linjc16/ctgov huggingface dataset:
Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.

Official Title
-----------------
An Open-label, Randomized, Parallel Group, Multicentre Study to Compare Oestradiol Suppression Between ZOLADEX 10.8 mg Depot Given 3 Monthly and ZOLADEX 3.6 mg Depot Given Monthly in Pre-menopausal Patients With ER Positive Early Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Goserelin acetate
* Drug: Goserelin acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed ER +ve breast cancer who have undergone radical surgery and WHO performance status 0,1 or 2. Exclusion Criteria: Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Zoladex 3-month depot | Drug: Goserelin acetate<br>* injection 10.8 mg every 3 months<br>* Other names: Zoladex;|
| Experimental: 2<br>Zoladex 1-month depot | Drug: Goserelin acetate<br>* Injection 3.6 mg monthly<br>* Other names: Zoladex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zoladex 10.8mg depot (every 12 weeks) is non-inferior to Zoladex 3.6mg depot (every 4 weeks) in terms of oestradiol (E2) suppression in patient population by assessment of area under the curve of E2 concentration during the first 24 weeks of treatment. |  | every 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Zoladex 10.8mg has similar safety and tolerability profile to Zoladex 3.6mg. Examination of goserelin pharmacokinetics (PK) in Japanese patients after injection of Zoladex 10.8mg. Efficacy of Zoladex 10.8mg is similar to 3.6mg by assessment of DFS. |  | every 12 weeks |
Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. This study is a retrospective study to compare the efficacy of two drugs.

Detailed Description
-----------------
Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.

Official Title
-----------------
Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome: Retrospective, Multicenter Study

Conditions
-----------------
Myelodysplastic Syndromes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed MDS by bone marrow examination Receiving azacitidine and decitabine as a first line chemotherapy Adequate hepatic, cardiac, and renal function Exclusion Criteria: Previously treated with another anti-cancer therapy due to MDS Not available for clinical information

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Azacitidine<br>200 MDS patients taking Azacitidine will be assessed | |
| Decitabine<br>100 MDS patients taking Decitabine will be assessed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Compare Azacitidine and Decitabine's treatment response rate in MDS patients | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | To compare hematologic improvement between Azacitidine and decitabine | 6 months | 
| Survival rate | To compare survival rate between Azacitidine and decitabine | 6 months | 
| Number of participants with non-hematologic toxicities | To compare toxicity between Azacitidine and decitabine | 6 months | 
| infection rate | To compare infection rate between Azacitidine and decitabine | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDS
Prevention of Melasma Relapse During Summertime

Study Overview
=================
Brief Summary
-----------------
Main objective is to show that a photoprotective sunscreen having a protection against the visible light is more effective than a sunscreen having the same UVA AND UVB protection but with a low (weak) protection against the visible, to prevent the relapses of the melasma during the summertime.

Detailed Description
-----------------
40 melasma affected women will be included and randomized in two parallel groups (one group protected by a UVA+UVB+visible extended sunscreen and one group group protected by a UVA+UVB sunscreen). There will be 3 visits: Baseline, T2.5months and T5months (final visit). Products application frequency: twice daily(morning and afternoon) and additional applications every 2 hours in case of solar exposure. Main evaluation criterion: the MASI score assessed from standardized photographs (system VISIA, Canfield Scientific, USA) at Baseline, middle and end of study.

Official Title
-----------------
Prevention of Melasma Relapse During Summertime

Conditions
-----------------
Melasma

Intervention / Treatment
-----------------
* Other: Sunscream with visible light protection
* Other: Sunscream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Melasma Exclusion Criteria: Other pigmentary disorders associated (including PIH)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teinted sunscream<br>UVA, UVB and visible light protection (exactly the same UVA and UVB protection as the comparator) | Other: Sunscream with visible light protection<br> <br> |
| Active Comparator: Regular sunscream<br>UVA and UVB protection | Other: Sunscream<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between MASI scores before prevention treatment and after 6 months | MASI scores are evaluated by two physicians blinded to the treatment received on standardized pictures taken before treatment and after 6 months of summer period | 6 months |
Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University and also understand it's impact on post-operative outcomes.

