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NCT ID: NCT02947347 Active, not recruiting - Follicular Lymphoma Clinical Trials

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Start date: January 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve participants with follicular lymphoma.

NCT ID: NCT02944019 Completed - Atrial Fibrillation Clinical Trials

Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

ETNA-AF-EU
Start date: August 2015
Phase:
Study type: Observational

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with NVAF who were not preselected.

NCT ID: NCT02941926 Completed - Breast Cancer Clinical Trials

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

COMPLEEMENT-1
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

NCT ID: NCT02941770 Active, not recruiting - Overweight Clinical Trials

Physical Activity Consultation in the Management of Adolescent Overweight

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

The prevalence of pediatric obesity makes this condition a worldwide public health concern. Physical Activity (PA) is recognized as having many health benefits, many of them related to obesity and its comorbidities. Despite of all the efforts, the majority of the overweight children/adolescents still present low levels of PA and high levels of sedentary behaviors. Thus, it seems that the greatest challenge is to influence behavior change in order to increase PA exposure in this population. PA consultation can be a cost-effective way of enhancing PA and improve weight status among overweight children. The main objective of this study is to analyze if the inclusion of a PA consultation in a multidisciplinary program for the management of adolescent overweight improves body mass index (BMI) z-score, PA levels and sedentary behavior outcomes at six and twelve months, compared to those attending only the Pediatric and the Dietetic consultations. This study was designed as a non-randomized, controlled clinical trial with six months duration and follow-up at the 12th month, that will include overweight adolescents (BMI ≥ p85) aged 12 to 17, attending the Clinic for the first time, and accepted to be enrolled. Those with (i) major pathologies (other than obesity or its related comorbidities), (ii) inability to perform regular PA, (iii) mental disorders, (iv) smoking habits, (v) under any kind of prescription (other than antihypertensives or metformin), or (vi) being involved in another weight loss program will be excluded. According to the sample size calculation, we expect to recruit 129 participants that will be allocated in three groups by consecutive sampling: (i) control group - standard care (Pediatric and Dietitian consultations); (ii) intervention group I - standard care plus PA consultation; (iii) intervention group II - 2 weekly exercise sessions additionally to the standard care and PA consultations..

NCT ID: NCT02940626 Terminated - Clinical trials for Pneumonia, Ventilator-associated

Prevention of S. Aureus Pneumonia Study in Mechanically Ventilated Subjects Who Are Heavily Colonized With S. Aureus.

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

The purpose of this study is the prevention of Staphylococcus aureus pneumonia in mechanically ventilated subjects heavily colonized with S. aureus. Staphylococcus aureus is a human pathogenic bacterium that causes severe infections, including pneumonia and sepsis. Hospital-acquired bacterial pneumonia (HABP) caused by S. aureus, including ventilator-associated bacterial pneumonia (VABP) in mechanically ventilated subjects, is a significant public health threat despite efforts to optimize antibiotic treatment. ASN100 is an investigational monoclonal antibody product that targets the toxins produced by S. aureus to protect subjects from developing S. aureus pneumonia.

NCT ID: NCT02936635 Completed - Clinical trials for Amyotrophic Lateral Sclerosis (ALS)

A Study for Patients Who Completed VITALITY-ALS (CY 4031)

VIGOR-ALS
Start date: October 17, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).

NCT ID: NCT02935088 Completed - Clinical trials for Coronary Artery Disease

PRESSUREwire Study

Start date: October 12, 2016
Phase:
Study type: Observational

The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

NCT ID: NCT02934815 Recruiting - Breast Cancer Clinical Trials

Relational and Emotional Mechanisms of a Supportive-expressive Group Intervention in Breast Cancer

BC-SEGT
Start date: January 2015
Phase: N/A
Study type: Interventional

To test the feasibility of supportive-expressive group intervention (SEGT) for women with primary breast cancer and to provide a preliminary test of its efficacy.

NCT ID: NCT02932410 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

TOMORROW
Start date: October 24, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

NCT ID: NCT02929329 Completed - Heart Failure Clinical Trials

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

GALACTIC-HF
Start date: January 6, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).