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  • SIMPLIFication of Care Pathways for Patients with Rare Brain Tumors Through Artificial Intelligence

    Participants will be adults with rare brain tumors and will be enrolled at two neurosurgery centers in Italy. The study aims to create a network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients. This study aims to improve the care and outcomes for patients with rare brain tumors (rBT) by standardizing clinical pathways and utilizing advanced technologies such as Artificial Intelligence (AI) and Machine Learning (ML). Rare brain tumors, including astrocytomas, oligodendrogliomas, neuronal tumors, malignant meningiomas, and embryonal tumors, are defined as rare due to their low incidence (<6 cases per 100,000 people/year). The study will be conducted in two phases: a retrospective phase and a prospective phase. The retrospective phase will involve the use of existing neurosurgical databases to implement ML algorithms. The prospective phase will include the collection of clinical, cognitive, and psychological data at multiple time points (pre-surgery, discharge, 3 months post-surgery, and 12 months post-surgery). Patients will participate in an early neuro-cognitive rehabilitation program using the RehaCom software, designed to enhance cognitive functions potentially affected by surgery. The rehabilitation will be conducted at the patient's home. The primary objective is to develop a common evaluation protocol that includes clinical, cognitive, psychological, and sociodemographic measures. Secondary objectives include identifying predictors of surgical outcomes through retrospective and prospective studies and developing predictive models for rare brain tumors. The study will enroll approximately 200 adult patients from two neurosurgery centers in Italy. Inclusion criteria include adults (≥18 years) undergoing craniotomy for rare brain tumors, while exclusion criteria include patients undergoing stereotactic biopsy, those with psychiatric disorders, or those lacking the necessary technology for home-based rehabilitation. The ultimate goal is to create a multidisciplinary network of professionals specialized in predicting surgical outcomes, thereby improving the overall quality of care and the quality of life for patients with rare brain tumors.

    Phase

    N/A

    Span

    79 weeks

    Sponsor

    Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    L'Aquila

    Recruiting

  • Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

    Phase

    N/A

    Span

    313 weeks

    Sponsor

    University of L'Aquila

    L'Aquila

    Recruiting

  • Transcranial Pulse Stimulation. a Potential Treatment for Early Dementia

    Aims of the project: The primary aim of our research protocol is to improve care for patients with AD by investigating whether Transcranial Pulse Stimulation (TPS) may induce cognitive improvement in patients with an early stage of dementia. Additional aims will include the investigation of the neurophysiological profile of patients and the search for a correlation between neuropsychological and neurophysiological data with the serum levels of brain-derived neurotrophic factor (BDNF) and of vascular endothelial growth factor (VEGF). Materials and Methods: Following a rigorous selection, included patients will be treated through a real/sham structured TPS protocol and followed-up with respect to cognitive improvement, by comparing baseline and follow-up clinical scores. A Double Blind Sham-Controlled Study will be performed: patients will be assigned randomly to receive TPS or sham TPS for 4 weeks in a parallel groups, double-blind study. Patients will receive ether TPS or sham treatment once a day for five days a week for the whole period and will be assessed according to the following schedule: baseline (t0); at two weeks following the start of TPS (t1); at 1 month following the start of TPS (t2); at 2 months following the start of TPS (t3); at 6 months following the start of TPS (t4). Electroencephalography (EEG) and Somatory Evoked Potentials (SEP) will be contextually recorded in all patients, to compare neurophysiological data of patients treated with real TPS and sham stimulation. Moreover, a serum sample will be collected from patients at baseline, at the end of the stimulation period and at the 6-month follow-up, to compare preprocedural and postprocedural levels of serum BDNF and VEGF.

    Phase

    N/A

    Span

    87 weeks

    Sponsor

    Francesca Pistoia

    L'Aquila

    Recruiting

  • OnaBotulinumtoxin-A in Chronic Migraine Patients with Short or Long Disease History (the BACH Study)