Official Title
-----------------
Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Total Knee Arthroplasty: A Retrospective Cross-sectional Study From a Developing Country

Conditions
-----------------
Knee Arthroplasty, Total, Hypothermia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults greater than 18 years who underwent total knee arthroplasty. Exclusion Criteria: Any patient below 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Surgical Site Infection (SSI) | Post-operative infection caused total knee arthroplasty | 2016-2017 | 
| Post-operative hypothermia | Body temperature after surgery when patient is in the recovery room. | Within an hour after surgery |
Emergency Agitation in T&A

Study Overview
=================
Brief Summary
-----------------
Sevoflurane has been used commonly in pediatric anesthesia since 1990. However, it has caused more emergency agitation (EA) that other inhalation agents and the incidence is up to 80%. Therefore, lower minimum alveolar concentration of sevoflurane will reduce the EA when it is used with remifentanil in pediatric general anesthesia.

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

Intervention / Treatment
-----------------
* Drug: remifentanil
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist physical status I or II 2-6 year-old children patients undergoing tonsillectomy and adenoidectomy Exclusion Criteria: upper respiratory disease mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: group SR<br> | Drug: remifentanil<br>* General anesthesia is maintained witn sevoflurane and remifentanil.<br>|
| Active Comparator: group S<br> | Drug: normal saline<br>* General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergency agitation | at post-anesthetic care unit | during 1 hour after recovering of anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy pediatric patients undergoing tonsillectomy and adenoidectomy
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Rheumatic heart disease usually accompanied by weakened immune function. And the cardiopulmonary bypass further aggravating the decline of immune function. Therefore, the prevention of Postoperative immune function collapse is of great clinical value, and immunomodulatory therapy with thymosin alpha 1 may be beneficial. This study was designed to test the hypothesis that the administration of thymosin alpha 1 will Improve the immune function and prognosis of patients.

Official Title
-----------------
Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass

Conditions
-----------------
Rheumatic Heart Disease, Cardiopulmonary Bypass, Immunotherapy

Intervention / Treatment
-----------------
* Drug: Thymosin Alpha1
* Other: Blank Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients are conformed to 2004 WHO guidelines for Rheumatic fever and rheumatic heart disease; Patients planning to undergo cardiac surgery were enrolled. The patients' age between 18  80 years old. Agree to participate in the study and sign the informed consent. Exclusion Criteria: Patients allergic to Thymosin α1; Lactating women and pregnant women; Patients with mental diseases, drug and alcohol dependence; Refuse to participate in this study and refuse to sign the informed consent

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymosin alpha 1<br> | Drug: Thymosin Alpha1<br>* Thymosin alpha 1, 1.6mg injection hypodermic (I.H), every 12 hours for 5 days at least during the ICU admission. The administration will be terminated any day during the treatment when the patient is deemed as qualified for ICU discharge or dead<br>|
| Sham Comparator: Blank control<br> | Other: Blank Control<br>* the Control group did not receive Thymosin alpha 1 or any placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The highest Sequential Organ Failure Assessment (SOFA) score of 5 days after surgery |  | 5 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Death from any cause of 30 days after randomization | 30 days after randomization |
The Gut-lung Axis in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Patients with chronic obstructive pulmonary disease (COPD) are 2-3 times more likely to occur together with chronic gastrointestinal tract (GIT) diseases, such as inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS). Similarly, despite many patients have no history of acute or chronic respiratory disease, up to 50% of IBD patients and 33% of IBS patients have pulmonary involvement, such as inflammation or impaired lung function. Increasing evidence indicated chronic gut and lung disease share key conceptual features with the disorder and dysregulation of the microbial ecosystem. However, the underlying mechanisms are not well understood. Our study is aimed to elucidate the intimate relationship between the gastrointestinal tract and respiratory tract, and uncover the mechanisms by which the gut microbiota affects the immune responses in the lungs, and vice versa.

Official Title
-----------------
Dynamic Changes of the Respiratory Microbiota and Its Relationship to Fecal Microbiota in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Microbiota, Immunity, Mucosal, Metabolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted to hospital with an exacerbation of COPD; with no history of probiotics taken; the duration of antibiotics treatment before enrollment should be less than 72 hours. Exclusion Criteria: being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy; history of long-term nursing home stays; history of recently hospitalized (<90 days).

