linjc16/ctgov huggingface dataset:
RWE on Patients With mPDAC Long-term Survival After Treatment With Liposomal Irinotecan

Study Overview
=================
Brief Summary
-----------------
The objective is to describe mPDAC patients still alive one year after the first cycle of nal-IRI

Detailed Description
-----------------
The objectives on patients still alive one year after the first cycle of nal-IRI : Characterize mPDAC patient population according to their demographics Identify PDAC treatment by line of treatment from diagnosis to last treatment Explore prognostic factors of longer Overall Survival (OS) and Progression Free Survivor (PFS) among mPDAC patients showing long-term Survival

Official Title
-----------------
Real-world Evidence on Patients With Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Long-term Survival After Treatment With Liposomal Irinotecan (NALLONG)

Conditions
-----------------
Pancreatic Cancer Metastatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years (≥ 19 years in South Korea) Cytologically confirmed mPDAC at initiation of the nal-IRI treatment All patients receiving a nal-IRI + 5-flurouracil/leucovorin regimen should have been pre-treated with a gemcitabine-based regimen Initiation of a systemic therapy with nal-IRI (index date) during the study eligibility period (between January 1, 2018, and December 31, 2021) At least one cycle of nal-IRI-containing regimen should have been administered A minimum 1-year survival from the index date (initiation date of nal-IRI-containing regimen) Availability of data related to survival outcomes in the patient medical record Patients deceased or not at the time of enrollment will be eligible for inclusion in the study Exclusion Criteria: No documentation of systemic therapy outcomes or prior treatments in patient medical records Patients with second concomitant metastatic malignancy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease characteristic according to age | Tumor stage (localized/locally advanced/metastatic) | Through study completion (approximatively 5 months) |
Pre-symptomatic Screening of Visual Acuity in Pre-school Students

Study Overview
=================
Brief Summary
-----------------
The present research process is a prospective, non-interventional clinical study that will be conducted -under the auspices of the Democritus University of Thrace (DUTH)- in the pre-school students of the city of Alexandroupolis, Greece. The study aims to assess the visual acuity of the kindergarten students. The measurement of monocular best-spectacle corrected visual acuity will be performed using a web-based visual acuity chart

Detailed Description
-----------------
Study protocol will adhere to the tenets of the Declaration of Helsinki and written informed consent will be obtained by the legal guardians of all participants. The measurement of the visual acuity (monocular and binocular) will be performed using DDART, a digital visual acuity tool that has been developed and validated by the Democritus University of Thrace and is also an approved Category 1 Medical Device by the country's National Organization for Medicines, via a web-based digital chart in a high-resolution screen. The same environmental lighting conditions and the same screen brightness will be applied. The examination will be performed at the same predetermined viewing distance. Finally, according to each participant's visual acuity, appropriate instructions will be given for further examinations directly to the legal guardians in order to comply with the GDPR.

Official Title
-----------------
Visual Acuity Assessment in Pre-school Students.

Conditions
-----------------
Visual Acuity, Refractive Errors, Low Vision, Vision Disorders

Intervention / Treatment
-----------------
* Other: Diagnostic Test: Distance Visual Acuity Examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-school students aged 5-7 years old. Exclusion Criteria: Age >7 years old Students with health conditions that do not allow the evaluation of the visual acuity .

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 7 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Pre-school students in Alexandroupolis, Greece | Other: Diagnostic Test: Distance Visual Acuity Examination<br>* Best spectacle-corrected distance visual acuity and reading capacity of pre-school students in Alexandroupolis, Greece will be examined via a web-based digital visual acuity chart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best spectacle-corrected distance visual acuity | Visual acuity of each eye using spectacle correction | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kindergarten, distance visual acuity, pre-school students, reading capacity
Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals

Study Overview
=================
Brief Summary
-----------------
Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide. In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019. Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis. The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.

