linjc16/ctgov huggingface dataset:
Micro-Technique Sampling

Study Overview
=================
Brief Summary
-----------------
This is a single-center, exploratory comparative pilot study to identify the most appropriate method for microbial consortia sampling from the skin. Ten subjects are expected to complete the study at one investigative site in the United States. The study will consist of 2 visits, Visit 1 (Screening), Visit 2 (Sampling). At Visit 1, subjects will be consented and have their eligibility reviewed. Visit 1 and Visit 2 may be combined into one visit. Visit 1 will involve the informed consent process, screening, and enrollment. Visit 2 will involve sampling of eight (8) test sites on the back with three (3) different sampling methods: swabbing (2 sites/method), cup scrub (2 sites/method), and tape stripping (4 sites/method). All samples will be returned to Kimberly Clark then sent to a laboratory for analysis.

Official Title
-----------------
An Exploratory Comparative Pilot Study to Identify the Most Appropriate Method for Microbial Consortia Sampling From the Skin-II

Conditions
-----------------
Dermatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF); Ability to complete the course of the study and comply with instructions; Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required); Individuals free of any systemic or dermatological disorder, tatoos in the testing area or recent tanning bed exposure Anticipated ability to complete the course of the study and to comply with instructions; Females practicing an acceptable method of birth control Caucasian individuals with Fitzpatrick skin type I, II, or III

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best method for collecting skin microbiome samples | Composition of skin microbiome by 16SrRNA pyrosequencing from 3 skin collection methods: Swabbing; Cup Scrub; and Tape Stripping | 1 day |
Prevalence and Predictors of CCI in Patients With Acute Respiratory Failure (CCI)

Study Overview
=================
Brief Summary
-----------------
Chronic Critical Illness (CCI) is a condition associated to patients surviving an acute phase of disease and respiratory failure (ARF) although remaining dependent on mechanical ventilation (MV). The prevalence and the underlying mechanisms of CCI have not been elucidated in this population.An observational prospective cohort study was undertaken at the Respiratory Intensive Care Unit (RICU) of the University Hospital of Modena (Italy) from January 2016 to January 2018. Patients mechanically ventilated with ARF in this unit were enrolled. Demographics, diagnosis, severity scores (APACHEII, SOFA, SAPSII) and clinical conditions (septic shock, infections, acute respiratory distress syndrome [ARDS]) were recorded on admission. Respiratory mechanics and inflammatory-metabolic blood parameters were recorded on admission and within the first seven days of stay. All these variables were tested as potential predictors of CCI through appropriate univariate and multivariate analysis.

Official Title
-----------------
Prevalence and Predictors of Chronic Critical Illness in Patients With Acute Respiratory Failure

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years of age consecutively admitted to RICU due to acute respiratory failure (ARF) requiring mechanical ventilation. Exclusion Criteria: refractory shock (death < 24h) patient goals of care not consistent with aggressive management end stage COPD requiring home oxygen long term therapy or home non invasive ventilation support presence of interstitial lung disease history of neuromuscular disease chest wall deformities pregnancy chemotherapy or radiotherapy within the past 30 days evidence of neurologic injury on CT scan and GCS < 8 tracheostomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of CCI among patients admitted to Respiratory Intensive Care Unit (RICU) for Acute Respiratory Failure | The presence of CCI was defined as the need to perform tracheostomy in ICU associated with prolonged MV (the need for ventilatory support for more than 21 consecutive days for at least 6 h per day | 60 days from RICU admission |
Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Prospective, controlled, randomized crossover volunteer study to investigate the effect of hyperoxemia due to inhalation of oxygen (80% inspiratory fraction) via reservoir-face-mask on blood coagulation, especially platelet function, as measured by thrombelastography. According to results of basic animal and in vitro investigations, hyperoxemia may activate platelets by means of reactive oxygen species. This study aims at investigating a possible pro-coagulant effect of hyperoxemia in healthy volunteers. Additional studies on possible mechanisms are integrated. Trial with medical device

