linjc16/ctgov huggingface dataset:
Healthcare Utilization in Liver Cirrhosis Patients, a Multicenter Retrospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
Multicenter, retrospective cohort study investigating healthcare utilization in compensated and decompensated liver cirrhosis patients, including disease course and characteristics associated with healthcare utilization and, for example psychosocial factors.

Official Title
-----------------
Healthcare Utilization in Liver Cirrhosis Patients, a Multicenter Retrospective Cohort Study

Conditions
-----------------
Liver Cirrhosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years of age Liver cirrhosis, based on biopsy, fibroscan or diagnostic imaging data Exclusion Criteria: Known malignancy with hepatic metastasis at baseline Liver transplantation at baseline

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 |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of liver cirrhosis related outpatient contacts before liver cirrhosis complications |  | 2 years before complication, death or loss to follow-up | 
| Number of liver cirrhosis related radiographic imaging before liver cirrhosis complications |  | 2 years before complication, death or loss to follow-up | 
| Number of liver cirrhosis related esophagogastroscopies before liver cirrhosis complications |  | 2 years before complication, death or loss to follow-up | 
| Number of liver cirrhosis related elastographies before liver cirrhosis complications |  | 2 years before complication, death or loss to follow-up |
Molecular Characterization of Induced Neuronal Cells in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
To describe the molecular, electrophysiological and morphological expression profile of dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease.

Official Title
-----------------
Molecular Characterization of Induced Neuronal Cells Derived From Fibroblasts of Patients With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Procedure: Skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects aged 18 years or older Patients with Parkinson's disease, according to the most recent diagnostic criteria Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Exclusion Criteria: Patients affected by drug-induced parkinsonism or atypical parkinsonian disorders Patients with neurological diseases other than Parkinson's disease Inability to sign an informed consent Severe psychiatric diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin biopsy<br> | Procedure: Skin biopsy<br>* Punch biopsy of the skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurophysiological characterization of dopaminergic neurons derived from patients with Parkinson's disease. | To evaluate the firing frequency in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease. | Baseline | 
| Biochemical characterization of dopaminergic neurons derived from patients with Parkinson's disease. | To determine the amount of dopamine released from differentiated neurons derived from fibroblasts of patients with Parkinson's disease. | Baseline | 
| α-synuclein misfolding in dopaminergic neurons derived from patients with Parkinson's disease. | To document the presence of abnormal accumulation of misfolded alpha-synuclein in the dopaminergic neurons derived from fibroblasts of patients with Parkinson's disease. | Baseline |
The Kallikrein-Kinin System in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
We aimed to established an interlink among the kallikrein-kinin system (KKS), endothelial dysfunction and cardiac inflammation in response to cardiosurgery , using clinic investigation.

Detailed Description
-----------------
The KKS, which is located on the vascular endothelium, plays a pivotal role in maintaining cardiovascular homeostasis. Tissue kallikrein (TK), a serine protease and a key enzyme of the KKS, is responsible for cleaving low-molecular-weight kininogen into bradykinin and kallidin. Under normal physiological conditions, the activation of the B2 receptor (B2R)/endothelial nitric oxide synthase (eNOS) signaling pathway leads to the transient release of nitric oxide (NO), resulting in cardiovascular protection. However, during reperfusion injury, the activation of the B1 receptor (B1R)/inducible nitric oxide synthase (iNOS) pathway leads to excessive NO production, promoting inflammation and cellular injury. Therefore, it is hypothesized that the KKS plays a critical role in the early stages of reperfusion injury during cardiac surgery with cardiopulmonary bypass.

Official Title
-----------------
The Involvement of the Kallikrein-Kinin System in the Pathogenesis of Postoperative Injury in Cardiac Surgery: An Observational Study

Conditions
-----------------
Cardiosurgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Willing to participate in the study. 2) Age ≥ 18 years and ≤ 80 years. 3) Patients undergoing cardiac surgery: (coronary artery bypass grafting, heart valve surgery, Morrow operation, aortic dissection surgery). Exclusion Criteria: 1) Patients with heart failure. 2) Patients experiencing adverse events during surgery. 3) Solid organ or bone marrow transplant recipients. 4) Patients with autoimmune diseases, tumors, or those who received high-dose steroid or immunosuppressant therapy within the past two months. 5) Deemed unsuitable for participation in this study by the researchers' judgment. -

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 |
| --- | --- | --- |
| survival | survival and KKS related factors levels | 24 hours | 
| Cardiac function | echocardiography and Myo-cardial enzymonram | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | survival and clinical symptom | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
KKS; tissue kallikrein; MMPs;cardiosurgery;cardiopulmonary bypass
Epidemiology and Risk Factors of Uterine Fibroids in China

Study Overview
=================
Brief Summary
-----------------
Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. The prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. What investigators don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. The purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in Chinese women.

