linjc16/ctgov huggingface dataset:
Study in Patients With Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control drug.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Formoterol Fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Require regular use of an inhaled Beta-2-selective adrenergic agent Exclusion Criteria: Active acute or chronic disorders of the respiratory system within one month prior to screening Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history Recent surgical interventions such as lung lobectomy or resection (< one year), or cardiothoracic interventions Life-threatening systemic and debilitating diseases.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Formoterol Fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of lung function. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function, vital signs, physical examinations, clinical laboratory assessments, and adverse event reporting. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Formoterol, Fumarate, Foradil
Safety and Surgical Performance Study of Aurosleek Surgical Blades

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and surgical effectiveness of surgical blades (Aurosleek) made by Aurolab.

Detailed Description
-----------------
Cataract till today remains the most common yet treatable cause of blindness accounting for more than 50% of blindness and visual impairment in the developing world. One of the most important features of a blade for cataract surgery is its predictable and repeatable behavior. The surgeon repeatedly and reliably needs to create similar tunnels of the proper length. Aurolab is producing surgical blades (Aurosleek) intended for making incision in cataract surgeries.

Official Title
-----------------
A Prospective, Open Label, Observational Study To Evaluate The Safety And Surgical Performance Of Surgical Blade (Aurosleek) In Cataract Patients

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Senile cataract Willing to give written informed consent Ability to follow study instructions and likely to complete required visits. Exclusion Criteria: Intraoperative complication including Posterior Capsular Rent and Zonular dialysis Traumatic cataract Uveitis and Complicated cataract One eyed 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aurosleek blades<br>Patients having cataract will undergo surgery by using Aurosleek blades | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physioclinical Characters | Assessment of physio-clinical characteristics of surgical blade such as handling of the blade, sharpness and smoothness of blade. Handling of the surgical blade will be assessed in grades of difficult to handle,easy to handle and very easy to handle intraoperatively. Sharpness and smoothness of the blade will be rated as poor or optimum while performing cataract surgery. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative complications | The frequency and occurrence of post operative complications such as rhexis tear, posterior capsular rupture, severe corneal edema, severe iritis and anterior vitrectomy. Post operative complications occurrence due to surgical blade will be observed and graded as none or mild or moderate or severe at surgery and post operative 30 days. | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients having cataract
Optimizing Resuscitation After Cardiac Arrest in the Community

Study Overview
=================
Brief Summary
-----------------
Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe hypoxic brain damage. Time to efficacious care is a primary determinant of disability-free survival. In the Jerusalem district, only 9% of OHCA patients present with ventricular tachycardia/ventricular fibrillation (VT/VF) as the primary rhythm, whereas 77% present with asystole; this seems primarily to be the result of long collapse-to-arrival times. Nevertheless, overly zealous resuscitation is undertaken in a high proportion of arrests with a futile prognosis, leading to excessive costs. Study hypotheses: Subpopulations for whom intervention is futile/counter-productive are identifiable Substantial waste of resources can be avoided Optimization of emergency medical services (EMS) reorganization without adding resources is an achievable goal

Official Title
-----------------
Optimizing Resuscitation After Cardiac Arrest in the Community: Increasing the Probability of Survival While Reducing Costs

Conditions
-----------------
Cardiopulmonary Arrest Outcome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district. Exclusion Criteria: Patients with do-not-resuscitate orders or an advance directive to that effect.

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
-----------------
resuscitation, sudden death, cardiopulmonary resuscitation, emergency medical services, termination of resuscitation, ventricular fibrillation, out-of-hospital cardiac arrest, asystole, medical futility, withdrawing treatment, transportation of patients, health expenditures, healthcare costs
Anlotinib Therapy in Patients With Advanced Lung Cancer.

Study Overview
=================
Brief Summary
-----------------
Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world. Subjects of the study: advanced Lung cancer. Methods of the study: This is a real world, prospective, Non-Interventional, Follow-up registration study. Patients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle. End point: Primary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).

Official Title
-----------------
Anlotinib Hydrochloride Therapy in Patients With Advanced Lung Cancer: A Real World Study.

Conditions
-----------------
Lung Neoplasms

Intervention / Treatment
-----------------
* Drug: Anlotinib Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment. Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment. Eastern Cooperative Oncology Group performance status of 0-2. Exclusion Criteria: Contraindication of anlotinib. Pregnant or lactating women. Other patients who can't enroll after investigator's assessment.

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 |
| --- | --- |
| experiment<br>The patients whose treatment strategy containing anlotinib. | Drug: Anlotinib Hydrochloride<br>* Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. Dose reduction is allowed.<br>* Other names: Other intervention depends on the patient's disease;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | progression-free survival | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | overall survival | 1 year | 
| ORR | overall response rate | 1 year | 
| DCR | disease control rate | 1 year |
Etanercept SFP in RA Patients

Study Overview
=================
Brief Summary
-----------------
Purpose of this study is to evaluate the immunogenicity and overall safety of etanercept SFP therapy administered once weekly for 24 weeks to subjects with rheumatoid arthritis.

Official Title
-----------------
Open-Label Study to Assess the Safety and Immunogenicity of Etanercept SFP When Administered to Subjects Diagnosed With Rheumatoid Arthritis.

