linjc16/ctgov huggingface dataset:
A Registry Study on Serumal Biomarkers About Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.

Study Overview
=================
Brief Summary
-----------------
This is a national registry study to determine the serumal biomarkers for prognosis of adverse events in patients undergoing coronary artery bypass grafting.

Official Title
-----------------
A Chinese Registry to Determine the Serumal Biomarkers for Prognosis of Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: A type of operation for coranary heart disease patients.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject undergoing coronary artery bypass grafting; Age is more than 18 and less than 80 years old; Male and non pregnancy female; Subject who 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 who doesn't agree to sign an informed consent from prior to study procedures. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.

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 |
| --- | --- |
| Cohort<br> | Procedure: A type of operation for coranary heart disease patients.<br>* A type of operation for coranary heart disease patients.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death and cardiac death |  | These data is collected during follow-up visit at in-hospital/1 year after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) | A composite of death, myocardial infarction, stroke, heart failure, ventricular arrhythmia | These data is collected during follow-up visit at in-hospital/1 year after discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery bypass graft, Biomarker, Prognosis
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension

Study Overview
=================
Brief Summary
-----------------
Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension

Detailed Description
-----------------
This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the IVC collapsibility index.

Official Title
-----------------
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anaesthesia: A Prospective Observational Cohort Study.

Conditions
-----------------
Hypotension on Induction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adult patients (>18years) ASA I-II Exclusion Criteria: • ASA physical status > II Dyspnea Systolic blood pressure ≥ 180 mmHg Systolic blood pressure < 90 mmHg Agitation (RASS > 1) IVC non visualized Epidural catheter in use Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC). Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| • Comparison of the accuracy Area under receiver operating characteristic curves (AUROC) of IVCD:AoD index and IVCCI in prediction of post-induction hypotension | Measurement of pre-operative IVC-AOrta diameter index and IVC collapsibility index | 15 minutes |
An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)

Study Overview
=================
Brief Summary
-----------------
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).

Conditions
-----------------
Macular Edema

Intervention / Treatment
-----------------
* Drug: dexamethasone 700 ㎍ intravitreal implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice Exclusion Criteria: None

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 |
| --- | --- |
| dexamethasone 700 ㎍ intravitreal implant<br>Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices. | Drug: dexamethasone 700 ㎍ intravitreal implant<br>* Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.<br>* Other names: OZURDEX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye |  | Baseline, 12 Months | 
| Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye |  | Baseline, 12 Months | 
| Average Change from Baseline in BCVA in the Study Eye |  | Baseline, 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye |  | Baseline, 12 Months | 
| Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye |  | Baseline, 12 Months | 
| Percentage of Patients with BCVA of 20/40 or Better in the Study Eye |  | Baseline, 12 Months | 
| Mean Number of Ozurdex Injections in the Study Eye |  | 12 Months | 
| Mean Time Between Ozurdex Injections in the Study Eye |  | 12 Months | 
| Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye |  | Baseline, 12 Months |
Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer

Study Overview
=================
Brief Summary
-----------------
There are different types of hormonal therapy medicines for the treatment of hormone-receptor-positive breast cancer. The purpose of this study is to determine the evolution of two types of hormonal treatment (the drug called tamoxifen and a group of medicines called aromatase inhibitors) during two time periods of 12 months each, in years 2006 and 2008, in the northeast Italian regions. The study will include post-menopausal women who have initiated hormonal therapy medicines in 2006. The study will also verify the rate of implementation of the updated national and international recommendations for the use of adjuvant hormonal therapy in the hormone-receptor-positive breast cancer.

Official Title
-----------------
Retrospective Observational Triveneto Study on the Use of Adjuvant Hormonal Therapies in the Treatment of Hormone-responsive Breast Cancer in Two Successive Time Periods

