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NCT ID: NCT01640080 Completed - Clinical trials for Major Depressive Disorder

A Study of the Efficacy of Intravenous Esketamine in Adult Patients With Treatment-Resistant Depression

Start date: June 27, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy of esketamine compared with placebo in improving symptoms of depression in patients with treatment resistant depression.

NCT ID: NCT01639833 Completed - Hemorrhage Clinical Trials

A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Verisetâ„¢ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery

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

The objective of this study is to assess the safety and effectiveness of Verisetâ„¢ Hemostatic Patch in cardiovascular procedures by comparing Verisetâ„¢ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or CABG.

NCT ID: NCT01639339 Completed - Lupus Nephritis Clinical Trials

Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

BLISS-LN
Start date: July 12, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

NCT ID: NCT01639105 Completed - Clinical trials for Scars After Surgical Intervention

10 600 nm Ablative Fractional Laser Treatment of Scars: a Prospective Single Blinded Within Patient Controlled Randomized Trial

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

Rationale The cosmetic aspect of scars is a frequent reason for consultation. It plays an important role in patient satisfaction and self-image. Several treatment modalities are proposed for scars with variable success. Ablative fractional laser treatment is a rather new concept. Many microscopic small laser beams target the dermis in a grid pattern. The vertical columns of skin hit by the laser beams heat up. This thermal effect stimulates the wound healing and potentially leads to a remodeling of the skin structure. Ablative fractional laser treatment has been used successfully for treatment of pigment changes, wrinkles, acne scars and thermal burn wounds. It has been reported that CO2 ablative fractional laser treatment has a positive clinical effect on various types of scars however this has not been proven yet in a prospective randomized trial. The low morbidity of the treatment and the lack of convincing adapted treatment modalities for various types of scars make this treatment attractive. That's why the investigators aim with this randomized study to evaluate the clinical effect and the safety of 10 600 nm ablative fractional laser therapy for patients with recent scars due to surgical interventions. Goal Evaluate the efficacy of three 10 600 nm ablative fractional laser treatments for the above mentioned scars, three months after the last laser treatment, with a prospective randomized intra-patient controlled study. Study design Prospective single blinded randomized intra-patient controlled study. The study comprises 4 study visits. Study population The population consists of one group of patients with scars after recent surgical operations. The patients must meet the inclusion and exclusion criteria described in the protocol. Method The scar will be divided in two equal halves. The two halves will be randomized. One part will not be treated. The other part will undergo three times the 10 600 nm ablative laser therapy with 4 weeks interval between the treatments. The efficacy of the treatment will be evaluated three months after the last treatment with objective and subjective parameters. Most important study endpoints: - Evaluation of the efficacy of the treatment. A blinded clinical scar evaluation will be done of the treated and untreated parts with the POSAS scar scale, by a study collaborator and by the patient himself, on a category scale of 0 to 10 (0 = normal skin, 10 = worst scar imaginable), before start and twelve weeks after the last treatment. - Evaluation of the pain related to the treatment. The pain will be scored by the patient with the VAS category scale from 0 to 10 (0 = no pain, 10 = worst pain ever). - Evaluation of the side effects of the treatment. A standardized form will be used. - Evaluation of the global patient satisfaction regarding the treatment. - Clinical photos, before start and twelve weeks after the last treatment.

NCT ID: NCT01639014 Completed - Ischemic Stroke Clinical Trials

Effect of F2695 on Functional Recovery After Ischemic Stroke

LIFE
Start date: July 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.

NCT ID: NCT01638000 Completed - Urologic Diseases Clinical Trials

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

BEYOND
Start date: June 12, 2012
Phase: Phase 3
Study type: Interventional

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

NCT ID: NCT01637272 Completed - Clinical trials for Dumping Syndrome Patients

Intra-patient Dose Escalation Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome

Start date: January 2013
Phase: Phase 2
Study type: Interventional

multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome

NCT ID: NCT01636102 Completed - Human Influenza Clinical Trials

Safety and Immunogenicity of a Subunit Trivalent Nonadjuvated Influenza Study Vaccine in Adults Aged 18 Years and Above

Start date: July 2012
Phase: Phase 2
Study type: Interventional

To evaluate the safety of a single intramuscular (IM) injection of trivalent nonadjuvated influenza study vaccine, formulation 2012/2013, in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

NCT ID: NCT01636076 Completed - COPD Clinical Trials

Efficacy and Safety of QMF149 vs. Salmeterol Xinafoate/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: November 2012
Phase: Phase 2
Study type: Interventional

To compare the efficacy, safety and pharmacokinetics of QMF149 delivered via Concept1 to salmeterol xinafoate/fluticasone propionate delivered via Accuhaler in adult patients with COPD

NCT ID: NCT01634152 Completed - Asthma Clinical Trials

Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma

Start date: July 2012
Phase: Phase 3
Study type: Interventional

The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.