cyrilzakka/clinical-trials huggingface dataset:
Buzzy Plus EMLA Cream for Vascular Access in Children

Venepuncture and peripheral intravenous cannulation are commonly performed in children and may cause substantial pain and distress. The aim of this study is to evaluate the efficacy of the combination of EMLA cream and Buzzy device in pain and distress relief during venipuncture or peripheral vascular access in hospitalized children.

The study is an open randomized controlled study. Eligible children will be randomized to receive the application of EMLA cream 60 minutes before the needle procedure or the application of EMLA 60 minutes before the procedure and the use of Buzzy device during procedure.

The primary study outcome will be the mean distress score experienced by children at the moment of the procedure, evaluated with the CEMS scale. Secondary outcomes will be the mean distress score recorded by operators; the self-reported mean pain score; the mean pain score reported by parents and operators.


Eligibility Criteria:
Inclusion Criteria:

* children between 4 and 12yrs of age needing venipuncture or peripheral vascular access
* children who have applied EMLA cream at least 60 minutes before the procedure

Exclusion Criteria:

* children with cognitive impairment
* children with skin lesion that does not allow the application of Buzzy device
* children diseases that cause hypersensibility to cold (i.e. Raynaud syndrome, sickle cell disease)
* children who have taken any analgesics in the 8 hours before enrollment
A Study to Determine Preferences Towards Interface Products

Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days documented.


Eligibility Criteria:
Inclusion Criteria:

* Adult Volunteers (ages 21-85)
* Willing and able to provide informed consent
* Able to follow instructions
* Able to read and speak in English as their primary language
* Currently diagnosed with Sleep Apnea through an in-lab sleep (polysomnography (PSG)) or home sleep testing, but has not started therapy and/or been fit with a mask.

Exclusion Criteria:

* Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, cribriform plate abnormalities, and prior history of head trauma that has resulted in current cognitive dysfunction.
* Prescribed an Adaptive Servo Ventilation (ASV) device
* The presence of physical or mental limitations that would limit the ability to test the mask.
* Obstructive Sleep Apnea (OSA) diagnosis achieved through a split night sleep study
* Known allergy to silicone
* Unique facial features (i.e. deformities of the face and/or head, piercings, etc) that could interfere with the use of masks.
* Employee of Philips or spouse of a Philips employee
* Currently participating in another interventional research study or planned participation in another interventional research study during the trial period (by self-report)
* Surgery involving the eyes, ears, nose, sinuses, or upper airway within the last 90 days.
* Planned surgical procedures involving the head, neck, face (eyes, ears, nose), or lung during the trial period.
* Uncontrolled or poorly managed gastroesophageal reflux
* Impaired cough reflex
* Untreated or symptomatic hiatal hernia
* Untreated glaucoma
* Untreated chronic dry eyes
* Unable to remove the sleep apnea mask without the assistance of others
* Use of prescription drugs that induce vomiting
Doctors' Understanding of Survival Statistics

The probably most commonly used measure for expressing the pay-offs of early detection and treatment are survival rates. Yet, over time and groups this metric comes with several biases and thus, is not reliable for judging such benefits. Epidemiologists recommend using reduction of disease-specific mortality rates instead, which is unbiased. The purpose of the study is to investigate how primary care physicians understand and use different survival measures for determining the benefit of cancer screening tests.


Eligibility Criteria:
Inclusion Criteria:

* primary care physicians (internal, general, and family medicine physicians)

Exclusion Criteria:

* all other types of physicians
Effects of High-intensity Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke.

Stroke is one of the major cause of morbidity and mortality and the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen.

The purpose of this study is to Determine the effect of high intensity speed based treadmill training on Balance, Walking capacity and quality of life in sub-acute stroke.