Conditions
-----------------
Post Menopausal, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy between January 2006 and December 2006 or between January 2008 and December 2008 Documented evidence of the way adjuvant hormonal treatment was initiated. Exclusion Criteria: Pre- or peri-menopausal patients with surgically treated breast cancer who started adjuvant hormonal therapy Patients already enrolled in clinical studies aimed at investigating hormone therapies
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Relative frequencies of the first adjuvant hormonal treatment (tamoxifen vs aromatase inhibitor) started during two time periods of 12 months each - the years 2006 and 2008 |  | May-July 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative frequencies of the type of initial treatment: upfront (a single drug - tamoxifen or aromatase inhibitor) or early switch (planned sequence of tamoxifen and inhibitor) |  | May-July 2009 | 
| Type of treatment and relative percentages of treatment undertaken by the patients after interruption of the first hormonal therapy |  | May - July 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tamoxifen, arimidex, adjuvant hormonal therapies, breast cancer, post-menopausal, Adjuvant hormonal therapy in patients post menopausal with breast cancer
Correlation of Ultrafiltered Volume (UFV) to Bioimpedance Changes

Study Overview
=================
Brief Summary
-----------------
Patient submitted to hemodialysis are followed through a dialysis - interim - dialysis cycle. No intervention is done. Additional blood tests and clinical tests are used as pseudo-endpoints. Correlation is made to ultrafiltrated volume (UFV).

Official Title
-----------------
Correlation of Ultrafiltered Volume (UFV) During Hemodialysis With a New Battery Powered, Body Worn Electronic Patch Measuring Bioimpedance.

Conditions
-----------------
Hemodialysis, Ultrafiltration, Bioimpedance

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for hemodialysis signed Informed Consent Form Exclusion Criteria: acute intercurrent disease, subjects with known hypersensitivity to plasters (adhesive or gel).

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Hemodialysis patients<br>Patients who undergo hemodialysis in hospital every two to three days. | Other: Observation<br>* Only observational study, no intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between ultrafiltered volume (UFV) and measured bioimpedance change | A change in measured thoracic bioimpedance is expected to correlate to UFV | During hemodialysis |
Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders

Study Overview
=================
Brief Summary
-----------------
Study to learn if the alternate formulation is effective in agitated schizophrenic patients

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agitated schizophrenic patients

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


Arms and Interventions

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

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
-----------------
agitated schizophrenic patients
The Effect of Vitamin D on Bone Accretion and Turn-Over in Young Girls

Study Overview
=================
Brief Summary
-----------------
Objectives To evaluate the effect of increased vitamin D intake on vitamin D status, bone mass and bone turnover in young girls aged 12-13. More specifically the effects on the following parameters will be assessed: Vitamin D metabolites. Parathyroid hormone. Bone turnover. Bone mineral accretion. Serum calcium and phosphate. Renal handling of calcium and phosphate.

Detailed Description
-----------------
This work package will consist of a randomised double blind one-year vitamin D supplementation study. Primary effect parameter is change in bone mineral content and therefore study duration will be one year. A total of 225 subjects, 75 in each of the three groups: one control and two intervention groups, will be included Two dosages of supplementation will be used: 5 µg per day and 10 µg per day.

Official Title
-----------------
Adolescent Girls-Impact of Vitamin D on Bone Accretion Work Package 1 (Danish Part) of OPTIFORD (Towards A Strategy for Optimal Vitamin D Fortification)

Conditions
-----------------
Vitamin D Deficiency

Intervention / Treatment
-----------------
* Behavioral: cholecalciferol (D3) (vitamin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Girls born in Denmark with Danish citizenship aged 10.0-11.0 years living in the municipals of Copenhagen and Frederiksberg Exclusion Criteria: Any chronical disease with influence on bone mass or turnover Intake of drugs with influence on bone mass or turnover Intake of calcium or vitamin D other than the intervention

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: cholecalciferol (D3) (vitamin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D level (status) measured as s-25 hydroxy vitamin D at baseline, after half a year and one year. |  |  | 
| Bone accretion measured by DXA. Measurement at baseline and after one year. |  |  | 
| Bone turnover measured at baseline, half a year and one year |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, adolescent girls, bone accretion, bone turn over, vitamin D status, Vitamin D insufficiency in young girls
Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs

Study Overview
=================
Brief Summary
-----------------
This is a single-center, observational clinical study that plans to recruit 64 ovarian cancer patients within one year. The purpose of this study is to evaluate the consistency and accuracy of the organoid model derived from patients with ovarian cancer and the patient's clinical medication, so as to predict the clinical efficacy of anti-cancer drugs

Official Title
-----------------
Study on the Consistency Evaluation of Organoids Used in the Clinical Treatment of Ovarian Cancer With Anti-tumor Drugs

