linjc16/ctgov huggingface dataset:
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.

Detailed Description
-----------------
The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.

Official Title
-----------------
Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers

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

Intervention / Treatment
-----------------
* Other: OTF Ocular Lubricant
* Other: Ocular Lubricant


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Is able to understand and sign an approved information consent letter; Habitually wears daily disposable soft contact lenses in both eyes Uses rewetting drops on a regular basis; Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Routinely sleeps in habitual contact lenses; Has any known active ocular disease and/or infection; Is pregnant or lactating; Other protocol specified exclusion criteria may apply.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTF Test 1<br>One application of ocular lubricant to each eye at night for 5 consecutive nights | Other: OTF Ocular Lubricant<br>* Ocular lubricant in 1 of 3 test formulations<br>|
| Experimental: OTF Test 2<br>One application of ocular lubricant to each eye at night for 5 consecutive nights | Other: OTF Ocular Lubricant<br>* Ocular lubricant in 1 of 3 test formulations<br>|
| Experimental: OTF Test 3<br>One application of ocular lubricant to each eye at night for 5 consecutive nights | Other: OTF Ocular Lubricant<br>* Ocular lubricant in 1 of 3 test formulations<br>|
| Active Comparator: Ocular lubricant<br>One drop of ocular lubricant applied to each eye at night for 5 consecutive nights | Other: Ocular Lubricant<br>* Commercially available ocular lubricant<br>* Other names: Genteal™ Gel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular comfort | Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent. | Up to Day 5 |
Endoscopic Submucosal Dissection Registry

Study Overview
=================
Brief Summary
-----------------
This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.

Detailed Description
-----------------
Cases will be registered one by one in an electronic record, with the consent of the patient and respecting all legal requirements.

Official Title
-----------------
Endoscopic Submucosal Dissection Patients Registry in Agrippa Ionescu Hospital, Bucharest, Romania

Conditions
-----------------
Neoplasm, Stomach, Neoplasm, Colorectal, Neoplasm, Esophagus, Neoplasm, Duodenal

Intervention / Treatment
-----------------
* Procedure: Endoscopic submucosal dissection (ESD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epithelial pre-neoplastic (eg. adenoma, dysplasia) lesion on the esophageal, gastric, duodenal or colorectal mucosa non-epithelial (eg. neuroendocrine tumor) lesion on the esophageal, gastric, duodenal or colorectal mucosa age > 18 years old informed consent Exclusion Criteria: age < 18 years old no informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic submucosal dissection (ESD)|Endoscopic injection of fluid into the gastrointestinal submucosal space followed by endoscopic knife dissection around and under the lesion so as to remove the lesion specimen in one piece with lesion free resection margins.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of curative resection |  | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of R0 resection |  | through study completion, an average of 1 year |
Effect of Baduanjin Exercise on Metabolic Syndrome Patients

Study Overview
=================
Brief Summary
-----------------
Pre/posttest randomized control trial design. In this study all patients will be randomly assigned into two groups (30 in each group) : Group A will do baduanjin exercise in addition to traditional medical treatment. Group B will take traditional medical treatment only.

Official Title
-----------------
Effect of Baduanjin Exercise on Quality of Life in Patients With Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Baduanjin exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome patients Exclusion Criteria: patients with Respiratory diseases patients with pacemaker patients patients with Neurological diseases patients with orthopedic diseases

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 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
Interventional Model Description: Pre/posttest randomized control trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baduanjin exercise in addition to medical treatment<br>30 patients with metabolic syndrome do baduanjin exercise in addition to traditional medical treatment | Other: Baduanjin exercise<br>* Baduanjin exercise<br>|
| Experimental: Traditional medical treatment<br>30 patients with metabolic syndrome taking traditional medical treatment | Other: Baduanjin exercise<br>* Baduanjin exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose level | Pre/post fasting glucose level in blood | 3 months | 
| Lipids profile | Pre/post HDL & lDL levels in blood | 3 months |
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy

