Srubo, Italy

Home-based Massage by Caregivers for Dementia

A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma

The study comprises of a 4-week (±2 weeks) screening period, a 24-week treatment period and a 12-week follow-up period. Approximately 100 subjects who meet the criteria for study entry are planned to be enrolled to the study. Eligible subjects will be randomized to receive placebo or FB825 in a 1:1 ratio with 50 subjects in each arm. Eligibility will be checked in patients with allergic asthma during the 4-week (±2 weeks) screening period. Potential candidates should provide signed informed consent forms before starting any screening activities. The subjects will receive one dose of 8 mg/kg FB825 or placebo, and five doses of 4 mg/kg FB825 or placebo every 4 weeks subsequently. The study drug will be administered as a 1-hour IV infusion. Patients may administer albuterol (or equivalents) as rescue medications as needed throughout the study. Prior to screening, patients must be on a stable dose of any of formulations of inhaled corticosteroids (ICS)/long-acting beta-agonist (LABA) combination therapy for at least 1 month, including Fluticasone/salmeterol, Budesonide/formoterol, or Mometasone/formoterol. Patients who have been on budesonide/formoterol or mometasone/formoterol will be switched to an equivalent dose of fluticasone/salmeterol at randomization (Day 1), and patients who have been on fluticasone/salmeterol will remain on their current treatment as background therapy. ICS/LABA (fluticasone/salmeterol) combination therapy during background therapy stable phase (Day 1 to Day 28) followed by ICS only (fluticasone) during ICS tapering phase (Day 29 to Day 140), and than followed by the FB825 monotherapy phase (Day 141 to Day 168). Upon completing 24 weeks of treatment with the investigational product, patients will be placed on their original dose of fluticasone/salmeterol combination therapy (dose at study entry) and albuterol (or equivalents) (as needed) to control their symptoms. Occurrence of an exacerbation of asthma will be evaluated as the primary endpoint at week 24. Mean change in morning PEF and the occurrence of an exacerbation of asthma at other time points will also be evaluated as the secondary endpoint in the study. Exacerbation of asthma as defined by any of the following: - A 30% or greater reduction from baseline in morning peak expiratory flow (PEF) on 2 consecutive days, or ≥6 additional reliever puffs of albuterol (or equivalents)in a 24 hour period (compared to baseline) on 2 consecutive days or, - Deterioration of asthma, as determined by the investigator, requiring: - Systemic (oral and/or parenteral) steroid treatment, or - An increase of ICS usage by ≥4 times of the protocol-defined dose (refer to 5.1.3 background therapy table) at each phase throughout the study period, or - Hospitalization, or - ER (emergency room visit) due to asthma attack Subjects will have site visits after receiving study drug for efficacy, safety, and biomarker evaluation (see Study Flow Chart). Subjects who prematurely withdraw from the study will have an end of study (EOS) visit within 7 days. The daily status of subject, such as peak flow, will be recorded in the e-diary every day during the study. PI can ask the subject for an unscheduled visit any time if any abnormal status reported on the e-diary. The e-diary system will send a notification to the PI automatically once the subject meets the protocol defined exacerbation of asthma. Relative change in pre-bronchodilator FEV1 , post-bronchodilator FEV1, and asthma symptoms will be evaluated during the study. Immunologic biomarkers including changes from baseline in total IgE, allergen-specific IgE, blood eosinophils, exhaled NO, mIgE B cell counts, Immunoglobulin G (IgG)2, Immunoglobulin G (IgG)4, and cytokines such as serum thymus and activation-regulated chemokine (TARC), periostin and eotaxin-3, will be measured and evaluated. Adverse events will be checked and recorded at every visit. Laboratory tests, vital signs and physical examinations will be performed as scheduled and will also be used in safety evaluation. Serum levels of FB825 for pharmacokinetic assessments will be measured via intensive and sparse PK. For intensive PK, 24 subjects (12 subjects of each Arm) participate in the intensive PK sub-study, serum samples will be collected at 0.5 hour pre-dose and at 0.5, 1, 1.25, 2, and 4 hours after the start of infusion on dosing days at Visits 2 and 9, and a single collection at any time on Visit 3 and Visit 10. For sparse PK, all other subjects will participate in the sparse pharmacokinetic (PK) assessments, serum samples will be collected at 0.5 hour pre-dose and at 1.25 hour after the start of infusion at Visits 2 and 9. Serum samples will be collected at 0.5 hour pre-dose and at 1.25 hour after the start of infusion at Visits 5, 6, 7 and 8, and a single collection will be conducted at Visits 4 as well as at follow-up Visits 11, 12, 13 and 14 for intensive and sparse PK. IgE (total IgE and allergen-specific IgE) will be analyzed and serum samples will be collected at all visits during treatment and follow-up periods. IgG2, IgG4, and biomarkers (e.g. TARC, eotaxin-3, and periostin), will be measured and collected at all Visits except visit 1. Peripheral Blood Mononuclear Cells (PBMC) analysis (assessing the mIgE B cell counts) will be measured at Visits 2, 4, 5, 7, 9, 11, 13 and 14. Serum anti-drug antibodies (ADAs) will be assessed in samples before infusion at Visits 2, 7, and 9, and at any time at Visits 11, 13 and 14. For risk management of the sponsor, independent Data Safety Monitoring Board (DSMB) meetings will be conducted to evaluate participant safety data during the study. The DSMB will be conducted in one month after the visit 2 of 10th, 30th, and 80th randomized patient. Unscheduled meetings may be recommended and initiated by the DSMB Chairperson, the sponsor, or the principal investigator.

