linjc16/ctgov huggingface dataset:
The Role of the GP in the Management of Ambulatory Heart Failure

Study Overview
=================
Brief Summary
-----------------
To describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ARS blockers of the type ACEinhibitor/ARA2/ARNi, ß- and/or anti-aldosterone).

Official Title
-----------------
The Role of the GP in the Management of Ambulatory Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a previous diagnosis of heart failure with impaired ejection fraction (LVEF < 40%) Under 85 years of age Admitted to an Emergency department for cardiac decompensation Hospitalized following this decompensation Not deceased within one month of hospitalisation Whose sum of the doses of ACEI or ARB2 + BB + aldosterone antagonist is less than 50% of the dose required for this patient* (definition in annex) Who did not object within one month of being informed Exclusion Criteria:- Patient objecting to the use of their data Patient who is a minor Patient who does not have a general practitioner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Heart Failure Patients with impaired ejection fraction<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative analysis of verbatims after grouping |  | Through study completion, an average of 1 year |
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis

Conditions
-----------------
Ocular Inflammation Associated With Blepharaconjunctivitis

Intervention / Treatment
-----------------
* Drug: Tobramycin 0.3%/Dexamethasone 0.05%
* Drug: TOBRADEX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ocular inflammation associated with blepharaconjunctivitis Exclusion Criteria: ocular allergy ocular disorders that would preclude safe administration of test article

Ages Eligible for Study
-----------------
Minimum Age: 2 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tobramycin 0.3%/Dexamethasone 0.05%<br>Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes | Drug: Tobramycin 0.3%/Dexamethasone 0.05%<br>* Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days<br>|
| Active Comparator: TOBRADEX<br>TOBRADEX 1 drop 4 times daily in both eyes | Drug: TOBRADEX<br>* TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) | Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria. | Day 4 - Test Of Cure (TOC) compared to Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular inflammation, blepharaconjunctivitis
TAP Block With Two Different Doses of Levobupivacaine

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to investigate the effects of two different doses of levobupivacaine in TAP (transversus abdominus plane) block for postoperative management. For this purpose we planned to include 50 children aged between 2 and 12 that will undergo unilateral inguinal surgery. The doses that will be used in the study were within usual dose limits which is stated in prospectus of the study drug.

Detailed Description
-----------------
Fifty children undergoing TAP block were randomly divided into two groups as levobupivacaine 0.25% 0.5 ml/kg and levobupivacaine 0.25% 0.25 ml/kg. Postoperative pain was evaluated with observational pain scale and modified pediatric objective pain scale.

Official Title
-----------------
Comparison of TAP Block With Two Different Doses of Levobupivacaine for Postoperative Pain Management in Pediatric Patients

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Levobupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers planned to undergo unilateral inguinal surgery under TAP (ilioinguinal and iliohypogastric block) and general anesthesia Aged between 2 and 12 Exclusion Criteria: Patients with coagulation dysfunction Patients with chronic pain Patients having infection at the site of intervention Patients with a history of allergy Patients having chronic diseases (hepatic dysfunction, renal failure)

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Levobupivacaine high volume<br>TAP block with levobupivacaine 0.25% of 0.5 ml/kg under general anesthesia | Drug: Levobupivacaine<br>* Transversus abdominis plane block with levobupivacaine<br>* Other names: Chirocaine;|
| Active Comparator: Group Levobupivacaine low volume<br>TAP block with levobupivacaine 0.25% of 0.25 ml/kg under general anesthesia | Drug: Levobupivacaine<br>* Transversus abdominis plane block with levobupivacaine<br>* Other names: Chirocaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative VAS score <4 at postoperative 24 hours |  | Postoperative first 24 hours |
Study of CS-3150 in Patients With Primary Aldosteronism

Study Overview
=================
Brief Summary
-----------------
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.

