linjc16/ctgov huggingface dataset:
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube in Modified Radical Mastectomy on Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Airway management in anesthesia is critical to guarantee appropriate treatment of possible respiratory complications and successful operative practice. LMA® is an alternative to tracheal tube in some surgeries like as mastectomy on breast cancer. Given no need using muscular relaxants in mastectomy, the investigators hypothesized that LMA® would be a superior manner in airway management in radical modified mastectomy on breast cancer than the tracheal tube, and the LMA® might produce less influence on patients' circulatory homeostasis, and easier to be placed before operation.

Official Title
-----------------
Comparison of Laryngeal Mask Airway (LMA®) and Tracheal Tube for Airway Management in Modified Radical Mastectomy on Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: LMA®
* Device: Endotracheal tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese Diagnosed breast cancer Undergoing modified radical mastectomy Agreed to participate the study with informed contract. Exclusion Criteria: Organic dysfunction Long-lasting post-anesthetic care unit(PACU) staying.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>LMA® is placed after anesthesia induction till the end of operation | Device: LMA®<br>* LMA® is placed after anesthesia induction and removed after the operation<br>|
| Active Comparator: 2<br>Standard tracheal tube is inserted after anesthesia induction till the end of operation | Device: Endotracheal tube<br>* Standard endotracheal tube is inserted after anesthesia induction and extubated after the operation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulatory Homeostasis |  | 15min prior to operation to 15min posterior to operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway pressure |  | 15min prior to operation to 15min posterior to operation | 
| Blood gas |  | 15min prior to operation to 15min posterior to operation | 
| Airway complications |  | Start of operation to 6h after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intubation, intratracheal, Homeostasis, Mastectomy, modified radical, Breast Neoplasms
Effect of Intravitreal Anti-VEGF on Retinal Vessels Diameter

Study Overview
=================
Brief Summary
-----------------
Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will be recruited in this prospective self-controlled trial. Fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. Using image analysis software, measurements summarized as the central retinal artery equivalent (CRAE) and central retinal vein equivalent (CRVE). Null Hypothesis: There is no significant difference between arteriolar/venular diameter before and after injection of intravitreal ranibizumab/bevacizumab in the treated and untreated eye

Official Title
-----------------
Effect of Intravitreal Anti-Vascular Endothelial Growth Factors on Retinal Vessels Diameter

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Intravitreal Ranibizumab
* Drug: Intravitreal bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients who wish and need bevacizumab or ranibizumab treatment for underlying disease Exclusion Criteria: History of previous systemic or ocular Anti-VEGF therapy History of previous intravitreal injection with any drug Intraocular pressure ≥ 22 Glaucoma History or presence of thromboembolic events Un-controlled blood pressure Blood donation during the previous 3 weeks Relevant media opacity of the lens

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravitreal Ranibizumab|nan|
|Drug: Intravitreal bevacizumab|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
-----------------
Anti vascular endothelial growth factor, retinal vessels
Partial Lacrimal Punctual Occlusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe a case series of patients with chronic dry eye submitted to partial punctual occlusion.

Official Title
-----------------
Partial Lacrimal Punctual Occlusion in the Management of Dry Eye

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Procedure: Partial Lacrimal Punctual Occlusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sin and symptom of dry eye Use more than 4 times a day topic lubricant for the eye Exclusion Criteria: Ocular diseases other than dry eye Use of systemic drugs

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Partial Lacrimal Punctual Occlusion<br>Cauterization of the edge of all lacrimal punctum was carried out in all patients | Procedure: Partial Lacrimal Punctual Occlusion<br>* Cauterization of the edge of all lacrimal punctum was carried out in all patients<br>|

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
-----------------
Cornea, Dry eye, lacrimal punctual occlusion, lacrimal film, ocular surface
CXCL9 and CXCL11 Levels in Patients With Autoimmune Thyroiditis and Habitual Abortions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure serum CXCL9 and CXCL11 levels in patients with autoimmune thyroiditis and habitual abortions

