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NCT ID: NCT03547271 Completed - Clinical trials for Meningococcal Infections

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Start date: December 14, 2018
Phase: Phase 3
Study type: Interventional

Primary objective is to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old Secondary objectives are: - To demonstrate the non-inferiority of the antibody (Ab) response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old. - To describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.

NCT ID: NCT03547258 Recruiting - AML Clinical Trials

Italian Non-Interventional Study of FLT3 Mutated AML Patients

FLAM
Start date: July 18, 2018
Phase:
Study type: Observational

This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations

NCT ID: NCT03547193 Completed - Anesthesia Clinical Trials

Two Neck Ultrasound Measurements as Predictors of Difficult Laryngoscopy

Start date: May 5, 2017
Phase:
Study type: Observational

Background: Unpredictable laryngoscopic difficulty remains a dramatic challenge for anaesthesiologists. Ultrasound (US) based airway assessment has been recently proposed as a useful tool in adjunct to clinical methods, but to date few studies are available about the potential role of ultrasound in difficult airway evaluation. The aim of this study is to determine the correlation between the sonographic measurements of anterior cervical soft tissues's thickness and Cormack-Lehane grade view at direct laryngoscopy in patients with normal clinical screening tests. Design: Prospective, single blinded, observational study. Number of patients: 300 adult patients Methods: All patients are assessed before surgery to evaluate clinical evidence of difficult airways. Simultaneous ultrasound measures of the anterior cervical soft tissues are performed. At induction of anaesthesia the laryngoscopic view is graded by a different anaesthetist, blinded to the ultrasound assessments. Statistical analysis: Receiver operating characteristic curves (ROC) are used to determine the "difficulty prediction capability" of each sonographic measurement and to assess the optimal cut-off scores To allow for comparisons between "restricted-difficult" airway and "easy" airway groups, a two-sided Student's t-test and Fisher's exact test is employed as appropriate. The results will be averaged (mean ± standard deviation SD) for each parameter for continuous data. Values of p < 0.05 are considered as statistically significant.

NCT ID: NCT03547050 Completed - Rolandic Epilepsy Clinical Trials

Rolandic Epilepsy Genomewide Association International Study

REGAIN
Start date: June 1, 2018
Phase:
Study type: Observational

We have discovered a small change in the genetic code which increases the risk of the brainwave abnormality that is found in rolandic epilepsy. We now wish to confirm this using a second much larger sample of patients. We will investigate the other genetic changes that cause people with the brainwave abnormality to develop seizures, as well as problems with speech, coordination, attention and learning.

NCT ID: NCT03546998 Recruiting - Achalasia Clinical Trials

Epidermoid Cancer Development in Esophageal Achalasia

Start date: January 1, 1973
Phase:
Study type: Observational [Patient Registry]

Esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. Incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

NCT ID: NCT03546699 Active, not recruiting - Respiratory Failure Clinical Trials

Hospital-wide Incidence, Clinical Characteristics and Outcomes of ARDS

Start date: October 24, 2018
Phase:
Study type: Observational

The Acute Respiratory Distress Syndrome (ARDS) impacts one of every four patients requiring mechanical ventilation for respiratory support and carries a mortality rate of 40%. To diagnose ARDS, doctors currently use the Berlin definition, that requires chest radiographs and analysis of oxygenation in the blood (arterial blood gas). These tests are not available in areas of the world with constrained resources and may be unnecessarily invasive. A modification of the Berlin definition, using ultrasound and pulse oximetry (a small device that measures oxygen level non-invasively by clipping to the body, typically a finger), has been recently developed and tested in Kigali, Rwanda. This study will try to confirm the validity of the Kigali modification initially in Boston and Toronto and subsequently in other hospitals worldwide. If confirmed, this new definition could allow for faster recognition and potentially improved treatment of patients with ARDS and facilitate studies worldwide. The purposes of this study are: 1. To describe clinical characteristics and outcomes of patients diagnosed with ARDS according to the Berlin and Kigali definitions; 2. To determine how well chest radiograph and ultrasound of the chest are able to define ARDS, in comparison to chest computer tomography (CT).

NCT ID: NCT03546426 Recruiting - Advanced Cancer Clinical Trials

Pembrolizumab Plus Autologous Dendritic Cell Vaccine in Patients With PD-L1 Negative Advanced Mesothelioma Who Have Failed Prior Therapies

MESOVAX
Start date: December 12, 2019
Phase: Phase 1
Study type: Interventional

Pembrolizumab plus autologous dendritic cell vaccine in patients with PD-L1 negative advanced mesothelioma who have failed prior therapies.This is an exploratory, single-arm, open-label, phase 1b clinical trial. Patients will receive pembrolizumab 200 mg and autologous dendritic cell vaccine every 3 weeks for the first 6 cycles, followed by pembrolizumab 200 mg every 3 weeks until confirmed progression or for a maximum of 2 years (see Figure 1 Study Schema). After each vaccine administration patients will receive IL-2 3 MU s.c. for 5 days, from day +2 to day +6.

NCT ID: NCT03546244 Recruiting - Parkinson Disease Clinical Trials

Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation

EMTPDR
Start date: January 3, 2018
Phase: N/A
Study type: Interventional

In order to evaluate the effectiveness of musical treadimll on gait parameters in patients with Parkinson's Disease, the investigators compare the outcome measures on two group of patients: one will undergo a 4-week daily musical treadmill training and one will undergo a 4-week daily traditional treadmill training

NCT ID: NCT03546114 Completed - Gender Role Clinical Trials

Does Gender Matter? Patient Preference in an Italian Osteopathic Clinical Setting

Start date: April 1, 2018
Phase:
Study type: Observational

This study evaluates patients preference for the gender of their osteopath. All patients referring to an Italian private osteopathic clinic will receive a proper questionnaire before knowing the gender of their designed osteopath.

NCT ID: NCT03546062 Completed - Heart Failure Clinical Trials

Diabetes and Lipid Accumulationand Heart Transplant

DCM-AHEAD
Start date: January 1, 2010
Phase:
Study type: Observational

Idiopathic dilated cardiomyopathy (IDC) is defined by the presence of left ventricular systolic dysfunction in the absence of an abnormal loading condition or significant coronary artery disease. IDC is the main cause of end-stage heart failure (HF) and is responsible for half of all heart transplants (HTx). Endocrine disorders, including diabetes, are known to be associated with IDC. Diabetes mellitus (DM), which is present in 75% of patients with idiopathic IDC, is an independent risk factor for the development of heart failure and death in IDC. Therefore, DM can exacerbate the need for HTx, in addition, diabetic patients are less suitable for HTx and DM remains an independent risk factor for death even after HTx. Recent studies have revealed the presence of diabetic cardiomyopathy, a condition of myocardial dysfunction without coronary artery disease. This term was introduced for the first time by Rubler et al. in 1972 which highlighted patients with diabetes and congestive heart failure with normal coronary arteries. The pathophysiological mechanisms through which diabetes affects the development and progression of diabetic heart disease are not known. Therefore, the purpose of our study will be to evaluate, in the explanted diabetic heart, the presence of possible cellular alterations attributable to the diabetic disease. Furthermore, the progression of these lesions in the transplanted heart in diabetic patients will be evaluated.