linjc16/ctgov huggingface dataset:
Tobacco Cessation in Postmenopausal Women (Part II) - 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement

Official Title
-----------------
The Effects of ERT on Appetitive Behavior and Withdrawal in Short-term Smoking Cessation in Postmenopausal Females on Transdermal Nicotine Replacement

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Nicotrol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (Same as Part I) Exclusion Criteria: Same as Part I, with the addition of those who have had a past reaction to transdermal nicotine patch or have active skin diseases will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nicotrol|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
-----------------
Smoking
Systane Clinical Experience Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the physical effect of SYSTANE QID in people that have moderate to severe dry eyes and to establish doctor confidence to prescribe Systane.

Official Title
-----------------
Study to Evaluate the Physical Effect of SYSTANE QID in People That Have Moderate to Severe Dry Feeling Eyes

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

Intervention / Treatment
-----------------
* Other: Systane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe dry feeling eyes 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Systane<br>Systane ocular product | Other: Systane<br>* Systane prescription<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal and conjunctiva staining score |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break up time |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, Systane, Moderate to severe dry eye
Percutaneous Interventions in Adults With CHD

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the clinical benefits of percutaneous intervention to improve pulmonary blood flow on oxygen saturations, symptoms, exercise tolerance and hematocrit in patients with complex cyanotic congenital heart disease who are not candidates for surgical repair.

Detailed Description
-----------------
This is a single center, retrospective study of adult patients with a diagnosis of un-repaired complex cyanotic congenital heart disease including Eisenmenger's Syndrome, single ventricle, pulmonary atresia with aorticopulmonary collaterals, complete atrio-ventricular canal defects, double inlet left ventricle, heterotaxy syndromes and truncus arteriosus. Patients with surgically placed systemic to pulmonary artery shunts will be included. Although generally incompatible with adult survival, rare patients with un-operated or palliated complex cyanotic congenital heart defects (CCHD) survive well into adulthood. Symptoms related to poor pulmonary blood flow and/ or increasing pulmonary vascular resistance progress with advancing age. Percutaneous interventions to improve symptoms and relieve hypoxemia have not been previously reported in adult patients with complex cyanotic congenital heart disease. Percutaneous interventions in patients with cyanotic congenital heart disease may be generally broken down into three types: percutaneous occlusion of shunt lesions, percutaneous balloon valvotomy or valvuloplasty, and balloon angioplasty and stenting of vascular structures (1). Percutaneous interventions for occluded or stenotic systemic to pulmonary artery shunts in childhood have been described (2,3). However, procedures to improve pulmonary blood flow in adults with CCHD have not previously been described.

Official Title
-----------------
Percutaneous Interventions in Adults With Complex Cyanotic Congenital Heart Disease

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: greater than 18 years of age complex cyanotic heart disease oxygen saturation prior to intervention < 90% Exclusion Criteria: those who do not meet inclusion 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult, congenital heart disease, percutaneous occlusion, percutaneous balloon valvotomy, balloon angioplasty, complex cyanotic congenital heart defects (CCHD)
Occupational Performance Problems in Individuals With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Aim: To identify the main occupational performance problems reported by individuals with rheumatoid arthritis and the relationship between these activities with work status of participants . Methods: the investigators conducted a cross-sectional study with 81 patients with RA. Individuals were interviewed the Canadian Occupational Performance Measure. Data was described in frequencies and percentages, and the Pearson's chi-square test was used to determine the asymptotic association between the occupational performance problems with work.

Detailed Description
-----------------
For this cross-sectional study, 81 patients were recruited by convenience at the Clinical Hospital (HC) of the Universidade Federal de Minas Gerais (UFMG), in Brazil. COPM was applied to identify the main occupational performance problems reported by participants. The COPM is an individual measure of self-awareness about the problems faced when carrying out the activities. It identifies problems in the areas of self-care, productivity, and leisure, and measure the individual's performance and satisfaction regarding these activities

Official Title
-----------------
Occupational Performance Problems Frequently Reported by Individuals With Rheumatoid Arthritis

Conditions
-----------------
RheumatoId Arthritis

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 46 years old; diagnosed with RA by rheumatologist (American College of Rheumatology); mental competency as assessed with the Mental State Mini-Examination; possessed the skills to understand the instructions study. Exclusion Criteria had undergone surgery in the upper limbs.

