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Filter by:The goal of this clinical trial is to evaluate the effects of Cannabigerol (CBG) on symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in a sample of participants with ADHD. The main question it aims to answer is: Does CBG reduce ADHD symptoms relative to placebo? Participants will complete two weeks of product administration for each condition (placebo or 80mg CBG daily), separated by a one-week washout period. Daily and weekly surveys will be administered to monitor effects.
The purpose of this study is to determine whether nasal high flow is non inferior to non invasive ventilation (NIV) in the early treatment of patients with acute exacerbation of chronic obstructive pulmonary disease (AE-COPD) and hypercapnic acidosis in the emergency department (ED). After obtaining informed consent, participants will be randomly assigned to receive either nasal high flow or non invasive ventilation (NIV, reference treatment) as respiratory support. Researchers will compare both respiratory support groups to see if their blood gas analysis and respiration return to normal ranges.
This study is designed to describe the clinical activity and safety profile of mogamulizumab at standard dose in the treatment of CTCL patients in real world setting
This is an observational study with the aim of SWELE Programme is to raise mental health knowledge and awareness by implementing a play-based approach on Supporting Wellness in E-Child Learning Environments (SWELE) programme combining unstructured outdoor play activities with mindfulness-based interventions to promote mental health in children and adolescents with special education needs (SEN), in the context of the COVID-19 pandemic. This is a 16-week SWELE programme and it will be conducted in two batches. Each batch has three special schools. The main activities include: One training workshop for three groups in each special school: 1) Scout Leaders (special schools' teachers), 2) SEN students (scouts in the school) to become Youth Mental Health Ambassadors and 3) for parents, school social workers, school nurses, schoolteachers and stakeholders; 30 minutes unstructured outdoor play with mindfulness activities 2 times per week for 16 weeks After participated the SWELE programme, the primary outcomes include reducing anxiety symptoms, reducing negative emotions, improving social skills in peer relationships; and changing in playfulness level among SEN children and adolescents. Main activities of SWELE programme: - Unstructured outdoor free play integrated into the school's extra-curricular activities (Youth Mental Health Ambassadors) to promote SEN students' mental health for objectives 1-4. - Use mindfulness-based podcasts, mindfulness games, mindfulness art for objectives 1-2. - Through meditation and deep breathing technique, storytelling with relaxing waves piano music, yoga and mindful art for objectives 1-2. - Training Workshops (Training of trainers) for Scout Leaders who will implement SWELE program in each special school. - Youth Mental Health Ambassador Program for SEN students who are enrolled in Scout Club in each special school; SWELE training workshops for parents and schoolteachers will also be held in each special school for objectives 1-4. - Examples of unstructured play might be creative play alone or with others, including artistic or musical games. imaginative games - for example, making cubbyhouses with boxes or blankets, dressing up or playing make-believe, exploring new or favorite spaces like school backyards, parks, playgrounds and so on.
LTF-001 is a long-term follow-up study of participants who received an investigational gene-editing therapy developed by the sponsor to evaluate the long-term effects of the investigational therapy. Participants will be followed for a total of 15 years after the first administration of the gene-editing therapy, including time in both the interventional study and study LTF-001.
The purpose of this open-label phase IIa clinical trial study is to evaluate the safety and preliminary efficacy of hBMMSC intravenous treatment in patients with aPAP.
The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire operation time, dose of contrast medium, radiation exposure doses, etc). All subjects will be followed up on the day of surgery, before discharge (or 48 hours after surgery) and 1 month after surgery to observe the safety indicators.
Prospective randomized control pilot study
Rationale: In France, 1,850 cases of cancer are diagnosed in children every year (28% of leukaemia). Despite a cure rate of 83% (all cancers combined), treatment remains a major burden. Changes to the body caused by the disease and its treatment can alter their self-image and the way they relate to their bodies. The massage benefits for children have been highlighted, improving their quality of life (QoL) during treatment. The importance of including parents in the paediatric care process in order to strengthen family ties was also highlighted. Recently, the La Roche-Posay Foundation, in conjunction with a group of experts, developed and rolled out a training course called "Magic Massages" (MM), aimed at parents. The Human and Social Sciences Department of the Léon Bérard Center, in collaboration with the Institute of Paediatric Haematology and Oncology, and with the support of the La Roche Posay Foundation, is conducting a longitudinal multicenter observational study, the main aim of which is to assess parental perceptions of the impact of therapeutic massage on their child's emotional QoL. The secondary objectives of this study are to assess parental perception of the impact of therapeutic massage on their child's QoL and emotional distress (i.e. anxiety and depression), as well as on the quality of the parent-child-caregiver relationship. Method: In this mixed-method study, 181 parents with a child aged 2 to 12 years treated for acute lymphoblastic leukaemia and diagnosed at least one month previously will be recruited; 161 for the quantitative part, and 20 others will be recruited for the qualitative part. Recruitment will take place nationwide in several oncopaediatric centres. Thus, in the quantitative part of the study, parent participants will complete self-reported measures of their child's QoL, anxiety and depression, as well as parent-child and parent-caregiver relationships. Data will be collected before training (T0); 3 weeks (T1) and 6 weeks after MM training (T2). Concerning the qualitative part, semi-directive interviews will be conducted with participants at T1. Expected results: The implementation of MM would lead to an improvement in QoL, as well as a reduction in anxiety and depression perceived by parents in their child. An increase in the perceived quality of parent-child-caregiver relationships is also expected. In the long term, large-scale deployment of MM could be envisaged, including in other diseases.
This pilot study uses [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in [18F]F AraG PET signal before and while on CkIT therapy and to correlate this change in [18F]F AraG PET signal with radiographic response. To explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment [18F]F AraG PET/CT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.