linjc16/ctgov huggingface dataset:
Study on the Myocardial Protective Effect of Upper Limb Ischemic Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

Study Overview
=================
Brief Summary
-----------------
The purpose of the study was to verify the myocardial protective effect of RIPC in patients undergoing OPCABG.

Detailed Description
-----------------
66 patients scheduled for OPCABG are randomly assigned to a RIPC group(n=33) or a control group(n=33). In the RIPC group, 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision. Patients in the control group wear the same cuff on an upper limb but no pressure is applied. Anesthetic and surgical techniques are standardized during the trial. Serum inflammatory cytokines and cardiac injury markers will be measured before and after surgery. Internal mammary artery and saphenous vein tissues will be collected during the surgery to assess hypoxia-inducible factor (Hif)-1a and other signalling proteins.

Official Title
-----------------
Study on the Myocardial Protective Effect of RIPC in Patients Undergoing OPCABG

Conditions
-----------------
OPCABG

Intervention / Treatment
-----------------
* Other: RIPC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: serious changes in several coronary arteries that need to receive OPCABG NHYA II-III ASA II-III Exclusion Criteria: LVEF< 35% acute myocardial infarction multiple organ dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC<br>4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb. | Other: RIPC<br>* 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision.<br>|
| Sham Comparator: control<br>patient in control group using a blood pressure cuff on an upper limb without inflating | Other: RIPC<br>* 4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU staying time | the time patients spend in ICU after surgery | average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RIPC, myocardial protective effect
Effect of Perineal Massage Combined With Cold Compress in the Second Stage on the Delivery Outcome of Primipara

Study Overview
=================
Brief Summary
-----------------
Objective: The aim of this study was to investigate the effect of perineal massage and cold compress in second stage on the delivery outcome of primipara. Method: This interventional study included a total of 200 primipara hoping for natural birth. Patients were randomly divided into two groups, one group used routine labor, one group used cold compress and perineal massage. Record the time of second stage of labor, degree of perineal laceration, etc.

Official Title
-----------------
Effect of Perineal Massage Combined With Cold Compress in the Second Stage on the Delivery Outcome of Primipara

Conditions
-----------------
Cold Compress

Intervention / Treatment
-----------------
* Behavioral: Perineal massage and cold compress


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: want give birth naturally have well developed perineum Exclusion Criteria: Abnormal fetal position and head basin Severe obstetric complications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: perineal massage and cold compress group<br> | Behavioral: Perineal massage and cold compress<br>* Using perineal massage and cold compress during the second stage of labor to observe the effect<br>|
| No Intervention: no intervention group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of second stage of labor | calculate the time taken for the second stage of labor | until the end of the second stage of labor | 
| Degree of perineal laceration | The degree of perineal laceration was judged according to the degree of perineal division table | about 30 minutes after the pregnant woman gives birth | 
| Lateral perineal resection rate | observe whether perineal lateral excision was performed during delivery | until the end of the second stage of labor | 
| Hospitalization days | observe how long pregnant women stay in the hospital | up to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
the second labor, perineal laceration, perineal massage
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot study is to provide credible performance estimate information in order to properly plan, design, and power a larger clinical study.

Official Title
-----------------
A Multi-reader, Multi-case, Controlled Clinical Trial to Evaluate the Fuji Film 3D Digital Mammography System Used in Conjunction With 2D Digital Mammography in the Detection of Breast Cancer / A Pilot Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: 3D
* Device: 2D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects participating in prior FMSU protocol with known clinical status Exclusion Criteria: Subjects with unkown clinical status Subjects not truthed in prior FMSU study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3D<br>Subjects that undergo 3D mammography | Device: 3D<br>* subjects that underwent 3D mammography<br>|
| 2D<br>Subjects that undergo 2D mammography | Device: 2D<br>* those subjects that underwent 2D mammography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Per Breast AUC | Breast AUC performance metrics to determine if 3D has improved breast cancer detection rate as compared to 2D. | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Recall Rate | For Cancer and Non-Cancer Cases to determine if 3D can reduce the need for follow-up mammography and/or improve time to determination of need for a biopsy | 1 Day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammography, 3D, Breast Cancer Detection
Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma

Study Overview
=================
Brief Summary
-----------------
Asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in asthma. Doctors have different ways to measure the inflammation in the airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by the lungs when asthmatic inflammation is present. The investigators have been using NO as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. In most asthmatics, even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in some people this does not seem to happen. The investigators now have portable NO machines that are designed for patients to use in the home. The investigators want to follow NO readings in patients with high levels to measure how they respond to different doses of steroid inhalers. The investigators hope this will help the investigators better understand asthma inflammation and treatments.

Official Title
-----------------
Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma

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

Intervention / Treatment
-----------------
* Drug: Fluticasone Propionate
* Drug: Fluticasone Propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day FENO greater than 30ppb on treatment Exclusion Criteria: Recent RTI or prednisolone Smoking within 1 year or 10 pack years ABPA, COPD, bronchiectasis

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High dose ICS<br>Fluticasone Propionate 250mcg bid | Drug: Fluticasone Propionate<br>* Inhaled Fluticasone Propionate 250mcg bid<br>|
| Active Comparator: Low dose ICS<br>Fluticasone propionate 50mcg bid | Drug: Fluticasone Propionate<br>* Inhaled Fluticasone Propionate 50mcg bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FENO |  | 2 weeks |
Database of Patients Treated With Respiratory Support

Study Overview
=================
Brief Summary
-----------------
An observatory of patients registered in 22 local homecare associations in France, for respiratory diseases, with annual data update. Demographic and clinical data are registered rendering possible extraction of clinical and prognostic data.

