linjc16/ctgov huggingface dataset:
To Evaluate the Efficacy and Safety of JW0201 Added on in Patients With T2DM

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2204

Detailed Description
-----------------
A multicenter, randomized, double blind, placebo controlled, parallel, phase Ⅲ study

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of JW0201 Added on in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With C2202 and C2204

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

Intervention / Treatment
-----------------
* Drug: JW0201
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus Exclusion Criteria: Type 1 Diabetes Mellitus The subject not meet the specified HbA1c and FPG

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: JW0201+C2202+C2204<br>Experimental group, Treatment period for 24 weeks | Drug: JW0201<br>* JW0201: 200mg/day For 24 weeks(PO, BID) C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)<br>* Other names: JW0201+C2022+C2204;|
| Placebo Comparator: C2202+C2204<br>Placebo group, Treatment period for 24 weeks | Drug: Placebo<br>* C2022: ≥1,000 mg/day for 24 Weeks(PO, BID) C2204: 10 mg/day for 24 Weeks(PO, BID)<br>* Other names: C2022+C2204;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C (24 Weeks) lowering effect | change in HbA1c | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c lowering effect | change in HbA1c | 6, 12, 18 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus
Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction

Study Overview
=================
Brief Summary
-----------------
This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.

Detailed Description
-----------------
The group allocation will be randomized. Outcome of the study is the quality of life score based on Acne-QoL-INA questionnaire. The study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.

Official Title
-----------------
Single-Blinded Randomized Controlled Trial: Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction

Conditions
-----------------
Acne Vulgaris, Quality of Life

Intervention / Treatment
-----------------
* Procedure: Lesion extraction
* Drug: Tretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed as moderate acne vulgaris Able to read and speak in Indonesia Indonesian Citizen Sign the consent form Exclusion Criteria: Pregnant of breastfeeding women Acne vulgaris lesion located only outside of face Experiencing COVID-19 symptoms Using retinoid acid containing cream or benzoil peroxide in the last 2 weeks Consume any oral antibiotics in the last 1 month Injected with intralesional steroid or having acne lesions extracted in the last 2 weeks Having laser or chemical peeling in the last 1 month

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Standard therapy and lesion extraction | Procedure: Lesion extraction<br>* Tretinoin and benzoil peroxide used concurent in both groups as standard therapy<br>* Other names: Benzoil peroxide;|
| Placebo Comparator: Control<br>Standard therapy without lesion extraction | Drug: Tretinoin<br>* Tretinoin and benzoil peroxide used concurent in both groups as standard therapy<br>* Other names: Benzoil peroxide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score | Measured using Acne-QoL-INA questionnaire | Every 4 weeks, measured until 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acne Grading | Lehmann classification of Acne Grading | Every 4 weeks, measured until 8 weeks |
Galectin-3 in Papillary Thyroid Carcinoma

Study Overview
=================
Brief Summary
-----------------
Thyroid cancer is a common head and neck malignancy. It is the most common endocrine tumor in the body accounting for 1% of all cancers worldwide. The incidence of thyroid cancer varies worldwide. Most countries have reported an upward trend in its incidence. Thyroid cancer encompass the most common well-differentiated papillary carcinoma (80% of all thyroid cancers) and follicular carcinoma (15%), as well as poorly differentiated carcinoma (< 1%) and anaplastic carcinoma (< 2%). Papillary thyroid carcinomas (PTCs) are the most commonly encountered thyroid malignancies. The diagnosis of PTC is based on the special nuclear features such as overlapping of nuclei, intranuclear inclusions, optical clearing, anisonucleosis and nuclear grooves. However, it is often difficult to differentiate PTC from benign papillary thyroid hyperplasia . As differentiation between benign or malignant thyroid lesions has clinical, therapeutic, and prognostic significance, it is necessary to make accurate diagnosis by using biomarkers. Recently, a large number of immunohistochemical (IHC) markers have been studied to assist in differentiating non-neoplastic lesions from malignant thyroid lesions. CK19, galectin-3, TG, Ki67, BRAF, calcitonin, HBME-1, TTF-1, and RET are some of the examples of these IHC markers. Galectin-3 is a 31-kDa β-galactoside binding lectin. It has been shown to be expressed by several types of non-neoplastic and neoplastic cells, and it is involved in cell-cell adhesion and in cell-matrix interactions.

Official Title
-----------------
Galectin-3 Immunoreactivity in Papillary Thyroid Carcinoma

Conditions
-----------------
Galactin 3-thyroid Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thyroidectomy specimens both hemithyroidectomy and total thyroidectomy. All the studied cases include sufficient materials for the immunohistochemical study. Complete clinical data Exclusion Criteria: Patients with recurrence of the primary tumor. Patients with a history of preoperative chemotherapy and/or radiotherapy. Insufficient or tiny tissue biopsies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis and prognosis of papillary thyroid carcinoma both classic variant and follicular variant | evaluation of Galectin-3 Immunostaining in Papillary Thyroid Carcinoma | Two or three days after staining tissue sections with Galactin 3 antibody |
Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

Study Overview
=================
Brief Summary
-----------------
There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.

Detailed Description
-----------------
The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.

Official Title
-----------------
Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

Conditions
-----------------
Bone Cysts

Intervention / Treatment
-----------------
* Other: datas of medical record.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel Exclusion Criteria: Refusal
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel®<br>Any patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel® will be included. Analysis datas of medical record. | Other: datas of medical record.<br>* Analysis datas of medical record: Feasibility of the technique Safety of the technique Efficacity (sclerose of the lesion)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the technique | Collect from medical records the number of procedures that were completed and performed as theoretically intended. | Year: 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the technique by number of adverse event | collect in the medical record | Year: 2 | 
| Number of discogel® injections by sclerose of the lesion | Efficacity of the technique | Year: 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Bone Cysts, Aneurysmal Bone Cysts, simple Bone Cysts, Discogel, Effectiveness
Multidetector CT Left Appendage Atrial Thrombosis Exclusion in Patients With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The aim of the LATE (multidetector CT Lefi Appendage atrial Thrombosis Exclusion in patients with atrial fibrillation) study is to evaluate the diagnostic accuracy of cardiac Computed Tomography (TC) with 64 detectors and double acquisition phase in candidate patients ablation of atrial fibrillation (AF) with the Navx (or Carto) technique, using trans-esophageal ultrasound (TEE) as the standard reference. This study is based on the use of an experimental protocol in cardiac TC which involves, in addition to the acquisition of an early arterial phase (standard protocol routinely performed in all patients), the execution of a possible late phase at a very low dose of radiation (experimental protocol) aimed at increasing the accuracy of the method in the diagnosis in patients with AF. The LATE study aims to demonstrate the high diagnostic accuracy of dual acquisition phase cardiac TC in the diagnosis of intraauricular thrombosis by comparing it with reference standard; in light of this result, cardiac TC could constitute a single non-invasive diagnostic tool in the future for the global evaluation of both atrial anatomy and endoawicular thrombosis with a clear improvement in patient management both in clinical and economic terms.

Official Title
-----------------
Multidetector CT Left Appendage Atrial Thrombosis Exclusion in Patients With Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients candidates for cardiac TC and transesophageal ultrasound examination for the evaluation of cardiac anatomy and for the exclusion of intra-auricular thrombosis. Exclusion Criteria: < 18 years patients

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 |
| --- | --- |
| Computed Tomography<br>Experimental computed tomography protocol: a few minutes after the administration of the contrast medium at a very low dose of radiation performed only in those patients in whom there is a doubt of thrombosis in the early arterial phase. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac computed tomography for the staging of patients with intraauricular thrombosis. | evaluation of the diagnostic accuracy of cardio CT in the diagnosis of intraauricular thrombosis in patients candidates for atrial fibrillation ablation. | 3 years |
Why in Hospital After Wedge Resection

Study Overview
=================
Brief Summary
-----------------
In the realm of lung surgery, video-assisted thoracoscopic surgery (VATS) offers distinct advantages, including shorter hospital stays, reduced pain, improved quality of life, and increased postoperative mobility when compared to thoracotomy. Additionally, the enhanced recovery after surgery (ERAS) protocol in lung surgery, characterized by a comprehensive, multidisciplinary approach, have streamlined postoperative recovery, resulting in early discharge and diminished postoperative complications. However, drawing from our extensive experience with fully implemented ERAS VATS for patients undergoing pulmonary lobectomy, we observed that approximately 45% of patients did not experience early discharge. Based on existing evidence, the length of stay (LOS) following wedge resection typically ranges from 3 to 6 days across various regions, including Europe, the United States, and China. However, there is a notable lack of procedure-specific data for ERAS VATS wedge resection to explore reasons of delaying discharge. This prompts us to undertake an investigation into individuals following pulmonary wedge resection under the same ERAS programs.

