cyrilzakka/clinical-trials huggingface dataset:
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006

Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects.

Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.


Eligibility Criteria:
Key Inclusion Criteria:

Healthy Subjects:

* With habitual time in bed \> 7 hours, with lights out 2200 to 2400 and lights on 0600 to 0800
* Who report typical sleep latency of \</= 30 minutes
* With typical total sleep time (TST) \>/= 420 minutes

Primary Insomnia Subjects:

* Otherwise healthy adult male and female subjects with a diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision \[DSM-IV-TR\]) present at the time of Screening for at least 3 months
* With a score of \> 15 on the Insomnia Severity Index (ISI) at Screening
* Who report taking \>/= 30 minutes to fall asleep on at least 3 nights per week for the past month
* Who report 6.5 hours sleep or less on at least 3 nights per week for the past month
* With mean latency to persistent sleep (LPS) on both baseline nights of \>/= 20 minutes with neither night \< 15 minutes
* With mean wake after sleep onset (WASO) \>/= 20 minutes on both baseline nights, with neither night \< 15 minutes or mean TST \> 420 minutes

Key Exclusion Criteria:

* With a current history of sleep disorders (e.g., obstructive sleep apnea, restless leg syndrome \[RLS\], narcolepsy, or circadian rhythm disorder) other than primary insomnia (for Part B)
* Subjects with any clinically abnormal symptom or organ impairment found in medical history, symptoms/signs, vital signs, ECG finding, or laboratory test results which require medical treatment
* All females must be of non-childbearing potential
* With a known history of significant neurological or serious psychiatric illness
Effects of Vertebral Derotation on Pulmonary Functions

This study was conducted to determine the physiological and mechanical effects of physical training post surgical correction of adolescent scoliosis using vertebral derotation.

Sixty patients from both sexes with idiopathic scoliosis underwent posterior correction (fusion). They were presented with idiopathic scoliosis for 6-12 month. Their mean Cobb's angle was measured in degrees and their mean angle of rotation was measured also in degrees. Before participation all the patients were examined clinically by a chest physician to exclude any cardio pulmonary or vascular disorders which may alter the pulmonary functions. All of them did not receive any physical therapy program prior to the operation.

Patients were arranged randomly into two groups (1 and 2), each containing 30 patients. Group 1 (DRG) received posterior correction, vertebral derotation technique during posterior correction and pulmonary rehabilitation program while group 2 (NDRG) received posterior correction and the same rehabilitation program given to group 1.

Eligibility Criteria:
Inclusion Criteria:

* Male patients suffering from adolescent idiopathic scoliosis.
* Participant age ranged from 12- 18 years old.
* All patients had the same medical care.
* Participants have received a good explanation of the treatment and measurement device.
* Treatment was conducted surgical intervention.

Exclusion Criteria:

* Instability of patient's medical condition.
* Presence of any diseases that could affect the study results.
* Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.
Ketone Ester Supplementation on Neuro-cardiovascular Responses to Stress in Humans

Ketone ester supplementation has become increasingly popular as an athletic supplement. However, the metabolic effects of these supplements on exercise performance are controversial. One potential reason for lack of an ergogenic benefit could be the effects of ketone bodies on other bodily systems, such as the sympathetic nervous system. During exercise and stress the body increases the activity of the sympathetic nervous system. This causes blood vessels to constrict (get smaller) and can increase blood pressure. Studies have shown that ketone bodies can suppress the sympathetic nervous system in mice. Additionally, ketone ester supplementation can reduce blood pressure in healthy adults. In humans, direct measures of sympathetic activity are usually made from sympathetic outflow to muscle, also called muscle sympathetic nerve activity (MSNA). Using a ketone ester supplement, the investigators plan to measure blood pressure and sympathetic outflow to muscle at rest and during handgrip exercise and a mathematical task stress test to investigate the effect of ketones on neuro-cardiovascular stress responses.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years of age
* Healthy, free of known cardiovascular, metabolic, or musculoskeletal disease

Exclusion Criteria:

* History of smoking (within 3 months), diagnosed cardiovascular or metabolic disease, recent musculoskeletal injury preventing handgrip exercise, prescription of chronic medications other than oral contraceptives.
* Current or recent (within 6 months) use of ketone ester supplementation or participation in a ketogenic diet.
* Inability to abstain from drugs, caffeine, alcohol, or strenuous physical activity prior to the study visit.
Assessing the Presence of Casomorphins in Human Plasma After Dairy Ingestion

This purpose of this study is to perform a pilot investigation to determine if opioid peptides such as casomorphin can be detected in human plasma after cheese ingestion.