Ages Eligible for Study
-----------------
Minimum Age: 46 Years
Maximum Age: 61 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|Canadian Occupational Performance Measure (COPM) was applied to identify the main occupational performance problems|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupational Performance Measure | The COPM protocol is divided into three areas: self-care, productivity, and leisure. Patients define important activities and classify them with a score of one to 10 (a score of one indicated no importance and a score of 10 indicated extreme importance), | June 2009 to August 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, human activity, Canadian Occupational Performance Measure
Prospective Screening Programme for Malignant Tumors

Study Overview
=================
Brief Summary
-----------------
In prospective part of study, the investigators have found that the parameters of routine blood tests can differentiate varieties of malignancy from healthy people. The investigators enrolled healthy subjects and patients with malignancy that aged from 18 to 85，and collected their clinical data and blood tests result to build the model.And retrospectlly enroll healthy subjects and patients to test the model.

Official Title
-----------------
A Large-scale, Prospective Screening Programme for Malignant Tumors Using Routine Blood Tests Parameters

Conditions
-----------------
Hematologic Tests, Malignant Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
For the cohort of healthy people Inclusion Criteria: Asymptomatic persons between the ages of 18 to 80 years Chinese ethnicity After 3 year follow-up, diagnosed with no malignant disease Subject underwent routine blood tests in our center Exclusion Criteria: 1.With a history of malignant disease For the cohort of patients with malignancy Inclusion Criteria: diagnosis with the following malignant disease，breast cancer, lung cancer, gastric cancer， esophageal cancer，colorectal cancer，nasopharyngeal cancer，liver cancer and cervical cancer Subject underwent routine blood tests in our center

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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 |
| --- | --- |
| Healthy cohort<br>People who received routine physical examination including blood test, and after 3 year follow-up, have not been diagnosed as any kind of malignant tumor. | |
| Malignancy Cohort<br>People who were diagnosed as one of the following malignant disease: breast cancer, lung cancer, gastric cancer， esophageal cancer，colorectal cancer，nasopharyngeal cancer，liver cancer and cervical cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity (true positive rate) | The proportion of persons with disease who have a positive test (positive test results among persons with disease) | 1 year | 
| Specificity (true negative rate) | The proportion of persons without disease who have a negative test (negative test results among persons without disease) | 1 year |
Study of Genotype and Phenotype in Patients With Alpha 1-Antitrypsin Deficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Establish cell lines from patients with alpha 1-antitrypsin deficiency in order to examine genetic traits that predispose to liver injury.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo blood draw and skin biopsy. Cells are isolated from patients' blood and skin, cell lines are established, and genetic traits are examined.

Conditions
-----------------
Alpha 1-Antitrypsin Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Alpha 1-antitrypsin deficiency

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
-----------------
alpha 1-antitrypsin deficiency, genetic diseases and dysmorphic syndromes, rare disease
Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study

Study Overview
=================
Brief Summary
-----------------
Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.

Official Title
-----------------
Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study (COMPARE)

Conditions
-----------------
End Stage Kidney Disease, End Stage Renal Disease, Acute Kidney Injury

Intervention / Treatment
-----------------
* Device: Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System
* Device: Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is 18 years of age. Participant weighs ≥ 34kg. Participant was hospitalized and had dialysis dependent End-Stage Renal Disease or Acute Kidney Injury and was prescribed acute intermittent renal replacement therapy. Exclusion Criteria: Treatments isolated to ultrafiltration only. Any documented condition the Physician feels would prevent the participant from successful inclusion in the study.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tablo Hemodialysis System<br>Participants who were prescribed acute intermittent renal replacement therapy on the Tablo Hemodialysis System at a dialysate flow rate of 300 mL/min | Device: Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System<br>* Intermittent renal replacement therapy using the Tablo Hemodialysis System in the acute setting for participants with AKI or ESKD<br>|
| Conventional Hemodialysis System<br>Participants who were prescribed acute intermittent renal replacement therapy on conventional hemodialysis systems (Non-Tablo) with dialysate flow rates of ≥ 500 mL/min | Device: Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems<br>* Intermittent renal replacement therapy using Conventional Hemodialysis Systems in the acute setting for participants with AKI or ESKD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BUN Lab Value | Change in Blood Urea Nitrogen | Change from baseline BUN measurement at 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bicarbonate Lab Value | Change in Bicarbonate | Change from baseline bicarbonate measurement at 24 hours. | 
| Potassium Lab Value | Change in Potassium | Change from baseline potassium measurement at 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tablo, Outset Medical, ESRD, AKI
Application of Indicator Based-electrical Impedance Tomography Method Assess Lung Regional Perfusion in ICU Patients

