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Effectiveness of a Comprehensive School-Based Sex Education Program for Young Adolescents

The objectives are firstly that Love is... promotes the healthy sexual development by increasing knowledge and positive attitudes towards sexuality. Secondly, characteristics of adolescents who do not improve from the general prevention program are…

Pre-Intervention Monitoring of Affect and Relationships in Youth

Primary objectives:1) Investigate the effectivity of PRIMARY on BPD related problems (especially self-harm, emotion regulation and social relationships)Secondary objectives:1) Understanding the underlying mechanisms (especially social relationships…

Value based health care in systemic sclerosis: what is the optimal follow-up for patients with systemic sclerosis?

To evaluate in SSc patients with low risk for disease progression 1) whether assessment in an outpatient clinic setting is an acceptable alternative for evaluation in the Care Pathway. Outcome parameters we will evaluate include 1) health care…

Clinical performance study protocol for use of the B7-H4 (A57.1) Assay to identify and select B7-H4 positive ovarian, endometrial, biliary tract, breast cancer, and squamous non-small cell lung cancer patients for recruitment into the AstraZeneca Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Solid Tumors

The primary objective of this clinical performance study is to evaluate the effectiveness of the B7-H4 (A57.1) Assay in identifying B7-H4 positive (B7-H4 membrane staining at any intensity in ≥25% tumor cells) ovarian, endometrial, biliary tract,…

Tina-quant Lp(a) RxDx Phase III Trial Sample Measurement

The objective of this study is to support the pharma partner*s Phase III trial using Tina-quant Lipoprotein (a) RxDx assay for subject selection and optional batch testing of follow-up samples. This study is carried out to evaluate the performance…

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination with Pembrolizumab Versus Chemotherapy in Subjects with Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma that Expresses HER2 (IHC 1+ and Greater)

Primary Objectives:Associated pharmaceutical trial:To compare the efficacy of disitamab vedotin in combination with pembrolizumab to chemotherapy as first-line treatment in participants with advanced UC that expresses HER2Clinical…

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…

A prospective, randomized study comparing chemotherapy versus chemotherapy plus immunotherapy in patients with advanced non-small cell lung cancer with low TMB and oncogenic driver, STK11, KEAP1 or NFE2L2 mutation and a PD-L1 TPS

To compare the objective response rate between patients with metastatic non-small cell lung cancer characterized by PDL-1 TPS<50% and low TMB and either actionable mutation, inactivating STK11, KEAP1 or NFE2L2 mutations, treated by…

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]. …

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…

PCT after rTMS for relapse prevention of depression

This pilot study aims to establish the feasibility of offering PCT live or online to MDD patients in remission due to rTMS by measuring treatment adherence using descriptive data and daily affect. Results will be used to improve patient compliance…

The effect of the EMD protocol for urge compared to care as usual on dermatology-specific quality of life

Primary Objective: To assess the add-on effect of the EMD-U treatment compared to CAU, in improving dermatology-specific quality of life in patients with atopic dermatitis or prurigo nodularis who suffer from severe scratching behaviour. Hypothesis…

Psychoeducation for Older Adults with Autism

The aim of this study on the one hand is to gain insight into: 1) the effects of a PE program for older adults with (suspected) ASD in terms of knowledge and recognition of ASD and traits, a better acceptance of the diagnosis,…

The cost-effectiveness of contingency management compared to standard cognitive behavioral treatment for treating cannabis use disorder in youth: A randomized controlled trial

We aim to investigate in an RCT the (cost-)effectiveness of CM, compared with usual care CBT in the treatment of CUD in youths aged 16 to 22 years. Both outpatient treatments are provided for 12 weeks.PRIMARY STUDY QUESTION:1. What is the efficacy…

Clinical Performance Study Plan (CPSP) for the use of GenDx CDx Tedopi for subject enrollment on to the OSE Immunotherapeutics Phase 3 trial (OSE2101C302) of OSE2101 versus docetaxel in HLA-A*02 positive patients with metastatic Non-Small Cell Lung Cancer (NSCLC) and secondary resistance to immune checkpoint inhibitor (ARTEMIA)

This clinical performance study/clinical investigation will evaluate the safety and effectiveness of GenDx CDx Tedopi in identifying HLA-A*02 status in metastatic NSCLC subjects who may be eligible for treatment with OSE2101.

Enhancing effect of dual interventions versus conventional TMS in the treatment of
depression

rTMS is an intensive but effective treatment that could benefit from further optimization. Cognitive control training (CCT) engages the same underlying neural circuitry as rTMS and has been shown to improve therapeutic response (Koster et al., 2017…

An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from adult participants with metastatic Non-Small Cell Lung Cancer (NSCLC) for potential inclusion in the MSD Phase 3 clinical trial (Protocol No MK-1084-004) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit.

To utilize the therascreen KRAS RGQ PCR Kit (KRAS Kit) as a screening test to identify KRAS G12C mutations in newly diagnosed metastatic NSCLC participants and thereby determine eligibility for enrolment into the Phase 3 clinical study (MK-1084-004…

Presepsin pilot study

The objective of this pilot study is to assess whether transportation of the sample via a pneumatic tube system (PTS) has any detrimental effects on the recovery of presepsin levels, when compared to traditional hand-delivery. This research will be…

Improving the mental health of working adults in Dutch small-to-medium-enterprises (SMEs): implementation of WHO*s Doing What Matters in times of stress (DWM)

Main objectives:a) examine and assess the (cost-)effectiveness of WHO's Doing What Matters in Times of Stress (DWM) in reducing psychological distress, improving mental health, and enhancing work-related well-being and…

RECALL

In this study we want to investigate whether the target group is reached well with this intervention, how patients and healthcare personnel experience the intervention and whether it has an effect on alcohol and healthcare use and participation in…