Petah Tikva, Israel Clinical Trials

G Gina Cravey

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study …

M Michal Laufer, MD

Evaluation and Management of Cardio Toxicity in Oncologic Patients

The survival rate of cancer patients has greatly increased over the past decades' mainly due to early detection and the use of new medications with higher doses and combined protocols. This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction ranged from transient asymptomatic left ventricular dysfunction …

Lysosomal Acid Lipase (LAL) Deficiency Registry

This is an observational, multi-center, international disease registry designed to collect longitudinal data and create a knowledge base that will be utilized to improve the care and treatment of patients with LAL Deficiency. Participation in the Registry by both physicians and patients is voluntary.

PASS of Paediatric Patients Initiating Selumetinib

Neurofibromatosis type 1 (NF1) is a rare, autosomal dominant genetic disorder that is caused by germline mutations in the NF1 tumour suppressor gene, which encodes the tumour suppressor protein neurofibromin 1. Plexiform neurofibromas (PN) are histologically benign nerve sheath tumours, which typically grow along large nerves and plexi. On 5 …

The European Paediatric Network for Haemophilia Management ( PedNet Registry)

Rationale Haemophilia is a rare disease; to improve knowledge international collaboration is needed. Well-defined clinical data will be collected from complete cohorts in order to prevent selection bias. Objective To collect data on bleeding during neonatal period, endogenous (genetic) and exogenous (treatment-related) determinants of inhibitor development and long term outcome.

R Rivi Tauman, MD

A Prospective Study to Evaluate the WP in Comparison to PSG in Patients Suspected of Sleep Disorders

The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep …

D Darius Adams, MD

Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)

Spinal muscular atrophy (SMA) is a neurogenetic disorder caused by a loss or mutation in the survival motor neuron 1 gene (SMN1) on chromosome 5q13, which leads to reduced SMN protein levels and a selective dysfunction of motor neurons. SMA is an autosomal recessive, early childhood disease with an incidence …

Observation of Clinical Routine Care for Heart Failure Patients Implanted With BIOTRONIK CRT Devices

The registry is primarily designed to assess outcome, efficacy and residual safety aspects of CRT based on long-term data from an unselected, real-life clinical set-up. Moreover, the observation of the patient status should help to find possible predictors for HF events and to identify areas of improvement for CRT and …

BoStOn SCientific Rhythm MAnagemenT REgiStry (SOCRATES)

SOCRATES is part of Boston Scientific's (BSC) Post-market surveillance system. The implementation of such systems is mandatory per local regulations such as the Regulation '(EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices' or short Medical Device Regulation (MDR). The SOCRATES design …

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.