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NCT ID: NCT06171893 Completed - Stress Clinical Trials

Assessing the Effect of the 'Wavy' Application, on Stress and Burden of Disease in Women With INOCA

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

For women that experience angina symptoms with underlying vascular spasm as the cause, stress has an aggravating role. Coping with stress is therefore included as an important pillar in dealing with this chronic disease, see the European Association of Percutaneous Cardiovascular Interventions (EACPI) consensus document on INOCA. In practice, stress management focuses on informing and identifying the role stress plays in their lives. A potential stress management tool: "Wavy" aims to help users manage stress more consciously through biofeedback. This research focuses on the effectiveness of stress management applications. The hypothesis is that the app will help to avoid the trigger stress as much as possible and thus reduce the burden of disease.

NCT ID: NCT06166992 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How BI 1291583 is Taken up by the Body

Start date: December 12, 2023
Phase: Phase 1
Study type: Interventional

The main objective of this trial is to investigate the absolute bioavailability of BI 1291583 (test treatment T, not radio-labelled) compared with BI 1291583 (C-14) (reference treatment R).

NCT ID: NCT06161155 Completed - Clinical trials for Protein Fermentation

Protein Fermentation Unraveled (PROFUN) - Exploring the Relationship Between Digestibility and Metabolite Production

PROFUN
Start date: November 21, 2023
Phase: N/A
Study type: Interventional

Background of the study: Protein intake is often higher than recommended in Western countries. This leads to increased amounts of protein flowing into the large intestine. Next to increased dietary protein intake, protein digestibility, and endogenous protein losses also affect the amount of protein entering the large intestine. However, these aspects have barely been studied, especially in humans. The large intestine is home to the largest bacterial ecosystem of the body. During the fermentation of protein by these bacteria (microbiota), metabolites are produced such as ammonia, branched-chain fatty acids, biogenic amines, phenolic compounds, indoles, and N-nitroso compounds. There is evidence that some of these metabolites could be harmful for gut epithelia, gastrointestinal health, and health in general after they enter blood circulation. In general, doing measurements inside the gastrointestinal tract is invasive. During this project the protein fermentation will be studied in the gastrointestinal tract using feces and urine, but also in situ using the GISMO GEN1 ingestible. This ingestible contains sensors to measure pH, ammonium, temperature, and redox potential. Objective of the study: The primary objectives of this study are: 1. To investigate the feasibility of the GISMO GEN1 System to monitor biomarkers in the gastrointestinal tract by studying the ingestible transit time, data coverage, participant experience, and serious adverse events (if applicable). 2. To study the effect of a 7-day high versus low digestible protein source present in the diet on protein fermentation in healthy subjects, measured by ammonia concentrations. Study design: The study is divided into 2 phases. In phase 1, preliminary feasibility of the GISMO GEN1 ingestible system will be assessed and the baseline measurements will be taken without any dietary restrictions. An interim analysis will be performed after phase 1 and only after a positive evaluation of the GISMO GEN1 System, the study will continue with phase 2. Phase 2 is a randomized cross-over controlled feeding trial. Two diets will be used: one diet containing a high digestible protein source, and the other diet containing a low digestible protein source. Each diet will be given for 7 days, with a wash-out period in between. Measurements done during the dietary interventions will be compared to the other diet, and to the baseline measurements. Study population: 15 healthy male or female volunteers, age 16 or older, BMI 18.5-30. Intervention: A high digestible protein diet (30 g/d whey protein) and a low digestible protein diet (30 g/d bovine plasma protein). Primary study parameters/outcome of the study: Ammonia as biomarker for protein fermentation, measured in feces and urine and in situ by the GISMO GEN1 ingestible. Also, ingestible transit time, data coverage, participant experience, and serious adverse events. Secundary study parameters/outcome of the study (if applicable): Secondary study parameters include other protein fermentation related metabolites measured in feces, urine and blood; microbiome composition; transit time; absorption kinetics.

NCT ID: NCT06160154 Completed - Pancreas Disease Clinical Trials

Minimally Invasive Robot-assisted and Laparoscopic Distal Pancreatectomy in a Pan-European Registry

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

A planned analysis of outcomes among consecutive patients after MIDP from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were intraoperative events, major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

NCT ID: NCT06148701 Completed - Anesthesia Clinical Trials

Preoperative Anesthesia Automatic System:a Retrospective Cohort Study

PACMAN
Start date: October 1, 2021
Phase:
Study type: Observational

To evaluate of PACMAN triage system is able to discern patient who may be safely screened by phone

NCT ID: NCT06135233 Completed - Pancreas Disease Clinical Trials

Implementation and Outcome of Minimally Invasive Pancreatoduodenectomy in Europe:

E-MIPS
Start date: January 1, 2019
Phase:
Study type: Observational

A planned analysis of outcomes among consecutive patients after MIPD from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.

NCT ID: NCT06132607 Completed - Lung Cancer Clinical Trials

3D Lung Reconstructions Using Open-source Software for Lung Cancer Surgery

3D-LUNG
Start date: December 21, 2022
Phase: N/A
Study type: Interventional

Preoperative three-dimensional (3D) lung reconstructions can reduce intraoperative blood loss, conversion rate, and operation duration. Commercial products predominantly provide these 3D reconstructions, hence the aim of this study was to assess the usability and performance of preoperative 3D lung reconstructions created with open-source software.

NCT ID: NCT06115057 Completed - Clinical trials for Gastrointestinal Tolerance of Dietary Fiber

Fiber Tolerance Study

Gitomix
Start date: October 4, 2023
Phase: Early Phase 1
Study type: Interventional

Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.

NCT ID: NCT06108817 Completed - Dyspepsia Clinical Trials

Low-value Chronic Prescription of Acid Reducing Medication Among Dutch General Practitioners

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

Dyspepsia is a commonly encountered clinical condition in Dutch general practice, which is often treated through the prescription of acid-reducing medication (ARM). However, recent studies indicate that the majority of chronic ARM users lack an indication for their use and that their long-term use is associated with adverse outcomes. A patient-focussed educational intervention was developed aiming to reduce low-value (chronic) use of ARM. This study is a randomized controlled study, evaluating its effect on the low-value chronic prescription of ARM using data from a subset of practices from the Nivel Primary Care Database. The intervention involves distributing an educational waiting room posters and flyers informing both patients and general practitioners (GPs) regarding the appropriate indications for prescription of an ARM for dyspepsia, which also referred to an online decision aid. The interventions' effect is evaluated through calculation of the odds ratio of a patient receiving a low-value chronic ARM prescription over the second half of 2021 and 2022 (i.e. pre-intervention vs. post-intervention).

NCT ID: NCT06105944 Completed - Amputation Clinical Trials

Economic Evaluation of Lower Limb Prostheses for Persons With a Knee-disarticulation or Transfemoral Amputation

Start date: December 17, 2022
Phase:
Study type: Observational

The goal of this retrospective questionnaire study is to evaluate the cost-effectiveness of non-microprocessor controlled prosthetic knees (NMPK) versus microprocessor controlled prosthetic knees (MPK) in persons with a knee-disarticulation or transfemoral amputation. The main aims are: - to provide an overview of the costs, health-related quality of life, and user experiences associated with the use of different types of prosthetic knees. - to evaluate the cost-effectiveness of the NMPK compared to the MPK for adult prosthesis users. Participants will fill out three questionnaires about (1) their medical consumption and productivity costs; (2) health-related quality of life; (3) utility, ambulation and well-being. Researchers will compare the persons with a NMPK to the persons with an MPK to investigate the cost-efficiency of both types of knees.