cyrilzakka/clinical-trials huggingface dataset:
Effect of Acute Sleep Restriction on Responses to Hypoxia

At altitude, humans are exposed to environmental hypoxia induced by the decrease in barometric pressure. On duty or in training, mountain troops, paratroopers or aircrew are regularly exposed to altitude. The effects of altitude on humans occur gradually from 1500 m and depend on both the duration of exposure and the altitude level. Cognitive disorders can occur from 3500 m (threshold of disorders) but there is a very large inter-individual variability.

The countermeasure to altitude hypoxia is oxygen but its use is not systematic between 3000 and 4000 m. Its use depends on the duration of exposure, without clearly established standards. Incapacitating effects on the operational capacity and health of soldiers can therefore occur as early as 3500 m.

In operations or during training, altitude exposure is often associated with a significant sleep debt (particularly during night or early morning missions), jet lag or precarious rest conditions in overseas operations. These sleep restrictions promote the degradation of mental performance with effects similar to those observed in hypoxia.

The combination of these constraints induces a physiological stress which can favour alterations in mental performance, an increase in incapacity, intolerance to altitude or the occurrence of altitude-related pathologies in military personnel. This could occur in particular in the operational zone around the threshold of disorders (3500 m) where the indication of oxygen is discussed.

The objective of this study is to assess the impact of acute sleep restriction on hypoxia tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Healthy
* Between 18 and 45
* Smoking \< 5 cigarettes per day or nicotine-free electronic cigarette
* Having regular physical activity (between 1 and 4 hours of physical activity per week)
* Affiliated or entitled to a social security plan
* No contraindication to physical exercise
* Having given their consent

Exclusion Criteria:

* Female
* BMI \> 30
* Active medical pathology (cardiological, renal, hepatic, cutaneous, neurological, etc.),
* History of active pathology of less than 6 months
* Significant deviation with the normal values observed during the interrogation, clinical examination or electrocardiogram
* Having spent time at altitude (\> 3500 m) during the last 3 months
* Absolute or relative contraindication to a stay at high altitude
* Medical contraindication to sport practice
* Skin allergy to modified ethanol or capsaicin
* Wearing a pacemaker or ferromagnetic implants
* Poor venous capital
* Pittsburgh Sleep Quality Index Questionnaire \> 5
* Usual sleep duration \< 6 hours
* Not covered by a health insurance plan
Efficacy of Low-level Laser Acupuncture and Microcurrent Electrical Stimulation on Gag Reflex on Children

the aim of the current study is to evaluate the effectiveness of the laser acupuncture in comparison to the electroacupuncure for controlling gag reflex in children

the study will select children who are suffering from gag reflex that can affect their dental appointments negatively. they will be diagnosed then randomly distributed to one of the 3 groups of the study gag reflex and anxiety will be measured before and after the intervention then the results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* children free of any systemic disease or special health care needs
* children with score 2 or 3 according to the frankle behavioral rating scale
* a full arch maxillary alginate impression is needed
* moderate to severe gagging according to the gagging severity index
* written informed consent of the legal guardian

Exclusion Criteria:

* children taking anti-emetic drugs
* children sensitive to alginate
Physical Resilience: Indicators and Mechanisms in the Elderly (PRIME) Collaborative Phase 2

The purpose of this study is to examine underlying physical resilience (the ability to bounce back) in response to a specific stressor (total knee replacement).

In general, a person's specific resilience (ability to bounce back from a stressor) is thought to be dependent upon that person's specific biological and genetic makeup. However, these specific elements remain poorly understood. The purpose of this study is to identify important predictors and characteristics of resilience in response to a total knee replacement by examining baseline resilience (prior to surgery) and post-surgical resilience at multiple time points, allowing us to track resilience outcomes over time.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or older
* Ability to speak English
* Planned elective knee replacement orthopedic surgery lasting 2 or more hours and requiring overnight observation or inpatient stay
* Community dwelling

Exclusion Criteria:

* Unable to ambulate independently, with or without assistive device
* Known dementia or screening 3MS score \<=77
* Inmate of a correctional facility (i.e. prisoners)
* Active non-skin cancer or medical treatment for non-skin cancer with 12 months (chemotherapy, radiation, immunotherapy, hormonal therapy)
* Vision or hearing impairment that, after best accommodation, prevents reliable cognitive assessment (visual/hearing) and/or precludes telephone interviews (hearing)
MR INFORM - MR Perfusion Imaging to Guide Management of Patients With Stable Coronary Artery Disease

The purpose of this study is to determine if MR Perfusion Imaging is non-inferior to coronary angiography with measurement of Fractional Flow Reserve (FFR) in guiding management of patients with stable chest pain.