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

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 |
| --- | --- |
| COPD<br>Patients who admitted to Peking Universtiy People's Hospital and Ningde City Hospital between January 2017 and January 2019 with AECOPD will be enrolled | |
| healthy control<br>People aged over 40, without any chronic respiratory disease or acute respiratory infections in the last 2 weeks, and be willing to participate in the study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality | all-cause death after the enrollment | patients will be followed for 3 months after their remission from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exacerbations | exacerbations of COPD | during the 3-month follow-up |
Rajaie Cardiomyopathy and Myocarditis Registry

Study Overview
=================
Brief Summary
-----------------
The prevalence of patients with cardiomyopathies who referred to Rajaei Cardiovascular medical and research center is remarkable, and also the mission of this center is to achieve center of excellence in the field of cardiomyopathy. Rajaie Cardiomyopathy and myocarditis Registry study is an observational registry of consecutive patients with four cardiomyopathy subtypes: hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), and restrictive cardiomyopathy (RCM) as well as myocarditis designed to determine clinical characteristics, natural history, current therapeutic approaches, response to treatment and long-term outcomes of patients with cardiomyopathy and myocarditis and to address limitations in extant evidence to improve prognostication in cardiomyopathies and myocarditis. Prediction of mortality and response to different treatments in these patients using artificial intelligence is another aim of this registry

Official Title
-----------------
Rajaie Cardiomyopathy and Myocarditis Registry

Conditions
-----------------
Clinical Characteristics, Natural History, Long-term Outcomes, Current Therapeutic Approaches

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age greater than one year documented cardiomyopathy/ myocarditis fulfilling standard diagnostic criteria able to give informed consent or in the case of child consent from a parent Exclusion Criteria: Patients who have not consent to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Admissions to hospital | Number of hospitalizations for cardiovascular reasons | 1 year | 
| Development of chronic heart failure | significant decrease in left ventricular ejection fraction | 1 year | 
| Prevalence of Stroke/Transient ischemic attack | At least 80% CT/MRI verification of the diagnosis of ischemic stroke/Transient ischemic attack, within the first week of stroke onset | 1 year | 
| Incidence of sudden death | unexpected death from a cardiovascular cause in a person with or without preexisting heart disease | 1 year | 
| Incidence of heart trasplantation | Cardiac transplantation in patients with end-stage HF who remain symptomatic despite optimal medical therapy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to current therapeutic approaches | Implantable cardioverter defibrillator implantation, Cardiac resynchronisation therapy, septal myectomy, ablation, cardiac transplantation and medications | 1 year |
Benefit of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of topical hemostatic powder containing hydrophilic polymer with potassium ferrate for bleeding control after nail surgical procedures

Official Title
-----------------
The Evaluation of Topical Hemostatic Powder Containing Hydrophilic Polymer With Potassium Ferrate for Hemostasis Following Nail Surgery

Conditions
-----------------
Nail Diseases

Intervention / Treatment
-----------------
* Device: Hydrophilic polymer and potassium ferrate powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Patients scheduled for any type of nail surgical procedure Willingness to participate in the study Ability to understand all instructions in the English language Exclusion Criteria: Failure to have nail surgery performed Likely inability to comply with the study protocol or cooperate fully with the research team

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrophilic polymer and potassium ferrate powder<br>Hydrophilic polymer with potassium ferrate powder is applied to the surgical wound with pressure until hemostasis is achieved | Device: Hydrophilic polymer and potassium ferrate powder<br>* Application with pressure until hemostasis is achieved<br>|
| No Intervention: Direct pressure with sterile gauze<br>Direct pressure with sterile gauze is applied to the surgical wound until hemostasis is achieved | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (in seconds) to bleeding cessation with hydrophilic polymer and potassium ferrate; time (in seconds) to bleeding cessation with direct pressure with sterile gauze | Time (in seconds) will be measured from application of intervention/nonintervention until bleeding cessation | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with at least one adverse event | Adverse events will only include those that are determined to be related to the study device | End of study (28 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nails, Nail Surgery, Hemostasis, Potassium Ferrate