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A pilot study of Acceptance and Commitment Therapy (ACT) for adolescents with autism spectrum disorder (ASD)

The goal of the current observational multicenter pilot study is to investigate if an 8-week Acceptance and Commitment group therapy for youth with ASD is an effective intervention to increase adaptive emotion regulation, psychological flexibility…

Thumb Hemi-Arthroplasty with Natural Kinematics; a Prospective Multicenter Study to Confirm the Safety and Efficacy of the InDx Implant (THANKS PRO)

The purpose of the investigation is to confirm the safety and efficacy of the InDx implant in treatment of CMC osteoarthritis.

Clinical Performance Study Protocol for Use of VENTANA PD-L1 (SP263)
CDx Assay in [redacted]

The objective of this study is to establish the clinical performance of VENTANA PD-L1 (SP263) CDx Assay as a companion diagnostic (CDx) for the identification of patients with NSCLC who may benefit from treatment with [redacted]. …

DIAMONDS

The objective of this study is to determine the ability of respiratory EMG measurements with a wearable to …

An Observational Study in Participants with Ryanodine Receptor 1-Related Myopathies (RYR1-RM) to Determine Optimal Endpoint Measurements.

Primary objective* To determine the extent to which muscle strength is affected in patients with RYR1-RM with autosomal dominantmutations and describe measurements over time.Secondary objectives* To determine the extent to which fatigue and…

Selecting Ovarian Cancer patients for PARP Inhibitor (SOPI) study

The main objective of the SOPI study is to select the HRD test that best predicts longest PFS on PARP-i in non-BRCA1/2 EOC patients, in order to adequately select patients that will benefit from a PARP-i. Secondary objectives are: to…

An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples in a first line setting from patients diagnosed with metastatic Colorectal Cancer (mCRC) to determine the KRAS G12C mutation status as part of the inclusion criteria into the Amgen Phase III clinical trial (Protocol No 20210081) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit.

To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of…

Corbotics' pivotal trial: Revolutionizing TTEs Through Robotics.

The goal of the study is to evaluate the quality of TTEs produced autonomously by the BBE. The primary endpoint will be the percentage of TTEs obtained autonomously by the BBE that are usable in clinical practice, compared to the…

Evaluation of cardiac troponin dynamics as an early biomarker for anthracycline-induced cardiotoxicity

Identification of the dynamics of hs-cTnI and hs-TnT release during and after anthracycline treatment (doxorubicine in combination with cyclofosfamide) in breast cancer patients in order to determine the optimal sampling time point, most reflective…

Prospective, Non-Randomised Clinical Trial to investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System treating Aorto-iliac Occlusive Disease with CERAB (Covered Endovascular Reconstruction of Aortic Bifurcation)

The objective of this clinical investigation is to evaluate the safety and performance of the BeGraft Aortic covered stent Graft System & the BeGraft Peripheral covered stent Graft System (Bentley Innomed, Hechingen, Germany) in CERAB…

A Pre-Market, First-In-Human, Pilot, Interventional, Clinical Investigation to Evaluate the Safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) in premenopausal women with Abnormal Uterine Bleeding (AUB).

Primary ObjectiveTo evaluate the safety of the Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS).Secondary Objectives1. To evaluate the change of menstrual blood loss (MBL).2. To evaluate the effect of MBL on the quality of life (…

Initial Safety and Performance of the CellFX® nsPFA* Cardiac Surgery System for the Treatment of Atrial Fibrillation

The primary objective of this feasibility study is to demonstrate the initial safety and effectiveness of the CellFX® nsPFA* Cardiac Clamp in performing a box lesion around the 4 pulmonary veins as an isolated procedure or as a part of a more…

Accuracy of synthetic CT-images based on MRI-images compared to conventional CT-images for shoulder osteoarthritis evaluation and surgical planning

The objectives are to determine the accuracy and reliability of sCT compared to conventional CT regarding (1) classification ofshoulder osteoarthritis morphology and (2) planning for the 3D-position of a compound used for shoulderreplacement…

Optimizing parasite transmission to laboratory-reared mosquitoes following controlled human malaria infection with Plasmodium vivax asexual blood stage parasites in malaria-naïve healthy volunteers in the Netherlands

Main objective: Develop a protocol to reproducibly infect mosquitoes with blood from human study participants undergoing asexual blood stage CHMI with the P. vivax clone PvW1.Secondary objectives: Maximize mosquito infection rate with PvW1 by I)…

Prediction of Freezing of Gait and evaluation of the Parkinson's Vibrating Socks during daily-life activities in a house-like environment for people with Parkinson's disease.

To develop a FOG prediction algorithm under free-living conditions, and to test evaluate the use of the Parkinson's Vibrating socks under the same conditions

Development and validation of a psychological measure and derived short screener to
estimate the risk to develop personality disorders based upon the taxation of ultra-high risk
domains

The prognostic accuracy of combining these four criteria to predict the later development of personality disorders (with/without psychosocial breakdown) is investigated in a longitudinal study. From this, a selection of items with the strongest…

A better treatment for depression with personalized just-in-time behavioral activation

Our aim is to develop JITAIs focused on behavioral activation (BA) for depression in close collaboration with patients and therapists, and to examine their usability, feasibility, and preliminary effectiveness.

UNIFAI

To generate a large, international Friedreich*s ataxia patient database (including healthy controls), alongside an integrated clinical and natural history database, which is linked to a biological samples and imaging repository, hereby creating a…

Measuring effects of high-fiber dried chicory root on the gut microbiota of patients with an intermediate to high-risk cutaneous melanoma: an explorative study

The primary objective of this study is to investigate the effect of dried chicory root (WholeFiber) during 6 weeks on fecal SCFA levels in intermediate to high-risk melanoma patients after surgical treatment with no concurrent adjuvant treatment.…

The effect of discontinuing estrogen containing oral contraceptives on corticosteroid-binding globulin and total cortisol concentrations

In this study we look at how long it takes for the levels of certain hormones and hormone-binding proteins to normalize discontinuation of COC use, in particular corticosteroid-binding globulin.