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Filter by:This is a phase IIa 24-week randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy and safety of Rotigotine (RTG) transdermal administration at the dosage of 4 mg or 6 mg per day versus Placebo (PLC) in newly diagnosed behavioural Frontotemporal Dementia (bvFTD) patients. 75 patients with a diagnosis of probable bvFTD will be randomly allocated to the 3 treatment arms (RTG 4mg/day, RTG 6mg/day or PLC), with 25 patients per group. Clinical and neurophysiological measurements and brain metabolism via FDG-PET will be collected before and after drug administration.
Behavioral and emotional disorders adversely affect overall health and well-being. Prevalence rates among children and adolescents classified with behavioral and emotional disorders or neurodevelopmental disorders (NDD), as recently redefined in ICD-11, have steadily increased over the past decade. In particular, prevalence rates among persons classified with Autism Spectrum Disorders (ASD), the fastest rising behavioral and emotional disorder, have sharply risen over the past five years and is now estimated at 1 in 54. Shared symptoms within behavioral and emotional disorders include persistent social, emotional and behavioral functioning deficits that often impact self-management, social-awareness and metacognition competences, in addition to adulthood health and wellness life course transition management. Social and Emotional Learning (SEL) stakeholder advocates have contributed meaningfully to the strengthening of behavioral and emotional health through interventions that focus primarily on physical and mental health outcomes of diagnosed individuals. However, focus on spiritual health outcomes and the at-risk population remain largely underutilized. Research that seeks to employ an integrative physical-mental-spiritual approach to strengthen social, emotional and behavioral resilience, of at-risk school age populations where social stigma and prohibitive treatment costs remain barriers to treatment is needed to help expand the field's understanding of the reciprocal relationship between spiritual health and emotional and behavioral outcomes. The RENEW (Resilience in Emotional and Behavioral Wellbeing) intervention will employ a multidisciplinary approach of social and emotional learning competency training, gamification principles and faith-centered values to strengthen social, behavioral and emotional resilience and competencies of those at risk for behavioral and emotional disorders, via a child-as co-researcher approach.
The purpose of this study is to examine the feasibility of a protocol in which individuals with comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete Amplification of Positivity for Alcohol Use Disorder (AMP-A)- a psychological treatment focused on increasing positive thoughts, emotions, and behaviors- or a traditional cognitive-behavioral therapy (CBT) intervention. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, and functional disability.
The research will make it possible to assess patients who recovered from COVID-19 for the incidence of neurological problems (impaired balance, gait, coordination, concentration and attention), and changes in the quality of life, physical activity, social contacts and education.
Children with Developmental Language Disorder (DLD) have many linguistic difficulties in syntax, lexicon, morphology and phonology. Frequently, they also present co-occurrent (or comorbidities) impairments which further impaired school learning. Thus, they have poor academic outcomes and many of these children have been maintained at least one time in a classroom, sometime more. The purpose of this project is to determine which modalities of speech and language therapy are the more efficient on academic outcomes of children with DLD. The main modalities that will be studied are the duration of speech and language intervention, the age at which begins the intervention and the intensity (number of intervention sessions per week).
This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1 of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will stay at site till Day 2 after PK collection. All subjects will return to the clinical sites at designated study days for dosing, PK sample collections and assigned clinical activities. All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the gluteal muscle with the last dose on Day 148. End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last dosing. At EOS visit, subjects will complete the study after a series of assigned clinical assessments. A 30-day follow up call will be conducted by the clinical research staff to ensure participant's well-being.
The investigators will conduct a randomized control trial enrolling 366 older Veterans with multiple chronic conditions receiving primary care at the Michael E. DeBakey VA Medical Center and VA Connecticut Medical Center to determine if Patient Priorities Care reduces treatment burden, increases priorities-aligned home and community services, and sets shared health outcome goals compared with usual care. The investigators will randomize at the patient level rather than clinic or clinician level to evaluate the effect of identifying patient priorities on clinician decision making and alignment of care with identified priorities.
The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.
The aim of this study is to evaluate the clinical effectiveness of internet-based cognitive therapy for severe health anxiety within regular psychiatric care. A longitudinal cohort study will be conducted investigating 400 patients who have received ICBT for severe health anxiety between 2018-2020 in an outpatient psychiatric clinic providing Internet-based treatment. The primary outcome measure will be the Short Health Anxiety Inventory, SHAI, and a within-group design with repeated measures will be used for primary analysis. It is hypothesized that ICBT will be associated with a significant reduction in health anxiety as measured with SHAI, both after treatment and at six-month follow-up.
The project aims at providing a better understanding of motor skill acquisition and learning processes. The primary objectives of the study are to determine how practice conditions, i.e., variable and constant practice conditions, in motor learning affect Central Nervous System. There are three objectives: 1. to determine functional changes following constant and variable practice conditions in motor learning (resting-state fMRI) 2. to determine the EEG activation and connectivity between cognitive, sensory, and motor cerebral cortex areas (central, temporal, parietal, occipital) in constant and variable practice conditions and as a function of practice time.