linjc16/ctgov huggingface dataset:
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to examine the effect of benzydamine hydrochloride to postoperative sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative sore throat using smartphone application in pediatric patients.

Detailed Description
-----------------
postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe scoring of pain with smartphone application (kids pain scale) incidence of use of rescue pain killer

Official Title
-----------------
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients: a Randomized Controlled Trial

Conditions
-----------------
Intubation Complication

Intervention / Treatment
-----------------
* Drug: Benzydamine Hydrochloride
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: general anesthesia intubation require Exclusion Criteria: recent upper airway infection could not express the pain

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>normal saline | Drug: Normal saline<br>* normal saline application<br>* Other names: ns;|
| Active Comparator: benzydamine hydrochloride<br>Benzydamine Hydrochloride | Drug: Benzydamine Hydrochloride<br>* Benzydamine Hydrochloride application<br>* Other names: difflam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | application based pain score | 30 minutes in postanesthetic care unit |
Genotype-related Molecular Targets in the Vitamin D Pathway for Spinal Disc Diseases

Study Overview
=================
Brief Summary
-----------------
The objective of our study will be to analyze the interplay between particular VDR variants and its ligand in cells obtained from intervertebral disc and cartilage endplate and their action on cell proliferation and phenotype maintenance. The identification of novel molecular targets in the vitamin D pathway, potentially promoting pathological alterations of the tissues involved in spinal disc diseases, will allow to develop innovative and more personalized preventive and pharmacological/nutritional therapies.

Official Title
-----------------
Identification of Genotype-related Molecular Targets in the Vitamin D Pathway for Personalized Pharmacological Treatments of the Spinal Disc Diseases

Conditions
-----------------
Intervertebral Disk Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with spinal disc diseases males and females 18≤age ≤ 70 years old Italian white patients with spinal disc diseases that will be surgically treated Exclusion criteria: - age < 18 or > 70 years old

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Phenotype and genotype characterization | To evaluate structural alterations of the intervertebral disc and of the cartilage endplate in patients with spinal disc diseases related to functional FokI polymorphism in the vitamin D receptor (VDR) gene. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disc cell functional response genotype-based | To characterize cells obtained from different disc tissues (nucleus pulposus, annulus fibrosus, cartilage endplate) and to evaluate their VDR FokI genotype-related response to vitamin D treatment, regulating the cell proliferation and phenotype. | 2 years |
The COVID-IYON Study - Study Examining Data Pertaining to Clinical Outcomes and Organisational Responses to the 2020 SARS-CoV-2 Pandemic

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multisite, descriptive, observational clinical/epidemiological study examining both quantitative and qualitative data pertaining to clinical outcomes and organizational responses to the 2020 SARS-Coronavirus-2 (SARS-CoV-2) pandemic.

Detailed Description
-----------------
This study collects real-time observational data regarding the impact of SARS-CoV-2 infection on patients with cancer, and on the functioning and organisation of cancer and malignant haematology services in the Republic of Ireland in response to the 2020 SARS-CoV-2 pandemic.

Official Title
-----------------
COVID-IYON Study. Prospective, Multisite, Descriptive, Observational Clinical/Epidemiological Study Examining Data Pertaining to Clinical Outcomes and Organizational Responses to the 2020 SARS-Coronavirus-2 (SARS-CoV-2) Pandemic

Conditions
-----------------
Cancer, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Informed consent has been obtained. Cytotoxic chemotherapy, targeted anticancer therapy, immunomodulatory anticancer therapy, hormonotherapy, radiotherapy, oncologic surgery, or other anticancer treatment within the last 12 months (ongoing and completed). Tested positive for SARS-CoV-2. Exclusion Criteria: There are no 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A qualitative description | A qualitative narrative description of national cancer care practises and risk mitigation strategies adopted in response to the SARS-CoV-2 pandemic. | Up til 1 year |
Analysis of a Population in Extreme Age of Life With a Hip Fracture

Study Overview
=================
Brief Summary
-----------------
Observational retrospective study of pacients over 95 years admitted in traumatology ward with a osteoporotic hip fracture

Official Title
-----------------
Análisis de Una población en Edad Extrema de la Vida Con Fractura de fémur (Analysis of a Population in Extreme Age of Life With a Hip Fracture)

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Other: No intervention performed by authors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: osteoporotic hip fracture Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 95 Years
Maximum Age: 120 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention performed by authors|Observational and retrospective study, no intervention performed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 
| Mortality |  | 3 months | 
| Mortality |  | 1 year |
Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD

Study Overview
=================
Brief Summary
-----------------
We attempt to examine the association between serum leucine-rich alpha-2 glycoprotein (LRG) levels and endoscopic activity in patients with possible ulcerative colitis (UC) or Crohn's disease (CD) to determine whether LRG was a predicting marker for UC or CD.

Detailed Description
-----------------
Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. Serum sampling and colonoscopy with histology were performed within 7 days.The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity index (CDAI), respectively. The Mayo endoscopy score was evaluated. UC patients whose Mayo endoscopy score was 2 or 3 were divided into the active UC group. CD patients whose CDAI >150 were divided into the active CD group.

