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NCT ID: NCT01807949 Completed - Clinical trials for Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation

TRANSPORT
Start date: April 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

NCT ID: NCT01807650 Completed - Wounds Clinical Trials

Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12)

BSG-12
Start date: March 2013
Phase: Phase 3
Study type: Interventional

The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

NCT ID: NCT01807520 Completed - Clinical trials for Moderate to Severe Nail Psoriasis

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Nail Psoriasis

TRANSFIGURE
Start date: June 20, 2013
Phase: Phase 3
Study type: Interventional

This purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.

NCT ID: NCT01807221 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

ARTS-HF
Start date: June 17, 2013
Phase: Phase 2
Study type: Interventional

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

NCT ID: NCT01806597 Completed - Clinical trials for Moderate to Severe Palmoplantar Psoriasis

Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

GESTURE
Start date: June 19, 2013
Phase: Phase 3
Study type: Interventional

Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.

NCT ID: NCT01805674 Completed - Menopause Clinical Trials

Isoflavones and Magnolia Extract in the Quality of Life in Menopausal Women

ESTROCALVI
Start date: March 2013
Phase: N/A
Study type: Observational

In menopause, the vasomotor symptomatology, accompanied or less by affective and behavioural symptoms, globally worsens the quality of daily life. The improvement of the quality could be reached with adequate food supplements, named phytoestrogens, in particular Soy Isoflavones (SI), which are natural substances with estrogen-like and estrogen-antagonistic activity, which are active in the control of menopausal vasomotor symptoms. Besides, combined with magnolia extract it could improve the psychological symptomatology also improving the quality of life.

NCT ID: NCT01804647 Completed - Clinical trials for Multiple Sclerosis (MS)

Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease

LOMBARD
Start date: November 2012
Phase:
Study type: Observational

This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients. The study will be conducted over one year in four cohorts of patients with different forms of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003, is performed in parallel and is part of another dedicated protocol).

NCT ID: NCT01803555 Completed - Asthma Clinical Trials

Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®

Start date: July 4, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.

NCT ID: NCT01803347 Completed - Anal Fistula Clinical Trials

Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

FISPAC
Start date: February 2013
Phase: Phase 3
Study type: Interventional

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

NCT ID: NCT01803295 Completed - Clinical trials for Carcinoma of Urinary Bladder, Superficial

Pre-TURBT TC-3 Gel Intravesical Instillation in NMIBC

OPTIMA
Start date: June 2013
Phase: N/A
Study type: Interventional

In the proposed study the investigators aim to evaluate the effect of the standard of care dose (40mg) of MMC mixed with TC-3 gel (with sustained release mechanism on the drug) on low risk recurrent NMIBC lesions and to compare our findings to instillation with the standard mode of instillation- 40mg MMC in water in order to examine our hypothesis that MMC mixed with TC-3 gel will have at least non-inferior and even superior results over the standard instillation mode The investigators believe that this study is of importance of several aspects: 1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode. 2. If proved effective this mode of treatment might save the need of TURBT performance and serve as a new mode of tumor ablation. 3. Even if proved partially effective this mode of treatment will diminish tumors size or number thus enable a more limited TURBT procedure. 4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT, which might improve the patient's prognostic outcome. 5. If this experimental treatment will prove to have a better ablative effect, this could be translated to a better prophylactic effect of tumor recurrence.