linjc16/ctgov huggingface dataset:
Helium-Hyperoxia and 6MWT Distance in COPD

Study Overview
=================
Brief Summary
-----------------
We assessed the effect of altering inspired gas on the 6MWT distance in COPD. We hypothesized that HeO2 would improve walking distance and reduce shortness of breath compared to both RA and O2, and potentially improve quality of life for COPD patients.

Detailed Description
-----------------
We hypothesized that inspiring helium-hyperoxia (HeO2) would significantly improve 6-minute walking test (6MWT) distance in Chronic Obstructive Pulmonary Disease (COPD) subjects. This was a blinded, randomized crossover study. At Visit 1 we assessed pulmonary function, exercise capacity and 6MWT distance. Visits 2 and 3 consisted of four 6MWT with different inspired gases: room air by mask (RA), 100% O2 by mask (Mask O2), 100% O2 by nasal prongs (Nasal O2), and 70% He/30% O2 by mask (HeO2). Walking distance, shortness of breath, leg fatigue, O2 saturation and heart rate (HR) were assessed

Official Title
-----------------
The Effects of Helium-Hyperoxia on 6-Minute Walking Distance in Chronic Obstructive Pulmonary Disease - A Randomized, Controlled Trial

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Oxygen
* Drug: Helium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exertional dyspnea Activity limitation COPD Exclusion Criteria: Recent exacerbation (< 4 wks) Supplemental O2 Significant cardiovascular/musculoskeletal abnormalities
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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxygen|nan|
|Drug: Helium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walking distance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shortness of breath |  |  | 
| leg fatigue |  |  | 
| arterial oxygen saturation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
6-Minute Walk Test, COPD, Helium-Hyperoxia, Exercise, Chronic Obstructive Pulmonary Disease (COPD)
Learning Curve for Gastric Endoscopic Submucosal Dissection

Study Overview
=================
Brief Summary
-----------------
Endoscopic submucosal dissection (ESD) for early gastric cancer is a widely accepted treatment option of expanded indication worldwide. ESD is relatively difﬁcult compared with endoscopic mucosal resection, thus, proper training is essential for the safe performance of the procedure. Thus, it is necessary to receive proper training in the procedure for safe performance of ESD. Previous studies reported that there was a learning curve in ESD training and preceptees needed to perform at least 30-40 procedures in order to master this technique. However, there is few study about the association between the clinical characteristics and competence level for gastric ESD.

Detailed Description
-----------------
This study aims to evaluate the clinical outcomes of ESD and to describe the learning curve for ESD of the gastric neoplasm, based on the analysis of a single endoscopist's experience.

Official Title
-----------------
Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm

Conditions
-----------------
Endoscopic Submucosal Dissection, Gastric Neoplasm

Intervention / Treatment
-----------------
* Procedure: Endoscopic submucosal dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically confirmed gastric neoplasm Exclusion Criteria: Age < 20 History of gastric surgery Severe systemic disease Advanced chronic liver disease Recent history of upper gastrointestinal bleeding

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic submucosal dissection|ESD was performed under conscious sedation. For sedation, midazolam and/or propofol were administered intravenously, with cardiorespiratory monitoring. Initially, indigo carmine dye was sprayed onto the tumor to clarify the margin. Then, markings were made 10 mm outside the tumor margin using argon plasma coagulation. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine was injected into the submucosa outside the marking dots. Circumferential mucosal incision and submucosal dissection were performed using a Dual and/or IT knife. During the procedure, immediate bleeding was treated by Coagrasper. After ESD, chest and abdominal plain radiography were performed routinely for detection of gastric perforation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection speed | Deﬁned as resected lesion size divided by ESD procedure time | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | ESD-related bleeding, gastric perforation, patient's death | 4 weeks |
Therapeutic Omegas for Triglyceride Suppression

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about how an omega-3 fatty acid supplement effects triglyceride levels in pregnancy. Triglycerides are a type of fat found in your blood. Your body converts extra calories into triglycerides to be stored and used later for energy. It is normal for triglyceride levels to go up during pregnancy however some women have levels that are  30-40% higher than normal when they reach their third trimester of pregnancy. Having high triglycerides in pregnancy may be related to an increased chance of having a baby that is large for their age. The goal of this study is to determine if taking an omega-3 fatty acid supplement can slow the rise in triglyceride levels later in pregnancy.