Cheese is one of the most commonly craved foods, suggesting the possibility of opiate activity, as has been demonstrated with other craved foods, particularly chocolate. Like other dairy products, cheese contains casein, which is the major protein in cow's milk. This is unlike human milk, in which the primary protein is whey. Casein includes αs1-, αs2-, β- , and κ-casein, with αs1 and β forms predominating. Human and bovine casein molecules are cleaved during digestion to release opioid peptides that are believed to have biological properties relevant to infant physiology and behavior. Specifically, β-casein is cleaved to form β-casomorphins. Like other opiate agonists, β-casomorphins prolong gastrointestinal transit time and have an antidiarrheal effect.

Casomorphin receptor binding has been demonstrated in opiate receptor assays and bioassays. Duodenal aspirates from human volunteers given cow's milk have demonstrated the presence of several casomorphins, particularly β-casomorphin-7. Few studies have assessed the presence or action of casomorphins in humans. The ability of casein-derived opioid peptides to pass into the bloodstream is not well characterized, and is the subject of the present study.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Male or female
* Either self-described as having a strong liking for cheese, or have been following a vegan diet for a least the previous six months.

Exclusion Criteria:

* Unstable medical status
* Physical condition affecting eating behavior, digestion, or intestinal absorption
* Dairy allergy or lactose intolerance
* Pregnancy
* History of severe mental illness
* Smoking during the past six months
* Alcohol consumption of more than two drinks per day
* History of substance abuse or dependency followed by any current use
* Inordinate fear of blood draws
Electronic Pharmacotherapy Risk Management

The purpose of the Utah ePRM (electronic Pharmacotherapy Risk Management) project is to improve quality and safety of medication use while simultaneously controlling costs and detecting fraud and abuse.

The ePRM project has two objectives:

1. Refine and implement a computerized surveillance and trigger tool to support medication therapy and risk management services. The ePRM tool will be used to (1) identify potential drug-therapy problems, which include quality, safety and cost-related problems; (2) select patients and providers for in-depth clinical reviews and possibly direct intervention (i.e., letter, phone call, Medication Therapy Management Services (MTMS), or Academic Detailing); (3) identify potential fraud and diversion of controlled substances; and (4) track patterns of medication use and evaluate ePRM performance, identify improvements, and direct policy change.
2. Conduct innovative multi-pronged interventions that are guided by the ePRM trigger tool. Clinical areas chosen for review include diabetes therapy, hypertension, asthma, antipsychotic therapy, pain management (opioid narcotics and anticonvulsants) and anticoagulation/antiplatelet drugs. Interventions in these areas will address potential under and overuse, or patient safety concerns. Clinical pharmacists and physicians will implement five types of inter-related interventions: a) provider level reviews, which includes prescribers' profiling and feedback for outlier prescribers; b) patient level reviews and letters to prescribers for high-risk patients; c) phone consultation and Academic Detailing with outlier prescribers; d) MTMS; and e) detecting and pursuing suspected fraud and abuse cases.

Eligibility Criteria:
Inclusion Criteria:

* All medicaid recipients and providers with in the salt lake area

Exclusion Criteria:

* each participant much be a Medicaid recipient
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy.

The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 1660 patients, over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT).

A pilot phase of the study was carried out with the first 200 patients. An interim analysis will also be performed with the first 820 patients recruited.

Eligibility Criteria:
Inclusion Criteria:

* T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment
* Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs
* Post-CT axillary response by ultrasound or MRI
* Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment.

Exclusion Criteria:

* cN2
* ypN0
* History of breast surgery for ipsilateral cancer in the last 10 years
* History of other cancer in the last 5 years, except squamous carcinoma of the skin.
Clairity in a University Mental Health Clinic

This is a clinical trial to evaluate the effectiveness of the Clairity tool within the university setting for students who are being seen by a mental health provider.

