linjc16/ctgov huggingface dataset:
Skincare Products and Environmental Health

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the potential for an association between the development of prepubertal gynecomastia and history exposure to lavender essential oil, tea tree essential oil, and other essential oils.

Detailed Description
-----------------
After being informed about the study and privacy, parents will give informed consent and complete the APICHS (Aromatic Plant Ingredient & Child Health Survey), a validated measurement tool for determining exposure to plant-based ingredients in pediatric personal care products.

Official Title
-----------------
Prevalence of Endocrine Disorders Among Children Exposed to Lavender Essential Oil and Tea Tree Essential Oils

Conditions
-----------------
Gynecomastia, Endocrine System Diseases

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent of child aged 2-15 living in the United States Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Cohort<br>Parents of children ages 2 to 15 years old will provide data using the APICHS. | Other: No Intervention<br>* There is no intervention; observation only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifetime prevalence of prepubertal gynecomastia | The number of participants who were exposed to lavender and tea tree essential oils and had ever experienced prepubertal gynecomastia | Baseline | 
| Lifetime prevalence of precocious puberty | The number of participants who were exposed to lavender and tea tree essential oils and experienced prepubertal gynecomastia | Baseline | 
| Endocrine Disruption - Comparison between exposed and unexposed | The difference in rates of endocrine disorders between children who were exposed to lavender or tea tree essential oil and those who were not. Exposure is measured using the Aromatic Plant Ingredient and Child Health Survey (APICHS), which measures total exposure, providing a continuous variable ranging from 0 to unlimited exposures, and a dichotomous yes/no exposure outcome variable. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prepubertal Gynecomastia, Essential Oils, Lavender, Tea Tree, Endocrine Disruption, Pediatric Environmental Health
Prevalence of Primary Aldosteronism in Patients With Resistant Hypertension in China

Study Overview
=================
Brief Summary
-----------------
Recent studies indicate that primary aldosteronism (PA) is a much more common cause of hypertension than had been demonstrated historically. In patients with resistant hypertension, the prevalence of PA from different clinics worldwide is about 10-20%. As has been no such data in China, the investigators are conducting a PA study in different province of China to evaluate the prevalence of PA in patients with resistant hypertension.

Official Title
-----------------
Prevalence of Primary Aldosteronism and Status of Renin-Angiotensin System in Resistant Hypertension:An Observational Study in China

Conditions
-----------------
Hypertension, Resistant to Conventional Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with resistant hypertension age 18-65 years Exclusion Criteria: known cause of hypertension heart failure renal dysfunction Stroke, transient ischaemic attack or myocardial infarction in the past 6 months cirrhosis pregnancy undertreatment of glucocorticoid

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| primary aldosteronism<br> | |
| essential hypertension<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.

Official Title
-----------------
Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 15 % Nitrous oxide
* Drug: 0.3 % Sevoflurane
* Drug: 30% Nitrous oxide
* Drug: 0.6% Sevoflurane
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 39 Years

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subject inhales no drug (100% oxygen) | Other: Placebo<br> <br> |
| Active Comparator: 0.3% sevoflurane<br> | Drug: 0.3 % Sevoflurane<br> <br> |
| Active Comparator: 0.6% sevoflurane<br> | Drug: 0.6% Sevoflurane<br> <br> |
| Active Comparator: 15% Nitrous oxide<br> | Drug: 15 % Nitrous oxide<br> <br> |
| Active Comparator: 30% Nitrous oxide<br> | Drug: 30% Nitrous oxide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire | 30 min of inhalation | 
| Psychomotor performance | Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation | Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery | 
| Cognitive performance | Subject underwent memory, sedation, visual analog, and drug effects testing | Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sevoflurane, nitrous oxide, subjective effects, healthy volunteer
EUFURO - EUS-based Follow-Up on R0-resected Patients for Esophageal, Gastric and Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Follow-up after successful operative treatment of cancer in the esophagus, stomach or pancreas in order to detect recurrent disease is a controversial topic. This is because the methods and the consequence of following these patients is unknown. Therefore the investigators will randomize these patients in to two groups: One group of patients will be offered visits with a specialist surgeon in a outpatient setting for a clinical evaluation every 3,6,9,12,18 and 24 months after surgery, as is the current standard at our department. The other group will be offered Endoscopic UltraSound, EUS, and PET/CT with the same intervals as the first group.

Official Title
-----------------
Endoscopic Ultrasound (EUS) and PET-CT Based Follow-up of Patients Radically Resected for Cancer of the Oesophagus, Stomach or Pancreas.

Conditions
-----------------
Esophageal Cancer, Stomach Cancer, Pancreatic Cancer

Intervention / Treatment
-----------------
* Behavioral: standard follow-up
* Procedure: PET/CT and EUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: R0- resection for primary adenocarcinoma or squamous cell carcinoma of the esophagus, stomach or pancreas.

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard outpatient follow-up<br>Outpatient clinic visits 3,6,9,12,18 and 24 mths after surgery | Behavioral: standard follow-up<br>* Outpatient clinic visits<br>|
| Experimental: Intervention PET/CT and EUS<br>PET/CT and EUS at 3,6,9,12,18 and 24 months after surgery | Procedure: PET/CT and EUS<br>* PET/CT and EUS<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients eligible for treatment | Does early detection of recurrent disease translate in to more patients being eligible for oncologic treatment? | 2 years |
Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Balanced, 4-Way, Incomplete Block Design to Evaluate the Effects of a Single Administration of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG (qEEG) in Healthy Subjects

Conditions
-----------------
Healthy, Adult

Intervention / Treatment
-----------------
* Drug: SAM-531
* Other: placebo
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women of non-childbearing potential aged 18 to 50 years inclusive on study day 1. Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram. Exclusion Criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, hematologic, neurologic, or psychiatric disease. Clinically significant abnormal standard EEG at screening. Consumption of any caffeine-containing products or alcoholic beverages within 48 hours before study day 1.