Study Overview
=================
Brief Summary
-----------------
Extracorporeal shock wave lithotripsy (ESWL) is the least invasive and effective treatment for upper ureteric stones with a stone clearance rate of 60-90%. Tamsulosin is an alpha-blocker widely used in urological practice to relax smooth muscle of the prostate and bladder neck. Its role as part of medical expulsion therapy for the treatment of patients with kidney and ureteric stones has proved to be of considerable success. However, its role in clearing upper ureteric stones as an adjunct to ESWL is controversial. Therefore, this study will be conducted to evaluate its role in stone clearance along with extracorporeal shock wave lithotripsy in patients with upper ureteric stones

Official Title
-----------------
Stone Clearance in Patients With Upper Ureteric Stones Using Extracorporeal Shock Wave Lithotripsy Compared With Extracorporeal Shock Wave Lithotripsy Combined With Tamsulosin Therapy

Conditions
-----------------
Renal Stone

Intervention / Treatment
-----------------
* Procedure: Extracorporeal shock wave lithotripsy
* Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single upper ureteric stone size ranging from 6-15 mm stones history less than 6 months Exclusion Criteria: Patients with urinary tract infection multiple ureteric stones, presence of a ureteric stricture distal to the stone, previous unsuccessful ESWL, concomitant use of calcium channel blockers or alpha-adrenergic antagonists patients with abnormal coagulation profile

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: ESWL alone<br>Extracorporeal shock wave lithotripsy will be given to the patient | Procedure: Extracorporeal shock wave lithotripsy<br>* Extracorporeal shock wave lithotripsy will given to the patients<br>|
| Active Comparator: ESWL combined with tamsulosin therapy<br>Extracorporeal shock wave lithotripsy combined with tamsulosin therapy will be given to the patient | Procedure: Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy.<br>* Extracorporeal Shock Wave Lithotripsy combined with Tamsulosin Therapy will be given to the patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone clearance | Number of patients cleared from ureteric stones | 4 weeks |
Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center, non-randomized, non-controlled study

Detailed Description
-----------------
Immunotherapy with immune-checkpoint inhibitors (ICIs) has enabled a leap forward in the treatment of various types of cancer within the past decade. However,only 12.46% of patients with cancer are expected to respond to ICIs.Our team have recently developed a multi-specific antibody technology platform for the microenvironment of solid tumors. In this study, we are going to study the tumor immune microenvironment of breast cancer patients by patient-derived organoids or PDX model，to design multi-specific antibody drugs for different tumor immune microenvironment，to look forward to improve the effectiveness of immunotherapy for breast cancer and solve the problem of drug resistance.

Official Title
-----------------
Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer

Conditions
-----------------
Invasive Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between 18 and 70 years old； Primary lesion >2cm on imaging examination, or suspected axillary lymph node metastasis on imaging examination； Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments； Subjects signed informed consent； Exclusion Criteria: A history of prior or concomitant malignancies; Advanced stage breast cancer (stage IV)； Suspected or confirmed lesion was surgically removed； Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antitumor rate of multi-specific antibody in patient-derived organoids and PDX model | Patient-derived organoids and PDX model | 24 months |
A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America

Study Overview
=================
Brief Summary
-----------------
Data from niraparib treatment is not available in real-world setting in Latin America. The present study aims to collect data from patients treated with niraparib within the Latin America Expanded Access Program (EAP) in clinical practice in Brazil and Argentina and who meet the eligibility criteria for this study, without additional intervention.

Official Title
-----------------
A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced OC in response following first line platinum-based chemotherapy who were treated with niraparib within the EAP in Argentina and Brazil; Patients who have received at least one dose of niraparib in the EAP. Exclusion Criteria: - Patients without medical record available (lost, empty or irretrievable clinical information).
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated within the EAPs with niraparib for ovarian cancer<br>This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care. | Other: Observational study<br>* This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety profile | To evaluate the safety profile, including dose modifications, of niraparib in patients with advanced ovarian cancer in response following first-line platinum-based chemotherapy treated in a real-world setting within the EAP. | through study completion, an average of 36 months |
Early Detection & Intervention of Cerebral Palsy in Ireland

Study Overview
=================
Brief Summary
-----------------
Cerebral palsy (CP) is the most common lifelong physical disability. It is defined as a non-progressive disorder of movement originating from neural lesions in the perinatal period, and is associated with a wide range of common comorbidities in many individuals. These include problems speaking, hearing, seeing, thinking, feeding and controlling their bladder. People with CP often have additional challenges such as behavioural and emotional issues, pain, and poor sleep. Many of these challenges respond well to intervention in early childhood, as brain plasticity is at its greatest in the first 2 years of life. However, in most clinical settings, the age for diagnosis of CP is between 24 to 29 months, after this window of neurodevelopmental opportunity. This project will aim to improve the Early Detection of Cerebral Palsy in Ireland. This will be achieved by implementing an evidence-based approach to follow-up of High risk infants.

