cyrilzakka/clinical-trials huggingface dataset:
Turkish Version of Kids BESTest, Validity and Reliability for School-Aged Children

The aim of this study is to present the Turkish version of Kids-BESTest and Kids-Mini-BESTest and practice of validity and reliability on school-aged children will be performed by utilizing the Turkish version of Kids-BESTest and Kids-Mini-BESTest in this study.

Postural control is the ability to control the body position in space for the purpose of postural stability.

Full-Balance Evaluation Systems Test (BESTest) comprises 36 items and evaluate all components of postural control. Full-BESTest classifies postural control across six domains as: Biomechanical constraints, Stability Limits/Verticality, Transitions - Anticipatory Postural Adjustment, Reactive Postural Response, Sensory Orientation and Stability in Gait. Items in each domain are scored from 0 (worst performance) to 3 (best performance), all requires 30 minutes (maximum score is 108).

Because of the clinical time limits, MiniBESTest is a shortened version of BESTest was developed with 14 tasks. MiniBESTest still addresses almost all components of postural control and can be performed 15 min. MiniBESTest is one of the most common methods practiced for adult patients. Recently BESTest and miniBESTest had modified by Dewar et al for 8-14 aged children which termed Kids-BESTest and Kids-Mini-BESTest.

The aim of this study is to present the Turkish version of Kids-BESTest and Kids-Mini-BESTest and practice of validity and reliability on school-aged children will be performed by utilizing the Turkish version of Kids-BESTest and Kids-Mini-BESTest in this study.

Eligibility Criteria:
Inclusion Criteria:

* Typical developing school-aged children who are volunteers.

Exclusion Criteria:

* Has medical or behavioural disorders
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes

The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers. The warmers are commonly used with both the supplied blankets and also with hospital blankets.

Subjects receiving standard care will not benefit from this study. Subjects in the investigational group may benefit in several ways:

* Increased comfort in the pre-operative period by being warmer
* Decreased incidence of mild hypothermia
* Possible decreased incidence of transfusion with less bleeding
* Possible decreased pain and discomfort in the Post-Anesthesia Care Unit (PACU)
* Possible shorter stay in the PACU and overall Length of Stay (LOS)
* Possible decreased risk for surgical site infection


Eligibility Criteria:
Inclusion Criteria:

* Elective or "urgent" surgery under general anesthesia
* ≥19 years but ≤85 years of age
* Able to provide informed consent.

Exclusion Criteria:

* Refusal of Informed consent
* Metabolic derangement/drug therapy already affecting thermal homeostasis
* Preexisting hypothermia (\<35.5 degreeC) or hyperthermia (\>37.5 degreeC) (oral)
* Surgical procedure anticipated to be longer than 6 hours or less than 1 hour
* Emergency (category 1a) Surgery
* Patients undergoing exclusively spinal or epidural anesthesia
* Patients receiving aortic cross-clamping
* Patients receiving transdermal medications
Myotubular Myopathy Event Study

X-Linked myotubular myopathy (XLMTM), a form of centronuclear myopathy (CNM) is the result of a mutation in the MTM1 (myotubularin) gene which leads to altered myotubularin. Myotubularin is essential for optimum muscle function. To date, over 100 mutations have been described resulting in a range of disease onset and symptom severity. The early onset form presents with neonatal hypotonia, muscle weakness, respiratory distress and an ongoing requirement for continuous ventilatory support with the inability to maintain a sitting position once placed. Males with both later onset and milder symptoms usually do not require ongoing ventilatory support, achieve a higher maximal motor function with ability to sit when placed and even walk, and have improved survival rates. Males with XLMTM may experience complications (events) at birth and throughout their lifetime. The goal of the study is to identify the number of events over twelve months in males with genetically confirmed XLMTM. Parents or affected individuals over the age of 18 years who are able to access telephone will provide answers to an established event survey to evaluate the frequency and types of events. Emergency department, hospital admissions and mortality will be confirmed by obtaining medical reports.

The investigators hypothesize that there will be no association between the frequency of events and markers of clinical severity including the need for ventilatory support at birth, current level of ventilatory support (no support, support less than 12 hours, support more than 12 hours) and current motor function (walking, sitting without support, inability to sit without support).


