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NCT ID: NCT05156047 Completed - Clinical trials for Idiopathic Hypersomnia

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Start date: May 25, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with idiopathic hypersomnia (IH) age ≥18 years. Key secondary objectives of this study are to assess the impact of pitolisant on: - Overall symptoms of IH - Patient impression of overall change in their symptoms of IH - Investigator assessment of overall disease severity of IH Other secondary objectives of this study are to assess the impact of pitolisant in patients with IH on: - Patient impression of overall severity of their EDS - Functional status and activities of daily living - Sleep-related impairment - Sleep inertia - Cognitive function

NCT ID: NCT05155852 Completed - Preeclampsia Clinical Trials

Bedside Monitoring to Identify Impaired Cerebral Autoregulation in Women With Postpartum Hypertension

Start date: August 13, 2021
Phase:
Study type: Observational

The purpose of this research study is to develop a protocol for NIRS-based bedside monitoring to identify impaired cerebral autoregulation in women admitted to the high-risk obstetrics unit with postpartum hypertension. The investigators will then pilot this protocol in 10 patients with high-risk neurological features, such as headache.

NCT ID: NCT05155800 Completed - Clinical trials for Traumatic Brain Injury

A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury

Sense-005
Start date: December 28, 2021
Phase:
Study type: Observational

The study population will consist of 3 mutually-exclusive sets of patients and subjects: - TBI patients with intracranial bleeding - TBI patients without intracranial bleeding - Control subjects with normal brain health. Research subjects between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.

NCT ID: NCT05155228 Completed - Clinical trials for Posttraumatic Stress Disorder

The Attachment, Regulation and Competency (ARC) Framework

Start date: September 1, 2016
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of the Attachment Regulation and Competency (ARC) treatment framework in comparison to treatment as usual for reducing symptoms of PTSD and Developmental Trauma Disorder among children ages 8 to 16 with a history of exposure to multiple traumatic events.

NCT ID: NCT05155176 Completed - Clinical trials for Alcohol Use Disorder

Novel Real-world Methods in Social Drinkers and AUD

ALR
Start date: May 1, 2022
Phase:
Study type: Observational

This research project proposes a novel approach to elucidate the biological adaptations associated with Alcohol Use Disorder and to assess whether such adaptations are predictive of higher alcohol craving in response to both alcohol cues and stressors and higher relapse risk and alcohol use in the real world.

NCT ID: NCT05155111 Completed - Clinical trials for Neonatal Encephalopathy

Telemedicine to Reduce Disparities in the Identification and Treatment of Neonatal Encephalopathy

Start date: December 22, 2021
Phase: N/A
Study type: Interventional

This is a clinical trial using telemedicine as an intervention twice in the first 6 hours of life to assess neonatal encephalopathy, one of the key factors involved in the decision to treat a neonate with therapeutic hypothermia (TH). The investigators aim to enroll up to 30 neonates, anticipating that there will be about 5 neonates, who do not demonstrate moderate to severe neonatal encephalopathy, and therefore do not meet criteria for treatment with TH. The investigators will prospectively follow the clinical course of all 30neonates through monitoring with electroencephalogram (EEG) for up to 24 hours after birth to determine if seizures are present and by MRI of the brain prior to hospital discharge to determine if there is evidence of brain injury. Neonates will be enrolled in the study for the duration of their hospital admission.

NCT ID: NCT05154981 Completed - Clinical trials for Autism Spectrum Disorder

Partners in School: Promoting Continuity Across Home and School

Start date: September 15, 2022
Phase: N/A
Study type: Interventional

Partners in School is a collection of implementation strategies (e.g., communication training, problem-solving consultation) to help parents/primary caregivers and teachers of children with autism spectrum disorder implement the same practices across home and school.

NCT ID: NCT05154929 Completed - Hypertension Clinical Trials

Improving Blood Pressure Control Through the myBPmyLife mHealth Application

myBPmyLife
Start date: December 21, 2021
Phase: N/A
Study type: Interventional

This study is enrolling eligible participants that have high blood pressure. Reducing dietary salt intake and engaging in regular physical activity is known to decrease blood pressure in people with hypertension. This trial will determine whether a smartwatch and a mobile health application, which together deliver notifications, can increase activity levels and reduce salt intake for people with high blood pressure. All study activities will be completed online or via a mobile medical application. Participants will not have any face-to-face visits with the study team.

NCT ID: NCT05154565 Completed - Clinical trials for Stress, Psychological

Effect of a Daily Meditation Intervention in Student Pharmacists

Start date: December 2, 2021
Phase: N/A
Study type: Interventional

Pharmacy school is a 3-to-4 year intensive program that demands a high level of performance from enrolled students. The fast-paced and challenging curriculum causes stress levels to rise in students. The increase in stress can negatively affect performance in the classroom, as well as affect relationships outside the classroom setting. While some level of stress may be beneficial, the substantial amount of stress experienced by pharmacy students may also negatively impact their quality of life. This proposed study aims to explore the effect a convenient intervention on perceived stress, mindfulness, well-being, and resilience as reported by student pharmacists. Headspace will be used as the main study intervention. This product is a mobile device application (aka, an app) that teaches users how to meditate through guided exercises. It contains a library of different meditation exercises the user can access from their smartphone or tablet at their own convenience. It is our hope that the use of Headspace will enhance the students' ability to practice mindfulness, which will allow them to better cope with stress in school and in future practice. This could translate into improved learning and overall well-being.

NCT ID: NCT05154422 Completed - Obesity Clinical Trials

Effects of Regular Activity on Physiology Between Recreational Athletes of Different Body Fatness

Start date: October 23, 2020
Phase:
Study type: Observational

The popularity of marathons and endurance events has increased over the last few decades and, interestingly, the demographics of participants have also changed. From 1980 to 2002 the average race time to complete the marathon lengthened from ~3.5 hours to ~4.5 hours. Likewise, many endurance races include "Clydesdale" and "Athena" divisions for heavier weight male and female runners, respectively. As such, there has been an increase of overweight and obese participants in these races. For example, one study consisting of 250 runners determined, according to BMI, that approximately 15% and 31% of the female and male participants, respectively, were classified as overweight, with 31% and 33% classified as obese. Therefore, many recreational endurance athletes are overweight despite their high level of activity. On one hand, these data are positive as regular exercise reduces cardiovascular disease and all-cause mortality in overweight and obese populations. Yet, it is well documented in sedentary obese individuals that excess adiposity can lead to disturbances in adipocyte lipolysis and altered substrate utilization at rest and during exercise, and can decrease muscle quality. However, it is unknown if overweight individuals that exercise regularly have disrupted fat metabolism, circulating hormones, or muscle quality. No study has directly determined if differences exist in fat metabolism, circulating hormones, and muscle quality between overweight recreational female athletes and their lean counterparts when training status is equivalent. Therefore, the purpose of this investigation is to determine if differences in pre and post-exercise fat metabolism, circulating insulin and growth hormone, and muscle quality exist between active overweight individuals compared to active lean individuals with similar training history and who have regularly trained for and participated in endurance events within the last few years.