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Slow continuous subcutaneous flumazenil infusion for benzodiazepine dependence: a pilot study

The primary objective is to demonstrate that detoxification of benzodiazepines in high-dose benzodiazepine dependent patients using continuous subcutaneous infusion of flumazenil is feasible and safe.Secondary goals of the study are to explore 1)…

A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non-Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent

Primary Objectives:• Part 1: To evaluate the safety and tolerability of ruxolitinib in combination with pemetrexed/cisplatin and select a dose for further evaluation• Part 2: To evaluate and compare the overall survival of subjects with nonsquamous…

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.

Efficacy of single dose intranasal dexmedetomidine for conscious sedation in dental practice in dentophobic uncooperative patients with intellectual disability.

To demonstrate non-inferiority of conscious sedation with intranasal dexmedetomidine for performing dental care in patients with intellectual disability and dentophobia.

The effect of head cooling on cognitive functioning in kickboxing; a pilot study.

The goal of the present study is to investigate the effect of head cooling after kickboxing matches on cognitive functioning amongst both amateur and professional kickboxers. Based on the above mentioned studies, it is hypothesized that head cooling…

The feasibility and efficacy of subcutaneous Plerixafor for mobilization of peripheral blood stem cells in allogeneic HLA*identical sibling donors: a prospective phase II study.

Primary objectiveTo determine the feasibility of plerixafor 320 *g/kg subcutaneously to harvest a sufficient number of CD34+ peripheral blood stem cells/kg recipient body weight. Feasibilty is defined as a minimum of 2.0x10^6/kg CD34+ cells in one…

A Randomized, Double-Blind, Four Treatment, Four Period, Crossover Study, with Placebo, Tizanidine Immediate-Release and Diphenhydramine to Study Effect of Tizanidine Extended-Release on Simulated Driving Performance, Cognitive, and Psychomotor Functioning

To investigate effect of tizanidine ER 12 mg on simulated driving performance, cognitive and psychomotor functions compared with placebo, tizanidine IR 8 mg (two 4 mg doses given 6.5 hours apart) and active-control in healthy subjects

A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment
Randomized Withdrawal Study to Evaluate the Efficacy and Safety of
BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With
Confirmed Small Fibre Neuropathy That Is Idiopathic or Associated With
Diabetes Mellitus

The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by subjects with confirmed SFN that is idiopathic or associated with diabetes mellitus.Sub study objective:Corneal Confocal Microscopy (CCM) as a…

STEPWISE Parkinson: A smartphone based, titrated exercise solution for patients with Parkinson*s disease in daily life

The aim of this study is to investigate whether a smartphone app can increase physical activity in PDpatients for a long period of time (one year). The secondary aim is to test the potential effects of an increase in physical activity on physical…

A Phase I/II study of Brigatinib in pediatric and young adult patients with ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or other solid tumors

This study has been transitioned to CTIS with ID 2024-513412-10-00 check the CTIS register for the current data. Phase 1: • To determine the MTD/RP2D regimen of brigatinib monotherapy when administered in pediatric and AYA patients with ALK+ ALCL or…

A PHASE 2 MULTICENTER, OPEN-LABEL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF POMALIDOMIDE (CC-4047) IN COMBINATION WITH LOW-DOSE DEXAMETHASONE IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA AND MODERATE OR SEVERE RENAL IMPAIRMENT INCLUDING SUBJECTS UNDERGOING HEMODIALYSIS

Primary Objective:- Evaluate efficacy of the combination of pomalidomide and low-dose dexamethasone in subjects with relapsed or refractory multiple myeloma and impaired renal function.Secondary Objectives:- Evaluate renal efficacy of the…

Phase II, open-label, single arm, multicenter study of encorafenib, binimetinib plus cetuximab in subjects with previously untreated BRAF V600E -mutant Metastatic Colorectal Cancer

Primary:- To evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the confirmed overall response rate (cORR) by local radiologist/investigator assessment in adult subjects with previously…

A phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, of oral FT011 in participants with diffuse systemic sclerosis

Primary objective: To assess the PK of oral FT011 in participants with diffuse SSc.Secondary objectives: • To assess the safety and tolerability of oral FT011 compared to placebo in participants with diffuse SSc.• To evaluate the short-term efficacy…

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM in Patients with Septic Shock. A Randomised, Double-blind, Two-stage, Placebo Controlled Study.

The objectives of the study are to: -To evaluate the safety and tolerability of MOTREM in patients with septic shock. -To evaluate the effects of MOTREM exposure over up to 5 days in patients with septic shock -To evaluate the PK/PD and dose/PD…

A TRIAL TO COMPARE THE INJECTION SITE PAIN EXPERIENCE OF 0.25 MG SEMAGLUTIDE SC ADMINISTERED BY 2 DIFFERENT PRODUCTS

The primary objective is to compare, in healthy subjects, the injection site experience of a single dose of 0.25 mg semaglutide sc, given as the DV3396 product to that of the PDS290 product.

A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in
subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3

Three cohorts will be included consisting of subjects with biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and all other solid tumorhistologies not included in Cohorts 1-2 such as NSCLC, head and neck cancer, thyroid cancer, oral…

A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab in combination with other anti-cancer therapies in participants with lymphoma

PrimaryPhase 1-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory cHL, DLBCL or PTCL, and to confirm the recommended Phase 2 dose (RP2D).Phase 2- Cohort A1 (anti-…

Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept.

The aim of this clinical trial is to evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.

validity, measurement feasibility and reliability in geriatric outpatients

To assess the clinical feasibility, reliability and validity of the combined barocontrol PPG-NIRS-ECG monitor.

A PHASE I/II, MULTICENTER, OPEN-LABEL, MULTI-ARM STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PRELIMINARY ACTIVITY OF IDASANUTLIN IN COMBINATION WITH EITHER CHEMOTHERAPY OR VENETOCLAX IN THE TREATMENT OF PEDIATRIC AND YOUNG ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LEUKEMIAS OR SOLID TUMORS.

This study will evaluate the safety, tolerability, and pharmacokinetics of idasanutlin as a single agent and the safety, tolerability, pharmacokinetics, and preliminary efficacy of idasanutlin in combination with either chemotherapy or venetoclax in…