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NCT ID: NCT05581199 Recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

Start date: December 15, 2022
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin [Ig] or plasma exchange [PLEX]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.

NCT ID: NCT05581017 Completed - Clinical trials for Surgical Site Infection

Association of Cephalosporin Resistance and Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy

Start date: June 16, 2020
Phase:
Study type: Observational

Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.

NCT ID: NCT05580315 Recruiting - Clinical trials for Discoid Meniscus of Knee

EPOS Discoid Meniscus (DiMe) Project

DiMe
Start date: September 8, 2022
Phase:
Study type: Observational

The aims of this Discoid Meniscus (DiMe) project are to analyze DM tears characteristics in the pediatric European population to describe current treatment options in symptomatic DM, and to evaluate clinical outcomes. To reach these objectives, a prospective database including symptomatic DM and variables associated with DM characteristics, type of tears, treatment, imaging, and clinical follow-up will be implemented. Data collection platform will provide future studies to understand the best treatment option for skeletally immature patient with symptomatic DM according to their history and lesion characteristics.

NCT ID: NCT05574062 Active, not recruiting - Children, Only Clinical Trials

Evaluation of the MiniMed 780 System in Paediatric Subjects

LENNY
Start date: March 24, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the safety and performance of the MiniMedâ„¢ 780G system in pediatric subjects (2-6 years old) with type 1 diabetes in a home setting. The objective of this study is to evaluate the safety and performance of the MiniMedâ„¢ 780G system in Auto Mode firstly in comparison to the MiniMedâ„¢ 780G system in Manual Mode with Suspend before low activated (currently available standard therapy) and secondly in comparison to the new MiniMedâ„¢ 780G BLE 2.0 system with DS5 sensor in Auto Mode among pediatric population (2-6 years old).

NCT ID: NCT05572801 Not yet recruiting - Anal Cancer Clinical Trials

NOAC9 - Circulating Tumor DNA Guided Follow-Up in Anal Cancer

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

This study investigates if circulating tumor DNA can improve the detection of early treatment failure or recurrence in localized squamous cell carcinoma of the anus (SCCA) after curative chemoradiotherapy thereby increasing the potential for cure. This will be done by comparing the standard follow-up program with ctDNA guided imaging follow-up. Secondly, the aim is to establish early interventions against late morbidities.

NCT ID: NCT05572710 Recruiting - Clinical trials for Aortic Valve Stenosis

Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population

Avalus
Start date: June 10, 2020
Phase:
Study type: Observational [Patient Registry]

This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.

NCT ID: NCT05571254 Completed - Syncope Clinical Trials

The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments

SEED
Start date: September 12, 2022
Phase:
Study type: Observational

Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.

NCT ID: NCT05570760 Recruiting - Knee Deformity Clinical Trials

Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy

Start date: April 8, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to obtain performance and safety data of the new investigational device, dual-part Adaptos®Ortho Wedge, for its intended use in orthopaedic surgery. The study intervention is medial open wedge high tibial osteotomy (OWHTO) with loadbearing plate fixation, where a bone graft substitute material Adaptos®Ortho Wedge is evaluated when used as a bone void filler. Investigational device is expected to support bone formation in osteotomy gap and to resorb in the body. The comparator arms are treated with medial OWHTO with plate fixation, either without a bone graft (the bone defect is left empty, non-augmented osteotomy) or by using a comparator product (chronOS® Wedge, semi-circular) as a bone void filler.

NCT ID: NCT05569330 Active, not recruiting - Diarrhea Clinical Trials

Effect of Aerosol Filtering on Infectious Diseases in Day Care

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Effect of aerosol flitration and removal on typical infectious diseases such as upper respiratory tract infectinos is studied in day care. Many filtration methods such as filters and electrical filtering are used to remove aerosol particles from room air.

NCT ID: NCT05568979 Completed - Clinical trials for Influenza (Healthy Volunteers)

Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23

Start date: October 6, 2022
Phase:
Study type: Observational

This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) of suspected adverse drug reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2022/23. The secondary objectives of the study are: - To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®) - To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS