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NCT ID: NCT02479880 Terminated - Hepatitis B Clinical Trials

Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection

Start date: July 3, 2015
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to characterize the long term (ie, 96 weeks of follow up) bone safety profile of open-label tenofovir disoproxil fumarate (tenofovir DF) treatment in CHB-infected adolescents. This includes prospectively evaluating and comparing the bone mineral density (BMD) change between CHB-infected adolescents 12 to < 18 years of age treated with tenofovir DF in European treatment centers who are assigned to one of two schedules for renal and bone laboratory monitoring and BMD measurement.

NCT ID: NCT02479386 Terminated - Geographic Atrophy Clinical Trials

A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Proxima A
Start date: June 24, 2015
Phase:
Study type: Observational

This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study is also intended to generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 48 months. There is a planned interim analysis around the 2-year time window for the study.

NCT ID: NCT02479204 Terminated - Healthy Subjects Clinical Trials

Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441

Start date: April 28, 2015
Phase: Phase 1
Study type: Interventional

The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.

NCT ID: NCT02477800 Terminated - Alzheimer's Disease Clinical Trials

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

ENGAGE
Start date: August 13, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].

NCT ID: NCT02474888 Terminated - Clinical trials for Microscopic Polyangiitis

Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis

MONITUX
Start date: September 15, 2015
Phase:
Study type: Observational

The aim of the investigators' study is to evaluate whether monitoring serum rituximab levels could be an interesting tool in the follow-up of ANCA-associated vasculitis patients. All consecutive patients, hospitalized for a new diagnosis of ANCA-associated vasculitis or the relapse of a known ANCA-associated vasculitis, in which the decision to start an induction regimen with rituximab has been taken, will be included. Serum rituximab levels (along with serum anti-rituximab antibodies levels) will be determined (at M+1 and M+3) and the correlation with clinical outcome at M+6 will be analyzed.

NCT ID: NCT02474719 Terminated - Clinical trials for End-stage Renal Disease

Transfer and Ultrafiltration In Peritoneal Dialysis

TULIPE
Start date: January 2015
Phase: N/A
Study type: Interventional

The aim of this study is to demonstrate the efficiency of an adapted and "alternate" peritoneal dialysis scheme in terms of sodium extraction and purification compared to an adapted conventional peritoneal dialysis scheme.

NCT ID: NCT02474706 Terminated - Clinical trials for Urinary Tract Infections

Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli

COLIFOX
Start date: March 2016
Phase: Phase 4
Study type: Interventional

Background Information: Infections caused by extended-spectrum β-lactamase (ESBL)-producing Escherichia coli are becoming increasingly common owing to incorrect use of antibiotics and cross-transmission in healthcare establishments. These give rise to major problems in standard clinical practice: penicillins and cephalosporins cannot be used, and resistance to the other classes of antibiotics normally used, such as fluoroquinolones or cotrimoxazole, is very frequently observed. The current therapeutic strategy involves the use of a carbapenem, which represents the last effective solution on an individual level. However, the growing use thereof is contributing, collectively, to the development of resistance due to the production of carbapenemases, which will become a major public health problem, with a potential therapeutic dead-end. This observation is particularly worrying due to the very small number of antibiotic agents currently in development. Infectious disease specialists and microbiologists are thus examining alternative agents to carbapenems in the management of infections caused by ESBL-producing E. coli. One of the avenues which could be developed is the use of known agents, already on the market, which are active in vitro on ESBL-producing E. coli, but which are not currently recommended for this indication in standard practice due to the lack of conclusive studies. Cefoxitin, an antibiotic belonging to the cephamycin group, could thus represent an alternative of particular interest in the treatment of infections caused by ESBL-producing E. coli, and help limit the use of carbapenems. The implementation of a prospective, randomized, non-inferiority study on ertapenem and cefoxitin is of the most interest from a methodological perspective. It will enable recommendations to be drawn up, with a high level of evidence, very long-awaited in the field. Primary objective: To evaluate the bacteriological non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin. Secondary objectives: - To evaluate the clinical non-inferiority of cefoxitin versus imipenem in the treatment of non-severe urinary tract infections (other than cystitis) caused by ESBL-producing E. coli susceptible in vitro to cefoxitin. - To evaluate the impact of cefoxitin and imipenem on the emergence of multiresistant bacteria in the gut flora.

NCT ID: NCT02473744 Terminated - Edema Clinical Trials

Oedematous Lower Limb Subcutaneous Drainage in Palliative Care

DSOPAL
Start date: July 27, 2015
Phase: N/A
Study type: Interventional

- Background : Edema of lower extremities is a concern ranging from 19 % to 60% of palliative cancer patients. Lymphedema decreases mobility, induces pain, impacts daily activities, esthetic and behavior. Usual treatment is based on diuretics and physiotherapy but is often unsuccessful. In case of conventional treatment failure, in palliative care, subcutaneous drainage can be discussed with the patients. The technique is simple, easy to use but remains off the record. Since 2004, 23 cases were reported with various methods. All the cases reported were undertaken with various technical approaches and efficacy criteria. - Purpose : Investigator hypothesize that the subcutaneous drainage of edema (SDO) is effective in case of refractory lymphedema of the lower limbs in palliative care and leads to an improvement in QOL in terms of behavioral and autonomy.

NCT ID: NCT02473029 Terminated - Horton Disease Clinical Trials

Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease

HORTIM
Start date: December 2014
Phase:
Study type: Observational

The study aims at measuring the sensitivity and specificity of a series of imaging signs (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis of Horton disease, the gold standard being the result of temporal artery biopsy.

NCT ID: NCT02472483 Terminated - Bipolar Disorder Clinical Trials

Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response

TCC-MBCT
Start date: September 13, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a large sample of refractory bipolar I patients on mood stabilizers.