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The PICAS-study: Validation of the Sexual Knowledge Picture Instrument (SKPI); about the verbal- and the nonverbal ways sexually abused children reveal sexual knowledge.

1) The validation of the SKPI used in children with a developmental age of 3 to 8 years old.Hypothesis:- By using the SKPI the examiner will be able to distinguish children who are victims of CSA from children who are not.2) The demonstration of the…

(Cost) effectiveness of open Microdiscectomy vs. percutaneous transforaminal endoscopic discectomy (PTED) for patients with lumbosacral radicular syndrome due to a lumbar disc herniation

Research question(s). There are two specific questions to be addressed:1) Is percutaneous transforaminal endoscopic discectomy (PTED) no worse in effectiveness than conventional unilateral open microdiscectomy for patients with symptomatic…

A phase II, single arm, multicenter trial to determine the efficacy and safety of CTL019 in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

to determine the safety and efficacy of CTL019 in adults with relapsed or refractory DLBCL and to monitor all patients exposed to CTL019 for 5 years following CTL019 infusion

Immunotyping lymph nodes in immune-mediated inflammatory diseases (IMIDs):
lymph node cellular and molecular biomarkers in IMIDs

The primary goal of this study is to identify immunological alterations in lymphoid tissue of patients with various forms of inflammatory arthritis and systemic inflammatory diseases, and to correlate these alterations with diagnosis, disease stage…

Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

To evaluate the safety of a new scaffold platform in native coronary arteries that includes incorporation of a deformable expansion technology and an enhanced scaffold material that is a polycarbonate co-polymer of tyrosine analogs. This will be…

Multicentre, Randomised, Placebo-Controlled Trial of Mebeverine in Children with Irritable Bowel Syndrome (IBS) or Functional Abdominal Pain- Not Otherwise Specified (FAP-NOS)

The primary objective of this study is to determine the effect of mebeverine on abdominal pain intensity and frequency in children with irritable bowel syndrome or functional abdominal pain - not otherwise specified.

the BREAST trial (the Breast Reconstruction with External pre-expansion and Autologous fat transfer vs Standard Therapy trial)

This study aims to determine the effectiveness of a new breast reconstruction technique: Autologous fat transfer (AFT). This technique combines the advantages of using the patients* own tissue (fat cells), while being minimally invasive compared to…

Study of brain areas involved in the sensation of bladder filling in healthy females and untreated females with Overactive Bladder (OAB) using fMRI and water pressure urodynamics

Main objectives are to identify brain areas involved in sensation of bladder filling through fMRI during urodynamic measurements. Secondary goals are to assess the correlation between bladder filling and subjects* bladder sensations in combination…

Registry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry).

1.To evaluate the efficacy of Radium-223 treatment in a non-study population by effects on Symptomatic Skeletal Event (SSE)2. Evaluate Radium-223 treatment efficacy by patient reported analgesic use and pain outcome3. Evaluate Radium-223 treatment…

TOwards Prepared mums (TOP-mums), for a healthy start: A lifestyle intervention to reduce overweight and smoking in women with a pregnancy wish to prevent perinatal morbidity

The overall objective of the study is to investigate a lifestyle intervention for women with a pregnancy wish or pregnant women in their first trimester, and a high risk on perinatal morbidity because of (prepregnancy) overweight or obesity. With an…

A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination with Cisplatin+5-Fluorouracil versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma;

Primary objectives:(1) Evaluate Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded central radiologists' review in subjects with PD-L1 Combined Positive Score (CPS) *1. (2) Evaluate overall survival (OS).Secondary Objectives(…

The Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaLuAtion

To set up a cohort of breast cancer patients, collecting information on patient characteristics, short and long-term clinical and patient reported data, and to compare outcomes with a healthy refrence population. whichThe cohort will also serve as…

AIPAC (Active Immunotherapy PAClitaxel): A multicentre, Phase IIb, randomised, double blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.

Primary objectives:* Safety run-in stage: determine the recommended phase two dose for therandomised phase* Randomised stage: to determine efficacy of IMP321 combined with weekly paclitaxel compared to weekly paclitaxel plus placebo in hormone…

A prospective randomized study to compare neurocognitive outcome after Stereotactic Radiosurgery or Whole Brain Radiation Therapy for the treatment of multiple brain metastases

Primary Objective Our primary aim is to compare cognitive decline at 3 months, defined as a significant decline (5 point decrease from baseline based on the reliable change index with correction for practice effects) in HVLT-R Total Recall score (…

Safe and easy application of BioComp implants for episthetic reconstruction of craniofacial defects - A pilot study

In this study we want to investigate the efficacy and safety of an implant system with a surface coating (Biocomp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region

N15DOP: Phase I and pharmacological study of weekly ModraDoc006/r in combination with high-dose intensity-modulated radiation therapy in patients with high-risk early stage prostate cancer

To determine the maximum tolerated dose (MTD) of ModraDoc006/r (as ModraDoc006 10 mg tablets in combination with one tablet of 100 mg ritonavir) that can safely be administered in a bi-daily weekly schedule in combination with high-dose intensity…

MONALEESA-3: A randomized double-blind, placebocontrolled study of ribociclib in combination with fulvestrant for the treatment of men and postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received no or only one line of prior endocrine treatment

Primary: To compare PFS between ribociclib plus fulvestrant to fulvestrant monotherapy (plus placebo) among men and postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for…

BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED PHASE II LYSA-FIL-EORTC INTERGROUP STUDY
BREACH

Primary objective:To improve the PET negativity after two cycles of immuno-chemotherapyPrimary efficacy endpoint:PET 2 assessment according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.…

A randomized controlled multicenter trial comparing bariatric surgery with a structured life style intervention program in subfertile obese women with PCOS

It is hypothesed that intervention (bariatric surgery) compared with control (life style intervention program) will increase fertility measured by the healthy born baby rate after at least 37 weeks of gestation (primary end point) within 3 years…

Delirium in Elderly Patients with Trauma of the Hip

The DEPTHip Study aims to shed light on the question whether the use of a continuous ultrasound-guided FICB employing catheter technique, administered in the ED within 2 hours after presentation of an elderly patient with a hip fracture, can…