cyrilzakka/clinical-trials huggingface dataset:
The Study of Blood Pressure Variability to Impact Arterial Stiffness and Carotid Atherosclerosis

The purpose of this study is to investigate whether and what extent blood pressure variability is associated with arterial stiffness and carotid atherosclerosis, furthermore to compare the difference in the relationship of the types of blood pressure variability with arterial stiffness and carotid atherosclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Can step by himself/herself

Exclusion Criteria:

* Cardiovascular and cerebrovascular diseases
* Secondary hypertension
* Chronic cardiac, renal, gastro-intestinal, pulmonary or any other systemic disease process requiring chronic intake of prescription medications
SmokefreeSGM, A Text-based Smoking Cessation Intervention for Sexual and Gender Minority Groups

The purpose of this study is to pretest the design of a text-based smoking cessation program tailored to sexual minority individuals.


Eligibility Criteria:
Inclusion Criteria:

* Smoke five or more cigarettes per day, has smoked at least 100 cigarettes in their lifetime and smokes everyday
* Have an interest in quitting smoking in the next 15 days
* Have a cellphone number with an unlimited short messaging service (SMS) plan
* Have US mailing and email addresses
* Positive cotinine saliva test results

Exclusion Criteria:

* Individuals who are found to have a prepaid cell phone
* Individuals who are found to have a cellphone number that does not work or is registered to someone else
* Pregnant or breastfeeding women
* Contraindication for nicotine patch
* Regular use of tobacco products other than cigarettes
* Current use of tobacco cessation medications
* Enrolled in another smoking cessation study
* Non-English speakers
* Having inadequate equipment/device (webcam, speakers, mic) for participating in telehealth sessions
The Effect of Online Peer and Adult Education Given to Adolescents With Allergic Asthma

Objectives: To examine the effect of interactive online education given by peers or adults on anxiety, self-efficacy, quality of life, and disease knowledge and management in adolescents with allergic asthma in the 10-14 age group.

Methods: The research was conducted as a randomized controlled study. The study sample consisted of 84 adolescents divided into experimental groups \[receiving peer(n=28) or adult(n=28) education\] and control(n=28) group. The adolescents in the peer or adults were given online interactive education concerning allergic asthma and the management thereof. The control group received only usual training.Data were collected using an Adolescent Personal Data Form, the State Anxiety Inventory for Children, the Self-Efficacy Scale for Children and Adolescents with Asthma, the Pediatric Asthma Quality of Life Questionnaire, and the Disease Knowledge and Management Questionnaire. Data were collected from the adolescents before (T0) and immediately after education (T1), and after one (T2) and three months (T3).

This study is a non-blinded randomized controlled trial. . All screened adolescents with asthma were randomly assigned to one of the three groups: the peer or adults education groups that received a 6 weeks asthma education and a control group that received usual care. The three groups were then followed prospectively immediately, 1, and 3 months after training to evaluate the effectiveness of training compared with usual care.


Eligibility Criteria:
Inclusion Criteria:

Age was 10 to 14 years, doctor-diagnosed allergic asthma, without allergic rhinitis with a diagnosis of allergic asthma (by medical record), internet access via computer or phone, the ability to speak Turkish, willingness to participate.

Exclusion criteria were those with moderate to severe cognitive or mental health impairment and a diagnosis of allergic rhinitis in addition to the diagnosis of allergic asthma (according to medical records).
Interfaces of Non-invasive Ventilation on Performance in Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to determine wether the interface (facial or nasal mask) influences performance in patients with chronic obstructive pulmonary disease exercising with non-invasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Chronic obstructive pulmonary disease Gold III-IV
* Eligible for pulmonary rehabilitation
* Exercise limitation : at least respiratory limitation (ventilatory reserve ≤ 30%)

Non-inclusion Criteria:

* Pregnant woman or likely to be
* Familiar with home non-invasive ventilation
* Patient under guardianship

Exclusion Criteria:

* Acute exacerbation of chronic obstructive pulmonary disease
Effectiveness of Active Video Games in Children With Intellectual Disabilities

Background: Children with intellectual disabilities (ID) are more vulnerable to obesity when compared to the normal children (Getchell et al., 2012; Maiano, 2011). Active video games (AVGs) on physical activity (PA) behavior have attracted academic interest and exploration since 2000. It has been demonstrated that an intervention with AVGs is compatible with the school setting and behavioral change in health and PA (Lau, et al., 2015). However, special populations such as ID children and their needs have been neglected in this area (Martins, Carvalho \& Soares, 2011). ID children's PA behavior, motor ability and physical fitness is still an under-explored area.

