linjc16/ctgov huggingface dataset:
Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.

Official Title
-----------------
Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

Conditions
-----------------
Social Phobia

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are diagnosed as having SAD Subjects who are expected to use paroxetine tablets for the first time Exclusion Criteria: Subjects taking pimozide Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor Subjects with hypersensitivity to paroxetine
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects prescribed paroxetine tablets<br>Subjects with SAD prescribed paroxetine tablets during study period | Drug: Paroxetine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets |  | 1 year |
Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
This is a Multicenter, observational, non-interventional registry designed to collect clinical data in Chinese patients who have received CUBICIN treatment under condition of actual usage in clinical practice.

Detailed Description
-----------------
MC MD

Official Title
-----------------
A Multicenter, Observational, Non-interventional Registry Designed to Collect Clinical Data in Chinese Patients Who Have Received CUBICIN® Treatment Under Condition of Actual Usage in Clinical Practice

Conditions
-----------------
S. Aureus Bloodstream Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has received CUBICIN treatment, decided by treating physician A patient who is considered as ethnic Chinese Provision of subject informed consent Exclusion Criteria: A patient record will not be eligible for the registry database if the patient received CUBICIN as part of a controlled clinical study for the current infection episode.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs of CUBICIN therapy |  | 2 weeks | 
| clinical response of CUBICIN therapy at each available time point |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPK level monitoring and results |  | 2 weeks | 
| treatment duration |  | 2 weeks | 
| Time to clinical response |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, efficacy, Chinese patients, practice
Immune Function Monitoring and Immunotherapy in Sepsis

Study Overview
=================
Brief Summary
-----------------
At present, the clinical studies of various anti-inflammatory drugs and immune-enhancing drugs show that immunotherapy will bring new hope for the treatment of sepsis. In order to further understand the current status of immunotherapy in China, this study aims to understand the current status and standardization of the use of sepsis immunosurveillance and immunotherapy in hospitals through a cross-sectional survey.

Official Title
-----------------
Immune Function Monitoring and Immunotherapy in Sepsis: a Cross-sectional Survey in China

Conditions
-----------------
Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with sepsis or septic shock according to Sepsis 3.0 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 |
| --- | --- |
| Sepsis<br> | Other: No intervention<br>* No intervention is involved in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of sepsis patients receiving immune function monitoring |  | 28 days | 
| Percentage of sepsis patients receiving immunotherapy |  | 28 days |
Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

Study Overview
=================
Brief Summary
-----------------
Topical steroids are used as treatment for non-retractile foreskin in children for decades, but, there are disagreement among physicians about the optimum potency of the agent used. This study is designed to determine any difference in the beneficial effects of mild versus potent topical corticosteroids in treatment of non-retractile foreskin in children.

Official Title
-----------------
A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.

Conditions
-----------------
Phimosis

Intervention / Treatment
-----------------
* Drug: hydrocortisone
* Drug: Betamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 2-16 with non-retractile foreskin Exclusion Criteria: Balanitis xerotica obliterans, balanitis, <2yrs

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild steroid<br>1%hydrocortisone for 8 weeks | Drug: hydrocortisone<br>* 1%hydrocortisone topical once daily for 8 weeks<br>|
| Experimental: Potent Steroid<br> | Drug: Betamethasone<br>* Betamethasone 0.1% topical once daily for 8weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of fully retractile foreskin with full exposure of glans at the end of therapy |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of topical corticosteroids |  | 16 weeks |
Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin 25 mg and Metformin

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin 25 mg and metformin

Official Title
-----------------
A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin 25 mg

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet
* Drug: Teneligliptin Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type II diabetes mellitus aged 19 years or older Subjects with 7.0%≤HbA1c≤10.5% at screening visit Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit Exclusion Criteria: Subjects with type 1 diabetes mellitus or secondary diabetes Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin) Body mass index greater than 40 kg/m2 at the screening visit Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Teneligliptin 20 mg<br>Once daily for 24 weeks | Drug: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet<br>* To be orally administered once daily<br>|
| Placebo Comparator: Teneligliptin placebo<br>Once daily for 24 weeks | Drug: Teneligliptin Placebo Oral Tablet<br>* To be orally administered once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline HbA1c at week 24 |  | Baseline (week 0) and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline FPG at week 24 |  | Baseline (week 0) and week 24 | 
| Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24 |  | Baseline (week 0) and week 24 | 
| Changes from baseline in BMI at week 24 |  | Baseline (week 0) and week 24 |
Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Study Overview
=================
Brief Summary
-----------------
Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole

Official Title
-----------------
Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Procedure: Large extent of ILM Peeling
* Procedure: Small extent of ILM Peeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clear diagnosis of macular hole; The minimum diameter of the macular hole is >400 μm; Without serious systemic disease that make patients can not be operated; Exclusion Criteria: suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.; opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination; eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis; traumatic macular hole, secondary macular hole, high myopia macular hole, etc.; having a history of vitrectomy surgery; glaucoma in stage of preclinical, severe stenosis or closure;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Large extent of ILM Peeling<br>Extent of ILM peeling is 4DD and the ILM flap is inserted | Procedure: Large extent of ILM Peeling<br>* The extent of ILM peeling is 4DD<br>|
| Experimental: Small extent of ILM Peeling<br>Extent of ILM peeling is 2DD and the ILM flap is inserted | Procedure: Small extent of ILM Peeling<br>* The extent of ILM peeling is 2DD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Condition of postoperative healing of macular holes | postoperative photograph of macular retina scanned by Angiography Optical Coherence Tomography(AngioOCT) | 1 year | 
| Mean change from baseline in best-corrected visual acuity (BCVA) | Assessed using the ETDRS protocol | 1 year | 
| change from baseline in foveal avascular zone (FAZ) areas and diameter | Assessed on AngioOCT | 1 year | 
| change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels | Assessed on AngioOCT | 1 year |
Spanish Validation and Cross-cultural Adaptation of the QoR-15E

