linjc16/ctgov huggingface dataset:
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Study Overview
=================
Brief Summary
-----------------
This study evaluates whether plaques in young patients with familial hypercholesterolemia (aged below 50 years) are susceptible to significant plaque regression with early, intensive lipid lowering therapy.

Official Title
-----------------
Plaque Reversal With Early, Aggressive Lipid Lowering Therapy

Conditions
-----------------
Coronary Artery Disease Progression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with heterozygous familial hypercholesterolemia Adult between 18 and 50 years old LDL cholesterol levels above 100 mg/dl (>2.6 mmol/L) at inclusion Exclusion Criteria: Renal insufficiency, defined as eGFR < 30 ml/min History of atherosclerotic cardiovascular events Atrial fibrillation Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| CAD Progression | Difference in total plaque volume between the initial and follow-up CCTA scan | 40 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-calcified plaque progression | Difference in non-calcified plaque volume between the baseline and follow-up CCTA scan | 40 Weeks | 
| Calcified plaque progression | Difference in calcified plaque volume between the baseline and follow-up CCTA scan | 40 Weeks | 
| Number of high-risk plaques | Difference in number of high-risk plaques between the baseline and follow-up CCTA scan | 40 Weeks | 
| Difference in Pericoronary Adipose Tissue Attenuation | Difference in Pericoronary Adipose Tissue Attenuation between the baseline and follow-up CCTA scan | 40 Weeks |
Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. The invastigators propose here to perform a retrospective study in a clinically well-characterized candidemic patient, with the goal of recognizing host immunological factors and virulence-associated fungal molecules relevant in the onset and evolution of infection. The researchers' ultimate goal is to identify new diagnostic and/or prognostic benchmarks useful in clinical settings. By combining serologic and immunologic expertise with clinical expertise, the research team has real potential to generate new markers of host pathogenesis and immune response in candidemia and to inform prospective clinical trials to control this terrible disease

Official Title
-----------------
Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients

Conditions
-----------------
Candida Infection

Intervention / Treatment
-----------------
* Diagnostic Test: collection of blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients hospitalized one or more positive blood cultures for Candida spp, positive beta-glucanemia the presence of at least one clinical symptom of infection will be considered cases of candidemia. Exclusion Criteria: age less than 18 years state of immunosuppression incompleteness of clinical data unavailability of serum samples in sufficient quantities for analysis and in good condition.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: collection of blood samples|For each patient, a serum sample collected at the time when candidemia is suspected (time of execution of blood cultures) will be examined. For patients with candidemia, all serum samples taken during infection follow-up will also be examined.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| levels of antibodies | i) presence and levels of antibodies directed towards beta-glucans and Candida virulence proteins. ii) presence and levels of circulating Candida virulence proteins. iii) presence and levels of soluble mediators of innate immunity and inflammation No genetic analysis will be performed. | 1 year |
Comparison Between Glandular Urethral Disassembly Versus Tubularized Incised Plate for Primary Distal Hypospadius Repair

Study Overview
=================
Brief Summary
-----------------
To compare Glandular Urethral Disassembly technique versus Tubularized Incised Plate technique for Primary Distal Hypospadius Repair

Detailed Description
-----------------
Aim of study to compare glandular Urethral Disassembly technique versus Tubularized Incised Plate technique for Primary Distal Hypospadius Repair

Official Title
-----------------
Comparison Between Glandular Urethral Disassembly Technique Versus Tubularized Incised Plate Technique for Primary Distal Hypospadius Repair

Conditions
-----------------
Glandular Urethral Disassembly, Tubularized Incised Plate, Distal Hypospadius Repair

Intervention / Treatment
-----------------
* Procedure: Glandular Urethral Disassembly technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary Distal Hypospadius Exclusion Criteria: secondary Distal Hypospadius Recurrent Hypospadius

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Years

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

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: Prospective randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First arm<br>Glandular Urethral Disassembly technique | Procedure: Glandular Urethral Disassembly technique<br>* For Primary Distal Hypospadius Repair<br>* Other names: Tubularized Incised Plate technique;|
| Active Comparator: Second arm<br>Tubularized Incised Plate technique | Procedure: Glandular Urethral Disassembly technique<br>* For Primary Distal Hypospadius Repair<br>* Other names: Tubularized Incised Plate technique;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital stay | Hospital stay will be recorded in days. | up to14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glandular Urethral Disassembly, Tubularized Incised Plate, Distal Hypospadius
Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?