Assessement of Vertebroplasty-related Cement Leakage

Background Vertebral compression fracture is a common disease. Most of them are osteoporotic and minority of them are pathological. It cause severe pain and compression to neuronal tissue, leading to debilitating symptom and deficits. The quality of life can be reduced; long-term bed ridden can also cause morbidity and mortality. It is thus a major public health issue. Vertebroplasty and related procedure is an invasive procedure to restore vertebral stability by injection bone cement, usually under minimal percutaneous approach. Because of its immediate efficacy of pain relief, it is very popular and common procedure. However, the cement is liquid before it become solid in the vertebrae. It can spread into venous system sometime, and even going into pulmonary circulation system. The latter cause pulmonary thromboembolism. Operators usually try their best to avoid such complication. Practically, severe complication is rare. According to prior literature, the cement leakage range from 2.1 to 26%. It indicate the problem is actually common. On the other hand, the cement can not be lysed by usual anticoagulant treatment. Detection of this condition can be of clinical importance. Currently, the clinical epidemiology of cement leakage after vertebroplasty is not well studied. Many factors can contribute its occurrence, including technical, material, and patient-specific reasons. Although operators have their approach to avoid such conditions, there are little evidence to support the efficacy of individual preventive method. Actually, some operator tolerate minor paraspinal leakage because they believe it can achieve optimal cement filling in the vertebrae. However, it is unclear the relationship between paraspinal leakage and pulmonary embolism. In detection of pulmonary thromboembolism, imaging method is mainstream. Currently, dual energy CT scan can provide optimal diagnosis of leaked cement and pulmonary perfusion status. The iodine map derived from material decomposition provide an easy way to detect perfusion defect. It can be used to detect and classify cement pulmonary embolism. In this study, we aim to evaluate the clinical epidemiology of cement leakage in vertebroplasty and related surgery, focusing on the prevalence, severity, and risk factors. Based on the reference dual energy CT, we also want to investigate its imaging characteristics. Study designs This is a prospectively hospital-based cohort study. We tend to enroll 60 patients in one year, in whom receive vertebroplasty or cemented screws for osteoporotic-related vertebral compression fracture. The postoperative spinal and thoracic imaging will be used to detect paraspinal and pulmonary embolism. Inclusion citieria 1. Age > 20 years 2. Osteoporotic vertebral compression fracture, receiving vertebroplasty o cemented screws fixation Exclusion criteria 1. Active infection, 2. Rapid neurological deterioration, 3. Bleeding tendency 4. Impaired renal function (serum creating > 1.5mg/dL) 5. Severe allergic reaction to contrast medium 6. Pregnant or breast-feeding women Operation and clinical follow-up The enrolled patient will receive plain radiograph before operation. After operation, the plain radiograph of thorax and spine will be performed after regain ambulation ability. The thoracic and vertebral CT scan will be performed within one month. The demongraphic data will be record. The surgical details, including methods, location, material used, cement amount and component, will be recorded. Any surgical complication within one month will be recorded. Imaging method 1. Vertebral and thoracic plain radiograph, in routine method, before and after operation 2. Dual energy thoracic CT scan after operation Contrast medium injection to highlight pulmomary artery. Post-processing to form iodine map to detect perfusion defect. P 3. Spinal vertebral CT of surgical location after opeation Statistical analysis Detailed imaging analysis to detect prevalence and severity of paraspinal and pulmonary cement leakage and embolism will be recorded. The imaging characteristics will be analysed.The demographic, surgical, and material factors will be analysed with imaging findings in details with common statistical methods.

