linjc16/ctgov huggingface dataset:
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Zepzelca™ inj. in real-world practice and to investigate important identified risks and gaps in information related to risk management plans.

Official Title
-----------------
Observational Study to Evaluate the Safety and Efficacy of Zepzelca™ Injection (Lurbinectedin) in Patients With Metastatic Small Cell Lung Cancer (SCLC) in Real-World Practice

Conditions
-----------------
SCLC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who voluntarily provide written consent for personal information collection and utilization after receiving an explanation about the objective and methods of the study Patients who have received or are scheduled to receive Zepzelca™ inj., according to domestic approval indications Patients with metastatic SCLC who have failed first-line platinum-based chemotherapy Exclusion Criteria: Patients with no prior history of platinum-based anticancer chemotherapy for cancer treatment Patients with a history of hypersensitivity reactions to this drug or its components Pregnant, potentially pregnant, or lactating women Patients currently participating in another clinical trial (drug or medical device) or planning to participate in another clinical trial during the study period (except for non-interventional clinical studies or cases where the clinical trial drug administration has ended and only follow-up is remaining) Patients who are judged by the principle Investigator or sub-Investigator to be ineligible to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| ORR (Overall Response Rate) | Percentage of subjects who reached complete remission (CR) and partial remission (PR) | 6 months after the start of administration |
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.

Official Title
-----------------
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Chocolate balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease; primary cases with no previous surgical treatment of the target lesion; presence of at least one vessel with patency in the distal outflow tract; survival >1 year. Exclusion Criteria: planned stenting; presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion; combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure; allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs; ineffective recanalization attempts; lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.

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 |
| --- | --- |
| Chocolate balloon<br> | Device: Chocolate balloon<br>* Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty<br>|
| Conventional ballon<br> | Device: Chocolate balloon<br>* Vascular preparation with chocolate balloons prior to drug-coated balloon angioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | No occlusion or restenosis (>50%) of the target vessel in the treated segment during follow-up and no further intervention is required. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral artery, Popliteal artery, Peripheral artery disease, Chocolate percutaneous transluminal angioplasty balloon, Drug-coated balloon
A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients with atypical endometrial hyperplasia, and 100 patients with endometrial cancer; and then to explore the underlying molecular mechanism, and establish the database system for the dynamic evolution of endometrial carcinogenesis.

Official Title
-----------------
A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis

Conditions
-----------------
the Dynamic Evolution of Endometrial Carcinogenesis, Multiomics Analysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathological diagnosis: normal endometrium, atypical hyperplasia endometrium, or endometrial cancer; Obtain pathological results after undergoing hysteroscopic surgery or hysterectomy; The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements; Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests. Exclusion Criteria: Patients with malignant tumors in other parts of the body; Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders; Poor compliance and inability to cooperate and describe treatment responders.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Group<br>Patients with normal endometrium | |
| Precancerous Group<br>Patients with atypical hyperplasia of endometrium | |
| Carcinoma Group<br>Patients with endometrial cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis |  | August 2023 to June 2026 | 
| Differences in the expression of these mutant genes among the three groups of participants as assessed by SAS® 9.4 |  | January 2026 to June 2026 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dynamic Evolution, Genomics, Transcriptome, Proteomics, Metabolomics
Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)

Study Overview
=================
Brief Summary
-----------------
Acute kidney failure remains one of the most challenging entities to diagnose in clinical medicine, especially in the field of intensive care. The diagnosis of acute kidney injury is based solely on urine output and serum creatinine, both of which could also be influenced by other factors. A more sensitive and faster diagnostic option would not only be desirable but of utmost clinical importance. Therefore, the investigators aim to identify Neuronal Guidance Proteins (NGPs) as potential biomarkers for the identification and early detection of AKI with this investigation. This investigation aims to identify the possibility of diagnosing acute kidney injury, the subsequent validation of a potential biomarker will then have to take place in a multicenter study approach: Data in preclinical mouse models suggest that SEMA7A as one of the NGPs could be valuable as a biomarker, the study now aims to attempt a preliminary survey in humans and measure various NGPs.

