linjc16/ctgov huggingface dataset:
Biomarkers and Cardiac CT

Study Overview
=================
Brief Summary
-----------------
Coronary artery disease (CAD) is the leading cause of morbidity and mortality in developed countries. In addition, many patients suffer from valvular and aortic disease. Although various tools are available to identify patients with cardiovascular (CV) disease at risk for major adverse cardiac events (MACE), the identification of these patients remains a clinical challenge. One promising avenue is the use of different serum biomarkers involved in atherothrombosis which could provide an easy and cost-effective step in risk stratification.

Official Title
-----------------
Biomarkers and Cardiac Computed Tomography: Relationship Between Cardiovascular Biomarkers and Coronary Artery Disease in Patients Undergoing Cardiac Computed Tomography

Conditions
-----------------
Coronary Artery Disease, Atherosclerosis

Intervention / Treatment
-----------------
* Biological: Venous blood sampling prior to CCTA.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred from the Cardiology clinic for routine CCTA. Exclusion Criteria: Pregnancy Severe renal insufficiency Severe allergy to contrast medium Inability to obtain informed consent Age below 18 years

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 |
| --- | --- |
| Venous blood sampling prior to CCTA.<br>In patients undergoing routine Cardiac Computed Tomography Angiography (CCTA) and given written informed consent blood sampling will be performed. The samples will be stored for a period of 15 years at the Biobank for future analyses. | Biological: Venous blood sampling prior to CCTA.<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data registration of patients undergoing CCTA and given written informed consent. |  | 15 years. | 
| To detect these patients for cardiovascular disease and Long term CV outcome (MACE). |  | 15 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship of novel blood biomarkers with CCTA findings. |  | 15 years. | 
| The predictive value of these biomarkers to predict CAD in patients undergoing CCTA. |  | 15 years. | 
| The prognostic value of these biomarkers (in combination) to predict MACE. |  | 15 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biological Markers, Multidetector Computed Tomography
Quality of Postoperative Pain Management in Cardiac Surgical Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the incidence and risk factors of moderate to severe pain after cardiac surgery, and compare the preoperative pain expectation and postoperative pain experience in the same patient.

Detailed Description
-----------------
Objectives To study the incidence of moderate to severe pain in cardiac surgical patients 48 hour postoperatively. To study the risk factors of moderate to severe postoperative pain in cardiac surgical patients. To compare the preoperative pain expectation and postoperative pain experience in the same patient.

Official Title
-----------------
Quality of Postoperative Pain Management in Cardiac Surgical Patients

Conditions
-----------------
Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for cardiac surgery in Siriraj Hospital age > 18 Exclusion Criteria: unable to communicate with the patient

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 |
| --- | --- | --- |
| Number of the patients having pain score more than 4 out of 10 in 48 hour postoperatively |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors of postoperative pain in cardiac surgical patients |  | 48 hours | 
| Patient's preoperative pain expectation and postoperative pain experience |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, cardiac surgery, risk factors
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family

Study Overview
=================
Brief Summary
-----------------
Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by demonstrating clinical safety evaluating performance based on sensing and pacing assessment collecting additional data of interest to assess other aspects such as the handling and usability

Official Title
-----------------
BIO|MASTER.Pamira Study

Conditions
-----------------
Heart Failure, Tachyarrhythmia

Intervention / Treatment
-----------------
* Device: Pamira ICD lead family


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Standard indication for ICD or CRT-D therapy according to clinical guidelines Planned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with Pamira Ability to understand the nature of the study and willingness to provide written informed consent Ability and willingness to perform all follow-up visits at the study site Ability and willingness to use the CardioMessenger and acceptance the BIOTRONIK Home Monitoring® concept Exclusion Criteria: Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease Known Dexamethasone acetate intolerance Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.) Less than 18 years old Pregnant or breast feeding Participating in another interventional clinical investigation Life-expectancy less than 12 months

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br> | Device: Pamira ICD lead family<br>* Implantation, measurements and follow-up schedule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pamira lead related SADE-d free rate at 6 months after implantation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1a and b: Pamira lead related SADE-d free rate at 3 and 12 months after implantation |  | 3 months, 12 months | 
| 2a and 2b: Rate of appropriate right ventricular sensing at the 6- and 12-month follow-up |  | 6 months, 12 months | 
| 3a and 3b: Rate of appropriate right ventricular pacing at the 6- and 12-month follow-up |  | 6 months, 12 months |
Pupillometry and Locus Coeruleus Activation (PuLCA)

Study Overview
=================
Brief Summary
-----------------
This project will apply non-invasive, trans-cutaneous vagal nerve stimulation using various stimulation parameters to young, healthy adults to find the optimal set of parameters to elicit pupil response.

