age of the child. The post-market clinical follow-up study will be performed to identify the residual risk related to re-fracture and to determine its impact to the risk/benefit ratio of Activa IM-Nail™.

NCT ID: NCT04844879 Not yet recruiting - Clinical trials for Musculoskeletal Diseases

Medacta NextAR TKA Pivotal Trial

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to assess the efficacy and safety of a navigation system providing personalized soft tissue balance data in medially-stabilized total knee arthroplasty (TKA).

NCT ID: NCT04844567 Recruiting - Covid19 Clinical Trials

Virtual Reality Intervention to Alleviate Breathlessness (COVID-19)

Start date: November 26, 2020
Phase: N/A
Study type: Interventional

This study evaluates the feasibility and limited efficacy of a Virtual Reality (VR) intervention to alleviate symptoms of perceived breathlessness and dyspnea in individuals recovering from severe COVID-19 pneumonia.

NCT ID: NCT04843072 Not yet recruiting - Valve Heart Disease Clinical Trials

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

BASELINE
Start date: May 2021
Phase: N/A
Study type: Interventional

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success. Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro. Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus. Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by - Absence of procedural mortality AND - Correct positioning of a single prosthetic heart valve into the proper anatomical location AND - Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

NCT ID: NCT04842214 Recruiting - Oncologic Disorders Clinical Trials

Disease Course in Oncological Patients During Inpatient Rehabilitation and After Three Months Follow-up

Start date: January 1, 2019
Phase:
Study type: Observational

Constant improvements in the areas of diagnostics and treatment lead to an increase of patients surviving an oncological diagnosis ("cancer survivors") thus increasing the cost factor on both society and health care systems. Meta-analysis have shown the effectiveness of multidimensional rehabilitation programs concerning cost-effectiveness and for improving different health parameters. However when submitted to oncological rehabilitation in Switzerland there is no clear definition when to use which specific assessment during the different stages of oncological rehabilitation. This cohort study aims to evaluate and systematically follow-up patients that are assigned for oncological inpatient rehabilitation at the Rehabilitation Center Walenstadtberg. The main purposes are i) to evaluate disease onset of oncological patients during rehabilitation and to identify relationships between mobility and cancer-related fatigue at discharge; ii) to identify predictive factors for everyday functioning and social participation after three months discharge.

NCT ID: NCT04839263 Completed - Gynecologic Disease Clinical Trials

Fast-track in Minimally Invasive Gynaecology

Start date: September 1, 2015
Phase: N/A
Study type: Interventional

Objective: Evaluate the effects of a fast-track (FT) protocol on costs and postoperative recovery. Design: randomized trial Setting: University Hospitals Population: 170 women undergoing total laparoscopic hysterectomy for a benign indication Methods: A FT protocol included the combination of minimally invasive surgery, analgesia optimization, early oral refeeding and rapid mobilization of patients was compared to a usual care protocol. Main outcomes measure: Primary outcome was costs. Secondary outcomes were length of stay, postoperative morbidity and patient satisfaction.

NCT ID: NCT04839120 Completed - Prostatic Neoplasms Clinical Trials

PK, PD, Tolerability and Safety of MDPK67b in Healthy Volunteers

Start date: February 21, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase I, single centre, prospective, randomized, alternating panels, ascending doses with interspersed placebo, double-blind, crossover trial. The trial will include 8 volunteers divided into 2 panels (A and B) investigated in alternance, each submitted to 4 investigation periods following a crossover design in double blind, with ascending intravenous doses of MDPK67b and an interspersed placebo. The ascending dose sequence ranges from 2 to 48 mg, with 2-fold increase steps (3 to 4- fold increase steps in each individual volunteer). Three single doses will be administered at a minimum of 2 weeks intervals during the first 3 periods, and finally during the last period 4 repeated doses will be administered at a three days intervals, using either the highest dose of the ascending sequence (i.e. 24 or 48 mg) or the maximal tolerated dose (if it has been exceeded in the ascending sequence of single doses).

NCT ID: NCT04839094 Completed - SARS-CoV-2 Clinical Trials

Dry Versus Wet Nasopharyngeal Rapid Test for the Detection of COVID-19.

RESTART
Start date: December 10, 2020
Phase:
Study type: Observational

Saliva sampling could serve as an alternative non-invasive sample for SARS-CoV-2 diagnosis while rapid antigen testing (RAT) might help to mitigate the shortage of reagents sporadically encountered with RT-PCR. Thus, in the RESTART study the investigators compare antigen and RT-PCR testing methods on nasopharyngeal (NP) swabs and salivary samples. The investigators conducted a prospective observational study among COVID-19 hospitalized patients between 10th December 2020 and 1st February 2021. Paired saliva and NP samples were investigated by RT-PCR (Cobas 6800, Roche-Switzerland) and by two rapid antigen tests: One Step Immunoassay Exdia® COVID-19 Ag (Precision Biosensor, Korea) and Standard Q® COVID-19 Rapid Antigen Test (Roche-Switzerland).

NCT ID: NCT04837599 Not yet recruiting - Adenoma Clinical Trials

Artificial Intelligence Performance in Colonoscopy in Daily Practice

Start date: August 1, 2021
Phase: Phase 4
Study type: Interventional

randomised, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical.Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional divice, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI). The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).

NCT ID: NCT04836260 Recruiting - Covid19 Clinical Trials

Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19

Start date: April 8, 2021
Phase: Phase 3
Study type: Interventional

Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population. The aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication