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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-…

Randomized, double-blind, placebo-controlled oxytocin trial in children with Prader-Willi syndrome.
Effects on social behaviour.

To evaluate the effects of intranasal oxytocin versus placebo on social behaviour and also on eating behaviour in children with PWS.

Short-term Efficacy of Stellate Ganglion Block to reduce Hot Flushes in women

To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

IEMO 80-plus thyroid trial

1. Does Levothyroxine treatment for subclinical hypothyroidism give multi-modal benefits for the oldest old people with subclinical hypothyroidism?2. Are benefits seen across a wide range of outcomes, including prevention of cardiovascular disease,…

Effect of Multiple healthy donor intestinal microbiota infusions on non Alcoholic Steatosis Hepatis (NASH) and vascular function in obese subjects

In this study we would like to investigate whether repetitive allogeneic (lean donor) fecal transplantations can reduce liversteatosis and if so which (small) intestinal bacteria cause this inflammation in the liver resulting in subsequent chronic…

Levothyroxine for euthyroid women with recurrent miscarriage and positive TPO antibodies: a randomized controlled trial

First objective: To assess improvement in live birth rate after levothyroxine supplementation. Secondary objective: 1) to test the hypothesis that levothyroxine lowers the risk for miscarriage and preterm birth 2) to test the hypothesis that…

The effect of a self controlled dose of Levothyroxine on the quality of life and thyroid stimulating hormone in patients treated for hypothyroidism: a randomized, double blind, consecutive study.

The goal of this study is to positively influence quality of life in patients with hypothyroidism by giving them back control in their treatment. We also want to see what the placebo effect will be. And at last we want to check if patients have the…

Women*s Hormonal Intervention Study in early Postmenopause of Estradiol-progesterone Replacement therapy - effects on quality of life

The primary objective is to evaluate health related QoL under an oral sequential treatment with natural steroid hormones: Duogestan®. The secondary objective is to evaluate the bleeding patterns over a one-year period.

A randomized, double-blind placebo-controlled, multicenter phase III study in patients with advanced carcinoid tumor receiving Sandostatin LAR and RAD001 10 mg/Day or Sandostatin LAR and Placebo

To determine whether treatment with RAD001 10 mg/d plus Sandostatin LAR® prolongs the progression free survival (PFS) compared to treatment with Sandostatin LAR® alone in patients with advanced carcinoid tumor.

Acute effects of growth hormone on cognitive functioning and related brain physiology in healthy subjects

We will evaluate the acute effects of GH on, and its relation with, cognition in healthy subjects. The present proposal focuses on the following questions:1. Does an acute rise of plasma GH levels have a (beneficial) effect on cognitive performance…

A multicenter, randomized, blinded efficacy and safety study of pasireotide LAR vs octreotide LAR in patients with metastatic carcinoid tumors whose disease-related symptoms are inadequately controlled by somatostatin analogues.

To compare the long term efficacy of pasireotide LAR vs. octreotide LAR at month 6 in controlling diarrhea and/or flushing in patients with metastatic carcinoid tumors whose disease-related symptoms are inadequately controlled by the maximum…

The effects of intravenous TRH administration on brown adipose tissue activity in healthy, lean men.

To investigate whether BAT tissue can be activated by intravenous administration of TRH. Secondary objectives are to determine whether intravenous TRH increases the degree of cardiovascular sympathetic stimulation and the response of skin…

A phase I, double-blind, randomised, placebo-controlled study, in three parts (parts A, B and C) to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BIM23B065 administered subcutaneously as single and multiple ascending doses to young healthy male subjects

Objectives:Primary Objective: • To assess the safety and tolerability of single and multiple ascending doses of BIM23B065 when given as a subcutaneous (s.c.) bolus injection in young healthy male subjects.Secondary objectives:• To determine the…

Two-Center, In-Patient, Randomized, Placebo and Active Comparator Evaluation of the Pharmacokinetics (PK) and Safety, Along with Initial Pharmacodynamic (PD) Efficacy of Three Dose Levels of TBS-2 Intranasal Gel Applied Twice-Daily (BID) for up to Three Days in Female Patients with Hypoactive Sexual Desire Disorder (HSDD) or Anorgasmia (ANOR).

This clinical trial is being performed to evaluate the PK profile of TBS-2 administered as single and multiple (BID) doses in patients with HSDD or ANOR. In addition, the study will evaluate the initial PD efficacy and safety of intranasal TBS-2 BID…

EFFECTS OF RANDOMIZED, DOUBLE-BLIND, MULTIPLE DOSE ADMINISTRATION OF OLANZAPINE OR TOPIRAMATE PLUS OLANZAPINE ON THYROID FUNCTION, GLUCOSE AND LIPID METABOLISM IN HEALTHY MALES

The objective of the study is to observe the effect of olanzapineat a dose of 10 mg daily for 14 days when given with/without topiramaat at a dose of 25 and 50 mg twice daily on bodyweight in healthy male subjects. In addition the effect of…

A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to reduce the Risk of Fracture in Osteoporotic Men Treated with Vitamin D and Calcium

1. To assess the effect of odanacatib 50 mg once weekly versus placebo on lumbar spine BMD over 24 months.2. To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo.

Randomized double blind multi-centre study of the effects on low-dose pegvisomant treatment in acromegalic subjects in whom the IGF1 levels has been normalized by long-acting somatostatin analogues

Primary Study Objective:To assess the efficacy and safety of the co-administration of low-dose pegvisomant (40 mg, administered via subcutaneous injection given once a week) and long-acting somatostatin analogs (administered once monthly) on the…

A Double-Blind, Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

The purpose of this study is to find out if patients with locally advanced/metastatic Radioactive Iodine-refractory (RAI) thyroid cancer (papillary, follicular or Hurthle cell carcinoma), will benefit from sorafenib treatment compared to patients…

A randomized, double-masked, placebo-controlled, efficacy and safety study of RV 001, an insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody (fully human), administered every 3 weeks (q3W) by intravenous (iv) infusion in patients suffering from active thyroid eye disease (TED)

The primary objective is to investigate the efficacy, safety and tolerability of RV 001 (a fully human anti-IGF-1R antibody) administered q3W for 6 months, in comparison to placebo, in the treatment of patients suffering from active TED.Secondary…

Evening versus Morning Administration of Levothyroxine: a randomised controlled double-blind trial

To study in a large randomised double-blind trial, if the administration of levothyroxine at bedtime significantly changes TSH and thyroid hormone levels compared to morning administration. Furthermore we want to evaluate the change of quality of…