Official Title
-----------------
A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism

Conditions
-----------------
Primary Aldosteronism

Intervention / Treatment
-----------------
* Drug: CS-3150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 20 years or older at informed consent Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing Patients satisfying following blood pressure; sitting systolic blood pressure (SBP) ≥ 140 mmHg and <180 mmHg sitting diastolic blood pressure (DBP) ≥ 90 mmHg and <110 mmHg Exclusion Criteria: Secondary hypertension except primary aldosteronism or hypertensive emergency Patients diagnosed diabetic nephropathy Patients with type 1 diabetes Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 Serum potassium level < 3.0 or ≥ 5.1 milliequivalent (mEq)/L

Ages Eligible for Study
-----------------
Minimum Age: 20 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: CS-3150<br>CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks. | Drug: CS-3150<br>* CS-3150 2.5 to 5.0 mg , orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting blood pressure | Change from baseline in sitting systolic and diastolic blood pressure | Baseline to end of Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of sitting blood pressure | Time course of sitting systolic and diastolic blood pressure | Baseline to end of Week 12 | 
| Proportion of patients achieving sitting blood pressure goal |  | Baseline to end of Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary aldosteronism, Hypertension, mineralocorticoid receptor antagonist, Developmental Phase III
Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.

Official Title
-----------------
Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be Responders

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: continuous negative external pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must have completed study SOM-012 and been categorized as a responder the subject agrees to participation by signing an informed consent statement Exclusion Criteria: medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk

Ages Eligible for Study
-----------------
Minimum Age: 22 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cNEP<br>continuous negative external pressure will be used nightly by all participants | Device: continuous negative external pressure<br>* continuous negative external pressure will be applied to the anterior neck at night<br>* Other names: cNEP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in baseline apnea hypopnea index from baseline | Reduction in apnea hypopnea index (AHI) from the baseline value of >50% and also <15/hr | End of Week 2 of home use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of adverse events | Collection of adverse events | two week study period | 
| Apnea hypopnea index, as measured by home sleep testing | Comparison of AHI from home sleep testing in this study to those of the polysomnogram (PSG) in SOM-012 | two weeks |
Post-marketing Surveillance of Ventilat® Metered Dose Inhaler in Chronic Obstructive Bronchitis

Study Overview
=================
Brief Summary
-----------------
Study to obtain further information on the tolerability and efficacy of Ventilat® metered-dose inhaler in the treatment of Chronic Obstructive bronchitis under conditions of daily practice

Official Title
-----------------
Postmarketing Surveillance Study (as Per § 67(6) AMG [German Drug Law]) of Ventilat® Metered-dose Inhaler in Chronic Obstructive Bronchitis

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Ventilat® - metered dose inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primarily Patients of both genders older than 40 years, who suffer from Chronic Obstructive bronchitis Only patients who have not been treated with an anticholinergic within the last year are to be considered for inclusion Exclusion Criteria: •Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Chronic obstructive bronchitis patients<br> | Drug: Ventilat® - metered dose inhaler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the clinical picture |  | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 4-point scale |  | after 4 weeks | 
| Assessment of efficacy by patient on a 4-point scale |  | after 4 weeks | 
| Number of patients with adverse drug reactions |  | up to 4 weeks | 
| Assessment of tolerability by investigator on a 4-point scale |  | after 4 weeks | 
| Assessment of patient by investigator on a 4-point scale |  | after 4 weeks |
Clinical Research Center for Dementia of South Korea (CREDOS)(or CRCD)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive impairment(MCI) in korea

Detailed Description
-----------------
The specific aims of this study is (1) construction & maintenance of cohort for Alzheimer's disease(AD) and mild cognitive impairment(MCI); (2) study of epidemiology, rate of progression, risk factor, prognostic factor; (3) study of biomarker such as neuropsychological assessment, peripheral & CSF markers, neuroimaging(both structural & functional)

Official Title
-----------------
Clinical Research Center for Dementia of South Korea (CREDOS)

