linjc16/ctgov huggingface dataset:
Core Body Temperature Measurement During Hot and Cold Environmental Exposure

Study Overview
=================
Brief Summary
-----------------
Accurate measurement of core body temperature at the scene of an accident is critical for both diagnosis and treatment/triage decisions for hypothermic patients. Measurement in the lower third of the oesophagus is considered the gold standard of CT reading, but invasive and hardly applicable with a conscious patient. Tympanic membrane sensors for CT reading have been widely tested by may be unreliable in extreme environmental temperatures. Similarly, the Double Sensor device is a non-invasive device and is promising for prehospital use but has not been sufficiently verified under very cold and hot environmental conditions. Furthermore, comparisons of different non-invasive methods with oesophageal measurement in extreme conditions are lacking. The objective of these studies is to compare different techniques of core body temperature measurement with exposure to cold and hot environments.

Official Title
-----------------
Tympanic and Frontal Versus Oesophageal Core Temperature Reading During Hot and Cold Environmental Exposure

Conditions
-----------------
Body Temperature, Hypothermia

Intervention / Treatment
-----------------
* Other: Exposure to cold environmental temperature (-20°C)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years old ASA class 1 Exclusion Criteria: <18 years old American society of anesthesiologists class >1 history of ear, nose, throat surgery congenital malformation of head/throat/ear/nose absence of informed consent

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cold first<br>temperature is measured in cold (-20°C) environment first, and warm (23°C) environment afterwards | Other: Exposure to cold environmental temperature (-20°C)<br> <br> |
| Other: Warm first<br>temperature is measured in warm (23°C) environment first, and cold (-20°C) environment afterwards | Other: Exposure to cold environmental temperature (-20°C)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between oesophageal and epitympanic temperature |  | 10 min measurment at +20 °C followed by 10 min measurment at -20 °C |
Inhibitory Capabilities Among Women With Eating Disorders

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to increase the flexible behavior toward food via inhibition training among restrained eaters. The expectation is that the train will increase food consumption, decrease food-related anxiety and affect implicit attitudes towards palatable foods

Official Title
-----------------
Inhibitory Capabilities Among Women With Eating Disorders

Conditions
-----------------
Food Response, Food Stop, Food Response-inhibition

Intervention / Treatment
-----------------
* Behavioral: Stop signal food task


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of restrained eaters Adults ages 18-40 Exclusion Criteria: Current history or diagnosis of the following according to the criteria of the DSM-5: Schizophrenia, schizoaffective disorder, hallucinations, unspecified psychotic disorder (NOS), a mental disorder due to acquired head injury, bipolar disorder, mental disorder as a result of organic development. Abuse or addiction to drugs and alcohol.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food response<br> | Behavioral: Stop signal food task<br>* The participants need to classify pictures of food and not food. They were asked to hold their response if they see a white frame around the picture.<br>|
| Experimental: Food stop<br> | Behavioral: Stop signal food task<br>* The participants need to classify pictures of food and not food. They were asked to hold their response if they see a white frame around the picture.<br>|
| Experimental: Food response-inhibition<br> | Behavioral: Stop signal food task<br>* The participants need to classify pictures of food and not food. They were asked to hold their response if they see a white frame around the picture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main outcome | The participants will increase food consumption,decrease food-related anxiety and affect implicit attitudes towards palatable foods | one hour |
A Novel Diagnostic Method for Exotropia Using Video-oculography

Study Overview
=================
Brief Summary
-----------------
Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared the value obtained using VOG and the angle of a rotating model eye, and subsequently made a new linear equation using these data. The calculated values obtained using VOG were compared with those obtained using APCT to determine the diagnostic accuracy of VOG.

