linjc16/ctgov huggingface dataset:
Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis

Study Overview
=================
Brief Summary
-----------------
In the study it will be tested whether transcranial direct current stimulation can reduce the perception of pelvic pain in patients with endometriosis. Hypothesis: Transcranial direct current stimulation can reduce the perception of pelvic pain in patients with patients with endometriosis.

Official Title
-----------------
Transcranial Direct Current Stimulation to Reduce Chronic Pelvic Pain in Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Device: tDCS : Transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometriosis Chronic pain (more than 3 months) Pain (VAS > 3/10) Exclusion Criteria: - Contraindication to transcranial direct current stimulation Pregnancy Sever internal or psychiatric condition

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br>tDCS will be applied for 20 min with 2 mA | Device: tDCS : Transcranial direct current stimulation<br>* Transcranial direct current stimulation<br>|
| Placebo Comparator: Placebo tDCS<br>tDCS will be applied for only 20 sec, monatge will be left on the head for 20 min | Device: tDCS : Transcranial direct current stimulation<br>* Transcranial direct current stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pelvic pain via pressure pain threshold | pressure pain threshold | 4 weeks |
Diet Composition - Metabolic Regulation and Long-term Compliance

Study Overview
=================
Brief Summary
-----------------
This study will compare a high-protein/low-carbohydrate diet (modified paleolithic diet, MPD) with a diet high in slow carbohydrates (Nordic Nutrition Recommendations, NNR). The diets will be compared with respect effects on weight reduction, metabolic regulation, and long-term compliance to the diet regimes. Seventy-two postmenopausal overweight healthy women have been recruited and will be followed for two years. The following variables will be studied: Anthropometry DEXA OGTT Liver fat content measured with 1H-MRS Hepatic 11β-HSD1 activity, measured with cortisone/cortisol conversion test

Official Title
-----------------
Diet Composition - Metabolic Regulation and Long-term Compliance

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: NNR (Nordic Nutrition Recommendations)
* Behavioral: MPD (Modified paleolithic diet)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Postmenopausal BMI>28 Exclusion Criteria: Disease Gravidity Smoking Prescribed medication

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>NNR | Behavioral: NNR (Nordic Nutrition Recommendations)<br>* Diet with equal amounts of fat, protein and carbohydrates<br>* Other names: Nordic Nutrition recommendations;|
| Active Comparator: 2<br>MPD | Behavioral: MPD (Modified paleolithic diet)<br>* A diet high in protein and fat, but low in carbohydrates<br>* Other names: Modified paleolithic diet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fat |  | Sept 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | Sept 2008 | 
| Apnea-Hypopnea Index (AHI) |  | Sept 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Postmenopausal, Diet intervention
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)

Study Overview
=================
Brief Summary
-----------------
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.

Official Title
-----------------
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA 2811 in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DA-2811
* Drug: DA-2811-R


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects BMI between 18.5 and 29.9 kg/m2 and weigh at least 50 kg Volunteer who totally understands the progress of this clinical trial, make decision by his or her free will, and signed a consent form to follow the progress Exclusion Criteria: Volunteer who has present or past history of clinically significant cardiovascular, respiratory, urinary, gastrointestinal, hepatic, renal, skin, immunological, musculoskeletal, endocrinal, neurological, psychiatric and/or hematological disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence I<br> | Drug: DA-2811<br>* single dose administration (one tablet once a day)<br>Drug: DA-2811-R<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence II<br> | Drug: DA-2811<br>* single dose administration (one tablet once a day)<br>Drug: DA-2811-R<br>* single dose administration (one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast | Area under the plasma concentration-time curve from time zero to time the last quantifiable time | pre-dose 48 hours post-dose | 
| Cmax | Maximum plasma concentration | pre-dose 48 hours post-dose |
Television Viewing (TVV) & Puberty on Lunchtime Food Intake

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that television viewing will affect food intake in adolescent girls, and will depend on pubertal stage. Food intake will be measured at 30 min following a glucose(1 g of glucose/kg body weight) or sweetened noncaloric beverage with or without the presence of TV. Subjective appetite will be measured as well.

