linjc16/ctgov huggingface dataset:
The Effect of Guided Narrative Technique on Child Post-traumatic Stress Symptoms Related to Teachers' Improper Criticism

Study Overview
=================
Brief Summary
-----------------
Teachers' improper criticism may lead to posttraumatic stress symptoms (PTSS) in children. This cluster randomized controlled trial examined the effect of guided narrative technique (GNT) on child PTSS caused by teachers' improper criticism in school settings.

Official Title
-----------------
The Effect of Guided Narrative Technique on Child Post-traumatic Stress Symptoms Related to Teachers' Improper Criticism: A Cluster Randomized Controlled Trial

Conditions
-----------------
Posttraumatic Stress Symptoms

Intervention / Treatment
-----------------
* Behavioral: guided narrative technique-writing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5th grade students 7-13 years old with the ability to read and write Exclusion Criteria: younger than 7 years old or older than 13 years old having psychotic disorders

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br> | Behavioral: guided narrative technique-writing<br>* The experimental group underwent the psychological intervention of guided narrative technique-writing with the theme of teacher criticism for 20 to 30 minutes once a day for three consecutive days.<br>|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline child posttraumatic stress symptoms at posttreatment | Foa et al.,(2018) revised the Self-Rating Scale for Symptoms of Post-traumatic Stress Disorder in Children (CPSS-5-SR), with Cronbach's α reliability coefficient of 0.78. Cpss-5-SR is a 27-item self-reporting measure. Symptom items were scored on a 5-point scale, ranging from 0 (not at all) to 4 (almost always). | 1 week | 
| change from baseline child posttraumatic stress symptoms at follow-up | Foa et al.,(2018) revised the Self-Rating Scale for Symptoms of Post-traumatic Stress Disorder in Children (CPSS-5-SR), with Cronbach's α reliability coefficient of 0.78. Cpss-5-SR is a 27-item self-reporting measure. Symptom items were scored on a 5-point scale, ranging from 0 (not at all) to 4 (almost always). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Teachers' Improper Criticism, Posttraumatic Stress Symptoms, Expressive Writing, Psychological Intervention, Guided Narrative Technique
Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 250 mg Terbinafine Hydrochloride Tablets Under Fasting Conditions

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: Terbinafine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to terbinafine or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Terbinafine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Twenty-one day washout |
The Role of Reactive Thrombocytosis in Children With Pneumococcal Infection

Study Overview
=================
Brief Summary
-----------------
Thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with infections. Streptococcus pneumoniae (S. Pneumoniae) is the most common pathogen. In this study, the investigators investigated the associations of clinical profiles and thrombocytosis and evaluated platelet counts, leukocyte counts and CRP levels as predictors of hospitalization days in patients with S. pneumoniae infection.

Official Title
-----------------
The Role of Reactive Thrombocytosis in Children With Pneumococcal Infection

Conditions
-----------------
Thrombocytosis, S. Pneumoniae Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients diagnosed with pneumococcal infection. Exclusion Criteria: Patients with automatic discharge.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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
-----------------
S. pneumoniae, thrombocytosis, pediatric patients, The study aimed to understand the diagnostic value of thrombocytosis in children with S. pneumoniae infection
Comparison of Hemodynamic Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy

Study Overview
=================
Brief Summary
-----------------
From postoperative patients having undergone pancreaticoduodenectomy; To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient To compare the safety of the 2 intravenous colloids in the patient population

Official Title
-----------------
Comparison of Hemodynamic and Clinical Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy

Conditions
-----------------
Pancreaticoduodenectomy

Intervention / Treatment
-----------------
* Drug: 6% hydroxyethyl starch 130/0.4
* Drug: Albumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects should be meet inclusion criteria to participated into the study Age-from 18-75 years adult In the immediate post-operative period of pancreaticoduodenectomy Written informed consent and admitted ICU immediate post-operative patient Exclusion Criteria: Any patient meeting one or more of the following exclusion criteria may not be entered into the study. Refusal to participate in the study Evidence of pre-operative oliguria (Serum creatinine>1.5mmol/dL) Known Severe congestive heart failure (NYHAIII,IV) Known severe respiratory diseases (PaO2/FiO2 <200) Known coagulopathy (Platelet<100k/mm3, aPTT>70s, PT(INR)>2.5) Known allergy to hydroxyethyl starch Known pregnancy or lactation Has participated in any other clinical trial within 3months Any contraindication to Voluven® or albumin according to their package inserts.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Albumin<br>albumin was administered to reach CVP up to 7mmHg | Drug: Albumin<br> <br> |
| Experimental: 6% hydroxyethyl starch 130/0.4<br>6% hydroxyethyl starch 130/0.4 was administered to reach CVP up to 7mmHg | Drug: 6% hydroxyethyl starch 130/0.4<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure |  | post-op 24hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume(ml) of colloid |  | post-op 24hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreaticoduodenectomy, postoperative patient, colloid, albumin, hetastarch
Identification of Gene Polymorphism in Patients With Sick Sinus Syndrome in Chinese Population in Taiwan

Study Overview
=================
Brief Summary
-----------------
Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. Evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. However, the influence of gene polymorphisms on sinus node dysfunction was not well studied. Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex- matched healthy control patients will be enrolled into this study. Gene polymorphism study includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene, HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node function based on previous reports. Genetic polymorphisms are identified with polymerase chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and single-locus analysis will be analyzed between the cases and controls. Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node function or rennin-angiotensin system will show association with sinus node dysfunction. In multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant difference between cases and controls. In single locus analysis, some genetic polymorphisms may be associated with sinus node dysfunction. Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These results will support the roles of these genetic polymorphisms in determining the risk of sinus node dysfunction among the Chinese population in Taiwan.

Conditions
-----------------
Sinus Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart rate was less than 40/min or long pause more than 3 seconds in series EKG or 24-hour EKG. Sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study. Exclusion Criteria: Severe systemic disease. Acute coronary syndrome. Bradycardia with reversible cause.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
The Long-term Safety Study of Idursulfase-beta in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the long term safety and efficacy of once weekly dosing of idurasulfase-beta 0.5mg/kg administered in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Official Title
-----------------
The Long-term Safety of Hunterase (Idursulfase-beta) in Hunter Syndrome(Mucopolysaccharidosis II) Patients

Conditions
-----------------
Hunter Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have a diagnosis of Hunter syndrome(Mucopolysaccharidosis II). Patients who are administered idurasulfase-beta or willing to be administered idurasulfase-beta. Patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study. Exclusion Criteria: Patients who have participated in any other blind clinical trials. Patient who cannot be tracked about safety. Patients who are judged disqualified to participate clinical trials by investigator for other causes.
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 |
| --- | --- | --- |
| Incidence of adverse event and adverse drug reaction. |  | Once a week up to 5years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of vital sign, physical and clinical examination, anti-idurasulfase-beta antibody status. |  | Base line and every three months up to 5years.(exception: clinical examination-> baseline and every six months up to 5years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hunter syndrome, Mucopolysaccharidosis II, Hunterase
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Official Title
-----------------
Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: Ecabet
* Drug: Ecabet
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female at least 18 years of age Agree to avoid disallowed medications Have a diagnosis of dry eye Exclusion Criteria: Have chronic systemic inflammation Have active seasonal ocular allergies

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecabet<br>Ophthalmic solution in the Study eye four times daily for 90 days. | Drug: Ecabet<br>* ophthalmic solution 2.83%<br>Drug: Ecabet<br>* ophthalmic solution 3.70%<br>|
| Placebo Comparator: Placebo<br>Ophthalmic solution in the Study eye four times daily for 90 days. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular signs and Symptoms | ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index (OSDI) | Questionaire | 90 days |
An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This study aim is to examine the prevalence, severity, and management of CRF among Taiwanese gynecologic cancer patients.

Detailed Description
-----------------
The cross-sectional survey is conducted at oncology inpatients unit and outpatients clinics of hospitals in Taiwan. Furthermore, the results will elucidate not only the epidemiology of CRF in Taiwan, but will supply physicians with more understanding about CRF, and help them to enhance the quality on cancer care to being perfected in the future.

