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Showing 1-20 of 1,060 trials
NCT06608966
The goal of this multi-site clinical trial is to determine the effectiveness of two components of a web-based intervention (Epilepsy Journey) to improve executive functioning in adolescents with epilepsy. The two components include web-based modules and problem-solving telehealth sessions with a therapist focused on executive functioning. This trial aims to answer the following questions: 1. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving executive functioning in adolescents with epilepsy? 2. Which components of Epilepsy Journey (web-based modules or telehealth sessions with a therapist) are essential for improving quality of life in adolescents with epilepsy? Participants will be randomly assigned to one of four groups: 1) Epilepsy Journey web-based modules and telehealth sessions, 2) Epilepsy Journey web-based modules only, 3) telehealth sessions with a therapist only, or 4) treatment as usual. Participants will: * Independently review Epilepsy Journey web-based modules focused on executive functioning skills (\~15-30 minutes) and/or have weekly telehealth sessions (\~30-45 minutes) with a therapist for 14 weeks. * Complete measures of executive functioning (parent and teen-report) and quality of life (teen-report) at the start of the study, 14-, 26-, and 66- weeks after randomization. The NIH toolbox will be completed at the start of the study and 26-weeks after randomization. Additional measures will also be collected.
NCT06455384
Genetic testing (GT) (including targeted panels, exome and genome sequencing) is increasingly being used for patient care as it improves diagnosis and health outcomes. In spite of these benefits, genetic testing is a complex and costly health service. This results in unequal access, increased wait times and inconsistencies in care. The use of e-health tools to support genetic testing delivery can result in a better patient experience and reduced distress associated with waiting for results and empower patients to receive and act on medical results. We have previously developed and tested an interactive, adaptable and patient-centred digital decision support tool (Genetics ADvISER) to be used for genetic testing decision making, and have now developed the Genetics Navigator (GN), a patient-centred e-health navigation platform for end-to-end genetic service delivery. The objective of this study is to evaluate the effectiveness of the GN in an RCT in reducing distress with patients and parents of patients being offered genetic testing. Results of this trial will be used to establish whether the GN is effective to use in practice. If effective, GN could fill a critical clinical care gap and improve health outcomes and service use by reducing counselling burden as well as overuse, underuse and misuse of services. These are concerns policy makers seek to address through the triple aims of health care1. This study represents a significant advance in personalized health by assessing the effectiveness of this novel, comprehensive e-health platform to ultimately improve genetic service delivery, accessibility, patient experiences, and patient outcomes.
NCT07654192
Blood sampling can cause pain, anxiety, and fear in children. Such negative experiences may cause the child to develop negative attitudes toward treatment and care procedures. Distraction techniques, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. ShotBlocker and finger puppets are one of these techniques. The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sampling in the pediatric blood sampling unit.
NCT07642388
The main goal of this study is to evaluate the effectiveness of adaptive sequential implementation strategies based on facilitation in promoting the sustainable and widespread adoption and scaling up of the Integrated Care Pathway for Acute Asthma - ASMAbat across all Primary Care and Hospital Pediatric Services of Osakidetza - Basque Health Service.
NCT04117360
The investigators are studying how speech is effected by jaw and tooth position in jaw surgery patients. Eighty percent of our jaw surgery patients have speech pathologies, compared to five percent of the general population, but speech pathologists do not understand why. The investigators hypothesize that open bites and underbites prevent most patients from being able to pronounce words normally and surgical correction will lead to improvement in speech. Patients will be audio recorded speaking and patients' tongue gestures ultrasound recorded before and after their jaw surgeries to observe what changes occur in their speech and tongue movements.
NCT07643753
What is this study about? The investigators want to see if exercise and education sessions can help children and young people (aged 10-17) with asthma, manage the participants asthma better. The investigators will place participants that are recruited to this study into one of three groups by a computer (randomly): Group 1: Usual Care: Continue with normal asthma treatment. Group 2: Education: Usual care + a 45-minute online asthma education class once a week. Group 3: Exercise \& Education: Usual care + 3 exercise sessions a week and asthma education classes.
NCT07635862
The goal of this study is to conduct a randomized, placebo-controlled trial (RCT) of ganaxolone, a neuroactive steroid (NAS), in autistic children and adolescents aged 5 to 17 years old. Ganaxolone is approved and effective for treating seizures in children as young as 2 years old who have CDKL5 deficiency disorder (CDD), a neurogenetic condition associated with developmental delays, seizure disorder, hypotonia, visual impairments, and autistic features. The primary outcome of interest for this trial is irritability on the Aberrant Behavior Checklist (ABC) because it is a common symptom of emotion dysregulation in ASD that impacts quality of life, including mental health, independence, educational opportunities, and integration into the community. The secondary domains of interest for this trial are restricted and repetitive behaviors (RRB), specifically insistence on sameness (IS), a subdomain of RRB characterized by inflexibility and a strong preference for predictable routines and familiar environments. Secondary outcome measures include the IS subscale from the Dimensional Assessment of Repetitive Behaviors (DARB) and subscales of the Clinical Global Impressions Scale for irritability (CGI-IR) and IS (CGI-IS). For participants living within 150 miles of Stanford University, we require participants to attend site visits and attempt EEG and MRI procedures before and after the trial, though we are recruiting nationally and the study can be completed without site vists.
