linjc16/ctgov huggingface dataset:
Exploring the Application of 3D Bioprinting for Personalized Treatment in Pancreatic Ductal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to test the application value of 3D bioprinting technology in personalized treatment of pancreatic cancer. The main questions it aims to answer are: Can 3D bioprinting technology be successfully applied to establish preclinical models of pancreatic cancer? Can 3D bioprinted preclinical models of pancreatic cancer be applied to personalized treatment of pancreatic cancer? Participants will have tumor tissue collected to extract primary tumor cells for the establishment of in vitro preclinical models, which will be used for drug sensitivity testing.

Official Title
-----------------
Exploring the Application of 3D Bioprinting Technology in Constructing Preclinical Models of Pancreatic Cancer for Drug Sensitivity Testing and Its Significance in Personalized Treatment

Conditions
-----------------
Pancreatic Ductal Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years old Diagnosed as colorectal cancer with or without liver metastases before Pathologically proven colorectal cancer after surgery Exclusion Criteria: History of other malignancies or serious medical conditions Inability to provide independent informed consent

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 |
| --- | --- | --- |
| Correlation of Drug Sensitivity in In Vitro Tumor Models with Clinical Response in Patients | Evaluation of the efficacy of neoadjuvant therapy in clinical response using the internationally recognized Response Evaluation Criteria in Solid Tumors (RECIST) 1.1: Stable Disease (SD) and Partial Response (PR) are considered indicators of chemotherapy sensitivity (good response), while Progressive Disease (PD) is considered indicative of chemotherapy resistance (poor response). Drug sensitivity testing results were assessed using standardized IC50 values. The standardized IC50 values were treated as the testing variables, while the clinical response to chemotherapy was designated as the state variable. The ROC curves for both variables were analyzed, and the area under the curve (AUC) was calculated to assess their correlation. To analyze the correlation between the drug testing results and clinical prognosis, linear regression analysis was performed to evaluate the correlation between standardized IC50 values and patients' progression-free survival (PFS) values. | From enrollment to end within 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival time (PFS) | The time from the start of postoperative adjuvant therapy to recurrence or death. | Up to 2 years. |
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate if pediatric patients who are undergoing a bowel preparation in anticipation of a colonoscopy may be able to take in a low fiber diet instead of a standard, clear liquid diet, while still accomplishing an adequate bowel prep.

Official Title
-----------------
Efficacy of a Low Fiber Diet for Pediatric Colonoscopy Prep

Conditions
-----------------
Colitis, Gastrointestinal Diseases, Pediatric Disorder, Pediatric Crohns Disease, Procedural Sequelae

Intervention / Treatment
-----------------
* Dietary Supplement: Low fiber diet
* Dietary Supplement: Standard clear liquid diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All outpatients undergoing colonoscopy at our institution Exclusion Criteria: Unstable medical condition Metabolic disease Inpatient status Requiring an emergency colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 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: Low fiber diet group<br>Subjects are allowed a low fiber diet the day of their colonoscopy prep | Dietary Supplement: Low fiber diet<br>* Low fiber diet including cereal, white bread, eggs, meat, dairy<br>* Other names: Experimental group;|
| Active Comparator: Clear liquid diet group<br>Subjects are allowed a clear liquid diet the day of their colonoscopy prep, as is standard of care | Dietary Supplement: Standard clear liquid diet<br>* Standard clear liquid diet including broth, jello, water, juice<br>* Other names: Standard group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Prep Score | Scale from 0 - 3 (0 = Unprepared segment colon; 3 = well-visualized segment of colon) | immediately after the colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerance | Internally developed questionnaire inquiring patients about their experience with their prep including likert scale measures of hunger, fullness, nausea, stress, and ease of compliance to regimen) | immediately before the colonoscopy |
The Diagnostic and Prognostic Value of Presepsin in Sepsis

Study Overview
=================
Brief Summary
-----------------
Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. No studies compared presepsin to procalcitonin and endotoxin in patients treated with by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA).

Detailed Description
-----------------
Intra-abdominal infections are a common cause of sepsis and frequently occur in intensive care unit (ICU) patient. Various markers such as procalcitonin, presepsin and endotoxin are used to identify patients at risk of sepsis or to guide proper treatment. Particularly, endotoxin can be removed from the blood by extracorporeal hemoperfusion with a polymyxin-B-adsorbing cartridge (PMX-HA). No studies compared presepsin to procalcitonin and endotoxin in patients treated with PMX-HA. The investigators aim to evaluate the trend and prognostic value of presepsin versus procalcitonin and endotoxin in ICU patients with septic shock from complicated major abdominal surgery, treated with PMX-HA.

