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NCT ID: NCT06320626 Recruiting - Child Clinical Trials

Pharmacokinetic-guided Dosing of Emicizumab

DosEmi
Start date: September 8, 2022
Phase: Phase 4
Study type: Interventional

The goal of this multicentre, prospective, open-label, cross-over clinical study is to determine whether individualized PK-guided dosing of emicizumab is non-inferior to conventional dosing of emicizumab in the prevention of bleeding in congenital haemophilia A patients.

NCT ID: NCT06319053 Not yet recruiting - Laparoscopy Clinical Trials

The Turbine-based Insufflator Safety and Feasibility Study

TBI
Start date: March 2024
Phase: N/A
Study type: Interventional

The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. Turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device.

NCT ID: NCT06318936 Recruiting - RSV Infection Clinical Trials

Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands

RAPID
Start date: November 1, 2022
Phase:
Study type: Observational

RSV infection is a leading cause of medical care in older adults, sometimes leading to hospital admission and severe outcomes. Although the majority of RSV infections are managed outside hospitals, little is known on the burden of RSV in older adults in the primary care setting. Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon. The use of high-quality point-of-care (POC) molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adults With this prospective, observational study, we aim to define the disease burden of RSV infection in older adults in the primary care setting.

NCT ID: NCT06317272 Terminated - Esophageal Cancer Clinical Trials

BReath Hold TecHniquEs for Radiotherapy of Esophageal Carcinoma

BROTHER
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study.

NCT ID: NCT06317142 Recruiting - Pre Diabetes Clinical Trials

Glucose and Glycogen Dynamics in Prediabetes

GGD
Start date: April 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to investigate changes in nocturnal and postprandial glucose and glycogen metabolism in individuals with impaired fasting glucose and impaired glucose tolerance compared to healthy, non-diabetic, overweight participants (15 per group). In addition, it will be investigated if reducing gluconeogenesis, by using the challenge agent Acipimox, in people with prediabetes can increase glucose tolerance and fat oxidation by increased reliance on hepatic glycogen. The main questions this project aims to answer are: - whether there are differences in nocturnal glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls. - whether there are differences in postprandial glucose/glycogen metabolism in individuals with impaired fasting glucose, impaired glucose tolerance and healthy overweight controls. Participants will visit the university for a screening visit and a visit with overnight stay for measurements of gluconeogenesis, glycogen, and substrate oxidation. A subgroup will receive [18F]-FDG to assess tissue-specific postprandial glucose uptake. Thereafter, 20 prediabetic individuals will follow a 4-day treatment with acipimox to decrease gluconeogenesis, followed by a second overnight visit with similar measurements as mentioned for the first visit.

NCT ID: NCT06314763 Recruiting - Clinical trials for Drug Drug Interaction Study

Rivaroxaban Sotorasib Interaction Study

ROSIE
Start date: November 9, 2023
Phase: Phase 4
Study type: Interventional

Venous thromboembolic Events (VTEs) are common in lung cancer patients with an incidence of >15%, requiring anticoagulant treatment or prophylaxis. Although direct acting oral anticoagulants (DOACs) are the agents of first choice due to ease and patient friendliness, these drugs are often avoided in cancer patients due to suspected pharmacokinetic drug-drug interactions with oncolytic drugs. Sotorasib is the first KRASG12C inhibitor that has been approved by the US [FDA] and EU [EMA] for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC. Sotorasib has a potential to cause CYP3A-mediated drug-drug interactions due to induction of CYP3A and inhibition of P-GP. Rivaroxaban is the most frequently prescribed DOAC in the Netherlands. As rivaroxaban is a substrate for this enzyme and efflux pump, sotorasib may increase or decrease the exposure to rivaroxaban and, thus, impact its benefit-to-risk ratio. To enable safe combination of sotorasib and rivaroxaban, it is pivotal to investigate the magnitude of the pharmacokinetic interaction between these drugs.

NCT ID: NCT06314503 Recruiting - Clinical trials for Chronic Kidney Diseases

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

CORDIAL
Start date: January 22, 2024
Phase: N/A
Study type: Interventional

The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid. The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment. The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions. Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber. Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).

NCT ID: NCT06312735 Recruiting - Chronic Pain Clinical Trials

VR for Patients With Chronic Pain (Wait & Work)

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.

NCT ID: NCT06311448 Completed - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Personalized Targeted Immunomodulation in COVID-19 ARDS

COMODULATE
Start date: March 2, 2020
Phase:
Study type: Observational

Rationale: In COVID19 single-targeted immunomodulation, mostly via an IL-6 receptor blocker, was used by a one-size fits all non-targeted approach. In future pandemics the same might occur. However, for individual patients, this might not yield optimal treatment. Objectives: This project aims to identify a way to individualize and target immunomodulation, using COVID19 as a testcase for the future. - Identify immunological pathways which are associated with outcome in C-ARDS. - Test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in C-ARDS(Tocilizumab, Anakinra, etc.). - Explore whether other immunological pathways were present in patients with C-ARDS which could have been intervened with medication which is already available and has been described in ARDS or similar diseases. Study type: Retrospective observational multicenter study in the Netherlands. Study population: Adult patients (≥ 18 years) hospitalized and admitted to the ICU with COVID-19 and acute respiratory distress syndrome (ARDS) (i.e., receiving invasive mechanical ventilation) will be included. Intervention (if applicable): Not applicable (retrospective study design). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. The target population of this study is specific to hospitalized patients with COVID-19.

NCT ID: NCT06308549 Not yet recruiting - Type 1 Diabetes Clinical Trials

MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY)

MyREMEDY
Start date: March 2024
Phase: N/A
Study type: Interventional

In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany.