linjc16/ctgov huggingface dataset:
Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows Feet Lines(CFL).

Official Title
-----------------
Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines: Active Controlled, Double-blind, Randomized, Multi-center, Phase II/III Clinical Trial

Conditions
-----------------
Crows Feet Lines

Intervention / Treatment
-----------------
* Drug: Clostridium Botulinum A Toxin
* Drug: Clostridium Botulinum A Toxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of at least 18 to 75 years old Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP450<br>Single-dose | Drug: Clostridium Botulinum A Toxin<br> <br> * Other names: NABOTA;|
| Active Comparator: Botox<br>Single-dose | Drug: Clostridium Botulinum A Toxin<br> <br> * Other names: BOTOX;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Wrinkle Scale(FWS) severity of Crow's feet lines(CFL) at maximum smile as assessed by investigators |  | At 4 weeks |
Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.

Official Title
-----------------
Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months Body mass index (BMI) below 40.0 kg/m2 HbA1c between 7.5-13.0% Exclusion Criteria: History of drug or alcohol dependence Mental incapacity, unwillingness or language barriers precluding adequate Subjects previously screened to participation or having already participated in this trial Receipt of any investigational drug within the last month prior to this trial Known or suspected allergy to trial products or related products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|
|Drug: metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose profiles |  |  | 
| Cardiovascular risk factors |  |  | 
| Incidence of hypoglycaemic episodes |  |  | 
| Adverse events |  |  |
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

Study Overview
=================
Brief Summary
-----------------
To determine if the effect of near-addition lenses (bifocals) is more prominent for children with high myopia progression. To study how different subject characteristics such as age, gender, baseline degree of myopia, baseline near phoria and baseline lag of accommodation affect the efficacy of bifocal lens wear in myopic children. To investigate the effect of incorporating near base-in prisms along with the near-addition lenses (prismatic bifocals) on myopia progression in myopic children.

Official Title
-----------------
Assessment of Bifocal and Prismatic Bifocal Spectacles for Myopia Control in Children

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

Intervention / Treatment
-----------------
* Device: Bifocal spectacles
* Device: Prismatic bifocal spectacles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 8 to 13 years Myopia: -1.00 to -5.00 D Myopia progression: at least 0.50 D/yr Astigmatism and anisometropia: not more than 1.50 D Distance monocular visual acuity: 6/6 or better Near monocular visual acuity: 0.4 M or better Stereoacuity: not more than 40 sec of arc at 40 cm Exclusion Criteria: Strabismus Ocular diseases

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bifocal spectacles<br> | Device: Bifocal spectacles<br>* +1.50D bifocal spectacles<br>|
| Active Comparator: Prismatic bifocals<br> | Device: Prismatic bifocal spectacles<br>* +1.50D bifocal spectacles combined with 3Δ base-in prisms<br>|
| No Intervention: Single vision spectacles<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myopia progression, measured by cycloplegic autorefraction |  | Every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length, measured by A-scan ultrasonography |  | Every 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, bifocal, children
Central Line Study

Study Overview
=================
Brief Summary
-----------------
Two different techniques for placing a central venous catheter will be compared.

Official Title
-----------------
A Randomized Study Comparing Two Techniques for Central Venous Catheter Insertion

Conditions
-----------------
Shock

Intervention / Treatment
-----------------
* Procedure: Central venous catheter insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients in the emergency department who require ultrasound guided central line placement are eligible for participation and will be referred for participation in the study by the clinical team. Exclusion Criteria: Inherited, acquired, or medication related coagulopathy or thrombocytopenia (platelets < 100,000). Patients will not be excluded for use of aspirin or other anti-platelet medication. Previous central venous access at the same anatomical site. Any indwelling catheter or wire that could potentially interfere with central line placement Anterior border of the target vein deeper than 3.5cm Or for any clinical feature that would interfere with obtaining informed consent including dementia, delirium, or encephalopathy, as determined by the clinical attending physician.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard technique<br>The conventional hollow bore needle on a syringe will be used | Procedure: Central venous catheter insertion<br>* The clinical team will use the technique to establish central venous access<br>|
| Experimental: Peripheral IV<br>A peripheral intravenous catheter will be used to obtain initial central venous access | Procedure: Central venous catheter insertion<br>* The clinical team will use the technique to establish central venous access<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Only 1 attempt | The frequency with which the central line can be placed with only one attempt. Each attempt is defined by skin penetration | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unable to place central line | The frequency with which the clinical team is unable to place the central line at that clinical site using the assigned technique. | 20 minutes | 
| Number of attempts | Total number of required attempts (skin penetration) | 20 minutes | 
| Time taken for completion of the procedure | Skin penetration to wire out | 20 minutes |
A Study for the Assessment of the Words Used by Patients and Physicians to Express Asthma Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma.

