linjc16/ctgov huggingface dataset:
Sharable Knowledge Mining Platform

Study Overview
=================
Brief Summary
-----------------
As a result of increasing adoption of health information systems in hospitals, more and more health records can be gathered and accumulated in the healthcare data repository. For this reason, the opportunity of analyzing and mining the healthcare data for quality improvement is increasing and becoming more and more important. The purpose of the project is to gather the clinical data relevant to liver cancer, and adopt the knowledge discovery and mining modules in information technology (IT) for analyzing and discovering the knowledge from the gathered clinical data. We can analyze the gathered clinical data for comparing the outcomes of different treatment strategies, finding out new diagnosis and staging criteria and factors, and other hidden knowledge included in the clinical data. Afterwards, the discovered results and the mining algorithms can be shared though the sharable knowledge mining platform provided by our project.

Official Title
-----------------
Sharable Knowledge Mining Platform for Clinical Data Extraction, and Medical Knowledge and Mining Services Sharing

Conditions
-----------------
Liver Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical data of patients with liver cancer. (ICD9 Code is 155.0) Males and females
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| liver cancer<br>Clinical data of patients with liver cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relationship between the clinical data and the decision of treatment strategies |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver cancer, data mining, knowledge discovering, The clinical data of the patients with liver cancer.
MK0916 in Patients With Type 2 Diabetes and Metabolic Syndrome (0916-005)

Study Overview
=================
Brief Summary
-----------------
This study will test the safety and effectiveness of MK0916 in patients with Type 2 Diabetes Mellitus and Metabolic Syndrome. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Conditions
-----------------
Diabetes Mellitus, Type 2, Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: MK0916


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have Type 2 Diabetes 18 to 65 years of age Exclusion Criteria: History of Type 1 Diabetes Mellitus Have been treated with insulin in the past 8 weeks On a weight loss program and have ongoing weight loss Taking weight loss medication Have had surgery requiring general anesthesia in the past 30 days or have a planned surgery Have taken another investigational drug in the last 8 weeks Have active liver disease Have a history of major surgery involving gastric or intestinal bypass

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Intervention/Treatment |
| --- |
|Drug: MK0916|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
EVA: Evista Alendronate Comparison

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: raloxifene HCI and alendronate Na


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria 50-80 years of age, inclusive 2 years since last menses Dx femoral neck osteoporosis No vertebral fractures Exclusion Criteria Poor candidate for study drugs Hx of diseases affecting bone metabolism Hx of breast/estrogen-dependent cancer Current use of osteoporosis drug therapy Hx/high risk of VTE

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: raloxifene HCI and alendronate Na|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open-label, dose-range finding Phase I study of hP1A8, a new adjuvant CD200 activation receptor ligand (CD200AR-L), in combination with imiquimod and the GBM6-AD vaccine to treat recurrent glioblastoma (GBM) in adults.

Official Title
-----------------
Study of CD200 Activation Receptor Ligand (CD200AR-L) and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent Glioblastoma

Conditions
-----------------
Glioblastoma

Intervention / Treatment
-----------------
* Drug: Treatment with hP1A8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and older. Confirmed diagnosis of GBM. Radiographically or histologically proven progression or recurrence of disease at any time after standard of care therapy (radiation, temozolomide, with or without a tumor treatment field device). Tumor debulking or biopsies may be performed to clinical trial enrollment if indicated and feasible. Exclusion Criteria: Bevacizumab or targeted therapy within 45 days of enrollment. Intercurrent immune system disorder such as hypoimmunity (marrow failure, HIV) or hyperimmunity (autoimmune disease). Unable to complete a standard upfront course of chemoradiotherapy due to disease progression or intolerance of therapy. History of Gliadel water, GammaTile or other implanted therapeutic agent. Concurrent use of tumor treatment field devices (e.g. Optune).

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: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hP1A8<br>Up to 3 dose levels of hP1A8 will be tested with a Dose Level -1 in the event of toxicity. The MTD will be identified using the standard 3+3 design. Upon determination of the MTD, additional patients will be enrolled as part of an expansion cohort. | Drug: Treatment with hP1A8<br>* Treatment with hP1A8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) of hP1A8 when administered with imiquimod and GBM6-AD |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events (SAEs) |  | 12 months | 
| Time to progression (TTP) |  | 24 months | 
| Progression free survival (PFS) |  | 24 months | 
| Overall survival (OS) |  | 24 months |
Registry of Translarna (Ataluren) in Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD)

Study Overview
=================
Brief Summary
-----------------
This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.

