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NCT ID: NCT02951949 Completed - Atherosclerosis Clinical Trials

Estrogen Exposure and Atherosclerosis in Postmenopausal Women

Start date: November 2014
Phase:
Study type: Observational

One hundred Spanish postmenopausal women accepted to be investigated for cardiovascular risk actors including clinical features, serum biochemical parameters, single nucleotide polymorphisms for estrogen receptor, and imaging parameters, carotid intima-media thickness (91 women) and coronary computed tomography (32 women). Multivariable analysis confirmed that both age and glucose level directly affected IMT. Estrogenic exposure, as measured by the allele associated with lower expression of the ER beta gene, was protective at the sinus and the wall. Findings at the coronary arteries, either moderate or high calcium index (CAC) and/or significant lumen stenosis were sporadic and did not allow for establishing association with any of the variables assessed.

NCT ID: NCT02951767 Completed - Bladder Cancer Clinical Trials

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)

Start date: May 31, 2014
Phase: Phase 2
Study type: Interventional

This Phase II, single-arm study is designed to evaluate the effect of atezolizumab treatment in participants with locally advanced or metastatic urothelial bladder cancer. Participants will be enrolled into 1 of 2 cohorts. Cohort 1 (reported here) will consist of participants who are treatment-naïve and ineligible for cisplatin-containing chemotherapy. Cohort 2 will contain participants who have progressed during or following a prior platinum-based chemotherapy regimen. The results of the second cohort are reported separately (NCT02108652). Participants in both cohorts will be given a 1200 milligrams (mg) intravenous (IV) dose of atezolizumab on Day 1 of 21-day cycles. Treatment of participants in Cohort 1 will continue until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or unmanageable toxicity. Treatment of participants in Cohort 2 will continue until loss of clinical benefit or unmanageable toxicity.

NCT ID: NCT02951481 Completed - Clinical trials for Clostridium Difficile

Antimicrobial Stewardship Program for Clostridium Difficile Infection.

PACTA-ICD
Start date: February 15, 2017
Phase:
Study type: Observational

The purpose of this study is to determine whether a bundle of measures specifically designed for patients with ICD and applied by and Infectious Diseases expert during a year period (2017) will improve the prognosis and reduce the rate of recurrence, compared with the baseline phase (2015) in which no intervention was made.

NCT ID: NCT02951429 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension

Start date: December 31, 2016
Phase: Phase 2
Study type: Interventional

This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and intermediate or high probability of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.

NCT ID: NCT02951390 Completed - Lynch Syndrome Clinical Trials

High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.

EndoLynch
Start date: July 2016
Phase: N/A
Study type: Interventional

Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which might occur despite a regular follow-up. Despite low evidence, high-definition technology (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection rate in patients with Lynch syndrome.

NCT ID: NCT02951182 Completed - Cystic Fibrosis Clinical Trials

A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis

Start date: October 2016
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo- and active-controlled, parallel group, multicenter study to evaluate the safety, tolerability, and efficacy of VX-440 in dual and triple combination with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF).

NCT ID: NCT02950909 Completed - Neck Pain Clinical Trials

Effect of Therapeutic Exercise on the Activation of the Neck Extensors in People With Chronic Neck Pain

Start date: October 2016
Phase: N/A
Study type: Interventional

The primary aim of this study therefore is to investigate the effects on pain and disability of an emphasized exercise program targeting the deep neck extensor semispinalis cervicis and a general exercise program for all neck extensor muscles in patients with chronic neck pain. As a secondary aim , pain intensity (VAS), cervical ROM, pressure pain threshold (PPT), cervical and thoracic posture and self-perceived benefit of treatment (GROC) were measured. The investigators hypothesized that both exercise programs would have similar effects on pain alleviation and pain related disability, but that the emphasized exercise program for the deep semispinalis cervicis would improve its activation more compared to the general exercise program. The results of this study will be relevant for designing effective rehabilitation/training programs for patients with chronic neck pain.

NCT ID: NCT02950883 Completed - Cystic Fibrosis Clinical Trials

Saline Hypertonic in Preschoolers + CT

SHIP-CT
Start date: March 24, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.

NCT ID: NCT02949622 Completed - Clinical trials for Metabolic Syndrome X

Multimodal Intervention Program for Patients With Metabolic Syndrome

PROMETS
Start date: February 2013
Phase: N/A
Study type: Interventional

The aim of this study is to identify the psychological, emotional and lifestyle variables that can have an influence on the different components of metabolic syndrome (MetS) and develop a program for change lifestyle in this patients.

NCT ID: NCT02949245 Completed - Clinical trials for Adult Spinal Deformity

Neurologic Complications in Spinal Deformity Surgery - Extension

Start date: August 17, 2017
Phase:
Study type: Observational

272 subjects with "high risk" adult spinal deformity requiring surgical correction were enrolled in the previous prospective multi-center international Scoli-RISK-1 study. "High risk" patients were defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurological complications in the form of new motor and sensory deficits were monitored prospectively in all patients at hospital discharge, at 6 weeks (± 2 weeks), 6 months (± 2 months) and 24 months (± 2 months) after the surgery. The relationship to the surgical intervention was assessed in all new deficits. Regression analyses were used to evaluate the association between patient demographics, co-morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery. All enrolled Scoli-RISK-1 participants will be re-consented and asked to return for a 5 year FU visit.