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NCT ID: NCT01117350 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

EAGLE
Start date: July 2010
Phase: Phase 4
Study type: Interventional

Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): >To assess the effect of insulin glargine in comparison with liraglutide on: - HbA1c level - Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period - Percentage of patients whose HbA1c has increased at the end of the comparative period - Fasting Plasma Glucose (FPG) - 7-point Plasma Glucose (PG) profiles - Hypoglycemia occurrence - Body weight - Adverse events Objectives of the extension period (24 weeks): >To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on: - HbA1c level - FPG - 7-point PG profiles - Hypoglycemia occurrence - Body weight - Adverse events

NCT ID: NCT01116713 Completed - Postoperative Pain Clinical Trials

Effect of Dexamethasone in Postoperative Symptoms After Mastectomy for Breast Cancer

dxt2010brca
Start date: June 2009
Phase: Phase 3
Study type: Interventional

Postoperative pain, nausea and vomiting (PONV) are the most common complications after anesthesia and surgery. Women undergoing mastectomy with axillary dissection are at a particularly high risk for the development of PONV and an incidence of 60-80% in patients receiving no antiemetic has been reported. Emetic episodes predispose to aspiration of gastric contents, wound dehiscence, psychological distress, and delayed recovery and discharge times. These justify the use of prophylactic antiemetics in women scheduled for mastectomy. Most of the currently used antiemetics, including antihistamines, butyrophenones and dopamine receptor antagonists have been reported to cause occasional undesirable adverse effects, such as excessive sedation, hypotension, dry mouth, dysphoria, hallucinations and extrapyramidal signs. Antiserotonins (e.g., ondansetron) are available for the prevention and treatment of PONV in patients undergoing various types of surgery [4]. However, the use of prophylactic antiemetic therapy with antiserotonins has been criticized for being too expensive. Dexamethasone was first reported to be an effective antiemetic regimen in patients receiving cancer chemotherapy. The purpose of this study was to evaluate the efficacy of dexamethasone treatment for reducing pain and PONV as well as analgesic and antiemetic requirements in women undergoing general anesthesia for mastectomy with axillary lymph node dissection.

NCT ID: NCT01114529 Completed - Clinical trials for Renal Transplantation

Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

ELEVATE
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study is designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

NCT ID: NCT01113567 Terminated - Liver Cirrhosis Clinical Trials

Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy

Start date: July 2010
Phase: N/A
Study type: Interventional

Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days. An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.

NCT ID: NCT01112371 Completed - Scars Clinical Trials

Contractubex Treatment in Scars After Abdominal Caesarean Section

ConMex
Start date: February 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean section compared to untreated scars after abdominal Caesarean section.

NCT ID: NCT01112306 Completed - Clinical trials for Pulmonary Arterial Hypertension

ACT-293987 in Pulmonary Arterial Hypertension

Start date: July 7, 2010
Phase: Phase 3
Study type: Interventional

Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

NCT ID: NCT01112189 Completed - Breast Cancer Clinical Trials

Use of Stem Cells in Lymphedema Post Mastectomy

SCL
Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The post-mastectomy lymphedema is a complication of removal of the breast and nodal plexus that causes accumulation of lymph and subsequent enlargement of the upper limb. It is the most common complication of all attributable to mastectomy with axillary dissection and which occurs in one third of patients who undergo radical mastectomy and radiotherapy post-operation. Currently the treatment of lymphedema of the upper limb is mainly the use of compression stockings, the use of pneumatic compression pumps and physiotherapy. Multiple reports indicate that endothelial progenitor cells (EPC) can differentiate into various cell lines, reproduced and participate in neoangiogenesis. This study was conducted in the General Surgery Service, of the Hospital Universitario "Dr. José Eleuterio González "and proposes the EPC obtained autologous transplantation of bone marrow for the treatment of postoperative lymphedema in upper limb following axillary lymphadenectomy through the stimulation of lymphatic neoangiogenesis. The investigators studied 20 female patients over 18 years after axillary lymphadenectomy. The objective is to develop an innovative and definitive treatment for these patients and to analyze the costs and complications that this treatment may have.

NCT ID: NCT01112085 Completed - Clinical trials for Diabetic Macular Edema

MIcrodoses of raNIbizumab in Diabetic MAcular Edema (MINIMA-2)

MINIMA-2
Start date: April 2010
Phase: Phase 2
Study type: Interventional

The objective of this study is to investigate if the drug ranibizumab administrated by microdose injection into the eye is safe and effective to treat diabetic macular edema.

NCT ID: NCT01111539 Terminated - Clinical trials for Major Depressive Disorder (MDD)

Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Start date: July 13, 2010
Phase: Phase 3
Study type: Interventional

This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.

NCT ID: NCT01110772 Recruiting - Clinical trials for Surgical Site Infection

Comparison of Iodine + Isopropyl Alcohol Versus Iodine + Antimicrobial Sealant for Skin Preparation

Start date: May 2009
Phase: Phase 4
Study type: Interventional

The purpose if this study is to determine whether a microbial sealant (iodine + cyanoacrylate) [InteguSEAL®, Kimberly-Clark] reduces surgical site infections when compared to iodine and isopropyl alcohol (povacrylex in isopropyl alcohol) [Duraprep®] in oncologic surgery.