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A Multi-national Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC 0129-0000-1003 (N8-GP) when Administered for Treatment and Prophylaxis of Bleeding in Patients with Haemophilia A

Co-Primary Objectives* To evaluate the immunogenicity of N8-GP in previously treated patients with haemophilia A* To evaluate the clinical efficacy of N8-GP in bleeding prohylaxis (number of bleeds during prophylaxis)Secondary Objectives* To…

Breast Density as Indicator for the Use of Mammography or MRI to Screen Women with Familial Risk for Breast Cancer: a RCT.

To assess, based on a woman*s risk profile, mammographic density and age, the most cost-effective screening method, mammography or MRI, for women at high risk.

A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…

The LINC-study: LInking EDCs in maternal Nutrition and Child health

To relate exposure markers of EDCs to health outcomes in children - in particular obesity and neurobehavioral disorders -, effect biomarkers, and other parameters via multiple regression and multivariate analysis, while taking into account relevant…

Risk factors for colorectal cancer in patients with inflammatory bowel disease undergoing surveillance: a prospective cohort study

1. To confirm established and identify new risk factors for colorectal cancer in a prospective cohort of IBD patients undergoing regular surveillance. Dysplasia or colorectal cancer will be the primary outcome.2. To provide evidence that mucosal…

MEtoclopramide, DExamethasone or Aloxi (palonosetron) for the prevention of delayed chemotherapy-induced nausea and vomiting in moderately emetogenic non-AC-based chemotherapy: the MEDEA trial

In this phase III non-inferiority trial, the aim is to evaluate whether metoclopramide and palonosetron prophylactic antiemetic treatment are non-inferior to dexamethasone with regard to its efficacy to prevent delayed CINV induced by non-AC based…

A multi-center randomized, open label, controlled study in primary liver transplantation comparing long term renal function in recipients treated with standard dose extended release tacrolimus alone and recipients treated with a combination of low dose extended-release tacrolimus and low dose sirolimus.

To evaluate the effectiveness and safety of concentration controlled combination of once daily dosed low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels:3-5 ng/ml), in order to provide superior renal function…

Q-Kids

To estimate the risk of Q fever infection in children and adolescents in various exposure groups, estimate the true regional incidence of Q fever infections in children and adolescents, identify associated risk factors, and assess the impact of Q…

The effect of different macronutrients on the ileal brake

Hypotheses: - Ileal delivery of casein and/or sucrose induces stronger effects on satiation compared to placebo- Ileal delivery of casein induces stronger effects on satiation than ileal fat delivery- Ileal delivery of sucrose induces stronger…

The use of Fibrin sealant In total knee Replacement Surgery Trial. A prospective randomised multicentre study.

Is the application of CryoSeal (CS) in primary total knee replacement surgery beneficial for the patient with respect to a faster track and improved postoperative rehabilitation. The beneficial effect may be due to quicker functional knee…

Comparison of Cousin Biotech® Adhesix* versus conventional mesh in open anterior inguinal hernia repair: a Multi-centre, Randomised, Double-blinded, Controlled Clinical Trial.

We would like to conduct a multicentre randomised controlled clinical trial to compare the difference in early postoperative pain after unilateral primary inguinal hernia repair in males. The procedures will be performed in day surgery. Early…

Transfusion of fresh frozen plasma in non bleeding ICU patients

With the aim to restrict inappropriate FFP transfusions to critically ill patients, a randomized clinical trial will be conducted in a subgoup of ICU patients undergoing an invasive procedure. The objective is to assess the effectiveness and costs…

A multicenter, two arm, randomized, open label clinical study investigating renal function in an advagraf®-based immunosupressive regimen with or without sirolimus in kidney transplant subjects.

Primary objective: to compare the effect two immunosupressive therapy regimens on GFR estimated by iohexol clearance at week 52 post kidney transplantationSecundary objective: to compare the safety and efficacy profiles of the two immunosupressive…

A phase II, randomized, double-blind, placebo controlled, parallel design, dose ranging, multi-center trial of four levels of exposure of QGE031 s.c. for 16 weeks in subjects aged 18-50 years with peanut allergy (CQGE031A2208)

Primary: To characterize the QGE031 dose response relationship for the increase in the threshold dose of peanut protein that induces objective hypersensitivity reactions after treatment.Secondary (only key parameters): The percentage of patients…

Effects of thyroid hormone treatment on mitochondrial function, ectopic fat accumulation, insulin sensitivity and brown adipose tissue in type 2 diabetes mellitus

The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type 2 diabetic patients suffering from overt hypothyroidism will improve muscular mitochondrial function, lower ectopic fat accumulation in muscle and liver,…

Red wine polyphenols improve cardiometabolic risk in obese subjects by alleviating
inflammation and microvascular dysfunction

Primary Objective: To study effects of RWPs on insulin sensitivity, glucose tolerance, microvascular function (skin and muscle), insulin-mediated microvascular responsiveness, and blood pressure.Secondary objectives: To study effects of RWPs on…

Social cognition in children treated for a brain tumour: A comparative prospective international multi-centre study

Primary Objective: 1) To study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a brain tumour in childhood as compared to a reference group of chronically ill…

Colorectal anastomosis protected by a biodegradable drain fixed to the anastomosis by a circular stapler. A Multi-Center Randomized Controlled Trial (C-seal study)

Primary objective: efficacy of the C-seal in reducing anastomotic leakage (AL).Secondary objectives: The number of dismantled anastomoses; AL within 30 days according to the ISGRC classification; interval between the operation and AL; The pain score…

A trial based economic evaluation of Kopstoring: A study on the costs and effects of an online prevention program for children of 16 to 25 years old of parents with mental or substance use disorders.

Main question: p. 12 of proposalIs the online psycho-educative prevention program Kopstoring a (cost) effective program for children of parents with mental or substance use disorders to reduce their symptoms (primarily reduction of internalising and…

Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…