linjc16/ctgov huggingface dataset:
Study of Surgical Treatment Versus Observation in Children With Moderate Intermittent Exotropia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the long-term effect and security of the surgical treatment and observation only on ocular alignment, binocular stereopsis, and quality of life in children with moderate intermittent exotropia.

Official Title
-----------------
Long-term Prospective Randomized Controlled Clinical Study on Surgical Treatment of Moderate Intermittent Exotropia

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

Intervention / Treatment
-----------------
* Procedure: recession or resection of the horizontal extraocular muscles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To correspond the definition of IXT: monocular or binocular alternative exotropia, exodeviation at distance for 15 prism diopters at least, can control the normal ocular alignment, normal ocular movements. Simultaneous perception and fusion point in synoptophore, but no normal function of fusion and stereopsis. Age at from 5 to 18 years, sex unlimited. No treatment for IXT previously (including surgical and non-surgical treatment). No amblyopia. Signed informed consent form voluntarily. Exclusion Criteria: Accompanied with ocular organic diseases. Accompanied with systemic diseases (e.g. nervous system disease). Unable to regular follow-up (e.g. from countryside and outlying district). Investigators concluded that should be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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: Surgical treatment<br>The recession or resection of the horizontal extraocular muscles will be processed in the beginning of the trial. | Procedure: recession or resection of the horizontal extraocular muscles<br> <br> |
| No Intervention: Observation only<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular alignment (Prism alternative cover test) |  | 5 years | 
| Binocular stereopsis at distance and near (Random dot stereopsis test) |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newcastle control scores |  | 5 years | 
| The intermittent exotropia questionnaire |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
moderate intermittent exotropia, surgical treatment, observation
EVOLUTION® Duodenal Stent for Duodenal or Gastric Outlet Obstruction Caused by Malignant Neoplasms

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to compile clinical experience on the use of the Evolution® Duodenal Stent (Cook Ireland), a CE marked device intended for the palliative treatment of duodenal or gastric outlet obstruction and duodenal strictures caused by malignant neoplasms. It is not the goal to change the usual treatment practice of the investigator or the center, nor to collect information on uses outside the product's indications. Patients will be treated as per usual medical practices.

Official Title
-----------------
Treatment of Duodenal or Gastric Outlet Obstruction and Duodenal Strictures Caused by Malignant Neoplasms With the EVOLUTION® Duodenal Stent

Conditions
-----------------
Duodenal Obstruction, Gastric Outlet Obstruction

Intervention / Treatment
-----------------
* Device: EVOLUTION® Duodenal Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for whom this device would be chosen in standard practice Exclusion Criteria: Patients for whom this device would not normally be chosen in standard practice

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVOLUTION® Duodenal Stent<br> | Device: EVOLUTION® Duodenal Stent<br>* EVOLUTION® Duodenal Stent<br>* Other names: TC325;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of the stent |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success, implant duration, symptom resolution |  | up to 6 months |
The Evaluation for Prognostic Factors After Catheter Ablation of Atrial Fibrillation: Cohort Study

Study Overview
=================
Brief Summary
-----------------
1. Purpose of the study 1) To explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics. 2) To develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. Scientific evidence of the study In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy. clinical outcome after catheter ablation is affected not only by age, sex and underlying disease, but also by electrophysiologic, imaging, serologic and electroanatomical remodeling of the heart. However, there are few studies concerning these multifactorial variables. 3. Study population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation Exclusion Criteria: patients who do not agree with study inclusion permanent AF refractory to electrical cardioversion AF with valvular disease ≥ grade 2 patients with left atrial diameter greater than 60mm patients with age less than 19

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Yonsei AF Cohort<br>Patients with atrial fibrillation who undergoing catheter ablation of atrial fibrillation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recurrence of atrial fibrillation (AF) after catheter ablation | We defined recurrence of AF as any episode of AF or atrial tachycardia lasting longer than 30 sec. Patients were asked to attend scheduled outpatient follow-up appointments 2, 6, 12, 18, 24, 36, 48 and 60 months after catheter ablation. | Participants will be followed for 5 year after catheter ablation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, catheter ablation, recurrence
A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use

Study Overview
=================
Brief Summary
-----------------
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in patients with relapsed or refractory multiple myeloma (hereinafter referred to as relapsed or refractory MM) who have received long-term treatment with it under the actual condition of use. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled, 300, is reached (estimated to be approximately 1 year and 3 moths). Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).

Official Title
-----------------
Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance. Exclusion Criteria: N/A

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Relapsed or refractory multiple myeloma (MM) patients<br>Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and this surveillance. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse events | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Teratogenicity, Thrombocytopenia and haemorrhage, Neutropenia and infection, Venous thromboembolism, Allergic reactions, Diarrhoea or constipation, Peripheral neuropathy, Cardiac failure, Arrhythmia, Renal failure, Myocardial infarction, Interstitial lung disease, Tumour lysis syndrome
A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to prospectively assess the relationship between changes in hemoglobin (hgb) and changes in symptom burden associated with anemia in cancer patients receiving chemotherapy supported with Aranesp®.