Official Title
-----------------
A Cross Sectional Study for the Assessment of the Words Used by Patients and Physicians to Express Asthma Symptoms and the Limitations of Daily Activities in Primary Care. The  Asthma Language  Survey

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of persistent asthma treated with inhaled corticosteroid-based maintenance treatment for at least 6 months and followed up by the investigator for at least the same period of time Exclusion Criteria: Patient with a cardiac disease (congestive heart failure, coronary heart disease) Patient with a respiratory disease other than asthma (COPD, sleep apnoea 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 |
| --- | --- |
| Asthma Language between patients and physicians<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concordance of the most frequently used words by the patients and the physicians to express asthma symptoms and the limitations of daily activities caused by asthma |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The most frequently used words (lexical intensity) by the patient and the physician to express asthma symptoms and the limitations of daily activities. |  | Day 1 | 
| The concordance of words used by physicians and patients according to the level of asthma control (as assessed by ACQ). |  | Day 1 | 
| The actions recommended by the physician or those initiated by the patient and are associated with words that express symptoms. |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Language, Symptoms,, Limitation of Daily activities, Patients, Physicians, Greece
Using Simulation to Ensure Basic Competence in Gastroscopy

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy.

Official Title
-----------------
Using Simulation to Ensure Basic Competence in Gastroscopy

Conditions
-----------------
Endoscopy, Simulation, Education, Gastroscopy

Intervention / Treatment
-----------------
* Other: Simulation training in gastroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical students enrolled at the University of Southern Denmark who have passed their anatomy exam. Experienced endoscopy nurses, who have assisted to more than 100 gastroscopies and with no prior self-performed gastroscopies. Experienced medical doctors in medical gastroenterology or surgery, who have self-performed more than 500 gastroscopies. 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 |
| --- | --- |
| Novices<br>Medical students | Other: Simulation training in gastroscopy<br>* Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.<br>|
| Intermediates<br>Endoscopy (EGD) assisting nurses. No prior self-performed endoscopies | Other: Simulation training in gastroscopy<br>* Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.<br>|
| Experienced<br>Medical doctors in medical Gastroenterology or surgery, who have self-performed more than 500 EGD | Other: Simulation training in gastroscopy<br>* Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulation gastroscopy test score | Test score based on time usage, landmark and pathology recognition | 1-hour test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time for the diagnostic exercises | A total time for two diagnostic virtual reality tests and a test on a phantom | 1-hour test | 
| Total time for the tool exercises | A total time of virtual reality tests and two tests on a phantom | 1-hour test | 
| Total landmark and pathology recognition for the diagnostic exercises | Recognition of a total number of 48 landmarks and pathologies | 1-hour test |
Rectal Cancer Staging Using Whole Body MR-PET

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the diagnostic performance of whole body (WB) MR-PET for staging rectal cancer, compared with current standard of care (chest/abdominopelvic CT and rectal MRI) to investigate clinical feasibility of WB MR-PET as a one-stop preoperative imaging modality in patients with rectal cancer.

Official Title
-----------------
Preoperative Imaging for Rectal Cancer Staging Using Whole Body MR-PET

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: MR-PET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients newly diagnosed with rectal cancer on colonoscopy or sigmoidoscopy, who are potentially eligible for neoadjuvant chemoradiotherapy. Patients who sign informed consent. Exclusion Criteria: Patients who are contraindication for CECT Patients who are contraindication for MRI/CE-MRI patients who are diagnosed with Tis or T1 cancer after polypectomy or EMR Patients who were already diagnosed with an active other cancers. Premenopausal female patients who are pregnant. Patients with fasting serum glucose level (>200mg/dL) on blood glucose meter prior to WB MR-PET. Patients who are physically compromised to undergo WB MR-PET.

