linjc16/ctgov huggingface dataset:
The Importance of ENDING-S Score in the Diagnosis of Palliative Patients in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
In our study, we aim to predict palliative care patients earlier, to reduce hospitalization periods and to prevent intensive care unit occupation by palliative care patients.

Official Title
-----------------
The Importance of ENDING-S Score in the Diagnosis of Palliative Patients in the Intensive Care Unit

Conditions
-----------------
Palliative Care, Critical Care, Length of Stay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years will be included in the study. Patients staying longer than 48 hours intensive care will be included in the study. Exclusion Criteria: Patients younger than 18 years. Patients staying less than 48 hours

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 |
| --- | --- | --- |
| Recognition of palliative care unit patients before intensive care discharge | ENDING-S Scoring system used to predict patients who were followed up in intensive care units and discharged to palliative care unit during their hospitalization. We aim to identify patients who are likely to be admitted to palliative care centers following their admission to intensive care units, and to prepare a palliative care center before the discharge from the intensive care. | Fourth day of intensive care follow up |
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)

Study Overview
=================
Brief Summary
-----------------
This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.

Official Title
-----------------
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of UFT Compared With Surgery Alone for Serosa-negative Advanced Gastric Cancer (NSAS-GC)

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: UFT (uracil, tegafur)
* Procedure: Surgery alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20 to 75 Performance status 0 , 1, or 2 (ECOG) Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 times ULN Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN Exclusion Criteria: Prior anticancer treatment

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: 1<br>UFT (uracil, tegafur) | Drug: UFT (uracil, tegafur)<br>* uracil-tegafur 360 mg per square meter per day orally 16 months<br>|
| Other: 2<br>Surgery alone | Procedure: Surgery alone<br>* Gastrectomy of tumour node metastasis(TNM) stage T2N1-2 gastric cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival and relapse-free survival |  | every course for first three courses, then every other course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | any time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stomach Cancer
Polycystic Ovary Syndrome and BETATROPHIN

Study Overview
=================
Brief Summary
-----------------
This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin.

Detailed Description
-----------------
Introduction: Betatrophin is a protein hormone which has a significant role in glucose homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum betatrophin in overweight and normal weight women with PCOS. Material and Method: Thirty-five patients normal weight women with PCOS (BMI<25) and 38 obese women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA method and then compared between these two groups besides the following additional parameters as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral glucose tolerance test) results and HOMA-IR levels.

Official Title
-----------------
Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?

Conditions
-----------------
Polycystic Ovary, Obesity

Intervention / Treatment
-----------------
* Diagnostic Test: serum marker levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria Exclusion criteria pregnancy, an additional systemic disease (i.e.,hyperprolactinemia, thyroid dysfunction, liver or kidney diseases, cardiovascular disease, hyperlipidemia, type 1 or type 2 diabetes, chronic or acute infection within the previous 30 days), morbid obesity, smoking, the use of medications for contraception, androgen excess, hypertension, hyperglycemia or dyslipidemia at least 3 months before the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Group 1 (normal weight with PCOS )<br>35 cases | Diagnostic Test: serum marker levels<br>* two groups comparisons<br>|
| overweight PCOS<br>38 cases | Diagnostic Test: serum marker levels<br>* two groups comparisons<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Betatrophin levels | ng/L | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist/hip ratio | centimeter | 5 min | 
| 75 gr OGTT(oral glucose tolerance test) | (mg/dl) | 2 hours | 
| BMI (body mass index) | kg/m2 | 5 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betatrophin, PCOS, obesity, insulin resistance
Readmissions of Lung Transplant Patients in ICU.

Study Overview
=================
Brief Summary
-----------------
A multi-centre, prospective and observational study was carried out from August 2012 to June 2016 in five Spanish tertiary-care university hospitals with well-established lung transplant programs: Vall d'Hebron (Barcelona), Marqués de Valdecilla (Santander), 12 de Octubre (Madrid), CHUAC (A Coruña), and Reina Sofía (Córdoba). The study population comprised all consecutive adult lung transplant recipients who required ICUr (after >7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr period).

