linjc16/ctgov huggingface dataset:
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected NSCLC with common EGFR mutations.

Official Title
-----------------
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations.

Conditions
-----------------
Completely Resected NSCLC With Common EGFR Mutations

Intervention / Treatment
-----------------
* Drug: gefitinib, pemetrexed,cisplatin
* Drug: Vinorelbine, cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completely resected non-squamous cell NSCLC with stage IIa to IIIb (excluding N3) according to Version 8 of the IASLC Staging Manual in Thoracic Oncology Tumors with common EGFR mutations (19del or L858R) Adequate oran function Exclusion Criteria: Patients who were exposed to the chemotherapy or EGFR TKIs for NSCLC. Patients with interstitial lung disease

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Intercalating arm<br>gefitinib, pemetrexed,cisplatin | Drug: gefitinib, pemetrexed,cisplatin<br>* Intercalation phase (Duration: 3weeks x 4 cycles = 12 weeks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, every 3week Maintenance phase (Duration: 1 year) Gefitinib 250mg D1-2<br>* Other names: Intercalating arm;|
| Active Comparator: chemotherapy alone arm<br>Vinorelbine, cisplatin | Drug: Vinorelbine, cisplatin<br>* Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week<br>* Other names: chemotherapy alone arm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | Time from the randomization to recurrence or any cause of death. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from the randomization to death of any cause | 5 year | 
| Number of participants with treatment-related adverse events as assessed by CTCAE4.0 |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NSCLC, EGFR, adjuvant, gefitinib, intercalating
Postcesarean Section Pain: Possible Demographic and Medical Predictors

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to find out if one or more of the following parameters has an impact on postcesarean section pain:age,ethnic origin, parity,body habitus, smoking, breastfeeding, education,newborn in intensive care unit, primary/repeated operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during operation.

Detailed Description
-----------------
The medical records of 600 consecutive women with a cesarean section will be reviewed.We will analyse the correlations between postcesarean section pain levels,analgesic consumption and; age,ethnic origin, parity,body habitus, smoking, breastfeeding, education,newborn in intensive care unit, primary/repeated operation,elective/emergency operation,junior/senior surgeon,type of anesthesia during operation.

Official Title
-----------------
Postcesarean Section Pain: Possible Demographic and Medical Predictors

Conditions
-----------------
Pain, Cesarean Section

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing a cesarean section Exclusion Criteria: Medical or psychological conditions not enabling reliable patients pain assessment
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesia
A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

Official Title
-----------------
A Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L PPDS)in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Latanoprost-PPDS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG. Adequate IOP control on topical prostaglandin monotherapy during the past 1 month. Exclusion Criteria: Functionally significant vision loss, or progressive field loss within the last year. Contact lens wear at any time during the treatment period. Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®. Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment. Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim. Currently on chronic ocular topical medications Currently on any ophthalmic or systemic steroid therapy. Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries. History of macular edema History of chronic/recurrent inflammatory eye disease. History of a non-response to topical prostaglandin therapy. Subjects who have epiphora.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-PPDS<br> | Drug: Latanoprost-PPDS<br>* Punctal Plug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline at 4 weeks | 4 Weeks minus baseline | Baseline to 4 Weeks |
Better Understand End-of-life Emergencies' Management Among Elderly in Nursing Homes: a Pilot Study in Brittany, France

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are : To know and to understand frequency and variability (quantitative and qualitative) of end-of-life emergencies in nursing homes. To know and to understand practices applied in these situations depending on the institution and the different reasons of hospital use. To know and to understand the practical and organizational elements, in nursing homes, that can determine a (re) hospitalization or an end-of-life

Conditions
-----------------
Died, in End-of-life Situation

Intervention / Treatment
-----------------
* Other: end-of-life emergencies' management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dead residents during the quarter preceding the date of the Survey Or Residents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of terminal condition contained in the guide of the CNSA (coding PATHOS - April 2011)). Exclusion Criteria: patients opposing the study, patients aged below 18 year old

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 |
| --- | --- |
| Residents in end-of-life situation<br>Residents in end-of-life situation the day of the survey, as determined by the physician coordinator of nursing homes (we will use the definition of terminal condition contained in the guide of the CNSA (coding PATHOS - April 2011)). | Other: end-of-life emergencies' management<br> <br> |
| dead residents<br>dead residents in the quarter preceding the date of the survey | Other: end-of-life emergencies' management<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of end-of-life emergencies' episodes |  | through study completion, an average of 1 year |
Monitored Saturation Post-ICU

Study Overview
=================
Brief Summary
-----------------
The overall aim with this project is to describe the correlation between measured and charted saturation after intensive care and also describe the saturation-pattern in these patients. The investigators will also correlate post-ICU desaturations measured as oxygen denaturation index and complications to pre-ICU obstructive sleep apnea and the STOP BANG screening questionnaire.

