linjc16/ctgov huggingface dataset:
Comparison of 22-gauge and 19-gauge Aspiration Needle During EBUS-TBNA

Study Overview
=================
Brief Summary
-----------------
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA concerning the diagnostic yield, the quality and quantity of each biopsy needle without raising the rate of complications.

Detailed Description
-----------------
Investigators intend to compare the 19-gauge needle and the 22-gauge-needle during EBUS-TBNA performed in rigid bronchoscopy for patients with probable lung cancer diagnosis and enlarged mediastinal lymph nodes.

Official Title
-----------------
Comparison of the Diagnostic Yield Between Various Endobronchial Ultrasound-guided-transbronchial Needles (EBUS-TBN) to Evaluate Suspect Mediastinal and Hilar Lymph Nodes

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: EBUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients aged over 18 Patients signed written informed consent Mediastinal or hilar enlarged lymph nodes (>10mm) in short axis radiological or clinical findings likely for lung cancer Exclusion Criteria: Severe impairment of any organs, with do not enable anaesthesia Quick <80%, INR >1,5, thrombocytes <50/nl or PTT>120sec Other clinically relevant medical or psychological diseases, which affect the patients judgement or ability to participate in this study. Insufficient language ability (spoken and written German)

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 |
| --- | --- |
| Study Product (19-gauge)<br>After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle | Procedure: EBUS<br>* 19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.<br>|
| Control Intervention (22-gauge)<br>After randomization, the subject undergo EBUS-TBNA either with the 19-gauge needle or the 22-gauge needle | Procedure: EBUS<br>* 19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sample weight |  | February 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of complications like bleeding, infections, pneumothorax and pain |  | February 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EBUS-TBNA, staging, lymph node metastases
Longitudinal Study of a Bionic Eye

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis.

Detailed Description
-----------------
To observe and assess visual, orientation and mobility behavior with primary and adjunct vision processing (AVP) methods that may enhance the performance with the suprachoroidal retinal prosthesis (ScRP). To investigate the effectiveness of primary and AVP methods in the laboratory and real-world environments with the ScRP. Assess structural and functional ScRP stability with objective and subjective assessments. Record participant experiences and feedback with the ScRP.

Official Title
-----------------
Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses

Conditions
-----------------
Retinitis Pigmentosa, Choroideremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing to provide signed informed consent; Implanted with a suprachoroidal retinal prosthesis; Be available for the study visits; Willing to comply with study assessments; In good general health and mobile. Exclusion Criteria: Medical condition that prohibits mobility; Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
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 |
| --- | --- | --- |
| Effectiveness of vision processing method in the laboratory. | Measure effectiveness of of the vision processing method via observational and quantitative data. | 5 years. | 
| Effectiveness of vision processing method in the 'real world' featured environment. | Measure the effectiveness of the vision processing method via observational qualitative and quantitative data in participant 'real world' featured environment. | 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device stability and functionality. | Monitor device stability with routine ophthalmic imaging, impedance and threshold testing. | 5 years. | 
| Participant experience. | Document participant anecdotal experience with the VP method in 'real world' environments. | 5 years | 
| Participant interview. | Interview participants to capture participant experience with the ScRP, determine differences in functional outcomes and utilise this information to improve assessment of functional outcomes. | 5 years |
Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study

Study Overview
=================
Brief Summary
-----------------
This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.

Official Title
-----------------
Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study

Conditions
-----------------
Safety Surveillance, Adverse Drug Events, Adverse Drug Reactions, Severe Adverse Events, Severe Adverse Reactions

Intervention / Treatment
-----------------
* Drug: Compound Kuh-seng Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who use Compound Kushen Injection in the monitoring hospitals Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Compound Kuh-seng Injection<br>Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc. | Drug: Compound Kuh-seng Injection<br>* Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.<br>* Other names: Fufang Kushen Zhusheye;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection |  | 2 years | 
| The incidence of anaphylactic reaction to Compound Kuh-seng Injection |  | 2 years | 
| The incidence of new ADRs to Compound Kuh-seng Injection |  | 2 years | 
| The incidence of new SARs to Compound Kuh-seng Injection |  | 2 years |
Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.

Official Title
-----------------
Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery in Soba Hospital Sudan

Conditions
-----------------
Caesarean

Intervention / Treatment
-----------------
* Drug: ceftizoxime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective Cesarean section Exclusion Criteria: Diabetes severe anaemia allergy

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ceftizoxime (cefizox) injection<br>ceftizoxime (cefizox) as single dose of 1 g at the interval of 30-60 minutes before the incision | Drug: ceftizoxime<br>* ceftizoxime (cefizox) injection either after clamping the cord<br>* Other names: cefizox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reducing post Cesarean section febrile morbidity | reducing infection rate | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ceftizoxime, Cesarean, post caesarean febrile morbidity
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. At the same time, the investigators will study the efficacy and safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.

Detailed Description
-----------------
This is a randmized, double-blind, placebo-controll study.