Official Title
-----------------
Effect of Television Viewing (TVV) & Puberty on Lunchtime Food Intake & Subjective Appetite in Girls

Conditions
-----------------
Obesity Prevention

Intervention / Treatment
-----------------
* Dietary Supplement: water with noncalorie sweetener
* Dietary Supplement: water with glucose
* Behavioral: TV program showed while feeding
* Behavioral: TV program showed while feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy girls with no emotional, behavioral or learning problems Exclusion Criteria: boys

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucose beverage<br> | Dietary Supplement: water with glucose<br> <br> |
| Experimental: noncaloric beverage with TV<br> | Behavioral: TV program showed while feeding<br> <br> |
| Experimental: glucose beverage with TV<br> | Behavioral: TV program showed while feeding<br> <br> |
| Experimental: noncaloric beverage<br> | Dietary Supplement: water with noncalorie sweetener<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| food intake (kcal) |  | at 30 min after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective appetite |  | 0-120 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
girls, obesity, television viewing, puberty
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2 Diabetes. Both the safety and blood sugar lowering effects of these treatments will be studied.

Official Title
-----------------
A Phase 3, Randomized, Double-blind, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Muraglitazar (BMS-298585) Compared to Pioglitazone in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

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

Intervention / Treatment
-----------------
* Drug: Muraglitazar
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes HbA1c > = 8.0% and < = 12.0% Serum triglyceride concentration < = 600 mg/dL Fasting c-peptide > = 1.0 ng/ml Body mass index < = 41 kg/m2 Drug naive patients Exclusion Criteria: History of MI (myocardial infarction), coronary angioplasty or bypass graft(s), valvular disease or repair, unstable angina pectoris, transient ischemic attack (TIA), cerebrovascular accidents, accelerated/malignant hypertension, or hypertension related CHF (congestive heart failure) within six months prior to screening and during the Lead-In Phase. Women of child Bearing Potential Uncontrolled hypertension, CHF defined as New York Heart Association (NYHA) Class II, III and IV, exacerbation of previously stable CHF (any NYHA class) or uncontrolled cardiac arrhythmia in the 30 days prior to screening and during the Lead-In Phase. History of renal disease, bladder cancer, pulmonary disease, gastrointestinal disease, active liver disease or endocrine disease.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Muraglitazar|nan|
|Drug: Pioglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HBA1c from baseline to Week 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change for baseline in TG and HDL-C at Week 24 |  |  | 
| Change from baseline in FPG, fasting insulin, fasting c-peptide, body mass index, body weight, waist circumferance, SBP and DBP. |  |  | 
| To assess safety and tolerability of both Muraglitazar regimens relative to pioglitazone regimen when administered for up to 24 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes
Ultrasound Assisted Peripheral Venous Access in Young Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn how the use of ultrasound helps with the placement of an intravenous (i.v.) catheter in young children.

Detailed Description
-----------------
In an academic pediatric Emergency Depratment (ED), we performed a randomized clinical trial of children < 7 years of age, who required i.v. access and who had failed the first i.v. attempt. We randomized patients to either continued standard i.v. attempts or ultrasound-assisted attempts. Clinicians involved in the study received one hour of training in ultrasound localization of peripheral veins. In the ultrasound group, vein localization was performed by an ED physician who marked the skin overlying the target vessel. Intravenous cannulation attempts were then immediately performed by a pediatric ED nurse who relied on the skin mark for vessel location. We allowed for technique cross-over after two failed i.v. attempts. We recorded success rate and location of access attempts.