Eligibility Criteria:
Inclusion Criteria:

* age 40-80 years; first episode of stroke; \>4 weeks of stroke onset; hemiparesis resulting from unilateral ischaemic stroke; Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively; mini-mental state examination score ≥23; ability to perform independent walking for at least five minutes with or without an assistive device (FAC=3). All patients will be determined to be in stable cardiovascular condition with a low although slightly greater risk for vigorous exercise than for apparently healthy persons (class B according to the American College of Sports Medicine \[ACSM\]).13

Exclusion Criteria:

* Participants will be excluded from the study if they had any of the following: (1) chronic cardiorespiratory or metabolic diseases; (2) severe osteoporosis; and (3) lesions pertaining to the brainstem or cerebellum; (4) having resting blood pressure above 160/100 mmHg even after taking medications; (5) cardiovascular comorbidity (aortic stenosis, depression of ST-segment, heart failure, arrhythmias, unstable angina, hypertrophic cardio-myopathy); (6) transient ischemic attack; (7) by-pass surgery in the recent three months; and (8) other musculoskeletal problems that prevented the participants from doing aerobic activity.
Comparison of the Severity of Coronary Atherosclerosis With Tissue Compliance in Patients Within First Degree Relatives

This study research the similarity of coronary artery lesions according to HLA tissue compatibility in fisrt degree relatives of the patients who just admitted clinic as Acute coronary syndrome and underwent angiyography before .

Coronary artery disease (CAD), which is mainly caused by atherosclerosis, is the most prevalent illness and the leading cause of death worldwide. Increasing evidence suggests that inflammation plays a primordial role in atherogenesis and is closely associated with the major histocompatibility complex (MHC) (human leukocyte antigen \[HLA\] in humans) molecules. HLA genes are located in 6p21.3, the proteins encoded by these HLA genes have a major role to play in antigen presentation and inflammatory pathways. HLA involvement in inflammation is mainly associated with the HLA-dependent activation of T cells. studies reported that the susceptibility to CAD is related with the polymorphisms in HLA-DRB1. The above evidence indicates that the polymorphisms in HLA class II are associated with the risk of CAD . This study research investigate three objects , firstly what is the similarity of the coronary artery lesions according to the compatability of HLA alleles between the first degree relatives who went angiography before , secondly is there any relation between HLA subtype allels and the coronary artery (RCA ?LAD ? ,CX? and can such a relation be responsible from the lesions in this artery ,finally is there any relation between HLA subtypes and turkish race coronary artery disease

Eligibility Criteria:
Inclusion Criteria:

* male or female with age between 18-70
* hospital admission due to acute coronary syndrome with first degree relative history who had coronary angiyography before

Exclusion Criteria:

* first degree relative without any angiyography history before for patients who admitted as acute coronary syndrome
Dietary Intervention in Type-2 Diabetes and Pre-Diabetes

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome.

Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.

Eligibility Criteria:
Inclusion Criteria:

Body weight/Diabetes:

* Diagnosis of type-2 diabetes with BMI \> 25 (without end-organ failure)
* Fasting glucose \>126 mg/dL or HbA1c \>6.5

Body weight/ Pre-diabetes:

• Diagnosis of metabolic syndrome with BMI \>30 and HbA1c \> 5.6 (note: this does not apply to usual care control subjects)

Ethnicity: all ethnic groups

Exclusion Criteria:

* BMI \<30 without diagnosis of Type-2 diabetes, metabolic syndrome
* Type 1 diabetes
* History of keto-acidosis
* History of MI, stroke, angina, coronary insufficiency within the last 6 months
* Diabetic retinopathy requiring treatment
* Creatinine \> 2.0
* Urinary albumin \> 1 g/d
* Impaired hepatic function (Bilirubin \>2, Albumin \< 3.5)
* Cholelithiasis or biliary dysfunction
* Cancer requiring treatment in the past 5 years, with the exception of non-melanoma skin cancer
* Chronic infectious disease requiring ongoing treatment
* Other chronic diseases or condition likely to limit lifespan to \<6 years
* Non-English speaking
* Unable or unwilling to participate in group sessions (e.g., plans to relocate within the next year) or conform to a carbohydrate restricted diet lifestyle (e.g., food intolerances, religious or personal restrictions)
* Weight loss of \>10% in past 6 months
* Currently pregnant or nursing, or planning to become pregnant during the study
* Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) currently uncontrolled
* Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week
Effect of Amino Acids and Sugar Alcohols on Gastric Emptying and Release of Satiation Peptides in Humans

With this study the investigators investigate the effects of amino acids (tryptophan in two different concentrations, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* Healthy normal weight subjects with a body-mass index of 19.0-24.9
* Healthy obese subjects with a body-mass index of \> 30
* Normal eating habits (no diets; no dietary changes; no special dietary habits, such as vegetarian/vegan)
* Age 18-40 years
* Stable body weight for at least three months