Official Title
-----------------
Epidemiology and Risk Factors of Uterine Fibroids in China

Conditions
-----------------
Uterine Fibroid

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current place of residence≥ 6 months; No serious mental illness or mental abnormality; Those who agree to participate in this survey and cooperate in completing the questionnaire. Exclusion Criteria: -

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of uterine fibroids in China | Prevalence of uterine fibroids in China | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of uterine fibroids in China | Incidence of uterine fibroids in China | Two follow-ups over a three-year period | 
| Risk factors of development of uterine fibroids in China | Associated risk factors for recurrence, infertility and malignancy of uterine fibroids in China | Two follow-ups over a three-year period |
Risk Stratifying COPD Exacerbations

Study Overview
=================
Brief Summary
-----------------
To identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of COPD.

Detailed Description
-----------------
Exacerbations of COPD (ECOPD) are heterogenous but are often considered as a single clinical entity. Clinical characteristics on presentation may predict outcome of patients with ECOPD. DECAF score was previously proposed to predict in-hospital mortality but has not been validated in Asian subjects. ROME classification was recently proposed to better risk stratify ECOPD according to symptoms, physiological parameters and laboratory findings on admission, but no prospective validation study is available so far. This study aims to identify clinical characteristics on presentation to predict outcome of patients with ECOPD.

Official Title
-----------------
Risk Stratifying COPD Exacerbations: a Prospective Study

Conditions
-----------------
COPD Exacerbation

Intervention / Treatment
-----------------
* Other: Observation only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Background history of COPD, defined by the GOLD 2023 guidelines Presented with exacerbation of COPD, defined by the GOLD 2023 guidelines Age >= 18 years old Informed consent available 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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD<br>Subjects with COPD exacerbation | Other: Observation only<br>* Observation only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Number of patients died during hospitalization of ECOPD | 3-month | 
| 3-month mortality | Number of patients died 3 months after ECOPD | 3-month | 
| Recurrent ECOPD | Number of patients with recurrent ECOPD post-discharge | 3-month | 
| Viral etiology | Frequency of various viral etiology identified during ECOPD | 3-month | 
| Bacterial etiology | Frequency of various bacterial etiology identified during ECOPD | 3-month |
Distinct Alterations in Gut Microbiota Composition Among Women of Reproductive Age With Elevated Homocysteine Levels.

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to test the alterations of gut microbiota composition among women of reproductive age with elevated homocysteine levels. The main question it aims to answer is: • the relationship between gut microbiota composition and recurrent abortion. Participants will provide their stool samples to be detected the composition of gut microbiota. . Researchers will compare women of reproductive age with normal homocysteine levels to see if any bacteria were involved in recurrent miscarriages.

Official Title
-----------------
1. Study Design 2. Sample Collection 3. Microbial DNA Extraction in Faecal Samples 4. PCR Amplification： 5. Sequencing： 6. HCY Test Principle: 7. Statistical Analysis

Conditions
-----------------
Recurrent Miscarriage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No recent antibiotic treatment Exclusion Criteria: Recently received antibiotics

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women of reproductive age with elevated homocysteine levels<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| homocysteine levels | Binding or dimer homocysteine (oxidized form) is reduced to free homocysteine, and then it is catalysed by cysteine β-synthetase (CBS) to react with serine to form cysteine sulfuric acid. Cysteine is then broken down by cysteine β-lyase (CBL) to form homocysteine, pyruvate, and ammonia. Pyruvate is then converted to lactate using lactate dehydrogenase (LDH), where nicotinamide adenine dinucleotide (NADH) is used as a coenzyme. The ratio of NADH to NAD* is directly proportional to the concentration of homocysteine (△ A340 nm). | The first day of the trail |
Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Quadrangular resection combined with annular plication and annuloplasty, as originally described by Carpentier, has been the standard approach for many years, before sliding/folding plasty and artificial chordae gained larger popularity.However, very few studies have been published on thevery long-term results (up to 20 years) of quadrangular resection and annular plication, often reporting only freedom from reoperation rather than from recurrent MR. This study aims to evaluate the very long-term (20 years) clinical and echocardiographic results of this approach, which was used for many years at the beginning of our mitral repair program.

