Clinical Trials Logo

Filter by:
NCT ID: NCT03190096 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation

SAFE-SVC
Start date: June 7, 2017
Phase: N/A
Study type: Observational

The present study is designed as a observational prospective, multicentre, international. The main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB in a prospective manner.

NCT ID: NCT03190044 Recruiting - Migraine Disorders Clinical Trials

Magnesium, Partenium, Andrographis, Co-enzyme Q10 and Riboflavin (PACR) in Migraine Prophylaxis

ParMig
Start date: June 6, 2017
Phase: N/A
Study type: Interventional

Migraine is a highly disabling disorder that affects hundreds of millions of people around the world. Yet, a little number of prophylactic treatments are available still now. The limited number of available drugs leads to a wide use of nutraceutical compounds in migraine therapy. To improve the efficacy, some of these nutraceuticals were combined. So far, we do not know if these combinations are really more effective than the single compounds alone, or an anti-synergic effect could be present because of a reciprocal antagonism of effects. For this reason, we decided to test the efficacy of a fixed combination of magnesium, partenium, andrographis, co-enzyme Q10 and riboflavin (PACR) as prophylactic treatment for migraine in a randomized controlled double blind study.

NCT ID: NCT03188367 Recruiting - Clinical trials for Nonceliac Gluten Sensitivity

Dose-finding Gluten Challenge Trial in Nonceliac Gluten-sensitivity

RAPLAGE
Start date: June 13, 2017
Phase: N/A
Study type: Interventional

An emerging problem in clinical practice is how to manage the growing number of patients who experience symptoms related to the ingestion of gluten-containing foods gluten and in whom celiac disease has been ruled out. These patients most frequently report gastrointestinal symptoms such as diarrhea, abdominal discomfort or pain, bloating, flatulence, but also extraintestinal symptoms, including headache, lethargy, attention-deficit/hyperactivity disorder, ataxia, or recurrent oral ulceration. This heterogeneous syndrome, which has been reported to improve or even disappear after gluten withdrawal and to relapse after gluten challenge, is called non-celiac gluten sensitivity.1 The concept of nonceliac gluten sensitivity is not completely new. Besides several sporadic single cases reported, more than 30 years ago an oral, double-blind, placebo-controlled, cross-over gluten challenge trial showed that six out of eight adult non-celiac patients, who suffered from intestinal symptoms caused by the ingestion of gluten-containing food, were affected by gluten-sensitive diarrhea. Over the last few years, an intense debate about the existence and the prevalence of nonceliac gluten sensitivity has emerged, as shown by the considerable increase in internet forums of discussion on this topic and in availability of gluten-free food. A definition of nonceliac gluten sensitivity based on definitive scientific evidence does not still exist, and the clinical trials conducted so far in order to fill this knowledge gap are burdened by a number of biases. In a cross-over trial of subjects with suspected NCGS, the severity of overall (intestinal plus extraintestinal) symptoms increased significantly during 1 week of intake of small amounts of gluten (daily 4.375 grams), compared with placebo. Among the 59 participants in this trial, the Investigatotors identified only three true gluten-sensitive patients, defined as having a delta overall score -calculated by subtracting the weekly overall score under placebo from that under gluten- higher than the mean delta overall score plus 2 standard deviations. However, these results should be cautiously interpreted due to the lack of a control group of non-gluten-sensitive subjects. On this basis, the Investigators will conduct a randomized, dose-finding, double-blind, placebo-controlled, cross-over gluten challenge trial aimed at comparing the effects of a daily dose of 8.4 grams of gluten with those of a daily dose of 6.0 or 4.2 grams of gluten on a cohort of subjects with nonceliac gluten sensitivity versus healthy volunteers.

NCT ID: NCT03185260 Recruiting - Clinical trials for Quality of Cardio-pulmonary Resuscitation

Registry of Laypeople's CPR Performance

Start date: May 1, 2016
Phase:
Study type: Observational [Patient Registry]

The aim of the registry is to collect laypeople's performance after a BLS/AED course carried out with the use of feedback devices.