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 18 years of age or older who have RA, as defined by the ACR criteria for classification of RA Naïve to etanercept therapy Able to self-inject investigational product or have a designee who can do so Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria Receipt of Corticosteroids> 10 mg/day of prednisone (or its equivalent) during 14 days befor 1st dose of investigational product Receipt of MTX witin 30 days of 1st dose of investigational product Receipt of an other investigational drug within 30 days of 1st dose Receipt of TNF inhibitor therapy within 90 days of 1st dose Receipt of cyclophosphamide within 6 mo of 1st dose Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) greather than the maximum recommended dose in the product info sheet Current use of insulin gnificant concurrent medical condition

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: 50 mg<br>50 mg once weekly | Drug: Etanercept<br>* 50 mg once weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etanercept seroreactivity response (ie, development of anti-etanercept antibodies) to etanercept (manufactured using the SFP) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Etanercept seroreactivity response to etanercept (manufactured using the SFP) |  | week 12 | 
| neutralizing antibodies to etanercept |  | week 12 and 24 | 
| Adverse events, serious adverse events (SAEs), serious infections and safety laboratory assessments |  | week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Etanercept, Enbrel, Amgen
Ultrasound vs Palpation for Radial Artery Cannulation

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.

Official Title
-----------------
Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery

Conditions
-----------------
Obese

Intervention / Treatment
-----------------
* Procedure: Ultrasound -guided cannulation
* Procedure: Palpation -guided cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists 1, 2, 3 BMI ≥ 30 bariatic surgery Exclusion Criteria: refusal infection or surgery history in wrist

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound group<br>Ultrasound-guided radial artery cannulation | Procedure: Ultrasound -guided cannulation<br>* radial artery cannulation using the ultrasound<br>|
| Placebo Comparator: Palpation group<br>Radial artery cannulation with palpation technique | Procedure: Palpation -guided cannulation<br>* radial artery cannulation using the palpation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Success rate at first attempt for radial artery cannulation | at first attempt, as average 5 min |
The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The authors propose to evaluate the prevalence of chronic post-operative pain (CPOP) and continued opioid use in the population that has undergone cardiac surgery at the Montreal Heart Institute. In addition, the authors wish to evaluate the presence of known risk factors for CPOP in this population.

Detailed Description
-----------------
This study will use a 15-minute telephone survey to prospectively evaluate the prevalence and intensity of chronic pain 6 months and 1 year after cardiac surgery. Data on the level of post-operative pain experienced on days 1 to 4, at the time of surgery, as well as opioid consumption, adjuvant pain treatments and other variables of interest that are currently recorded prospectively at time of surgery will be culled from patient charts. Additionally, the possibility of continued opioid use by patients at 6 months post-surgery will be evaluated.

Official Title
-----------------
The Prevalence of Chronic Pain and Continued Opioid Use After Cardiac

Conditions
-----------------
Chronic Pain, Cardiac Surgery, Opioid Use

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who have surgery at the Montreal Heart Institute between October 1 2017 and October 1 2018 will be eligible for selection. Exclusion Criteria: Patients who have declined to be contacted after surgery as noted on the MHI form Consent for futur projects. All patients who accepted to be contacted but decline to participate when contacted after their surgery. Patients who cannot be reached by phone. Patients who cannot speak French

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 |
| --- |
|Other: observation|Observation,|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of CPOP | Prevalence of CPOP at 6-months post-surgery. | 6 (+ or - two weeks) months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic pain, cardiac surgery, opioids
Determination of Glycemic Index (GI) of Ten Food Products

Study Overview
=================
Brief Summary
-----------------
This study is initiated to investigate the glycemic index value of ten food products.

Official Title
-----------------
Determination of Glycemic Index (GI) of Ten Food Products

Conditions
-----------------
Glycemic Index

Intervention / Treatment
-----------------
* Dietary Supplement: Food products


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-pregnant females (at least 6 weeks postpartum, non-lactating) Age between 21 to 60 years Exclusion Criteria: Suffering from any chronic diseases. Suffering from gastrointestinal diseases that may interfere with nutrient absorption, distribution, metabolism and excretion. History of diabtes mellitus or use of antihyperglycemic drugs or insulin to treat diabetes and related conditions. History of AIDS, hepatitis, renal or heart disease or any other serious complications that may interfere with glucose metabolism. Current use of medication that may interfere with the digestion and nutrient absorption (for examples steriods, protease inhibitors or antipsychotics medications). Current use of medication known to affect glucose tolerance (excluding oral contraceptives). Known food allergy or intolerance.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Food products<br>Ten food products will be given to all subjects | Dietary Supplement: Food products<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic index values of all ten products | Glycemic index values at 120 minutes post adminstration. | 120 minutes post adminstration |
Reproducibility of the Array-Based Comparative Genomic Hybridization (aCGH) System Using Whole Blood Samples

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to validate the performance characteristics of the GeneTrait CGH Microarray System DX. Reproducibility among sites, lots, and operators will be evaluated.

Official Title
-----------------
Reproducibility of the GeneTrait™ CGH Microarray System DX Using Whole Blood Samples

Conditions
-----------------
Genetic Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be able to donate at least 10 mL of whole blood Must be able to provide consent, or parental consent and patient assent (if applicable) Must be currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites Must have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or fluorescence in situ hybridization (FISH) analysis (within any of the 73 critical regions) Exclusion Criteria: Unable to donate at least 10 mL of whole blood Unable to provide consent, or parental consent and patient assent (if applicable) Not currently followed as a patient of a genetic clinic or counselor at one of the recruiting sites Does not have at least one chromosomal change that is detectable by the GeneTrait CGH Microarray System DX as determined by karyotype and/or FISH analysis (within any of the 73 critical regions)

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
Multiple genetic conditions will be studied