linjc16/ctgov huggingface dataset:
Clinical and Laboratory Characteristics of Polycythemia Vera

Study Overview
=================
Brief Summary
-----------------
The study is observational, longitudinal, retrospective and prospective, on patients with PV. Patients with PV diagnosed from 2000 to 2023 according to WHO2017 criteria will be considered. The main purpose of the study is to determine the impact of clinical and laboratory characteristics of Polycythemia Vera on patients' prognosis, understood as long-term survival

Detailed Description
-----------------
The structured collection of data necessary for the evaluation of the objectives will take place through the creation of a specific electronic archive with an expected duration of 7 years, possibly extendable. The electronic archive may be used to review case histories and to obtain or confirm new scientific evidence on Polycythemia Vera. Patients will be followed and treated within the care pathway provided by normal clinical practice. The following elements will be considered in each patient: age, recent and remote pathological history, characteristics of PV onset, histological, cytogenetic and molecular investigations of diagnostic definition, medical therapies performed, type of response to the therapies performed, complications of these therapies and pathology. All useful data will be collected exclusively through consultation of outpatient medical records. The planned enrollment period is 60 months (January 2019-December 2023). The observation period of enrolled patients is at least 2 years.

Official Title
-----------------
Clinical and Laboratory Characteristics of Polycythemia Vera

Conditions
-----------------
Polycythemia Vera

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with PV according to WHO 2017 criteria, Obtaining informed consent for data collection and processing Exclusion Criteria: None

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term survival | To determine the impact of clinical and laboratory characteristics of Polycythemia Vera (PV) on patients' prognosis, in terms of lon term survival | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | To assess the incidence of thrombotic events on PV patients | 6 years | 
| Haemorrhages | To assess the incidence of haemorrhagic events on PV patients | 6 years | 
| Therapies | To assess the use of high-cost therapies | 6 years | 
| Therapies Toxicity | To assess the toxicity of therapies | 6 years | 
| Therapies Efficacy | To assess the effects of therapies | 6 years | 
| Development of second neoplasms | To assess the incidence of second malignancies | 6 years | 
| Evolution to acute leukemias | To assess the incidence of acute leukaemias | 6 years |
A Study of LY3972406 in Adult Participants With Moderate-to-Severe Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3972406 in Adults With Moderate-to-Severe Plaque Psoriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: LY3972406
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have moderate-to-severe chronic plaque psoriasis for at least 6 months prior to baseline Have venous access sufficient to allow for blood sampling Are able to swallow oral medication Agree to skin biopsies Exclusion Criteria: Have any other skin conditions, excluding plaque psoriasis Have a current or recent acute, active infection Have manifestations of other autoimmune diseases, such as systemic lupus erythematosus. Are lactating or breastfeeding women

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3972406 Dose 1<br>Participants will receive an oral dose of LY3972406 | Drug: LY3972406<br>* Administered orally<br>|
| Experimental: LY3972406 Dose 2<br>Participants will receive an oral dose of LY3972406 | Drug: LY3972406<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Participants will receive placebo. | Drug: Placebo<br>* Administered orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI 75) |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline in Body Surface Area (BSA) |  | Baseline, Week 12 | 
| Mean Change from Baseline in Dermatology Life Quality Index (DLQI) |  | Baseline, Week 12 | 
| Pharmacokinetics (PK): Plasma Concentration of LY3972406 |  | Week 12 |
SOSteniamoci: Stakeholders' Survey

Study Overview
=================
Brief Summary
-----------------
Informal care is defined as the unpaid care provided to an older, frail, or ill person, by a person such as a spouse, a parent, a child, another relative, a neighbor, or a friend. This phenomenon may lead to stress, burden, and decreased informal caregivers' quality of life. Since lack of time, distance from services, and financial strains make the provision of psychological interventions to informal caregivers often challenging, Internet-based (self-help) programs might represent a viable solution to promote their emotional well-being. Still, despite the proven benefits of internet-based intervention, no available programs for informal caregivers are available for the Italian population. Nevertheless, planning and developing an online intervention, involving possible stakeholders (caregivers), might facilitate the understanding and dissemination of, willingness to use, and success of the future intervention. Thus, the goal of the current study is to assess Italian stakeholders' knowledge about, awareness of, attitudes towards, willingness to participate and use, and expected barriers to internet-based interventions.

Detailed Description
-----------------
The present study assessed the knowledge and awareness, attitudes, willingness to participate in, and expected barriers towards using Internet-based interventions to alleviate caregivers' burden in a sample of Italian caregivers and clinicians. To this aim, an online stakeholders' survey was conducted in Italy among clinicians and informal caregivers, using a snowballing sampling technique. Participants were asked to fill in the informed consent and complete the online survey as a clinician, a caregiver, or both. Data were monitored daily. Descriptive statistics and Pearson correlation analysis were used for data analysis.