Conditions
-----------------
Ovarian Cancer, Organoid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with ovarian cancer who are diagnosed as ovarian cancer by tissue and/or cytology and need neoadjuvant, adjuvant or standard treatment Age 18-75 years old (including 18 years old and 75 years old) It is clear that there are measurable lesions (according to RECIST1.1) Exclusion Criteria: - Patients with concurrent radiotherapy and chemotherapy, less than half a year of radiotherapy, or patients undergoing radiotherapy during the study period During the study period, patients need other tumor treatment methods such as surgery, intervention, radiofrequency ablation, etc. Immune deficiency or severe bone marrow suppression The patient has severe liver and kidney disease, cardiovascular disease, blood disease, etc. Illegal use of drugs or chronic alcohol abuse or total daily alcohol intake> 50 g/d Lack of autonomy, unable to walk, or unable to participate in the 6-month follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Prediction of the response to treatment by the patient-derived organoids | The drug sensitivity was tested on patient-derived tumour organoids, which is compared with clinical response of the chemo- or targeted therapy treatment. | 2021-2022 |
Amniotic Membrane and Anterior Stromal Puncture to the Treatment of Symptomatic Bullous Keratopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether amniotic membrane transplantation is as effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.

Detailed Description
-----------------
Patients with symptomatic bullous keratopathy were randomized in 2 groups and submitted to amniotic membrane transplantation or anterior stromal puncture. The follow up was made with 1, 3, 6 and 12 months. Evaluation included complete ophthalmologic exam, esthesiometry, pachymetry, impression cytology and evaluation of pain.

Official Title
-----------------
Amniotic Membrane and Anterior Stromal Puncture: a Comparative Study in the Treatment of Symptomatic Bullous Keratopathy

Conditions
-----------------
Bullous Keratopathy

Intervention / Treatment
-----------------
* Procedure: amniotic membrane transplantation
* Procedure: anterior stromal puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bullous keratopathy Exclusion Criteria: age under 18 years old asymptomatic bullous keratopathy corneal infection ocular hypertension

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 |
| --- |
|Procedure: amniotic membrane transplantation|patients are submitted to amniotic membrane transplantation|
|Procedure: anterior stromal puncture|the other group is submitted to anterior stromal puncture|

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
-----------------
pain, bullous keratopathy, amniotic membrane, anterior stromal puncture
Goal-orientated Coagulation Management in Hypothermic Cardiac Arrest Surgery

Study Overview
=================
Brief Summary
-----------------
Cardiac surgery including hypothermic cardiac arrest (HCA) commonly involves perioperative transfusion of allogeneic blood products which is associated with increased morbidity and mortality. In this retrospective analysis, the investigator aimed to evaluate the effect of a thromboelastometry-guided treatment algorithm promoting fibrinogen concentrate as first line hemostatic agent on the perioperative use of allogeneic blood products.

Detailed Description
-----------------
The investigators will analyze the data of patients undergoing elective and emergent surgical procedures involving the ascendent aorta and/or the aortic arch with the help of HCA from January 2009 to June 2011. The investigators will collect and document baseline characteristics, the use of thromboelastometry, thromboelastometric data, and perioperative laboratory data. In addition, the investigators will evaluate perioperative bleeding from mediastinal drainages, perioperative use of blood and hemostatic products, and the adverse events within the hospitalisation including re-exploration, renal impairment, myocardial infarction, severe brain injury, and death.

Official Title
-----------------
Does the Intraoperative Thromboelastometry-guided Coagulation Management Reduce the Administration of Allogeneic Blood Products in Cardiac Surgery With the Help of Hypothermic Cardiac Arrest? A Retrospective Data Analysis

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery with HCA due to pathology of the proximal aorta from January 2009 until June 2011 Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac surgery with HCA<br>Patients undergoing cardiac surgery with the help of hypothermic cardiac arrest for pathologies of the proximal aorta | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion of allogeneic blood products |  | within 24 hours including surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients without allogeneic blood products |  | 24 hours including surgery | 
| Adverse events | Adverse events include: renal impairment (RIFLE criteria), stroke, severe neurologic impairment, myocardial infarction, death, re-exploration | within 24 hours including surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood component transfusion, Hypothermic