Official Title
-----------------
Pilot RCT Intervention Targeting Elevated Triglycerides With a Point-of-Care Meter and Omega-3 Fatty Acids to Normalize Triglycerides and Fetal Growth

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Dietary Supplement: Intervention Omega 3 Supplementation
* Dietary Supplement: Control Safflower Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women between the ages of 21-39 yrs Pre-pregnancy BMI 28-39 Fasting Triglyceride ≥120 mg/dL measured by 15 wks Exclusion Criteria: Pre-gestational diabetes or prediabetes History of gestational diabetes, History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks Tobacco or illicit substance use Chronic steroid use

Ages Eligible for Study
-----------------
Minimum Age: 0 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 Supplementation<br>Supplementation of 4g of DHA/EPA daily | Dietary Supplement: Intervention Omega 3 Supplementation<br>* Participants will supplement 4g of Omega 3 fish oil daily (750DHA/250EPA)<br>|
| Placebo Comparator: Safflower Oil Supplement<br>Supplementation of Safflower Oil daily | Dietary Supplement: Control Safflower Oil<br>* Participants will consume 2.5g of a Safflower oil supplement daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Fasting and Postprandial Triglycerides | Differences in maternal fasting and postprandial triglycerides between groups | 34 weeks gestational age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
triglycerides, glucose, adiposity, Air displacement plethysmography, Continuous glucose monitoring
Laparoscopic Liver Resection

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the feasibility and safety of laparoscopic liver surgery.

Detailed Description
-----------------
Perioperative course of patients undergoing liver resection is evaluated.

Official Title
-----------------
Prospective Evaluation of Laparoscopic Liver Resection

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Procedure: Laparoscopic liver surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: benign or malignant tumors tumor size less than 12 cm Exclusion Criteria: Operations that required laparotomic procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| A<br> | Procedure: Laparoscopic liver surgery<br>* Ultrasonic dissector, harmonic scalpel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Morbidity and mortality |  | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfation |  | Perioperative | 
| Patients satisfaction |  | Postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients must be candidable to liver resection
Behavioral Treatment for Cocaine Dependent Women

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of Community Reinforcement Approach (CRA) and 12-Step Facilitation (TSF) counseling and of voucher based reward therapy (VBRT) and a yoked, non-contingent voucher control (VC) for the treatment of cocaine dependent pregnant women or women with young children.

Detailed Description
-----------------
Subjects were randomly assigned to 1 of 4 treatment groups (CRA+VBRT, CRA+VC, TSF+VBRT, TSF+VC). VBRT voucher value increased for each successive cocaine-free urine sample obtained twice weekly during the 1st 12 weeks and was faded from the final earned value to $5 during the last 12 weeks. All subjects earned vouchers for attendance at scheduled twice weekly counseling sessions. Manual-guided CRA and TSF were provided by experienced clinicians.

Official Title
-----------------
Behavioral Treatment for Cocaine Dependent Women

Conditions
-----------------
Cocaine Dependence

Intervention / Treatment
-----------------
* Behavioral: Behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women meeting DSM IV criteria for cocaine dependence Women meeting DSM IV criteria for cocaine dependence with custody of a young child Exclusion Criteria: Opioid dependence Psychosis Severe depression Current treatment with any anti-depressant or anti-psychotic medication Medical instability Inability to understand or read English

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRA + CM<br>Community Reinforcement Approach (CRA) combined with Contingency Management (CM) | Behavioral: Behavioral therapy<br> <br> |
| Active Comparator: TSF + CM<br>Twelve-Step Facilitation (TSF) combined with Contingency Management (CM) | Behavioral: Behavioral therapy<br> <br> |
| Active Comparator: CRA + VC<br>Community Reinforcement Approach (CRA) combined with Voucher Control (VC) | Behavioral: Behavioral therapy<br> <br> |
| Active Comparator: TSF + VC<br>Twelve-Step Facilitation (TSF) combined with Voucher Control (VC) | Behavioral: Behavioral therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine abstinence |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced HIV risk behavior |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community reinforcement approach, Contingency management, 12-step facilitation counseling, Cocaine dependence, Women
Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which secreted by IGRP-specific T cell. Results were compared between these groups.

Official Title
-----------------
Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the criteria of type 1 and type 2 diabetes Exclusion Criteria: no diabetes
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 1 diabetes<br> | Other: No intervention<br>* No intervention<br>|
| type 2 diabetes<br> | Other: No intervention<br>* No intervention<br>|
| healthy people<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of positive reactivation against the IGRP epitopes |  | 5 months |
Is There Any Correlation Among Neonates Anthropometry and Neuromotor Behaviour

Study Overview
=================
Brief Summary
-----------------
To explore the association among anthropometric parameters and neuromotor behaviour in neonates for early identification and prediction of later neuromotor deficit.

Detailed Description
-----------------
The association between anthropometric (birth weight, length and occipitofrontal circumference) measurement and hands-on measurement of above mentioned anthropometric dimensions and demographic dimension (bilateral forearm, midarm, calf and thigh) with neuromotor behaviour were explored.