Conditions
-----------------
Habitual Abortion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-pregnant women with euthyroid autoimmune thyroiditis and a history of first trimester recurrent spontaneous abortions Exclusion Criteria: 1) presence of acute or chronic systemic diseases; 2) other autoimmune diseases; 3) pregnancy and lactation over the previous 6 months; 4) evidence of infectious diseases in the last 3 months; 5) treatment with drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs, amiodarone, and lithium; 6) clinical history of hyperthyroidism and/or the presence of anti-TSH receptor antibodies.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| authoimmıne thyroiditis and habitual abortus<br> | |
| authoimmune thyroiditis<br> | |
| healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum CXCL9 and CXCL11 levels in patients with autoimmune thyroiditis and habitual abortions |  |  |
Adalimumab in Combination With Methotrexate vs Methotrexate Alone in Early Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effectiveness of adalimumab in combination with methotrexate compared to methotrexate alone on work disability in subjects with early rheumatoid arthritis

Official Title
-----------------
A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: adalimumab
* Drug: methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria Subject must be in paid employment Subject has self-reported work impairment since onset of symptoms Exclusion Criteria: A subject has chronic arthritis diagnosed before age 16 years. Subject has been on preceding treatment with methotrexate Subject unable to withdraw from current DMARDs Subject has preceding treatment with any biological TNF antagonist Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast-feeding or considering becoming pregnant

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: adalimumab|nan|
|Drug: methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Job loss measurement |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Job productivity measurements |  |  | 
| Patient reported outcomes |  |  | 
| DAS28 |  |  | 
| Safety parameters |  |  |
Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. If this can be shown, it has the potential to spare patients multiple invasive blood draws as well as allow for earlier detection of significant blood loss and therefore positively impact on patient morbidity and mortality. Additionally, it may represent significant financial cost savings in that it may allow for patients to be monitored in a non-intensive care unit setting. This will be an observational study. The continuous hemoglobin monitor will be connected to the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin monitoring will occur concurrently at a pre-specified frequency as well as at the physician's discretion based on usual clinical information. The physician will be blinded to the continuous hemoglobin monitoring readings and therefore patient care will not be affected by the use of the monitor. Once the study has ended, the data will then be analyzed to assess for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin measurement.

Detailed Description
-----------------
No recruitment initiated

Official Title
-----------------
Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective

Conditions
-----------------
Bleeding, Acute Blood Loss Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age admission to surgical intensive care unit suspected or high risk for ongoing blood loss 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients at risk for bleeding<br>Patients at risk for bleeding | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of hemoglobin level measurement between continuous hemoglobin monitor and laboratory analysis |  | minimum of every 6 hours after intensive care unit admission, shorter intervals if determined indicated by physician based on clinical information, over an estimated period of 3 days, or until patient transferred out of intensive care unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, blood loss, hemoglobin, hemoglobin monitoring, noninvasive monitoring
Long Term Follow-up After Embolization of Brain Arteriovenous Malformations

Study Overview
=================
Brief Summary
-----------------
The time-frame and the follow-up elements after embolization of brain arteriovenous malformations are not standardized. Therefore, few reliable follow-up data are available for these patients. This study aims at collecting standardized long term data for these patients.

Official Title
-----------------
Long Term Follow-up After Embolization of Brain Arteriovenous Malformations

Conditions
-----------------
Arteriovenous Malformations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: arteriovenous malformation age > 18 years old Exclusion Criteria: none

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic evaluation of the arteriovenous malformation occlusion |  | 5 years after embolization |
Participation of Breast Milk Feeding Mothers in Research

Study Overview
=================
Brief Summary
-----------------
To assess concerns and barriers for measuring milk intake of breast fed infants using the remote food photography method and SmartIntake smartphone application. These data will 1) provide support for further development of the Infant RFPM and 2) provide important preliminary data in a National Institutes of Health grant application being developed and assess the prevalence of exclusive breastfeeding and complementary breastfeeding in the study population.

Detailed Description
-----------------
Study participation will be the completion of an anonymous, online survey powered by HIPAA compliant REDCap database. The survey will be made available to potential participants through the internet. The survey will take approximately five minutes to complete. The expected duration of recruitment and completion of the study is six months.

