cyrilzakka/clinical-trials huggingface dataset:
Assessment of Depression, Anxiety and ADHD Among Children and Adolescents with Congenital Heart Disease.

Congenital heart disease (CHD) is the most common birth defect, affecting ∼1% of all live births.The spectrum of CHD is wide, ranging from simple (not requiring immediate or possibly any surgical intervention) to severe or complex (typically defined as CHD requiring surgical intervention within the first month to year of life).

Although overall mortality has improved, most notably in those with complex CHD, many surgical and medical procedures are palliative, and these patients often require multiple interventions throughout their lifetime. Increased CHD survival is now resulting in a continually growing population of adolescents and adults with CHD; this has drawn more attention to the noncardiac comorbidities, including overall mental health, of patients with CHD.There are multiple psychological theories that can potentially explain some of the mental health disorders seen in patients with CHD, such as stressful life events and sociocultural impacts (eg, parenting style).Cognitive models, including learned helplessness and negative information processing, may also contribute to the mental health of children with CHD, who often spend significant amounts of time in the hospital and undergo cardiac procedures and surgeries. The presence of underlying genetic syndromes, parental mental health disorders, cardiopulmonary bypass, prematurity, and prolonged hospitalizations are factors that increase the risk of neurodevelopmental disabilities (NDDs) and likely contribute to anxiety, depression, and attention-deficit/hyperactivity disorder (ADHD) in adolescents and adults with complex CHD.

Eligibility Criteria:
Inclusion Criteria:

* childern age from 6 to less than 18
* childern with simple and complex CHD
* in patient and out patient childern
* preoperative and postoperative patient

Exclusion Criteria:

* patient indicated for icu
* patient with critical arrythmias
* caregiver refuse to participate in the study
Sleep and Nocturnal Enuresis: Ambulatory Polysomnographic Study

Full ambulatory polysomnography at home performed two nights in 30 healthy children and one night in 30 children with mono-symptomatic nocturnal enuresis (15 with polyuria and 15 without polyuria). The children will be aged 7-14 years of age.

The sleep will be evaluated on sleep quality, number of periodic limb movements per hour, blood pressure and pulse, beat to beat variation by electrocardiography during sleep, respiration during sleep, nocturnal urine production, and enuresis episodes.

Purpose and perspectives:

The purpose of the study is to investigate the quality of sleep, the sleep architecture and the intra-individual variation from night to night in healthy children and children with mono-symptomatic nocturnal enuresis (MNE) using full polysomnography at home.

Hypotheses:

* There is large intra-individual night to night variation in sleep quality and architecture.
* Children with MNE have different sleep architecture than healthy children when looking at sleep quality and arousals.
* Periodic limp movements at sleep is more frequent in children with MNE than in healthy children.

Design:

The study is a case-control study.

Materials and methods:

The study will recruit 30 healthy children and 30 children with MNE (15 with polyuria and 15 without polyuria) recruited from the Childrens Incontinence Center at the Department of Pediatrics and Adolescent Medicine at Aarhus University Hospital. Children of both sexes aged between 7 and 14 years of age will be enrolled. Children and their parents will be informed about the study both verbally and in written. Written informed consent from both parents must be obtained before the children can be enrolled in the study.

The healthy children will go through two nights of full polysomnography to be able to view intra-individual changes. The children with MNE will only have to do one night of polysomnography.

Primary parameters:

* Sleep quality
* Number of periodic limb movements per hour
* Blood pressure and pulse
* Beat to beat variation by electrocardiography during sleep
* Respiration during sleep
* Nocturnal urine production
* Enuresis episodes

Eligibility Criteria:
Inclusion Criteria:

* 7-14 years of age
* Normal objective evaluation including blood pressure
* For healthy controls achieved continence both day and night before the age of 5.
* For children with nocturnal enuresis at least 3 wet nights per week.
* For children with enuresis clinical characteristics and at least one week of home recordings of nocturnal urine production and two days of full recording of fluid intake and urine production.

