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NCT ID: NCT03460990 Completed - Cystic Fibrosis Clinical Trials

A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

Start date: May 1, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).

NCT ID: NCT03459521 Completed - Hepatitis B Virus Clinical Trials

Efficacy of HBVaxpro40© and Fendrix© in Patients With Chronic Liver Disease.

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Background: Cirrhotic patients have an increased risk of infections. In these patients is important to prevent hepatitis B virus (HBV) infection, as it may cause a deterioration of liver function. However, HBV vaccine efficacy in this group of patients is lower than in healthy population. Despite increasing standard doses to double doses or administering an accelerated pattern, the response to HBV vaccination remains suboptimal. For this reason, an alternative strategy may be using vaccines with novel adjuvants such as Fendrix® or the recombinant vaccine HBVAXPRO®. Aim: To assess the adjuvanted HBV vaccine (Fendrix ®) efficacy in patients with chronic liver disease and to understand the kinetics of anti-HBs titers over time in patients who respond to vaccination. Methods: Prospective and multicenter study. Serological markers of HBV will be assessed prospectively in consecutive patients with non-cirrhotic liver disease (permanent abnormal liver blood tests > six months; elastogram ≥8 kilopascal (kPa); serum markers of fibrosis (APRI or FIB-4 ≥ F2); ultrasound changes suggesting chronic liver disease) and cirrhotic patients (diagnosed by liver biopsy and/or non-invasive methods: clinical, blood tests and ultrasound). Seronegative patients will receive four doses of Fendrix ® at 0,1, 2 and 6 months. Antibodies against HBV superficial antigen (anti-HBs) will be determined at 2 months +/- 10 days, six months and one year after having received the fourth dose of the vaccine (to see kinetics). The study will differentiate between responders and non-responders to the vaccine: adequate immunity to HBV will be defined as anti-HBs higher than > 10mUI/mL (standard definition of seroconversion) and> 100mUI/mL. Investigators will evaluate the factors that influence the response, kinetics and safety of the vaccination in patients with chronic liver disease and cirrhosis.

NCT ID: NCT03459430 Completed - Core Stability Clinical Trials

Chronic Effect of Individualized Core Stability Programs in Recreational Athletes.

Start date: March 10, 2018
Phase: N/A
Study type: Interventional

Core stability (CS) training is nowadays largely used in several fields, mainly to enhance athletic performance and to prevent and rehabilitate musculoskeletal injuries. However, in several experimental studies, CS training programs have not delivered as positive results as could be expected. The lack of proper modulation and quantification of the training load parameters (such as intensity, volume, frequency, etc.) may be one of the main explanations. Although training intensity has been manipulated by modifying the CS exercise difficulty through variations in mechanical constraints (i.e. participant posture, lever arms, base of support, unstable surfaces, etc.), to the best of the authors' knowledge no experimental study has quantified the CS training intensity based on objective parameters. The quantification of the load intensity is fundamental to analyze the dose-response relationships between training and CS adaptations. Therefore, the main aim of this study is to evaluate the effectiveness of two individualized CS training programs using smartphone accelerometers placed on the pelvis to quantify the intensity of several of the most common CS exercises employed in fitness, sports and rehabilitation. The expected effect is that the experimental groups will improve CS significantly.

NCT ID: NCT03459001 Completed - Malnutrition Clinical Trials

Evaluation of a High Calorie, High Protein Tube Feeding Product in an Adult Population With or at Risk of Malnutrition

Start date: June 8, 2018
Phase:
Study type: Observational

This prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care.

NCT ID: NCT03458377 Completed - Clinical trials for Educational Problems

Telephone Educational Intervention by the Gastrointestinal Endoscopy Nurse. Global Impact on the Quality of Colonoscopy

Start date: February 20, 2018
Phase: N/A
Study type: Interventional

This study assesses what impact has on colonoscopy quality the implementation of a telephone educational intervention carried out individually on the patient in the days before the test. Half of the study patients will receive the educational intervention and the other half will not.

NCT ID: NCT03456830 Completed - Clinical trials for Enteric Hyperoxaluria

Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

Start date: May 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

NCT ID: NCT03456583 Completed - Clinical trials for Breast Cancer Female

Brevera™ Breast Biopsy System Data Collection Study

Start date: November 20, 2017
Phase:
Study type: Observational

The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System.

NCT ID: NCT03456414 Completed - Clinical trials for End Stage Renal Disease

Virtual Reality During Hemodialysis

VRHD
Start date: April 11, 2018
Phase: N/A
Study type: Interventional

The main objective of this investigation is to assess if an intradialysis virtual reality exercise-based program results in an improvement in physical function and if it results in high adherence rates to exercise. The secondary aim is to assess the effect of intradialysis VR in physical activity level, health related quality of life and in cognitive function.

NCT ID: NCT03456375 Completed - Clinical trials for Endometrial Receptivity

Serum and Uterine Progesterone Levels and ERA Test.

Start date: March 13, 2018
Phase:
Study type: Observational

Since the implantation is related with endometrial receptivity, the patient specific plasma progesterone concentration influences this pattern. Following this hypothesis, the study establishes a correlation between the serum progesterone measured on the day of the endometrial biopsy and the endometrial receptivity with the ERA test.

NCT ID: NCT03456349 Completed - Alzheimer's Disease Clinical Trials

Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care

Start date: November 10, 2017
Phase: Phase 1
Study type: Interventional

Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to standard-of-care