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Multimodal effects of Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism* a randomised placebo controlled Trial

Main objective: To test the efficacy of thyroxine replacement for subclinical hypothyroidism (SCH) in older adults. Primary Objective: To determine multi-modal effects (quality of life; cognitive; musculoskeletal and cardiovascular) of levo-…

A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer.

The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an
All COmeRs PopulaTion (BIO-RESORT): Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

The aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all…

TElmisartan in the management of abDominal aortic aneurYsm
(TEDY)

The aim of this study is to investigate if telmisartan reduces AAA growth

A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (>= 7.5 mg daily prednisone or its equivalent for >= 3 months and are planning to continue treatment for…

FDC116115: A prospective study of sexual function in sexually active men treated for BPH

Primary: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with Combodart, compared to placebo. Secondary: changes in sexual function during 1st 9 months of the study,…

CoDeLaGe
A translational cohort study on self-injurious behaviour in people with Cornelia de Lange Syndrome

PrimaryEffective treatment regimes and preventive tools of SIB in CdLS by studying phenomenology, etiology and pathogenesis.Secondary a. Development of a flow chart for daily care (diagnostics; management) b. Evaluation whether the present study can…

A phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple subcutaneous doses of BMN 045 (previously known as PRO045) in subjects with Duchenne muscular dystrophy

Primary objective:To assess the efficacy of BMN 045 after 48 weeks treatment in ambulant subjects with Duchenne muscular dystrophy.Secondary objectives:To assess the safety and tolerability of BMN 045 after 48 weeks of treatment in all study…

Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…

A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

The primary objective of this Registry is:• To evaluate HCV viral sequences and the persistence or evolution of treatment emergent viral mutations in subjects who fail to achieve an SVR after treatment with a Gilead oral antiviral containing regimen…

Lung Volume Reduction Coil for Treatment in Patients with Emphysema (RENEW) Study

The primary objective of this study is to determine whether treatment with the RePneu LVRC System results in improved exercise capacity and quality of life, as measured by improvements in the 6 Minute Walk Test (6MWT).

Cost-effectiveness of a lifestyle intervention on health and sustainable employability among workers of 40 years and older with high physical work demands: a randomized controlled trial

- to evaluate (cost-) effectiveness of a personalized health intervention among workers of 40 years and older with high physical work demands to contribute to a reduction in CVD and sustainable employability.

Betacel dysfunction induced by impaired pancreas anatomy and insulin sensitivity in subjects with heterozygous EXT1 or EXT2 Mutations

Assessment of glucose homeostasis and pancreas size (MRI) in 10 subjects with heterozygous mutations in EXT-1, in 10 subjects with heterozygous mutations in EXT-2 and 10 unaffected related controls as well as 10 subjects with known type 2 diabetes…

Feasibility of MRI-imaging of the Affinis short shoulder prosthesis

To Establish the usefulness of MRI for assessment of the rotator cuff in patients with an Affinis short prosthesis implanted in the shoulder.

The real distribution of microbiota along the colonic mucosa using a novel device capable of taking *protected* biopsies

Primary Objective: to show the differences in distribution of microbial DNA proximal versus distal in the colon as well as luminal composition versus mucosa adherent. Secondary Objective: to test whether bowel lavage has influence on the microbial…

psychological consequences of pre-eclampsia

1. the primary objective of this study is to examen the incidence and prevalence of PTSDand depression in pre-eclampsia patients after delivery2. a secondary objective is to identify risk factors during pregnancy, durante partu and postpartum…

Fast-track thyroidectomy and I-131 radioiodine ablation therapy in patients with differentiated thyroid cancer.

Firstly, to study the reduction in sick-leave time achieved by the treatment protocol. Secondly to study the quality of life in the patients treated in the fast-track protocol, to study the reduction in societal costs and to stdy the efficacy of a…

A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease.

Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…

An advanced configuration (the third generation) of the DIAMOND System for the treatment of T2DM patiënts- A randomized double blind study "Ruby Study".

In previous studies, the chronic effect, up to 6 months, of the one gastric lead continuous stimulation was demonstrated resulting in an improvement in blood glucose levels. The present hypothesis is that this effect is mediated by either a…

Proactive versus reactive inhibition in ADHD: Genetics, Neurobiology and pharmacology

The aim of this research is, following the aforementioned theoretical framework, to investigate whether the two candidate genes in combination with EEG and fMRI markers differentiate between children that do and do not show a clinical response to…