Clinical Research Directory

Effectiveness of an Advanced Practice Nurse-Led Health Education Program (APN-HEALTH)

Advanced Practice Nursing (APN) has demonstrated a positive impact on improving health outcomes in various international clinical settings. In Spain, however, its integration is still limited and variable, especially in specialized fields such as neurology and surgery. Existing evidence suggests that health education led by an APN can improve key indicators such as health literacy, self-efficacy, and patient satisfaction, although further research is needed in our context. Hypothesis: Health education provided by an APN significantly improves health literacy, self-efficacy, quality of life, and the healthcare experience of patients seen in neurology and surgery nursing clinics. Objective: To evaluate the impact of health education provided by an APN on health literacy, self-efficacy, quality of life, and the experience of patients seen in a neurology and surgery nursing clinic. Methods: A quasi-experimental, pre- and post-intervention, single-group study. The study will begin after approval by the relevant Ethics Committee. The intervention will consist of providing comprehensive, individualized health education that includes information on the person's health history, recommended lifestyle habits and practices, available treatment options, identification of warning signs and symptoms, how to respond appropriately to them, available care pathways, and contact information for the unit. Patients seen by a Primary Care Team (PCT) in neurology and surgery nursing consultations will be included, with data collected at three points in care: before the intervention, after the intervention, and at 6 months. The primary variable is health literacy, and secondary variables are self-efficacy, quality of life, and patient experience. A pre-post comparability analysis will be performed on the variables studied. Relevance: The results will provide applicable evidence to promote organizational models that integrate PCTs into specialized care, improving the quality of care and the patient experience, and guiding future lines of research and implementation policies. In turn, they intend to demonstrate the value provided by the EPAs on the outcome indicators and the experience of the people attended in the neurology and surgery nursing consultations.

Newborn Screening and Early Diagnosis of AADC Deficiency in the Ligurian Population

Aromatic L-amino acid decarboxylase deficiency (AADC-D) is a rare genetic disorder that affects the production of neurotransmitters in the brain and can cause severe neurological and developmental problems. Early diagnosis may allow affected children to be referred promptly for specialist care and evaluation for available treatments, including gene therapy. The purpose of this study is to develop a newborn screening protocol for AADC-D in the neonatal population of Liguria, Italy, and to estimate the incidence of the disease in this population. The study will also establish reference values for 3-O-methyldopa (3-OMD), a biochemical marker used to identify newborns who may have AADC-D, and determine appropriate screening cut-off values. Approximately 16,000 newborns born in participating hospitals in Liguria will be included in the study. After informed consent is obtained from their parents or legal caregivers, blood samples will be collected using dried blood spot cards as part of the existing regional newborn screening procedures. The samples will be analyzed using tandem mass spectrometry to measure 3-OMD levels. Samples with positive screening results will be retested. If the result remains positive, genetic testing of the DDC gene will be performed to confirm the diagnosis. The study will evaluate 3-OMD levels in the neonatal population, establish and periodically refine screening thresholds, and assess the preliminary performance of the screening method. The results are expected to support the development of a reliable newborn screening program for AADC-D in Liguria and facilitate the early identification of affected newborns.

Remote Assessment of Digital Neurologic Testing

The RADiaNT study investigates whether guided meditation, using the Muse™ headband and biofeedback app, can improve sleep, mood, and cognitive performance, aiming to assess its impact on mental and emotional well-being.

Establishment of a Sleep and Sleep-disorder Research Cohort in Patients With Neurological Disorders

This study aims to establish a research cohort on sleep and sleep disorders in patients with neurological diseases to systematically evaluate the relationship between various neurological conditions and sleep characteristics or disturbances.

A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects

The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are: How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate? Participants will be asked to: * Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days * Stay overnight at MGH's research unit for two separate 2-week periods * Participate in two separate 24 hour periods of multiple MRIs and blood draws