Official Title
-----------------
Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis

Conditions
-----------------
LRG Levels

Intervention / Treatment
-----------------
* Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients whom possible UC or Crohn disease was suspected Exclusion Criteria: other autoimmune diseases acute or chronic renal failure chronic heart diseases liver cirrhosis cancer acute or chronic infections ischemic colitis infectious colitis
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels|Patients who were diagnosed with possible UC or Crohn disease according to endoscopic, radiological, histological, and clinical criteria were enrolled. Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. Serum sampling and colonoscopy were performed within 7 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LRG measurement | Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. | one year |
Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)

Official Title
-----------------
PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)

Conditions
-----------------
Locally Advanced Breast Cancer

Intervention / Treatment
-----------------
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women Primary locally invasive breast cancer Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with > 10% positive malignant epithelial cells. Post menopausal status Tumor measurable by clinical examination, mammography and ultrasound Exclusion Criteria: Prior treatment with letrozole or tamoxifen. Patients with bilateral breast tumors Patients who are eligible for breast conserving surgery Evidence of inflammatory breast cancer or distant metastasis. Other concurrent malignant disease Concomitant anti-cancer treatments such as chemotherapy Other protocol-defined exclusion criteria may apply.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br> | Drug: Letrozole<br>* 1 tablet of Letrozole 2.5 mg orally adminnistered once a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of Letrozole |  | frequency and severity of the clinical adverse events | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer,, Letrozole,, Hormonal receptors
A Simplified Questionnaire to Detect OSA in COPD Patients

Study Overview
=================
Brief Summary
-----------------
To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA.

Detailed Description
-----------------
To detect the existence of severe obstructive sleep apnea (OSA) in chronic obstructive pulmonary disease (COPD) patients, which had higher mortality and hospitalization rate, a simplified questionnaire was developed for identifying those COPD patients with severe OSA. With patient's BMI, neck and waist circumference, snores, witnessed apnea... Time frame suspect to enroll 5 patients in 1 month and complete 4 patients at least we need 24 months to complete 120 patients

Official Title
-----------------
A Simplified Screening Questionnaire to Detect the Existence of Severe Obstructive Sleep Apnea in Chronic Obstructive Pulmonary Disease Patients

Conditions
-----------------
OSA, COPD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable COPD patients Exclusion Criteria: cancer exacerbation in recent 2 months pregnancy central type sleep apnea claustrophobia chronic respiratory failure

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| develop group<br>previous COPD study | |
| validation group<br>consecutive COPD patients from outpatient clinics | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of simple questionnaire to detect severe OSA in COPD patients | The main outcome of this study : calculate the sensitivity, specificity, positive predictive value, negative predictive value, ROC curve Time frame: enroll 5 patients in 1 month and complete 4 patients at least we need 24 months to complete 120 patients PSG is standard diagnostic tool and it is no safety issue in this study | since Dec 1, 2012 to Dec 1, 2014 (up to 2 years) |
The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.

Detailed Description
-----------------
After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome. In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.

Official Title
-----------------
The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK

Conditions
-----------------
Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea, Posterior Polymorphous Corneal Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing DMEK Exclusion Criteria: no specific 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Endothelial Cell Density | measured in cells/mm2 | three months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity | measured in logMAR | prior to surgery, three and six months after surgery | 
| Central Corneal Thickness | measured in μm | prior to surgery, three and six months after surgery | 
| Number of Re-Bubblings | need of surgical intervention after DMEK in order to attach the graft | six months after surgery | 
| Corneal Endothelial Density | measured in cells/mm | six months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Descemet Membrane Endothelial Keratoplasty, DMEK, Fuchs Endothelial Corneal Dystrophy, Pseudophakic Bullous Keratopathy, Chemical Burn of Cornea, Posterior Polymorphous Corneal Dystrophy, Postoperative Head Position, Corneal Transplantation, Head Tracking Sensor
State of Obesity Care in Canada Evaluation Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether care gap(s) exist in the management of obesity and its related conditions in obese patients seen by primary care physicians and specialists. The study will also look at whether there is a compliance and adherence gap that exists in patients prescribed medication for obesity management.

Detailed Description
-----------------
Obesity currently affects over 15% of the adult population in Canada. The economic burden associated with obesity is estimated at $4.3 billion or 2.2% of the total health care costs in Canada. Despite increasing recognition as a public health problem, clinical management of obese patients in Canada has received little attention. This study will collect information on the current status, characteristics and management of subjects with obesity. The design of the study will mirror real-life management of these subjects.There are three goals in this study: the primary goal is to document appropriate obesity management strategies aimed at reducing and maintaining a healthy body weight by participating primary care physicians and specialists. The second goal is to explore factors that determine patients compliance and adherence to anti-obesity medication when prescribed. Obesity management is currently not a priority in tertiary care centres in Canada. An exception being the Bariatric Clinic located at McMaster University, which is one of the few academic centers dedicated to obesity management in Canada. The primary goal of the Bariatric Clinic Substudy is to evaluate the management, compliance and adherence of patients seen at a tertiary care obesity clinic compared to those of primary care physicians and specialists.

Official Title
-----------------
State of Obesity Care in Canada Evaluation Registry An Observational Study of Clinical Care of Patients With Obesity

Conditions
-----------------
Obesity, Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older and is able to provide informed consent Has not been enrolled in this study at an earlier office visit; and Provides signed informed consent BMI > = 27 kg/m Exclusion Criteria: Participation in a clinical trial Hospitalized patient Subject expected to have difficulties to come back at follow-up visits Pregnant or nursing

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Weight, Obesity, Weight gain, Anti-obesity medication, Anti-obesity management strategies
Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

Official Title
-----------------
A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: Gefitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Life expectancy of at least 8 weeks. Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma Not suitable for chemotherapy WHO Performance status 0,1, 2 or 3 Exclusion Criteria: Newly diagnosed CNS mets Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity ALT/AST greater than 5 x upper limit of normal ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| · ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure |  |  | 
| · ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall |  |  | 
| · objective tumour response (CR + PR) |  |  | 
| · ZD1839 + BSC versus Placebo + BSC in terms of tolerability |  |  | 
| · ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes |  |  |