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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,…

Deep Brain Stimulation for MOtor symptoms in patients with Parkinson*s disease DEmentia (DBS- MODE)

The primary objective of the proposed research is to investigate in patients with PDD the efficacy of STN-DBS with best oral medical treatment (DBS-group) for disabling motor symptoms during off-drug phase compared to best oral medical treatment…

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma (MelMarT-II)

This study will determine whether there is a difference in disease free survival for patients treated with either a 1cm excision margin or 2cm margin for clinical stage II (pT2b-pT4b) primary cutaneous melanoma (AJCC 8th edition, Table 1). The…

Grip on knee Osteoarthritis; DIstraction Versus Arthroplasty (GODIVA) for young knee osteoarthritis patients in regular care.

To determine whether KJD is non-inferior on patient reported effectiveness as compared to a KP (i.e. usual care) for relatively young patients with end-stage knee OA. For the substudy: the primary objective is to predict the benefit from knee…

The effectiveness of Cerclage for the reduction of extreme preterm birth and
perinatal mortality in Twin pregnancies with a short cervix.

To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix compared to standard treatment (no cerclage) in the prevention of extreme preterm birth (PTB) < 28 weeks of GA.

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.

DIStal gastriC bypass Outcome in Revision SurgEry after roux-en-y gastric bypass

The aim of this study is to investigate the effect of two distalisation techniques of a gastric bypass in revisional surgery with standardised limb lengths in total weight loss (TWL) and the need for treatment for protein calorie malnutrition (PCM…

Hearing preservation in cochlear implantation surgery

Comparison of hearing preservation and outcome of two fundamentally different cochlear implants designs (LW or PM) and the two most used surgical approaches (RW or CO). Secondly, asses the structure preservation (i.e., scalar position) of each…

Translabyrinthine acquisition of human adult cochlear tissue for molecular and cellular characterisation of the human cochlea

To study the human adult cochlea, in specific it's RNA and protein expression patterns and morphology.

LIMited wEdge ResectIon for Colonic T1 cancer - a prospective multicenter cohort study

The aim of this study is to investigate the safety and efficacy of CAL-WR as primary and curative colon-preserving treatment for T1 colon cancer. Our primary endpoint is reduction of oncologic resections for low-risk T1 colon cancer. As secondary…

TUbectomy with delayed oophorectomy as alternative for risk-reducing salpingo-oophorectomy in BrcA-Women to assess the Safety of Prevention: the TUBA-WISP II study

To evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers. We hypothesize that RRS with delayed RRO leads to an equal ovarian cancer incidence when compared to RRSO.

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…

Personalized elective neck irradiation guided by sentinel lymph node biopsy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx with a clinically negative neck: (chemo)radiotherapy to the PRIMary tumor Only. The PRIMO study.

To compare safety and efficacy of treatment with sentinel lymph node biopsy guided elective neck irradiation versus standard elective neck irradiation in patients receiving definitive (chemo)radiotherapy for squamous cell carcinoma of the…

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…

Sentinel node and organ sparing surgery in stage I colon carcinoma (SENTRY trial)

The aim of this study is to reduce the need for colectomy and its* associated morbidity and mortality in patients with high-risk pT1 or low-risk pT2 colon carcinoma after endoscopic polypectomy by performing a (robot-assisted) laparoscopic wedge…

Randomized trial Evaluating first time shoulder Dislocation: sUrgery vs Conservative carE (REDUCE)

The primary objective of the pilot study is to assess the feasibility of a definitive trial to determine the effect of arthroscopic soft tissue stabilization vs. non-surgical treatment on rates of recurrent anterior …

PreventPAP trial

To compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients receiving a lower extremity amputation with standard neurectomy versus those who received targeted muscle reinnervation.

Study on Prognosis of Acutely Ruptured intracranial Aneurysms

The goal of this study is to investigate which treatment(-s) lead to the best outcome by using existing variation of practice.

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…