Official Title
-----------------
Role of Neuronal Guidance Proteins as Diagnostic Markers for Acute Kidney Injury (AKI)

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing cardiac surgery written consent Exclusion Criteria: no written consent possible Polytrauma, severe burns Immunosuppression Pregnancy Diagnosis of Hepatitis B, Hepatitis C, and/or HIV Sepsis Pre-existing kidney damage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Cardiac Surgery<br>Patients undergoing cardiac surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AKI | Development of AKI after cardiac surgery | 1-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NGP | Concentration of NGPs in Blood and Urine | 1-7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuronal Guidance Protein, Acute Kidney Injury
Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics

Study Overview
=================
Brief Summary
-----------------
In pediatric patients, the accuracy of body temperature measured with an esophageal temperature probe placed through the gastric lumen of the supraglottic airway device is investigated.

Detailed Description
-----------------
Pediatric patients using a supraglottic airway device during general anesthesia are targeted. When the patient enters the operating room, standard monitoring is performed, general anesthesia is induced, a supraglottic airway device is installed, and an anesthesiologist inserts an esophageal thermometer through the gastric lumen. We recorded the body temperature measured in the esophagus, tympanic membrane, temporal artery, and rectum every 10 minutes from 10 minutes after insertion.

Official Title
-----------------
Feasibility and Accuracy of Core Temperature Measurements Using the Esophageal Temperature Probe Inserted Through the Gastric Lumen of Supraglottic Airway Device in Pediatrics: a Prospective Observational Study

Conditions
-----------------
Temperature Change, Body, Supraglottic Airway Device, Pediatric ALL

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatrics patients under six years old with ASA PS 1-3 Patients undergoing general anesthesia using the Supraglottic airway device Patient's weight: 10-30kg Exclusion Criteria: Patients who refused to participate in the study Patients with tumors in the esophagus or esophageal varices Patients with a monitoring device inserted through the esophagus during surgery Patients with ear inflammation Patients with congenital anomaly in the rectum Patients judged unfit to participate in the study by medical staff for other reasons

Ages Eligible for Study
-----------------
Maximum Age: 6 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 |
| --- | --- | --- |
| Comparison of esophageal temperature and temperature at tympanic membrane, rectum, temporal artery | 'c | 10min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of gastric suction through an esophageal temperature probe | Evaluated via gastric sonography | After inserting the esophageal temperature probe |
Vision Screening Study for College Students at Nankai University

Study Overview
=================
Brief Summary
-----------------
The prevalence of myopia among high school students in China is as high as 80%-90%. For college students with longer years of education, the majority of myopia and the factors influencing the prevalence of high myopia should be better understood for timely prevention and treatment. This study aims to investigate the prevalence of myopia and education-related influencing factors among college students at Nankai University.

Official Title
-----------------
Vision Screening Study for College Students at Nankai University

Conditions
-----------------
Myoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All 1st year students Exclusion Criteria: No eye diseases such as cataracts, glaucoma,keratoconus, etc. No psychiatric disorders Astigmatism ≤ -6.00D

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 30 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| College Students<br> | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of myopia | Myopia was defined as an equivalent spherical refraction ≤ -0.50D in either eye | One day measurement | 
| Prevalence of high myopia | High myopia was defined as an equivalent spherical refraction ≤ -6.00D in either eye | One day measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Venous blood pressure was measured using a sphygmomanometer, and systolic and diastolic blood pressure results were recorded. | One day measurement | 
| Pulse | Measure the number of pulses in the quiet state and record the number of beats per minute. | One day measurement |
Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

Study Overview
=================
Brief Summary
-----------------
The main goal of this study is to determine if static or dynamic [18F]NaF PET/CT (positron emitting tomography) can identify the source of lower backpain in at least 20% of the patients experiencing lower backpain, yet could not be diagnosed from MRI or CT scans.

Detailed Description
-----------------
Patients with chronic lower backpain are routinely scanned with MR and/or CT to diagnos the source of pain. Larger studies have reported that approximately 20% of patients are given a certain diagnosis from the scans and in the majority of cases the source of the pain is not determined. The use of [18F]NaF PET/CT to map bone perfusion and metabolism is a routine clinical scan that can potentially identify the source of lower backpain in MRI and CT negative patients. Hypothesis: That [18F]NaF PET/CT bone metabolism and bone perfusion images would contain information that allow the correct diagnosis in at least 20% of patients where MRI and CT images did not reveal pathology.

Official Title
-----------------
Diagnosis of Bone Metabolism in Patients With Inexplicable Lower Back Pain

Conditions
-----------------
Lower Back Pain Chronic

Intervention / Treatment
-----------------
* Diagnostic Test: [18F]NaF PET/CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years Chronic lower back pain with no concrete diagnosis after MRI and/or CT Under the the care of Rigshospitalets centre for Rheumatology and Spine Disease Exclusion Criteria: previous operation in the lower back area Known inflammatory related illness or progressive rheumatism

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic lower back pain patients<br>Patients with chronic lower back pain where the source could not be identified on MRI scans | Diagnostic Test: [18F]NaF PET/CT scan<br>* Patients will have their lower back scanned using [18F]NaF PET/CT<br>|
| Age matched healthy controls<br>Healthy individuals without any previously known pain or intervention on lower back | Diagnostic Test: [18F]NaF PET/CT scan<br>* Patients will have their lower back scanned using [18F]NaF PET/CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal foci of elevated bone metabolism, blood pooling or bone perfusion | [18F]NaF PET/CT scan | 1 hour examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone metabolism, NaF PET, Bone perfusion
Rebound Pain and Related Factors in Postoperative Patients With Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.

Detailed Description
-----------------
Total knee arthroplasty is an effective treatment method for knee osteoarthritis and because it is an invasive method, more than 50% of patients experience postoperative pain. Peripheral nerve blocks are widely used for optimal pain control. The femoral block is a frequently preferred peripheral nerve block method for postoperative analgesia in total knee arthroplasty surgery. However, after peripheral nerve block, a condition called rebound pain (rebound pain), which is described as very severe pain, lasting about 2 hours, usually of the burning type, occurs. The aim of this prospective observational study is to detect rebound pain and related factors in postoperative patients with total knee arthroplasty.

Official Title
-----------------
Rebound Pain and Related Factors in Patients Who Underwent Femoral Nerve Block for Postoperative Pain Control in Total Knee Arthroplasty

Conditions
-----------------
Postoperative Pain, Postoperative Complications, Postoperative Nausea and Vomiting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years older age who underwent total knee arthroplasty Exclusion Criteria: ASA score 4 or >4 Active infection End stage organ failure Pregnancy Established diagnosis neuropsychiatric disease ( epilepsy, neuropathy, neuromuscular disease, cerebrovascular disease...) Uses of oral corticosteroids

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 |
| --- | --- | --- |
| Visual Analogue Scale | The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | postoperative 3-5 days fellow-up |
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
Mitral regurgitation is a pathology affecting the left atrioventricular valve that causes a volumetric and pressure overload in the left chambers due to the loss of unidirectionality normally guaranteed by the cardiac valve system. The gold standard for severe mitral regurgitation is currently mitral valve plastic surgery. Edge to edge, on the other hand, allows shorter CEC and aortic clamping times and does not require significant surgical experience in the field of mitral valve repair, therefore edge to edge could be an excellent strategy in patients suffering from mitral regurgitation caused by P2 prolapse when quadrangular resection cannot be performed. The main objective of the present study is to examine the medium to long-term outcomes (in terms of survival and plastic outcomes) of patients undergoing central edge-to-edge to treat posterior flap pathology (P2).

Official Title
-----------------
Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation

Conditions
-----------------
Degenerative Mitral Valve Disease, Mitral Regurgitation

Intervention / Treatment
-----------------
* Procedure: Central edge-to-edge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mitral regurgitation with degenerative etiology Mitral pathology exclusively dependent on P2 Surgical creation of a double mitral valve orifice with or without a ring as the only mitral valve repair technique. Exclusion Criteria: - Other mitral regurgitation etiologies (eg. functional, radiation-induced, rheumatic...)

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: Central edge-to-edge|Suture of free margins of the mitral leaflets in central position to restore coaptation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MR 2+ or more recurrency |  | through study completion, a minimum of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintervention |  | through study completion, a minimum of 2 years |