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NCT ID: NCT01754480 Completed - Clinical trials for Parenchymous Tissue Surgical Bleeding

Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

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

This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that FS Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of FS Grifols and a Primary Part (II) to assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either FS Grifols or Surgicel.

NCT ID: NCT01753349 Completed - Cervical Dystonia Clinical Trials

Phase IV-Cervical Dystonia-INTEREST IN CD2

INTEREST_INCD2
Start date: December 2012
Phase:
Study type: Observational

The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

NCT ID: NCT01753193 Completed - Clinical trials for Lupus Erythematosus, Systemic

An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

Start date: March 28, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

NCT ID: NCT01751399 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Single Dose Study of LY2605541 in Participants With Liver Impairment

Start date: December 2012
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to help answer the following research questions: - To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function - To assess the safety of LY2605541 and any side effects that might be associated with it

NCT ID: NCT01751126 Completed - Clinical trials for Vernal Keratoconjunctivitis

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

NCT ID: NCT01751022 Completed - Heart Failure Clinical Trials

Attain Performa(TM) Quadripolar Lead Study

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

The purpose of the study is to evaluate the safety and efficacy of the Medtronic Attain Performa Quadripolar Leads (Model 4298, 4398, and 4598) during and post the implant procedure. This study will also assess the interactions of the Attain Performa leads with the entire Medtronic CRT-D system.

NCT ID: NCT01750281 Completed - Clinical trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Assess Efficacy and Safety of AZD6244 in Combination With Docetaxel in Patients Receiving Second Line Non Small Cell Lung Cancer Treatment.

SELECT-2
Start date: December 18, 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to treat patients with locally advanced or metastatic NSCLC with a combination therapy of selumetinib and two different doses of docetaxel 75mg/m2 or 60 mg/m2 vs placebo and compare how well each dose affects how their cancer responds. It will also help us to understand the tolerability profile of the different dosing regimens in these patients

NCT ID: NCT01748448 Completed - Clinical trials for Cutaneous Malignant Melanoma

Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

ViDMe
Start date: December 2012
Phase: Phase 3
Study type: Interventional

To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

NCT ID: NCT01747915 Completed - Clinical trials for Generalized Tonic Clonic Seizures

A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

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

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

NCT ID: NCT01743989 Completed - Clinical trials for Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

ENESTPath
Start date: April 15, 2013
Phase: Phase 3
Study type: Interventional

This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.