linjc16/ctgov huggingface dataset:
Association Between Carotid Plaque Length and Cardiovascular Outcomes

Study Overview
=================
Brief Summary
-----------------
This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 5000 consecutive patients without known CAD who underwent first coronary angiography for stable chest pain and carotid ultrasound was performed during hospitalization from January 2017 through December 2018.

Detailed Description
-----------------
Patients who had obstructive CAD (defined as ≥50% luminal stenosis) confirmed by coronary angiography and who underwent carotid scanning were included in the final analysis.Carotid ultrasonography was performed simultaneously, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.The incidence of major adverse cardiovascular events was recorded during follow-up.

Official Title
-----------------
Association Between Carotid Plaque Length and Cardiovascular Outcomes

Conditions
-----------------
Coronary Artery Disease, Carotid Plaque

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent coronary angiography for stable chest pain and carotid ultrasound simultaneously; Patients with obstructive CAD (≥50% coronary stenosis); Exclusion Criteria: <18 years of age; previous carotid surgery or significant carotid artery disease; prior stroke or transient ischemic attack; previously documented CAD (including history of myocardial infarction, acute coronary syndrome, or coronary revascularization);

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 |
| --- | --- |
| Carotid plaque length<br>Patients underwent carotid ultrasonography and first coronary angiography simultaneously | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events | cardiovascular death, myocardial infarction, ischemic stroke and coronary revascularization | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death |  | 3 years | 
| cardiovascular death |  | 3 years | 
| myocardial infarction |  | 3 years | 
| ischemic stroke |  | 3 years | 
| coronary artery revascularization |  | 3 years | 
| heart failure |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carotid Artery Ultrasound, Carotid Plaque, Coronary Artery Disease
Effects of RF Microneedle on Photoaging Skin

Study Overview
=================
Brief Summary
-----------------
Melasma relapse is almost common after discontinuation of conventional treatment. Recent studies have suggested that photoaging dermis is main pathomechanism of melasma emphasizing stromal targeting therapy. Therefore, we investigated maintenance effect of microneedle radiofrequency (RF) for melasma treatment.

Official Title
-----------------
RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study

Conditions
-----------------
Pigmentation, Pigmentation Disorder

Intervention / Treatment
-----------------
* Device: RF Microneedle
* Drug: Combination cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult more than 19 years old Melasma clinically diagnosed by three dermatologists Exclusion Criteria: Aesthetic medical procedures in three months prior to the study Use of topical depigmenting agents in three months prior to the study Pregnant or lactating

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: split lesion study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional therapy with RF microneedle<br>Half face Oral tranexamic acid combined with triple combination cream with RF microneedle | Device: RF Microneedle<br>* Pulsed-type RF device in bipolar mode with 25 non-insulated microneedles every 2 weeks for 6 month<br>Drug: Combination cream<br>* 5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months<br>|
| Active Comparator: Conventional therapy<br>Half face Oral tranexamic acid combined with triple combination cream | Drug: Combination cream<br>* 5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of modified melasma area severity index score | Change of modified melasma area severity index score | Every 1 month up to 8 months | 
| Change of lightness value | Change of lightness value by a chromometer | Every 1 month up to 8 months |
Longitudinal Advanced Prostate Cancer Cohort (LAPCC)

Study Overview
=================
Brief Summary
-----------------
This study examines information from patients with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). By collecting biological samples (like blood, urine, and tissue), and health information (such as treatment, diet, and quality of life) researchers hope to learn more about prostate cancer and ways to improve outcomes in the future.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To create an annotated biorepository with prospectively collected blood and urine samples from men with advanced prostate cancer. OUTLINE: This is an observational study. Patients undergo blood and urine sample collection, complete surveys, and have their medical records reviewed on study.

Official Title
-----------------
Longitudinal Advanced Prostate Cancer Cohort (LAPCC)

Conditions
-----------------
Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: Non-Interventional Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: * Men of all racial and ethnic groups 18 years of age or older Men with a diagnosis of advanced (metastatic) prostate cancer who are scheduled to begin a new systemic treatment (including first or subsequent lines of therapy) Prior participation on clinical trials is allowed Exclusion Criteria: * Inability to give informed consent

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

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients undergo blood and urine sample collection, complete surveys, and have their medical records reviewed on study. | Other: Non-Interventional Study<br>* Non-interventional study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of biological specimens and clinical data for future research related to prostate cancer. | The objective of this study is to create a biorepository of biospecimen and clinical data. There is no primary clinical outcome for this study. | Up to 5 years |
A Study to Explore the Role and Impact of Wearable Smart Devices in Perioperative NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
The trial was designed as a single-center non-interventional prospective observational study to explore the role and impact of wearable smart devices in perioperative NSCLC patients.

Official Title
-----------------
A Prospective Observational Study to the Role and Impact of Wearable Smart Devices in Perioperative NSCLC Patients

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Device: Wearable smart devices and PROs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must provide voluntary consent to participate in this research and possess the capacity to sign an informed consent form. Participants must be aged over 18 years. Participants must have undergone pulmonary resection surgery with a postoperative pathological confirmation of primary lung cancer. Exclusion Criteria: Patient refusal to participate in this research. Inability to wear wearable smart monitoring devices due to various reasons. Pathological reports suggesting non-small cell lung cancer (NSCLC). History of secondary lung cancer surgery.

