linjc16/ctgov huggingface dataset:
Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to determine the extent of bioavailability of two low dose estradiol/norethisterone acetate (NETA) preparations with a marketed estradiol/norethisterone acetate (NETA) preparation.

Official Title
-----------------
Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1.0 mg Estradiol + 0.5 mg Norethisterone Acetate

Conditions
-----------------
Menopause, Healthy

Intervention / Treatment
-----------------
* Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)
* Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)
* Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Postmenopausal Caucasian race Smoking (up to 5 cig./per day) is allowed Good state of health: evidenced by medical history, physical examination including gynecological examination, results of laboratory examination Exclusion Criteria: Known or suspected allergy to trial products or related products Previous participation in this trial Previous estrogen and/or progestin hormone replacement therapy Known, suspected or history of breast cancer Systolic blood pressure (BP) at least 160 mm Hg and/or diastolic BP at least 100 mm Hg, currently treated or untreated Body Mass Index (BMI) above 35.0 kg/m^2

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: 0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)<br>* A single oral dose of 2 tablets under fasting conditions<br>|
| Experimental: B<br> | Drug: 0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)<br>* A single oral dose of 2 tablets under fasting conditions<br>|
| Active Comparator: C<br> | Drug: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)<br>* A single oral dose of 1 tablet under fasting conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC(0-∞)) |  |  | 
| Maximal concentration (Cmax) |  |  | 
| Time to maximum (tmax) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) from dosing up to last sample |  |  | 
| Terminal half-life (t½) |  |  |
Randomized Study of Botulinum Toxin Type A for Achalasia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the efficacy of two doses of botulinum toxin in the treatment of achalasia. II. Compare the safety of these two doses in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, dose response study. Patients are randomized to one of two treatment arms; each arm receives a different dose of botulinum toxin type A. All patients undergo a flexible upper gastrointestinal endoscopy. Botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants. Some patients may receive a second treatment, depending on response and/or time of relapse. Patients are followed daily for 7 days, then every 1-6 months for 1-2 years after treatment. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Esophageal Achalasia

Intervention / Treatment
-----------------
* Drug: botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of achalasia by esophageal manometry and upper endoscopy Symptomatic including dysphagia, regurgitation, etc. No esophageal ulcers, Barrett's esophagus, significant esophagitis, or esophageal varices --Patient Characteristics-- Hematopoietic: Platelet count at least 50,000/mm3 Hepatic: PT no greater than 3 seconds No severe hepatic problems Renal: No severe renal problems Cardiovascular: No recent myocardial infarction No unstable angina No decompensated congestive heart failure Pulmonary: No severe pulmonary disease with dyspnea at rest Other: No altered mental status No serious systemic disease Not 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: botulinum toxin type A|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
-----------------
achalasia, gastrointestinal disorders, rare disease
Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to pathologic myopia.

Detailed Description
-----------------
In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment. Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.

Official Title
-----------------
Efficacy of Combining Intravitreal Bevacizumab With Photodynamic Therapy Using Reduced Light Fluence Rate in Choroidal Neovascularization Secondary to Pathologic Myopia.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: Combination therapy IVB + rf-PDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopic CNV, CNV leakage Exclusion Criteria: CNV not associated with high myopia No activity of CNV

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 60 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: Bevacizumab and verteporfin<br> | Drug: Combination therapy IVB + rf-PDT<br>* low-fluence photodynamic therapy combined with intravitreal bevacizumab<br>* Other names: Combined therapy: IVB + rf-PDT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA improved |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| no CNV leakage |  | 6 months |
European Perioperative Brugada Survey

Study Overview
=================
Brief Summary
-----------------
The aim of this survey is to assess the current perception and clinical practice of Resident and Board-certified Anaesthesiologists and Intensivists regarding perioperative care of patients burdened with the Brugada Syndrome. It is intended to investigate this primarily on national and secondarily on European level.

Official Title
-----------------
European Perioperative Brugada Survey

Conditions
-----------------
Brugada Syndrome

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants must have received an invitation to participate in the survey through the online platform of the European Society of Anaesthesiology and Intensive Care. Exclusion Criteria: Uninvited participation in the survey is not possible.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brugada Survey<br>Survey will be answered by all participants | Other: Survey<br>* Participants will fill in the survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire about treatments for Brugada patients | Number of participants with treatment-related information as assessed by the survey/questionnaire N/A | 1 hour |
Relationship of Mindfulness, Artistic Activities and Quality of Life

Study Overview
=================
Brief Summary
-----------------
Methods: This study has the descriptive-correlational method and the statistical population was all artistic females of Bojnord city in 2018. In this study, 200 women of carpet weavers were selected by cluster random sampling. Participants filled out researcher-made questionnaires on how to do artistic activities, mindfulness, and quality of life. Data were analyzed using the Pearson correlation coefficient and hierarchical regression (moderator).