Official Title
-----------------
Monitored Saturation Post-ICU; Correlation to Charted Saturation, Pre-intensive Care Unit Obstructive Sleep Apnea and Outcome

Conditions
-----------------
Sleep Apnea, Obstructive, Respiratory Insufficiency

Intervention / Treatment
-----------------
* Device: Pulseoximetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age. Admitted to the Central Intensive Care Unit (CIVA) Signed informed conscent by the patient or a relative Exclusion Criteria: -

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

| Intervention/Treatment |
| --- |
|Device: Pulseoximetry|Peripheral saturation will be recorded continuously|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation index (ODI) | Measured by continuous pulseoximetry | Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STOP Bang screening questionnaire | At inclusion the STOP BANG screening questionnaire will be completed | Days |
Hemodilution and Outcome in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
An hematocrit of 21-25% is supposed to perform the best organ protection during cardiopulmonary bypass for cardiac surgery. The investigators want to establish the best timing for a transfusion (in patients with a predicted low hematocrit during cardiopulmonary bypass) and the efficacy of preprocedural hemodilution (in patients with a predicted high hematocrit during cardiopulmonary bypass) in patients undergoing cardiac surgery.

Official Title
-----------------
Effect of Moderate Hemodilution During Cardiopulmonary Bypass on Postoperative Outcome Following Cardiac Surgery

Conditions
-----------------
Kidney Failure, Intraoperative Complications

Intervention / Treatment
-----------------
* Procedure: Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing cardiac surgery Exclusion Criteria: Age < 18 years old Not signing written consent Age < 65 years old (subgroup 1) Emergency, aortic stenosis, main left coronary stenosis (subgroup 2)

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

| Intervention/Treatment |
| --- |
|Procedure: Different timing of red blood cells transfusion (substudy 1); Acute hemodilution versus no hemodilution (substudy 2)|Subgroup 1,with Ht<21% receive an hemotransfusion before or after CEC;subgroup 2,with Ht>25% bleed or not|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other organ damage |  |  | 
| prolonged mechanical ventilation, Intensive Care Unit (ICU) and hospital stay |  |  | 
| sepsis |  |  | 
| exitus |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hematocrit, Hemodilution, Blood Transfusion, Cardiopulmonary Bypass, Multiple Organ Failure, Surgery, Cardiac, Kidney Failure, Cardiac Surgical Procedures
Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
This study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Conditions
-----------------
Focus of Study is STEMI

Intervention / Treatment
-----------------
* Drug: danegaptide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years ST-segment elevation myocardial infarction Acute onset of chest pain of < 12 hours duration Exclusion Criteria: Pregnancy Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure Contraindication for cardiac MRI Inability to understand information or provide informed consent

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: danegapetide high dose<br>7,5 mg bolus injection, followed by 22,5 mg infused over 6 hours | Drug: danegaptide<br> <br> |
| Active Comparator: danegaptide low dose<br>2,5 mg bolus injection, followed by 7,5 mg infused over 6 hours | Drug: danegaptide<br> <br> |
| Placebo Comparator: Placebo<br>bolus injection, followed by infused over 6 hours | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Salvage Index | Myocardial Salvage Index as assessed by MRI and calculated as the difference between myocardial volume at risk and final infarct size in relation to myocardial volume at risk | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI |  | 3 months | 
| Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure |  | 60 minutes | 
| Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure |  | 3 months |
Comparison of Sevoflurane and Isoflurane Anesthesia for Benign Breast Tumor Excision

Study Overview
=================
Brief Summary
-----------------
Generally, benign breast tumors are excised under the local anesthesia. But such action was so invasive that every patient would experience the physiological and psychological stimuli unavoidably. Sevoflurane was advised as a better inhalational anesthesic for its easy come,easy go property during short-lasting operations than isoflurane. We purposed that sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane with relative less alteration in hemodynamics, less postoperative side effects and easily-control the depth of anesthesia.

Official Title
-----------------
Anesthesia With Sevoflurane and Isoflurane for Excision Surgeries in Benign Breast Tumors

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Isoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese Diagnosed benign breast tumor patients 18-64 yrs Exclusion Criteria: Allergic to any interventional drugs Organic dysfunction Long-lasting PACU staying

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Sevoflurane: induction 3-6%, maintenance 2-3% | Drug: Sevoflurane<br>* 3-6% sevoflurane inhaled for anesthesia induction, and 2-3% sevoflurane was used to maintain the anesthesia till the end of the operation.<br>* Other names: Sevofrane;|
| Active Comparator: 2<br>Isoflurane: induction 3-6%, maintenance 2-3% | Drug: Isoflurane<br>* 3-6% isoflurane inhaled for anesthesia induction, and 2-3% isoflurane was used to maintain the anesthesia till the end of the operation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of induction, maintenance and resuscitation |  | 0h to the end of the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative hemodynamics; Postoperative side effects; |  | 0h to 24h after the end of the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sevoflurane, Isoflurane, Breast tumor, Anesthesia
Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of this Non-Interventional study is to evaluate the effectiveness & safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age >70 years) and younger patients (age <70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.

Official Title
-----------------
Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib Exclusion Criteria: Exclusion criteria must be read in conjunction with the local product information.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* The treatment with Sorafenib 200mg tablets should comply with the recommendations written in the local product information. The decision about the duration of treatment is solely at the discretion of the attending physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy related variables are status of tumor / metastases. |  | After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) | 
| Efficacy related variables are patient's performance status. |  | After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) | 
| Efficacy related variables are efficacy assessment by the physician. |  | After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) | 
| Efficacy related variable - Quality of Life (QOL) assessment by the patient |  | After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General tolerability assessment by physician and reports of adverse events. |  | After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SORAFENIB, RENAL CELL CARCINOMA, TYROSINE KINASE INHIBITOR, OBSERVATIONAL STUDY