Eligibility Criteria:
Inclusion Criteria:

* males with a confirmed MTM1 mutation OR
* males with a muscle biopsy consistent with myotubular myopathy AND family history consistent with X-linked inheritance AND
* English-speaking parent/guardian of a living male child or a decisionally impaired adult OR English-speaking affected male over 18 years of age who can access telephone
* signed study consent
* enrolled in the Congenital Muscle Disease International Registry (CMDIR)

Exclusion Criteria:

* males with only a clinical diagnosis of XLMTM but without family history of XLMTM
* an affected male who has a genetically confirmed form of centronuclear myopathy (CNM) that is not caused by a mutation in the MTM1 gene
* females with MTM1 due to the limited number of females affected and the variability of clinical presentation
Home-based Pulmonary Rehabilitation With Remote Monitoring in Pulmonary Arterial Hypertension

The purpose of this study is to test new technology and health coaching aimed to help people with PAH become more physically active in their daily lives.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PAH, confirmed by right heart catheterization (mean pulmonary artery pressure of 20 mmHg or greater, pulmonary vascular resistance of 3.0 Woods units or greater, Pulmonary capillary wedge pressure of 15 mmHg or lower).
* On PAH-specific therapy which is at stable dosing (i.e., not currently titrating therapy).
* NYHA class II-III symptoms.
* Able to complete a six-minute walk test.

Exclusion Criteria:

* Patients experiencing syncope or exertional syncope.
* Patients not experiencing exertional dyspnea.
* Inability to walk.
* Patients currently in pulmonary rehab or having completed pulmonary rehab within three months (unlikely to improve).
SDH of HPV Vaccine Completion

The purpose of this research study is to find out which factors influence parents' ability to complete the human papillomavirus (HPV) vaccine series for their child. The information learned from this study may help the investigators develop programs to improve HPV vaccine completion rates among adolescents and reduce barriers to receiving the second shot of the vaccine series.


Eligibility Criteria:
Inclusion Criteria:

* For adolescents, participants need to be between the ages 11 to 14 years.
* Received 1 dose of the HPV vaccine series between January 2017 and December 2017.
* For parents, there is no age limit required.
* Parents as defined as the adolescent's biological mother or father, step-parents, or legal guardian.
* Parents or legal guardians who self-identified as the primary caregiver of the adolescent child and most likely to make medical decisions for the adolescent.

Exclusion Criteria:

* Parents with cognitive impairment.
* Adolescents with cognitive impairment.
* Adolescents emancipated from their parents or legal guardian
* Pregnant adolescent girls.
Prediction Tool for Premature Labour and Neonatal Outcome

A register and prediction model will be developed to predict the outcome of preterm labour and birth.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children

Exclusion Criteria:

* Patients who choose not to participate in the research.
* Intra-uterine prelabour fetal death.
* Fetuses or neonates with a major congenital disorder. Major is defined as a disorder that has an impact on neonatal respiratory and cerebral outcome and/or long-term outcome.
* Postpartum transfer/outborn.
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, IncobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study investigated the efficacy and safety of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar frown lines compared to placebo. The study consisted of a Main Period and an Open-Label Extension \[OLEX\] Period of 120 days each.


Eligibility Criteria:
Inclusion Criteria:

•Moderate to severe glabellar frown lines

Exclusion Criteria:

* Previous insertion of permanent material in the glabellar area
* Neuromuscular function disease
An Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety

The purpose of this observational study is to evaluate patients who are planning to administer sugammadex after rocuronium or vecuronium is used.

The main questions it aims to answer are:

1. Prescription pattern of sugammadex
2. Effectiveness and safety of sugammadex

Since this study is observational, only data generated under daily treatment are to be collected, and no additional tests or drug administration is conducted for the study. The patients are observed from baseline to 24 hours after the initial administration of sugammadex.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged 19 or older
* Is to undergo elective surgery under general anesthesia
* Is planned to use rocuronium or vecuronium as an NMBA
* Is planned for extubation before/after being moved to the recovery room
* ASA physical status I - III
* Patients who have signed the informed consent after receiving information about the purpose and method of this study

Exclusion Criteria:

* Has myasthenia gravis or Eaton-Lambert myasthenic syndrome
* Has hypersensitivity to ingredients of sugammadex, rocuronium, or vecuronium
* Has received an investigational product within 12 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study.
* Other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.
Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study

Inadequate management of preoperative mental health disorders often contributes to poor postoperative outcomes, including increased rates of readmission, delirium, falls, and mortality. However, very little work has been done to improve perioperative mental health. In particular, there have been limited systematic efforts that identify evidence-based behavioral and pharmacological strategies that were originally developed for depression and anxiety in otherwise medically well psychiatric patients. A mental health intervention bundle, composed of behavioral and pharmacological strategies, can mitigate anxiety and depression symptoms during the perioperative period. However, lacking is conclusive evidence on effectiveness of such an intervention bundle focused on the delivery of perioperative mental health care in older surgical patients. Towards this end, the investigators will develop and test an intervention bundle that encompasses: (1) behavioral activation, and (2) medication optimization.

The proposed research is relevant to public health because the prevalence of undertreated depression/anxiety in older adults coupled with the increasing number of surgeries performed in this population are creating a crucial need for the integration of mental health interventions into critical periods, such as the perioperative period. Thus, the proposed research is relevant to the mission of the NIMH to transform the treatment of mental illnesses through clinical research, paving the way for prevention, recovery, and cure.