Study Overview
=================
Brief Summary
-----------------
This study is an observational study. Investigate the relationship of oxgenation and lung regional ventilation and perfusion assessed by the indicator based-EIT method in the critically ill patients in ICU

Detailed Description
-----------------
Written informed consent was obtained from all patients or next of kin before data were included in the study. When the research team was available, adult patients within 1w, who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters for resuscitation were eligible for the study. Information collected at enrollment included demographic characteristics such as age, sex, Acute Physiology and Chronic Health Evaluation II score (APCHEII); . The global hemodynamic, respiration condition and PaO2 were measured. At the same time, the lung regional ventilation and perfusion assessed by the indicator based-EIT method(injection 10%NaCL). The 10%NaCL was injected by the central venous catheter.

Official Title
-----------------
Application of Indicator Based-EIT Method Assess Lung Regional Perfusion for Critically Ill Patients in ICU

Conditions
-----------------
Respiratory Failure, Hypoxemia, ARDS, Human

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Time of admission ICU < 7days Age (> 18 years old) Have been placed central venous catheter based on clinical requirement Exclusion Criteria: .Chest skin injured and cannot be monitored by EIT. Severe Hypernatremia Pregnancy

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 |
| --- | --- |
| acute respiratory failure group<br>acute respiratory failure (ARF) group: arterial oxygen partial pressure to fractional inspired oxygen ratio, PaO2/FiO2<300 mmHg and/or peripheral oxygen saturation SaO2<94% under air condition and/or severe dyspnea with respiratory rate >30bpm. | |
| control group<br>postoperative ICU patients without ARF were included | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung regional perfusion | Lung regional perfusion monitored by EIT with saline | Hour 1 | 
| oxygenation | oxygenation(SpO2) measured by bedside monitor | Hour 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EIT, pulmonary perfusion
Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population

Study Overview
=================
Brief Summary
-----------------
The study is a survey to answer the specific question, What is the prevalence of metabolic syndrome in maintenance hemodialysis patients? Metabolic syndrome is a cluster of conditions that increase an individual's risk for developing cardiovascular disease and diabetes.

Detailed Description
-----------------
Risk factors for metabolic syndrome will be collected for each consented patient. They include elevated serum triglycerides, reduced HDL cholesterol, hypertension, elevated fasting blood sugar concentration and abdominal obesity. The investigator will measure waist circumference of each consented patient in a secure area according to standardized procedures. The other data is available from the patient's medical record.

Official Title
-----------------
Prevalence of Metabolic Syndrome in a Maintenance Hemodialysis Population

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing maintenance hemodialysis equal to or greater than 3 months Patient at lest 18 years of age Availability of all data in the medical record for classification of the metabolic syndrome, including serum triglycerides, serum HDL-cholesterol, systolic BP and diastolic BP, and serum glucose Exclusion Criteria: Patients unwilling or unable to give informed consent to participate Patients with a history of thyroid disease Patients unable to stand upright

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 |
| --- | --- | --- |
| Percent of maintenance patients with at least three risk factors of metabolic syndrome |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, ESRD patient
Forearm-Supported Head Extension to Decrease Dental Contact

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the forearm-supported head extension decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy

Official Title
-----------------
Forearm-Supported Head Extension to Decrease Dental Contact Between Laryngoscope Blade and Maxillary Incisors During Direct Laryngoscopy

Conditions
-----------------
Endotracheal Intubation

Intervention / Treatment
-----------------
* Procedure: Laryngoscopy with forearm-support
* Procedure: Laryngoscopy without forearm-support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery that require endotracheal intubation for general anesthesia Exclusion Criteria: Trauma or disease or cervical spine Toothless patient Dentoalveolar injury Anatomical anomaly of face or airway History of difficult intubation Patient refusal

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Forearm-supported<br>forearm-supported head extension during direct laryngoscopy | Procedure: Laryngoscopy with forearm-support<br>* forearm-supported head extension during direct laryngoscopy<br>|
| Active Comparator: Control<br>without forearm-support for head extension during direct laryngoscopy | Procedure: Laryngoscopy without forearm-support<br>* without forearm-support for head extension during direct laryngoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental contact | Dental contact between laryngoscope blade and maxillary incisors (Y/N) | during laryngoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blade-to-tooth distance | Teeth distance between laryngoscope blade and maxillary incisors (mm) | during laryngoscopy | 
| Angle of head extension | Angle of head extension during direct laryngoscopy | during laryngoscopy |