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NCT ID: NCT02716194 Completed - Hemophilia A Clinical Trials

BAX 826 Dose-Escalation Safety Study

Start date: March 3, 2016
Phase: Phase 1
Study type: Interventional

1. To assess tolerability and safety of BAX 826 after a single infusion in previously treated patients (PTPs) with severe hemophilia A 2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE 3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)

NCT ID: NCT02715596 Completed - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Changes in Body Composition After EPA Supplementation in Head and Neck Patients

hepaneck
Start date: December 23, 2015
Phase: Phase 3
Study type: Interventional

Evaluates the effect of EPA supplementation in terms of muscle mass in patients with squamous cell carcinoma of the head and neck locally advanced

NCT ID: NCT02715453 Completed - Fragility Clinical Trials

Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction

FRAMIP
Start date: January 2016
Phase: N/A
Study type: Interventional

Frailty has been associated to a worse outcome in acute coronary syndromes, but the best management of frail patients after an acute coronary syndrome remains unknown. The aim was to investigate the benefit of an intervention on frailty in frail patients after an acute myocardial infarction. Patients survivors after an acute myocardial infarction (with and without ST-segment elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points) according to the Fried's scale measured 24 hours before hospital discharge, will be included. The participants will be randomized to 2 strategies: a) intervention on frailty in addition to the usual care by the cardiologist, and b) conventional strategy consisting only of the usual care by the cardiologist. A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty The study contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year. The secondary endpoint will be the clinical events, both cardiovascular and not cardiovascular events, including recurrent events (cumulative events analysis), for the total follow up (3 years in the case of the first included patient). The hypothesis is that an intervention on frailty will improve frailty status and the clinical outcomes in frail patients after an acute myocardial infarction.

NCT ID: NCT02715245 Completed - Clinical trials for Multiple Chronic Diseases

Multiple Chronic Diseases: the RITH Trial

Start date: January 8, 2013
Phase: N/A
Study type: Interventional

In this research, investigators pretent to evaluate the effectiveness of clinical, functional, psychological and social impact of an intervention model based on shared care between the Mobile Rehabilitation and Physical therapy team (MRPTT) and nurse case managers of Primary Care in a sample of patients with multiple chronic diseases (comorbidities) and their caregivers. A non-randomised controlled trial.

NCT ID: NCT02715011 Completed - Clinical trials for Leukemia, Myeloid, Acute

Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Start date: June 1, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and to characterize the safety and tolerability of JNJ-63709178 at the RP2D(s) in Part 2.

NCT ID: NCT02714751 Completed - Asynchronies Clinical Trials

Evaluation of an Informative Intervention to the ICU Team About the Presence of Asynchronies in Mechanically Ventilated Patients: Effect Over Incidence Reduction

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

Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can develop adverse effects. Patient-ventilator asynchronies can be present from the beginning of MV, it can be associated with poor outcome and it can develop clinical changes. The aim of this study is to evaluate if the knowledge of the presence of asynchronies by the healthcare team can help to reduce its incidence, improving outcomes of critically ill patients. A prospective, single-center, before and after study will be conducted in the ICU of Hospital de Sabadell. The study will have 2 phases: a first observational period where the incidence of asynchronies will be assessed, and a second period where a daily information of the presence of asynchronies to the healthcare team will be done with the aim to reduce the incidence. A continous record of asynchronies and clinical variables will be done during ICU stay.

NCT ID: NCT02714595 Completed - Sepsis Clinical Trials

Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

CREDIBLE - CR
Start date: September 7, 2016
Phase: Phase 3
Study type: Interventional

This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.

NCT ID: NCT02714218 Completed - Melanoma Clinical Trials

A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Start date: April 4, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

NCT ID: NCT02713867 Completed - Lung Cancer Clinical Trials

A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

CheckMate 384
Start date: May 24, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

NCT ID: NCT02713763 Completed - Clinical trials for Pancreatic Neuroendocrine Tumour Metastatic

Efficacy of Rechallenge With Sunitinib in Metastatic Pancreatic Neuroendocrine Tumor Previously Failed to Sunitinib

RESUNET
Start date: February 14, 2017
Phase: Phase 2
Study type: Interventional

The therapeutic goals in the management of pancreatic neuroendocrine tumors (pNET) are the control of symptoms and tumor growth control in order to improve patient survival. In recent years, data from two phase III studies with targeted therapies, sunitinib and everolimus, have broadened the possibilities for treatment of patients with neuroendocrine tumors of the pancreas. Unfortunately, patients progress and development of new active drugs and evaluating the best treatment approach is decisive. Given the lack of data comparing the activity of different treatment strategies, final decisions are based on medical experience and consensus of experts. In this context, different questions are still unanswered, as which is the best sequence of treatment and if all patients can benefit from all available drugs. Neuroendocrine pancreatic tumors are highly vascularized tumors in which cells may be dependent on this pathway for growth throughout the entire history of the tumor and in which inhibition of this pathway is crucial. On the other hand, this aspect has not been endorsed by the population of patients with pNET who have previously failed treatment with sunitinib. In this scenario the investigators will assess retreatment with sunitinib to evaluate the activity of this drug in the context of therapeutic rescue in patients with metastatic pNET.