Search for a trial

Somatosensory electrical stimulation to augment skill acquisition and motor memory consolidation: An electroencephalography study

To determine the mechanisms underlying motor skill training, somatosensory electrical stimulation, and a combined intervention on motor skill acquisition, motor memory consolidation, and interlimb transfer in healthy younger and older adults.

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…

RCT to investigate the quality of the of endometrial sample obtained by aspiration when performed before or after the SIS in postmenopausal women.

The primary objective is to investigate the quality (whether assessable by a pathologist or not) of the endometrial sample obtained by aspiration when performed directly before or after the SIS in postmenopausal women. Secondary objectives are to…

Uniform FDG-PET guided gradient dose prescription to reduce late radiation toxicity (UPGRADE RT): a randomised controlled trial with dose reduction to the elective neck in head and neck squamous cell carcinoma

The UPGRADE-RT trial will investigate whether de-escalation of the elective radiation dose and introduction of an intermediate dose-level in the treatment of head and neck cancer will results in less radiation sequelae and improved quality of life…

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…

Influenza vaccination in patients with Myasthenia Gravis

The main objective of this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG). The secondary objectives are to determine if vaccination…

A Randomized, Placebocontrolled, Double blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Subjects

The primary objectives of this study in healthy subjects are:- To investigate the safety and tolerability of JNJ-61393215 versus placebo after single oral dose administration under fasted (ascending dose levels) and fed condition.- To characterize…

Self-monitoring and personalized feedback as a tool to boost depression treatment

The main aim of the ZELF-i project is to investigate the effectiveness of self-monitoring and personalized feedback as an add-on tool in the treatment of depression. By starting directly after intake, patients can make the most out of the usual…

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 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…

A Multicenter, Randomized, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies

The chief aim of the proposed study is to compare the safety and efficacy of NiCord® single ex vivo expanded cord blood unit transplantation to unmanipulated cord blood unit transplantation in patients with hematological malignancies following…

The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy

Primary objective: To evaluate the effect of treatment with oral hypoglycemic agents (OHA) on the incidence of large-for-gestational-age (LGA) infants in women with GDM requiring medication, compared to insulin (INS) treatment.Secondary objectives:…

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 Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab with a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients with BRAF V600E mutant Metastatic Colorectal Cancer

Safety Lead-inIn patients with BRAF V600E mutant (BRAFV600E) metastatic colorectal cancer (mCRC):Primary: • Assess the safety/tolerability of the combination of encorafenib + binimetinib + cetuximabSecondary:• Assess the activity of encorafenib +…

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 Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

Primary objective:- To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing forms of multiple…

Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event
International, multi-centre, randomized, double-blind placebo-controlled phase II study.

Efficacy and safety trial with S 44819 after recent ischemic cerebral Event