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness
* History of gastrointestinal disorders
* Food allergies
* Pregnancy, breast feeding
Assessment of Needs of Moisturizers After Various Laser Treatments

Assessment of needs of moisturizers after various laser treatments

The investigators would like to assess of needs of moisturizers after various laser treatment

: by investigating the changes in the skin barrier function after fractional carbon dioxide laser and fractional Er:Glass laser in mice and human skin

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age without any dermatologic diseases

Exclusion Criteria:

* Taking other known dermatologic disease
* Others who are shown pigmented lesion on treated-area
* Who have allergy or history of hypersensitivity reaction to moisturizers
* Who have other definitive cutaneous findings
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in dyslipidemic patients including familial hypercholesterolemia and severe hypertriglyceridemia.


Eligibility Criteria:
Inclusion Criteria:

* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* On a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study
* Normal electrocardiogram (ECG) at Screening

Exclusion Criteria:

* Clinically significant health concerns
* Regular use of alcohol within one month prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
* Recent use of illicit drugs
* Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)

NOTE: additional inclusion/exclusion criteria may apply, per protocol
Effect of Playful Cognitive-motor Mobility Training on Balance, Gait and Cognition and on the Prevention of Falls in Seniors

Falls in the elderly are the cause of considerable morbidity and mortality and constitute a public health problem with more than 9000 deaths in France among the over 65s following an accidental fall. Many scientific data suggest that regular physical activity has significant and long-lasting beneficial effects on the health of the elderly and is associated with better functional status, a lower risk of falls and improved cognitive functions. However, the attraction to physical activity fades over the years and the reasons mentioned by the elderly for a low practice of physical activity are multiple, the main one being the worsening of their state of health.

The objective of this study is therefore to evaluate the impact of playful, motivating mobility training, stimulating both mobility and cognition, for 8 weeks, on the balance and mobility of elderly people in EHPAD, in particular in conditions of dual-task well known to be at high risk of falling, as well as on the prevention of falls.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged over 60, residing in nursing homes
* Subjects able to walk 15 meters unaided
* MMSE \> 10
* Visual acuity in both eyes \> 6/10
* Affiliated subject or beneficiary of a social security scheme
* Subject having given and signed an informed consent to participate in the study, or his/her guardian
* Subject having a sedentary activity or practicing a usual light to moderate physical activity (physical activities \< 6 METs)

Exclusion Criteria:

* Subject with a parkinsonian syndrome, any impairment of the motor neuron, pain limiting the practice of physical activity
* Subject with a modification of less than 3 months of psychotropic drugs
* Subject practicing high intensity physical activity (\> 6 METs)
A Prospective Cohort Study of Aged People for Chronic Diseases

This study is a hospital-based, prospective cohort study to elucidate the predictive factors including muscle and fat mass for chronic diseases and mortality in elderly persons aged 60 years and older.

This study is a hospital-based, prospective cohort study to elucidate the predictive factors among anthropometric and biochemical parameters and body composition information for chronic diseases including diabetes mellitus, myocardial infarction, stroke, osteoporosis, fracture, and cognitive dysfunction, and mortality in elderly persons aged 60 years and older.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years and older
* Capable of communication with the research team
* Provided written informed consent

Exclusion Criteria:

* Age \< 60 years
* active malignancy
* uncompensated liver cirrhosis
* ESRD
* severe cognitive impairment which cannot communicate with the research term
Hepatic Hemodynamic Changes and Simulation in Living-Related Liver Transplantation

This 1-year project is intended to study the hemodynamic changes of poratal and hepatic artery during living related liver transplantation. We hypothesize that after right hepatectomy for living related liver transplatation, portal vein overflow will change the remnant liver contour and result in liver hyperplasia.

We use CT as tools to reconstruct 3D images of portal vein and hepatic artery before and one month after operation. The images are transferred to CAD and computer simulation is performed.

Eligibility Criteria:
Inclusion Criteria: - Informed adult-to adult living donor underwent right lobectomy

Exclusion Criteria:

* no written informed contents
OASIS: Peer Support for T2DM in Appalachia (Peer Participant)

The goal of this clinical trial is to compare the effects of peer coaching models in older adults with unmanaged type two diabetes. The main questions it aims to answer are:

Are peer coaching models effective at promoting Type 2 Diabetes Mellitus self-management?

