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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to investigate the frequency of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) in children aged 2 to 6 who exhibit nonspecific neurological symptoms such as idiopathic seizures, speech disorders, and motor dysfunctions. The study targets children without hypoxic ischemic encephalopathy, head trauma, or developmental brain anomalies who visit Pediatric Metabolism, Neurology, and Developmental Pediatrics clinics over a 12-month enrollment period. It is a multicenter, non-drug screening study designed to better understand CLN2 disease among this population. During the study, demographic data, medical and family history will be collected at the first visit. Assessments will include seizure frequency, cognitive and language development evaluations, physical exams focusing on muscle strength, gait, and coordination, as well as neurological tests such as EEG and MRI scans. Children showing specific neurological signs or imaging findings will have blood samples taken for Tripeptidyl Peptidase 1 enzyme measurement. Those with low enzyme activity will undergo genetic testing to investigate CLN2 disease. Participants will be monitored for disease frequency over one year. Researchers will measure clinical and demographic characteristics including speech impairment, motor symptoms, EEG responses, and brain imaging changes. Safety monitoring includes obtaining informed consent and following up on enzyme and genetic test results. Total participation spans from initial screening through diagnostic testing and data collection during the 12-month study period.

Age: 2Years - 6YearsAll Genders
34 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Age: 12Years +All GendersPhase 3
285 locations
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Actively Recruiting

Researchers are evaluating the effects of St. John's wort extract compared with triamcinolone acetonide and hyaluronic acid gel in treating Recurrent Aphthous Stomatitis (RAS), a common oral condition characterized by painful ulcers with no definitive cure. The study focuses on reducing pain and inflammation to accelerate ulcer healing and improve oral function. St. John's wort is known for its antiviral, antibacterial, antioxidant, and anti-inflammatory properties, making it a candidate for enhancing tissue repair in RAS. Participants will be randomly assigned to receive one of three topical treatments applied to the ulcer area four times daily: Kenacort A Orabase (triamcinolone acetonide), Aftamed Oral gel (hyaluronic acid), or St. John's wort oil. These treatments aim to manage pain and reduce ulcer size. The study compares these therapies over the treatment period to assess their effectiveness. During the study, pain levels will be measured on days 0, 3, 5, and 7 to monitor changes. Participants will be assessed for clinical symptoms and ulcer healing rate. The study includes regular evaluations to track pain relief and tissue repair progression, ensuring safety and treatment adherence throughout the trial.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Autism Spectrum Disorder (ASD) is a neurodevelopmental condition that affects social interaction, communication, and causes repetitive behaviors. Mothers of children with ASD often face high levels of physical, emotional, and psychological stress due to the caregiving demands. This stress can lead to burnout, depression, and negatively impact family life and overall satisfaction. Interventions that promote psychological well-being, especially those based on positive psychology, may help these mothers cope better with their caregiving challenges. This research evaluates the effects of a micro-appreciation intervention called the "Three Things Journal," where mothers write down three positive events each day for four weeks. This behavioral intervention encourages focusing on positive daily experiences to reduce stress and improve emotional resilience. The study aims to assess changes in caregiver burden, family functioning, and happiness levels through this journaling activity. Participants will be assessed at the start and after five weeks using questionnaires measuring happiness, caregiver burden, and family function. Researchers will monitor how the journaling impacts these areas over time. The study provides support and insight into how simple positive psychology practices might improve the well-being of mothers caring for children with ASD, with participation lasting just over a month.

Age: 18Years - 75YearsFEMALEPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

This research aims to evaluate the use of a surgical incision drape to secure endotracheal tubes in preterm infants. The study focuses on minimizing unplanned extubation and skin damage caused by tube fixation. It also assesses the relationship between skin moisture, skin pH, and neonatal skin condition using specialized measurement devices and scales. The study is a randomized controlled trial involving preterm infants between 28 and 34 weeks gestation who are intubated and hospitalized in a neonatal intensive care unit. Participants will be divided into two groups: one using the surgical incision drape and the other using standard methods. Data including skin condition, skin pH, and moisture will be collected every 24 hours during the intubation period. Throughout the study, researchers will monitor demographic data and skin health measures using the Neonatal Skin Condition Rating Scale, skin pH meter, and moisture meter. The study duration corresponds with the intubation period, with data collected daily until study completion, averaging about one year. The outcomes will help understand the effects of different fixation methods on skin wounds, unplanned extubation rates, and skin parameters in preterm infants.

Age: 28Weeks - 34WeeksAll GendersPhase Not Applicable
1 location
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