Study Overview
=================
Brief Summary
-----------------
It is well documented in the literature that myocardial revascularization during valve surgery increases the risk of early mortality and morbidity. According to the most recent version of the European Guidelines, the possibility of myocardial revascularization via coronary artery bypass should be evaluated in patients with an indication for surgical treatment of heart valve disease but with coronary artery stenosis ≥ 50-70%. In this study, patients hospitalized for surgical heart valve disease, with occasional pre-operative finding of ≥ 50-70% coronary artery stenosis, without angina, are examined. After interdisciplinary discussion in the Heart Team, it was decided not to treat coronary artery disease during valve surgery. The aim is to evaluate the short and medium-term results of this conscious omission.

Official Title
-----------------
Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?

Conditions
-----------------
Coronary Artery Disease, Heart Valve Diseases

Intervention / Treatment
-----------------
* Procedure: Valvular interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients Presence of valve disease of surgical interest. Occasional pre-operative finding of coronary stenosis >= 50-70%. Exclusion Criteria: angina

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: Valvular interventions|Any kind of intervention on heart valves|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | through study completion, a minimum of 18 months | 
| Percutaneous revascularization risk |  | through study completion, a minimum of 18 months |
Segmentectomy vs Lobectomy

Study Overview
=================
Brief Summary
-----------------
Actual indications for stage Ia NSCLC patients suggest lobectomy and lymphadenectomy. On the other hand, recent studies reported non-inferiority of segmentectomy in case of nodule < 2cm or with ground glass appearance at computed tomography. However, most of these studies did not report specifical analysis on kind of segmentectomy (single or multiple) and kind of lobectomy. Moreover, a specific study on solid nodules only is still missing. For these reasons, the effectiveness of segmentectomy instead lobectomy for every kind of segment or tumor is still to be defined. Aim of this study is to analyze survival outcome in patients underwent single or multiple segmentectomy compared to lobectomy in stage I non small cell lung cancer.

Official Title
-----------------
Different Segmentectomy vs Lobectomy Comparison in NSCLC

Conditions
-----------------
Non-small Cell Lung Cancer Stage I, Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adenocarcinoma or squamous cell carcinoma cStage cIA with or without nodal upstaging lymphoadenectomy age > 18 years old Radical resection anatomical resection (lobectomy or segmentectomy) PET CT done Exclusion Criteria: Nodal or distant metastasis confirmed before surgery Pure solid GGO Follow up < 12 months Bilobectomy/pneumonectomy Trans fissure tumor Multiple lung tumors

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 |
| --- | --- |
| Single Segmentectomy group<br>patients underwent single segment resection, | |
| Lobectomy group<br>Patients underwent lobectomy | |
| Multiple segmentectomy group<br>patients underwent multiple segments resection, | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival | Time between surgery and recurrence appearance | 1 YEAR | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
segmentectomy, lobectomy
Patient Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine the preference weightings in term of risk/ benefit attributes of treatment in prostate cancer patients from different stages of disease..

Official Title
-----------------
A Study to Evaluate Patient Benefit/ Risk Preferences for Treatment of Metastatic Prostate Cancer (mPC) in Hong Kong: a Discrete Choice Experiment

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18 years or older, diagnosis of metastatic prostate cancer within 5 years, able to read and write, accepting and signing the informed consent Exclusion Criteria: if patients are unable to complete the survey by themselves due to physical or psychological reasons, deemed ineligible by treating physicians if patients are unable to complete the survey by themselves due to physical or psychological reasons, deemed ineligible by treating physicians

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

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

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 |
| --- | --- | --- |
| Patient preferences for treatment attributes in prostate cancer from different stages of disease | Derived from discrete choice experiment | 15 minutes (Once through survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of socio-economic status on preference weighing | Derived from discrete choice experiment | 15 minutes (Once through survey) | 
| To examine the status of comorbidities on preference weighing | Derived from discrete choice experiment | 15 minutes (Once through survey) | 
| To examine their willingness of trading off survival with improving QOL | Derived from discrete choice experiment | 15 minutes (Once through survey |
Cognitive Reserve on Pain Catastrophizing and Cognitive Function in Geriatric Patients With Chronic Pain

Study Overview
=================
Brief Summary
-----------------
To investigate the association between cognitive reserve, pain catastrophizing, and cognitive function in geriatric patients with chronic pain, and to explore whether cognitive reserve moderates the relationship between pain catastrophizing and cognitive function.