Exclusion Criteria:

* Obstipation (according to ROM IV criteria)
* Day incontinence or severe urgency
* Insomnia or known sleep disorders such as sleep walking, heavy snoring, night terrors or abnormal circadian rhythm.
* Present or former deceases in the urinary tract, liver or in the endocrinological system.
* Hypertension
* Treatment with medication at the time of the study
* ADHD, autism or other psychiatric disorders.
Gait Analysis in Multiple Sclerosis Patients

In the literature, the results of vestibular rehabilitation treatment applied in patients with Multiple Sclerosis (MS) have been investigated in detail under the headings such as fatigue, physical activity level, and quality of life, and its effects on walking have also been tried to be examined. However, in the studies conducted, gait assessments were made through questionnaires and timed tests, and devices that provide more objective data such as 3-dimensional gait analysis were not used. Again, the effects of vestibular rehabilitation programs on dual-task were not examined in previous studies.

Therefore, the aims of our study are:

1. To determine the effect of individually designed vestibular rehabilitation exercises on the kinetic and kinematic components of walking;
2. To determine the effect of vestibular rehabilitation exercises specially designed for the person on gait parameters during cognitive and motor tasks.


Eligibility Criteria:
Inclusion Criteria:

* Between aged 25-60 years
* Diagnosed with MS for at least 5 years
* Relapsing and progressive MS according to Mc Donald criteria
* EDSS score of ≤ 3.5 ≤ 6
* Modified Ashworth Scale \< 3
* Being eligible to work by a neurologist

Exclusion Criteria:

* Having had an MS-related attack in the 3 months before the study
* Changes in medications within 6 months prior to the study
* To have participated in the rehabilitation program within 1 month before the study
* Serious neurological, cardiac, pulmonary, rheumatological, audiovisual, or orthopedic disorders that limit assessments and/or intervention programs
Study to Evaluate the Efficacy of Tetracycline in Epidermolysis Bullosa

Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4 months with tetracycline or placebo. After one month of wash out they will be treated for additional 4 m with placebo or tetracycline. The patients will be examined each month to estimate bulla formation,rate of healing .

Epidermolysis Bullosa(EB) is an inherited bullous disease. Tetracycline is believed to have anti inflammatory properties. 20 patients with EB older than 13 years will be treated for 4 months with tetracycline or placebo. After one month of wash out they will be treated for additional 4 m with placebo or tetracycline. The patients will be examined each month to estimate bulla formation,rate of healing .

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as epidermolysis bullosa
* not pregnant
* active disease
* more than 5 bulla-

Exclusion Criteria:

* age less than 13
* known sensitivity to tetracyclin
* abnormal liver and kidney tests.
ENTact™ Septal Stapler Shelf Life Extension

This study is a prospective, limited-use evaluation of the ENTact™ Septal Stapler for tissue approximation utilizing staples with extended shelf life. The ENTact™ Septal Stapler will be used to approximate the mucoperichondrial flaps in all patients. Each treatment group will be implanted with product that has been aged for a specified amount of time.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum.
* Patient is able to provide a signed informed consent form.
* Patient will agree to comply with all study related procedures.
* Subject is not pregnant at this time by confirmation of one of the following:

  * subject is male,
  * subject not of child bearing age,
  * subject is surgically sterile,
  * subject is not pregnant per negative hCG test.
* Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.

Exclusion Criteria:

* Patients who have had previous septoplasty
* Patients with uncontrolled diabetes
* Presence of infection at the study site
* Subject is a:

  * smoker,
  * severe drug abuser,
  * severe alcohol abuser.
* Patient with autoimmune disease deemed clinically significant by the Principal Investigator.
Improved Post-Transplant Cyclophosphamide Regimens for Pediatric Patients With Refractory AML

No more datas about post-transplant cyclophosphamide (PT/Cy) used in pediatric refractory acute myeloid leukemia (R-AML）patients. Investigators reasoned that this group of patients if they have been treated with ablative conditioning regimens for HSCT combined with PT/Cy, under the rapid of immune reconstitution will have better outcomes.

