There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background: Multimodal prehabilitation programs are effective in reducing complications after colorectal surgery in patients with high risk of postoperative complications due to low aerobic capacity and/or malnutrition. However, high implementation fidelity is needed to achieve these effects in real-life practice. Therefore, this study aimed to investigate the implementation fidelity of an evidence-based prehabilitation program in the real-life context of a regional hospital. Methods: In this observational cohort study with multiple case analysis, we enrolled all patients who underwent surgery for colorectal cancer from January 2023 to June 2023, in one Dutch peripheral hospital. Patients meeting criteria for low aerobic capacity or malnutrition were advised to participate in a personalized prehabilitation program. Implementation fidelity was investigated on four domains; 1) coverage (participation rate), 2) duration (number of days following the prehabilitation program), 3) content (delivery of prescribed intervention modalities), and 4) frequency (attendance of sessions and compliance with prescribed parameters). An aggregated percentage of content and frequency was calculated to determine overall adherence. The intended outcomes were improvement in preoperative aerobic capacity and malnutrition, and improved postoperative recovery (i.e., reducing complications, length of stay, and time to functional recovery).
Monitoring hemoglobin levels (Hb) is important to identify anemia in hospitalized patients. Changes in posture and mobilization efforts, as demonstrated by previous research, can lead to significant shifts in Hb concentrations. This phenomenon has not been studied in ICU patients. This study aims to investigate whether postural changes and mobilisation affect Hb in ICU patients. We hypothesize that significant Hb shifts may occur, potentially leading to misinterpretations of anemia and unnecessary diagnostic and therapeutic workup. Understanding this impact can guide clinical practice and prevent unwarranted interventions.
Rationale: Collagen protein is the central structural component of extracellular connective tissues within skeletal muscle, bone, cartilage and skin. Dietary collagen peptides are a promising protein source to deliver the specific amino acid precursors required to support an increase in connective tissue protein synthesis across several tissues (e.g. muscle, skin). However, the digestion and absorption kinetics of multiple boluses of collagen peptides and the subsequent impact on muscle and skin connective tissue protein synthesis rates have not yet been assessed in vivo in humans. Objective: To assess the impact of ingestion of multiple boluses of collagen peptides on muscle connective and skin protein synthesis in vivo in humans. Study design: Double-blind, parallel-group, placebo-controlled intervention study. Study population: 20 healthy young males, aged 18-35 years. Intervention : Participants will perform unilateral resistance exercise followed by the ingestion of either 100 g of collagen peptides (in boluses) or a non-caloric placebo (flavoured water) drinks, while all drinks will contain vitamin C. Continuous intravenous stable isotope amino acid tracer infusions will be applied, plasma, skin and muscle samples will be collected in order to assess protein synthesis rates in skin and muscle tissue. Main study parameters/endpoints: Primary study parameters are muscle connective protein synthesis rates. Secondary study parameters are skin and myofibrillar protein synthesis rates, plasma amino acid concentrations and body composition.
Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.
A cluster Randomized Controlled Trial (cRCT) that aims to determine the effect of the Palliative Reasoning (PR) methodology on the quality of life and symptom burden of patients dealing with a life-limiting illness and their loved ones, receiving palliative care services at home. Palliative Reasoning will be implemented from the first of may 2024 to 30 april 2025 in twenty nursing teams of a large homecare organization in Utrecht, the Netherlands, and will be compared with twenty control nursing teams. The effect of PR will be measured by means of questionnaires filled out by clients with a life expectancy of less than one year according to the surprise question "Would I be surprised if this person would die within one year?" and family caregivers. Parallel to the effect study, a process evaluation will be conducted in order to understand the implications of the results and its' societal and practical impact.
The primary objective of the study is to characterize the PK of single doses of salbutamol in healthy participants delivered via an MDI containing propellant HFA-152a (test), and to compare with an MDI containing propellant HFA-134a (reference).
As people around the world are living longer, the number of individuals with dementia, particularly Alzheimer's disease (AD), is expected to triple by 2050. There's growing evidence suggesting that our gut health might play a role in the prevention of dementia. The connection between our gut and brain, known as the gut-brain axis, is becoming an important area of study. Research in animals has shown that different types of dietary fibre can improve gut health, brain function, mood, blood sugar level and the immune system and may even prevent certain harmful brain changes seen in Alzheimer's disease. Subjective Cognitive Decline (SCD) is a condition where individuals notice a decline in their mental abilities, and it can be an early sign of Alzheimer's disease. The goal of this clinical trial is to learn if dietary fibres can improve gut and brain health in older individuals, between the ages of 60 and 79 years, who notice problems in their mental abilities, and meet the criteria of SCD. Three different dietary fibres will be given, and researchers will compare three different fibres to a placebo product to see if there is a difference between the fibres and the placebo. The main questions it aims to answer are: 1. Does dietary fibre improve working memory? 2. Does dietary fibre improve other markers of brain function? 3. Does dietary fibre improve gut health? 4. Does dietary fibre improve the immune system and blood glucose levels? 5. Does dietary fibre improve mood? Participants will: - Consume dietary fibres twice a day, mixed in water, tea or coffee, for a period of 26 weeks - Have two functional MRI scans, and three additional study visits, where blood, urine and feces will be collected - Undergo a number of neuropsychological tests, aimed at evaluating brain function - Fill out questionnaires on their general health, mood, dietary habits, gut health - Wear smartwatches for one week, at the beginning and the end of the study
The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary. The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy. Methods: Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B: Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).
The goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation CFT (fuCFT) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index CFT) and ongoing angina(-like) complaints. Participants will - Use either endothelin receptor antagonist or placebo for 10 weeks - Undergo follow-up acetylcholine spasm provocation test after 10 weeks - Answer online questionnaires on angina and quality of life
The goal of this study is to assess the safety and tolerability of GSK5733584. The study will also see how the levels of GSK5733584 change over time at different dose amount.