* All patients will undergo an MR Perfusion Imaging test.
* Further management will be guided by the result of the cardiac MRI in half of the patients (chosen by random).
* The other half will undergo coronary angiography with measurement of FFR. The result of this test alone will guide their further management. The result of the initial MR Perfusion test will not be available to the treating doctors of this group.
* All patients will receive optimal medical therapy (OMT)
* All patients will undergo follow-up to find out if they have any relevant heart related events.


Eligibility Criteria:
Inclusion Criteria:

* Angina pectoris CCS class II and III and either
* ≥2 cardiovascular risk factors
* or positive exercise treadmill test
* Signed written informed consent
* age: at least 18 years

Exclusion Criteria:

* contraindication to MR
* contraindication to adenosine infusion
* EF≤ 30%
* inability to lie supine for 60 minutes
* previous Coronary Artery Bypass Grafts
* revascularization within the previous 6 months
* cardiac arrhythmias (atrial fibrillation, \>20 ectopic beats/min)
* poor renal function (eGFR \<30ml/min)
* body weight \> 140kg or waist perimeter \> 95cm
* known allergy to contrast media
Involving Men in Maternity Care in Burkina Faso

The uptake of postpartum contraception, postpartum care attendance and the practice of exclusive breastfeeding are low in Sub-Saharan Africa. Although the involvement of men in maternity care has been shown to be a promising strategy for the achievement of other reproductive health goals, little is known about the effect of their participation on these outcomes. This study aims to test whether the involvement of men can improve care-seeking and promote healthy behaviours among postpartum women in Burkina Faso.

There is a paucity of evidence on strategies to increase the uptake of postpartum contraception and attendance at facility-based postpartum care in developing countries, including in Sub-Saharan Africa. There is also a need to test new solutions to improve adherence to recommended infant feeding practices in these settings. Partner opposition is a major barrier to women's uptake of contraceptive methods in the postpartum period in Burkina Faso, and research has shown the need to sensitise and inform men about a broad range of topics related to reproductive health. However, the effect of involving male partners on women's and newborns' health and wellbeing in low-resource settings is not well known, and there is particularly little evidence for outcomes related to the postpartum period.

The aim of this study is to assess whether male partner involvement in maternity care has the potential to increase care-seeking and promote healthy behaviours among postpartum women in an urban West-African setting. A randomized controlled trial (RCT) of an intervention to promote the involvement in maternity care of the partners of pregnant women attending primary health care facilities will be conducted in the city of Bobo-Dioulasso. The intervention consists of three extra components in addition to standard maternity care: one extra couple counselling session during pregnancy (A), partner participation in a group education session for men (B), and partner participation in the pre-discharge consultation after birth (C). Women in the control group will receive standard maternity care only, in which men do not participate.

A qualitative component will be carried out alongside the RCT, in order to examine the factors that may have determined the success, or lack thereof, of the intervention by reflecting on the experience of participants (women, partners , and health workers), and to explore their attitudes, beliefs and concerns relative to partner involvement in maternity care, through focus group discussions and in-depth interviews.

The policy implications of the study findings will be assessed and, if appropriate, a strategy will be developed for their dissemination among policymakers and other stakeholders.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-18, married, or
* Age 18+, in a co-habiting relationship
* Pregnant 24-36 weeks
* No obstetric risk factors requiring hospital delivery
* Lives no more than one hour away on foot, not planning to move from the city
* Gives informed consent

Exclusion Criteria:

* Not meeting inclusion criteria
* Declines to participate
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty

The purpose of this study is to evaluate the efficacy and safety of VX-548 in treating acute pain after an abdominoplasty.


Eligibility Criteria:
Key Inclusion Criteria:

* Before Surgery

  * Participant scheduled to undergo a standard ("full") abdominoplasty procedure
* After Surgery

  * Participant is lucid and able to follow commands and able to swallow oral medications
  * All analgesic guidelines were followed during and after the abdominoplasty
  * Abdominoplasty procedure duration less than or equal to (≤3) hours

Key Exclusion Criteria:

* Before Surgery

  * Prior history of abdominoplasty
  * History of Intra-abdominal and/or pelvic surgery that resulted into complications
  * History of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s)
  * Any prior surgery within 1 month before the first study drug dose
* After Surgery

