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NCT ID: NCT02260674 Completed - Alzheimer's Disease Clinical Trials

A Safety and Tolerability Study of JNJ-54861911 in Participants With Early Alzheimer's Disease

Start date: November 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 during 6 months of treatment in participants with early (predementia) alzheimer's disease (AD [degenerative disease of the brain characterized by the insidious onset of dementia, impairment of memory, judgment, attention span, and problem solving skills are followed by severe apraxias and a global loss of cognitive abilities]).

NCT ID: NCT02259712 Completed - Clinical trials for Urinary Incontinence

Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy

HEPFD
Start date: October 2013
Phase: N/A
Study type: Interventional

Introduction: Hypopressive Exercises are included within a method of physiotherapy which was created with the purpose of strengthening the deep muscles of the abdomen without damaging ligamentous and muscular structures of the perineum, also strengthening the muscles of pelvic floor reflexively. Although this technique has been included as treatment and a prevention method of pelvic floor dysfunction, there are few studies supporting its benefits. The investigators hypothesis is that the combination of both physiotherapy treatments will provided the best results for women who suffer pelvic floor dysfunctions. Objective: To determine whether Hypopressive Exercises are an option to include in the physiotherapy treatment of women suffer at least one pelvic floor dysfunction and whether the results reported are comparable to those provided by pelvic-perineal physiotherapy. Subjects and methods: A randomized clinical trial, the examiner being blinded unaware of the intervention group to which subjects were assigned. Participants will be randomly assigned to three groups: 1. An experimental group, where the participants will be treated by Hypopressive exercises and hygienic and behavioral measures; 2. Another experimental group where pelvic-perineal physiotherapy will join with Hypopressive exercises and hygienic and behavioral advises; 3. And a third group where will be done pelvic-perineal physiotherapy and hygienic and behavioral measures. Pre- intervention, immediate post-intervention, 3, 6 and 12 months assessments will be made. The selection criteria will be: adult women who present signs and symptoms that indicate a pelvic floor dysfunction or have a medical diagnosis to confirm it. All participants must understand and sign freely Informed Consent. Sample size: Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 26 subjects were required in each group to detect a difference equal to or greater than 3 microvolts (Total of 78 subjects). It assumes a standard deviation of 4.8 microvolts and the rate of loss to follow up esteem 20% (Magalhães-Resende et al. 2012). Data Analysis: A descriptive analysis of all variables was performed. It establish for all cases a confidence level of 95% (p <0.05). The effectiveness was assessed by comparing the experienced change of the three goups in outcome variables between physicaltherapy examinations.

NCT ID: NCT02259582 Completed - Clinical trials for Nonsquamous Nonsmall Cell Neoplasm of Lung

A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer

DENALI
Start date: February 2015
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. The administration of carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small cell lung cancer.

NCT ID: NCT02258542 Completed - Asthma Clinical Trials

A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

BORA
Start date: November 19, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

NCT ID: NCT02258451 Completed - Breast Neoplasms Clinical Trials

Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer

Start date: June 4, 2015
Phase: Phase 2
Study type: Interventional

The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.

NCT ID: NCT02258126 Completed - Obesity Clinical Trials

Effect of Exercise on Hepatic Fat in Overweight Children

EFIGRO
Start date: November 2014
Phase: N/A
Study type: Interventional

The objective of the present study is to evaluate the effect of 6 months exercise intervention program on hepatic fat fraction in overweight children. Methodology: A total of 160 children, 9-11 years old, will be randomly assigned to control (N=80) or intervention (N=80) groups. Training sessions will include 90 minutes of exercise, comprising warm-up and skill development. The control group will attend a healthy lifestyle education program (2 days/month) and the intervention group an exercise (3 days/week) and healthy lifestyle education (2 days/month) combined program. Before and after the intervention (6 months) hepatic fat fraction, body composition, , and cardiometabolic risk factors will be measured. Furthermore, dietary habits and physical activity, blood pressure and pubertal development will be evaluated before and after the intervention.

NCT ID: NCT02257567 Completed - Lymphoma Clinical Trials

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

Start date: October 15, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.

NCT ID: NCT02256319 Completed - Parkinson's Disease Clinical Trials

Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators

DEXPROPAR
Start date: September 2014
Phase: Phase 4
Study type: Interventional

This clinical trial has been designed to study and compare changes in deep brain activity (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation with dexmedetomidine or propofol. The recording is made through a deep brain stimulation (DBS) electrode implanted for PD management. The investigators hypothesize that dexmedetomidine produces fewer changes as compared to propofol, and that those changes are consistent and recognizable when compared to activity in patients not exposed to any sedation. Typification of those changes would in the future allow for patients to undergo this surgery comfortably while not compromising the quality of the recording and of the final clinical outcome. The principal variable analyzed is the signal's power in each of the frequency bands, absolute and relative. The analysis will include usual clinical methods such as rapid Fourier transform (FFT) and window fast Fourier transform (WFFT), wavelet analysis, Gabor, and coherence.

NCT ID: NCT02255656 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

TOPAZ
Start date: January 7, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: - To evaluate long term efficacy of alemtuzumab. - To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. - To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. - To evaluate as needed re-treatment with alemtuzumab and other DMTs.

NCT ID: NCT02254967 Completed - Clinical trials for Clostridium Difficile

A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

EXTEND
Start date: November 6, 2014
Phase: Phase 4
Study type: Interventional

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).