Official Title
-----------------
Effects of Various Non-invasion Stimulation Parameters on Pupil Dilation

Conditions
-----------------
Visual Impairment, Ocular Illness

Intervention / Treatment
-----------------
* Device: transcutaneous electrical nerve stimulation devices


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluent English speaker with reading and writing proficiency. Exclusion Criteria: Participants with significant visual impairment or ocular illness may be excluded at the discretion of the principal investigator. Major medical illnesses including severe neurological illness (e.g. stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) Any history of brain surgery, tumor, intracranial metal implantation, pacemakers, or other implanted devices. Current (i.e. within 48 hours of the session) prescription medication or over-the-counter medication use. Illicit alcohol or drug use. Caffeine (e.g, coffee, energy drinks) consumption prior to the visit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study has a within-subjects design with a randomization of the order of tVNS administered parameters
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Experimental<br>Within-subjects design with a randomization of the order of tVNS administered parameters | Device: transcutaneous electrical nerve stimulation devices<br>* electrical stimulation through surface electrodes<br>* Other names: Digitimer DS7A, Ultima Neo, or InTENSity EX4.;|
| Active Comparator: Group B: Active Comparator<br>Within-subjects design with a randomization of the order of tVNS administered parameters | Device: transcutaneous electrical nerve stimulation devices<br>* electrical stimulation through surface electrodes<br>* Other names: Digitimer DS7A, Ultima Neo, or InTENSity EX4.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular response after transcutaneous nerve stimulation | Number of participants with pupil response after transcutaneous nerve stimulation | Visit 1 day |
A Retrospective Study of Immunotherapy in Conversion Therapy of Unresectable Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This study was an observational, non-interventional, multicenter retrospective study to evaluate the feasibility and safety of sintilimab combined with chemotherapy (SOX or PS) in the clinical practice of unresectable locally advanced or stage IV gastric cancer/gastroesophageal junction carcinoma.

Official Title
-----------------
A Retrospective Study of Sintilimab Combined With Chemotherapy in Conversion Therapy of Unresectable Locally Advanced or Stage IV Gastric Cancer/Gastroesophageal Junction Carcinoma

Conditions
-----------------
Unresectable Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages: 18-75 Years (concluding 18 and 75 Years) Pathologically confirmed gastric/gastroesophageal junction adenocarcinoma Unresectable, locally advanced or limited distant metastasis of IV gastric cancer(AJCC 8th) Meets only ≤2 of the following conditions: highly locally advanced (T4b), or extensive or bulcky lymph nodes; Para-aortic lymph node metastasis(mainly 16A2/B1 region); limited liver metastasis(H1); limited Peritoneal metastasis(CY1, P1), with or without ovarian metastasis(Kukernburg tumor); Untreated(e.g. radiotherapy, chemotherapy, target therapy, immunotherapy, et al.) At least 1 measurable lesion by RECIST v1.1 criteria ECOG PS: 0-2 Received sintilimab combined with chemotherapy(SOX or PS) at least 1 cycle Exclusion Criteria: Known Her2 positive Patients with incomplete data or other factors affecting the judgment of efficacy and safety

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical conversion rate |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| R0 resection rate | Defined as no residue under the microscope after resection | two years | 
| Major pathological response (MPR) | MPR is defined as less than 10% residual tumor after neoadjuvant therapy | two years | 
| Overall response rate ( ORR) | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment | two years | 
| adverse event (AEs) |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Unresectable Gastric Cancer, Conversion Therapy, Immunotherapy, Sintilimab
Community-Onset Bacteremia Due to ESBL Producing E.Coli or K.Pneumoniae in China: Prevalence, Risk Factors and Prognosis