Official Title
-----------------
The Association Between Cognitive Reserve, Pain Catastrophizing, and Cognitive Function in Geriatric Patients With Chronic Pain: A Cross-sectional Study

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: No intervention (cross-sectional study)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 65 to 85 years Experiencing chronic pain (≥3 months) attributable to osteoarthritis or neuropathic conditions Able to read, write, and speak the language in which assessments are administered Willing and able to provide informed consent Exclusion Criteria: Diagnosed with a neurodegenerative disorder (e.g., Alzheimer's disease, Parkinson's disease) History of significant head injury, stroke, or brain tumor Current substance abuse or dependence Severe psychiatric illness (e.g., schizophrenia, bipolar disorder) Significant sensory or motor impairments that may interfere with the ability to complete assessments

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Chronic Pain Patients with Varying Cognitive Reserve<br>Community-dwelling adults aged 65-85 years with chronic pain (≥3 months) attributable to osteoarthritis or neuropathic conditions. | Other: No intervention (cross-sectional study)<br>* This is a cross-sectional study examining the association between cognitive reserve, pain catastrophizing, and cognitive function in geriatric patients with chronic pain; no intervention is being implemented or tested.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between pain catastrophizing and cognitive function | he relationship between pain catastrophizing, as measured by the Pain Catastrophizing Scale (PCS), and cognitive function, as measured by the Montreal Cognitive Assessment (MoCA version 7.1). | Baseline assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderating effect of cognitive reserve on the association between pain catastrophizing and cognitive function | Investigate whether cognitive reserve, as measured by the Cognitive Reserve Index Questionnaire (CRIq), moderates the relationship between pain catastrophizing (PCS) and cognitive function (MoCA version 7.1). | Baseline assessment |
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy

Study Overview
=================
Brief Summary
-----------------
This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

Official Title
-----------------
An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy

Conditions
-----------------
Neuromyelitis Optica Spectrum Disorder, Pregnancy Related

Intervention / Treatment
-----------------
* Drug: UPLIZNA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide informed consent Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UPLIZNA|Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of newborns with Major Congenital Malformations (MCMs) |  | Minimum of 10 years | 
| Number of newborns with Preterm birth |  | Minimum of 10 years | 
| Number of newborns with low birth weight |  | Minimum of 10 years | 
| Number of stillbirths |  | Minimum of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of newborns with Minor Congenital Malformations |  | Minimum of 10 years | 
| Number of infants with developmental milestone abnormalities |  | Minimum of 10 years | 
| Number of infants with neurologic abnormalities |  | Minimum of 10 years | 
| Number of infants with immune system development abnormalities |  | Minimum of 10 years | 
| Number of Spontaneous Abortions |  | Minimum of 10 years | 
| Number of Induced or Elective Abortions |  | Minimum of 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
birth complications, Neuromyelitis Optica Spectrum Disorder, Pregnancy, UPLIZNA, inebilizumab
Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)

Study Overview
=================
Brief Summary
-----------------
To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.

Official Title
-----------------
A Prospective, Non-interventional, Multi-country Cohort Study of the Effectiveness and Safety of Filgotinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Filgotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Filgotinib-naïve participants with moderately or severely active UC as judged by the physician and starting filgotinib treatment according to local treatment guidelines, routine practices and product information. Exclusion Criteria: Participation in any interventional or non-interventional study without prior approval from the medical leader. This does not preclude inclusion of participants enrolled to national registries. Participant is diagnosed with Crohn's disease.

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 |
| --- | --- |
| Arm A: Filgotinib<br>Participants diagnosed with moderately or severely active UC taking filgotinib according to local treatment guidelines or routine clinical practice and product information. | Drug: Filgotinib<br>* Jyseleca<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Persistence Rate at week 52. | The persistence rate is defined as the percentage of participants who have continued filgotinib treatment since initiation. | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Persistence Rate at weeks 10 and 24 |  | Weeks 10, 24 | 
| Clinical Response Rate |  | Weeks 10, 24, 52 | 
| Clinical Remission Rate |  | Weeks 10, 24, 52 | 
| Change from Baseline in Health-Related Quality of Life (HRQoL) as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) |  | Baseline, Weeks 10, 24, 52 | 
| Change from Baseline in HRQoL as measured by the Urgency Numeric Rating Scale (NRS) |  | Baseline, Weeks 10, 24, 52 | 
| Change from Baseline in HRQoL as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) |  | Baseline, Weeks 10, 24, 52 | 
| Number of Participants with Adverse Events (AEs) |  | Up to 52 Weeks | 
| Number of Participants with Serious Adverse Events (SAEs) |  | Up To 52 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
filgotinib, safety, efficacy