    Onabotulinumtoxin-A (OBT-A) is a worldwide approved preventive treatment for patients suffering from Chronic Migraine (CM, 1.3, ICHD III 2018). Its effectiveness in reducing headache frequency and disability has been demonstrated by two well-designed phase III clinical trials, PREEMPT 1 and 2 and, more recently, by some real-life studies. However, the use of OBT-A in the real world clinical practice has been still raising some issues: i.e. searching for more adequate patients' selection, when discontinuing the OBT-A treatment and when resuming it, finding associated patients' psychopathological profile possibly influencing the treatment, and so on. Moreover, finding some indicators of good or bad prognosis coming from OBT-A real-life experience could be of help for the clinicians to individuate the best candidates to the treatment. The aim of the present study is mainly to investigate whether the history of Chronic Migraine and, more precisely, its duration for over or less than 10 years, can predict OBT-A treatment effectiveness. In other words, the study will aim to establish whether starting OBT-A treatment earlier in CM patients' life could make it more effective. Since psychiatric symptoms may represent prognostic factors influencing treatment effectiveness, the present study will also aim at evaluating if the psychopathological profile of the enrolled patients may influence the outcome. Consecutive CM patients treated in Italian tertiary level Headache Centers and classified according to CM history (shorter/longer than 10 years) will be enrolled. Aims To compare OBT-A treatment effectiveness in patients with shorter (1-9 yrs) and longer (10 or longer) years history of CM, in terms of: - monthly migraine (MMD) or headache (MHD) days - monthly acute medications (MAM) - disability scales (Headache Impact Test, HIT-6; Migraine Disability Assessment MIDAS questionnaire) scores - pain intensity and quality Objectives - to investigate whether the history of Chronic Migraine (over or less than 10 years) can predict OBT-A treatment effectiveness - to find possible indicators of good or bad prognosis coming among psychiatric comorbidities of the enrolled patients Consecutive CM patients (according to ICHD-3 1.3) treated in Italian headache centers, undergoing OBT-A, will be enrolled. Methods All patients will fill a headache diary to report MMDs and acute medications taken every month. Disability will be assessed by means of HIT-6 and MIDAS. Moreover, the intensity and quality of perceived pain will be evaluated by means of Numerical Rating Scale (NRS), 11-point Box Scale (BS-11), Present Pain Intensity (PPI), Behavioral Rating Scale (BRS-6) e Short-form McGill Pain Questionnaire (SF-MPQ). The psychopathological profile will be evaluated at different times of the study by means of the following psychological questionnaires: Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI-Y), Toronto Alexithymia Scale (TAS-20). At enrolment (T0), before starting the treatment, patients will have to fill a questionnaire about the previous 3 months (screening phase) including: - MMD and MHD - MAM - NRS, BS-11, PPI, BRS-6 e SF-MPQ scales - MIDAS e HIT-6 scale - BDI-II, STAI-Y, TAS-20 questionnaires After completing the diary and scales above, patients will receive OBT-A treatment according to PREEMPT protocol. Patients will be divided into 2 groups according to their CM history (duration): A) those from 1 to 9 years and B) those with 10 or more years of CM history. Patients will be re-evaluated every 3 months, at each OBT-A cycle, during the whole year of treatment. At every evaluation time patients will show their diary of headaches with MMD and MAM taken. At T3 and T9 (3 and 9 months respectively after T0), patients will fill the questionnaire including MMD and MAM taken in the previous 3 months, pain evaluation scales, MIDAS e HIT-6 scales. At T6 and T12 (6 and 12 months respectively from T0, T12 being the final evaluation) patients will have to fill all questionnaires/scales as at T0. Outcomes Primary endpoint Change in the mean number of MMD (or MHD) from baseline to months 6 through 12 between groups Secondary 1. 