In this study, the investigators plan to evaluate the effect of the Clairity process in a university setting. The Clairity process will be implemented as a 15-20 minute "between-the-visit" mental health check-in between a patient and clinical staff. Clairity will record and analyze patient speech using artificial intelligence algorithms developed for early detection and monitoring of mental health and suicidal risk. This study will be the first to return Clairity results real time to the clinician. The study employs a mixed-methods design, using rolling recruitment of clients of the Xavier University Psychological services clinic (XUPS) during the 2022-2023 school year. Study-trained clinical research coordinators will begin enrolling participants after completing the online protocol training and brief human subject's protection training.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Currently a client receiving services from XUPS
* Able to provide informed consent
* Speaks and understands English fluently
* Willing to abide by all research procedures

Exclusion Criteria:

* Participants with communication disorders (linguistic or articulation) or who cannot articulate clearly in English.
* Participants with an intellectual and/or neurocognitive disability that the study staff deems a barrier to participation.
* History of any other serious medical or psychiatric condition that would interfere with the ability of the patient to complete the study or would make it ethically unfeasible to enroll.
* Any participant, who at the discretion of the study staff, should not be enrolled.
Single Nuclei Sequencing in Human Skeletal Muscle After Unloading

Injuries often require people to undergo some degree of limb immobilization. This comes at a high cost in terms of muscle mass and function losses. At the molecular level, it is completely unknown how the different cells in the muscle respond to this complete lack of mechanical stimuli.

The investigators will explore cell type specific changes in skeletal muscle after a short period of unloading, and specifically examine the behavior of myogenic stem cells with particular attention to potential unloading-induced maturation into fast- or slow-twitch muscle fibers.

Ten healthy young participants will perform a 5-day Unilateral Lower Limb Suspension (ULLS) intervention, where one leg is continuously subjected to unloading, i.e., lack of mechanical stimuli. Before and after the ULLS period, participants will perform muscle function testing and MRI scans to assess muscle size in the lower limbs. Immediately after the ULLS, two muscle biopsies will be obtained, one from each leg. The tissue will be employed for single-nuclei RNA sequencing analysis and immunohistochemistry experiments.

This project will be the first to analyze cell type specific changes induced by complete, short-term lack of mechanical stimuli in skeletal muscle. This will add a new dimension to the understanding of the processes directing this type of muscle atrophy (i.e., muscle loss in otherwise healthy individuals) and thus help to develop effective countermeasures to offset muscle changes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young adult men

Exclusion Criteria:

* An age younger than 18 or older than 40 years
* Contraindications to magnetic resonance imaging (MRI)
* Contraindications to maximal intensity resistance exercise
* Contraindications to unloading (i.e., ULLS)
* Very high physical activity levels (determined using a standard Godin Leisure-Time Exercise Questionnaire (GLTEQ))
* Hypertension (\>140/90 mm Hg)
* History of malignancy
* History of coagulation dysfunction
* History of musculoskeletal or neurological disorders
* History of cardiovascular disease
* History of cerebrovascular disease
* History of respiratory disease
* History of gastrointestinal disease
* History of renal disease
* History of past or present condition requiring long-term drug prescriptions.
Small Bowel Motility in Patients With Systemic Sclerosis

Several studies using intestinal manometry have reported alterations in small bowel motility in patients with systemic sclerosis. Our aim is to apply endoluminal image analysis to stratify the intestinal motor dysfunction in these patients can be assessed by non-invasive techniques. Consecutive patients with systemic sclerosis referred to our institution will be prospectively investigated using automated non-invasive techniques developed in our laboratory. Intraluminal images of the gut were obtained by capsule endoscopy. Endoluminal image analysis will be performed with original, previously validated programs based on computer vision and machine learning techniques.