Official Title
-----------------
Effect of Hyperoxemia on Platelet Function in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: oxygen inhalation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: informed consent; no coagulation disorder or other illnesses; non-smoker; women: no pharmacological contraception, negative pregnancy test; 25-45 years old; no medication; no acute or chronic airway problems; for 24 hours before study: no extreme physical activity, no polyphenol-containing food (red wine, apples, cabbage, garlic); for 48 hours: no caffeine-containing drinks, no dark chocolate. Exclusion criteria: Lack of one of the inclusion criteria; allergy or incompatibility to substances/materials applied in the study; very thin veins/arteries.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inhalation of 80% Oxygen<br>Inhalation of 80% Oxygen by nonrebreathing reservoir face masks for 4 hours | Drug: oxygen inhalation<br>* Inhalation of 80% oxygen via face mask<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum amplitude in thrombelastography |  | 1 hour |
Time Course Comparison of Contact Lens Maintenance Systems for Hydrogel Lenses

Study Overview
=================
Brief Summary
-----------------
The principal aim of this project is to determine the time course of development of contact lens and contact lens case contamination during daily wear of silicone hydrogel lenses. The secondary aim of the study is to determine whether the time course of development of contact lens and contact lens case contamination varies between two different contact lens care systems.

Conditions
-----------------
Myopia, Hyperopia

Intervention / Treatment
-----------------
* Device: Silicone Hydrogel Contact Lenses
* Device: 1x PMBH preserved MPS
* Device: 1x Polyquad/Aldox MPS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Distance contact lens prescription between +8.00 and -10.00D. Cylindrical component of refractive error no greater than 1.25D in either eye. Vision correctable to 6/12 (0.30 logMAR) or better in each eye. Healthy normal eyes without anterior segment infection, inflammation or abnormality, or significant slitlamp findings. Exclusion Criteria: Concurrent ocular medication Eye injury or surgery within twelve weeks immediately prior to enrolment. Current ocular irritation that would preclude contact lens fitting. Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. Pregnant, lactating or planning a pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Group 1 | Device: Silicone Hydrogel Contact Lenses<br> <br> |
| Experimental: 2<br>Group 2 | Device: 1x PMBH preserved MPS<br> <br> |
| Experimental: 3<br>Group 3 | Device: 1x Polyquad/Aldox MPS<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Impact of Exercise Training on Cardiac Function in Man

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the impact of exercise training on cardiac functions and lipoprotein lipids.

Detailed Description
-----------------
Exercise can increase the mass of left ventricle, which is also called athletic heart. Athletic heart is most frequently encountered as a pathological manifestation of cardiovascular disease, and the early determinants of athelitic remodeling in the general population are largely unknown. We will recruit 45 men aged 18-25 years who will run 5000 meters 2/day for 3 months. caridac function is examined by ECG and echocardiogram, blood pressure, lipoprotein, heart rate, body weight, cardiac troponin will be examined prior to exercise program and 3 months after exercise.

Official Title
-----------------
Effects of Exercise Training on Cardiac Function and Lipid Metabolism in Mem 18-22 Year Old

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Behavioral: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men age 18-25 years body mass index (BMI) 18-25 kg/m2 no regular exercise no tobacco use no current use of prescribed medications no self-report of acute of chronic diseases Exclusion Criteria: conditions that do not meet the inclusion criteria listed.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental 1<br>men with exercise training for 3 months | Behavioral: exercise training<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of cardiac function at baseline to exercise training for 3 months |  | baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of lipoprotein at baseline to exercise training for 3 months |  | baseline to 3 months | 
| change of heart rate at baseline to exercise training for 3 months |  | baseline to 3 months | 
| Change of body weight at baseline to exercise training for 3 months |  | baseline to 3 months | 
| change of cardiac troponin frome baseline to exercise training for 3 months |  | baselin to 3 months | 
| Change of blood pressure from baseline to exercise training for 3 months |  | baseline to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Lipid, Left ventricular, heart function
The Associations Between Dietary Choline, Genetics and Anxiety/Depression

Study Overview
=================
Brief Summary
-----------------
The associations between dietary choline, genetics and anxiety/depression