Aims: To determine the effect of a prescribed AVG intervention on ID children's PA levels (sedentary, light, moderate, and vigorous), motor ability, and physical fitness. The intervention effects in children with mild intellectual disability will be explored.

Design: A standard two-arm parallel, single-blinded, randomized control cluster trial.

Schools: Participants will be recruited from six special schools in Hong Kong. Schools with same intellectual disability categories will be randomly assigned into intervention group and control group.

Participants: 200 Children aged 8\~18 years old with intellectual disabilities will be recruited.

Intervention: ID children randomized to the intervention group will participate in an AVG intervention 60 minutes per week for 12 weeks in their PE class, in addition to their usual activity levels. The research team will prescribe updated AVG consistent with moderate-vigorous intensity.

Control: The control group will continue with usual PA alone and will not receive the AVG intervention.

Analysis: Repeated measures mixed model (2 groups X 2 time points (12-week post- test and 8-week follow up test)) by SPSS 23.0 will be used to investigate the intervention effect on primary and secondary outcomes, adjusting for baseline characteristics and correlation between repeated observations.

Significance: This will be the pioneering study to provide definitive evidence for the impact of a prescribed AVG intervention on ID children's PA level, motor ability and physical fitness. If effective, this research will provide significant evidence from the innovative method to inform health professionals and PE teachers how to incorporate AVG to enhance physical active behaviors, motor ability and physical fitness in ID children. Finally they may be able to enjoy a better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* students with ID (mild category) aged 8-18 years old from special education schools including primary and secondary schools;

Exclusion Criteria:

* students without physical disability.
Immune and Scfa Profile of Stunting Children

1. Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect).
2. Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency.
3. Population and Research Sample The population is children between three and five years old in the village of stunting locus.

The sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.

The variables studied will be the nutritional status of children between three and five years old, the characteristics of these children (age, sex, LBW, birth length, history of immunization, history of diarrhea, history of upper respiratory tract infection, food intake), mother and family characteristics (mother's age, mother's education, mother's occupation, father's occupation), home environment (aspects of the components of the house, aspects of sanitation facilities, aspects of occupant behavior), the composition of the intestinal microbiota. Data will be obtained through measurements, interviews using a questionnaire, and direct observation using a checklist.

Stunting anthropometric measurements are measured based on parameters of length/height according to age compared to the WHO anthropometric standards 2005 and the Indonesian Minister of Health Decree No. 1995 / MENKES / SK / XII / 2010.

The nutritional status of each child included in this study will be quantified using the WHO recommended three nutritional Z-scores namely, height for age (referred to in this study as Zscore

1. weight for age (referred as Z-score
2. and weight for height (referred as Z-score
3. .A structured questionnaire was used for face-to-face interviews with the respective child mother to collect sociodemographic information. In addition, age and anthropometric measurements (height, weight) based on the Department of Health Ministry of Indonesia The regulation will be recorded. For stunting, the thresholds for height-for-age are: 'severely stunted' (\<-3 SD); 'stunted' (-3 SD to \< -2 SD); 'normal' (-2 SD to +3 SD); 'tall' (\> +3 SD). Furthermore, in order to obtain an overall measure of the nutritional status of these children, the children will be classified into weight-for-height categories: 'severely wasted' (\<-3 SD); 'wasted' (-3 SD to \< -2 SD); 'normal' (-2 SD to +1 SD); 'possible risk of overweight' (+1 SD to +2 SD); 'overweight' (\> +2 SD to +3 SD); 'obese' (\> +3 SD)

Eligibility Criteria:
Inclusion Criteria:

* Children age : 3 - 5 years old (36-60 months)
* Live in the research area
* Apparently healthy children, after examination by a physician
* Involved in a research study (informed consent signed by parent or guardian)

Exclusion Criteria:

* Children age \< 36 month and \> 60 month
* Live outside research area
* Unhealthy, after examination by a physician
Covid-19 Lockdown and Deviant Sexual Fantasies

Our society is going through an unprecedented situation: the COVID 19 Pandemic is forcing many populations, worldwide, into confinement for their own protection. The very characteristics of this confinement and of the disease (isolation, potential severity of the illness, being psychologically unprepared for such a circumstance) have a significant impact on one's psyche, like emotional disorders -anxiety/depression-, difficulties when returning to normal life, vicarious traumas... Confinement is paradoxical in as although well-intended to protect the individual, it leads to the isolation of the individual. This paradox is destabilizing one's feelings, because when the investigators feel the need for protection and reassurance, the investigators are left alone and feel abandoned. The investigators therefore understand that this confinement framework is in essence a situation that might revive unresolved deprivation situations from the childhood. How to react in front of this upsurge in anxiety? Strategies used may include, among others, escape in the imaginary through numerical tools or others, and /or going to the actual characterized by deviant sexual behaviours. The investigators know in fact that certain moments, like anxiety, depression, boredom, psychological unrest are propicious for acting, for violent sexual offenders. The investigators therefore pay extra attention to our patients in such periods favoring these kinds of trouble.