Official Title
-----------------
Ultrasound Assisted Peripheral Venous Access in Young Children: A Pilot and Feasibility Randomized Controlled Trial

Conditions
-----------------
Catheterization, Peripheral

Intervention / Treatment
-----------------
* Device: ultrasound
* Device: standard technique for venipuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 7 years of age Emergency Department patients Parents available for consent Exclusion Criteria: Critical illness

Ages Eligible for Study
-----------------
Maximum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ultrasound used to visualize peripheral venous anatomy. This guides subsequent attempts at venipuncture. | Device: ultrasound<br>* ultrasound used to identify target vein<br>|
| Active Comparator: 2<br>Routine venipuncture using standard methods. | Device: standard technique for venipuncture<br>* routine equipment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous visualization (with ultrasound) and venipuncture success rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated difficulty of venipuncture (rated on visual analog scale) |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics, Venous access, Emergency
Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia

Study Overview
=================
Brief Summary
-----------------
To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in Staphylococcus aureus bacteremia.

Conditions
-----------------
Staphylococcus Aureus, Bacteremia, Endocarditis, Sepsis

Intervention / Treatment
-----------------
* Drug: trovafloxacin and levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling. Exclusion Criteria: age younger than 18 years imprisonment proven or suspected pregnancy breastfeeding, epilepsy another bacteremia during the previous 28 days polymicrobial bacteremia (_>3 microbes) history of allergy to any quinolone antibiotic previous tendinitis during fluoroquinolone therapy prior fluoroquinolone use for more than 5 days before randomization positive culture for Staphylococcus aureus only from a central intravenous catheter neutropenia (<0.5 x 109/L) or failure to supply an informed consent patients with bacteremia due to methicillin-resistant S. aureus and a S. aureus strain resistant to any fluoroquinolone patients with meningitis at the time of randomization

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 |
| --- | --- |
| 1 and 2<br>Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin). | Drug: trovafloxacin and levofloxacin<br>* Trovafloxacin: <60 kg 200 mg iv/orally once daily and >60 kg 300 mg iv/orally once daily Levofloxacin: < 60 kg 500 mg iv/orally once daily and >60 kg 500 mg iv/orally bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Case fatality rate |  | At 28 days and at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of complications (e.g. deep infections) observed after the first week antibiotic treatment, decrease in serum C-reactive protein concentration, length of antibiotic treatment, need for surgical intervention, and time to defervescence. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bacteremia, Staphylococcus aureus, endocarditis, sepsis, fluoroquinolone, rifampin, levofloxacin, trovafloxacin
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.

Study Overview
=================
Brief Summary
-----------------
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis

Detailed Description
-----------------
To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Official Title
-----------------
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: DSXS topical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations. Exclusion Criteria: Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 17 Years

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

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

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: DSXS topical<br>active treatment | Drug: DSXS topical<br>* topical treatment<br>* Other names: active;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Patients in the Study With HPA Axis Suppression | Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator | 29 Days |
NLP to Aid in the Evaluation and Diagnosis of FGIDs

Study Overview
=================
Brief Summary
-----------------
The study has two arms, where the same natural language processing (NLP) and probabilistic graphical modeling technology will be utilized on patients' report of symptoms in both arms. The clinical arm is focused on patients presenting for consultation with a gastroenterologist. The endoscopy arm is focused generally on patients presenting for a diagnostic endoscopy, with the goal of capturing Functional Gastrointestinal Disorder (FGID) patients prior to diagnosis.

Official Title
-----------------
Using Natural Language Processing of Novel Biopsychosocial Disease Constructs to Aid in the Evaluation and Diagnosis of Functional Gastrointestinal Disorders

Conditions
-----------------
Functional Gastrointestinal Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for consult in the Motility Clinic in the MGH Gastroenterology Unit or for diagnostic endoscopy in the MGH Gastroenterology Unit Patient must agree to have their interactions audio-recorded Informed consent form signed by the subjects Exclusion Criteria: Non-native English speaker Patients unable to communicate their own symptoms

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 |
| --- | --- |
| Patients scheduled for consult with gastroenterologist<br> | |
| Patients scheduled for diagnostic endoscopy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latent themes present in patient descriptions of FGIDs symptoms | Latent themes present in patient descriptions of FGIDs symptoms as generated by machine learning as well as quantitative comparisons to traditional metrics of patient descriptions including Rome IV criteria and patient descriptions of severity. | 08/09/2018-08/09/2023 |