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NCT ID: NCT05818332 Recruiting - Clinical trials for Perioperative Patient Safety

ClassIntra® for Better Outcomes in Surgery - CIBOSurg

CIBOSurg
Start date: July 17, 2023
Phase:
Study type: Observational [Patient Registry]

Intra- and postoperative adverse events (iAEs/pAEs) occur in up to one third of all patients, may be devastating to patients and costly to health care systems. Up to 50% of these events are potentially preventable. As iAEs are highly associated with pAEs, systematic and routine recording of iAEs and discussing them during the sign-out of the WHO Surgical Safety checklist (WHO SSC) is a prerequisite for diminishing or avoiding pAEs. However, in contrary to the first two parts of the WHO SSC, adherence with the last part, the sign-out, is only about 50%. Hence, the aim of this project is to increase adherence and quality of the performance of the WHO SSC and to implement routine recording of iAEs during the sign-out to improve patient safety and quality of care and, ultimately, reduce healthcare costs. Implementation science principles will be applied with a hybrid implementation-effectiveness approach and a multifaceted, tailored implementation strategy, which will be co-developed involving all relevant stakeholders.

NCT ID: NCT05817968 Completed - Respiratory Failure Clinical Trials

Solid State vs. Balloon Esophageal Catheter for Estimation of Pleural Pressure

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid-state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice. This method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.

NCT ID: NCT05817942 Recruiting - Ulcerative Colitis Clinical Trials

Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

GALOCEAN
Start date: June 12, 2023
Phase:
Study type: Observational

To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

NCT ID: NCT05817812 Active, not recruiting - Clinical trials for Hemophilia A, Severe

A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa

FREEDOM
Start date: July 31, 2023
Phase: Phase 3
Study type: Interventional

FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study. The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24. Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.

NCT ID: NCT05817669 Completed - Clinical trials for Primary Sjögren's Syndrome

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

rho
Start date: April 4, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.

NCT ID: NCT05817279 Recruiting - Clinical trials for Basal Cell Carcinoma

AI-aided Optical Coherence Tomography for the Detection of Basal Cell Carcinoma

Start date: April 10, 2023
Phase:
Study type: Observational

Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. A BCC diagnosis is commonly establish by means of an invasive punch biopsy (golden standard). Optical coherence tomography (OCT) is a safe non-invasive diagnostic modality which may replace biopsy if an OCT assessor is able to establish a high confidence BCC diagnosis. Hence, for clinical implementation of OCT, diagnostic certainty should be as high as possible. Artificial intelligence in the form of a clinical decision support system (CDSS) may improve the diagnostic certainty of newly trained OCT assessors by highlighting suspicious areas on OCT scans and by providing diagnostic suggestions (classification). This study will evaluate the effect of a CDSS on the diagnostic certainty and accuracy of OCT assessors.

NCT ID: NCT05816577 Completed - Diabetes Clinical Trials

Safety and Viability of an E. Coli Nissle Colibactin Knockout in Healthy Volunteers

SECONI
Start date: September 18, 2023
Phase: Phase 1
Study type: Interventional

E. coli Nissle (EcN) is a well-established human probiotic. However, it has been found that it produces colibactin, linked to colorectal cancer. In this safety trial, the safety and properties of a novel, colibactin-knockout EcN strain (EcNΔClbP) is investigated.

NCT ID: NCT05816382 Recruiting - Narcolepsy Type 1 Clinical Trials

A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions

Start date: April 5, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 and type 2 narcolepsy from previous parent studies, TAK-861-2001 (NCT05687903) and TAK-861-2002 (NCT05687916).

NCT ID: NCT05814614 Recruiting - Parkinson Disease Clinical Trials

Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation

LIPPE
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effect of pelvic physical therapy with different types of electrical stimulation(ES) for bladder complaints in people with Parkinson's disease. The main question it aims to answer is: What is the effect of pelvic physical therapy with ES for bladder complaints in people with Parkinson's disease. Secondary question: What is the most effective type of ES on bladder complaints in people with Parkinson's disease. Participants will be randomized into three groups. Two different kinds of ES and a sham group. Participants will receive eight session of pelvic physical therapy. Pelvic physical therapy consists of e.g. bladder training, pelvic floor muscle exercises and biofeedback.

NCT ID: NCT05813769 Completed - Clinical trials for Amino Acid Plasma Profile

Dairy and Plant Amino Acid Uptake. An Explorative Study

DaPa
Start date: May 9, 2023
Phase: N/A
Study type: Interventional

To optimize the environmental sustainability, a protein transition to more plant-based protein sources is required. However, the protein quality of plant-based sources is lower than that of the dairy proteins casein and whey, which contain high levels of essential amino acids. The amino acid absorption characteristics of many plant-based proteins are unknown. The present study aims to estimate differences in postprandial plasma total essential amino acids (TEAA) profiles after protein consumption of different protein sources in blood of healthy participants. This explorative study has a randomized, cross-over, double-blind, controlled design.