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 |
| --- | --- |
| NSCLC patients wearing wearable smart devices<br>NSCLC patients wearing wearable smart devices while utilizing PROs for regular follow-up | Device: Wearable smart devices and PROs<br>* Patients wearing wearable smart devices to monitor physiological data while regularly utilizing PROs to report subjective assessments of their own health status.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of hospital stay | Postoperative Length of Stay (LOS) refers to the duration of a patient's hospitalization following surgery, typically measured from the completion of the surgical procedure to the time of patient discharge. | From time of surgery to time of discharge from the hospital (assessed up to 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Operative time is defined as the time from the start of the surgical procedure to its completion, including anesthesia induction, surgical incision, manipulation of tissues, closure, and completion of all surgical tasks. | From time of the start of surgery to the end of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, Wearable Devices
Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.

Study Overview
=================
Brief Summary
-----------------
An optimum recovery profile after AT includes a rapid, smooth awakening without emergence agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia. The ketamine/midazolam combination was administered in different ways with controversial results about their effect on the EA and recovery profile. Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative EA and PONV. This study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.

Official Title
-----------------
Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.

Conditions
-----------------
Emergence Delirium

Intervention / Treatment
-----------------
* Drug: ketamine/midazolam
* Drug: Ketofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I or II Children scheduled for AT under general anesthesia (GA). Exclusion Criteria: Congenital cardiovascular anomalies Behavioral changes Delayed physical development Children receiving sedatives or anticonvulsants therapy

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group-A; ketamine/midazolam premedication<br> | Drug: ketamine/midazolam<br>* premedication<br>|
| Active Comparator: Group-B: Ketofol pre-extubation<br> | Drug: Ketofol<br>* Pre-extubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of Emergence agitation |  | starting from time of PACU admission after recover from anesthesia till 6 hours postoperative |
Study to Evaluate the Safety and Effectiveness of GP0116

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).

Official Title
-----------------
A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as Nasolabial Folds.

Conditions
-----------------
Skin Manifestations

Intervention / Treatment
-----------------
* Device: GP0116
* Device: Active Comparator: FDA approved dermal filler device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and non-pregnant, non-breastfeeding women aged 22 years or older. WSRS grade of 3 or 4 (moderate to severe folds) on each NLF as assessed by the Blinded Evaluator. The WSRS for each NLF does not need to be equal. Intent to undergo treatment for correction of both left and right NLF. Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel Known/previous allergy or hypersensitivity to local anesthetics Previous or present severe or multiple allergies manifested by severe reactions Previous facial surgery near the treatment area

Ages Eligible for Study
-----------------
Minimum Age: 22 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: GP0116<br> | Device: GP0116<br>* GP0116 is an injectable, sterile, transparent product.<br>|
| Active Comparator: FDA Approved Device<br> | Device: Active Comparator: FDA approved dermal filler device<br>* FDA approved dermal filler device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate non-inferiority of GP0116 versus a comparator control | To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS). | At 3 months after Baseline |
A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.

Official Title
-----------------
Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia

Conditions
-----------------
Myelodysplastic Syndrome, Beta Thalassemia

Intervention / Treatment
-----------------
* Drug: Luspatercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants 19 years of age or older Participants who will be treated with luspatercept according to the approved label in the Republic of Korea Participants who sign the informed consent form Exclusion Criteria: Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea Participants for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with myelodysplastic syndrome or beta thalassemia who will begin luspatercept treatment<br> | Drug: Luspatercept<br>* According to the approved label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 6 months |
ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
To compare the number of patients with AF recurrence detected in a 24-h Holter monitoring with a 5-day record.

Official Title
-----------------
ECG Monitoring Short vs Middle Term After Atrial Fibrillation Ablation

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

Intervention / Treatment
-----------------
* Device: device e-patch Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have undergone an AF ablation procedure at the Hospital Clínic and have a 12-month follow-up planned. Having been previously assessed by the AF nurse. Having signed the informed consent. Exclusion Criteria: Extreme skin fragility at chest level Allergy to latex or adhesive tape No electrophysiology follow-up at the Clínic hospital. Patients who are already included in other studies that may interfere with the expected results of this one. Patients with cognitive impairment or disorientation.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: device e-patch Implantation|The ePatch device (Phillips) was used. This device is attached to the sternum, using a specific dressing adapted for the device itself. Manufacturer's recommendations for skin preparation and placement will be followed. The device will remain in place for 4-5 days, at which time the patient will be readmitted for data extraction and reading. The team of research nurses will analyze the data through the ePatch platform and later, the electrophysiologists will review the results and make a diagnosis.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrence | Number of patients with AF recurrence detected in a cardio loop monitoring. | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects | skin injuries, losses, allergies, etc. | up to 5 days | 
| Burden of AF | Burden of AF in the two groups (Day/Hours/minuts) | up to 5 days | 
| Number of patients with recurrent AF / atrial flutter / atrial tachycardia | Number of patients with recurrent AF / atrial flutter / atrial tachycardia in two groups | up to 5 days | 
| Total time of noise | Total time of noise in each group | up to 5 days | 
| Total time analized | Total time analized in each group | up to 5 days | 
| premature losses | loss of connection of the device before 5 days | up to 5 days | 
| time to analyze | time it takes to analyze and interpret the logs obtained, in minutes. | min:hours |