This study will enable us to understand if the confinement associated with COVID 19 has generated anxiety that lead sexual offenders or individuals with paraphilic disorders to engage into deviant fantasies or, potentially sexual activities.

The questionnaire is handed only one time to each patient and the questions it contains are part of those commonly used.

How do the investigators precisely operate: self questionnaire on paper, handed to each patient followed by the CRIAVS in the waiting room, and returned by the patient to the therapist, or the department, in a sealed envelope. Digital data collection thereafter.

Eligibility Criteria:
Inclusion criteria:

* Adults
* Consulting at the CRIAVS between June and end October 2020

Exclusion criteria:

* no demance
* no decompensated psychatric disorder
* no tutelage
Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study

This study is an experimental single-center pilot study investigating Volatile Organic Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed Back Surgery Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.

Exclusion Criteria:

* Patients with a diagnosis of cancer.
* Patients with major psychiatric problems.
* Patients with an underlying respiratory disease.
Frequency and Origin of Dysnatremias in the Emergency Department

Hypo- and hypernatremia are the most frequent electrolyte disorders found in hospitalized patients. The increasing use of diuretics and other medications influencing the water and sodium homeostasis potentially lead to a rise in the prevalence of the electrolyte disorders. Only little data is available on the frequency and the mechanisms leading to hypo-/hypernatremia.

Thus, the investigators aim to A.) determine the frequency of hypo- and hypernatremia in the emergency department of a large tertiary university hospital and B.) explore the mechanisms leading to the development of dysnatremias by detailed clinical and laboratory examinations.


Eligibility Criteria:
Inclusion Criteria:

* Serum sodium below 135 mmol/L (i.e. hyponatremia); serum sodium exceeding 145 mmol/L (hypernatremia)

Exclusion Criteria:

* Patients below age 18 years; patients declining study participation.
Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages

NeuroPrems is a prospective, monocentric, longitudinal, not relating to a medicinal product for human use, non-randomized, non-controlled research. The study mainly aims to identify longitudinal changes and events in multimodal markers of neurodegeneration and neuroinflammation during the presymptomatic phases of neurodegenerative diseases.


Eligibility Criteria:
1. Inclusion Criteria :

   1. For all participants :

      * Male or female
      * Age ≥ 18 years
      * Signed Informed consent by the subject
      * Affiliated with a social security system or beneficiary of such a regime
      * Ability to undergo an MRI exam with Gadobutrol
   2. For presymptomatic participants only :

      * Absence of a diagnosis of neurodegenerative disease. And at least one of the criteria :
      * Known carrier or relative of a patient carrying a mutation in a causal or at-risk responsible for a neurodegenerative disease
      * Isolated REM sleep behavioral disorder
      * Radiological isolated syndrome
      * Abnormal brain protein aggregates
   3. For controls only :

      * Absence of symptoms or diagnosis of neurodegenerative disease (or criteria corresponding to at risk group)
2. Exclusion Criteria :

   * Clinical symptoms fulfilling the criteria of a neurodegenerative disease (see table in criteria section)
   * Refusal of blood draw or brain MRI
   * MRI contraindication (see criteria section)
   * Known allergy to gadoteric acid
   * Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)
   * Pregnancy or breastfeeding. For women in fertile age a urine pregnancy test will be performed before the MRI.
   * Inability to understand information about the protocol
   * Person deprived of their liberty by judicial or administrative decision
   * Person under legal protection (legal guardianship, tutelage or maintenance of justice)
   * Person without any protection and unable to consent
   * Other medical, neurological, psychiatric, or social conditions that in the investigator's opinion are likely to interfere with study conduct.
TCM Syndrome Differentiation of T2DM & MetS

This study aims to include type 2 diabetes (T2DM) patients comorbid with metabolic syndrome (MetS). The primary aim of the study is to investigate the TCM (Traditional Chinese Medicine) syndrome differentiation of T2DM comorbid with MetS.

