linjc16/ctgov huggingface dataset:
Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla

Study Overview
=================
Brief Summary
-----------------
This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.

Detailed Description
-----------------
Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.

Official Title
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Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla

Conditions
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Adenoma, Villous

Intervention / Treatment
-----------------
* Procedure: Endoscopic Mucosal Resection


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: * Duodenal and ampullary lesion > 10mm Lesion limited to the mucosal and/or submucosal layer (T1 lesion) Aged 18 years or older Exclusion Criteria: Lesion less than 10mm Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS) Aged younger than 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Endoscopic Mucosal Resection<br>Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort. | Procedure: Endoscopic Mucosal Resection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the costs of this procedure compared to previous treatments | Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions | 14 days |
Home-based Disease Management Program to Improve Clinical Outcomes in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
Although many studies have demonstrated the efficacy of disease management programs on mortality, morbidity, quality of life (Qol), and medical cost in patients with heart failure (HF), no study has focused on psychological status as an outcome of disease management in patients with HF. Disease management could lead to the reduction of psychological distress, thus improving the self-care ability and adherence of patients with HF. In addition, very little information is available on the effectiveness of disease management programs in areas other than the US and Europe.The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE) has designed a randomized controlled trial to evaluate the efficacy of home-based disease management programs compared with usual care in improving psychosocial status, mortality, HF hospitalization, and Qol in Japanese HF patients.

Official Title
-----------------
The Japanese Heart Failure Outpatients Disease Management and Cardiac Evaluation (J-HOMECARE)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: Home-based disease management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria 1. Age ≥ 18 years Exclusion criteria End-stage HF defined as requiring mechanical support or continues intravenous inotropic support A serious life-threatening illness with a life-expectancy of <6 months Within the past 3 months Cognitive dysfunction Substance abuse or psychotic disorder Managed by visiting nursing Long distance between patients' home and hospital

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disease management<br> | Other: Home-based disease management<br>* Symptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses<br>|
| No Intervention: Usual treatment and care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial status (depression, anxiety) |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | up to 12 months | 
| Readmission due to heart failure |  | up to 12 months | 
| Hospital admission |  | up to 12 months | 
| Quality of life |  | up to 12 months | 
| Physical activity |  | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, disease management
The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.

Study Overview
=================
Brief Summary
-----------------
In total 50 subjects with iron deficiency anemia treated with intravenous iron are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant before iron treatment. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). patient will go face to face interview and will be asked to answer structured questionnaire which will include information on demographics, clinical data ( fever, allergies , etc.) and comorbidities Two weeks after completing intravenous iron administration additional blood samples will be taken: thrombin generation will be measured

Official Title
-----------------
The Purpose of the Study is to Examine Whether Iron Deficiency Anemia is Associated With Increased Production of Thrombin and Whether Correction of Anemia by Providing Iron Intravenously Causes a Significant Reduction in Production of Thrombin.

Conditions
-----------------
Iron Deficiency Anemias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years Iron deficiency anemia that did not response to oral iron treatment and is planned to receive iron supplement intravenously. Signing the informed consent exclusion criteria: chronic inflammatory disease renal failure Malignancy Infectious disease Other reason for anemia except iron deficiency anemia. Pregnant women Use of anti aggregating agents or anticoagulants

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thrombin generation levels |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemias, Iron-Deficiency, thrombin
Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.

Official Title
-----------------
A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.

Conditions
-----------------
Heart Surgery

Intervention / Treatment
-----------------
* Procedure: Left atrial appendage occlusion surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject undergoing coronary artery bypass grafting according to clinical indications; Age is more than 18 and less than 80 years old; Male and non pregnancy female; Subject understands study requirements and agrees to sign an informed consent from prior to study procedures. Exclusion Criteria: Pregnancy female; Participate in other clinical trial in the last 1 month. Subject doesn't agree to sign an informed consent from prior to study procedures. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery. New York Heart Association (NYHA) Class IV heart failure.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br> | Procedure: Left atrial appendage occlusion surgery<br>* CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage<br>|
| No Intervention: Sham Comparator<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 3 year after discharge (These data is collected during follow-up visit at in-hospital) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation |  | 3 year after discharge (These data is collected during follow-up visit at in-hospital) | 
| Composite of ischemic stroke, thromboembolism and all death |  | 3 year after discharge (These data is collected during follow-up visit at in-hospital) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery bypass graft, Left Atrial Appendage Occlusion, stroke, prevention
Clinical Significance of Hepatic Biomarkers in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Study Overview
=================
Brief Summary
-----------------
Lung cancer is the leading cause of cancer death worldwide. The emergence of immune checkpoint inhibitors (ICIs) has revolutionized the treatment of lung cancer over the past 10 years. Nivolumab, ipilimumab, pembrolizumab, atezolizumab, and durvalumab have been successively approved in non-small cell lung cancer, small cell lung cancer, and pleural mesothelioma. Although the efficacy of ICIs is remarkable in some patients, the objective response rate is only about 20%. The development of predictive biomarkers for treatment response is essential. Non-invasive methods and easily accessible biomarkers at low cost are required.ICIs activate the immune system through the inhibition of checkpoints (PD-L1, PD-1). The immune system and the liver are interconnected and constantly interact through a complex regulatory system. Patients with lung cancer frequently suffer from liver damage, due to metastases, treatments or underlying pathologies. The objective of the study is to evaluate the clinical significance of key liver biomarkers (AST, ALT, PAL, GGT, bilirubin, PT) in patients with lung cancer treated with ICI.

