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NCT ID: NCT01689025 Terminated - Inflammation Clinical Trials

An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

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

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.

NCT ID: NCT01688375 Not yet recruiting - Clinical trials for Obstructive Jaundice

The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice

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

ABSTRACT: In patients with obstructive jaundice, multi-organ dysfunction may develop. The aim of this study is to evaluate the effect of ursodeoxycholic acid on liver functional restoration on patients with obstructive jaundice after surgical or endoscopic treatment. Patients with obstructive jaundice will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic or surgical procedure and will last fourteen days, and (B) control group. Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamyl transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic or surgical procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or surgical intervention. Our hypothesis is that patients with obstructive jaundice under treatment with ursodeoxycholic acid will have better outcome than patients in control group.

NCT ID: NCT01678898 Completed - Fabry Disease Clinical Trials

Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients

Start date: October 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.

NCT ID: NCT01677182 Terminated - Bipolar Disorder Clinical Trials

Safety and Efficacy Study of Ramelteon (TAK-375) Tablets for Sublingual Administration (SL) in Adults With Bipolar 1 Disorder

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

To evaluate the efficacy of ramelteon for treatment of acute depressive episodes associated with Bipolar 1 Disorder.

NCT ID: NCT01675427 Completed - Clinical trials for Hepatitis C, Chronic

A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C

Start date: August 2011
Phase: Phase 4
Study type: Interventional

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

NCT ID: NCT01674764 Completed - Clinical trials for Acute Spinal Cord Injury of Traumatic Origin (tSCI)

Surgical Treatment for Spinal Cord Injury

SCI-POEM
Start date: November 2012
Phase:
Study type: Observational

Despite many years of research, an incomprehensible amount of scientific efforts worldwide and billions of dollars invested, no effective therapy resulting in major neurological or functional recovery is available to date for traumatic spinal cord injury (tSCI). Although there is increasing experimental evidence from animal models that surgical decompression of the spinal cord improves recovery after tSCI, clinical studies have not shown conclusive data yet. The main explanations for this lack of convincing evidence are relatively small sample sizes in previous studies, their predominantly retrospective nature, suboptimal measurement methods for the assessment of neurological deficits, and inappropriate recording and documentation of potential confounding factors.

NCT ID: NCT01671059 Completed - Clinical trials for Rheumatoid Arthritis

A Non-Interventional Study Evaluating Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

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

This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

NCT ID: NCT01668797 Completed - Acute Schizophrenia Clinical Trials

Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

EQUATOR
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.

NCT ID: NCT01667562 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

ESSENCE
Start date: January 20, 2012
Phase: Phase 3
Study type: Interventional

This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.

NCT ID: NCT01667419 Completed - Melanoma Clinical Trials

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

BRIM8
Start date: September 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.