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NCT ID: NCT04321668 Completed - Knee Osteoarthritis Clinical Trials

Innovative Tool to Analyse Synovial Fluid of Patients With Knee Ostearthritis After IA Injection of Synvisc-one®

RESYF
Start date: February 12, 2020
Phase: N/A
Study type: Interventional

The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®.

NCT ID: NCT04321382 Completed - Prosthesis User Clinical Trials

Subjective Perception of Ocular Prosthesis Wear

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

The loss of an eye, whether congenital or acquired, is a severe psychological trauma with negative impact on the quality of life of the patient. While rehabilitation with a customized ocular prosthesis anatomically restores the facial appearance, the final outcome is largely determined by the subjective satisfaction of the patient. By investigating the level of subjective perception, the quality of care can be improved.

NCT ID: NCT04321252 Completed - Malaria Clinical Trials

Study to Assess Safety, Tolerability and Phamacokinetics of KAE609 Administered Intravenously in Healthy Subjects

Start date: July 22, 2020
Phase: Phase 1
Study type: Interventional

This was a randomized, subject and investigator-blinded, placebo-controlled, single and multiple ascending intravenous (iv) dose study in healthy subjects to assess the safety and tolerability of KAE609 given in the vein.

NCT ID: NCT04317599 Completed - Clinical trials for Metastatic Colorectal Cancer

A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

CAPSTAN CRC
Start date: April 12, 2020
Phase:
Study type: Observational

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting. This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

NCT ID: NCT04315948 Completed - Clinical trials for Corona Virus Infection

Trial of Treatments for COVID-19 in Hospitalized Adults

DisCoVeRy
Start date: March 22, 2020
Phase: Phase 3
Study type: Interventional

DisCoVeRy is a randomized controlled trial among adults (≥18-year-old) hospitalized for COVID-19. This study is an adaptive, randomized, open or blinded, depending on the drug to be evaluated, clinical trial to evaluate the safety and efficacy of possible therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. The study will compare different investigational therapeutic agents to a control group managed with the SoC including corticosteroids and anticoagulants. There will be interim monitoring to allow early stopping for safety and to introduce new therapies as they become available. If one therapy proves to be superior to others in the trial, this treatment may become part of the SoC for comparison(s) with new experimental treatment(s). In previous versions of the DisCoVeRy protocol, remdesivir, lopinavir/ritonavir with or without interferon ß-1a and hydroxychloroquine were evaluated as potential treatments for COVID-19. These treatments have been discontinued based on analyses review by both DSMC/DSMB, the Solidarity Executive Group and the DisCoVeRy steering committee. This version of the protocol, therefore, describes a randomized blinded placebo-controlled trial among adults (≥18-year-old) hospitalized for COVID-19 that randomly allocates them (1:1 ratio) between 2 arms: SoC + placebo versus SoC + AZD7442. Randomization will be stratified by region (according to the administrative definition in each country), antigenic status (positive or negative) obtained from the result of a rapid antigen test on nasopharyngeal swab performed at enrolment and vaccination initiation (yes or no). The primary analyses will be conducted on patients with antigen-positive results. A positive antigenic test is evidence of high viral shedding consistent with a recently started or uncontrolled infection. Overall, the number of antigen-negative patients will be at most 30% of all included subjects. The number of patients with vaccination (partly or fully) will be limited to 20% of all participants, split evenly between antigen positive and antigen negative patients (i.e. vaccinated patients can make up at most 20% of antigene positive patients and 20% of antigene negative patients). Sensitivity analyses will be performed in all patients, stratified by antigenic status and vaccination initiation. A global independent data and safety monitoring board (DSMB) monitors interim data to make recommendations about early study closure or changes to conduct, including adding or removing treatment arms. However, the current version of the protocol does not allow for efficacy or futility analysis, and the ability to add trial arms will be limited by the study being blinded and placebo-controlled during the investigation of AZD7442.

NCT ID: NCT04314427 Completed - Clinical trials for Diabetes Mellitus Type 2 in Obese

Early Glycaemic Control in Type 2 Diabetes Patients After Bariatric Surgery; ECODABS

Start date: September 2012
Phase:
Study type: Observational

Describe and characterize the time-course for improvement in glucose control after bariatric surgery in obese patients with type 2 diabetes Compare these changes in glycemic control after different techniques for bariatric surgery

NCT ID: NCT04313517 Completed - Clinical trials for Psychological Stress

Yoga@Work Intervention to Reduce Work-related Stress Among Information Technology Workers

Start date: January 12, 2019
Phase: N/A
Study type: Interventional

Over the last several decades, occupational stress at workplace comprise a major burden. Office based work are more prone to sedentary lifestyle, postural issues, workplace stress, repetitive strain injury, poor employee health. Workplace wellness programs has been very feasible access to employees at their own convenience and need. Yoga@Work Program was developed to suit the need for information technology workers.

NCT ID: NCT04310085 Completed - Malaria,Falciparum Clinical Trials

Study in Blood Stage Malaria Infection After DVI of Cryopreserved P. Falciparum (NF54 Strain) Sporozoites

Start date: February 19, 2020
Phase: Phase 1
Study type: Interventional

This is a single-centre, open-label, Phase Ib study designed to assess if intravenous injection of approximately 3200 P. falciparum (NF54 strain) sporozoites can be safely administered to achieve blood-stage parasitaemia with a kinetics/PCR profile that will allow for the future characterisation of antimalarial blood-stage activity of new chemical entities in a relatively small number of participants during early drug development. Healthy, malaria-naïve adults, aged 18-55 years, will be enrolled in a maximum of 2 cohorts. Enrolment into the cohorts will proceed sequentially, with two target levels of parasitaemia, i.e., 5000 parasites/mL blood in Cohort 1 and 10000 parasites/mL blood in Cohort 2. (Based on observed levels of parasitaemia in Cohort 1, the target threshold for treatment in Cohort 2 was maintained at 5,000 p/mL (vs 10,000 p/mL in the protocol)). The 3-day antimalarial therapy regimen will be further administered and monitored until parasite clearance. Safety and tolerability will be monitored during the whole study duration.

NCT ID: NCT04308681 Completed - Pulmonary Fibrosis Clinical Trials

A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

Start date: July 29, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

NCT ID: NCT04307745 Completed - Primary Prevention Clinical Trials

Primary Prevention Habits for the Shoulder: Survey of the Sportsman's Entourage

Start date: June 5, 2020
Phase:
Study type: Observational [Patient Registry]

Purpose: To provide an update on the implementation of prevention among overhead athletes by their entourage. Materiel and method: This study will be conducted by the means of a questionnaire. The target population consisted of doctors, trainers, physical trainer and physiotherapist. The questionnaire will be validated by experts in each categorie and published on an online survey website