Detailed Description
-----------------
Patients on treatment for respiratory failure and for sleep apnoea are registered on entry into treatment with recording of clincal and demographic data. Data available on age, sex, region, respiratoy function, blood gases, smoking status and some bilogical data

Official Title
-----------------
Observatoire de l'ANTADIR - Database of Patients Registered as Treated With Respiratory Support in a Multicenter Homecare Federation for Patients Wirh Respiratory Problems

Conditions
-----------------
Chronic Respiratory Failure

Intervention / Treatment
-----------------
* Device: oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: requiring respiratory support
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oxygen therapy<br>Database of patients on oxygen | Device: oxygen<br>* oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea<br>* Other names: CPAP;|
| ventilation<br>database of patients on ventilatory support | Device: oxygen<br>* oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea<br>* Other names: CPAP;|
| Continuous positive airway pressure<br>Sleep apnoea patients on CPAP | Device: oxygen<br>* oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea<br>* Other names: CPAP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | long term follow up of a regularly updated database | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment adjustment | Change of treatment from oxygen to ventilatioion or other evolution | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory failure, oxygen, sleep apnoea, ventilation
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Study Overview
=================
Brief Summary
-----------------
Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.

Official Title
-----------------
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Conditions
-----------------
Diabetic Cardiomyopathy

Intervention / Treatment
-----------------
* Drug: Perhexiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus(WHO definition) HbA1C <9 No history of chest pain No evidence of Coronary Artery Disease or peripheral vascular disease Left ventricular ejection fraction over 50% No evidence of respiratory disease Exclusion Criteria: Patients < 16years or who cannot provide informed consent Evidence of significant epicardial coronary artery disease Evidence of peripheral vascular disease Abnormal liver function tests Clinically apparent peripheral neuropathy Severe chronic renal failure (creatinine >250) or diabetic nephropathy Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme Patients on statin therapy for primary dyslipidemia. Patients with recurrent hypoglycaemia Women of child bearing age who are not using effective contraception (or if pregnancy test positive)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Perhexiline<br>* Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Perhexiline<br>* Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio. |  | 2 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perhexiline, diabetes, diabetic cardiomyopathy, high energy phosphate kinetics, magnetic resonance spectroscopy
A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol

Study Overview
=================
Brief Summary
-----------------
This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.

Detailed Description
-----------------
This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive ASP1941 alone, Miglitol alone and ASP1941 + Miglitol.

Official Title
-----------------
A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.

Conditions
-----------------
Healthy Volunteers, Pharmacokinetics of ASP1941

Intervention / Treatment
-----------------
* Drug: ASP1941
* Drug: Miglitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests Body weight ; ≥50.0 kg, <80.0 kg Body Mass Index ; ≥17.6, <26.4 Written informed consent has been obtained Exclusion Criteria: Received any investigational drugs within 120 days before the screening assessment Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment Received medication within 7 days before hospital admission A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission History of drug allergies With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases Previous treatment with ASP1941

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one group<br>Subjects will receive ASP1941 alone, Miglitol alone and ASP1941 + Miglitol in different order. | Drug: ASP1941<br>* oral<br>Drug: Miglitol<br>* oral<br>* Other names: Seibule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples |  | For 72 hours after each administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1941, Miglitol
Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy.

Official Title
-----------------
Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study

Conditions
-----------------
Thyroidectomy

Intervention / Treatment
-----------------
* Device: application of oxidized regenerated cellulose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operable thyroid neoplasm Exclusion Criteria: a history of previous neck surgeries or uncontrolled medical diseases such as hyperthyroidism, diabetes, and hypertension administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interceed<br> | Device: application of oxidized regenerated cellulose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative adhesion after thyroidectomy
Paper vs. Internet

Study Overview
=================
Brief Summary
-----------------
Research has shown that questionnaires completed on the internet have the potential to provide more complete and honest data with fewer errors in a more efficient manner than questionnaires completed using the paper and pencil format. Despite the numerous advantages of internet-administered questionnaires, it is important to make sure that the internet questionnaires will yield comparable results to the well-established paper and pencil versions. No one has studied internet administration of scoliosis specific questionnaires in adolescents with scoliosis. The investigators will test whether the internet administration of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The investigators predict that the internet-administered questionnaire will provide the same reliability as the paper-administered questionnaires.

Official Title
-----------------
Internet-administered Adolescent Scoliosis Questionnaires Compared With Traditional Pencil and Paper Versions: a Randomized Crossover Design

Conditions
-----------------
Idiopathic Scoliosis, Adolescent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 10-18 Male or female Diagnosis of Adolescent or Juvenile Idiopathic Scoliosis Home access to computer and internet Capable or oral and written communication in English Exclusion Criteria: Unable to communicate in English

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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 |
| --- | --- |
| Paper/Paper<br>This group will complete paper questionnaires at baseline and two week follow up. | |
| Paper/Internet<br>This group will complete paper questionnaires at baseline and internet questionnaires at two week follow up. | |
| Internet/Paper<br>This group will complete internet questionnaires at baseline and paper questionnaires at two week follow up. | |
| Internet/Internet<br>This group will complete internet questionnaires at baseline and two week follow up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test the reliability of the internet-administered PODCI and SRS-30 questionnaires in adolescents with idiopathic scoliosis | The reliability of internet-administered questionnaires will be determined by comparison to standard paper questionnaire implementation. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scoliosis, Adolescents, Questionnaire, Reliability