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

| Intervention/Treatment |
| --- |
|Procedure: MR-PET|whole body MR-PET with dedicated liver+rectal protocol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concordance rate between rectal cancer staging performed by WB MR-PET and the current standard of care (chest/abdominopelvic CT and rectal MRI | the concordance rate between two protocols (standard protocol vs. WB-MR-PET) would be calculated. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of recommendation for further workup after examination | incidence of recommendation for further w/u after two protocols (standard vs. study) would be compared. | 12 months | 
| concordance rate of clinical staging between standard of care and that obtained by combination of WB MR-PET and chest CT. |  | 12 months | 
| concordance rate of clinical stagings and true M staging obtained by biopsy or follow-up |  | 18 months |
Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

Study Overview
=================
Brief Summary
-----------------
This echocardiography study will characterize heart structure and function during labor. Imaging of the heart during the stress of labor could increase detection of subclinical cardiovascular disease using advanced imaging techniques. Cardiac serum biomarkers and complication rates will also be measured and compared between patients with and without evidence of cardiovascular disease on echocardiography.

Official Title
-----------------
Transthoracic Echocardiography of Cardiac Function of Parturients in Labor

Conditions
-----------------
Obstetric Labor Complications, Cardiovascular Diseases in Pregnancy, Cardiovascular Risk Factor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All healthy parturients 18 years of age or older with estimated gestation greater than or equal to 37 weeks who are expected to deliver during their hospitalization. During the echocardiographic exam, the patient must be in active labor with cervical dilation between 6-10 cm and contractions that are spaced less than 5 minutes apart. Exclusion Criteria: Known functional or structural heart disease Previously diagnosed pulmonary hypertension. Comorbid disease other than diet controlled gestational diabetes, uncomplicated obesity, mild asthma and euthyroid patients with a history of hypo or hyperthyroidism. Parturients endorsing active use of non-prescription mind-altering drugs including cocaine, methamphetamine, or ketamine. Other non-inclusion criteria include inability to tolerate left lateral positioning either symptomatically or by fetal heart rate monitoring, suspected hypo-or hypercoagulable states that was not previously diagnosed, hemodynamic instability requiring >2 L crystalloid administration within 1 hour time frame after epidural placement or vasopressor administration of >15 mg ephedrine or >300 mcg phenylephrine administration within 1 hour after epidural placement.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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 proportion of patients with an abnormal strain pattern as compared to parturients not in labor | Left ventricular strain | During echocardiogram procedure | 
| The proportion of patients with diastolic dysfunction as compared to parturients not in labor | Abnormal diastolic function | During echocardiogram procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated right ventricular systolic pressure | Comparing estimated right ventricular systolic pressure between patients in active labor as compared to those who are not in active labor (mm Hg) | During echocardiogram procedure |
Efficacy of Kangliuwan for Recurrent Grade IV Glioma

Study Overview
=================
Brief Summary
-----------------
A Prospective Exploratory Clinical Study to explore the efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma.

Official Title
-----------------
Efficacy of Hospital Traditional Chinese Medicine Preparation Kangliuwan for Recurrent Grade IV Glioma: A Prospective Exploratory Clinical Study

Conditions
-----------------
Glioma of Brain, Recurrence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient signed informed consent voluntarily; The age of patient is between 18 and 80 years; KPS score ≥40 ; The patient has normal liver and kidney function Normal heart function Better follow-up and compliance; Exclusion Criteria: The patient did not sign informed consent or signed unvoluntarily. Non-glioma patients Active infection Human immunodeficiency virus (HIV) positive Hepatitis C or hepatitis B infective Pregnancy or breast-feeding women Patients did not agree to use effective contraception during treatment and the following 3 months. Patients also participated in other clinical studies. The subjects researchers believe are not suitable for participation or completion of the study.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tumor volume | the volume of tumor decreased after taking Kangliuwan | 3 months |