If effective, which facets of the peer model are most effective? Peer coaches will Undergo peer coach training.

Reach out to peer participants on a weekly/biweekly time frame to discuss self-management and goal setting.

Retain records of contact, topics discussed, and general notes on interactions. Researchers will compare differences in the frequency of contact, as well as how peer coaches were matched to peer participants to see if efficacy of the intervention is altered between groups.

The Older Adults using Social Support to Improve Self-Care (OASIS) intervention is an asset-based approach, utilizing the unique social structure existing in Kentucky's rural Appalachian communities to address self-care behaviors as they relate to Type 2 Diabetes Mellitus (T2DM) management. The intervention will be composed of two groups: peer coaches who have managed T2DM (HbA1c \< 7.5%), and peer participants who have unmanaged T2DM (HbA1c\> 7.5%). Peer coaches will undergo training prior to intervention initiation to develop coaching skills. Peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. In addition to evaluating the effectiveness of a peer coaching model, the four groups will be evaluated allowing for a more detailed understanding of factors that influence self-care behaviors. Stakeholders will also be engaged at three time points: prior to the intervention, study mid-point, and at study conclusion. At study conclusion, a small cohort of both peer participants and peer coaches will be invited to contribute to stakeholder group interviews. Information exchange with stakeholders will aid in developing a robust understanding of influential factors and how to effectively promulgate the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 55 years
* Resident in Rural Kentucky
* Positive Diagnosis of Type 2 Diabetes Mellitus
* HbA1c greater than or equal to 7.5%
* Passing score on cognitive assessment administered by study personnel
* English Speaking

Exclusion Criteria:

* Age less than 55 years
* Not a resident of a Rural Kentucky County
* No Type 2 Diabetes Mellitus Diagnosis
* HbA1c under 7.5%
* Cognitive Impairment
* Non-english speaking
Effects of Social Isolation From Coronavirus; on Physical Activity, Quality of Life and Stress

The aim of our study is to investigate the physical activity, quality of life and stress levels of individuals living in their homes isolated due to coronavirus (COVID-19) disease. The last three sections of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Parameters such as housework, home care and family care, rest, sports and leisure physical activities, sitting time will be evaluated. Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. Beck Depression Scale will be applied to investigate the stress levels of the individuals participating in our study.

Coronaviruses (CoV) make up a large family of viruses found in nature. The first CoV of this decade called 2019-nCoV originated in Wuhan, China. On January 30, 2020, the "International Public Health Emergency" was declared by the World Health Organization (WHO). As of February 11, 2020, the data of the World Health Organization (WHO) reported more than 43,000 confirmed cases in 28 countries. As of March 19, 2020, 2019-nCoV reported more than 150 countries, 209,839 cases and 8,778 cases resulted in death. Since efforts to design and develop an antiviral agent will take time to combat the currently occurring coronavirus pathogen, great emphasis is placed on implementing control measures to minimize the risk of 2019-nCoV transmission and spread. Countries have implemented serious interventions to prevent the spread of the disease. Some of those; holiday of schools, cancellation of all crowded meetings, the cancellation of social events and organizations, encouraging citizens to work and stay at home and provide social isolation. Turkey is also taken similar measures to control the outbreak. In this process, people isolate themselves in their homes and live a quiet life away from the social environment. Being away from the social environment and loneliness are among the factors that contribute negatively to the mental health of individuals. It is also an issue associated with quality of life and depressive symptoms. It is uncertain how and how much an individual's isolated life at home affects the level of physical activity. The aim of our study is to investigate the physical activity, quality of life and stress levels of individuals living in their homes isolated due to coronavirus (COVID-19) disease.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-55
* To continue their active education or business life before the social isolation period.
* Spending time at home differently from routine life recently
* Having a smart phone
* Not having visual impairment
* Being literate in Turkish

Exclusion Criteria:

* Mental disability or diagnosed severe psychological discomfort
* Being diagnosed with serious systemic disease (cardiovascular, metabolic, pulmonary...)
* Changing the living conditions in the last 3 months (moving, changing jobs ...)