To define an optimal dosage of intravenous acetaminophen to close DA in EPI and thereafter to evaluate the consequence of early prophylactic acetaminophen treatment on mortality/morbidity at 36 weeks (w) of postconceptional age (PCA).

Population: paediatric | Intervention type: therapeutic medicinal product

Purpose: To prospectively study the efficacy of Teriflunomide in extending the time to a seminal acute or progressive demyelinating event in a cohort of RIS subjects.
Rationale: RIS subjects are frequently exposed to disease modifying therapies despite the lack of scientific literature supporting the use of such treatments. Earlier treatment intervention may extend the time to the first acute or progressive clinical event resulting from CNS demyelination and reduce radiological progression. In addition, early treatment may result in more profound effects on reducing disability progression long-term.
Primary outcome: The primary outcome measure for this trial is the time to the first acute or progressive neurological event resulting from CNS demyelination.
Population: This study will include RIS subjects from the Europe who fulfill 2009 RIS Criteria.

Population: adult | Intervention type: therapeutic medicinal product

TENSION is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 714 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

Population: adult | Intervention type: therapeutic medical device

This study is a post-market, multicenter, prospective, single arm observational registry that aims to collect performance and safety clinical data of NEOCEMENT (CE marked device) in the treatment of bone defects as part of routine clinical practice. The results of the Clinical Investigation shall be used as clinical evidence for clinical evaluation of the device aiming for submission to the new Medical Device Regulation (EU) 2017/745. This protocol does not include any new intended uses, new populations, new materials or design changes.

Population: adult | Intervention type: non-interventional medical device

The overall aim of the randomised controlled trial SWEET (S&SEs: Prolonged effects on health, obesity and safety) is to investigate the efficacy and safety of combined (foods and drinks) and prolonged use of S&SEs—as part of a whole healthy ad libitum diet approach—in a population of overweight adults and children. The two primary outcomes on efficacy and safety will be assessed in adults by 1-year changes in body weight and 1-year changes in gut microbiota related to metabolic health outcomes, respectively. Secondary objectives concern effects on obesity-related risk factors such as fat mass, glucose metabolism and lipidemia as well as safety aspects such as allergenicity. Other outcomes include appetite sensations, food cravings, food preferences and preference for sweet taste.

Population: adult & paediatric | Intervention type: therapeutic medicinal product

Sesame is a European, multi-center, single arm, prospective, observational registry.
Sesame aims to demonstrate that use of SOFIA™/SOFIA™ PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment. 250 patients will be enrolled. All patients will be followed for 90 days or until death.

Population: adult | Intervention type: therapeutic medical device

In Europe, Rare Eye Diseases (RED) are the leading cause of severe visual impairment/blindness (SVI/B) in children. This sensory disability with its accompanying psychological distress hugely impacts their lives and their families. Understanding this impact is key in care, shared decision making, developing therapies, and improving social integration. However, current tools to evaluate vision related quality of life (VR-QoL) disregard age and cultural differences, while we lack knowledge on what aspects of this impact are important at the individual child’s level. Instruments capable of yielding high-quality data, with broad applicability and regulatory compliance, remain to be developed.

SeeMyLife convenes a multidisciplinary team from 6 EU countries to generate data on the experience of these children. We will combine quantitative (QUAN) and qualitative (QUAL) data in a mixed methods research framework. QUAN data will be generated using standardized, validated VR-QoL questionnaires. QUAL data will be generated from a socio-anthropologic study including semi-directive interviews to address how their disability affects lives. The conclusions of the QUAN study, comparable across several countries, will be reinforced by the richness of the individual data collected during the QUAL study.

SeeMyLife will provide tools for RED children/teenagers’ self-report which will be used in clinical care and research as a new European standard, and the long-awaited knowledge about the patient’s position within his/her own life course and within his/her family and healthcare actors.

Population: paediatric | Intervention type: therapeutic medical device

The primary outcome of this trial is to evaluate the effectiveness of intradiscal injection of bone marrow mesenchymal stromal/stem cells (BM-MSCs) in reducing chronic lower back pain (LBP) using the visual analog scale (VAS) and functional status (Oswestry scale) after 12 months of treatment, defining responders in case of at least 20% improvement in VAS or Oswestry scale at month 12 compared to a baseline with absolute change of 20 mm on a 100 mm scale.

Population: adult | Intervention type: therapeutic medicinal product

The objective of this study is to identify the eligibility criteria for treatment with Li in BDI in terms of response, safety and tolerability.

Population: adult | Intervention type: therapeutic medicinal product