Haploidentical stem cell transplantation (HSCT) is a potentially curative therapy for patients with high risk or refractory acute myeloid leukemia (R-AML). Graft-versus-host disease （GVHD）is a major barrier to achieve success for patients with HSCT. High dose cyclophosphamide given after HLA-matched related and unrelated allogeneic stem cell transplantation for patients with hematologic malignancies is effective single agent (GVHD) prophylaxis in adults and in pediatric benign patients. Data describing outcomes for pediatric maligant patients has not been reported. Investigators have recruited 26 pediatric patients (3 years \< age \<18 years) between March 2015 to July 2018 with primary induction R-AML treated in investigators' institution for R-AML with modified myeloablative regimen, post-transplant cyclophosphamide (PTCy) has been used as GVHD prophylaxis.

Conditioning regimen of the group of patient consisted Idrabine(IDA,10mg/m2/day) which was administered intravenously for 2 days, from days -14 to -13, total body irritation (TBI, 9 Gy) which was divided into 3 fractions and 3 days from -12 to -10, thymoglobulin (2.5mg/kg/day) was administered for 3 days, from -9 to -7, etoposide (VP-16, 300mg/m2) which was infused intravenously on day -6, cladribine (10mg/m2/day) which was administered for 3 days from -5 to -2 .

Eligibility Criteria:
Inclusion Criteria:

-refractory AML

Exclusion Criteria:

- complete remission AML
Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients With Acute Renal Failure

OBJECTIVES: I. Determine the maximum tolerated dose and safety of alpha-melanocyte stimulating hormone (alpha-MSH) in patients with acute renal failure.

II. Determine the safety and pharmacokinetics of alpha-MSH in patients at high risk of acute renal failure after renal transplantation.

III. Determine the safety and pharmacokinetics of alpha-MSH in patients with established ischemic acute renal failure.

IV. Determine the effect of alpha-MSH on interleukin-10 pharmacokinetics.

PROTOCOL OUTLINE: This is a dose escalation, double blind, placebo controlled, multicenter study.

Group 1: Patients are infused with alpha-melanocyte stimulating hormone (alpha-MSH) or placebo over 5 minutes. A cohort of 5 patients is infused at each dose level of alpha-MSH until the minimum effective dose (MED) and the maximum tolerated dose (MTD) are determined.

Group 2: Patients receive a single dose of the MED of alpha-MSH IV over 5 minutes at the time anastomoses are complete. Other patients receive alpha-MSH at the MTD. Cohorts of 5 patients each are treated at the MED and the MTD.

Group 3: Patients receive alpha-MSH as in group 2. Additional dose levels are also tested.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Group 1: Patients on chronic hemodialysis

Group 2: Patients at high risk of developing acute renal failure (ARF) after cadaveric renal transplantation Received high risk allograft Cadaveric kidneys with greater than 24 hours of cold ischemia time Donor had rising creatinine before organ procurement Donor over 60 years

Group 3: Patients with ischemic ARF due to hypotension, surgery, or trauma ARF severity index 20-60% Creatinine clearance 12-14 mL/min Rising creatinine of at least 0.5 mg/dL per day for 2 days without evidence of recovery despite standard supportive care No drug or contrast induced renal failure No oliguric renal failure (creatinine clearance 3-4 mL/min) No prior chronic renal failure Baseline creatinine greater than 2.5 mg/dL (males) or 2.0 mg/dL (females) No ARF due to bacterial or fungal sepsis, nephrotoxins, acute tubulointerstitial nephritis, cyclosporine toxicity, bilateral renal vascular disease, or systemic diseases (hepatorenal syndrome, glomerulonephritis, renal vasculitis, etc.)