50% or greater reduction in MMD from baseline to months 6 through 12 between groups 2. change in the number of MAM from baseline to months 6 through 12 between groups 3. change in pain intensity and quality scores from baseline to months 6 through 12 between groups 4. change in terms of psychological profile (STAI-Y, TAS-20 scales) in the stratified subgroups based on Z score of BDI-II scale (< 0 ≥ 1,8) between groups Statistical analysis The data will be collected in an electronic database in anonymous form that will be protected by a password for each participant center. On the basis of primary outcome (change during the follow-up vs. baseline of MMD), a general linear model with mixed effects will be applied, which will allow to evaluate, considering the within-subject dependencies and allowing to use all the observations available for each subject (even if for example the measurement of a subject at the time Tx should be missing), the interaction time X group and estimate if and when during follow-up a significant difference between the two groups will occur. According to a previous study (Vernieri et al, Headache 2019), the distribution of MMD is expected to follow a Gaussian distribution, therefore the general linear model will be a mixed-effects ANOVA. For some of the other variables (such as the number of analgesics or MIDAS) a generalized model will be applied to take into account the non-Gaussian nature of their distributions. The sample size has been predefined according to the primary outcome with the following approach. Thanks to the previous study (Vernieri et al, 2019), it was possible to estimate the standard deviations (SD) of the changes of MMD between baselines and subsequent times. The maximum standard deviation was observed between baseline (T0) and T4 (1 year) and was 8 (with very similar values in two independent centers: 7.8 and 8.2). Since this SD was estimated on 100 patients, the 95% confidence interval for SD is 7.0-9.3. In order to avoid underestimation of the variability of the primary outcome, we have therefore set SD equal to the upper limit of the confidence interval built on the maximum SD found of the variations (vs. baseline) during the follow-up and that is SD=9.3. In the following table it is reported the sample size required to have a power of 90% to recognize as statistically significant (at two-tails alpha level set at 0.05) the differences between the expected decreases specified in the first two columns. Since the evaluation times at follow-up will be 4 (T3, T6, T9, T12), the probability of error of type I has been divided by 4, in order to keep the overall alpha error below 5%. In the cited study a decrease after 6 months of treatment (and confirmed at 12 months) of about 7 days of migraine/month was observed. This absolute decrease corresponded to a percentage change of about 30-35%. The hypothesis is that chronic patients from more than 10 years may benefit less from treatment and, in particular, that between the two groups there is a difference in efficacy of 4 (hypothesis 1) and 6 (hypothesis 2) days/month. Hypothesis 1 Expected pre-post decrease Group1 (>=10y) 5 (SD=9.3) Expected pre-post decrease Group1 (<10y) 9 (SD=9.3) Power (1-b) 90% a (two-tails) 0.0125 N Group1 115 N Group1 115 Hypothesis 2 Expected pre-post decrease Group1 (>=10y) 4 (SD=9.3) Expected pre-post decrease Group1 (<10y) 10 (SD=9.3) Power (1-b) 90% a (two-tails) 0.0125 N Group1 52 N Group1 52 With these numbers it is also possible to calculate that there will be a probability of 90% to recognize as statistically significant (at alpha level 0.05) standardized effect size f=0.08 (hypothesis1) and f=0.12 (hypothesis 2) for the interaction Time X Group. The calculation for the interaction was based on an ANOVA with 4 repeated measurements after T0 (T3, T6, T9, T12), assuming the same correlation between the baseline follow-up assessments observed in the study by Vernieri et al, 2019 and applying a correction for lack of sphericity epsilon=0.9. Considering that f=0.10 is conventionally classifiable as "small", the indicated number of values therefore allow to be sensitive to small variations (even if clinically relevant). Reference Vernieri et al. Onabotulinumtoxin-A in Chronic Migraine: Should Timing and Definition of Non-Responder Status Be Revised? Suggestions From a Real-Life Italian Multicenter Experience. Headache. 2019 Sep;59(8):1300-1309.

