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NCT ID: NCT06221475 Completed - Healthy Volunteers Clinical Trials

A Study to Learn How BAY2927088 is Taken up and Handled by the Body in Healthy Male Participants

Start date: January 25, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment works by blocking the mutated EGFR and HER2 protein present in NSCLC cells and may help stop the further spread of NSCLC. BAY2927088 is under development, once it is approved, it may help treat people with NSCLC. The participants of this study will be healthy men and will have no benefit from the administration of BAY2927088. However, the study will provide important information for the design of subsequent studies with BAY2927088 in people with NSCLC. The participants in this study will get the non-radiolabeled and radio-labeled study treatment BAY2927088 in the form of tablets and solution by mouth and as an intravenous infusion in the arm. By radiolabeling the study treatment, researchers can track its movement and breakdown in the body of the participants. During the study, the study team will do physical examinations, take medical history, ask the participants questions about their smoking or alcohol consumption habits and other medications used, check vital signs such as blood pressure, heart rate, body temperature and the number of breaths taken per minute (respiratory rate), take blood and urine samples, do HIV (human immunodeficiency virus), hepatitis and optional COVID-19 tests per local regulations, and examine heart health using electrocardiogram (ECG). Each study participant will go through a first test phase (screening) of up to 28 days before the start of treatment. The study will have two parts. In part 1, the study participants will take a single dose of the non-radiolabeled study treatment in the form of tablets by mouth 30 minutes following a light meal. They will then receive the radiolabeled study treatment as an intravenous infusion in the arm over 15 minutes. After 2 days of washout, the same group of participants will move on to Part 2 of the study. They will take a single dose of the radio-labeled study treatment as a solution by mouth 30 minutes after a light meal. The participants and the study team know what treatment the participants will take. The total duration of the study will be approximately 8 weeks per participant, including an in house stay of approximately 23 days and 22 nights. There will be a final examination on the last day of their in-house stay before the participants are discharged and go home. The study doctors and their team will contact the participant to learn about the participant's health until the participant completes the study.

NCT ID: NCT06202729 Completed - Fear Clinical Trials

Focus on Experienced Anxiety Related to an Emergency Department Visit

FEAR-ED
Start date: November 8, 2023
Phase:
Study type: Observational

The aim of the present study is to determine the prevalence of anxiety in adult patients attending the ED of the Medical Centre Leeuwarden.

NCT ID: NCT06200142 Completed - Clinical trials for Inherited Metabolic Disorders

Zoektocht Naar Erfelijke MetaBole Aandoening (Dutch)/ Solve The Unsolved (English)

ZOEMBA/STU
Start date: December 10, 2019
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to integrate genomic (WES/WGS) and other -omics technologies in order to find the genetic causes, in 500 patients (children and adults) with an unexplained metabolic phenotype in whom standard care (genetic and metabolic evaluation) did not provide a diagnosis. The overall aim of this study is to diagnose patients with an unknown metabolic phenotype. In addition, we want to provide evidence that the combination of approaches and techniques used in this study will increase diagnostic yield compared to current separated approaches. All participants will undergo a multi-omics(WES, WGS and metabolomics) approach to solve the unsolved genetic basis of their metabolic phenotype.

NCT ID: NCT06176105 Completed - Anemia Clinical Trials

Mortality After Transfusion of Ever-pregnant Donor Red Blood Cells

MATER
Start date: October 1, 2019
Phase:
Study type: Observational

The MATER study is an observational cohort study on first ever transfusion recipients in six hospitals in the Netherlands, with information collected on both donor and patient characteristics. We aim to further specify which combination of characteristics of both donors and patients determine the increased risk of mortality after blood transfusions.

NCT ID: NCT06175130 Completed - Diet; Deficiency Clinical Trials

Cross-sectional Dietary Intake Survey on Ivorian School-Aged Children and Women of Reproductive Age

AN
Start date: February 1, 2021
Phase:
Study type: Observational

A cross-sectional dietary intake study was conducted with 423 Ivorian school aged children (SAC, 6-12 years) and 423 women of reproductive age (WRA, 15-49 years) from four cities, recruited by two-stage random sampling.

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