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A placebo-controlled double blind randomized trial to investigate the efficacy and safety of the combination of Penicillin G / Hydrocortisone treatment in ALS patients (PHALS).

The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

Prevention of rheumatoid arthritis by atorvastatin in seropositive arthralgia patients: a multi-center doubleblind randomized placebo-controlled trial

To investigate whether statin treatment can prevent or delay the development of RA in persons at increased risk of RA.

The DANCE study: Duration of ANtibiotic therapy for CEllulitis

To determine if 6 days of antibiotics has equal efficacy compared to 12 days for patients hospitalized with cellulitis.

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…

Mood, serotonin and social interaction

This project aims to study how changes in serotonin alter interpersonal functioning in adults with or without a first degree family member diagnosed with MDD. The primary goal is to investigate the effect of experimentally lowered brain serotonin…

A randomised sequential trial of Lithium in amyotrophic lateral sclerosis

To determine the effect of lithium treatment (plasma levels between 0,4-0,8 mEq/liter) versus placebo - in addition to riluzole 2dd 50 mg - on reaching a clinical endpoint in patients with ALS.

CHRONIC PAIN MANAGEMENT AFTER HERNIORRAPHY
PREGABALIN VERSUS PLACEBO

The primary objective of this study is to investigate whether pregabalin at a dose of 150-600 mg twice a day reduces pain in patients with chronic neuropathic pain after herniorraphy. This research question will be answered by testing of the…

Effects of seaweed on blood glucose

We hypothesize that dietary supplementation with seaweed will improve glucose regulation in T2DM patients.

A double-blind, randomised, placebo-controlled trial of prolonged antibiotic treatment after intravenous ceftriaxone in patients with (possible) persistent Lyme disease.

Prolonged antibiotic treatment of patients diagnosed with presumed PLD (as endorsed by the international ILADS guidelines) leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO guidelines.

A Phase II, multicentre, double-blind, randomised, placebo-controlled study
of Rifaximin delayed release 400 mg tablet: clinical efficacy and safety in the prevention of post-operative endoscopic Crohn*s disease recurrence
(STOP-Postoperative Endoscopic Recurrence Study)

Primary objective:To demonstrate the efficacy of Rifaximin -EIR 400 mg Tablet (800mg /BID, total daily dose 1600 mg) versus placebo in the prevention of endoscopic Crohn*s disease recurrence following ileocolonic resection

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients with Heart Failure and Impaired Systolic Function

Primary* Evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo. Secondary* Evaluate the effects of BMS-986231 on the left ventricular (LV)…

GRAVITAS-301: A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft Versus Host Disease

Primary objective: Compare the efficacy of itacitinib in combination with corticosteroids versus placebo in combination with corticosteroids in terms of overall response rate (ORR) at Day 28 in subjects with aGVHD.Secondary objectives:- Compare the…

A Phase 3, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of
Oral Azacitidine Plus Best Supportive Care versus Placebo Plus Best Supportive Care in
Subjects with Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia due to
IPSS Lower-risk Myelodysplastic Syndromes.

Primary Objective:To evaluate RBC transfusion independence in the 2 treatment arms (oral azacitidine plus best supportive care versus placebo plus best supportive care) in subjects with RBC transfusion-dependent anemia and thrombocytopenia (platelet…

A 6-part first-in-human study of LOU064 consisting of a 4 part randomized, double-blind, placebo-controlled SAD and MAD study to investigate the safety and tolerability in healthy volunteers, subjects with atopic diathesis and subjects with atopic dermatitis, an open-label food effect study and a double-blind formulation effect study in healthy volunteers

To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.

A Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders.

Primary Objective: To compare the efficacy of MEDI-551 versus placebo in reducing the risk of an NMO/NMOSD attack in subjects with NMO/NMOSD.Secondary Objectives:1. To compare the efficacy of MEDI-551 versus placebo on the reduction of EDSS…

Study to clinically evaluate the QT/QTc interval prolongation potential of vericiguat in patients with stable coronary artery disease in a 2-arm, placebo-controlled, randomized, double-blind, double-dummy design including a vericiguat multiple-dose part with fixed up-titration periods and moxifloxacin as positive control (for assay sensitivity testing, nested into the placebo treatment)

The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTcinterval in patients with stable CAD10 within the exposure range observed in Phase II/IIIstudies:Primary objective:* To investigate whether there is a…

A First-in-Human, randomized, double-blind, placebo-controlled ascending dose study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects.

To investigate the safety, tolerability and efficacy of STR-324 infusions in healthy subjects.Primary objective (Parts 1 and 2)* To assess and characterise the safety and the tolerability of STR-324, over a 4-hour (Part 1) and a 48-h infusion (Part…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ISIS 416858 (IONIS-FXIRX an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients with End-Stage Renal Disease on Hemodialysis

Primary objectives: To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ISIS 416858 (200, 250, and 300 mg once weekly) as compared to placebo.Exploratory Objectives: Incidence of myocardial infarction (MI), stroke, systemic…

Validation of the capsaicin (1%) sensitization model in the context of the PainCart test battery

Primary objectivePart A• Evaluating the effect and reproducibility of the capsaicin sensitization model on the predefined primary endpoints in both primary and secondary hyperalgesia areas for LS• Evaluating the effect and reproducibility of the…

A PHASE III, MULTICENTER, RANDOMIZED,
PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB
(ANTI*PD-L1 ANTIBODY) AS MONOTHERAPY AND IN
COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY
IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR
METASTATIC UROTHELIAL CARCINOMA

The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab plus gemcitabine/carboplatin or cisplatin compared with placebo plus gemcitabine/carboplatin or cisplatin on the basis of the following endpoints:- Co-primary…