    Phase

    N/A

    Span

    105 weeks

    Sponsor

    Fondazione Policlinico Universitario Campus Bio-Medico

    L'Aquila

    Recruiting

  • A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

    Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo

    Phase

    3

    Span

    192 weeks

    Sponsor

    Pfizer

    L'Aquila, Abruzzo

    Recruiting

  • Post-marketing Clinical Follow-up for Long-term Use of Intranasal Kinetic Oscillation in Subjects With Chronic Migraine

    Subjects who provided written informed consent and are eligible for the study will be asked to complete a daily diary for 4 weeks during the screening period. In the diary the subjects will record headache and migraine days, any changes in their health, and concomitant medications they may be using. The data collected in the diary during this screening period will be used as Baseline for the performance assessments. A non-controlled, long term, multi-center investigation for symptom improvement in subjects suffering headache and migraine attacks. During the run-in (baseline) period and through the whole study the subjects will continue using their existing prescribed or over the counter (OTC) treatments. Following the run-in period (4 weeks) the subjects will be treated six times within a period that is approximately 6 weeks. The first treatment will be given the first day after the run-in period. During 12-month follow-up period (from the time of the first treatment), subjects will be treated when needed but a maximum of 14 treatments.

    Phase

    N/A

    Span

    164 weeks

    Sponsor

    Chordate Medical

    L'Aquila

    Recruiting

  • The Effects of Inositol on Glucose Metabolism in Patients with Metabolic Syndrome At Risk of Cardiac Fibrosis

    Phase

    N/A

    Span

    163 weeks

    Sponsor

    Lo.Li.Pharma s.r.l

    L'Aquila

    Recruiting

  • Adjunctive Effect of Erythritol on Pocket Closure Rates

    This study is testing whether erythritol powder, used during non-surgical periodontal treatment (also known as deep cleaning), can help improve gum health in people with advanced periodontitis (stage 3 or 4). Periodontitis is a serious gum infection that damages the soft tissue and bone supporting the teeth. Standard treatment includes removing plaque and tartar using manual tools or ultrasonic devices. In this study, gum pockets that are 4 mm deep or more are treated either with standard care alone or with standard care plus a cleaning method that uses air pressure and erythritol powder (a sugar alcohol with antibacterial properties). The goal is to determine whether this additional step leads to improved clinical outcomes. Participants are randomly assigned to one of the two treatments. The study tracks improvements in gum pocket depth after 2 and 4 months, as well as other indicators of periodontal health like bleeding and plaque levels. Researchers are also evaluating whether factors such as age, sex, smoking status, or diabetes influence treatment response.

    Phase

    N/A

    Span

    60 weeks

    Sponsor

    University of L'Aquila

    L'Aquila

    Recruiting

  • Herpes Zoster Hospitalizations in Italy

    Varicella (chickenpox) is a highly contagious illness sustained by an α Herpes virus called varicella-zoster virus (VZV). A replication phase in the penetration site is followed by a viremic phase when VZV spreads to skin and mucosae, leading to the typical rash and infection of sensory nerves in the epithelium, and then the reach of the sensory ganglia where it becomes latent. The reactivation of the latent virus, years or decades after primary infection, causes the typical clinical expression called Herpes Zoster (HZ) or shingles. Post-herpetic neuralgia (PHN), an intractable pain in the dermatome affected by HZ, is the most common complication. It is estimated that it affects 10-20% of all patients with HZ aged ≥ 50 years and up to 30% of those aged ≥80 years. Management of PHN is not easy, but vaccination for prevention of PHN may be a strategic choice. The most common complications of herpes zoster, other than PHN, often requiring hospitalization, include secondary bacterial infections, ophthalmic complications, cranial and peripheral nerve palsies, and segmental zoster paresis. All authors agree that factors such as age, cell-mediated immunity (CMI) depression, intrauterine exposure to VZV and varicella occurring in early age (<18 months) are typically associated with HZ incidence. It further should be noted that age and CMI depression are strictly related since increasing age leads to CMI decrease. An increased incidence of hospitalization for HZ among patients aged >72 years (0.46/1000-person year), compared to those aged 15-44 years (0.03/1000-person year) was reported, suggesting that aging is also a risk factor for HZ requiring hospitalization. Besides age, HZ risk can be related to other co-morbidities, including diabetes, major depression or immunosuppressive therapies, that induce reduced VZV-specific CMI response. Immunosuppressed patients are within the high-risk group, with increasing morbidity and mortality associated with herpes zoster. Immunosuppression may be associated with malignancy (especially hematological), human immunodeficiency virus (HIV) infection or medications used for organ transplantation or autoimmune disease. HZ incidence is similar all over the world and its trend is related to population age, with two thirds of the cases affecting subjects aged >50 years. Among European adult population, the percentage of subjects estimated to be seropositive for anti-VZV antibodies is 95%: all of them are therefore potentially susceptible to develop HZ in their lifetime. In Italy, the annual incidence of HZ is 6.3/1000 person-years, with 73% of cases affecting adults. Italy is one of the countries with the highest proportion of elderly people in its population, and yet data on the epidemiology of HZ and PHN are limited. As the immune system weakens with increasing age, many infectious diseases, such as HZ, are more severe and more closely associated with long-term consequences in the elderly than in younger people. With the growing aging population, a rise in the number of cases of HZ in the near future is expected; thus, this disease will become a public health issue. While awareness of childhood vaccination is well established, the prevention of infectious diseases in groups other than children is a challenging, yet fundamental, objective that public health systems should pursue in order to promote healthy aging. In order to evaluate the epidemiological burden of HZ, hospital discharge records for HZ between 2011 and 2021, with or without complications, will be extracted from the national hospital discharge database (HDD). The characteristics of hospitalizations will be described for the 18 years of age and older adults (2011-2021 years). The characteristics of hospitalizations in 2020-21 will be described in patients with or without concomitant COVID-19 infection.

    Phase

    N/A

    Span

    92 weeks

    Sponsor

    University of L'Aquila

    L'Aquila

    Recruiting

  • Efficacy and Safety of Tocilizumab in the Treatment of SARS-Cov-2 Related Pneumonia

    Phase

    N/A

    Span

    52 weeks

    Sponsor

    University of L'Aquila

    L'Aquila

    Recruiting

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