Study Overview
=================
Brief Summary
-----------------
The satisfactory recovery of the patient after a surgery with an anesthetic request is very important for a quality and excellence assistance. The quality of recovery questionnaire QoR-15 was validated by their authors in 2013 with the study titled development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. This questionnaire allows a comprehensive assessment by associating the physiological parameters until then assessed with the subjective personal perception of the patient of his state of health. With the consent of its original author, this study is carried out to validate the questionnaire in Spanish and adapted to our environment.

Official Title
-----------------
Spanish Validation and Cross-cultural Adaptation of the QoR-15 Post-anesthetic Recovery Quality Questionnaire: The QoR-15E

Conditions
-----------------
Humans, Reproducibility of Results, Cross-Cultural Comparison, Surveys and Questionnaires, Postoperative Period, Anesthetics, Perception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years old. Comprehensive and sign informed consent. Knows and understands the Spanish language. Undergo a scheduled surgical intervention under any type of anesthetic procedure from the specialties of general surgery, urology and gynecology. Score > 26 points in the Mini Mental State Examination (MMSE) test. Exclusion Criteria: Patients under 18 years old. Not having signed the informed consent. Not knowing or understanding the Spanish language. Surgical intervention from other specialties than general surgery, urology and gynecology. Score < 27 points in the Mini Mental State Examination (MMSE) test.

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 |
| --- | --- | --- |
| Spanish version of the Quality of Recovery 15 questionnaire: The QoR-15E. | The aim of this study is to carry out cross-cultural adaptation and validate the postoperative questionnaire QoR-15 to the Spanish environment and evaluate its validity and reliability. This questionnaire consists of 15 items with a total score of 150 points where 150 points is better than 0 points for the patient. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality, Recovery, Anesthesia, Validation, Adaptation, Spanish
Chronic Obstructive Pulmonary Disease Gene Localization

Study Overview
=================
Brief Summary
-----------------
To localize within the genome a chronic obstructive pulmonary disease susceptibility gene.

Detailed Description
-----------------
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a slowly progressive disorder characterized by airways obstruction that lasts for at least several months. The two major causes of COPD are chronic bronchitis and emphysema. Either disorder may occur with or without airways obstruction, but airways obstruction causes impairment of lung function leading to disability and death. COPD is a major health problem in the United States and throughout the world, consistently ranking among the most common causes of death in the United States. Cigarette smoking is the primary environmental factor that increases the risk of COPD, but other environmental factors have also been implicated. However, despite a well-established role, environmental factors alone do not cause COPD. Symptomatic COPD develops in only 10-20 percent of heavy cigarette smokers, probably those with a genetic susceptibility, although common COPD susceptibility genes have yet to be identified. DESIGN NARRATIVE: The study applied statistical linkage analysis to family data. Pulmonary measurements had already been collected on 159 members of 16 pedigrees and evidence supporting a COPD susceptibility gene in these pedigrees had been obtained from segregation analysis. Each of 11,995 genetic markers, which had already been genotyped on pedigree members, were tested for evidence of linkage to the inferred COPD susceptibility gene. Evidence of linkage to one or more genetic markers identifed genomic locations of COPD susceptibility genes. The high density of markers allowed fine-mapping of the gene. Successful completion of this gene localization project was the necessary prerequisite for a project to identify and characterize a COPD susceptibility gene. Identifying a gene that when mutated increased the risk of COPD may increase understanding of pulmonary function, as well as allowing gene-carriers to be identified and made aware of their susceptibility.

Conditions
-----------------
Lung Diseases, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)

Study Overview
=================
Brief Summary
-----------------
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.

Official Title
-----------------
INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)

Conditions
-----------------
Proliferative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Intravitreal injection of ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior; logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse. Exclusion Criteria: history of vitrectomy in the study eye; history of thromboembolic event (including myocardial infarction or cerebral vascular accident); major surgery within the prior 6 months or planned within the next 28 days; uncontrolled hypertension; known coagulation abnormalities or current use of anticoagulative medication other than aspirin.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravitreal anti-VEGF<br>Intravitreal injection of 0.5 mg of ranibizumab | Drug: Intravitreal injection of ranibizumab<br>* 0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography<br>* Other names: Lucentis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total area of fluorescein leakage from active new vessels |  | baseline, weeks 1,6,12,24,36,48 | 
| Best corrected Visual Acuity (BCVA) |  | Baseline, weeks 1,6,12,24,36,48 | 
| central macular thickness |  | baseline, weeks 1,6,12,24,36,48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic retinopathy, ranibizumab, new vessels, intravitreal injection, Persistent retina new vessels