Official Title
-----------------
University of Bojnord

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Other: descriptive


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be female, having 21 -60 years old, to work in workshops of weaving carpet, be literacy Exclusion Criteria: be male, having under 21, upper 60, no work in workshops of weaving carpet , having psychotic disorders, be illiteracy

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: descriptive|correlation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | quality of life was measured by The World Health Organization Quality of Life. the questionnaire has 26 items measuring physical, psychological, social and environmental health factors. the items are also assessed on a 5-point scale. the high score on this questionnaire indicates a good quality of life. | 3 day | 
| mindfulness | mindfulness was measured by 39-item self-report scale made by Bauer et al (2006). this scale has observation, conscious action, non-judgmental of inner experience, description, and non-reaction factors. The items were assessed on a 5-point Likert scale. the high score on this scale indicates good mindfulness. | 3 day | 
| artistic activities | The researcher of this study designed seven items to measure the amount of artistic activity during the day and the week. the means of artistic activity is carpet weaving. a participant who is weaving carpet every day, she has high level artistic activities. | 3 day |
Evaluation of Innovated Screening Tools for Type 2 Diabetes Among Chinese Population(SENSIBLE STUDY I)

Study Overview
=================
Brief Summary
-----------------
Evaluation of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population

Detailed Description
-----------------
Using the WHO criteria as the golden standard，drawing the ROC curve of 2h-UG combined with FPG, AGEsP alone or in combination with FPG，calculating the area under the ROC curve.

Official Title
-----------------
Using 2h-glycosuria Combined With Fasting Plasma Glucose , Advanced Glycation End-product Alone or in Combination With Fasting Plasma Glucose in Diabetes Screening in Chinese Natural Population

Conditions
-----------------
Type II Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 70 year old urban and rural residents; Volunteer to participate in this study and sign informed consent. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| area under the ROC curve | area under the ROC curve of different method of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity of screening | Using WHO criteria as golden standard,sensitivity and specificity of using 2h-UG combined with FPG, AGEsP alone or in combination with FPG in diabetes screening in Chinese natural population | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced glycation end-product, Glycosuria
Needle Puncture Point During Central Venous Catheterization With Ultrasound Guidance

Study Overview
=================
Brief Summary
-----------------
In this observational study, we will measure the shortest distance from the cricoid cartilage level to the puncture site of the introducer needle when anesthesiologists perform central venous catheterization.

Detailed Description
-----------------
After anesthesia induction and tracheal intubation, we will prepare central venous catheterization for patients requiring it. After anesthesiologists who are blinded to this study perform central venous catheterization, an investigator measured the shortest distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle.

Official Title
-----------------
Position of Puncture Point of the Introducer Needle During Internal Jugular Venous Catheterization With Ultrasound Guidance

Conditions
-----------------
Central Venous Catheterization

Intervention / Treatment
-----------------
* Device: central venous cathterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery under general anesthesia requirement of central venous catheterization Exclusion Criteria: disagreement for participation

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: central venous cathterization|central venous catheterization through the right internal jugular vein|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| puncture site | distance from the crease line of the cricoid cartilage to the puncture site of the introducer needle | intraoperative |
Computerized Mobilization of the Cervical Spine Utilizing the Occiflex Device for the Treatment of Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of the Occiflex device in the treatment of neck pain.

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Device: Occiflex Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic neck pain: post-whiplash injury, myofacial pain, cervical facet joint disease and idiopathic chronic neck pain Exclusion Criteria: Radiculopathy Myelopathy Cerebral vascular disease Malignancy Osteoporosis Cervical disc herniation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: I. Patients with chronic neck pain<br> | Device: Occiflex Device<br>* This device is a computerized robotic platform that allows continuous mobilization of the cervical spine in a three dimensional space. The patients undergoes biweekly 20 minute therapeutic session for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of computerized continuous mobilization of the cervical spine |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of computerized mobilization of treatment of patients with chronic neck pain |  | one year |
Dexcom G6 Continuous Glucose Monitoring in Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This is a pilot study enrolling adult hemodialysis patients with diabetes recruited from the University of California Irvine Medical Center (UCIMC) who will undergo simultaneous measurement of glucose levels using 1) continuous glucose monitor (CGM) measured by a Dexcom G6 device vs. 2) gold-standard blood glucose levels using capillary fingerstick or venous blood glucose measurements obtained on a point of care (POC) blood glucose meter. The study will assess Dexcom G6 accuracy by comparing glucose levels on the CGM device vs. blood glucose measurements in the study population.

Official Title
-----------------
Comparison of Dexcom G6 Continuous Glucose Monitoring System and Blood Glucose Levels in Adult Hemodialysis Patients With Diabetes

Conditions
-----------------
Diabetes, Hemodialysis, Glucose Measurement

Intervention / Treatment
-----------------
* Device: Dexcom G6 Continuous Glucose Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult hemodialysis patients age 18 years or older Have a comorbidity of diabetes Receipt of care from the inpatient University of California Irvine Medical Center nephrology consult service Expected hospital stay ≥48 hours Have the ability to directly provide informed consent for participation in the study Exclusion Criteria: Critically-ill patients receiving care in the intensive care unit (ICU) or cardiac care unit (CCU) Moribund patients expected to die within 48 hours Presence of any condition deemed by PI's judgment that would seriously limit life expectancy (i.e., poor survival) Pregnant Unwilling or unable to provide informed consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexcom G6 Continuous Glucose Monitor<br> | Device: Dexcom G6 Continuous Glucose Monitor<br>* Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose measurement | Proportion of CGM values within 20% of blood glucose levels >100 mg/dl or within 20 mg/dl of blood glucose level for levels <=100 mg/dl. (Will examine different thresholds of CGM values within a certain range of blood glucose levels, i.e., 10%, 15%, 25%.) | 3 to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia events | Comparison in number of hypoglycemia events (glucose <70 mg/dl) determined by CGM or by blood glucose measurements | 3 to 5 days |