Official Title
-----------------
Early Detection & Intervention of Cerebral Palsy in Ireland

Conditions
-----------------
Cerebral Palsy, Neurodevelopmental Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Legal guardians must be able and willing to give written informed consent and to comply with the requirements of this study protocol. All infants considered high risk for cerebral palsy and neuro-developmental impairment will be eligible, specifically including: All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight All encephalopathic infants Neurological risk factors (e.g., injury/malformation on neuroimaging, persistently abnormal neurological exam) Exclusion Criteria: Death prior to discharge from the neonatal unit.

Ages Eligible for Study
-----------------
Maximum Age: 40 Weeks

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 |
| --- | --- | --- |
| Reduce the age of CP diagnosis in Ireland. | Reduce the age of diagnosis of cerebral palsy in Ireland to less than 12 months of age by using evidence based standardised motor and neurological assessments at set time points. | 5 years | 
| Standardised Approach to Assessing infant at risk of CP | To establish a standardised approach to assessing infants at risk of CP in High Risk Follow-up Clinics across Ireland. | 5 years |
Blood Pressure Monitor Clinical Test (Cuff Range: 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify the accuracy of the 4 blood pressure cuffs with blood pressure monitor device. Cuff circumference is : 15cm-24cm, 20cm-34cm, 30cm-44cm, 22cm-42cm

Official Title
-----------------
Blood Pressure Monitor#Model#BPM1#Clinical Test

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal blood pressure and hypertensive patients over 12 years old Exclusion Criteria: Patients with serious arrhythmias or a high frequency of arrhythmias Pregnant woman Other investigators believe that it is not suitable to participate in this clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Subject use both BPM1 Arm Automatic Electronic BPM and mercury sphygmomanometers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure monitor accuracy | All the test results of the electronic blood pressure monitor with 4 cuffs is within the accuracy creteria, with the merury sphygmomanometer as control | 30 minutes |
Deep Learning Models for Prediction of Intraoperative Hypotension Using Non-invasive Parameters

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to investigate the deep learning model to predict intraoperative hypotension using non-invasive monitoring parameters.

Detailed Description
-----------------
Intraoperative hypotension is associated with various postoperative complications such as acute kidney injury. Therefore, precise prediction and prompt treatment of intraoperative hypotension are important. However, it is difficult to accurately predict intraoperative hypotension based on the anesthesiologists' experience and intuition. Recently, deep learning algorithms using invasive arterial pressure monitoring showed the good predictive ability of intraoperative hypotension. It can help the clinician's decisions. However, most patients undergoing general surgery are monitored by non-invasive parameters. Therefore, the investigators investigate the prediction model for intraoperative hypotension using non-invasive monitoring.

Official Title
-----------------
Prediction of Intraoperative Hypotension Using Non-invasive Monitoring Devices: Development of Deep Learning Model

Conditions
-----------------
Intraoperative Hypotension, General Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who are included in the open database, VtialDB. The patients who underwent inhaled general anesthesia for non-cardiac surgery. The patients who have non-invasive monitoring data including blood pressure, electrocardiography, pulse oximetry, bispectral index, and capnography. Exclusion Criteria: The patient with missing data.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group<br>In the open source database (VitalDB, https://vitaldb.net), the patients who underwent general anesthesia with non-invasive monitoring including blood pressure, electrocardiography, pulse oximetry, bispectral index, capnography, and minimal alveolar concentration of inhalation agent. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep learning model's prediction ability on intraoperative hypotension event | Area under the curve the receiver operating characteristic (AUROC) curve for the deep learning model to predict intraoperative hypotension. | through study completion, an average of 3 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intraoperative hypotension, noninvasive monitor, deep learning algorithm