Official Title
-----------------
An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Gynecologic

Conditions
-----------------
Fatigue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who signed the informed consent form The age of eligible patients should be ≥ 20 years old. Inpatients or outpatients who have been given a diagnosis of gynecologic cancer. Able to communicate verbally and completely fill out the questionnaires Exclusion Criteria: Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires

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

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

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 |
| --- | --- | --- |
| Cancer-related fatigue evaluation-1 | ICD-10 Fatigue Criteria | 10 minuts | 
| Cancer-related fatigue evaluation-2 | Brief Fatigue Inventory-Taiwan Form (BFI-T) | 8 minuts | 
| Symptoms and Quality of Life Assessments-1 | Functional Assessment of Cancer Therapy-General quality of life questionnaire (FACT-G7) | 4 minuts | 
| Symptoms and Quality of Life Assessments-2 | cancer symptom survey (self-designed questionnaire) | 5 minuts |
Intensive Lipid-lowering in Patients With STEMI

Study Overview
=================
Brief Summary
-----------------
Patients admitted to the Jena University Hospital with ST-elevation myocardial infarctions will be closely followed-up to achieve ESC/EAS-guideline recommended LDL-cholesterol goals.

Detailed Description
-----------------
Patients admitted to the Jena University Hospital (UKS) with an ST-elevation myocardial infarction (STEMI) will be closely monitored to achieve ESC/EAS-guideline recommended LDL-cholesterol goals. Lipid profiles of each patient will be evaluated on the day of admission, on discharge and during follow-ups at 4-8 weeks, 6 months and 12 months after the index event. If the ESC/EAS-guideline LDL-C target is not attained with a statin and ezetimibe, then escalation of lipid-lowering therapy accordling to the current ESC/EAS dyslipidemia guidelines with either bempedoic acid, PCSK9mabs or inclisiran is indicated. Lipid profils, in particular LDL-c goal attainment and lipid-lowering treatment will be documented in patients cards.The aim is to get all patients on ESC/EAS LDL-C targets.

Official Title
-----------------
Intensive Lipid-lowering Therapy for Early Achievement of Guideline-recommended LDL Cholesterol Levels in Patients With ST-elevation Myocardial Infarctions

Conditions
-----------------
LDL-cholesterol

Intervention / Treatment
-----------------
* Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ST-elevation myocardial infarctions Exclusion Criteria: patient without informed concent patients in cardiogenic shock patients with contraindication to lipid-lowering therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran|dietary advice for low cholesterol food|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C | LDL-C target attainment (ESC/EAS dyslipidemia guidelines) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reasons for changes in lipid-lowering therapy | reasons for changes in lipid-lowering therapy, e.g. LDL-C goal not attained | 24 months |
Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Evaluation of efficacy of treatment with epirubicin (5 years follow-up). Evaluation of frequency of dose reduction. Evaluation of frequency of neoadjuvant treatment with E(120mg) / C(600mg). Evaluation of unexpected and serious adverse events. (E=Epirubicin; C =Cyclophosphamide)

Detailed Description
-----------------
Postmarketing surveillance study. Non-Probability Sample

Official Title
-----------------
Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer ((ANWENDUNGSBEOBACHTUNG,MOI 99056 -Neo-/Adjuvante Chemotherapie Des Primären Mammakarzinoms Der Frau Mit Farmorubicin®))

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Drug: Epirubicin: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre- and postmenopausal female patients with histologically confirmed primary breast cancer Exclusion Criteria: Metastatic breast cancer, locally advanced or recurrent breast cancer, previous cancer history
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Interventional Study<br>Chemotherapy containing Epirubicin | Drug: Epirubicin: Observational Study<br>* Observational: Chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Disease Free Survival (DFS) | Percentage of participants with DFS who completed 5 year follow-up visit. | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP) |  | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y | 
| Time to Recurrence (DFI) |  | 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Neoadjuvant Treatment, Chemotherapy, Adjuvant, Epirubicin