Official Title
-----------------
Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation

Conditions
-----------------
Mitral Valve Disease

Intervention / Treatment
-----------------
* Procedure: Quadrangular resection and annular plication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Affected by mitral valve posterior leaflet prolapse/flail causing severe mitral regurgitation Treated with quadrangular resection of the posterior leaflet and annulus plication Exclusion Criteria: Other patients

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: Quadrangular resection and annular plication|Mitral regurgitation is treated removing the redundant tissue of the posterior leaflet, which is then reconstructed by sutures and plicating the posterior annulus|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Up to 20 years |
A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of Inaxaplin (IXP) in participants with severe renal impairment and healthy participants with normal renal function.

Detailed Description
-----------------
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Official Title
-----------------
A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Safety of a Single Dose of Inaxaplin in Subjects With Severe Renal Impairment and Healthy Subjects With Normal Renal Function

Conditions
-----------------
Renal Impairment

Intervention / Treatment
-----------------
* Drug: IXP


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Body mass index (BMI) of 18.5 to 40.0 kilogram per meter square (kg/m^2) Stable renal function for at least 1 month prior to enrollment Key Exclusion Criteria: Uncontrolled hypertension Any condition possibly affecting drug absorption Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Severe Renal Impairment<br>Participants will receive a single dose of IXP on Day 1. | Drug: IXP<br>* Tablets for oral administration.<br>* Other names: Inaxaplin;|
| Experimental: Cohort 1: Healthy Participants<br>Participants will receive a single dose of IXP on Day 1. | Drug: IXP<br>* Tablets for oral administration.<br>* Other names: Inaxaplin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of IXP |  | Day 1 up to Day 7 | 
| Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP |  | Day 1 up to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 through completion of study participation (up to a maximum of 17 days) |
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Study Overview
=================
Brief Summary
-----------------
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.

Official Title
-----------------
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Conditions
-----------------
Nerve Injury

Intervention / Treatment
-----------------
* Device: Temporary Peripheral Nerve Stimulation System
* Device: Sham Temporary Peripheral Nerve Stimulation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Peripheral nerve injury Exclusion criteria: Peripheral neuropathy Patients with any active implanted device

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 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: Active treatment<br> | Device: Temporary Peripheral Nerve Stimulation System<br>* Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.<br>|
| Sham Comparator: Sham treatment<br> | Device: Sham Temporary Peripheral Nerve Stimulation System<br>* Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory recovery |  | 6 months | 
| Cumulative incidence of adverse events |  | 6 months |
Evaluation of the Effectiveness of a Flu Vaccination Campaign for Healthcare Workers of a Teaching Hospital: a Pre-post Study

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to evaluate the effectiveness of the vaccination strategy implemented during the 2019/2020 flu vaccination campaign compared with the previous one. The main question it aims to answer is whether there are differences in the total coverage of influenza vaccination, in different categories of professionals and in different operating units.

Official Title
-----------------
Evaluation of the Effectiveness of a Flu Vaccination Campaign for Healthcare Workers of the Fondazione Policlinico Universitario A. Gemelli IRCCS and the Catholic University of the Sacred Heart (UCSC): a Pre-post Study

Conditions
-----------------
Influenza Vaccination

Intervention / Treatment
-----------------
* Other: Influenza Vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health personnel employed by the Fondazione Policlinico Universitario A. Gemelli IRRCS Exclusion Criteria: -

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

| Intervention/Treatment |
| --- |
|Other: Influenza Vaccination|Describe and measure any differences in total influenza vaccination coverage, in different categories of professionals and in different operational units.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influenza vaccination coverage | Describe and measure differences in total influenza vaccination coverage between the vaccination seasons considered, in different categories of professionals and in different operational units. | 16 months |