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A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of DNL104 in Healthy Subjects

- Investigate the safety and tolerability of single ascending doses of DNL104 in healthy volunteers.- Characterize the pharmacokinetics of DNL104 in plasma, CSF, and urine.- Characterize the effect of a high fat meal on the pharmacokinetics of…

Improving cognitive functioning in Parkinson*s disease with transcranial Direct Current Stimulation (PD-tDCS)

Determine the efficacy of atDCS as compared to ctDCS and sham stimulation in the improvement of executive functioning in PD-MCI.

Metacognitive therapy vs. exposure and response prevention for obsessive-compulsive disorder: A randomized clinical trial.

The present trial is initiated to compare the effectiveness of MCT with ERP, the current treatment of choice for OCD, in an outpatient clinical sample of patients with OCD. The following hypothesis is formulated: MCT is more effective than ERP, both…

A randomized, double-blind, placebo-controlled, parallel-group study to investigate the safety, tolerability, and pharmacodynamics of JNJ-54175446 in subjects with major depressive disorder.

Primary objective:-To investigate the safety and tolerability of JNJ-54175446 in subjects with major depressive disorder.Secondary objectives:-Investigate the effect of JNJ-54175446 versus placebo on total sleep deprivation-induced changes in…

A STUDY OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH CONNECTIVE TISSUE DISEASE-ASSOCIATED PULMONARY ARTERIAL HYPERTENSION

Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…

The influence of breathing techniques and exposure to cold on inflammation during human endotoxemia, an explorative study

The primary objective of the present study is to determine the effects of the `strength ventilation` breathing technique and exposure to cold, both separately and in combination, on the inflammatory response during human endotoxemia. To this end, we…

A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).

Primary• To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician*s Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment• To assess the effects of RVT-101 versus…

A randomized controlled trial comparing Dried Blood Spot sampling to venous sampling for Therapeutic Drug Monitoring in tacrolimus using kidney transplant patients: a cost minimization analysis.

To determine the difference in the amount (average per patient) of clinical check-ups performed in the hospital for the DBS and the non-DBS group. To compare the total economic burden for the intervention and non-intervention groups from a societal…

Become Active in Beating osteoarthritiS (BABS): A randomized controlled trial on the effectiveness of a promotional campaign in improving the management of osteoarthritis and quality of care

An information campaign was developed targeting early-stage KHOA patients and healthcare professionals (HCPs) to optimise timing of referral to secondary care.

ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

To evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain and no prior spine surgery when used in conjunction with medical management.

Understanding gut feelings: Probiotics and cognition

Translating these animal findings to humans is one of the aims of the current study. The proposed project aims to replicate the aforementioned preliminary findings (Evrensel & Ceylan, 2015; Steenbergen et al., 2015; de Noos et al., 2015;…

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

An internet-based intervention for the prevention and early intervention of eating disorders: A randomized controlled trial investigating the effectiveness and cost-effectiveness of automatic feedback on self-monitored eating behaviour with or without weekly support from an expert patient.

The current study has two aims. Firstly, to investigate the effectiveness and cost-effectiveness of 8 weeks of the E-health program, Featback, in comparison to Featback with online support from an expert patient, online support from an expert…

A multicenter, randomized, open label, efficacy assessor-blinded study of risankizumab compared to secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systematic therapy.

The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.

A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and
Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

The primary objective of the study is to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects…

Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg in Subjects with Previously Untreated, Unresectable or Metastatic Melanoma

Primary Objective:The primary objective is to compare the incidence of drug-related Grade 3 - 5 AEs of N3I1 to N1I3 in subjects with previously untreated, unresectable or metastatic melanoma.Secondary Objective:• To evaluate the ORR, as determined…

Evaluation of a novel alternative protein source to stimulate post-exercise muscle protein synthesis

From p11 of C1 protocol document:1) To define the characteristics of mealworm protein ingestion on protein/digestion absorption kinetics and both whole-body and myofibrillar muscle protein synthesis after a single bout of resistance exercise in…

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…

A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN)

Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…

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…