linjc16/ctgov huggingface dataset:
Lifestyle Intervention for Prevention of Gastric Neoplasm

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether positive lifestyle interventions (diet modification and smoking cessation) are effective in the prevention of gastric pre-cancer and cancer occurrences and reccurence of gastric cancer after endoscopic resection.

Official Title
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Positive Lifestyle Interventions for the Prevention of Gastric Pre-cancer and Cancer Occurrences in Patients With Chronic Atrophy Gastritis and Reccurence of Gastric Cancer After Endoscopic Resection

Conditions
-----------------
Stomach Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Active measures of lifestyle modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic atrophy gastritis proved by gastroscopy biopsy pathology or early gastric cancer patients who have recieved endoscopic resection have one or several bad lifestyle habits such as eating too much salt, eating too few fruits, smoking, drinking wine, and lack of sleep. Exclusion Criteria: patients who refuse to change lifestyle according to the trial plan
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to lifestyle intervention group or the control group without lifestyle intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle intervention<br>A better lifestyle that are supposed to prevent gastric cancer occurrence are advised to patients. Measures includes dietary change and cessation of smoking and alcohol abuse. Behavioural and cognitive strategies from investigators are performed to patients to ensure adherence to established intervention. | Behavioral: Active measures of lifestyle modification<br> <br> |
| No Intervention: No intervention<br>No meassures are taken to change life style of enrolled patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric caner occurrence | gastric cancer proved by gastroscopy biopsy | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 5 years | 
| gastric tissue DNA methylation change of selected genes | All patients have gastric biopsy through gastroscopy at the enrollment time and the last follow-up. DNA methylation status of selected genes are tested. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lifestyle, early gastric cancer
Enteral Feeding Study of Formula Containing Fish Oil in Critical Care Setting

Study Overview
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Brief Summary
-----------------
The purpose of this study is to evaluate the clinical applicability of an enteral tube feeding formula containing fish oil and prebiotics in a critical care population.

Detailed Description
-----------------
In terms of nutrition support in the acute care setting, it is generally accepted that earlier is better enteral is superior to parenteral the quality of nutrients appears more important than quantity select populations will show additional benefit from specific nutrient supplementation. The current study is designed to evaluate the tolerance of an enteral formula in trauma and surgery patients, as demonstrated by achieving and maintaining enteral feeding goal, gastrointestinal tolerance and inflammatory markers.

Official Title
-----------------
Use of a High-protein Enteral Formula Containing Prebiotics and Fish Oil in Critical Care

Conditions
-----------------
Trauma, Tube Feeding

Intervention / Treatment
-----------------
* Procedure: Tube feeding


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 18 - 70 years old New ICU admit Enteral tube feeding anticipated for at least 7 days Informed consent Exclusion Criteria: Enteral tube feeding immediately prior to admit Parenteral feeding Medical condition that preclude receiving tube feeding or formula Determined by PI to be inappropriate Participating in another clinical trial

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 |
| --- |
|Procedure: Tube feeding|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical applicability as measured by the length of time between start of feeding to the first achievement of 800ml/day |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance |  |  | 
| Time to advance to full feed |  |  | 
| Inflammatory markers |  |  | 
| Infection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enteral feeding, critical care, fish oil, surgical
Lateral Rectus Muscle and Anterior Segment Optical Coherence Tomography (AS-OCT)

Study Overview
=================
Brief Summary
-----------------
•Background and study aims : The investigators conducted this study to evaluate the movement of extraocular muscle after strabismus surgery with non-invasive tool called AS-OCT. Who can participate? patients who underwent typical lateral rectus recession surgery for correcting intermittent exotropia What does the study involve? Volunteers will attend a clinic for four visits over six months. They will undergo AS-OCT at every visits during follow up period. AS-OCT is non-invasive test to evaluate operation site. The test only requires their cooperation when they undergo AS-OCT. What are the possible benefits and risks of participating? This is non-invasive test for your postoperative follow up. Therefore, there will be no risks about this test. Where is the study run from? Samsung Medical Center When is the study starting and how long is it expected to run for? From Feb 2014 to Dec 2014

Detailed Description
-----------------
The aim of this study is 1) to evaluate the reliability and accuracy of AS-OCT in the measurement of the lateral rectus (LR) insertion distance, 2)to investigate the longitudinal change of LR muscle insertion after strabismus surgery, and 3)to determine the effect of insertion movement on the angle of deviation after strabismus surgery. An AS-OCT scan of the LR muscle was performed every visits. Preoperative limbus-LR insertion distance was compared with intraoperative surgical caliper measurement of LR insertion using intraclass correlation coefficient analysis (ICC). Data on gender, age, degree of deviation (prism diopter), and spur-LR insertion distance using AS-OCT were collected at postoperative months 1,3 6.

