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REVERSAL OF ANTICOAGULANT EFFECT OF DABIGATRAN® BY PROTHROMBIN COMPLEX CONCENTRATE (BERIPLEX®) ASSESSED WITH A NOVEL METHOD OF BLOOD LOSS MEASUREMENT

To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…

Efficacy and safety of delta-9-tetrahydrocannabinol (delta-THC) in behavioural disturbances in dementia

The primary objective is to evaluate the efficacy of Namisol® in the management of behavioural disturbances in patients with dementia. Secondary objectives are:- To evaluate the efficacy of Namisol® on secondary outcome measures, such as quality of…

A Multi-Centre Clinical Study to Evaluate the Safety and Effectiveness of the ESS505® Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception

To Evaluate the Safety and Effectiveness of the Essure® ESS505 Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception (*Study*)

A Randomized, Multicenter, Phase II study to Investigate Efficacy and Safety of ITF2984 in Acromegalic patients.

- To investigate the biochemical response of ITF2984, defined as a reduction in (random) GH < 1.0 mcg/l and/or normalization of IGF-1.- To investigate the biochemical response of ITF2984, defined as a reduction of GH to no more than 2.5 mcg/l…

A Phase 1/2 Combined Dose Ranging and Randomised, Open-label, Comparative Study of the Efficacy and Safety of Plerixafor in Addition to Standard Regimens for Mobilisation of Haematopoietic Stem Cells into Peripheral Blood, and Subsequent Collection by Apheresis, Versus Standard Mobilisation Regimens Alone in Paediatric Patients, Aged 1 to <18 Years, with Solid Tumours Eligible for Autologous Transplants

In this study, plerixafor, the study drug, will be given in addition to GCSF to see if it works the same way in children as in adults.

A phase 2 multicentre randomized controlled comparative efficacy and safety study of Tiscover and AS210 in chronic (arterio-)venous ulcers

Determine the safety and efficacy of Tiscover compared to AS210 (acellular donor dermis, construct Tiscover is cultured on) for the treatment of chronic, therapy resistant (arterio-) veneus leg/foot ulcers in an out patient setting.

A randomized, double blind, placebo controlled, multi-centre study to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of BYM338 in chronic obstructive pulmonary disease patients with cachexia (CBYM338X2204)

Primary: Assess the effect of i.v. infusions of BYM338 on muscle volume of the thigh (assessed by MRI) at 4, 8, 16 and 24 weeks, compared to placebo, in COPD patients with pulmonary cachexia.Secondary: Effect on 6-minute walk test, safety and…

A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.

The primary objective of this study is to investigate equivalence of weight gain from randomisation until the age of 17 weeks in infants receiving the test product compared to infants receiving the control product. Secondary objectives of this study…

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF 3-MONTH SUBCUTANEOUS REGN1033 TREATMENT IN PATIENTS WITH SARCOPENIA

Please refer to protocol, section 1.2 "Rationale"

A pilot randomized controlled trial on the feasibility and efficacy of an exercise intervention to improve cognitive functioning in patients with glioma

The objective of this pilot randomized controlled trial (RCT) is to assess the feasibility and to determine the effect size of a physical activity/exercise program in improving objective cognitive functioning and reducing self-reported cognitive…

A double-blind, randomised, placebo-controlled, Phase II study to evaluate ProCervix efficacy to clear HPV 16 and HPV 18 infection in women with normal cytology or ASCUS/LSIL

Primary Objective To evaluate the efficacy of ProCervix adjuvanted with imiquimod, in comparison with placebo adjuvanted with imiquimod, to induce HPV 16 and 18 viral clearance at 12 months in HPV 16 and/or 18 infected women using a type specific,…

A randomised, open label, placebo controlled exploratory study in healthy volunteers, to characterise the acid neutralisation activity of sodium alginate oral suspension in the fasted state, using a custom-designed intragastric and oesophageal pH catheter

The objective of this exploratory study is to investigate the acid neutralisation action of sodium alginate oral suspension versus placebo liquid, within the stomach and to assess suitability and robustness of the pH monitoring methodology.

The potential of do-it-yourself devices for obtaining personal health data

The first objective of this study is to evaluate the potential of do-it-yourself devices for self-measuring health parameters by subjects in obtaining interesting data. The second objective of this study is to evaluate if increased awareness of own…

A Multi-Centre, Randomised, Double Blind, Placebo Controlled, Parallel Group Study of TA 8995 in Patients with Mild Dyslipidaemia, Alone and In Combination with Statin Therapy

The primary objective of this study is to evaluate the efficacy of different doses of TA 8995, a cholesteryl ester transfer protein (CETP) inhibitor, on the elevation of high density lipoprotein cholesterol (HDL C) and reduction of low density…

A 90-week, multi-center, randomized, double-blind, placebo-controlled study in patients with mild Alzheimer*s Disease (AD) to investigate the safety, tolerability and Abeta-specific antibody response following repeated i.m. injections of adjuvanted CAD106

The purpose of this study is to evaluate the benefit of adding an adjuvant to CAD106 and to select the dose of CAD106 and adjuvant to be used in further development. Additionally, clinical and biomarker measures (CSF, plasma biomarkers, volumetric…

Gastric versus distal to the ligament of Treitz feeding in healthy volunteers

Primary objective: To evaluate the differences in digestion and absorption on the administration of enteral nutrition either gastric or distal to the ligament of Treitz in the jejunum.Secondary objective: To evaluate the differences in endocrine…

Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma

The primary endpoint is overall survival (OS) in patients with low hENT1 expression. Ifthe hENT1 expression data are available for analysis prior to randomizing 250 patientsthen an interim analysis for sample size re-estimation may be performed.

A Phase 2, Multicenter, Randomized, Double blind, Parallel group, Placebo controlled Study Evaluating the Safety and Efficacy of Treatment with Ustekinumab or Golimumab in Subjects with Chronic Sarcoidosis

See above

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine
the Efficacy, Safety, and Tolerability of AMG 785 in Adults with Fresh Unilateral
Hip Fracture, Status Post Surgical Fixation

To investigate the effect of AMG 785 compared to placebo on functionalhealing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjectswith fresh unilateral low energetic hip (intertrochanteric or femoral neck) fracture

An fMRI-study on the effects of NicVAX® and placebo on Central Nervous System activation and behaviour following a nicotine challenge.

Main aim; to show that NicVAX attenuates nicotine induced CNS effects on brain activation and cognitive performance relative to placebo. The secondary aim; to evaluate how these changes in CNS stimulation alter subjective measures and the addictive…