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NCT ID: NCT04847336 Enrolling by invitation - Clinical trials for Quality of Care During Childbirth

Improving MAternal Newborn carE In the in the WHO European Region During COVID-19 Pandemic

IMAgiNE-EURO
Start date: September 2, 2020
Phase:
Study type: Observational

BACKGROUND COVID-19 response is heavily impacting the availability of essential health services, especially services for pregnant women and newborns that cannot be delayed or rapidly reorganized in other settings. In the current pandemic, due to multiple factors access to high quality and timely maternal and newborn (MN) health care is threatened. Major concerns have also been raised with respect to maternal rights and on disruption of essential practices and increased medicalization of care, despite existing WHO guidance. Based on preliminary reports heterogeneities in practices is expected within the WHO European Region, with major inequities (eg women experiencing disruption of essential MC health services only in selected countries or areas within the countries, while having access to adequate care in others). With IMAgiNE EURO we aim at conducting a survey to explore the health service preparedness, quality and resilience, with a specific focus on health services around the time of childbirth, in the WHO European Region during COVID-19 pandemic, and to make available data, which, in collaboration with WHO and other partners, can contribute in improving the quality of MN health care. HYPHOTESIS AND SIGNIFICANCE - This project has been developed in coordination with WHO Regional Office for Europe (EURO) and other partners, and ultimately aims at making available and disseminate data that can help improving the quality of MN health services in the Region. Collecting data on the quality of essential MN health services across different countries within the WHO European Region will help addressing specific gaps and planning coordinate response to improve quality of MN care and improve MN health outcomes. - The project will also offer the opportunity to develop tools and methods to monitor the quality of MN health care across different countries and settings. - The project will establish and consolidate a research network Primary objective: 1. Record, analyse, and describe data on MN health service preparedness, quality and resilience - with a specific focus around the time of childbirth as measured both from health workers and women perspectives- across different countries within the WHO European Region, during COVID-19 pandemic. Secondary objectives: 2.Develop tools and methods to measure, through rapid online surveys, the quality of MN health care across different countries and settings 3.Establish and consolidate a research network

NCT ID: NCT04803188 Enrolling by invitation - Clinical trials for Prostate Cancer (Diagnosis)

Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I

ProSa-I
Start date: September 21, 2020
Phase: N/A
Study type: Interventional

Prostate Cancer (PCa) screening is still a controversial topic in the urology community, this is mostly linked to the low specificity of Prostate Specific Antigen (PSA) value. Screening with total PSA value has cause overdiagnosis of clinically insignificant prostate cancer (ciPCa) for many years, with lack of survival improvement. Non-contrast MRI, on the other hand, has become one of the most promising MRI applications, as it is a more sensitive test able to perform clinically significant PCa early detection. With this background the primary endpoint was to investigate the role of non-contrast MRI (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test, in a randomized fashion.

NCT ID: NCT04776382 Enrolling by invitation - Simulation Training Clinical Trials

Eye Movement Modeling Examples as a Teaching Tool

Start date: March 25, 2022
Phase: N/A
Study type: Interventional

This study will evaluate whether eye-tracking assisted teaching (EMME, Eye Movement Modeling Examples) changes the visual patterns and improve the inexperienced trainee's performance in executing an epidural block on an epidural simulator.

NCT ID: NCT04760769 Enrolling by invitation - Parkinson Disease Clinical Trials

Open-label Trial in Parkinson's Disease (PD)

TEMPO-4
Start date: February 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.

NCT ID: NCT04755309 Enrolling by invitation - Infant Development Clinical Trials

Efficacy of an Early Rhythmic Intervention in Infancy

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. Long-term goals of the study include the characterization of language/learning developmental trajectories in children at high risk for language disorders and the implementation of ecological interventions based on enriched auditory experience to be employed to these children in an attempt to modify their atypical developmental trajectory before the emergence and crystallization of any behavioural symptoms and within the early period of known maximum cerebral plasticity. Specifically, the main aim of this study is the development and implementation of an innovative and ecological early intervention based on environmental auditory enrichment (labelled "rhythmic intervention"). This intervention is tested both on a sample of typically developing infants and on a sample of infants at high familial risk for language disorders during a time span between 7 and 9 months of age. The efficacy of the intervention is tested on the electrophysiological markers tested before and after the intervention activities and on the linguistic outcomes within a longitudinal approach. The efficacy of such an intervention is compared to the spontaneous development observed in comparable groups of infants with and without familial risk for language disorders. In addition, only in a group of typically developing infants, a control intervention providing passive exposure to the same auditory stimulation is tested, in order to verify the specific contribution of the active participation of the children to the intervention. The investigators hypothesize that the rhythmic intervention may modify the electrophysiological markers underlying auditory processing and the linguistic skills of all children, with a larger increase in infants at familial risk for language disorders who are specifically impaired in such skills.

NCT ID: NCT04749186 Enrolling by invitation - Clinical trials for Educational Problems

Achieving Lumbar Epidural Block Competency in Inexperienced Trainees After a Structured Teaching Model

Start date: April 7, 2021
Phase: N/A
Study type: Interventional

There is currently no universally accepted, comprehensive, or standard systematic way to teach the epidural block. Typical teaching of epidural catheter placement consists of a combination of didactic education and hands-on experience, where apprentice and master approached the task together in the clinical setting, with live patients as the learning model. The learning curve is one of the most common tools to assess how the physician in training is progressing at a skill, and it is defined as a curve generated by plotting the success or failure against the number of attempts. More complex learning curves using an acceptable and unacceptable failure rate can be constructed. To perform these more complex learning curves a statistical tool such as the Cumulative Sum Technique (CUSUM) may be used. The CompuFlo Epidural Trainer can differentiate tissue types by pressure signatures that are imperceptible to touch. This allows the trainee to accurately identify the needle location and discriminate between false and true loss of resistance. Having displayed, recorded and printed a graph illustrating the procedure, may also lead to a greater appreciation of the anatomy of the structures the needle must pass. Eye-tracking is the process of measuring either the point of gaze or the motion of an eye relative to the head. This method has been successfully used for proficiency assessment. The aim of this study will be to investigate whether the use of a Structured Didactic Model (SDM) including standardized video lessons, construction of a 3D epidural module, practical training by using an epidural simulator with CompuFlo Trainer instrument, eye tracking assisted technique, may affect the CUSUM learning curve for lumbar epidural block in novice, inexperienced trainees and their eye-tracking patterns.

NCT ID: NCT04729907 Enrolling by invitation - Clinical trials for Muscular Atrophy, Spinal

Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen

ONWARD
Start date: April 19, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566). The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).

NCT ID: NCT04708834 Enrolling by invitation - Clinical trials for Obsessive Compulsive Disorder

Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Start date: March 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).

NCT ID: NCT04682093 Enrolling by invitation - Covid19 Clinical Trials

Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED

EUROCOV
Start date: March 9, 2020
Phase:
Study type: Observational

This project is an unfunded collaboration of approximately 30 emergency departments across Europe led by the EUSEM research network. It involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected Covid infection.

NCT ID: NCT04678024 Enrolling by invitation - Covid19 Clinical Trials

Sensitivity Evaluation of Serological Tests for Covid-19

COVIDIAGNOSTIX
Start date: November 18, 2020
Phase:
Study type: Observational

The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.