NCT ID: NCT03183700 Recruiting - Cervical Cancer Clinical Trials

Self Collected Sampling in Non-attendees Cervical Cancer Screening: DNA Test and Molecular Triage for HPV Positive Women

Start date: August 9, 2016
Phase: N/A
Study type: Interventional

The aims of the present study are to assess the effects of a hrHPV self-sampling test as strategies to reach non-attending women in organized cervical screening in comparison with standard recall by letter in 8000 women; to evaluate the performance of two self sampling devices with and without a preservative buffer and to explore their acceptability among invited women and to evaluate a molecular triage approach for management of HPV positive women in self sampling collected material by HPV genotyping and DNA methylation marker panel

NCT ID: NCT03178552 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

B-FAST
Start date: September 22, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

NCT ID: NCT03175224 Recruiting - Lung Cancer Clinical Trials

APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

SPARTA
Start date: September 27, 2017
Phase: Phase 2
Study type: Interventional

To assess: - efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET - efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)

NCT ID: NCT03171649 Recruiting - Stroke Clinical Trials

Reaching Training Based on Robotic Hybrid Assistance for Stroke Patients

RETRAINER-S1
Start date: November 10, 2016
Phase: N/A
Study type: Interventional

Stroke is the third most common cause of death and the main cause of acquired adult disability in high-income countries. The most common deficit after stroke is motor impairment of the contralateral arm, with more than 80% of stroke survivors experiencing this condition in the acute phase, and only half regaining some useful upper limb function after six months. Within the European project RETRAINER (grant agreement No 644721), the consortium developed a platform for the rehabilitation of the upper limb after stroke, which combines a passive arm exoskeleton for weight relief supporting both shoulder and elbow movements, Functional Electrical Stimulation (FES) of the two-most impaired muscles of the affected side, interactive objects, and voluntary effort. The system also provides a graphical user interface which helps the therapist set the training session and save the training data and parameters, and provides the subject a visual feedback about his/her active involvement in the exercise. The training consists of the execution of a series of exercises involving the affected arm during daily life activities. Typical exercises are anterior reaching on a plane or in the space, moving an object on a plane or in the space, moving the hand to the mouth, with or without an object in the hand, and lateral elevation of the shoulder. The aim of this clinical study it to evaluate the efficacy of this novel training platform on patients between two weeks and nine months after their first stroke, who preserved at least a visible muscle contraction for the arm and shoulder muscles. Participants are randomized in an experimental and a control group. The control group is trained with an advanced rehabilitative program, including physical training, occupational therapy, FES, and virtual reality, while the experimental group is trained with the RETRAINER system for about 30 minutes, in addition to the same program of the control group. The daily training time is the same for the two groups. The intervention consists of three sessions a week for nine weeks. Patients are assessed at baseline, soon after the end of the intervention, and in a 4-week follow-up visits. It is planned to recruit 68 subjects for this study. Since the RETRAINER platform was built on the up-to-date theory of motor re-learning, which supports task-oriented repetitive training, a close temporal association between motor intention and stimulated motor response, and an intensive and frequent training paradigm, the study's hypothesis is that the experimental group shows a greater treatment effect than the control group.

NCT ID: NCT03169608 Recruiting - Atrial Fibrillation Clinical Trials

Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

Start date: April 3, 2017
Phase: N/A
Study type: Observational

Characterization of the perioperative autonomic nervous system state, cardiovascular and cerebrovascular control and microcirculation in order to predict postoperative atrial fibrillation and acute kidney injury in patients undergoing coronary artery bypass graft surgery

NCT ID: NCT03165734 Recruiting - Clinical trials for Primary Myelofibrosis

A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

PACIFICA
Start date: June 26, 2017
Phase: Phase 3
Study type: Interventional

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib