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NCT ID: NCT01892722 Recruiting - Multiple Sclerosis Clinical Trials

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Start date: July 26, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

NCT ID: NCT01892618 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Pneumococcal Vaccine in Untreated CLL Patients

Start date: August 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether patients with chronic lymphocytic leukaemia (CLL) will benefit from vaccination with a 13-valent conjugated pneumococcal vaccine, Prevenar13, compared with a conventional 23-valent capsular polysaccharide vaccine in terms of immune response.

NCT ID: NCT01891240 Recruiting - Pregnancy Clinical Trials

IMproved PRegnancy Outcome by Early Detection

IMPROvED
Start date: November 2013
Phase: N/A
Study type: Observational

The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia. This will involve a multicentre, phase IIa clinical predictive study to assess and refine novel and innovative prototype tests based on emerging metabolomic and proteomic technologies developed by SMEs (small to medium size enterprise) within the consortium. The study will i) recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms translate to the clinical environment; iv) assess potential synergy of a combined metabolomic and proteomic approach and v) progress regulatory approval and development of the selected test into the clinical arena.

NCT ID: NCT01888159 Not yet recruiting - Ovarian Cancer Clinical Trials

Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve

Start date: September 2013
Phase: N/A
Study type: Interventional

Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.

NCT ID: NCT01887912 Terminated - Clinical trials for Clostridium Difficile Infection

Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Start date: July 30, 2013
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: - To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: - To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. - To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: - To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: - To describe the safety profile of all participants who received at least 1 injection.

NCT ID: NCT01887405 Completed - Clinical trials for Handling of Auto-injectors

Comparative Evaluation of Handling Characteristics of Two Adrenaline Autoinjectors,EpiPen in Comparison With Jext

HEJ
Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of the study is to demonstrate non-inferiority of Jext compared with EpiPen for the proportion of subjects with a successful self-injection. And to evaluate and compare the handling characteristics of two auto-injectors (Jext and EpiPen).

NCT ID: NCT01885377 Completed - Shoulder Pain Clinical Trials

SWESS: The SWedish Exercise Shoulder Study in Primary Care for Patients With Subacromial Pain

SWESS
Start date: September 2011
Phase: N/A
Study type: Interventional

Objective: A randomized clinical trial in order to evaluate the efficacy of a specific exercise strategy for patients with subacromial pain. Hypothesis: H1 - The three month specific exercise strategy has a satisfactory effect improving shoulder function and/or shoulder pain. H0 - No difference between the two exercise strategies (specific exercise strategy and active control exercises). Method: Patients attending primary care with subacromial pain are offered participation. If accepted, they will participate in a three month rehabilitation program. The duration of symptoms can vary from 2 weeks and longer. The patients will be randomized to either rehabilitation; the specific exercise strategy or active control exercises. All patients has an equal number of sessions with the physical therapist (PT) to offer similar attention and support with exercise performance. A blinded physical therapist evaluates the following outcomes at baseline and after three-, six and twelve months: Primary outcomes: Constant-Murley shoulder assessment (CM-score). Secondary outcomes; Disabilities of the Arm Shoulder and Hand questionnaire (DASH), different aspects of pain by Visual Analogue Scale (VAS), EuroQol-5D index (EQ-5D) and EuroQol-VAS (EQ-VAS), The Patient Specific functional Scale, and Patients' global impression of change (PGIC). Also sick-leave and return to work will be recorded. All patients are evaluated with a diagnostic ultrasound to reveal the status of the rotator cuff. Additional to the analysis of treatment effect on shoulder function and pain, factors influencing and explaining the CM-score at follow-ups will be analyzed. This study is warranted in order to evaluate if an earlier reported positive effect on shoulder function and pain with the specific exercise strategy, in patients on waiting list for subacromial decompression, can be repeated in the primary care population of patients with subacromial pain. There is no consensus about first-line exercises for patients with subacromial pain, and these positive results on pain and shoulder function need to be reproduced in primary care before they can be recommended and implemented. Further, knowledge about which factors that can be used in prediction rules for patients that will respond to the exercises or needs surgery is lacking.

NCT ID: NCT01885078 Completed - Clinical trials for Rheumatoid Arthritis

An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis

RA-BEYOND
Start date: June 27, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The study provides 7 years of additional treatment with baricitinib.

NCT ID: NCT01885026 Completed - Clinical trials for Substance Use Disorders (SUD)

Substance-focused SBI as a Complement to Internet-based Psychiatric Treatment: RCT

eScreeniPsy
Start date: July 2013
Phase: N/A
Study type: Interventional

Objectives: This study evaluates the efficacy of eScreen for internet psychiatry patients treated for major depressive disorder, panic anxiety and social phobia. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. Method: This is a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) and/or problematic drug use (DUDIT > 1 for both men and women) are randomized into one of two groups: T1, eScreen referral or Control group. Outcomes on alcohol and drug use as well as health-related symptoms are assessed after 3, 6 and 12 months. The hypothesis is that the group receiving the eScreen intervention will reduce their alcohol/drug use to a larger extent than the control group at follow-up compared to the baseline level.

NCT ID: NCT01885000 Completed - Rosacea Clinical Trials

Patient-Reported Outcome Of Facial Erythema (PROOF)

PROOF
Start date: July 1, 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the patient-reported outcomes (feedbacks of patients)of a new drug for the treatment of erythema of rosacea (central facial redness). The feedback of patients receiving the active drug will be compared to the feedback of patients receiving the placebo.