This study adopts a cross-sectional design, to include type 2 diabetes (T2DM) patients comorbid with metabolic syndrome (MetS). The primary aim of the study is to investigate the TCM (Traditional Chinese Medicine) syndrome differentiation of patients with T2DM and MetS. The demographic data, anthropometric data, fasting glucose and HbA1c, lipid panel, TCM syndrome differentiation information, dietary assessment, physical activity, sleep quality, and quality of life, will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* (1) Age between 18-75y.
* (2) Diagnosed with Type 2 diabetes.
* (3) Diagnosed with Metabolic Syndrome according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) from Chinese Diabetes Society. People who meet 3 of the following diagnostic criteria or more can be diagnosed as Metabolic Syndrome: (a) Abdominal obesity: waist circumference ≥ 90cm for male and ≥ 85cm for female; (b) Hyperglycemia: Fasting blood glucose ≥ 6.1mmol/L or 2-hour postprandial glucose ≥ 7.8mmol/L and/or those who have been diagnosed with hyperglycemia and in treatment; (c) Hypertension: blood pressure ≥ 130/85mmHg and/or those who have been diagnosed with hypertension and in treatment; (d) Fasting triglyceride ≥ 1.70mmol/L; (e) Fasting HDL-C \< 1.04mmol/L.
* (4) Clearly understand the content of the study and voluntarily sign the informed consent form.
* (5) Provide complete data (basic information, TCM diagnosis data, and blood test results).

Exclusion Criteria:

* (1) Diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes.
* (2) Diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc.
* (3) Secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.).
* (4) Secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.).
* (5) Secondary hyperlipidemia (e.g., hypothyroidism, nephrotic syndrome, etc.).
* (6) With severe heart, liver, or kidney disease or bleeding disorders, or with other serious diseases (e.g. cancer, dementia, etc.).
* (7) With severe mental disorders, speech or hearing impairments.
* (8) Pregnancy or lactation female.
* (9) Currently join other clinical trial.
Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation(TMS) on Brain Derived Neurotrophic Factor (BDNF) in Depressed Patients.

To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post treatment for patients with depression with either ECT or TMS.


Eligibility Criteria:
Inclusion Criteria:

* MDD or bipolar disorder;
* current depressive episode, ham-d17\>17 and ymrs\<8;
* recommended to receive ECT or TMS as part of clinical care;
* male/female;
* age 18-65;
* inpatient or outpatient;
* comorbid dysthymic disorder, gad, or social anxiety will be included;
* able to give written consent and agree.

Exclusion Criteria:

* current manic, hypomanic, or mixed episode, ymrs\>7;
* current schizophrenia, anorexia, bulimia, substance dependence (current within past 6 months excluding caffeine and nicotine);
* TMS or ECT in the last 3 months;
* any other primary diagnosis;
* uncontrolled medical illness;
* epilepsy or severe personality disorder at the discretion of the investigators;
* 3 weeks prior to first blood test, antidepressants, mood stabilizers, antipsychotics can not be added or increased;
* pregnant women or women of childbearing potential not willing to use appropriate contraception, nursing women;
* known intolerance or lack of response to treatment receiving as judged by the investigator;
* medical conditions that would affect serum levels of BDNF;
* involvement in planning and conduct of the study.
Short Term Effect of Vitamin D Supplementation on the Clinical Outcomes in Patients Undergoing Valve Replacement Surgery

This study evaluates the effect of Vitamin D supplementation on ICU and hospital LOS in patients undergoing valve replacement surgery. Half of the patients will receive Alfacalcidol, while the other half-the control group- will be exposed to the same environment without receiving alfacalcidol.

Vitamin D insufficiency has been reported in more than 80% of critically ill patients, hospitalized in intensive care unit (ICU), including cardiac surgical patients. Moreover, 25(OH)D levels continue to decrease from baseline throughout the hospital stay and resolves by 6 months. Vitamin D levels \< 20 ng/ml is associated with higher mortality, infection rates and prolonged length of ICU saty.

The discovery of vitamin D receptors (VDR) expressed on cardiac muscle and vasculature, released a strong hypothesis suggesting that vitamin D regulates RAAS activity and cardiac remodeling.

The beneficial effects of vitamin D on cardiovascular system, immune function and wound healing could be of particular interest in critical care, and patients undergoing valve replacement surgery will benefit the most.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing mechanical valve replacement surgery

Exclusion Criteria:

* combined valvular replacement surgery and Coronary Artery Bypass Graft (CABG) surgery
* valvular replacement redo
* valvular replacement surgery secondary to infective endocarditis
* on dialysis
* ALT levels 2-3 times higher than normal range
* CHD,
* impaired gastrointestinal function
* indication for vitamin D supplementation within the prior month
* hypercalcemia defined as total calcium \>10.4 mg/dl
* hyperphosphatemia defined as serum phosphate \> 4.5 mg/dl
* pregnancy and lactation.