Official Title
-----------------
Why in Hospital After ERAS VATS Wedge Resection

Conditions
-----------------
Thoracic Surgery, Video-Assisted, Enhanced Recovery After Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent video-assisted thoracoscopic surgery wedge resection Exclusion Criteria: < 18 year old Unable to understand Danish No residence in the Eastern Denmark Transfer to anatomical resection or cancel surgery Reject to join or withdraw from the study

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 |
| --- | --- | --- |
| Length of stay | Number of overnight stay | Up to the day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scale | The pain scale (from 0 to 10) will be evaluated by patients. | Up to the day of discharge | 
| Duration of chest drain | Days of chest drain placed | Up to the day of chest drain removed | 
| Postoperative complications | Diagonosis is following ICD-10 | Up to postoperative day 30 | 
| 30-day readmissions | Admission to hospital again within 30 days after surgery | Up to postoperative day 30 |
Role of HLA Genes and Innate Immunity in the Phenotypic Variability of COVID-19

Study Overview
=================
Brief Summary
-----------------
Case-control, prospective retrospective association study of patients infected with SARS-CoV2 and cured by COVID19. Recruited patients were divided into two cohorts (cases: patients with respiratory failure that required hospitalization and ventilatory assistance. Controls: patients who had oligo-asymptomatic forms of COVID19). Patients' blood samples were collected on bibula paper, from which genomic DNA was extracted. Next-generation sequencing of HLA and innate immunity genes was performed on these samples. Genetic risk and protective variants were identified, based on the distribution of allele frequencies in the two cohorts. The aim of the study is to evaluate the role of genes of the HLA system and innate immunity in modulating the host response to SARS-CoV2 infection. The identification of these factors is essential from the perspective of public health (identifying individuals most in need of protection from infection as they are at higher risk of severe forms), basic research (characterization of molecular mechanisms of disease) and therapeutics (through knowledge of basic mechanisms, identify potential therapeutic targets and optimize the protective efficacy of vaccines).

Official Title
-----------------
Role of HLA Genes and Innate Immunity in the Phenotypic Variability of COVID-19 an Italian, Prospective, Multicenter Association Study

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Genetic: HLA-genotyping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oxygen saturation (SaO2) <94% on room air; <90% if known chronic hypoxic conditions or receiving chronic supplemental oxygen Respiratory rate >24 breaths/min Exclusion Criteria: Patients who still test positive for the presence of SARS-CoV-2 genome at the recruitment. Patients who cannot understand the meaning of the study and/or do not sign the informed consent form.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients<br> | Genetic: HLA-genotyping<br>* HLA genotyping in DNA samples from peripheral blood of patients and controls<br>|
| controls<br> | Genetic: HLA-genotyping<br>* HLA genotyping in DNA samples from peripheral blood of patients and controls<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe COVID19 |  | 52 weeks |
Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia

Study Overview
=================
Brief Summary
-----------------
The optimal method of prehospital insulation and rewarming of hypothermic patients have been subject of debate, and there is a substantial lack og high-quality evidence to guide providers. One question concerns whether or not the patients clothing should be removed prior to being wrapped in an insulating model with a vapor barrier. Evaporative heat loss is one of four mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task for providers. Removal of wet clothing usually means subjecting the patient to the environment, but will reduce the evaporative heat loss considerably. An other alternative is to encapsulate the patient in a vapor barrier. Evaporative heat loss will stop when the humidity inside the vapor barrier reaches 100%. We aim to investigate whether it is recommended to removed wet clothing or encase the patient in a vapor barrier.

Official Title
-----------------
Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study

Conditions
-----------------
Emergencies, Accidental Hypothermia

Intervention / Treatment
-----------------
* Procedure: Wet clothing removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age <18 American Society of Anaesthesiologists class 1 No nicotine use Exclusion Criteria: Acute illness on study day, fever or malaise

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wet clothing removal<br> | Procedure: Wet clothing removal<br>* The participants in the intervention group will have their clothing removed prior to insulation.<br>|
| No Intervention: Vapor barrier<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean skin temperature | Change in mean skin temperature during rewarming phase | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective thermal comfort and shivering | Using a validated questionnaire at regular intervals | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Accidental hypothermia, Mountain Medicine