Official Title
-----------------
Descriptive Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals

Conditions
-----------------
Pulmonary Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child (1 to 17 years old) Child hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022. Child and/or his/her parental authority who have not expressed their opposition to the reuse of data for scientific research purposes. Exclusion Criteria: - Subject and/or their parental authority having expressed their opposition to the re-use of the child's data for scientific research purposes.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 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 |
| --- | --- | --- |
| Incidence and risk factors for pulmonary tuberculosis in children hospitalized at Strasbourg University Hospital between 2012 and 2022 |  | 1 month after hospitalization for pulmonary tuberculosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary tuberculosis, Tuberculosis in children, Childhood tuberculosis, Mycobacterium tuberculosis
Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.

Official Title
-----------------
Pyrotinib Plus Trastuzumab and Chemotherapy in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman, age > 18 years old diagnosed with HER2 +Metastatic Breast Cancer received pyrotinib plus trastuzumab and chemotherapy for at least one cycle, starting from 2018.07-2022.09 available medical history Exclusion Criteria: medical history was incomplete

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PyroHC<br>Patients used pyrotinib (Pyro) plus trastuzumab (H) and chemotherapy (C) as treatment for metastatic breast cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival (PFS) | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyrotinib
Comparative Study of Static and Dynamic Hand Grip Endurance in Pregnancy

Study Overview
=================
Brief Summary
-----------------
Background: Physiology of the mother, changes constantly during pregnancy including reduced HGS that is require for carrying the child after delivery. Activities of daily living require manual gripping tasks that require dynamic and static contractions. Predictor of upper extremity function is Hand Grip Strength and handgrip endurance. Screening of hand grip strength during antenatal care is still uncommon. Objectives: To compare static and dynamic hand grip endurance in pregnant females and to find its correlation with deep breathing. Material and Methods: The study recruited 40 participants of primi-gravida of 1st and 2nd trimester, between ages 20 and 35 years from SHALAMAR GYNAE OPD. The participants assigned to the groups (Group 1: with DB, Group 2: without DB) based on their trimester and gravidity. Static and dynamic endurance assessed using hand held dynamometer. Key words: Pregnancy, deep breathing, trimester, endurance, peak grip endurance

Official Title
-----------------
Comparative Study of Static and Dynamic Hand Grip Endurance With Correlation of Deep Breathing Among Pregnant Women; A Cross-sectional Study

Conditions
-----------------
Hand Grasp, Pregnancy Related

Intervention / Treatment
-----------------
* Device: Dynamometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primigravida Exclusion Criteria: multigravida Cardiac patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Device: Dynamometer<br>* to assses hand grip<br>|
| Group 2<br> | Device: Dynamometer<br>* to assses hand grip<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand grip in pregnancy |  | feb 2022 to aug 2022 |
NSAA NON-Interventional Study Protocol

Study Overview
=================
Brief Summary
-----------------
The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD). The iTakeControl (iTC) software platform will be utilized to remotely administer and score the NSAAs.

Official Title
-----------------
Use of Telemedicine and At-Home Video for Remote Administration of the North Star Ambulatory Assessment (NSAA): A Feasibility Study

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Other: Remote Administration of NSAA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent. Confirmed diagnosis of DMD Participant with DMD aged 4 to12 (inclusive) at t Enrollment date Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application Participant and caregiver are based in the US throughout study Participant and caregiver are fluent in the English language (verbally and in writing) Exclusion Criteria: Non-ambulatory DMD participant at any study timepoint Caregiver/participant unwilling or unable to administer/perform the NSAA Anticipated deterioration of participant's ambulatory status during the study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 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 |
| --- | --- |
| Group A<br>Group A will have Live telemedicine assessments completed prior to caregiver Asynchronous Video | Other: Remote Administration of NSAA<br>* Remote Administration of NSAA<br>|
| Group B<br>Group B will have Caregiver Asynchronous Video first, followed by live telemedicine | Other: Remote Administration of NSAA<br>* Remote Administration of NSAA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores |  | 6 Months |
DETECT-RPC Universal EM Screening

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether the use of the Detection of Elder Mistreatment Through Emergency Care Technicians-Revised for Primary Care (DETECT-RPC) screening tool increases the average reporting of elder mistreatment (EM) by homebased primary care (HBPC) clinicians.