A Deep Learning Algorithm Platform to Predict Autism Diagnosis and Subtypes

Due to the high prevalence (1% in Taiwan), long-lasting impairment, unclear etiologies, and a lack of effective detection, prevention, and biological treatment, autism spectrum disorder (ASD) has been prioritized for biomarker, mechanism, and treatment research. Recently the gut-brain-axis has been proved, mainly with animal models, to be altered in psychiatric disorders and notably in ASD. With PI Gau's long-term achievement in ASD multi-dimensional research and our preliminary finding of altered gut microbiota in ASD and their unaffected siblings, we propose this 4-year prospective large-scale study with sibling design and multi-dimensional measures (environmental, clinical, cognitive, imaging, gut microbiome, metabolome) to establish a deep learning algorithm platform for predicting ASD and searching potential biomarkers and probiotic treatment for ASD. Specific Aims: 1. To demonstrate the metagenomics profiles analysis based on the gut microbiome and metabolome of ASD patients, unaffected siblings, and typically developing controls (TDC). 2. To investigate environmental factors such as pregnancy and birth history from the mother's medical records and interviews or national health insurance data, for the microbiome, metagenomics, and brain anatomy and function. 3. To develop a deep learning algorithm platform using the environmental, behavioral/clinical phenotypes, neurocognitive/imaging endophenotypes, and metagenomics profiles to identify microbiota (metagenomics, too) makers and other predictors for ASD diagnosis, subtypes, and level of impairments. 4. To establish a web application based on our deep learning algorithm platform for clinical use to assist medical doctors in diagnosing ASD.

Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section

Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients

Intelligent Sports Injury Prevention and Training System

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module

After mild traumatic brain injury (mTBI), patients often complain of dizziness, balance disturbances, and gait instability. On average, dizziness accounts for about 23 to 81%, and dizziness symptoms persist from 1.2% 6 months after the injury. Between 32.5% in 5 years. In the past, in the process of neuron regeneration and repair after mild traumatic brain injury, it was found that vestibular function and biomarkers may be related to balance restoration and treatment. It is necessary to conduct further research to explain its potential mechanism and clinical significance. In addition, balance training after mTBI can accelerate dizziness recovery, balance control and gait stability, but the effect lasts for a limited time. The development of a dual-task balance training module can extend the recovery time, this project needs to be discussed in depth. This project mainly explores the influence of balance control and gait strategies after mTBI, linking vestibular function and biomarkers; innovative design and development of computerized dual-task balance training and home modules; combined with computerized dual-task balance training modules can accelerate the recovery of dizziness, balance control and gait stability after injury.