NCT07631754
The aim of this research is to trial a new version of Happy Homework (HH) on children and parent health outcomes. HH was previously a paper-based 8-week program designed to encourage positive eating habits, physical activity, and healthy sleep routines among children at home. By working together, investigators are aiming make sure HH is easy to use, that it reduces teachers' workload, and enable the students to easily track and engage with HH. We also hope that this will all help contribute to the students meeting 24-hour movement behaviour targets. Children are invited to participate in the research study. In the study investigators are going to examine children's activity behaviour profiles, and the following measures will be taken: * Physical activity levels * Sedentary behaviours * Sleep duration * Body mass index (which can be self-reported by the child). These measures will be conducted at two time-points; (1) 1 week before the intervention begins and (2) 1 week after the intervention. Should children agree to participate in the study; children will wear an accelerometer on their non-dominant wrist and a small device on their right thigh for 8 consecutive days at both time points, along with having their height and weight recorded (the child can self-report this information).
NCT06513832
The goal of this study is to improve health equity in children aged 5-16.9 years admitted to the PICU for asthma. The objectives are: * To identify the factors related to differential experiences of asthma self-management * To pilot the effectiveness of an individualized asthma navigator intervention at PICU discharge.
NCT03811535
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.
NCT07591636
The goal of this qualitative study is to develop a therapy protocol for fathers of children with special needs in Hong Kong. The therapy is called Acceptance and Commitment Therapy (ACT), which helps people cope with difficult emotions by building psychological flexibility - the ability to accept and adjust to hard situations. The main questions it aims to answer are: 1. What are the experiences and needs of fathers raising children with special needs? 2. What content and format of an ACT programme would be most helpful for these fathers? Researchers will conduct focus group interviews with two groups of participants: fathers raising children with special needs and social workers who work with these families. The interviews will take about 60 to 90 minutes each. Participants will: 1. Take part in a recorded focus group interview 2. Share their experiences, challenges, and views on what an ACT program should include The findings will be used to develop a protocol for an ACT programme to improve the mental health of fathers raising children with special needs.
NCT07589218
This research aims to complement existing podiatric studies by providing information on the relationship between ligamentous hyperlaxity, a benign condition more frequently found in the pediatric population, and ankle range of motion in child basketball players aged 8-15. Furthermore, this hyperlaxity will allow us to correlate it with the most frequent type of injury experienced by the participants and assess whether future research could develop a prevention plan for this population and extrapolate it to more professional categories.
NCT07360600
The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them. The main questions this study aims to answer are: * Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)? * Is the program usable and acceptable/appropriate/feasible to implement in this setting? * Do parents show improvements in mental health and coping-related outcomes after participating in the program? * What are the experiences and perspectives of parents and therapists regarding the program? Parents as participants will: * Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics. * Complete online questionnaires before starting and after completing the program. * Take part in one online interview about their experiences and perspectives on the program. Occupational therapists as participants will: * Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist. * Complete brief online questionnaires before starting and after delivering the program. * Take part in one online interview about their experiences and perspectives on the program.
NCT07441668
This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.
NCT07512622
The primary objective is to examine the efficacy of an mHealth adherence intervention (Asthma Ctrl) on adherence to daily inhaled corticosteroids as measured by electronically monitored adherence in adolescents with asthma. The secondary objective is to compare the effectiveness of three intervention strategies: 1. asthma management app (control); 2. Asthma Ctrl; 3. Asthma Ctrl+ on adherence, lung function, and health care utilization at post-intervention and 1- and 6-month follow-up. The third objective is to explore and contrast different challenges and combinations of challenges to identify which are most impactful in determining response to the three intervention strategies.
NCT06380816
This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells. The four main aims of the clinical trial are to find out: 1. The best dose of UCB4594 that can be given safely to participants in the trial. 2. What the side effects of UCB4594 are and how they can be managed. 3. What happens to UCB4594 inside the body and how it affects cancer cells. 4. Whether UCB4594 can cause cancer to shrink.
NCT05331456
In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.
NCT07540871
Parents and daycare providers for children between the ages of 1 and 3 years old at participating daycares will be asked to join this study. Parents will be provided with three thermoses designed to keep breastmilk at a safe temperature for 15+ hours, and asked to use each thermos for four weeks. Parents and daycare providers will be asked to complete weekly questionnaires about any problems they experience with a thermos. Study staff will check the temperature of the milk each day before lunch and afternoon snack to ensure the milk is at a safe temperature for consumption.
NCT06320496
A WHO study in 2020 revealed that 81% of adolescents (aged 11-17) do not respect the recommendation of one hour of moderate physical activity per day. In the context of disability, many factors impose limits on physical activity. While the pathology itself induces limitations and restrictions (prolonged sitting time, assisted movement, etc.), organizational constraints also apply to both children and parents, who have to divide their time between work, school and therapeutic care, which is sometimes numerous and varied over the course of a single week. These limitations generate stress and fatigue, and prolonged sedentary periods lead children with chronic illnesses, rare diseases or disabilities into a process of physical deconditioning. The accumulation of sedentary time is detrimental to cardiovascular and metabolic health. To combat this deconditioning, the 2008 National Physical Activity and Sport Plan (PNAPS) sets out the main guidelines for treatment and implementation. The plan explains that "for patients with chronic illnesses, rare diseases or disabilities, the aim is to encourage care and guidance towards Adapted Physical Activity (APA). The attending physician will be able to identify local therapeutic education programs, rehabilitation services and "sport-santé" offers, to improve access for these patients to supervised local programs". In addition, the plan suggests "developing APA programs in healthcare establishments to enable people with chronic illnesses, rare diseases or disabilities to access health education incorporating practical sessions". In line with this plan, an exercise reconditioning program has been set up at our facility. This three-month stay includes children with a variety of pathologies, but with a common feature of physical deconditioning.
NCT07564037
The aim of this study is to compare between nebulized dexmedetomidine, ketamine, or midazolam for premedication in children undergoing adenotonsillectomy.