Eligibility Criteria:
Inclusion Criteria Patient Participants

* Age ≥60 years on the day of surgery;
* Scheduled major orthopedic surgery, or major surgical resection of a thoracic or abdominal malignancy, or major cardiac procedure;
* Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10

Exclusion Criteria Patient Participants

* Estimated life expectancy \< 12 months;
* Unable to read, speak, and understand English;
* Current alcohol or other substance abuse;
* Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10;
* Acutely suicidal
Infants Colics : Towards a Migrainous Origin ?

According to recent studies, we want to find evidences that infant colics could be a episodic symptom associated to migraine as cyclic vomiting syndrome or abdominal migraine are. The main purpose is to compare the presence of colics in infants between 60 days and 180 days of life and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents.

Recent studies shows that :

* Infants with colics have more probability to become migrainous when they will grow up
* Migrainous children have more colic history in their past
* Migrainous parents have more babies with colics than non-migrainous parents

According to these studies, we want to find othen evidences that infant colics could be a migraine equivalent as cyclic vomiting syndrome or abdominal migraine are. Recently, the international classification of headache disease IIIbeta added in its appendix colics in the episodic symptoms associated to migraine

The main purpose of our study in the pediatric emergency unit of Nancy is to compare the presence of colics in infants and the presence of migraine in their parents to determine if colicky children's parents are more migrainous than other parents. The data collection will be made thanks to a survey which will be completed by the parents.

Eligibility Criteria:
Inclusion Criteria:

* All infants between 60 days and 180 days of life who comes to the Nancy University Hospital pediatric emergency unit

Exclusion Criteria:

* Language barrier of parents
Performance of Continuous Glucose Monitoring Systems at Altitude

10 healthy volunteers will undergo the controlled lowering of their blood glucose level at sea level and a simulated altitude of 8,000 feet, to test the hypothesis that continuous glucose monitoring system measurement of blood glucose is as accurate at altitude as at sea level.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 60 years.
* No known medical conditions or concomitant medication.

Exclusion Criteria:

* Pregnancy.
* Marine diving in preceding 24 hours.
* Unable to provide written informed consent.
Sebum Collection and Skin Barrier Function Analysis

The goal is this study is to evaluate how the skin surface lipid composition is correlated with overall sebum production, barrier function, and inflammatory disease status. We hypothesize that there will be differences in the skin surface composition among subjects of various groups:

1. Young vs older healthy population
2. Atopic dermatitis vs Acne vs Healthy controls
3. Active smokers vs non-smoker controls

This study will be conducted through the use of painless tapes to collect lipid. These will be applied to the skin and removed. Secondly, the barrier function will be evaluated through the use of non-invasive painless devices that measure sebum, skin water loss, and skin hydration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that are 12 years of age or older

Exclusion Criteria:

* None
A Phase IV Study of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver

An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. Those who meet the diagnostic criteria of non-alcoholic simple fatty liver and traditional chinese medicine syndrome classification of damp-heat obstruction syndrome;
3. Voluntarily sign informed consent;
4. Liver-to-spleen CT ratio \< 1.0; The imaging findings of liver were consistent with the diagnostic criteria of diffuse fatty liver;
5. HbA1c≤6.5%；ALT、AST、TBil≤2×ULN；GFR≥60（ml/min/1.73m2）.

Exclusion Criteria:

1. Fatty liver caused by chronic heart failure, malnutrition and pregnancy, encephalopathy fatty liver syndrome (Reye syndrome), B-lipoprotein deficiency, localized fatty liver; Fatty liver caused by diabetes, long-term use of hormones, enteritis, gastrointestinal postoperative chronic infection, etc.; Small intestinal bypass surgery, hepatocyte toxicity injury, chronic febrile diseases such as tuberculosis, ulcerative nodules;
2. Severe fatty liver with ascites, edema, hyponatremia and other suspected cirrhosis; Hepatitis or cirrhosis caused by viruses, drug poisoning, immune diseases and other factors;
3. Pregnant and lactating women, women of childbearing age who do not take effective contraceptive measures (such as condoms, hormonal contraceptives, intrauterine devices) or male subjects who do not want to use contraception;；
4. Patient with serious primary cardiovascular disease, kidney disease and other serious diseases that affect survival;
5. Patient with a history of cancer;
6. Patient with HCV antibody, HIV antibody positive or HBsAg positive and HBV-DNA titer positive;
7. Have a history of alcohol abuse (alcohol equivalent male≥30g/d, female ≥20g/d) or drug abuse；
8. Allergic to the components of this drug；；
9. Those who participated in other clinical investigators within 3 months prior to screening;
10. Those who with a history of diabetes；
11. Patients who had used the same traditional Chinese medicine for the treatment of non-alcoholic simple fatty liver within 2 weeks before screening (except experimental drugs);
12. The investigators consider she/he inappropriate to participate in this study.
The Establishment of Large-sample Database of "Multiple-MRI/Gene/Cognition"

Aim to establish a large-sample database of "Multiple-MRI/Gene/Cognition" for healthy Chinese (sample number, 5000; age, 6-70 years). This is a fundamental but very necessary work for future researches such as development, aging, relation of gene and behavior, relation of gene and neuroimaging, relation of behavior and neuroimaging. Importantly, this work will provide a norm for researches on psychological or neurological patients. This large-sample will be shared with world-wide researchers.