Official Title
-----------------
A Novel Diagnostic Method for Exotropia Using Video-oculography

Conditions
-----------------
Strabismus, Exotropia

Intervention / Treatment
-----------------
* Diagnostic Test: Video-oculography
* Diagnostic Test: APCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have horizontal strabismus, cooperative, visual acuity >= 1.0/1.0 Exclusion Criteria: have vertical strabimus> 5prism diopter, not cooperative, no agree

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOG group<br>Video-oculography | Diagnostic Test: Video-oculography<br>* Diagnostic Method for Exotropia Using Video-oculography<br>|
| Active Comparator: APCT group<br>alternative prism cover test | Diagnostic Test: APCT<br>* alternative prism cover test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The angle of ocular deviation (degree,°) measured by VOG and PCT | strabismic angle (degree,°) measured by VOG and PCT | 2 weeks after approval |
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders

Study Overview
=================
Brief Summary
-----------------
Eating disorders are conditions that are defined by abnormal eating habits that involve insufficient or excessive food intake. With regards to treating these disorders, there is an increasing interest in fat deprivation due to a lack of proper diet, particularly dietary fats such as polyunsaturated fatty acids. These fatty acids are essential components of the brain and are important for normal functioning of the body. Since the body cannot synthesize these fats, it has to rely completely on diet to obtain a sufficient amount. Hence, diets that lack sufficient fats or under fasting conditions, the imbalance of these fats can severely alter brain functions. The investigators want to see if these supplements are well tolerated and accepted by adolescent patients with eating disorders.

Official Title
-----------------
Omega-3 Fatty Acids as Adjunctive Treatment for Adolescents With Eating Disorders

Conditions
-----------------
Eating Disorder

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 Fatty Acid Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Eating Disorder, less than 18 years of age Exclusion Criteria: unable to read and understand English

Ages Eligible for Study
-----------------
Maximum Age: 18 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: Omega-3 Fatty Acid Supplement<br> | Dietary Supplement: Omega-3 Fatty Acid Supplement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropout rate |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients reporting side effects |  | 2 months | 
| Change in weight |  | 2 months |
A Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.

Detailed Description
-----------------
The purpose of this randomized, double-blind, placebo-controlled, parallel-group, multi-center designed trial is to determine the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma.

Official Title
-----------------
A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Tacrolimus Inhalation Aerosol in Subjects With Persistent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Tacrolimus Inhalation Aerosol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of persistent asthma for at least 6 months Require use of beta-agonists at least four times per week Exclusion Criteria: Diagnosis of chronic obstructive pulmonary disease (COPD)

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus Inhalation Aerosol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the change in FEV1 from baseline to end-treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment Effectiveness, Treatment Efficacy, Investigational, Therapies, Asthma, Antiasthmatics, Antiasthmatic agents
A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide data on the dose response of simvastatin in lowering LDL-C when it is co-administered with valsartan in patients with both essential hypertension and hypercholesterolemia. The primary objective of the study will be to show that the combination of valsartan 160mg/simvastatin 40mg has superior efficacy compared to the combination of valsartan 160mg/simvastatin 20mg in percentage change from baseline in LDL-C.

Official Title
-----------------
A Study to Evaluate the Efficacy of the Valsartan/Simvastatin Combinations 160/20mg up Titrated to 320/20mg Versus 160/40mg up Titrated to 320/40mg in Patients With Both Essential Hypertension and Hypercholesterolemia

Conditions
-----------------
Essential Hypertension, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: simvastatin
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated LDL-Cholesterol Essential hypertension Exclusion Criteria: Severe Hypertension Prior or known muscular or neuromuscular disease of any type A history of cardiovascular disease Hypertension or hypercholesterolemia due to secondary causes Uncontrolled diabetes or insulin treatment Evidence of hepatic or renal disease Other protocol-defined exclusion criteria may apply

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: simvastatin|nan|
|Drug: valsartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoproteins after 6 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile at 6, 12 wks |  |  | 
| BP < 140/90 mmHg in non diabetics, or < 130/80 mmHg in diabetics, and LDL-C < 2.6, 3.4 or 4.1 mmol/l based on risk group at 6, 12 wks |  |  | 
| SBP < 140 mmHg in non diabetics, < 130 mmHg in diabetics, or 20 mmHg decrease in SBP from baseline and DBP < 90 mmHg in non diabetics, DBP < 80 mmHg in diabetics, or 10 mmHg decrease in DBP from baseline at 6, 12 wks |  |  | 
| Systolic and diastolic bp at 6, 12 wks |  |  | 
| Serious/adverse events, labs, physical exams, vitals up to 12 wks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Valsartan, simvastatin, hypertension, hypercholesterolemia, angiotensin II receptor blocker
Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section

