46 results
Primary Objective: To test whether the Feeling Safe-NL programme is more effective in improving wellbeing over time than CBTp (from baseline to 18-month follow-up).Secondary objectives: To test whether the Feeling Safe-NL programme is more effective…
To assess the efficacy of transcutaneous pulsed radiofrequency therapy (tPRF) as a treatment for pain in hand OA.
The aim of this study is to establish pharmacokinetic data on inhaled nebulized prednisolone: Time from start nebulizing to serum peak prednisolone concentration (Tmax) and prednisolone area under. We derive this pharmacokinetic data from two…
The main objective of this study is to determine the performance of the closed-loop system in adolescents with T1DM. Secondary objectives include: • to assess the safety of the closed-loop system; • to determine the time that the closed-loop…
In this study we will investigate what the effect of food is on how the study compound PTC518 is absorbed, transported, and eliminated from the body.We will also investigate how safe the new compound PTC518 is and how well it is tolerated when it is…
Primary Objective: To assess the safety of the single flap peritoneum vaginoplasty procedure by studying adverse events and complications during, directly after and within 90 days of the operation. Secondary Objectives: - To assess short- (12 weeks…
This study has been transitioned to CTIS with ID 2023-507041-28-00 check the CTIS register for the current data. The primary objectives of this study are to:• Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious…
Part A (Single Ascending Dose):Primary: To assess the safety and tolerability of single oral doses of PRAX-628 Secondary: To evaluate the pharmacokinetics (PK) of single oral doses of PRAX-628 Part B (Multiple Ascending Dose):Primary: To assess the…
We aim to introduce 166Ho radioembolization combined with systemic chemotherapy and investigate its safety and feasibility.
The primary objective of this study is to assess the feasibility of ultrasound-based navigation for assistance during hepatic resection. Secondary objectives are 1) to evaluate the ease of use and support for decisiveness during surgery, 2) to…
The main objective is the %TBWL 5 years after surgery. Secondary objectives include Percentage Excess Weight Loss (%EWL); decrease of comorbidities such as diabetes mellitus (DM), hypertension, and hypercholesterolemia; improvement of quality of…
This study has been transitioned to CTIS with ID 2023-508129-28-00 check the CTIS register for the current data. The primary objective of this study is to characterize the pharmacokinetic (PK) profile of asciminib in pediatric patients, with the…
This study has been transitioned to CTIS with ID 2023-503795-24-00 check the CTIS register for the current data. Primairy objectives:- Determine the safety and tolerability of orally administered BAY 2927088- Determine the maximum tolerated dose (…
This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.
Primary Objectives: Determine oncologic outcomes after fertility-sparing treatment in AYAs with cervical, ovarian or endometrial cancer (Q1). Determine fertility and obstetric outcomes after fertility-sparing treatment in AYAs with cervical, ovarian…
The primary objectives of this study are to assess the safety and estimate the radiation dose of the radioligand [18F]FB610, and to assess the optimal kinetic model for quantification of the tracer uptake. Secondary objectives are to determine…
Primary Objective:Register the incidence of cardiovascular toxicity of anticancer treatment.Secondary Objectives: Identification of risk factors for cardiotoxicity.Improvement in the early detection of cardiotoxicity by imaging modalities such as…
To evaluate the efficacy and dose-response relationship of XXB750 30 mg SC q4w, 60 mg SC q4w, 120 mg SC q4w, and 240 mg SC q4w compared to placebo in reducing the mean 24hr ambulatory systolic blood pressure (mean 24hr SBP) from baseline to Week 12.…
To assess postprandial muscle protein synthesis rates in older males in response to ingesting a blend of plant protein fortified with free leucine as compared to (gold standard) whey protein and compared to a plant protein blend without additional…
This study has been transitioned to CTIS with ID 2023-508349-42-00 check the CTIS register for the current data. Stage 1 Primary ObjectiveTo evaluate the safety and tolerability, determine the expansion dose, and characterize dose-limiting…