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NCT ID: NCT01957163 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: October 1, 2013
Phase: Phase 3
Study type: Interventional

After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

NCT ID: NCT01955161 Completed - Alzheimer's Disease Clinical Trials

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

STARSHINE
Start date: October 2013
Phase: Phase 3
Study type: Interventional

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

NCT ID: NCT01949129 Recruiting - Clinical trials for Acute Lymphoblastic Leukaemia

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Start date: April 2013
Phase: Phase 2/Phase 3
Study type: Interventional

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

NCT ID: NCT01948830 Completed - Clinical trials for Age-related Macular Degeneration

Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD

TREND
Start date: December 2013
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration

NCT ID: NCT01933932 Active, not recruiting - Clinical trials for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

SELECT-1
Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

NCT ID: NCT01929135 Completed - Clinical trials for Chronic Periodontitis

Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.

Start date: May 2013
Phase: Phase 2
Study type: Interventional

Periodontal disease (PD) is an inflammatory, infectious and destructive condition of the tissues surrounding the teeth. However, even if bacteria are required to initiate periodontal disease, the immune response is responsible for most of the destruction of the periodontal tissues. Statins may be used to control the immune response to periodontal pathogens, a factor that has not yet been managed clinically and even less massively. Recently it has been reported the pharmacological effectiveness of topically used statins. For periodontal disease, at least four well conducted clinical trials have been published using a topically statin formula for pocket irrigation in adult populations with chronic periodontal disease, observing surprising clinical results in all of them (with clinical and statistical significance) and no adverse reactions. The purpose of the present study is asses the effectiveness of a medicated 2% atorvastatin dentifrice, as complement to non-surgical conventional periodontal treatment. Clinical examination will be made at the beginning and after one month of treatment.

NCT ID: NCT01927562 Completed - Type II Diabetes Clinical Trials

Initial Clinical Evaluation of an Endoscopic Therapy for Type 2 Diabetes

Start date: July 13, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and feasibility of the Fractyl Duodenal Remodeling System for the treatment of patients with poorly controlled Type 2 Diabetes.

NCT ID: NCT01926535 Completed - Bullous Keratopathy Clinical Trials

Amniotic Membrane Graft In Syntomathic Bullous Keratopathy

AMBUK
Start date: November 2011
Phase: Phase 2
Study type: Interventional

The amniotic membrane (AM) is an avascular structure derived from fetus, which is a good choice for regenerative medicine and effective treatment in eye surface pathologies such as bullous keratopathy (BK). This disease generates a chronic corneal edema evolving to the production of vesicles and bullae, chronic eye pain and visual acuity decrease. Definitive treatment for those patients is corneal transplant; however, donation is not always available and thus requires long waiting times. The currently available palliative treatment consists in the use of contact lenses to prevent the corneal epithelium from falling. However, this may be associated with corneal neovascularization, lens displacement or loss, infections, and discomfort for the patient. The objective of this work was to compare the use of amniotic membrane grafts versus contact lenses in patients suffering from BK awaiting a corneal transplant. A randomized clinical trial assay was performed with patients with a clinical diagnosis of BK. Twenty patients were randomized into 2 groups: amniotic membrane and therapeutic contact lenses. Eye pain intensity (Analog visual scale), visual acuity (Snellen questioner), bullae and corneal epithelial defects presence, as well as corneal neovascularization and complications (biomicroscopy) were compared during 6 months.

NCT ID: NCT01916603 Not yet recruiting - Obesity Clinical Trials

Diet, Physical Activity and Breastfeeding Intervention on Maternal Nutrition, Offspring Growth and Development

Start date: September 2013
Phase: N/A
Study type: Interventional

NCDs are observed mostly in adults, however there is strong evidence that suggests NCDs origin early in life, thus the first 1000 days of life (conception to age 2yrs). Studies show that maternal BMI before conception and during pregnancy predict future risk of obesity and associated metabolic conditions in both mother and offspring. Weight gain during the first two years of life is also critical in defining the infant's predisposition to obesity during adulthood. Objective: to assess the effectiveness of delivering a primary health care intervention to enhance compliance with updated nutrition and health care (diet, physical activity and breastfeeding) standards from early pregnancy through the first year of life. Methods: cluster randomized controlled trial (CRCT), designed as a public health intervention "program effectiveness" study (i.e. intervention will be available through the established national health system under standard operating conditions). A cluster unit will be a primary health care centers (PHCC) in South-East Santiago 12 PHCC will be randomly allocated to: enhanced nutrition and health care (intervention group) or routine nutrition and health care (control group).We will recruit 200 women in each of 12 PHCC; assuming a 20% loss to f-up we will complete 960 women per arm. After randomization, pregnant women in the intervention PHCCs starting at their first pre-natal visit (< 15 wks.) will receive, diet and physical activity (PA) counseling-support based on updated recommendations and monitoring goals for weight gain & glycemic control and breastfeeding (BF) promotion till 12 m postpartum. Pregnant women who attend control PHCCs will receive routine antenatal care according to national guidelines. Expected results: participants in the intervention PHCCs will benefit by achieving adequate nutritional status & metabolic control, during and early after, pregnancy as well as adequate infant growth & development as a result of improved nutrition and health care practices. The results will likely be generalizable through the primary health care system; considering this is a "program effectiveness" trial conducted under "real life" conditions . Additionally, we will include specific ancillary mechanistic projects to better characterize the intervention and its impact.