Official Title
-----------------
Pre and Post-operative Rectus Muscle Insertion Site Changing Using Anterior Segment Optical Coherence Tomography in Strabismus Patients

Conditions
-----------------
Intermittent Exotropia

Intervention / Treatment
-----------------
* Procedure: lateral rectus recession


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent lateral rectus recession surgery for correcting intermittent exotropia Exclusion Criteria: previous ocular surgery other ocular diseases except intermittent exotropia amblyopia

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: lateral rectus recession|typical surgery for correcting intermittent exotropia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of limbus-muscle insertion distance measured with AS-OCT |  | baseline and 1.3.6 months |
The Physiological Effect of High Flow Oxygen Therapy

Study Overview
=================
Brief Summary
-----------------
Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.

Official Title
-----------------
The Physiological Effect of High Flow Oxygen Therapy on Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Conditions
-----------------
High-flow Nasal Cannula, Non-invasive Positive Pressure Ventilation, Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Device: HFNC
* Device: NPPV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AECOPD patients with acute hypercapnic respiratory failure Exclusion Criteria: other lung/pleural diseases or thoracic deformity severe heart failure (New York Heart Association class IV), severe dysrhythmia unstable angina, or malignant comorbidity obesity (BMI ≥ 35 kg/m²) severe obstructive sleep apnea syndrome

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNC group<br>AECOPD patients receive ventilation support via HFNC. | Device: HFNC<br>* HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.<br>|
| Active Comparator: NPPV group<br>AECOPD patients receive ventilation support via NPPV. | Device: NPPV<br>* NPPV is the standard therapy for ventilatory failure in AECOPD.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural respiratory drive | Neural respiratory drive is calculated by diaphragm electromyogram | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work of breathing | Work of breathing is calculated by the transdiaphragmatic pressure | 30 minutes | 
| Transcutaneous CO2 | Transcutaneous CO2 is a non-invasive method estimated the partial pressure of arterial blood CO2. | 30 minutes |
Quantification of UE Use and Effects of Feedback in the Home Setting

Study Overview
=================
Brief Summary
-----------------
The investigators are proposing a pilot study, the purpose of which is to use accelerometers to quantify UE use (1 and two hand use) in people post-stroke from which the investigators will develop use-based feedback to improve recovery in the home setting. The objectives of this pilot study are to: i.) determine the feasibility of using accelerometers to quantify amount of UE use in the home setting in individuals chronic post-stroke, ii.) quantify and compare the unilateral activity of the weaker (paretic) versus stronger (non-paretic) UEs, and iii.) assess the effect of a 7 sessions of in-home accelerometer used-based feedback on unilateral and bilateral UE use. iv.) assess kinematic, kinetic, and EMG data during UE movements unilaterally and bilaterally in subjects post-chronic stroke pre and post feedback.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Accelerometer based feedback about paretic arm use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects post-stroke chronic post ischemic or hemorrhagic cortical or subcortical stroke 25 - 100 years old upper extremity impairment Subjects will need to be able to flex their paretic shoulder and their elbow > 40° without assist able to follow 2-step commands community dwelling with or without assistance intact superficial light touch sensation in both upper extremities must also have some movement in both arms Exclusion Criteria: can't currently have another neuromuscular disorders such as spinal cord injury, traumatic brain injury, Parkinson disease or multiple sclerosis no upper extremity injury within the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 100 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: Feedback Intervention<br> | Behavioral: Accelerometer based feedback about paretic arm use<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer based paretic arm amount of use |  | 3 week period |
Study Evaluating IMA-026 in Healthy Japanese Males

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending, single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Japanese Male Subjects

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

Intervention / Treatment
-----------------
* Drug: IMA-026


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men ages 20 to 40 years, inclusive, at screening Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight > 45 kg Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vitals signs, and 12 lead ECG.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IMA-026|SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses. |  | 6 months |
Pediatric Perioperative Satisfaction Questionnaire

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.