Voice Assistant for Outpatient Neurology Visits

Documentation duties account for a substantial portion of an outpatient physician's working time and reduce time available for direct patient interaction. Voice assistants based on automatic speech recognition and large language models are being developed to automate medical documentation across clinical specialties. However, such ambient AI-based services have not been systematically validated in Russian-language outpatient neurology practice integrated with a regional electronic health record platform. This pilot, multicenter, prospective, before-after study evaluated the feasibility and preliminary effectiveness of a voice assistant Service designed to automatically pre-fill the structured outpatient neurology visit protocol in the Moscow regional medical information system (EMIAS). The Service implements a pipeline of streaming speech-to-text transcription, two-speaker diarization, and large language model-based mapping of the dialogue between the physician and the patient onto the fields of the standardized neurology examination protocol. Five neurologists at five outpatient clinics in Moscow participated. The study comprised three stages: (1) baseline timing of consultations without the Service; (2) timing of consultations with the Service after a two-week adaptation period, with parallel evaluation of transcription and pre-fill quality and of physician and patient satisfaction; and (3) statistical analysis. Three hundred twenty consultations were timed (160 per stage). A stratified random sample of 30 audio-recording / generated-protocol pairs was used to evaluate Service quality; free-text fields were rated on a 5-domain Likert questionnaire and on a 10-point visual analogue scale, and binary fields were rated dichotomously to derive sensitivity, specificity, accuracy, Jaccard index, and false-positive rate. Patient satisfaction was assessed by the modified Patient Satisfaction Questionnaire 8 (PSQ-8); physician feedback was assessed by a custom questionnaire (including the Net Promoter Score) and by semi-structured in-depth interviews with thematic analysis using grounded theory. The primary outcomes were the change between stages in (a) the time of focused physician attention to the patient and (b) the time spent filling and editing the protocol. Secondary outcomes addressed total consultation time, transcription quality (Word Error Rate), expert-rated quality of pre-filled fields, patient satisfaction, and physician satisfaction. The study was conducted under the framework of the Moscow Healthcare Department experiment on the use of digital innovation technologies in health care (Order No. 153 of 21 February 2025), and was approved by the local independent ethics committee.

Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)

Evaluate the safety and effectiveness of Echo-Focusing using Exablate Neuro as a tool for treating patients with treatment-refractory neurologic and psychiatric disorders.

BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe

Lack of adherence to treatment is a widespread issue worldwide, which leads to higher healthcare utilisation rates and even premature death. While the level of adherence may differ based on the specific condition and treatment, studies estimate that approximately 50% of medications are not taken according to the prescribed instructions. In addition, adherence rates tend to decrease even further when the treatment requires a behavioural change. Literature reviews about factors that affect people's adherence show that it is challenging to predict whom can be considered to have adherent and non-adherent behaviours. In addition, the studies highlight that it is challenging to support a person to be adherent. Based on this knowledge the BEAMER project was established (Behavioural and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe). The overall goal of the project is to improve the quality of life of individuals, enhance healthcare accessibility and sustainability, thereby transforming the way healthcare stakeholders engage with patients to understand their condition and adherence levels throughout their healthcare journey. To address the overall goal, the BEAMER project has developed a disease agnostic model named "B-COMPASS: BEAMER-COmputational Model for Patient Adherence and Support Solutions". The aim of the B-COMPASS is to identify patients' needs and preferences which enables the creation of patient-specific supports, with the intention of improving their adherence to treatment within the heterogeneity of the different disease-areas and healthcare contexts. Based on the validated BEAMER questionnaire, the B-COMPASS predicts relative adherence and offers an elicitation process of patient needs and preferences to enable targeted supports to improve patient adherence. This results in an allocation of patients to different groups based on their needs and preferences. Overall, the B-COMPASS provides patient insights that will enable more effective design of patient support, most likely resulting in better patient experience, improved adherence and lower healthcare and societal costs. So far, several activities from a technical and user perspective have already been conducted in the project to refine the B-COMPASS. This has been done by applying an iterative mixed method approach were both stakeholders (regulator, pharma, academic/research and small and medium-sized enterprises) and end users (patients, health providers and health systems) have been involved. Despite the finetuning of the B-COMPASS, the effectiveness of the B-COMPASS hinges on empirical investigations into the structural elements that impact patient behaviour and the identification of predictive factors that can assist healthcare providers' (HCP) and Research Leads in designing more effective treatment plans (the term HCPs/Research Lead include both the individuals and the institutions where care is delivered). Therefore, validation studies will be conducted to assess the B-COMPASS's performance in six therapeutic areas (cardiovascular, endocrinology, immunology, neurology, oncology and rare diseases) with patients recruited in at least Italy (FISM), Portugal (APDP and MEDIDA) Norway (AHUS), Spain (FHUNJ and FIIBAP), The Netherlands (WDO), and Germany (UDUS). The collected data will be used to evaluate the B-COMPASS's capacity to attend to a variety of needs and challenges for adherence.

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications

This registry is a prospective, multicenter, international, single arm, observational post-approval registry with follow-up at 3, 6, and 12 months, and annually for 5 years. The proposed registry will enroll 60 subjects and will be conducted at approximately 10 centers worldwide.

Evaluation of A-DIVA Score Effectiveness at Admission for Preserving Venous Capital in Patients With Difficult Access

In certain cases (e.g.: patient who are difficult to perfuse, thin veins, etc.), an increase in venipunctures performed by study nurses in healthcare services can lead to a loss of venous capital, repeated pain during punctures, discontinuous treatment follow-up and numerous requests for assistance from colleagues, including nurse anesthetists, but often too late. The main objective of project is to reduce the number of punctures to access the venous system after evaluation of adult patients upon entering the hospitalization department using the A-DIVA tool. the A-DIVA score predicts the difficulty in infusing an adult patient