Official Title
-----------------
A Study to Assess Symptom Burden in Subjects With Nonmyeloid Malignancies Receiving Chemotherapy and Aranesp®

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Aranesp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with nonmyeloid malignancy(ies) Anemia (hgb less than or equal to 11.0 g/dL) due to cancer and chemotherapy Exclusion Criteria: Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndromes (MDS) Unstable cardiac disease or anemia due to other causes

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aranesp|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemoglobin endpoints and RBC transfusion requirements |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy induced anemia, Amgen, Aranesp®, darbepoetin alfa
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore

Study Overview
=================
Brief Summary
-----------------
Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.

Official Title
-----------------
Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes

Conditions
-----------------
COVID, Coronavirus, COVID-19

Intervention / Treatment
-----------------
* Drug: Hydroxychloroquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic with COVID illness (either RT-PCR test confirmed or highly suspect clinical symptoms) Call into office within the first 7 days of illness Have any of the following high risk conditions: Age >60 HTN, CAD, or chronic heart disease Diabetes Chronic kidney disease Chronic lung disease Active or recent chemotherapy for malignancy Organ transplant Taking Immune-suppressing medications HIV with CD4 <200 cells/mm3 Experiencing at least one of the following high risk symptoms: Severe cough Fever 100.0F or greater Diarrhea Shortness of Breath Hypoxia Exclusion Criteria: • HCW not meeting high-risk criteria or those with a contraindication to HCQ will not be offered HCQ

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Eligible participants will be offered the standard Montefiore HCQ dosing regimen of 400mg every 12 hours x 24 hours, then 400mg daily for remaining 4 days and complete a survey study | Drug: Hydroxychloroquine<br>* 400 mg tablet<br>|
| No Intervention: Control Group<br>Participants who opt not to receive the study drug will also be invited to participate in the survey study assessing COVID19 symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of symptoms | Time that it takes for symptoms to be resolved in those who were treated vs untreated | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days from onset of illness to symptom resolution |  | up to 4 weeks | 
| Number of days to return to work |  | up to 4 weeks | 
| Rate of hospital admission in treated and untreated healthcare workers |  | up to 4 weeks | 
| Adverse effect of HCQ during treatment |  | up to 5 days |
Personality of Diabetic Patients Will Influence Their Medical compliance-a 5 Years Cohort Follow up With Type D Personality

Study Overview
=================
Brief Summary
-----------------
Diabetes is one of the most common causes of death in Taiwan. With the raising prevalence of diabetes, it became the fourth most common cause of death since 2002. Up to one-tenth of the national health insurance expenditure was used directly in diabetic care. Besides, more expenditure was used in the management of the complications of diabetes, like vascular diseases, renal disease, blindness and neuropathy. Diabetes is a chronic disease, the target treatment is to control HbA1c below 7%, by intensive life style modification, diet control, exercise and medications. Diabetic patient should have a good medical compliance, in order to prevent the tragedy of the complication. A good medical compliance is depended on the individual personality. Personality is the major cause of chronic stress, which is one of the most important cause of psychological stress and the risk factors of the vascular disease and hypertension. Recently, Type D personality had shown the close relationship with patients' prognosis, morbidity, mortality and life quality in different vascular diseases. These vascular diseases are the result of the atherosclerotic process, and diabetes is one of the most important risk factors of the atherosclerotic changes. The investigators believed that type D personality may also affect the medical compliance, the severity (in terms of HbA1c), and the prognosis of diabetic patients. The first part of this study is a cross sectional study, the investigators will try to figure out the relationship of the type D personality toward diabetic medical compliance, and their comorbidity. The second part of this study is a cohort study, base on the population in first part of the study, the investigators will like to construct the correlation of type D personality and diabetic patients' 5-years complication and mortality. The investigators want to establish a more complete vascular care system, improve the medical compliance, lower the complication rates, and improved the quality of life.

Official Title
-----------------
Personality of Diabetic Patients Will Influence Their Medical compliance-a 5 Years Cohort Follow up With Type D Personality

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T2DM patients for OPD Age 18-80 y/o Inform consent

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Type D personality, diabetes, medical compliance, HbA1c, complication, mortality, T2DM
of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).

Study Overview
=================
Brief Summary
-----------------
An observational, non-interventional, multi-centre study to provide further information on the utility of test for a predictive marker by investigating the current prevalence of high sensitivity CRP (hs-CRP) testing and characteristics of each CVD risk group.

Official Title
-----------------
of PATient Education Related to CV Risk factOrs in Type 2 Diabetes Mellitus(Patrol).

Conditions
-----------------
Low Density Lipoprotein Cholesterol Goal Achievement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who was diagnosed as diabetes Subjects who was diagnosed as dyslipidaemia or takes lipid lowering medication Clinic visit in the past 6 months more than once Exclusion Criteria: Subjects who are unwilling or unable to provide their examination and lab result of medical chart.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2500 patients<br>Who have records of clinic visit with endocrine internal medicines of nationwide secondary/tertiary hospitals within the last six months. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate LDL-C goal achievement rate according to ADA recommendation |  | Within the last 6 months from the date of data entry. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate reduction of 10-year risk for CHD by using UKPDS risk engine |  | Within the last 6 months from the date of data entry. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADA recommendation