Study Overview
=================
Brief Summary
-----------------
Escherichia coli is the leading cause of community-onset gram-negative bloodstream infections. There has been a dramatic increase in the prevalence of extended-spectrum b-lactamases producing E. coli and K.pneumoniae in the community, which was considered to be exclusively a nosocomial pathogen in recent years. As a result, the treatment options for community-onset infections due to ESBL-producing E. coli or K.pneumoniae are limited and the initial empirical therapy is often ineffective and associated with increased mortality. Although there were some reports of the risk factors of community-onset ESBL producing E. coli in Spain, Korea, and Canada, few empirical data were available about China. Therefore, the investigators aim was to investigate the epidemiology, risk factors, and the hospital outcomes for patients with community-onset bacteremia caused by ESBL producing E. coli or K.pneumoniae in China.

Detailed Description
-----------------
Eligibility criteria: Inclusion criteria:Blood cultures demonstrated E.coli or K.pneumoniae among nonhospitalized patients or within 48 h after hospitalization. Exclusion criteria:Patients with hospitalization in the past 1 month. Outcome measures: Risk factors for community-onset bacteremia due to ESBL producing E. coli or K.pneumoniae Microbial and clinical efficacy of commonly used antibiotics for community-onset bacteremia due to ESBL producing E. coli or K.pneumoniae

Official Title
-----------------
Community-Onset Bacteremia Due to Extended-Spectrum β-Lactamase (ESBL)Producing Escherichia Coli or Klebsiella Pneumoniae in China: Prevalence, Risk Factors and Prognosis

Conditions
-----------------
Community Acquired Infection

Intervention / Treatment
-----------------
* Other: bacteremia caused by ESBL producing E.coli or K.pneumoniae


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years old community-onset bacteremia Exclusion Criteria: recent hospitalization within one month in any hospital

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Case Patients<br>Case Patients with Community-Onset Bacteremia Due toESBL producing E.coli or K.pneumoniae | Other: bacteremia caused by ESBL producing E.coli or K.pneumoniae<br>* community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae<br>|
| control group<br>bacteremia caused by ESBL producing E.coli or K.pneumoniae | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae |  | one year |
A Study to Compare a New Eye Drop Formulation With Refresh Contacts®

Study Overview
=================
Brief Summary
-----------------
This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.

Conditions
-----------------
Contact Lens Lubrication

Intervention / Treatment
-----------------
* Drug: carboxymethylcellulose based eye drop formula
* Drug: carboxymethylcellulose sodium based eye drop solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week. Exclusion Criteria: Wearing monovision lenses Have had refractive surgery within the previous 12 months Have infection of the eye, eyelids or eye structures.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carboxymethylcellulose Based Eye Drop Formula<br>1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. | Drug: carboxymethylcellulose based eye drop formula<br>* 1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.<br>|
| Active Comparator: REFRESH CONTACTS®<br>1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. | Drug: carboxymethylcellulose sodium based eye drop solution<br>* 1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.<br>* Other names: REFRESH CONTACTS®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline | Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more. | Baseline, Day 90 |
Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.

Official Title
-----------------
Implementation of Onsite, Rapid Antiretroviral Therapy (ART) Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

Conditions
-----------------
Harm Reduction, HIV Infections, Drug Use

Intervention / Treatment
-----------------
* Drug: Biktarvy 50Mg-200Mg-25Mg Tablet
* Other: HIV care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (age>18 years); positive rapid HIV test; ability to provide informed consent; HIV RNA > 200 copies/ml; creatinine clearance > 30 mg/dl as measured by serum creatinine; no allergy to bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) as indicated by patient history and self-reported allergies. Exclusion Criteria: 1) Any other comorbidities at the discretion of the investigator

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid ART group<br>Patients will receive HIV care including Biktarvy for 6 months at the syringe services program followed by 6 months of standard of care at a traditional clinic. | Drug: Biktarvy 50Mg-200Mg-25Mg Tablet<br>* Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months<br>Other: HIV care<br>* HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with HIV viral load suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with HIV viral load suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | 1 month | 
| Percentage of participants with HIV viral load suppression | HIV viral load suppression is defined as <200 copies/ml in participants' blood | 12 months |