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Effects of BCG vaccination on immunological characteristics of hematopoetic stem cells: an explorative study

To examine the effect of BCG vaccination on the composition and function of the bone marrow.

A phase IIb, Double Blind, Randomized, placebo- controlled, Double-Dummy, Dose Rangining Study To Evaluate the Clinical Efficacy and Safety of Induction and Maintenance therapy with BMS- 945429 in subjects with Moderate to Severe Crohn's Disease.

Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…

A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer*s Disease Spectrum

The primary objective of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in subjects in the early AD spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ 54861911 (e.g., Study 54861911ALZ2002),…

A Phase 1b, randomized, partially double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of multiple doses of orally administered JNJ-53718678 in infants hospitalized with RSV infection

Primary ObjectivesThe primary objectives are to evaluate in infants who are hospitalized with RSV infection:• the pharmacokinetics of JNJ-53718678 after multiple oral doses;• the safety and tolerability of JNJ-53718678 when administered for 7 days.…

A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF VEMURAFENIB VERSUS VEMURAFENIB PLUS GDC-0973 IN PREVIOUSLY UNTREATED BRAFV600-MUTATION POSITIVE PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

Efficacy ObjectivesThe primary efficacy objective of study GO28141 is as follows:* To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive…

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis

Cohort 1:A data monitoring committee (DMC) will evaluate all available safety data from the study. The first 2 meetings for safety surveillance will occur after 50 and 100 subjects complete or discontinue from the Blinded Induction Phase from Cohort…

A Phase I Partially Blinded Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Rivastigmine with Glycopyrrolate or Trospium in Healthy Elderly Volunteers

Primary:To establish the safety and tolerability of rivastigmine when given with concomitant glycopyrrolate at an accelerated dose escalation schedule up to 12 mg BID.To establish the safety and tolerability of rivastigmine when given with…

Evaluation of Continuous Glucose Monitoring as a Tool to Measure Glucoregulatory Effects of a Twice Daily Oral Insulin Secretagogue

Primary:To estimate the treatment effects of vildagliptin 50 mg PO BID on 24h weighted-mean glucose (WMG), using CGM and plasma glucose, collected at the end of a two-week treatment period.Secondary:1) To estimate the treatment effects of…

A MR30365/07 dose-ascending, cohort group, single-blind pilot phase followed by a randomised, double-blind, placebo controlled parallel group study to compare the effect of intravenous MR30365/07 and intravenous fentanyl on respiration and analgesic responses, in healthy volunteers.

The aim of the main study is to compare the effects of MR30365/07 and fentanyl on ventilation and analgesic responses to noxious electrical and heat stimulation in healthy volunteers, by performing pharmacokinetic / pharmacodynamics (PK/PD) modeling…

A PHASE I STUDY, TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF SINGLE AND MULTIPLE DOSES OF ORALLY ADMINISTERED HM71224 IN HEALTHY, ADULT MALE VOLUNTEERS

Primary:To evaluate the safety and tolerability, and if possible to determine the maximum tolerated dose (MTD) of HM71224 after single and multiple ascending dose administration in healthy subjects.Secondary: To determine the pharmacokinetics (PK)…

A phase III, randomised, observer-blind, placebo-controlled,
multicentre, clinical trial to assess the prophylactic efficacy, safety,
and immunogenicity of GSK Biologicals* herpes zoster gE/AS01B
candidate vaccine when administered intramuscularly on a twodose
schedule to adult autologous haematopoietic stem cell
transplant (HCT) recipients.

The purpose of this study is to test how well a new vaccine works to protect against shingles in people after they have received a transplant with their own blood stem cells.

Assessing the Effect of Missing Doses (Off-Days) of Daily Medication in Patients Stable on Pharmacotherapy for ADHD Receiving Atomoxetine or OROS Methylphenidate: A Parallel Matched Group Clinical Study (On/Off Study)

The primary objective of the study is to assess the effect of missed doses of atomoxetine and OROS methylphenidate in ADHD patients who are stable on pharmacotherapy based on the patient*s daily behavior as assessed by the Daily Parent Report of…

Clinical outcome and cost effectiveness analysis of nutritional rehabilitation on physical functioning and cardiometabolic risk profile in COPD patients with muscle atrophy

To study in clinically stable COPD patients with muscle atrophy eligible for out-patient pulmonary rehabilitation:1.The short-term effects of 4 months exercise training including nutritional supplementation versus exercise training alone on physical…

A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNF?? Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy

The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by more or equal to 5 joints with active arthritis despite MTX therapy…

EVALUATION OF THE EFFICACY AND SAFETY OF 6 REPEATED DAILY
DOSES OF NEBULISED RPL554 0.018 mg/kg (6X)
IN ALLERGIC ASTHMATICS

To investigate the efficacy of repeated daily doses of nebulised RPL554 (0.018 mg/kg) by assessing the effect on FEV1 at day 1, 3 and 6 after daily inhaled doses of nebulised RPL554 0.018 mg/kg (6X) in 16 allergic asthmatics.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Postherpetic Neuralgia and Post-Traumatic Neuralgia, Followed by a Double Blind Safety Extension and an Open-Label Safety Extension

Primary Objectives• To evaluate the analgesic efficacy of JNJ-42160443 (1, 3, and 10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity, in subjects with postherpetic neuralgia neuralgia • To…

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain

Primary ObjectivesThe primary objectives of this study are to evaluate the analgesic effect size over 12 weeks of several doses and dosage regimens of JNJ-42160443 compared with placebo in subjects with moderate to severe, chronic, low back pain (…

Thiazolidinedione Intervention with Vitamin D Evaluation (TIDE). A Multicenter Randomized Double-Blind Placebo-Controlled Trial of a Thiazolidinedione (TZD) or Placebo and of Vitamin D or Placebo In People With Type 2 Diabetes at Risk For Cardiovascular Disease.

This trial will determine the relative incidence of CV outcomes compared to placebo forthe TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to thetherapeutic regimen of a person with type 2 diabetes who has additional…

The protective effect of tomato ketchup consumption on inflammation induced ex-vivo in human blood

The objectives of the study are to investigate the acute effects of a single consumption of tomato ketchup on ex-vivo elicited inflammation (release of the cytokines TNF-α, IL-8 and IL-10 upon LPS stimulation), chemotaxis of monocytes ex-vivo and on…

LUME-Lung 3. A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first line NSCLC patients with squamous cell histology.

Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…