Eligibility Criteria:
Inclusion Criteria:

* Systemic sclerosis diagnosed by ACR criteria

Exclusion Criteria:

* Lung transplantation
* End stage kidney disease
Perceived Wellbeing and Focus with Daily Greens Supplementation

This study aims to investigate whether daily consumption of Gainful Daily Performance Greens for four weeks contributes to improved scores of wellbeing and focus in healthy adults, as compared to a control group of non-supplement takers. The research question will be addressed by evaluating participants' responses using the World Health Organization's WHO-5 Wellbeing Index and the Mindful Attention Awareness Scale.

Purpose: The primary objective of this study is to assess the potential benefits of Gainful Daily Performance Greens on wellbeing and focus in healthy adults. The formulation of this supplement includes ingredients believed to support mental clarity and overall wellbeing. Understanding the impact of this product on subjective measures of wellbeing and focus will provide valuable insights into its potential benefits for a broader population.

Hypotheses: H0 (null hypothesis): There is no significant difference in wellbeing and focus scores between baseline and after four weeks of daily Gainful Daily Performance Greens consumption in healthy adults. H1 (alternate hypothesis): Daily consumption of Gainful Daily Performance Greens for four weeks results in improved scores of wellbeing and focus as measured by the WHO-5 Wellbeing Index and Mindful Attention Awareness Scale compared to baseline in healthy adults.

Goals and Objectives: The primary goal is to examine the potential positive effects of Gainful Daily Performance Greens on wellbeing and focus. Specific objectives include comparing pre- and post-supplementation scores using validated measures, identifying any changes in subjective experiences related to mental clarity and wellbeing, and exploring potential factors influencing individual responses.

Significance of Study: Understanding the impact of Gainful Daily Performance Greens on wellbeing and focus addresses the growing interest in functional foods and dietary supplements. If the study demonstrates positive effects, it may provide evidence for the inclusion of such supplements in promoting overall mental health and wellbeing in healthy adults.

Contribution to Field: This study contributes to the emerging field of nutritional interventions for overall wellbeing. By using established scales to measure wellbeing and focus, the research aims to provide valuable insights into the potential benefits of Gainful Daily Performance Greens, informing future research and dietary recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Not currently taking cognitive-enhancing supplements or medications
* Provide informed consent
* Have the ability to comply with the study protocol

Exclusion Criteria:

* Known allergy to the ingredients of Daily Performance Greens
Wetsuit and Life Jacket Induced Effects on Spirometry and VO2 in Windsurfers

The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers.

Windsurfers will perform resting spirometry and exercise test on cycle ergometer until exhaustion in two conditions: with or without equipment. The investigators will measure Forced Vital Capacity, FEV1 peak flow at rest and oxygen uptake, carbon dioxide consumption, ventilation at each step of the incremental exercise and at exhaustion.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 35
* Do not contraindicate any of the investigations in the study
* Being affiliated to a social security system
* free, informed and written consent
* Have already performed a cardiopulmonary exercise test without any electrocardiographic abnormality
* Subject practicing windsurfing (whatever the level of practice (leisure or competition))

Exclusion Criteria:

* Subjects \< 18 years old
* Pregnant woman
* Inability to consent
* Taking any of the following: oral or inhaled Beta 2 short-acting or long-acting mimetics, oral or inhaled corticosteroids, oral anti-leukotrienes.
* Abnormalities in the resting ECG pattern
Transversalis Fascia Plane Block in Pediatric Patients

to investigate the effects of Transversalis Fascia Plan Block after induction of anesthesia on perioperative opioid consumption, hemodynamic changes, postoperative FLACC pediatric pain score, non-opioid analgesic use and parental satisfaction in pediatric patients undergoing unilateral inguinal hernia or undescended testicular repair under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 1-9 years old
* ASA I-II risk group
* Patients whose consent was obtained from their parents with an informed consent form
* Patients who will undergo Inguinal Hernia or Undescended Testi

Exclusion Criteria:

* ASA \>2
* History of allergy to local anesthetics
* Known coagulation disorders
* Infection near the entry site
* Body mass index \>30
* Those whose parents refused to participate in the study
* Those contraindicated for regional anesthesia
* Those with neurological or neuromuscular disease
* Patients with psychiatric problems
* Patients with a history of opioid use
* Chronic analgesic use
* Operation duration exceeding 2 hours