--Prior/Concurrent Therapy--

Group 1: No recent immunosuppressive therapy Group 2 and 3: No prior renal transplantation No prior alpha-MSH Group 3: No prior dialysis for this episode of ARF No anticipated need for dialysis for at least 24 hours At least 12 hours since prior diuretics, mannitol, or dopamine At least 14 days since prior immunosuppressive drugs

--Patient Characteristics--

No recent infection No known reaction to Terumo T175 dialyzer Not a prisoner Not pregnant or nursing No allergy to drugs used in study Not mentally impaired Group 3: No severe nonrenal medical condition that would interfere with the study (e.g., terminal cancer)
Change in Physical Activity Levels in Women at Working Place

The purpose of this study is to evaluate the impact of different types of intervention on physical activity level and co-morbidities in women workers aged between 40 and 50 years. Method: A total of 195 sedentary women aged between 40 and 50 years and those who agreed to participate were randomized to one of the following interventions: GI = Control (n = 47), GII = Individual counseling (n = 53), GIII = Counseling group (n = 48); GIV = physical training set (n = 47). Were evaluated: Physical Activity level (steps number evaluated by a pedometer), quality of life (SF-36), body composition (BMI, waist circumference and bioelectrical impedance) and clinical variables (plasma glucose and blood pressure).

Protocols and Randomization of subjects: Subjects were randomized into 4 groups: control group (GI), individual counseling (GII), group counseling (GIII) and aerobic training set (GIV). The protocols of interventions are described in detail below:

GI - Control: Comprising session of 15-20 minutes duration. It took place guidelines on physical activity, delivering a manual with general information about physical activity.

GII - Individual counseling: Consisting of three sessions within a maximum period of 3 months. We conducted a counseling, aimed at increasing physical activity, aiming to raise at least 2000 steps over the first week of monitoring. Furthermore, we discuss the importance of physical activity, such as overcoming barriers to physical activity and targets agreed between the parties. The pedometer is given along with a diary to record the number of steps and returned in the last session.

GIII - Group Counseling: The counseling was conducted in groups (10-12 individuals) for 6 sessions at weekly intervals, and two sessions with fortnightly. Each session lasts 60 minutes. The advice is aimed at behavioral changes using the following approaches: advantages and disadvantages of behavior change, how to overcome barriers to physical activity, self-monitoring of physical activity by using the pedometer and setting goals (number of steps / day) in the short term and what to do in case of relapse (not accomplish what was represented) besides livings practices. As the GII and the goal is to raise steps daily, with the main focus physical activity in leisure time and transport.

GIV - Programmed Aerobic Training: The fitness program is held two times per week with individuals and groups with three sessions lasts for 40 minutes performed on a treadmill.

All interventions lasted between 12 and 15 weeks and were carried out on time or before the commencement of work or during lunch or after work hours.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy (no serious chronic disease), sedentary (less than 60 minutes of aerobic physical activity per week scheduled), employees of HC / FMUSP aged between 40 and 50 years.

Exclusion Criteria:

* Perform some type of pharmacotherapy for weight reduction, have a BMI \> 45 kg/m2 and have functional limitations that would prohibit the execution of hiking.
Vascular EffectS of regUlar Cigarettes Versus electronIc Cigarette USe

The purpose of this study is to assess the effects of electronic cigarettes-nicotine and electronic cigarette-nicotine free on endothelial function as compared to traditional cigarettes. Due to ethical reasons, we cannot fully randomise all particpants to the three arms.

Participants who wish to quit smoking will be randomized to

1. Switch to electronic cigarettes containing nicotine plus flavor
2. Switch to electronic cigarettes containing flavor alone Those who do not wish to quit smoking will continue on the Tobacco Cigarette arm Treatment period will be 28 days

Electronic cigarettes (EC) are gaining popularity as an alternative to Traditional Cigarettes (TC). Despite not containing all the harmful substances seen in TC, EC are known to contain impurities that may have a detrimental impact on human health. The effects of ECs compared with TC on vascular function, inflammation and oxidative stress are unknown. It is increasingly recognised that nicotine itself has significant atherothrombotic effects. Therefore, clinicians are unable to confidently recommend ECs as a less risky alternative to TC.

Hypothesis: Endothelial function will be improved on EC compared to TC when measured by flow mediated dilatation (FMD).