Official Title
-----------------
Informal Caregivers and Clinicians' Knowledge, Awareness, Attitude and Expect Barriers Towards Internet-based Interventions: A Stakeholders' Survey in Italy

Conditions
-----------------
Informal Caregivers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinicians and informal caregivers aged 18 years or older internet access basic computer literacy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean score in Online survey for clinicians | Online survey for clinicians - 30 items | At baseline, during online survey, performed after signing informed consent | 
| Mean score in Online survey for informal caregivers | Online survey for informal caregivers - 45 items | At baseline, during online survey, performed after signing informed consent |
Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

Study Overview
=================
Brief Summary
-----------------
The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. The study team hopes to answer the following questions: 1) What is the quality of RBCs salvaged during spine surgery? 2) Does intraoperatively transfused RBC salvage impact clinical outcomes?

Official Title
-----------------
Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

Conditions
-----------------
Spinal Deformity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any/all patients undergoing spine surgery who utilizes Cell Saver and has blood to be given back. This will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery. Only patients with the capacity to consent will be included. Exclusion Criteria: Patients indicated for spinal surgery without the use of Cell Saver.
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 |
| --- | --- | --- |
| Lactate Dehydrogenase (LDH) Levels | LDH assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo. | Day 1 (Day of Surgery) | 
| Hemoglobin Levels | Hemoglobin assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo. | Day 1 (Day of Surgery) | 
| Elongation Index (Deformability) | Ektacytometry will be employed to measure elongation index of salvaged RBCs. | Day 1 (Day of Surgery) | 
| Critical Shear Stress (Aggregation) | Ektacytometry will be employed to measure critical shear stress of salvaged RBCs. | Day 1 (Day of Surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized Quantified Blood Loss (mL) |  | Day 1 (Day of Surgery) | 
| Use of Cell Saver | This will be reported in a binary manner: 0 = yes, 1 = no | Day 1 (Day of Surgery) | 
| Volume (mL) collected via Cell Saver |  | Day 1 (Day of Surgery) | 
| Units of autologous blood transfused intraoperatively |  | Day 1 (Day of Surgery) | 
| Units of allogeneic blood transfused intraoperatively |  | Day 1 (Day of Surgery) | 
| Units of allogeneic blood transfused postoperatively |  | Day 1 (Day of Surgery) | 
| Duration of pressor use |  | 1 Day (Day of Surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Red Blood Cells
Application of Lung Near-Infrared Spectroscopy (NIRS) in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Premature infants are more likely to develop hypoxemia after birth often requiring invasive and Non-Invasive Mechanical ventilation and surfactant therapy to improve alveolar gas exchange and oxygen transport. Near-infrared spectroscopy (NIRS) has been used to detect pulmonary regional oxygen saturation (rpSO 2 ) as well as cerebral regional oxygen saturation (rcSO2 ) and evaluate the oxygenation state of the lung and brain. This is a prospective observational study to evaluate utility of rpSO2 and compare it with rcSO2 in preterm infants born between 23-32 weeks of gestation receiving noninvasive ventilation and surfactant treatment. Enrolled patients will be continuously studied with placement of NIRS monitor using cerebral sensor (INVOS™) for 6 hrs and 15 min before and after surfactant administration. Pulmonary regional oxygen saturation (rpSO2) with a sampling interval of 6 s will be followed for 6hrs.

Official Title
-----------------
Application of Lung Near-Infrared Spectroscopy (NIRS) During Invasive and Non-Invasive Ventilation and Pre- and Post-Surfactant Administration in Preterm Infants

Conditions
-----------------
Respiratory Distress Syndrome, Newborn

Intervention / Treatment
-----------------
* Device: Neer Infrared Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born between 23-32 weeks of gestation admitted to the Neonatal Intensive Care Unit with respiratory distress receiving non-invasive ventilation and requiring Surfactant Replacement Therapy. Exclusion Criteria: Neonates with no need for respiratory support/Surfactant. Neonates with congenital malformations.

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 24 Hours

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neer Infrared Spectroscopy|Premature infants will be studied with brain and lung NIRS before and after surfactant administration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rpSO2 before and after surfactant therapy | brain and lung rpSO2 will be compared before and after surfactant administration | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variations on rpSO2 and rcSO2 during changes in ventilation modes | Will evaluate for variations with various ventilation modes | 6 hours | 
| correlation between rpSO2L and SpO2/FiO2 ratio, a/APO2, and O.I | Correlation will be assessed between rpSO2 and other ratios | 6 hours |
Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy

Study Overview
=================
Brief Summary
-----------------
In France, it has been recommended since 2022 that pregnant women be vaccinated against pertussis from 20 to 36 weeks' gestation. This vaccination schedule is inspired by the Anglo-Saxon model and studies showing the effectiveness of this practice. The aim of this vaccine is to protect the newborn by transferring antibodies from the fetus to the placenta, because Pertussis is a particularly serious disease in newborns.