Official Title
-----------------
Participation of Breast Milk Feeding Mothers in Research

Conditions
-----------------
Breastfeeding, Energy Intake, eHealth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual may take the survey. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anyone<br>Any individual may complete this survey | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receptivity for measuring milk intake for 5-7 days using a smartphone app | Outcome measured by questionnaire | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receptivity for expressing human breast milk to assess milk intake for 5-7 days | Outcome measured by questionnaire | 1 day |
Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This real-life Health Economics and Outcome Research (HEOR) study will enable to assess the impact of current therapies on quality of life (QoL), productivity loss and health care resource utilization in metastatic breast cancer (mBC). This prospective study will estimate patient-reported outcomes (PROs) and resource utilization data for mBC patients stratified according to treatment type, treatment line and disease status (progression vs. progression free) in a real-life setting. To estimate QoL, work productivity and health care resource utilization of post-menopausal patients with ER+/HER2- locally advanced or metastatic breast cancer in a real-life setting. The secondary objective is to estimate QoL and work productivity of mBC patients' caregivers. During the course of the study, data will be collected on quality of life and work productivity. Patients and caregivers will be asked to fill a set of questionnaires at their recruitment in the study, at 3 months and at 6 months after recruitment.

Official Title
-----------------
Real-World Outcome Research Study on Quality of Life, Work Productivity and Health Care Resource Utilization in Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of locally advanced or metastatic breast cancer Post-menopausal women ER+/HER2- mBC Signature of informed consent form Ability to read and understand English or French Exclusion Criteria: Participation to a clinical trial

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacoeconomic impact of current therapies for the treatment of mBC in a real-life setting. | Pharmacoeconomic impact will be evaluated by questionnaires completed by the patient and the caregiver. These include quality of life, health care resource utilization, work productivity and activity impairment, and health questionnaires. Data will be summarized by time points (recruitment, 3 months and 6 months) and categorized by the line of treatment (first line, second and subsequent line), by disease status (progression and progression free), by treatment type (chemotherapy and endocrine therapy, and if sample size permits by type of endocrine therapy such as anti-estrogen and aromatase inhibitors), and by specific treatment (such as letrozole and anastrozole), if sample size permits. | 6-month follow-up after recruitment |
Randomized Trial for Pharmacogenomics-based Tuberculosis Therapy (RT-PGTT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to elucidate whether the individualized medicine based on NAT2 gene polymorphism could improve the safety, efficacy and economical benefits of multi-drug therapy for the pulmonary tuberculosis with isoniazid.

Conditions
-----------------
Pulmonary Tuberculosis

Intervention / Treatment
-----------------
* Drug: Isoniazid
* Drug: isoniazed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed pulmonary tuberculosis patients Informed consent including pharmacogenomic analysis Exclusion Criteria: Abnormal liver and kidney function test before treatment Long-term use of steroids and/or immunodepressants Inadequate clinical conditions

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: PGx-treatment<br>NAT2 genotype-guided treatment with stratified isoniazid dose (approx. 7.5 mg/kg b.w., patients homozygous for NAT2*4: rapid acetylators; 5 mg/kg, patients heterozygous for NAT2*4: intermediate acetylators; 2.5 mg/kg, patientes without NAT2*4: slow acetylators) | Drug: Isoniazid<br>* Modified daily isoniazid dose : approx. 7.5 mg/kg, 5 mg/kg and 2.5 mg/kg for rapid, intermediate and slow acetylators, respectively<br>|
| Active Comparator: STD-treatment<br>Treatment with conventional standard isoniazid dose (approx. 5 mg/kg b.w.) | Drug: isoniazed<br>* Conventional standard daily isoniazid dose : approx. 5 mg/kg b.w. for all<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidences of unfavorable events in two different treatment regimens based on the NAT2 gene polymorphism | 1) the incidences of drug-induced liver injury associated with INH that occurred within 8 weeks of the treatments, and 2) the incidence of early treatment failure as indicated by a persistent positive culture or no improvement in chest radiographs at the 8th week |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other adversed events during the 8 weeks of the intensive phase of the anti-tuberculosis therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary tuberculosis, isoniazid, arylamine N-acetyltransferase 2, pharmacogenomics, genetic polymorphisms, individualized medicine, drug-induced hepatotoxity