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Aspirin for the prevention of spontaneous preterm birth

The objective was to assess the effectiveness of low-dose aspirin in the prevention of recurrent preterm birth.

Basophil Activation Test cow's milk for replacement of the food challenge test

Determination of the (cost)effectiveness of the replacement of the expensive, risky and time-consuming food challenge test bythe Basophil Activation Test (BAT) for the diagnosis of an IgE-mediated cow*s milk allergy in children.

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,…

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…

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…

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…

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…

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]. …

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.

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…

The social role of menstrual health interventions

Máxima MC is organising this study. The aim of the study is to gain insight into the effect ofdifferent treatments (medication, IUD, endometrial ablation, uterus removal) formenstruation-related complaints on labour and educational participation.…

BOOST - BMI of children with diabetes type 1: a study on the transition to smart technology

The objective is to investigate if AHCL in children with DM1 leads to a greater difference in BMI SDS compared to MDI. The second objective is to study if there is a difference between MDI and AHCL in DM1 regarding blood glucose regulation and…

Comparing oxycodone and morphine in relation to long-term opioid use.

The aim of this study is to compare oxycodone and morphine as the first-choice opioid for postoperative pain after orthopedic surgery regarding: The proportion of patients with new long-term opioid use (>6 months). The total proportion of…

iPrEx-DISCOVER Weight Change Study

The primary objective of this study is:  To compare weight change/trajectory distributions between F/TAF and placebo cohorts.  The secondary objectives of this study are:  To compare outlier weight gain between F/TAF…

A European multicenter, observational study to understand how the use of lebrikizumab affects health-related well-being and disease symptoms in patients with moderate-to-severe atopic dermatitis (ADTrust).

Primary objective: To assess the long-term effect of treatment with lebrikizumab on the overall well-being in patients with moderate-to-severe AD using the WHO-5 questionnaire. Secondary objectives: To assess the clinical effectiveness of…