Official Title
-----------------
Readmissions of Lung Transplant Patients in the Intensive Care Unit

Conditions
-----------------
Lung Transplant; Complications

Intervention / Treatment
-----------------
* Other: Colection of clinical data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive adult lung transplant recipients who required ICU readmission (after >7 days post-transplant discharge from ICU) during august 2012 - June 2016 (4-yr period). Exclusion Criteria: ICU readmission < 8 days post-transplant discharge from ICU. ICU readmission for early postoperative care following lung transplantation.

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 |
| --- | --- |
| Lung transplant patients readmitted in ICU<br> | Other: Colection of clinical data<br>* Colection of clinical data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Causes of ICU readmission in LT adults | To assess the principal causes of ICU readmission in LT adults. | Augist 1. 2012 - June 30, 2016 | 
| Predictors of ICU and hospital mortality. | To identify potential predictors of ICU and hospital mortality. | Augist 1. 2012 - June 30, 2016 |
The Safety and Effectiveness of Intravenous Anidulafungin as a Treatment for Patients With Invasive Candidiasis.

Study Overview
=================
Brief Summary
-----------------
Anidulafungin may be effective for the treatment of invasive Candida infections. The purpose of the study is to find the balance between dose tolerance and effectiveness of several doses for the treatment of United States patients with invasive candidiasis.

Official Title
-----------------
A Phase 2, Open-Label, Randomized, Dose-Ranging Study of the Safety and Efficacy of Intravenous Anidulafungin (VER002) in the Treatment of Patients With Invasive Candidiasis

Conditions
-----------------
Candidiasis

Intervention / Treatment
-----------------
* Drug: Anidulafungin, VER002


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive culture plus at least one clinical sign and symptom consistent with invasive candidiasis preferably within 96 hours of the proposed first dose of study drug Life expectancy: greater than 72 hours Exclusion Criteria: Pregnant Females Treatment with other investigational drug(s) within 4 weeks Hypersensitivity to anidulafungin or echinocandin therapy Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anidulafungin, VER002|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
-----------------
Anidulafungin, Candidemia, Invasive Candidiasis
Impact of Current Smoking in the Tolerance of Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the impact of smoking in the preceding hours before a bronchoscopy on the tolerance of this exam.

Detailed Description
-----------------
Tolerance evaluation of the bronchoscopy on current and regular smokers. The investigators assess episodes of cough, dyspnea, volume of lidocain (liquid 1% and in spray 10%), duration of the procedure, episodes of desaturation and completion of the bronchoscopy. The investigators compare patients who did not smoke in the 6 hours before the bronchoscopy and those who have smoked.

Official Title
-----------------
Impact of Current Smoking in the Tolerance of Bronchoscopy

Conditions
-----------------
Smokers

Intervention / Treatment
-----------------
* Procedure: bronchoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current and regular smoker bronchoscopy under local anesthesia Exclusion Criteria: patients needing EBUS or fluoroscopy intravenous sedative

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 |
| --- | --- |
| Current smokers<br> | Procedure: bronchoscopy<br>* Routine bronchoscopy under local anesthesia (lidocain). Duration: +/- 10 min<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough | number of cough episodes during the bronchoscopy | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dyspnea | dyspnea evaluation before and during the bronchoscopy | day 1 | 
| Lidocaine volume | Volume of local anesthesic needed during bronchoscopy | day 1 | 
| length of bronchoscopy | length of bronchoscopy | Day 1 | 
| desaturation episodes | desaturation episodes during bronchoscopy | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking, bronchoscopy, cough
Livalo Acute Myocardial Infarction Study

Study Overview
=================
Brief Summary
-----------------
Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs concomitantly; there are some risks due to the drug interaction. Especially, statins are reported to have many drug interactions, these might influence to therapeutic prognosis and safety in AMI patients. This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI patients over 1 year, and the results will be compared with the other results from the KAMIR study which is expected to the large scale of AMI patients using statins be enrolled. Finally, from that comparison, we will investigate the influence of the statins metabolism by CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major ADR of statins like CK increase, myalgia.