Official Title
-----------------
Significance of Hepatic Biomarkers in the Evaluation of Response to Treatment and Prognosis in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Conditions
-----------------
Immune Checkpoint Inhibitor, Lung Cancer, Liver Biomarkers, Transaminases

Intervention / Treatment
-----------------
* Other: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria: Age > 18 years Patient with lung cancer of any histological type Initiation of ICI therapy Signed consent for the study Exclusion Criteria: Patient with previous ICI treatment

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: Other
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood sample|Liver blood tests (AST, ALT, PAL, GGT, bilirubin, PT) will be performed before each ICI injection during the first three injections and again at 6 months.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| basal ALT blood concentration in lung cancer patients treated with ICI determined | To Identify baseline blood ALT concentration as a predictive liver biomarker of treatment response in lung cancer patients treated with ICI. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immune checkpoint inhibitor, Lung Cancer, liver biomarkers, transaminases
The Relationship Between Pre-pregnancy BMI and Weight Gain and Outcomes in Women With Twin Pregnancy

Study Overview
=================
Brief Summary
-----------------
Prepregnancy body mass index (BMI) and gestational weight gain (GWG) have Significant effects on the risk of pregnancy outcomes such as gestational hypertension disease and gestational diabetes mellitus in singleton pregnancies. This paper is to investigate the relationship between pre-pregnancy body mass index (BMI) and weight gain during pregnancy and pregnancy outcomes in women with twin pregnancy.

Official Title
-----------------
The Relationship Between Pre-pregnancy Body Mass Index (BMI) and Pregnancy Weight Gain and Pregnancy Outcomes in Women With Twin Pregnancy

Conditions
-----------------
Twin Pregnancy; Body Mass Index; Weight Gain; Pregnancy Outcome

Intervention / Treatment
-----------------
* Other: collect date about all participants


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18   41 years old; The gestational age of the first diagnosed twin pregnancy is ≤10weeks; Double chorionic double amniotic sac pregnancy; Exclusion Criteria: with heart disease, liver disease, kidney disease, complications (chronic hypertension, hyperthyroidism, diabetes and others ), genetic diseases, psychological and mental diseases; with history of habitual abortion and cervical insufficiency;

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| underweight woman with twin pregnancy<br>underweight (BMI < 18.5 kg/m2) | Other: collect date about all participants<br>* a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.<br>|
| normal weight woman with twin pregnancy<br>normal (BMI: 18.5-23.9 kg/m2) | Other: collect date about all participants<br>* a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.<br>|
| overweight and obese woman with twin pregnancy<br>overweight and obese (BMI ≥24 kg/m2) | Other: collect date about all participants<br>* a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of gestational diabetes mellitus, gestational hypertension and small for gestational age | pregnant outcome | 35 weeks to 40 weeks gestation |
The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

Study Overview
=================
Brief Summary
-----------------
This clinical study is for small-penis syndrome males who have previously been treated with hyaluronic acid filler for the purpose of increasing their penis. This study will determine the long-term efficacy and safety of Potenfill.

Official Title
-----------------
A Single-center, Open-label, Long-term, Exploratory Study to Determine the Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement

Conditions
-----------------
Penile Girth Enhancement, Penile Enhancement

Intervention / Treatment
-----------------
* Device: Potenfill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects aged above 19 and below 65. (20≤male≥65) Subjects will sign an informed consent form Exclusion Criteria: Prior treatment for penile enhancement (e.g. fat, dermal graft). Allergic to hyalluronic acid.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 65 Years

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

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: Potenfill<br> | Device: Potenfill<br>* Maximum: 22ml<br>* Other names: hyaluronic acid filler;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction on the penile appearance at 12 months after application of Potenfill | Satisfaction with the physical appearance of penis as assessed by the subject at 12 months after the application of investigational medical device. | 12 month |
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.

Official Title
-----------------
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: CardioFocus HeartLight Endoscopic Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 70 years paroxysmal atrial fibrillation failure of at least one AAD others Exclusion Criteria: overall good health as established by multiple criteria

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with HeartLight System<br>Treatment of paroxysmal atrial fibrillation (PAF) with HeartLight System | Device: CardioFocus HeartLight Endoscopic Ablation System<br>* PVI ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom From Recurrence of Atrial Fibrillation | Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, PAF