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NCT ID: NCT03731260 Active, not recruiting - Clinical trials for Indolent Systemic Mastocytosis

(PIONEER) Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, Versus Placebo in Patients With Indolent Systemic Mastocytosis

Start date: April 16, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of avapritinib + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC. The study will be conducted in 3 parts. All patients will receive treatment with avapritinib during Part 3 including those rolling over from the placebo group.

NCT ID: NCT03731234 Recruiting - DLBCL Clinical Trials

Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

Start date: July 2, 2019
Phase: Phase 2
Study type: Interventional

This is a prospective, multicenter, single arm, phase II trial in patients with ≥ 18 and <65 years with poor-prognosis (IPI ≥ 2) and newly diagnosed ABC-DLBCL. Aim of the study is to assess the efficacy and the safety of R-CHOP in combination with ibrutinib for 6 cycles followed by ibrutinib maintenance for 18 months in ABC-DLBCL patients achieving at least a PR after the induction phase

NCT ID: NCT03731182 Completed - Clinical trials for Pneumococcal Infections

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.

NCT ID: NCT03730298 Recruiting - Clinical trials for Breast Cancer Female

American Ginseng for the Prevention of Moderate-severe Fatigue in Breast Cancer Patients

Start date: November 29, 2018
Phase: N/A
Study type: Interventional

Among the symptoms referred by cancer patients, cancer related fatigue (CRF) is one of the most disabling symptom with a relevant impact on the quality of life. CRF can occur before, during and after anti-cancer treatment. The aim of the present study is to verify the efficacy of American Ginseng in preventing or reducing the intensity of moderate-severe CRF in breast cancer women receiving adjuvant chemotherapy with anthracyclines plus cyclophosphamide after surgery.

NCT ID: NCT03730025 Completed - Clinical trials for Neonatal Resuscitation

Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation

Start date: November 2, 2018
Phase: N/A
Study type: Interventional

NeoTapAdvancedSupport (NeoTapAS) is a free-of-charge mobile application that showed good accuracy in HR estimation. This study aims to evaluate the impact of NeoTapAS on timing of HR communication and of resuscitation interventions in a high fidelity simulation scenario.

NCT ID: NCT03729739 Active, not recruiting - Clinical trials for Coronary Artery Disease

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Japan Study

FAVOR III EJ
Start date: November 6, 2018
Phase: N/A
Study type: Interventional

Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.

NCT ID: NCT03729414 Recruiting - Clinical trials for Hemorrhoids Prolapse

Doppler-guided or Non Doppler-guided Arterial Ligation and Mucopexy for Third Degree Hemorrhoids: That is the Question

HAMLeT
Start date: September 30, 2020
Phase: N/A
Study type: Interventional

Hemorrhoidal disease is one of the most common proctological disease affecting the general population from the mid-teens onward with considerable implications for the National Health Service (NHS) both from an economic point of view and from surgeon's workload.Improved understanding of the pathogenesis of hemorrhoids and of the complications associated with excisional hemorrhoidectomy led to the invention of newer surgical procedures, including Doppler guided hemorrhoidal artery ligation (DGHAL). This technique was introduced in 1995 by Morinaga et al. and consists in the use of a proctoscope with a Doppler transducer that detect the arterial structures. Since DGHAL does not involve tissue excision, it is expected to be associated with reduced postoperative pain if compared with hemorrhoidectomy. In the last decade several devices (THD and AMI/ HAL-RAR - Hemorrhoidal Artery Ligation and Recto Anal Repair) have been developed in order to improve and facilitate the execution of the technique, making easier the procedure. The hypothesis of the study is that a simple mucopexy procedure by suture-fixation of anal cushion without the aim of a Doppler device, could be as effective as DGHAL and mucopexy to manage prolapsing grade III hemorrhoids.

NCT ID: NCT03729362 Completed - Clinical trials for Pompe Disease (Late-onset)

A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease

PROPEL
Start date: December 4, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

NCT ID: NCT03728621 Completed - Obesity Clinical Trials

Lifestyle Interventions and Metabolic Profile in Obese Children

Start date: January 2012
Phase: N/A
Study type: Interventional

This study evaluates if promotion of a normocaloric and balanced diet and of physical activity, through an individual- or group-based lifestyle intervention of 12 months, may affect anthropometric measurements and metabolic profile in obese children.

NCT ID: NCT03728478 Recruiting - Clinical trials for Polyarthritis, Juvenile, Rheumatoid Factor Negative

STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS

STARS
Start date: May 29, 2019
Phase: Phase 3
Study type: Interventional

This study aims to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on the initial start of a combination of conventional and biological DMARDs (step-down strategy).