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?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SAM-531<br>* dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531<br>|
| Placebo Comparator: 2<br> | Other: placebo<br>* placebo<br>|
| Active Comparator: 3<br> | Drug: Donepezil<br>* dosage form: 5 mg encapsulated tablets one single dose of 5 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the pharmacologic effect of SAM-531 on sleep EEG in healthy subjects |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer Disease
Metabolic Syndrome and Inflammatory Markers

Study Overview
=================
Brief Summary
-----------------
The metabolic syndrome has been recognized as a proinflammatory state. It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, may be effective in improving the metabolic syndrome. Our objective was to evaluate the effect of Ramadan fasting on High-sensitive C-reactive protein (hs-CRP) and fibrinogen levels in metabolic syndrome.

Official Title
-----------------
Effect of Fasting With Two Meals on Inflammatory Markers of Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Behavioral: Ramadan Fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males with metabolic syndrome Exclusion Criteria: Conditions with insulin resistance including; Type 2 diabetes mellitus, Infections, Stresses, Uremia, Acromegaly, Glucocorticoid excess, Hypertension , Cirrhosis and Any addiction or drug therapy and conditions witch cause changes in hs-CRP and fibrinogen levels including infection, trauma, infarction, inflammatory arthritis, various neoplasm and liver diseases.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Ramadan Fasting|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring inflammatory markers in metabolic syndrome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome,Ramadan,Fasting,Inflammatory markers,, Iran
Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.

Study Overview
=================
Brief Summary
-----------------
Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.

Official Title
-----------------
Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Epworth Sleepiness Scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated by CPAP for Obstructive Sleep Apnea Syndrome Exclusion Criteria: Central Apnea Syndrome Central Hypersomnia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Epworth Sleepiness Scale|Maintenance Wakefulness Test|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment | Three levels of vigilance are defined by the MWT : more than 34 min is rated as good vigilance; ≥ 20 et < 34 min as intermediate vigilance; under 20 min as bad vigilance. | one day | 
| Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment | Two levels of vigilance are defined by the ESS score: score ≥11: bad vigilance, <11: good vigilance | one day |
Study on the Response to Tetanus Vaccination of People Living With HIV

Study Overview
=================
Brief Summary
-----------------
The response to primary tetanus immunization of HIV-infected children is lower than that of uninfected children. Response to tetanus toxoid (TT) booster doses in adults living with HIV who have received primary vaccination prior to infection is not known. Currently, it is recommended to have a TT booster for people living with HIV (PLHIV) every 10 years. In general population, this recall is made only at 25, 45 and 65 years, then every 10 years.

Official Title
-----------------
Study on the Response to Tetanus Vaccination of People Living With HIV

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Diagnostic Test: additional blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person aged ≥ 18 years Person infected with HIV followed in the infectious diseases department of CH Niort Born in France Affiliate or beneficiary of a social security scheme Being able to give free and informed consent to participation in research Exclusion Criteria: Persons with a contraindication to tetanus vaccination Persons under guardianship or curatorship or without civil law

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: additional blood sampling<br> | Diagnostic Test: additional blood sampling<br>* additional blood sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the vaccine response to tetanus vaccination | An anti-tetanus IgG level> 0.1 is considered long-term protective. An anti-tetanus IgG level between 0.01 and 0.1 is considered protective in the short term. The measurement of the vaccine response will be correlated with the age of the last VAT recall (<10 years, between 10 and 20 years,> 20 years and unknown) | Month 6 |
A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.

Study Overview
=================
Brief Summary
-----------------
A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all proven to have locoregional recurrence after curative treatment and unsuitability for further local treatment, distant metastases at presentation or acquired metastases after curative treatment. the presence of at least one measurable disease, which was defined as lesion that could be measured at least 20 mm in one dimension by conventional computed tomography (CT) or at least 10 mm by spiral CT scan; KPS≥70, and a life expectancy of at least 6 months. Exclusion Criteria: other malignancy prior to study entry; bone-only metastasis;previous radiotherapy within 4 weeks; previous exposure to gemcitabine;patients with any active, non-controlled infection or other severe systemic diseases, such as congestive heart failure, angina pectoris, respiratory insufficiency and arrhythmia were all rejected at enrollment. Other exclusion criteria included concurrent treatment with other investigational drugs, hypersensitivity to platinum compounds,and current pregnancy or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma. | Drug: S-1<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | through study completion, an average of 1 year |
Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II

Study Overview
=================
Brief Summary
-----------------
Comparison of indirect calorimetry by Q-NRG (Cosmed) with Deltatrac II (Datex)

Detailed Description
-----------------
The aim of the present study is to compare the measured resting energy expenditure by Q-NRG (Cosmed) with Deltatrac II (Datex), in healthy volunteers. Q-NRG is a new device. It is relevant to compare its results with the blog standard calorimeter, the Deltratrac II. The study will include sports healthy subjects. The could benefit from the determination of their resting energy expenditure in order to adapt their nutritional intakes.

Official Title
-----------------
Comparison of Indirect Calorimetry by Q-NRG With Deltatrac II in Healthy Volunteers

Conditions
-----------------
Indirect Calorimetry

Intervention / Treatment
-----------------
* Other: no drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult sport practice > 1h per day at moderate intensity Exclusion Criteria: refusal to participate unable to give a consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no drug|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting energy expenditure | comparison of resting energy expenditure measured using Q-NRG calorimeter with resting energy expenditure measured using Deltatrac II | during the calorimetry | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
indirect calorimetry