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NCT ID: NCT01659723 Completed - Clinical trials for Cystitis, Radio Induced

Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial

RICH-ART
Start date: August 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this study is to assess the relief of symptoms after Hyperbaric Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate cancer Index Composite (EPIC)symptom estimation scale as primary variable. Study hypothesis: - HBOT can reduce or reverse the change or otherwise limit the damage of the bladder function and/or structure, which arose as a result of radiation therapy of cancer in the pelvic region organs. - The effects of HBOT are associated with relief of symptoms that, at least in part, is related to the reduction of the extent of the radiation damage. - Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as a sign of an improved function of the mucosa. - Treatment results of HBOT remains, in whole or in part, during the follow-up (residual effect)

NCT ID: NCT01657305 Completed - Wounds Clinical Trials

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

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

The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

NCT ID: NCT01651195 Completed - Clinical trials for Respiratory Tract Infections

Probiotics and Infections in Conscripts in Military Service

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

The aim was to study whether probiotic intervention has an impact on seasonal occurrence of upper respiratory and gastrointestinal infections in two different conscript groups. In a randomised, double-blinded, placebo controlled study a total of 983 healthy adults were enrolled from two intakes of conscripts. Conscripts were randomised to receive either a probiotic combination of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium animalis ssp. lactis BB12 (BB12) or a control chewing tablet twice daily for 150 days (recruits) or for 90 days (reserve officer candidates). Clinical examinations were carried out and daily symptom diaries were collected. Outcome measures were the number of days with respiratory and gastrointestinal symptoms and symptom incidence, number and duration of infection episodes, number of antibiotic treatments received and number of days out of service because of the infection. Statistically no significant differences were found between the intervention groups either in the risk of symptom incidence or duration. However, probiotic intervention was associated with reduction of specific respiratory infection symptoms in military recruits, but not in reserve officer candidates. Probiotics did not significantly reduce overall respiratory and gastrointestinal infection morbidity.

NCT ID: NCT01649856 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

Start date: August 24, 2012
Phase: Phase 3
Study type: Interventional

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.

NCT ID: NCT01649778 Completed - Clinical trials for Carcinoma, Renal Cell

Observational Study of Real World Effectiveness Data and Safety in Patients Receiving Pazopanib With Advanced or Metastatic Renal Cell Carcinoma

PRINCIPAL
Start date: July 19, 2012
Phase:
Study type: Observational

This is a global, multi-centre, long-term, prospective, observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated for the first time with pazopanib. The study is designed to enroll approximately 700-1000 patients in over the course of an enrollment period of approximately 18 months.There are no protocol-mandated visits or procedures associated with the study. Each patient is expected to participate for a maximum of 30 months or until premature discontinuation (i.e., due to death, withdrawal of consent, lost to follow-up or study termination).

NCT ID: NCT01649375 Completed - Clinical trials for Anklyosing Spondylitis

16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

MEASURE2
Start date: October 18, 2012
Phase: Phase 3
Study type: Interventional

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

NCT ID: NCT01644474 Completed - Clinical trials for Hypercholesterolemia

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

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

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points - To evaluate the effect of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab

NCT ID: NCT01638416 Completed - Transfusion Clinical Trials

Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial

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

In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.

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: 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