Official Title
-----------------
Association Among Anthropometric Parameters and Neuromotor Behaviour in Neonates

Conditions
-----------------
Cerebral Palsy, Autism or Other Neuromotor Behavior Abnormalities Correlation With Anthropometry

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates born between ≥28 weeks and ≤ 42 weeks of gestation Birth weight between 1500 and 3000 grams Neonates are born under all the classifications of Fenton growth charts (SGA, AGA and LGA) Stable Hemodynamics Free from infection Stable vitals Exclusion Criteria: Dermal conditions Chromosomal abnormalities History of surgery Neural tube defect Cardiac abnormally

Ages Eligible for Study
-----------------
Minimum Age: 28 Weeks
Maximum Age: 42 Weeks

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 |
| --- | --- | --- |
| Neuromotor behaviour | INFANIB scoring from 14- 70 score was documented | at the baseline, single time on day first of assessment | 
| Demographic dimension | Weight (kg) measured at baseline | at the baseline demographic dimension measured, single time on day first | 
| Demographic dimensions | length (cm) and occipitofrontal circumference (cm) measured at baseline | at the baseline demographic dimension measured, single time on day first | 
| Anthropometric measurement | Both the sides forearm (cm), midarm (cm), thigh (cm) and calf circumference (cm) measurement | Anthropometry was documented single time on same day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Correlation; infants; muscles; weight; length
Tobacco Cessation in Postmenopausal Women (Part I) - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers.

Detailed Description
-----------------
Female subjects were screened and randomized. Following two weeks of medication monitoring, all participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks (the experimental period), participants were randomized to a continued smoking or smoking abstinence condition. The abstinent group was provided with cessation counseling and monitored for abstinence. For all participants, data were collected during five clinic visits on all dependent measures: MNWS, QSU, Beck Depression Inventory (BDI), Profile of Mood States, Motor Speed Tasks and Reaction Time Tests. Question of interest was whether hormone replacement therapy would improve these dependent measures as manifested during short-term smoking cessation.

Official Title
-----------------
The Effects of ERT on Appetitive Behavior and Withdrawal in Short-term Smoking Cessation Compared to Smoking ad Lib in Postmenopausal Female Smokers.

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Behavior Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female smokers ages 40-79, smoking at least 15 cigarettes per day for at least one year, have natural menopause, have a transvaginal ultrasound to confirm loss of follicular activitiy, have a normal baseline mammogram, a normal chemistry at baseline, willing to take hormone replacement therapy for the duration of the study, normal thyroid function, and have a normal TSH. Exclusion Criteria: Women who have had formal dieting with or without pharmacological methods within the last three months; a weight change greater than or equal to 10 pounds within the last three months, BMI greater than or equal to 40, severe menopausal symptoms, active medical problems, alcohol or drug abuse, other forms of nicotine use.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Behavior Therapy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Cessation Outcomes |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tobacco Cessation, Postmenopausal Women
Topical Steroid Treatment After Posterior Lamellar Corneal Transplantation

Study Overview
=================
Brief Summary
-----------------
After corneal transplantation, topical corticosteroids are used to reduce the risk of rejection. However, the optimal postoperative treatment regimen is unknown. In most cases, a topical steroid is administered for at least 6 months after surgery, but it remains to be determined whether potent steroids offer better protection than weak steroids. Also, the length of the treatment is debated. Since the use of steroids is not without potential serious ocular side effects, it is of considerable importance to investigate these problems. The study aims to examine the frequency of rejection episodes after posterior lamellar keratoplasty; specifically comparing a short course of potent steroids versus a long course of weak steroids.

Official Title
-----------------
Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation

Conditions
-----------------
Endothelial Dystrophy, Secondary Bullous Keratopathy, Posterior Lamellar Keratoplasty, Descemet's Stripping Endothelial Keratoplasty

Intervention / Treatment
-----------------
* Drug: Weak steroid (Flurolon, Allergan)
* Drug: Potent steroid (Maxidex, Alcon)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated for primary or secondary corneal endothelial failure at the department of ophthalmology, Aarhus University Hospital Exclusion Criteria: Not fulfilling the above

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weak steroid<br>Initial treatment with dexamethasone 6x per day for two weeks, followed by Fluorometholone 4x per day for 2 months, 3x per day for 2 months, 2x per day for 2 months, and finally 1x per day continually during 2 years. | Drug: Weak steroid (Flurolon, Allergan)<br> <br> * Other names: Flurolon, Allergan;|
| Experimental: Potent steroid<br>Initially Dexamethasone 6x per day for 2 weeks followed by 4x per day for one month, 3x per day for one month, 2x per day for one month, and finally 1x per day for one month - giving a total of 4,5 months of steroid treatment. | Drug: Potent steroid (Maxidex, Alcon)<br> <br> * Other names: Maxidex, Alcon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from rejection |  | 2 years |