Official Title
-----------------
PRESEPSIN: Biomarker in the Early Diagnosis of Sepsis

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Diagnostic Test: presepsin, procalciton, endotoxin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caucasian patients patients undergoing laparoscopic major abdominal surgery Exclusion Criteria: pregnancy, organ transplantation, palliative care metastatic cancer head trauma and polytrauma coagulopathies use of anticoagulants neurological disease autoimmune disease thyroid disease.

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: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: septic shock patients<br>Septic shock patients undergoing major abdominal surgery treated with polymyxin-B | Diagnostic Test: presepsin, procalciton, endotoxin<br>* measurement of presepsin, procalciton, endotoxin plasmatic levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of mortality at 30-days | incidence of mortality | up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock
Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

Conditions
-----------------
Gastritis Acute, Gastritis Chronic

Intervention / Treatment
-----------------
* Drug: DA-5219
* Drug: Stillen® Tab
* Drug: DA-5219 Placebo
* Drug: Stillen® Tab Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Men or women aged ≥ 19 years and ≤ 75 years Subjects who diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy within 7days prior to the randomization Subjects who have one or more erosions identified on upper gastrointestinal endoscopy within 7days prior to the randomization Subjects who voluntarily signed a consent form Main Exclusion Criteria: Ineligible for upper gastrointestinal endoscopy Subjects with active or healing gastroduodenal ulcer, reflux esophagitis, Barrett's esophagus, or gastroesophageal varices identified on upper gastrointestinal endoscopy within 7days prior to the randomization Subjects with hypersensitivity to investigational drugs and similar drugs Pregnant or breastfeeding women

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-5219<br>administered for 2weeks(DA-5219 + Stillen® Tab placebo) | Drug: DA-5219<br>* 1 tablet/day<br>Drug: Stillen® Tab Placebo<br>* 3 tablets/day<br>|
| Active Comparator: Stillen® Tab<br>administered for 2weeks(Stillen® Tab + DA-5219 placebo) | Drug: Stillen® Tab<br>* 3 tablets/day<br>Drug: DA-5219 Placebo<br>* 1 tablet/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement rate of gastric mucosal erosion |  | Change from baseline at 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure rate for gastric mucosal erosion |  | Change from baseline at 2 weeks | 
| Cure rate for gastric mucosal edema |  | Change from baseline at 2 weeks | 
| Improvement rate for gastric mucosal erythema |  | Change from baseline at 2 weeks | 
| Improvement rate for gastric mucosal bleeding |  | Change from baseline at 2 weeks | 
| Improvement rate for gastric subjective symptoms |  | Change from baseline at 2 weeks |
A Multicentre Retrospective Study on Bicuspid Aortic Valve

Study Overview
=================
Brief Summary
-----------------
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners. Asian populations with BAV have different morphological characteristics from those of the Western populations, and further elucidation of these differences will serve as a guide for the treatment and follow-up of Asian patients. Therefore, we conducted this multicentre retrospective study to analysis the clinical features, long-term development and surgical prognosis of BAV .

Detailed Description
-----------------
Bicuspid Aortic Valve (BAV) is a common congenital heart disease with an incidence ranging from 0.16% in Asians to 2% in Westerners, and more than one half of patients require medical or surgical treatment within 20 years of diagnosis. Therefore, early diagnosis and effective treatment can help to reduce the incidence of irreversible cardiac impairment and adverse outcomes such as sudden death. Asian populations with BAV have morphological characteristics that differ from those of the Western populations, and further elucidation of these differences could serve as a guide for the treatment and follow-up of Chinese patients. Based on the above background, We conducted this multicentre retrospective study. We will search for patients diagnosed with BAV by echocardiography or other imaging examinations from December 2021 to October 2022 at Nanjing Gulou Hospital, Jiangsu Provincial Hospital and Nanjing Children's Hospital; collect clinical symptoms, signs and examination results of them; find out the specific surgical plan and time of surgery if they have undergone surgery; follow up for symptoms, medication and reexamin Echocardiography to confirm any endpoint events.

Official Title
-----------------
Multicentre Retrospective Analysis of the Characteristics and the Long-term Prognosis of the Bicuspid Aortic Valve

Conditions
-----------------
Bicuspid Aortic Valve

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with a suspected diagnosis of Bicuspid Aortic Valve by echocardiogram from December 2021 to October 2022 Exclusion Criteria: Patients with suspected Bicuspid Aortic Valve not clearly diagnosed by echocardiography and not confirmed by cardiac surgery
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 |
| --- | --- | --- |
| All-cause death | Death from any causes | 1 year | 
| Cardical mortality | Death due to cardiac disease including MI, arrhythmia, heart failure and aortic lesions | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bicuspid Aortic Valve, Echocardiography, Long-term progress
To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.