Detailed Description
-----------------
Step 1 : development of the questiontionnaire Face to face interview to report the satisfaction of the children after surgery and to identify recurrent themes to generate questions. Step 2 : validation of the questionnaire Evaluation of the psychometric validity of the final questionnaire

Official Title
-----------------
Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population

Conditions
-----------------
Perioperative, Children, Satisfaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: children 7 years and older elective surgery general anesthesia abiliy to understand and read questions Exclusion criteria: emergency cognitive trouble intellectual disability

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 Years

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 |
| --- | --- | --- |
| Children satisfaction after surgery | to develop a questionnaire (score 0 to 100) to assess the satisfaction of children after surgery (from the day of surgery to 2 weeks) | at discharge of hospital ( from the day of surgery up 14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain intensity | to assess the level of children postoperative pain intensity (from the day of surgery to 2 weeks). Pain was assessed using the Face Pain Scale revised tool (0-10). | at discharge of hospital ( from the day of surgery up 14 days) | 
| perioperative anxiety level | to assess perioperative anxiety level using the Visual Analog Scale (0-10) of children after surgery (from the day of surgery to 2 weeks) | at discharge of hospital ( from the day of surgery up 14 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Validity, Questionnaire, Children, health quality of life, Self report
CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
In order to identify the association between clonal hematopoiesis of indeterminate potential (CHIP) and cardiovascular risks after smoking cessation, this study intends to recruit ACS patients undergoing complete revascularization and perform whole-exome sequencing for enrolled patients to identify the prevalence of CHIP mutations. After 1-year follow-up, the relationship of presence of CHIP mutations and the occurrence of MACCEs will be explored, irrespective of smoking cessation or not. CHIP may be a potential risk factor of poor prognosis of ACS.

Official Title
-----------------
Clonal Hematopoiesis of Indeterminate Potential and Residual Cardiovascular Event Tendency After Smoking Cessation

Conditions
-----------------
ACS, Clonal Hematopoiesis of Indeterminate Potential, Smoking Cessation

Intervention / Treatment
-----------------
* Genetic: clonal hematopoiesis of indeterminate potential


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. In-patients with acute coronary syndrome to undergo PCI 2. Complete revascularization during the index hospitalization 3. Written informed consent Exclusion Criteria: 1. Periprocedural complications (coronary artery dissection, perforation, myocardial infarction, stroke, death) 2. Planned coronary revascularization at discharge 3. Patients with severe chronic disease (uremia, liver cirrhosis, COPD (chronic obstructive pulmonary disease) 4. Abnormal blood counts caused by hematological diseases 5. Diagnosed malignancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Current-smoking<br>exposure: smoking | Genetic: clonal hematopoiesis of indeterminate potential<br>* Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)<br>|
| Smoking-cessation<br>exposure: smoking cessation | Genetic: clonal hematopoiesis of indeterminate potential<br>* Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)<br>|
| non-smoking<br>exposure: none | Genetic: clonal hematopoiesis of indeterminate potential<br>* Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of CHIP mutations | Whole-exome sequencing is performed to detect the presence of CHIP mutations | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | MACCE includes cardiac death, non-fatal MI, non-fatal stroke, rehospitalization due to heart failure, ischemia-driven revascularization at 12 months | 1 year |
Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
Urodynamic study is an objective method to evaluate female patients with lower urinary tract symptoms (LUTS). However, this method includes place a urinary catheter, thus prevents it as a routine method to evaluate and follow up patients with LUTS. Therefore, it is necessary to find a simple and objective method to help in evaluating female patients with LUTS. Several kinds of biomarker had been reported in diagnosing patients with overactive bladder; however, the sensitivity remained poor. The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS.

Official Title
-----------------
Studies of Biomarkers in Different Urodynamic Diagnoses of Female Patients With Lower Urinary Tract Symptoms

Conditions
-----------------
Lower Urinary Tract Symptoms

Intervention / Treatment
-----------------
* Other: biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All female patients (> 20 years) with Lower urinary tract syndrome. Exclusion Criteria: Female patients with tumor and stone were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| urodynamic studies<br> | Other: biomarkers<br>* To define a biomarker or combination of overactive bladder syndrome<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The aim of this study is to find a useful biomarker, biomarkers, or combinations, with the aid of urodynamic study, to objectively and precisely in evaluating the female patients with LUTS. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lower urinary tract symptoms, biomarkers, urodynamic studies