  * Participant had a non standard abdominoplasty, collateral procedures during the abdominoplasty or any surgical complications during the abdominoplasty
  * Participant had a medical complication during the abdominoplasty that, in the opinion of the investigator, should preclude randomization

Other protocol defined Inclusion/Exclusion criteria may apply.
STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma

The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma


Eligibility Criteria:
Inclusion Criteria:

* - Diagnosis of asthma ³ 3 months
* Prescribed daily use of glucocorticosteroids at a dose \> 320 mcg/ day for at least 3 months prior to Visit 1

Exclusion Criteria:

* Smoking history \> 10 pack-years
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
* Any significant disease or disorder that my jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.
Phase 1 to Evaluate the Safety and Pharmacokinetic Durg-drug Interaction of YYC506-T and YYC506-A

To evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A

Phase 1 to evaluate the safety and pharmacokinetics drug-drug interaction of YYC506-T and YYC506-A. Which is designed as two cohort, single-sequence, paralle, open label, multiple oral dosing.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 ages healty men
* Over 50.0kg, 18.0kg/m2 ≤ BMI ≤30.0kg/m2
* Men who dont have congenital disease and other cronic disease need to be cared etc.

Exclusion Criteria:

* Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
* Men who have drunken or eatten something including carffeine within 24 hours before etc.
Development of an Assessment Method for Obstructive Tonsillar Hypertrophy in Children by Ultrasonography

Chronic tonsillar hypertrophy is one of the most common causes of upper airway obstruction in children. Currently, several clinical staging systems are used to evaluate airway obstruction due to tonsillar hypertrophy. However, as these staging systems are based on a physical examination, it is not always possible to accurately evaluate the tonsil size, especially in children, and so objective and reliable methods are required in this field. In this study, the investigators aimed to develop a new method for the objective evaluation of airway obstruction due to tonsillar hypertrophy using submental ultrasonography (US) in children.

Tonsillectomy is one of the most frequently performed operations in childhood, and one of the most important indications of this surgery is chronic tonsillar hypertrophy. Chronic tonsillar hypertrophy accounts for 80% of cases with obstructive sleep apnea syndrome (OSAS) in childhood, and growth and development delay, low academic performance, facial developmental abnormalities, and cardiopulmonary diseases may emerge as a result. For this reason, an accurate evaluation of tonsil size is crucial both during clinical follow-up and in tonsillectomy decisions.

Currently, several clinical staging systems are used to evaluate tonsil size in children, with the "Brodsky" and "Friedman" scales being the most commonly used systems. These staging systems make use of a physical examination, with tonsil hypertrophies generally classified into 4 stages based on the extension of the tonsil from the anterior plica to the midline. Stages 3 and 4 tonsil hypertrophy are generally accepted as obstructive, and a tonsillectomy decision is made when clinical complaints support this. For such an evaluation of tonsil grade, the child should be cooperative, should easily open his/her mouth, and should not gag. In the event of the patient's non-compliance, the size of the tongue and tongue base, the hyperactive gag reflex, and trismus may challenge this evaluation. The gag reflex during the examination causes the tonsils to move towards the midline, making the tonsils seem bigger than the real size. An obstruction at the hypopharyngeal level due to hypertrophic tonsils may be missed due to poor visualization of the inferior pole of the tonsil in patients with a large tongue. For these reasons, a correct clinical evaluation of the tonsil size may not always be possible through a physical examination. Thus objective and reliable methods are required for the classification of tonsillar hypertrophy.

There have been no studies to date investigating the use of ultrasonography (US) in the evaluation of airway obstruction due to tonsillar hypertrophy, despite the advantages of high patient compliance, low cost, and no radiation exposure. The present study suggests a new method for the evaluation of airway obstruction due to tonsillar hypertrophy using the submental US in children.

Eligibility Criteria:
Inclusion Criteria:

* The pediatric patients

Exclusion Criteria:

* Adult patients
* Patients identified with active infections
Online Mindfulness-Based Intervention for ADHD

This study aims to evaluate the efficacies of an online mindfulness-based intervention for emerging adults with ADHD in Malaysia. The investigators hypothesized that online mindfulness-based intervention may improve ADHD symptoms and executive functions of emerging adults with ADHD.

Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder that often persist to adulthood. In Malaysia, the Chinese ethnic is having the highest prevalence rate of hyperactivity symptoms. Nevertheless, there are only limited evidence-based treatment options targeting the core symptoms of ADHD, as well as executive functions in adulthood. In addition, conventional psychotherapeutic approaches for adults with ADHD have found to be highly labor-intensive. Emerging adulthood is a distinct developmental stage of 18 - 29 years old, with unique challenges that rarely addressed in mental health system. Recently, mindfulness-based intervention appears to be a promising treatment for adults living with ADHD but it has not been evaluated among Malaysian emerging adults with ADHD. The investigators proposed a two-arm randomized controlled trial, comparing an eight-week online mindfulness-based intervention program with an online introductory psychology program. The outcomes include changes of inattention symptom, changes of hyperactivity-impulsivity symptom, and changes of executive functions from pretest to posttest, 1-month follow-up and 3-month follow-up. To investigators' best knowledge, this randomized controlled trial will be the first to test the efficacious of online mindfulness-based intervention for ADHD among emerging adults. It will provide evidence on the efficacious of online treatment for this often-overlooked population in the mental healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 29 years old.
* Diagnosis of ADHD.
* Completed at least six years of Chinese education.
* Participants taking psychotropic prescriptions will be allowed to participate, if they prescriptions were stable for at least 6 weeks prior to their participation in this study.

Exclusion Criteria:

* History or current presence of substance dependence, psychotic illness, bipolar disorder, personality disorders, conduct disorder, chronic suicidal, or self-injurious behaviour as reported in the Diagnostic Interview For Anxiety, Mood, Obsessive-Compulsive and Related Neuropsychiatric Disorders (DIAMOND).
* Non-verbal intellectual ability of percentile ranks 25 or below.
* Received cognitive-behavioural therapy (CBT) for ADHD or any form of mindfulness-based intervention in the past 2 years.
Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.

* Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment.
* Patients will receive cytoxan (cyclophosphamide) and epirubicin intravenously on day 1 of each treatment cycle. On days 4-17 of each cycle, patients will take capecitabine orally twice a day.
* While on the study patients will be required to complete a diary of they capecitabine treatment.
* Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patient's experience with the oral chemotherapy.
* Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
* 18 years of age or older
* ANC \> 1,000/mm3
* Platelet count \> 100,000/mm3
* Hemoglobin \> 10
* Creatinine \< 2.0
* SGOT \< 2 x ULN
* Bilirubin \< 1.5mg/dl
* Able to swallow and retain oral medication
* LVEF greater than or equal to 50%
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Pregnant or lactating
* Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
* Prior chemotherapy within 5 years
* Prior anthracycline therapy
* Serious comorbid physical or psychological condition
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will test an experimental drug called DS-8201a that has not been approved by the health authorities yet.

DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).

The expected time from the first subject's enrollment until the last subject's enrollment is approximately 8.5 months. The screening period is 28 days and each cycle of treatment is 21 days.

The data for the primary analysis will cutoff after all subjects have either discontinued the study or completed at least 3 cycles, whichever comes first. After the primary analysis, the main study will be closed and transition to the extension period.

Depending on the preliminary results of Cohort 1, Sponsor may decide whether Cohort 2 will be opened or not.

The number of treatment cycles is not fixed in this study. Subjects who continue to derive clinical benefit from the study drug in the absence of withdrawal of consent, progressive disease (PD), or unacceptable toxicity may continue the study drug.

Eligibility Criteria:
Inclusion Criteria:

* Has a pathologically documented unresectable or metastatic solid malignant tumor, with HER2 expression \[immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization (ISH) +\], Next Generation Sequencing, or other analysis techniques as appropriate\] that is refractory to or intolerable with at least one prior systemic chemotherapy regimen, or for which no standard treatment is available
* Has a left ventricular ejection fraction (LVEF) ≥ 50%
* Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

* Has a contraindication for receiving ritonavir or itraconazole according to the prescribing information
* Has a medical history of myocardial infarction within 6 months before enrollment or symptomatic congestive heart failure
The Validity of Modern Mobile Applications in Management of COVID-19 Home Isolation Patients: a Survey for Health Care Professionals

In late 2019, a novel coronavirus, SARS-CoV-2, was identified as the causative agent of a cluster of pneumonia cases (COVID-19) in Wuhan, China. Clinical symptoms of COVID-19 may be mild or severe. The location where a person will self-isolate will be determined by their healthcare provider and their health authority. When determining the location, several factors to determine the suitability of the home setting are described as the case should stay in a room of their own so that they can be isolated from other household members. The rapid increase and evolution of modern mobile applications for communication and messaging for personal purposes have proved great benefit in healthcare management


Eligibility Criteria:
Inclusion Criteria:

* healthcare professionals in Ain Shams University, Cairo, Egypt.

Exclusion Criteria:

* junior Staff