Potential benefit: This study will provide further information on the potential use these devices and the risks and/or benefits associated with them, specifically in relation to vascular health.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and over
* Currently smoking ≥15 full strength tobacco cigarettes per day for at least 2 years, or roll-up tobacco equivalent (cigar or pipe smokers not included).
* Willing to stop tobacco cigarettes for period of study if required
* Willing not to use electronic cigarettes if required
* Able to give informed consent

Exclusion Criteria:

* Pregnant or lactating.
* Women of childbearing potential who do not abstain from sex or use effective contraception.
* On current prescribed medication for cardiovascular disease.
* History of cardiovascular disease (excluding hypertension), diabetes, active malignance or chronic renal disease.
* Nut allergy
* Participation in another clinical trial (other than observational trials and registries) with an investigational product and/or intervention within 30 days before visit 1.
Peppermint Inhalation Versus Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia

Clinical trials was used to compare the effect of peppermint inhalation and Swedish massage on chemotherapy induced-nausea and vomiting in children with leukemia. the main research hypotheses are:

* Children with leukemia who receive peppermint inhalation exhibit less chemotherapy induced- nausea and vomiting than those who don't receive.
* Children with leukemia who receive Swedish massage exhibit less chemotherapy induced-nausea and vomiting than those who don't receive.
* Children with leukemia who receive Swedish massage exhibit less chemotherapy induced- nausea and vomiting than those who receive peppermint inhalation. children divided into three groups of study ( control group, peppermint inhalation group and Swedish massage group) to identify its effect on chemotherapy induced nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Received first chemotherapy session
* Intact skin in the massage

Exclusion Criteria:

* Chronic and acute disorders such as respiratory, cardiovascular diseases...etc.
* Allergy from any essential oils.
Chinese Hospital Acquired Pneumonia Collaboration Network: Epidemiology, Diagnosis and Treatment

The goal of this prospective and observatory study is to learn about the pathogen, clinical manifestations, prognosis, treatment and antibiotic resistance of bacteria in hospital-acquired pneumonia patients in China.

The main purposes of this study are:

1. clarify the regional differences and changes over time in the pathogen spectrum and antibiotic resistance rate among HAP patients in China;
2. build a continuously optimized nationwide HAP pathogen and antibiotic resistance surveillance network;
3. identify the molecular epidemiology of common pathogens


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old.
2. Meets the clinical diagnostic criteria for HAP in the 2018 HAP/VAP guidelines. Chest X-ray or CT shows new or progressive infiltrative shadows, consolidation shadows, or ground glass shadows, combined with 2 or more of the following 3 clinical symptoms, to establish a clinical diagnosis: 1) Fever, body temperature\>38 ℃; 2) Purulent airway secretions; 3) Peripheral blood white blood cell count \>10 × 10\^9/L or \<4 × 10\^9/L.
3. Having qualified evidence of responsible pathogen. On the basis of clinical diagnosis, one of the following conditions should be met simultaneously: 1) Qualified lower respiratory tract secretions (neutrophil count \>25/low magnification field, epithelial cell count \<10/low magnification field, or a ratio of the two \>2.5:1), pathogenic bacteria cultured through bronchoscopy anti pollution brush (PSB), bronchoalveolar lavage fluid (BALF), lung tissue or sterile body fluid, and consistent with clinical manifestations; 2) Pathology, cytopathology, or direct microscopic examination of lung tissue specimens showing fungi and evidence of tissue damage; 3) The serum IgM antibodies of atypical pathogens or viruses change from negative to positive, or the titers of specific IgG antibodies in both acute and recovery phases show a 4-fold or more change. During the outbreak of respiratory viruses and with a history of epidemiological contact, respiratory secretions were tested positive for corresponding virus antigens, nucleic acid tests, or virus culture.
4. obtained informed consent

Exclusion Criteria:

1. Those who cannot understand and execute the investigation plan.
2. Active pulmonary tuberculosis;
3. Severely immunosuppressed patients: absolute neutrophil count \<0.5× 10\^9/L, CD4\<200/ml.