Official Title
-----------------
Detection of Elder Mistreatment Through Emergency Care Technicians - Revised for Primary Care (DETECT-RPC) Universal EM Screening

Conditions
-----------------
Elder Abuse

Intervention / Treatment
-----------------
* Behavioral: Detection of Elder mistreatment Through Emergency Care Technicians-Revised for Primary Care (DETECT-RPC) screening tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (physicians): clinician who actively provides home-based primary care to patients enrolled in one of our partner home-based primary care programs at least part time. Exclusion Criteria: - Inclusion Criteria (patients): in home-based primary care 60 years or older seen by a clinician participating in the study Exclusion Criteria: -

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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with DETECT-RPC screening tool<br> | Behavioral: Detection of Elder mistreatment Through Emergency Care Technicians-Revised for Primary Care (DETECT-RPC) screening tool<br>* DETECT-RPC is an elder mistreatment (EM) screening tool designed for medics who respond to older adults' homes and will be adapted for home-based primary care (HBPC). The DETECT-RPC tool is designed to (1) be brief, (2) be based on the clinician's direct observations of the older adult and the older adult's physical and social environment, (3) provide reporting guidance, and (4) be integrated into their existing procedures and medical charting software.<br>* Other names: DETECT-RPC screening tool;|
| No Intervention: without DETECT-RPC screening tool<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of reports of EM | Data will be collected on the number of reports of EM made by clinicians to the appropriate authorities [for example, adult protective services (APS)] | from randomization to termination of data collection (3 years) | 
| Mortality | Mortality among patients will be assessed among patients enrolled in the partner home-based primary care programs. | from randomization to termination of data collection (3 years) |
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.

Study Overview
=================
Brief Summary
-----------------
Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.

Official Title
-----------------
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.

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

Intervention / Treatment
-----------------
* Procedure: Commissural edge to edge mitral valve repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients; Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin; Patients operated on with median sternotomy or left minithoracotomy; Patients in whom the commissural MR has been treated with commissural closure and annuloplasty; Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007. Exclusion Criteria: Patients underwent a mitral valve replacement

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: Commissural edge to edge mitral valve repair|Edge to edge is the suture of mitral valve leaflets tissue in the regurgitant spot. If the regurgitant jet is near a mitral commissure, it is called a commissural edge to edge.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Through study completion, an average of 14,5 years |
Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests

Study Overview
=================
Brief Summary
-----------------
Multiple myeloma (MM) is the most common bone marrow malignancy of terminally differentiated plasma cells. It accounts for about 1% of all malignant diseases and 10% of haematological malignancies and takes the second place after non-Hodgkin lymphoma . There are some serological and clinical criteria that help to detect the stage of MM and predict the patients' prognosis. These criteria include the level of M protein, calcium, haemoglobin, albumin, creatinine, β2-microglobulin and glomerular filtration rate (GFR).

Official Title
-----------------
Cyclin D1 as a Prognostic Factor in Multiple Myeloma and Its Association With the Immunological Prognostic Factor PDL1 and Clinical and Biochemical Lab Tests

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Bone marow biopsy and aspiration
* Diagnostic Test: biochemical and heamatological tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 year with newly diagnosed MM. Approval to sign an informed written consent. Exclusion Criteria: 1. Patient younger than 18 years. 2.Refusal to sign an informed written consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diagnostic group<br> | Procedure: Bone marow biopsy and aspiration<br>* Bone marrow biopsy and biopsy aspiration<br>Diagnostic Test: biochemical and heamatological tests<br>* complete blood count ,serum urea and creatinine<br>* Other names: complete blood count ,urea and creatinine in serum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycline D1 expression in bone marrow biopsy of multiple myeloma patient | Cycline D1 expression in bone marrow biopsy of multiple myeloma patient | 1 year |