Study Overview
=================
Brief Summary
-----------------
Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Detailed Description
-----------------
Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Official Title
-----------------
Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material

Conditions
-----------------
Hysterotomy Closure

Intervention / Treatment
-----------------
* Procedure: Stratafix synthetic barbed suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia. Exclusion Criteria: General Anesthesia Non-consent to participation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Group of patients receiving standard hysterotomy closure with synthetic braided suture | Procedure: Stratafix synthetic barbed suture<br>* hysterotomy closure in Cesarian section<br>|
| Experimental: Stratfix<br>group of patients having the hysterotomy incision closed with barbed synthetic suture. Time to closure, blood loss, and postoperative pain | Procedure: Stratafix synthetic barbed suture<br>* hysterotomy closure in Cesarian section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss in closure with barbed synthetic suture | monitoring of preoperative and postoperative hemoglobin and hematcrit | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain after cesarean secton | using visual analog pain scale, compare standard closure to barbed suture closure pain | 3 days |
Exploratory Study for the Validity of QuQu Scale

Study Overview
=================
Brief Summary
-----------------
Examine the construct validity, the group discriminant ability, and the inter-rater reliability of a novel dementia rating scale (QuQu scale: QUick QUestion scale) candidate for the evaluation of patients with Alzheimer Dementia (AD)

Official Title
-----------------
Exploratory Study for the Validity of a Novel Dementia Rating Scale (QUick QUestion Scale) for Alzheimer's Disease Dementia

Conditions
-----------------
Alzheimer Dementia

Intervention / Treatment
-----------------
* Other: Standard therapy of Alzheimer Dementia (AD)
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer Dementia (AD) patients and patients with cognitive concern without dementia Written Informed consent by each subject and/or a legal representative, and study informant. If the doctor decides that the patient has no trouble in understanding this study, the written informed consent of a legal representative may be exempted. If not, this study needs a written informed consent by a legal representative and the patient except the case where the consent is hardly obtained due to the progression of the disease. Exclusion Criteria: patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia) patients with other diseases which cause secondary dementia prior to Alzheimer Dementia (AD) patients with other severe neurological disease or psychiatric disorder without Alzheimer Dementia (AD) patients with other medical conditions where the investigators determine that it is inappropriate for the subject of this study (e.g. inappropriate for the evaluation of dementia rating scale)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alzheimer Dementia (AD)<br>Patients with dementia caused by Alzheimer's disease | Other: Standard therapy of Alzheimer Dementia (AD)<br> <br> |
| Non-dementia<br>Patients with cognitive concern without dementia | Other: Observation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Novel Dementia Rating Scale (QUick QUestion Scale) |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer Dementia, AD, patients, cognitive
Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is investigating the clinical characteristics of newly diagnosed, drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.

Detailed Description
-----------------
Primary Objective:To investigate whether insulin resistance or insulin deficiency is primary in the pathogenesis of type 2 diabetes mellitus in Korea Secondary Objectives:To investigate proportion of patients with severe insulin deficiency at diagnosis,To investigate proportion of metabolic syndrome in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus,To investigate proportion of obesity in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus

Official Title
-----------------
Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: HOMA-IR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Newly diagnosed, drug naïve type 2 DM patients who gave informed consent, Diagnosis of type 2 DM will be made according to ADA guideline 2009 Exclusion Criteria:Patients age under 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Drug naive type II DM<br>Newly diagnosed type II Diabetes Mellitus | Other: HOMA-IR<br>* Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance assessed using HOMA-IR |  | within 3months after DM diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients with severe insulin deficiency assessed using C-peptide |  | within 3months after DM diagnosis | 
| proportion of metabolic syndrome in patients |  | within 3months after DM diagnosis | 
| proportion of obesity in patients |  | within 3months after DM diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin resistance, Insulin deficiency, HOMA-IR, Drug naive, Diabetes mellitus, type II