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NCT ID: NCT02737501 Completed - Lung Cancer Clinical Trials

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

ALTA-1L
Start date: May 26, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).

NCT ID: NCT02736214 Completed - Pregnancy Clinical Trials

Reproductive Life Plan-based Counseling With Men

Start date: October 2014
Phase: N/A
Study type: Interventional

Many women and men in fertile age are at risk for sexual transmitted infections and unwanted pregnancies, and have insufficient knowledge of health promoting lifestyle prior to conception. There is a need to increase awareness among people in fertile age about how sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy outcomes. Previous studies on preconception health and care have mainly focused on women. The aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife could increase men's reproductive knowledge. The second aim was to evaluate men's experiences of the intervention.

NCT ID: NCT02735915 Completed - Herpes Zoster Clinical Trials

Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older

Start date: April 11, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).

NCT ID: NCT02735044 Completed - Clinical trials for Type 1 Diabetes Mellitus

Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

EDITION JUNIOR
Start date: April 14, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: - Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). - To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.

NCT ID: NCT02733939 Completed - Dementia Clinical Trials

Technologies to Reduce Caregiver Burden for Informal Caregivers of People With Dementia

TECH@HOME
Start date: March 2016
Phase: N/A
Study type: Interventional

This randomized controlled trial aims to recruit a total of 320 dyads composed by persons with dementia living in community settings and their primary informal caregivers. In the intervention group, persons with dementia will have a home monitoring kit installed in the household while participants in the control group will receive their usual care. The kit includes home leaving sensors, smoke and water leak sensors, bed sensors as well as automatic lights that monitor the individual's behavior. Alerts (text message and/or phone call) will be sent to the caregiver if anything unusual occurs. All study participants will receive three home visits by project administrators that have received project specific training in order to harmonize data collection. These will take place at enrollment and 3 and 12 months following installation of the home kits. At every home visit, a standardized questionnaire will be administered to all study participants to assess their health, quality of life and resource utilization. The primary outcome of this trial is the amount of informal care support provided by primary informal caregivers to the Person with Dementia.

NCT ID: NCT02733406 Completed - Blood Pressure Clinical Trials

Hypotensive Effect of Anaesthesia With TCI

HEAT
Start date: April 2016
Phase: N/A
Study type: Interventional

Hypotension will often complicate induction of anaesthesia. The investigators want to test the hypothesis that Target Controlled Infusion, as opposed to Velocity Controlled Infusion, leads to less degree of hypotension.

NCT ID: NCT02732665 Completed - Clinical trials for Carcinoma, Renal Cell

Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced Renal Cell Carcinoma

Start date: June 2016
Phase:
Study type: Observational

In this study, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. To this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. A positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. Data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly.

NCT ID: NCT02732652 Completed - Clinical trials for Carcinoma, Renal Cell

Glycosaminoglycan Scores as Monitoring Biomarkers in Confined Renal Cell Carcinoma

Start date: June 2016
Phase:
Study type: Observational

In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early actionable clinical decisions are desirable. For example to diagnose early recurrence after surgical treatment; to screen population at risk of RCC; or to distinguish benign masses from RCC before surgical treatment. To this end, plasma and urine GAGs will be measured in a prospective cohort of patients referred to surgical treatment for RCC. The resulting GAG scores are then correlated to post-surgical recurrence, to post-surgical definitive diagnosis and and to tumor size if RCC. In a subset cohort of patients at high risk of RCC recurrence, plasma and urine GAGs will be monitored to observe its correlation with disease recurrence.

NCT ID: NCT02731664 Completed - Clinical trials for Functional Gastrointestinal Disorders

GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans

GLPMOT
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach, duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper gastrointestinal tract in man.

NCT ID: NCT02730416 Completed - Endometrial Cancer Clinical Trials

Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer

Start date: December 12, 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.