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A double-blind, randomized, placebo-controlled study to investigate the efficacy and safety of cannabidiol (GWP42003-P, CBD) as add-on therapy in patients with tuberous sclerosis complex who experience inadequately-controlled seizures

Primary Objective Blinded Phase:• To evaluate the efficacy of GWP42003-P as add-on therapy in reducing the frequency of seizures when compared with placebo in patients with TSC.Open-label Extension:• To evaluate via the adverse events (AE) profile…

Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients

Primary: Dose confirmation part: To establish the Maximum Tolerated Dose (MTD) and/or Recommended dose for expansion (RDE) of PDR001 with platinum-doublet chemotherapy in treatment naïve patients with PD-L1 unselected, advanced NSCLC of squamous or…

CANGLIA: Endocannabinoid control of microglia activation as a new therapeutic target in the treatment of schizophrenia

The primary objective of this study is to compare microglia activation as measured with proton Magnetic Resonance Spectroscopy (1H-MRS) between recent-onset schizophrenia patients who are randomised to CBD and those randomised to placebo. Secondary…

Core elements of Cognitive Behavioral Therapy in preventing depression in youth:
Does the type and sequence of elements matter?

The primary objective is to investigate whether (and if so, which) type of CBT-element (cognitive restructuring (CR), behavioral activation (BA), relaxation (RE) and problem solving skills(PS)) is relevant for the positive effect of CBT-programs on…

A randomised multicentre, prospective, double blind phase III trial investigating the effect of radiotherapy on patients with Ledderhose disease.

The aim of this study is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.

A Randomised Phase II Study of Nintedanib (BIBF1120) Compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium

The objectives are to assess the efficacy, safety and effect on quality of life of Nintedanib compared to chemotherapy in women with relapsed, advanced or metastatic clear cell cancer of the ovary of endometrium.

Tailored treatment of functional dyspepsia with nortriptyline: a multi-center double-blind placebo-controlled trial (TENDER)

Aim: To investigate the efficacy of nortriptyline in FD patients with a predicted CYP2D6 extensive metabolizer phenotype. Nortriptyline is a second generation TCA with significantly fewer anticholinergic side effects compared to the first generation…

Exploratory intervention study: the use of a medical nutrition supplement in patients with metastatic colorectal cancer receiving first line of capecitabine-containing (CAP-containing) treatment

Main study objective: to explore the compliance to nutritional test product intake after the first 3 cycles of systemic therapy in patients with metastatic colorectal cancer receiving first line of CAP-containting systemic treatment. Other study…

Newborns with Congenital Diaphragmatic hernia: inhaled Nitric Oxide versus intravenous Sildenafil: ;an international randomized controlled trial

To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…

Study protocol for a randomized clinical trial of a continuous butylscopolamine infusion versus a placebo in patients with a renal colic not responding to oral NSAIDs

The purpose of this study is to analyse the effect on pain reduction of butylscopolamine in a continuous intravenous infusion compared to a placebo in patients with renal colics not responding to oral NSAIDs.

Efficacy, safety and tolerability of a bowel cleansing preparation (Eziclen®/Izinova®)
in paediatric subjects undergoing colonoscopy: a Phase III, multicentre, randomised, comparative study versus Klean-Prep® (PEG-Electrolytes), administered on the day before colonoscopy,
Investigator-blinded, non-inferiority in adolescents of 12 to 17 years of age (inclusive) > 40 kg.

Primary objective:To demonstrate that Eziclen, given on the day before colonoscopy has non-inferior efficacy to Klean-Prep on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight > 40 kg, scheduled to undergo a…

Effect of a banded extended pouch in aRoux-en-Y gastric bypass

To investigate the effect of a banded-extended RYGB on weightloss and weigtregain on the long term.

Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial

To determine the effectiveness of more intensive BP lowering provided by a *Triple Pill* strategy on top of standard of care, on the time to first occurrence of recurrent stroke after ICH.

Combined Phase 3, Double-blind, Randomized, Placebo-Controlled
Studies Evaluating the Efficacy and Safety of Filgotinib in the
Induction and Maintenance of Remission in Subjects with Moderately
to Severely Active Crohn*s Disease

The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of clinical remission, as well as , endoscopic response in subjects with moderately to severely active Crohn's disease (…

Phase 1B Study to assess safety and efficacy of Neo-Adjuvant Bladder Urothelial Carcinoma COmbination-immunotherapy (NABUCCO)

Primary objectives: 1. Establish whether a sequenced pre-operative schedule of ipilimumab and nivolumab is safe in urothelial cancer patients (cohort 1)2. Study objective for cohort 2: to evaluate which treatment regimen is most effective.…