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NCT ID: NCT01541579 Completed - Crohn's Disease Clinical Trials

Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's Disease

ADMIRE-CD
Start date: July 2012
Phase: Phase 3
Study type: Interventional

The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.

NCT ID: NCT01541423 Completed - Clinical trials for Hereditary Angioedema (HAE)

A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema

Start date: May 11, 2012
Phase:
Study type: Observational

This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.

NCT ID: NCT01541215 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes

Ellipse™
Start date: November 13, 2012
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is to assess the efficacy and safety of liraglutide in the paediatric population in order to potentially address the unmet need for treatment of children and adolescents with type 2 diabetes.

NCT ID: NCT01540812 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Treatment of Acute Lymphoblastic Leukemia HIGH RISK BCR / ABL NEGATIVE IN ADULTS

Start date: February 2012
Phase:
Study type: Observational

Trial protocol intended the optimization of induction treatment with: 1. Inclusion of PEG-ASP in induction and in the three blocks of consolidation. 2. Reduction of the dose of daunorubicin, and recent studies have shown that the use of high doses of anthracyclines has not brought higher response rates or longer duration 3. Replacing the poor cytological response at day 14 by the level of ER at the end of induction as a criterion to decide the further treatment (consolidation or second induction), so as to have only one criterion (the ER) throughout the study to decision making. For another hand, reducing non-essential drugs consolidation blocks to try to reduce toxicity during it, and replace the ASP E. coli in induction and consolidation of PEG-ASP to ensure a more sustained asparagine depletion. Also, increasing the dose of methotrexate (3 to 5 g/m2) in patients with ALL-T, since there is recent evidence of a higher response rate with this strategy. Performing an allo-HSCT early (after one cycle of consolidation) for patients with inadequate level of ER after two cycles of induction or in those patients who required two courses of induction and have obtained proper ER after the second. Conducting studies of RD centrally by cytofluorometry following Euroflow consensus standards, to avoid bias in making treatment decisions

NCT ID: NCT01540799 Completed - Clinical trials for High Frequency, High Disability Migraine

Pathway M-1: Sphenopalatine Ganglion Stimulation for the AcuteTreatment of High Disability Migraine Headache

Pathway M-1
Start date: February 2012
Phase: N/A
Study type: Interventional

The purpose of the clinical study is to evaluate the use of an implanted sphenopalatine ganglion (SPG) neurostimulator for the treatment of migraine headache pain, migraine headache symptoms and migraine frequency in high disability migraineurs.

NCT ID: NCT01539577 Completed - Macular Edema Clinical Trials

A Long-Term Safety Study of OZURDEX® in Clinical Practice

Start date: March 2012
Phase: N/A
Study type: Observational

This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.

NCT ID: NCT01539239 Completed - Clinical trials for Primary Open Angle Glaucoma

Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

Start date: January 2012
Phase: N/A
Study type: Interventional

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.

NCT ID: NCT01538394 Completed - Smoking Cessation Clinical Trials

Clinical Trial to Evaluate the Efficacy of Smoking Cessation

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

The purpose of this study is to assess the efficacy of smoking cessation by using varenicline as monotherapy (VRN + placebo patches) or combined therapy (VRN + nicotine patches).

NCT ID: NCT01537718 Completed - Bradycardia Clinical Trials

Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

DREAM
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

NCT ID: NCT01536132 Completed - Heart Failure Clinical Trials

Intermittent Intravenous Levosimendan in Ambulatory Advanced Chronic Heart Failure Patients

LION-HEART
Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of intravenous administration of intermittent doses of levosimendan (infusions of 0,2 μg/kg/min, of levosimendan or placebo, without bolus, for 6 hours every 2 weeks) compared to placebo in ambulatory patients with advanced chronic heart failure.