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NCT ID: NCT01109212 Completed - Clinical trials for Diabetic Nephropathy

The Effects of Bindarit in Diabetic Nephropathy

Start date: March 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether bindarit is effective to reduce albuminuria, compared to placebo, in nephropathic patients treated with irbesartan, as a background therapy.

NCT ID: NCT01108510 Completed - HIV Infections Clinical Trials

Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and efficacy of a regimen containing Cobicistat (COBI)-boosted atazanavir (ATV/co) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus FTC/TDF in HIV-1-infected, antiretroviral treatment-naive adults. Development of COBI as a "pharmacoenhancer" could provide a beneficial alternative to RTV for use in combination with protease inhibitors.

NCT ID: NCT01107886 Completed - Clinical trials for Type 2 Diabetes Mellitus

Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

SAVOR- TIMI 53
Start date: May 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

NCT ID: NCT01107444 Completed - Clinical trials for Non-small Cell Lung Cancer

Study of LY2181308 in Combination With Docetaxel Versus Docetaxel in Patients With Non-Small Cell Lung Cancer

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the anti-tumor activity of LY2181308 in combination with docetaxel compared to docetaxel alone in participants with non-small cell lung cancer who were previously treated with first line chemotherapy.

NCT ID: NCT01107197 Completed - Pressure Ulcers Clinical Trials

Nutritional Support in Pressure Ulcer Patients

OEST
Start date: February 2010
Phase: N/A
Study type: Interventional

Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.

NCT ID: NCT01106586 Completed - HIV Infections Clinical Trials

Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Start date: April 2010
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

NCT ID: NCT01106430 Completed - Clinical trials for Attention-Deficit/Hyperactivity Disorder

Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

Start date: June 28, 2010
Phase: Phase 3
Study type: Interventional

This study will evaluate how long it takes for ADHD symptoms to improve in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate therapy. The study will also test the safety of Lisdexamfetamine Dimesylate and how well it works.

NCT ID: NCT01106261 Completed - Colorectal Cancer Clinical Trials

A Randomised Trial of Pulmonary Metastasectomy in Colorectal Cancer

PulMiCC
Start date: December 2, 2010
Phase: N/A
Study type: Interventional

Patients who have been treated successfully for bowel cancer (colorectal cancer) sometimes go on to develop nodules of disease in another part of the body. If this disease is found to be related to the original cancer it is called a metastasis. Some patients develop one or more metastases particularly in the lungs or the liver. There is a growing trend to remove lung metastases with an operation, in the belief that this will help patients live longer, however there have not been any scientific studies to prove this. There is also very little published information about the side effects of this surgery and how it affects subsequent daily living. This is a feasibility study to determine whether it will be possible to conduct a large randomised controlled trial investigating the value of pulmonary metastasectomy (surgery to remove lung metastases) in patients who have been successfully treated for colorectal cancer. There is a two stage consent and randomisation process. Firstly, patients will be invited to consent to having a full range of investigations to assess their suitability for surgery. If found to be suitable, they will then be invited to consent to randomisation between active monitoring of their disease or active monitoring with pulmonary metastasectomy. Patients will be followed up regularly for 5 years to assess their disease status and to measure their quality of life and lung function.

NCT ID: NCT01106014 Completed - Clinical trials for Pulmonary Arterial Hypertension

Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

GRIPHON
Start date: December 1, 2009
Phase: Phase 3
Study type: Interventional

The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

NCT ID: NCT01104727 Completed - Cholelithiasis Clinical Trials

Multi-Port Versus Single-port Cholecystectomy

MUSIC
Start date: April 2011
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare results of the new surgical strategy to the traditional 4-ports technique for cholecystectomy in a randomized controlled trial (RCT). In particular we are going to investigate the procedures in terms of overall morbidity, while taking into considerations skin-incision's related morbidity, postoperative pain and cosmetic results which are the hypothetical benefits of the new approach. Other parameters are supposed to be unchanged, considering evidences from recent literature. Surgical procedures: 4 ports cholecystectomy (4PC): a 12mmHg pneumoperitoeum is created either by a 10mm umbilical Hasson's port or by a Verress needle followed by a 10mm umbilical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique. Single Port Access cholecystectomy (SPC): the single-port device is inserted through the umbilicus, by means of an adeguate incision, as the only access to the abdominal cavity. A trans-abdominal suture in right hypochondrium is placed through the gallbladder wall of the fundus to retract it. Primary endpoint: overall morbidity rate (at 60 days from surgery) Secondary endpoints: 1. skin-incision's related morbidity rate (at 60 days from surgery) 2. perioperative pain 3. cosmetic results 4. long-term morbidity (12 months) 5. intraoperative time 6. "conversion SPC to 4PC" rate 7. "conversion to laparotomy" rate 8. hospital stay