A part of data have been used in a publication which is preparing to submit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese
* Age: 6-70 years old
* Right handed
* No smoking or alcoholic addiction

Exclusion Criteria:

* Psychological or neurological patients
* Hypertension or cardiopathy patients
* Pregnant woman
* Take medicine or drink tea/coffee before scanning-
Photoprotection Habits in Patients With Vitiligo

Intro:

Patients with vitiligo have a reduced protection on depigmented areas. To date, however, little is known about photoprotection habits in patients with vitiligo even though these patients are thought to have a decreased ability to efficiently protect their skin against sun damage. Moreover, exposure to artificial UV is one of the major elements of the treatment of vitiligo even though certain phenotypes of vitiligo could be photoinduced.

Hypothesis The Primary objective is to describe patients behaviour with sun exposition

The Secondary objectives are:

* to assess the link between sun exposition and vitiligo outbreaks
* to assess photoprotection habits according to initial phototype and vitiligo severity (SA-VES)
* To validate a short form of the VIPs questionnaire, a validated burden questionnaire.

Method We aim to conduct a prospective cross sectional study in patients with Vitiligo with the aim to evaluate sun protection habits in patients with vitiligo. For that purpose a semi-directed questionnaire to investigate the sun protection behavior of vitiligo patients (adults\> 18 years of age) have been created by experts in the field. Vitiligo severity will be self-assessed by patients using a recently validated patient reported outcome, the SA-VES. Consecutive vitiligo patients consulting in the dermatology department of Henri Mondor Hospital (Créteil, France) will be proposed to participate the study after having given their oral consent. We are planning to enrol 500 patients.

In a first step, a descriptive analysis will be carried out in order to describe the characteristics of the sample. Basic summary statistics, such as proportions, means and standard deviations, will be used to characterize the population. In order to identify the factors associated with the severity of the disease on the one hand and the phototype on the other, comparisons between groups (severe versus non-severe and light phototype versus dark phototype) will be carried out by unconditional logistic regression. All potential predictors of severity will first be assessed individually, and Odds Ratio (OR), corresponding 95% CIs and P values will be calculated. The significance of the OR will be determined by the Wald test χ2, and the predictors with P \<.20 will then be evaluated using a multivariate analysis with a pre-selection procedure. Possible interactions and multi-colinearity will be examined. Finally, the quality of fit of the final model will be evaluated using the logistic regression diagnostic procedure. P ≤ 0.05 will be considered as statistically significant. The Hosmer-Lemeshow test will be carried out to test the suitability of the model.

Conclusion This study will help to identify gaps in the knowledge of sun protection habits in patients with vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 y.o
* Men or women with Vitiligo

Exclusion Criteria:

* Oral or written opposition expressed by patient
* Patient under tutorship or curatorship
* cognitive dysfunction making communication or questionnaire filling impossible
Metabolic Effects of One-weak Heavy Drinking

Examination of the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Metabolic effects of intermittent unhealthy lifestyle in otherwise young healthy adults are poorly studied. The investigators evaluated the effect of one week's unhealthy lifestyle on glucose metabolism and liver parameters in a group of young, healthy males participating in Roskilde Festival 2016.

Festival participants were studied before and after participation (one week) in Roskilde Festival 2016 and matched with controls who lead a normal life for an equivalent period of time. An oral glucose tolerance test (OGTT), abdominal ultrasound and strain elastography for liver stiffness were performed together with a bioimpedance scan and cognitive tests.

Eligibility Criteria:
Inclusion Criteria:

* BMI of 18,5-25 kg/m2
* Normal liver function (assessed by ASAT, ALAT, GGT, alkaline phosphatase, albumin and bilirubin, coagulation factors II, VII and X, INR and platelets)

Exclusion Criteria:

* Planning alcohol withdrawal or dieting/a special low-fat diet during Roskilde Festival
* Diabetes or pre-diabetes
* First degree relatives with diabetes
* Kidney disease (eGFT\<60 ml/min and/or albuminuria)
* Chronic diseases (in addition to those already mentioned) that could affect participation in festival activities (concerts and parties)
* Any condition in which the investigator believed would make it impossible to participate