Official Title
-----------------
A Prospective Clinical Observation Study to Evaluate the Influence of Long Term Treatment of Pitavastatin on the Therapeutic Prognosis and Safety in Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who have taken pitavastatin since AMI 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 |
| --- | --- |
| Acute myocardial infarction<br>AMI patients who are in need to be treated by statins | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death/MACE for 1 year after the registration |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of LDL cholesterol target level according to the NCEP ATP III guideline |  | 1 year | 
| Abnormal change of lab value including CK etc |  | 1 year | 
| Adverse event including myalgia |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Quitting Caffeine for Better Glucose Metabolism

Study Overview
=================
Brief Summary
-----------------
This project is a pilot study of caffeine abstinence in coffee-drinkers who have type 2 diabetes. Evidence suggests that caffeine may impair the control of glucose levels, especially in those people who have type 2 diabetes. Eliminating caffeinated beverages from the diet might improve glucose control, but the difficulty of quitting is unknown. This pilot study will follow a small number of type 2 diabetic patients for three months after a brief intervention designed to help people quit caffeine. Data on success with maintaining abstinence and on changes in glucose control will be collected.

Official Title
-----------------
Quitting Caffeine for Better Glucose Metabolism

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

Intervention / Treatment
-----------------
* Behavioral: Caffeine abstinence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-month history of type 2 diabetes impaired chronic glucose control (HbA1c >= 7%) daily consumption of 250 mg caffeine or more in coffee, tea, and other caffeinated beverages Exclusion Criteria: use of exogenous insulin use of non-diabetes medications that impact glucose metabolism medical of psychiatric history that prevents participation or increases risk current pregnancy current participation in other clinical trials deemed unable to comply with the study protocol for other reasons

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Caffeine abstinence|Brief instruction on beginning and maintaining caffeine abstinence.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caffeine abstinence |  | baseline, 2 weeks, 1, 2, and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | Baseline, 3 months |
Comparison of Normal Readings and Repeatability Across Skin Colors

Study Overview
=================
Brief Summary
-----------------
Observational comparison study of three commercially available regional oxygen saturation devices on a wide range of skin colors.

Official Title
-----------------
Comparison Study of Three Regional Oxygen Saturation (rSO2) Systems Across a Wide Range of Skin Colors

Conditions
-----------------
Near Infrared Spectroscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female of any race or ethnicity greater than eighteen years of age weighs greater than or equal to 40 kilograms is not currently admitted to the hospital is not known to be pregnant understands English is willing and able to provide informed consent and comply with study procedures Exclusion Criteria: is less than eighteen years of age weighs less than 40 kilograms if known to be pregnant is a current patient in the hospital does not understand English has known anemia is unwilling and able to provide informed consent and comply with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The mean and standard deviation of readings with all four regional oxygen saturation devices. |  | Data analysis will be performed when 240 subjects have been enrolled (7 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Near infrared spectroscopy, Skin pigmentation, Regional oxygen saturation
Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS

Study Overview
=================
Brief Summary
-----------------
A multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients with Essential Hypertension Inadequately Controlled with AGLS

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: AGSAVI
* Drug: AGLS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension patient who satisfied below condition at Visit 1. patient who takes antihypertensive drug 140mmHg <= MSSBP < 200mmHg 130mmHg <= MSSBP < 200mmHg at or before visit 1(In high-risk patients) patient who doesn't take antihypertensive drug 160mmHg <= MSSBP < 200mmHg Hypertension patient who satisfied below condition at Visit 2. 140mmHg <= MSSBP < 200mmHg at Visit 2 130mmHg <= MSSBP < 200mmHg at or before Visit 1(In high-risk patients) Exclusion Criteria: Patient who have received 4 or more antihypertensive drug Patient with 20mmHg>= of difference in MSSBP or 10mmHg>= of difference in MSDBP between 2 times of BP measuring at Visit 1 Patient with MSDBP >= 120mmHg at Visit 1 or 2 Patient with secondary hypertension(including past medical history)

Ages Eligible for Study
-----------------
Minimum Age: 19 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGSAVI<br> | Drug: AGSAVI<br>* Uptitation<br>|
| Active Comparator: AGLS<br> | Drug: AGLS<br>* Uptitration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of MSSBP(Mean Sitting Systolic Blood Pressure) | Change of MSSBP(Mean Sitting Systolic Blood Pressure) From Baseline to Visit 5(For 10 weeks) | From Baseline(Visit 2) to Visit 5(For 10 weeks) |