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's disease(AD) and mild cognitive impairment(MCI)will be enrolled in the study. the diagnostic criteria of Alzheimer's disease(AD) according to DSM IV or NINCDS -ADRDA the diagnostic criteria of mild cognitive impairment(MCI) A. Memory or other cognitive complaint preferably corroborated by an informant B. Objective memory impairment or other cognitive for age and education C. Largely intact general cognitive function D. Essentially preserved ADL E. Not demented Exclusion Criteria: Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Mild Cognitive Impairment, cohort study
Long Term Outcomes After Surgery for Anal Fistula

Study Overview
=================
Brief Summary
-----------------
Anal fistula is a common condition with a wide variety of clinical presentations, which can make evaluation and treatment challenging and surgical outcomes uncertain. This study was undertaken to identify lessons learned in the surgical treatment of 483 patients over a 20- year period leading to a pragmatic approach to treatment of this condition.

Detailed Description
-----------------
The wide array of variations of anal fistulas makes them challenging both to classify and to treat. The aim of the study is to determine if a systematic approach to their evaluation and surgical treatment, regardless of how one wishes to classify them, can be based on careful assessment of sphincter length and of the anatomical and etiological characteristics of the fistula.

Official Title
-----------------
Long Term Outcomes After Surgery for Anal Fistula

Conditions
-----------------
Fistula in Ano

Intervention / Treatment
-----------------
* Procedure: surgical procedures commonly done for anal fistula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anal fistulas 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| persons with anal fistulas<br>all persons with anal fistulas treated by a single surgeon over 22 years | Procedure: surgical procedures commonly done for anal fistula<br>* Surgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug;<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who heal after simple or staged operations for fistula |  | typically 1 year, but up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anal fistula, fistulotomy, ano-rectal advancement flap, sphincter saving
Improving Influenza Vaccination Rates Among Health Care Professionals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to see if reminder letters and a large raffle prize would encourage health care workers to receive influenza vaccinations.

Detailed Description
-----------------
Eight hundred employees of an urban tertiary care hospital, 200 each from the following four categories: professional staff, resident physicians, registered nurses, and licensed practical nurses comprised the study group. Subjects were randomly assigned to receive: 1) no intervention, 2) a reminder letter for flu vaccine, 3) a raffle ticket to win a free Caribbean vacation with flu vaccine administration, or 4) both the reminder letter and raffle ticket. We compared the proportion of employees receiving vaccination and participating in the raffle across groups.

Official Title
-----------------
A Novel Approach To Improve Influenza Vaccination Rates Among Health Care Professionals: A Prospective Randomized Controlled Trial

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Behavioral: influenza vaccine, reminders letters, raffle prize


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospital employees, staff physicians, residents, rn's, lpn's Exclusion Criteria: non patient care hospital employees
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: influenza vaccine, reminders letters, raffle prize|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of employees receiving vaccination and participating in the raffle across groups. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza vaccine, influenza immunization, reminder letters, raffle prize
Therapeutic Strategy in Postmenopausal Women Using Osteoporotic Diagnostic Kits

Study Overview
=================
Brief Summary
-----------------
The frequency of osteoporosis in Japan is increasing. Also, the frequency of osteoporosis-based fractures in postmenopausal women is increasing. Therefore, it is urgently required to improve osteoporosis. Life expectancy in Nagano prefecture is the longest in Japan, however, healthy life expectancy in Nagano is not very long in Japan. There are several problems in this issue from the medical site and the patient site. The aim of this study is, from the patient site, to increase the motivation of postmenopausal women for osteoporosis using osteoporotic diagnostic kit.

Official Title
-----------------
Phase 1 Study of Osteoporotic Diagnosis Using Osteoporotic Diagnostic Kits

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Device: diagnostic osteoporotic kit ( including 7 genes and 4 life styles)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, mainly postmenopausal women Exclusion Criteria: Men

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Osteoporosis diagnostic kit<br> | Device: diagnostic osteoporotic kit ( including 7 genes and 4 life styles)<br>* Most osteoporotic patients want to know what kinds of life styles they should take care of. The device will help it.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with osteoporosis in Kami-Ina area of Nagano prefecture |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
number, To decrease, osteoporotic, patients in, Kami-Ina area, Nagano prefecture