Official Title
-----------------
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging

Conditions
-----------------
Mild Cognitive Impairment, Biomarker, Diagnosis, Treatment

Intervention / Treatment
-----------------
* Drug: Huperzine A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: memory complaint, preferably corroborated by a spouse or relative. objective memory impairment. normal general cognitive function. intact activities of daily living. absence of dementia. the positive of brain senile plaque. Exclusion Criteria: more than two lacuna ischemia (of diameter < 1 cm) as revealed by MRI fluid-attenuated inversion recovery (FLAIR) sequence. other type of dementia except AD

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment group<br>Huperzine A treatment. | Drug: Huperzine A<br>* The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.<br>* Other names: shuang yi ping;|
| Placebo Comparator: Placebo group<br>The placebo in 52 weeks. | Drug: Placebo<br>* The participants will treatment by the placebo in 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average annual conversion rate in patients of MCI due to AD convert to the AD. |  | 52 weeks |
Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg

Study Overview
=================
Brief Summary
-----------------
In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication.

Official Title
-----------------
Tolerability, Compliance and Indications of Aspirin Protect 100 mg in Longterm Use (12 Months) Under Everyday's Conditions - Data Collection With Questionnaires Handed Out in Pharmacies to Aspirin Protect 100 mg Consumers

Conditions
-----------------
Aspirin, Drug Safety, Effects, Longterm

Intervention / Treatment
-----------------
* Drug: Acetylsalicylic acid (Aspirin, BAYE4465)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who buy Aspirin protect 100 mg in a pharmacy and are willing to participate in the study. 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 |
| --- | --- |
| Group 1<br> | Drug: Acetylsalicylic acid (Aspirin, BAYE4465)<br>* Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and gastrointestinal tolerability assessed by questionnaire |  | After 12 months |
Exploratory Study of a New Urine Collection Device for Men

Study Overview
=================
Brief Summary
-----------------
The aim of the investigation is to evaluate the subjects experience of a new collection device for men. An open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.

Official Title
-----------------
Exploratory Study of a New Urine Collection Device for Men

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Device: Urine collection device for men


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Male Be at least 18 years of age and have full le-gal capacity Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day Have had current incontinence issues for at least 3 months Able to understand patient information and able to change the product himself Up to 6 of the subjects can be users who are using an intermittent catheter due to re-tention, but who are also dribble inconti-nent in-between catheterizations, and hence need a product to handle the inconti-nence. Able to fit the test product. Exclusion Criteria: If experiencing incontinence less than once per week Bedridden, using wheelchair or using a walking aids regularly

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urine Collection Device for Men<br>Test of Urine Collection Device for Men for 7 (+/- 3/0 days). | Device: Urine collection device for men<br>* Use of urine collection device for men<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire used to measure the frequency of success in support of comfortable: How comfortable was the product to wear? | Questionnaire | One week |
Participation to Colorectal Cancer Screening With Fecal Occult Blood Test and Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Adherence rate to screening colonoscopy (TC) in the average-risk general population is still unclear. Aim of this study was to compare the uptake of TC screening with that of fecal occult blood (FOBT) in the general population of different Italian areas.

Detailed Description
-----------------
A nationwide, population-based, multicenter, randomized trial comparing attendance to TC with that to FOBT was performed. Sixty-four general practitioners (GPs), overall including in their lists 9,889 average-risk subjects aged 55-64 years, were randomized between TC and FOBT screening programs. Eligible subjects were mailed a personal invitation letter co-signed by their GP and the coordinator of the area-reference GI centre. Attendance rate and detection rate for advanced neoplasia (colorectal cancer, adenoma >10 mm or with villous histology or high-grade dysplasia) for each arm of the study were assessed.

Official Title
-----------------
Participation to Colorectal Cancer Screening With Faecal Occult Blood Test and Colonoscopy: an Italian, Multicenter, Randomized Population Study

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: colonoscopy
* Procedure: faecal test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asymptomatic 55-64 years subjects Exclusion Criteria: already studied for colorectal cancer, severe comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 64 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fobt<br>faecal occult blood test | Procedure: faecal test<br>* faecal occult blood test for screening<br>|
| Active Comparator: colonoscopy<br>colonoscopy screening | Procedure: colonoscopy<br>* colonoscopy screening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation to colorectal cancer screening |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
average-risk subjects for
Clinical, Physiological and Prognostic Implication of Microvascular Status

Study Overview
=================
Brief Summary
-----------------
There are several physiologic parameters in evaluating cardiovascular disease. This study will reveal which parameter is the most proper value in predicting disease severity and risk factors of patients.

Detailed Description
-----------------
Fractional Flow Reserve (FFR), index of microcirculatory resistance (IMR), and coronary flow reserve (CFR) will be measured in stable angina patients before coronary intervention. Relationship between angiographic characteristics of patients and FFR, IMR, CFR will be analyzed. Comparison of risk factors and prognosis between parameters will be also analyzed. This study will evaluate that which parameter is correlate with disease severity and risk factors of patients.

Official Title
-----------------
Clinical, Physiological and Prognostic Implication of Index of Microcirculatory Resistance

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 Patients with stable angina FFR, IMR, CFR were measured before coronary intervention Exclusion Criteria: Patients who have severe side effects or contraindication to hyperemic agents (ex. adenosine) Patients with hemodynamic instability elevation of cardiac enzymes, evidence of acute MI, or a culprit vessel of acute coronary syndrome

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 |
| --- | --- |
| Korea<br>patients in South of Korea | |
| United Kingdom<br>patients in England | |
| Spain<br>patients in Spain | |
| United State of America<br>patients in USA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spearman correlation coefficient between FFR, IMR, CFR and angiographic severity |  | during coronary angiography | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Angina, Stable, Fractional Flow Reserve, Myocardial, Coronary Angiography