Study Overview
=================
Brief Summary
-----------------
Ultrasonic-guided radiofrequency ablation is the most common minimally invasive treatment for liver cancer. This study will use my country's self-developed intelligent ultrasonic navigation tool (NAVIRFA® Navigation System) to assist in the puncture of the needle during ablation, to observe the operation time, Whether the needle accuracy, ablation effect and complications are different from the traditional free-hand ultrasonic guidance technology.

Official Title
-----------------
To Improve the Clinical Outcome of Ultrasound-guided Radiofrequency Ablation by NAVIRFA® Navigation System.

Conditions
-----------------
Radiofrequency Ablation

Intervention / Treatment
-----------------
* Device: NAVIRFA® Navigation System
* Device: ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with malignant liver tumors less than three centimeters in size who are expected to suffer radiofrequency tumor ablation in the hospital. At least 20 years old. Exclusion Criteria: Patients with abnormal coagulation function and low platelets are not suitable for ablation therapy after evaluation by the trial host. Those who are unable to accept computerized tomography and MRI examinations, such as poor renal function or contrast agent allergy, are not suitable for examination after the evaluation of the test host.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAVIRFA® Navigation System<br> | Device: NAVIRFA® Navigation System<br>* radiofrequency ablation by NAVIRFA® Navigation System.<br>|
| Active Comparator: ultrasound-guided<br> | Device: ultrasound<br>* radiofrequency ablation by ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| required scan time | the time required until start of the ablation (measured from the time of the first US scan to the start of the ablation). | Before ablation treatment |
Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients

Study Overview
=================
Brief Summary
-----------------
This study was a multicenter, non-intervention, real world study. To evaluate the efficacy and safety of azvudine in nursing homes with mild/common COVID-19 patients. The primary outcome measure was the proportion of patients with severe/critical illness within 28 days.

Official Title
-----------------
A Non-interventional Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients With Mild/Normal COVID-19

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

Intervention / Treatment
-----------------
* Drug: Azvudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living in a nursing home who has taken or intends to take azvudine tablets depending on their condition; Mild/normal subjects who are SARS-CoV-2 RT-RCR positive or antigen-positive; Subjects have at least one or more of the following clinical symptoms of COVID-19 in the 24 hours prior to initial administration, including but not limited to: fever, cough, sore throat, stuffy or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or difficulty breathing, chills or chills; Volunteer to participate in the experiment and sign the informed consent in person or complete the informed consent over the phone. Exclusion Criteria: Subjects have received antiviral therapy, such as Paxlovid and SARS-CoV-2 monoclonal antibody therapy (except previous treatment for COVID-19 infection) before entering the study; Shortness of breath, RR≥30 times/min or resting state, oxygen saturation of finger when sucking air ≤93%; Mechanical ventilation is required or expected to be urgently required; Severe infections requiring systemic treatment within 14 days prior to initial medication; Use of other antiviral drugs (such as anti-HIV, hepatitis B, and hepatitis C drugs) within 14 days prior to the first medication.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azvudine|Azvudine tablets are taken orally 5mg daily for a maximum of 14 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with severe/critical illness within 28 days |  | up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality within 28 days |  | up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection | 
| Proportion of hospitalization within 28 days and the duration of hospitalization |  | up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection |
Artificial Intelligence in Computed Tomography for Quantifying Lung Changes of Bronchiectasis Patients

Study Overview
=================
Brief Summary
-----------------
Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Chest computed tomography (CT) remains the imaging standard for demonstrating cystic fibrosis (CF) airway structural disease in vivo. However, visual scoring systems as an outcome measure are time consuming, require training and lack high reproducibility. Our objective was to validate a fully automated artificial intelligence (AI)-driven scoring system of CF lung disease severity.

Official Title
-----------------
Artificial Intelligence Based on Machine Learning in Computed Tomography for Quantifying Lung Changes of Bronchiectasis Patients

Conditions
-----------------
Bronchiectasis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis) Exclusion Criteria: Patients with CT data and medical records missing
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Train dataset<br>This group is dedicated to developing an automated algorithm. | Other: No intervention<br>* No intervention<br>|
| Test dataset<br>This group is dedicated to testing the performance of an automated algorithm. | Other: No intervention<br>* No intervention<br>|
| Clinical Validation<br>This group is dedicated to assessing the clinical validity of the measurement in an independent validation cohort. | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations of the artificial intelligence-driven scores with manual scores | Correlations and comparisons of the artificial intelligence-driven scores with manual scores by thoracic radiologists on CT scans of bronchiectasis patients. | From date of inclusion until the date of final quantification, assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the artificial intelligence-driven scores with pulmonary function test | Correlation of quantitative measurement with pulmonary function | From date of inclusion until the date of final quantification, assessed up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchiectasis, Machine Learning, Artificial Intelligence