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NCT ID: NCT03516214 Completed - Bronchial Neoplasms Clinical Trials

EGF816 and Trametinib in Patients With Non-small Cell Lung Cancer Harboring Activating EGFR Mutations

EATON
Start date: April 25, 2018
Phase: Phase 1
Study type: Interventional

The aim of this trial is to identify the maximum tolerated dose (MTD)/recommended phase II dose (RP2D), to define pharmacokinetic (PK) parameters and the preliminary efficacy of a continuous treatment with EGF816 and trametinib in locally advanced or metastatic (stage IIIB or IV) lung cancer patients with activating mutations in the epithelial growth factor receptor (EGFR).

NCT ID: NCT03515837 Completed - Clinical trials for Non-small Cell Lung Cancer

Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)

Start date: June 29, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.

NCT ID: NCT03515811 Completed - Thoracic Diseases Clinical Trials

A Post Market Study to Confirm the Safety and Performance of the Signia™ Stapling System.

Start date: January 22, 2019
Phase:
Study type: Observational

The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.

NCT ID: NCT03515148 Completed - Clinical trials for Achilles Tendinopathy

Effectiveness of EE With Vibration Versus Cryotherapy in Rectus Abdomini Muscle Thickness and Inter-recti Distance

Start date: January 30, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determinate de efectiveness of eccentric exercise combined with vibration or cryotherapy in achilles tendinopathy and its effects on the anterior rectus abdominis muscle. The investigators hypothesis is the combined eccentric exercise with vibration get better results than cryotherapy with eccentric exercise in rectus abdominis muscle parameters.

NCT ID: NCT03513978 Completed - Clinical trials for Sports Physical Therapy

Effects of Two Multimodal-programs of Exercises in Male Soccer Players.

Start date: April 30, 2018
Phase: N/A
Study type: Interventional

The prevention of injuries has a close relation with the proprioception. In this sense, the proprioception is defined as the information about the corporal and segmental movement, as well as the position of the body and the corporal segments of oneself in the space. Some authors divide the proprioception into kinesthesia and the Joint Position Sense (JPS). The hypothesis of the study is the implantation of a progressive multimodal exercise protocol with transferences to sport in the trainings of amateur male soccer players in the age range from 18 to 30 years, can decrease the adverse effects of the fatigue during the high intensity activities and its relation with the JPS. Due to the close relation between fatigue and incidence of injuries, the obtaining of positive results could be an important finding for the design of prevention and rehabilitation protocols in soccer.

NCT ID: NCT03513926 Completed - Hypertension Clinical Trials

Molecular Profile of Cardiovascular Risk in Obstructive Sleep Apnea Patients: Personalized Predictive Model.

Start date: November 2014
Phase:
Study type: Observational [Patient Registry]

Evaluation of anthropometric, clinical and biological profile in four groups that represents transversely the natural history of Obstructive Sleep Apnea (OSA) and its associated cardiovascular comorbidities: non-OSA, OSA without hypertension, OSA and with hypertension and OSA with a cardiovascular event (CVE).

NCT ID: NCT03513744 Completed - Infant Nutrition Clinical Trials

Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

NCT ID: NCT03513276 Completed - Hip Osteoarthritis Clinical Trials

Effect of Local Infiltration Anesthesia in a Hip Arthroplasty Fast Track Program.

Start date: February 2016
Phase: Phase 4
Study type: Interventional

Fast-track programs in Orthopaedic Surgery require early motion that can only be achieved by optimal pain management protocols. Multimodal analgesia protocols including local infiltration anesthesia (LIA) have obtained excellent results in fast-track programs involving Total Knee Arthroplasty but further research and data is needed in Total Hip Arthoplasty programs.

NCT ID: NCT03512704 Completed - Heart Failure Clinical Trials

Development of Clinical Prediction Rules and Health Services Research in Patients With Heart Failure

ESSIC
Start date: October 2013
Phase:
Study type: Observational

Objectives: Objective of this project are to create several clinical prediction rules (CPR) to stratify patients into different prognostic levels: on arrival at the emergency room, at hospital discharge, in the evolution at 90 days, and up to 1 year; for clinical parameters (mortality, complications, readmissions) and the evolution of the patient health related quality of life. Additional objectives include the analysis of equity in access, continuity of care after discharge, costs, psychosocial support received, and variability in clinical decisions and in the results obtained from inclusion in the study after the visit to the emergency room until 1 year of follow-up. Methods: Prospective observational cohort study with a one year follow-up. Multicenter and coordinated study with 9 hospital in Spain. This project will include around 1000 patients diagnosed of heart failure who come to emergency services of these hospitals, whether discharge home or admitted to the hospital. Multiple parameters (about the process of care, clinical outcomes, and quality of life), will be retrieved in the emergency room visits, admission, discharge and up to one year follow up after discharge. This project bases its work in the large number of variables to be collected and would not be viable with few centers, so centers from other communities will collaborate providing more cases. Statistical analysis using multivariate logistic regression models or Cox or general linear models or multilevel analysis will derive the CPR in a subsample of the original sample which will be validated in another different subsample.

NCT ID: NCT03512600 Completed - Lithiasis, Urinary Clinical Trials

Study of the Effects of the Consumption of Different Products Cocoa Derivatives at the Risk of Crystallization of Uric Acid in Urine of Volunteers.

Start date: September 4, 2017
Phase: N/A
Study type: Interventional

The present study aims to assess the effectiveness of theobromine, -product present in high proportion in the cacao-, to prevent the development of uric acid kidney stones.