Detailed Description
-----------------
Choline, previously considered to be a vitamin, is an essential nutrient involved in a plethora of biological pathways. Choline status is thought to be associated with depression and anxiety, however, the lack of evidence regarding the exact mechanism of its action warrants further investigation. This study aims to explore the associations between dietary choline and depression and anxiety in healthy individuals and how these may differ according to genetics, specifically Phosphatidylethanolamine N-Methyltransferase gene involved in endogenous and exogenous choline metabolism. Establishing these associations could reinforce the need for future intervention trials that could in turn establish causality and determine the mechanistic effects of dietary choline and the PEMT gene activity on depression/anxiety

Official Title
-----------------
The Association Between Dietary Choline, Genetics and Anxiety/Depression

Conditions
-----------------
Choline Deficiency, Anxiety, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overall healthy males pre-menopausal females of 18-50 years of age. Exclusion Criteria: Individuals with a current clinical diagnosis of anxiety and depression pregnant or lactating post-menopausal women individuals suffering with chronic disease (cardiovascular disease, type-2 diabetes mellitus and cancer) individuals using choline, lecithin or soy supplements, obese individuals with a Body Mass Index (BMI) >30 kg/m2.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Hospital Anxiety and Depression questionnaire score higher than 11 | 1 day observation | 
| Anxiety | Hospital Anxiety and Depression questionnaire score higher than 11 | 1 day observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choline intake | Dietary choline intake | 3 day observation | 
| Plasma choline levels | Choline levels in plasma obtained by colorimetry | 1 measurement |
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

Study Overview
=================
Brief Summary
-----------------
This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.

Official Title
-----------------
Open, Multi-center, Non-interventional, Prospective/ Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature

Conditions
-----------------
Growth Hormone Deficiency, Idiopathic Short Stature, Turner Syndrome, Small for Gestational Age

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA) Children who has official height record at least 6 months prior Exclusion Criteria: Children with Epiphyseal closure

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Growth hormone<br>Growtropin®-II | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety assessed through the adverse events | Number of occurrence of treatment-related adverse events | Up to 2 years after epiphyseal closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of annualized height velocity | To assess the difference in change of annualized height velocity between baseline and every 6 months | Up to 2 years after epiphyseal closure | 
| The difference between target height and final height | To assess the difference in target height and final height | Up to 2 years after epiphyseal closure | 
| Changes in Height SDS | To assess the changes in Height SDS between baseline and every 6 months | Up to 2 years after epiphyseal closure | 
| Changes in skeletal maturity | To assess the changes in skeletal maturity between baseline and every 6 months | Up to 2 years after epiphyseal closure | 
| Changes in IGF-1 | To assess the changes in IGF-1 between baseline and every 6 months | Up to 2 years after epiphyseal closure | 
| Changes in IGFBP-3 | To assess the changes in IGFBP-3 between baseline and every 6 months | Up to 2 years after epiphyseal closure | 
| Changes in BMI SDS | To assess the changes in BMI SDS between baseline and every 6 months | Up to 2 years after epiphyseal closure |
Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether person-centered high-intense aerobic / strength training during five months reduces inflammation and disease activity, improve immune cell function, and increases muscle strength, fitness and ability of the individual independence in elderly patients with rheumatoid arthritis.

Official Title
-----------------
Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Behavioral: Person-centered high-intense training under supervision
* Behavioral: Personalized exercise program to perform at home


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Patients 65 years or older with RA diagnosed according to the ACR / EULAR 1987/2010 criteria, disease duration 2 years or more, disease activity as measured by DAS28 <5.1 Exclusion Comorbidities, such as unstable coronary artery disease, uncontrolled cardiac arrhythmia, or uncontrolled high blood pressure, which prevents moderate to intense exercise. Joint surgery completed within 6 months prior to study entry. Ongoing training at moderate to high level 2 or more times per week

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Person-centered high-intense training three times a week under supervision (supervision two times a week) during 5 months | Behavioral: Person-centered high-intense training under supervision<br>* A person-centered training program including a person-centered high-intense aerobic / strength training<br>|
| Active Comparator: Control<br>Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week during 5 months | Behavioral: Personalized exercise program to perform at home<br>* Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to manage daily activities as measured by the rheumatoid arthritis-specific measure of the Health Assessment Questionnaire (HAQ). |  | 5 months |