Detailed Description
-----------------
The aim is to describe pregnant women's knowledge concerning pertussis, vaccination against pertussis during pregnancy and the cocooning strategy.

Official Title
-----------------
Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy

Conditions
-----------------
Pertussis

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant between 20 and 41 weeks of amenorrhea Primiparous aged more than 18 Agreed to participate in the study Exclusion Criteria: Multiparous Protected by law (guardianship, guardianship, safeguarding of justice) Not agreed to participate in this study

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women<br>Pregnant women between 20 and 41 weeks of amenorrhoea, primiparous. | Other: Data collection<br>* Data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recommendation of vaccination against pertussis | Knowledge of pregnant women's concerning recommendation of vaccination against pertussis from 20 to 36 weeks' gestation : does the woman know or not the recommandation concerning the vaccination | day0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocooning strategy, pregnancy, vaccination against pertussis, pertussis
The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg

Study Overview
=================
Brief Summary
-----------------
Veress techniques and open laparoscopy are the techniques most used by gynecological surgeons to date. Advantages of the direct introduction unknown because technique still little used. The research hypothesis is that very few major complications are expected showing the safety of direct introduction. A look back at the practice of direct introduction into laparoscopy from 2012 to 2022 at the CMCO (Medical-Surgical and Obstetrical Center of Strasbourg)

Official Title
-----------------
The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg

Conditions
-----------------
Laparoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult woman who had a scheduled or emergency laparoscopy at the CMCO between 01/01/2010 and 12/31/2022. Subject, having not expressed their opposition to the reuse of data of their data for the purposes of scientific research. Exclusion criteria: - Subject having expressed its opposition to the reuse of its data for scientific res

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of intraoperative complications of direct introduction in open laparoscopy |  | Files analysed retrospectively from from January 01, 2010 to December 31, 2022 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopy, coelioscopie, Veress Needle Technique
Multi-modality Echocardiography for Cardiac Assessment in Primary Electrical Disease

Study Overview
=================
Brief Summary
-----------------
From 2020 to 2023, patients with primary electrical disease (idiopathic ventricular fibrillation, long QT syndrome, Andersen-Tawil syndrome type I, Brugada syndrome, early repolarization syndrome, CPVT, and short QT syndrome) were first diagnosed at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and clinical data and echocardiographic indicators were recorded. Follow-up is until December 30, 2025 or endpoint event occurs. Endpoint events were defined as sustained ventricular tachycardia, ventricular fibrillation, sudden cardiac death, ICD discharge events, all-cause death, heart failure and heart transplantation, which were statistically analyzed as a composite endpoint of cardiovascular analysis. The predictors of primary electrical disease and the risk factors for adverse cardiovascular events were analyzed.

Official Title
-----------------
Multi-modality Echocardiography for Cardiac Assessment in Primary Electrical Disease

Conditions
-----------------
Multi-modality Echocardiography, Primary Electrical Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary electrical disease Exclusion Criteria: Congenital heart disease, poor echocardiographic images, moderate or severe valvular disease
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 |
| --- | --- |
| primary electrical disease<br> | Diagnostic Test: Echocardiography<br>* Multi-modality echocardiography<br>|
| control<br> | Diagnostic Test: Echocardiography<br>* Multi-modality echocardiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-modality echocardiography | tissue Doppler imging, speckle-tracking-strain, myocardial work, mechanical dispersion,electro-mechanical window | 2 years |
Contrast-enhanced CT-based Deep Learning Model for Preoperative Prediction of Disease-free Survival (DFS) in Localized Clear Cell Renal Cell Carcinoma (ccRCC)

Study Overview
=================
Brief Summary
-----------------
This study aims to preoperatively predict DFS of patients with localised ccRCC using a deep learning prognostic model based on enhanced contrast CT images, validate it's predictive ability in multicentre data and compare it's predictive ability with traditional models.

Official Title
-----------------
Urology Department of the First Affiliated Hospital of Chongqing Medical University

Conditions
-----------------
Predictive Ability of Contrast-enhanced CT-based Deep Learning Model in Patients With Localised ccRCC, Generalisation of a Deep Learning Prediction Model in Multicentre Data, Comparison of Prediction Performance Between Deep Learning Prediction Model and Traditional Prediction Models

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent partial/radical nephrectomies and histologically diagnosed as ccRCC Exclusion Criteria: (1) with incomplete clinic-pathological data; (2) lack of preoperative contrast-enhanced CT images or the image quality was unsuitable for analysis; (3) who received pre-surgery neoadjuvant or adjuvant therapies; (4) with multiple renal tumors or/and had synchronous metastasis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-recurrence group<br> | |
| Recurrence group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival (DFS) | the interval from the date of surgery to disease recurrence, all-cause mortality or the last visit | recruitment occurred between June 2013 and March 2020 |