Detailed Description
-----------------
This is a multicenter, observational study of participants receiving Translarna based on inclusion of their data in a registry. This study is intended to enroll 360 participants across  50 care centers in Europe and other regions over a period of   2 years. The study population will include participants who are receiving usual care treatment with commercial supply of Translarna (or receiving care within a named participant early access program) and who provide consent. Participants will be followed for at least 5 years from their date of enrollment. Safety and efficacy data will be collected in conjunction with routine visits conducted as per usual care. Although there are no protocol-mandated procedures, it is expected that physicians and other caregivers will follow published treatment guidelines and standards of care.

Official Title
-----------------
Long-Term Observational Study of Translarna Safety and Effectiveness in Usual Care

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving or will be receiving usual care treatment with commercial supply of Translarna (or receiving care within a named participant early access program) Willing to provide written informed consent to allow the study data collection procedures (either by the participant or through authorisation by a legal guardian) Exclusion Criteria: Participants who are receiving ataluren or placebo in a blinded, randomized clinical trial, or ataluren in any other ataluren clinical trial or cohort early access program that prevents participation in this study

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Translarna<br>Participants with nmDMD receiving Translarna will be followed for at least 5 years from their date of enrollment, or until participant withdrawal of consent or death, whichever occurs first. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescriber and Participant Compliance With Prescribing Information According to the Approved Labelling |  | 5 years |
Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This clinical study aims to investigate the anti-HPA antibodies caused neonatal alloimmune thrombocytopenia in Chinese pregnant women. The survey and data collect will help form an appropriate clinical screening procedure

Official Title
-----------------
A Multi-center Prospective Cohort Study on the Anti-HPA Antibodies Caused Neonatal Alloimmune Thrombocytopenia in Chinese Pregnant Women

Conditions
-----------------
Neonatal Alloimmune Thrombocytopenia

Intervention / Treatment
-----------------
* Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-28 weeks pregnant Chinese women between Jan 1, 2017 and Dec 31, 2018 Exclusion Criteria: Not willing to participate in this study Plan to terminate pregnancy early

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Control Group<br>Pregnant women with anti-HPA antibody negative from the same hospital, the same race, and the same gravidity and parity, who are admitted at the same time. | Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion<br>* Observational study.<br>|
| Experimental Group<br>pregnant women with anti-HPA antibody positive | Procedure: Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion<br>* Observational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The positive rate of anti-HPA antibody |  | Up to one and a half years after the study completed | 
| The morbidity of NAIT |  | Up to one and a half years after the study completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antigenic specificity of anti-HPA antibodies |  | Up to one and a half years after the study completed | 
| Association of anti-HPA antibody with HLA genotype as assessed by Chi-square test |  | Up to one and a half years after the study completed | 
| The relationship between the titer of anti-HPA antibody and clinical symptom severity in NAIT as assessed by Spearman Correlation assay |  | Up to one and a half years after the study completed | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal Alloimmune Thrombocytopenia, pregnancy, human platelet allogantigen, asian, Chinese
The Prevalence of Psychological and Medical Comorbidities Among Children Suffering From Autistic Spectrum Disorder and the Differences Between Ethnic Groups in Israel

Study Overview
=================
Brief Summary
-----------------
It is known that several psychological and medical comorbidities are frequently found among children suffering from autistic spectrum disorders. Our aim is to investigate which comorbidities are most common among those children and whether there are differences among the different ethnic groups found in Israel.

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Other: Retrospective case study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with autism Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- |
| Autistic Children<br> | Other: Retrospective case study<br>* Retrospective case study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of autistic children with comorbidities |  | One year |
Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging

Study Overview
=================
Brief Summary
-----------------
Cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region. This study using imaging modality (2D CT images) is done to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Detailed Description
-----------------
Using imaging modalities (CT, MRI), the funnel-shape of the airway in children has been questioned and subglottis rather than cricoid is considered the narrowest part with the shape of airway defined as elliptical with the subglottis as the narrowest region. This is the first study using imaging modality (2D CT images) to determine the airway shape and dimensions in neonates and infants. The purpose of this investigation was to determine any differences in airway shape between infants and children, and to evaluate the dimensional transition between the subglottic area and the cricoid ring.

Official Title
-----------------
Shape and Dimensions of the Upper Airway in Infants Using Computed Tomography Imaging

Conditions
-----------------
Child

Intervention / Treatment
-----------------
* Device: CT Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates and infants. Exclusion Criteria: Patients with tracheostomy, tracheo-esophageal fistulas lung collapse mediastinal masses diaphragmatic hernias chest masses intubated patients patients, preterm infants syndromic patients patients with primary lung diseases

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CT Scan|CT imaging|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shape of airway in neonates and infants |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Subglottis, cricoid, airway shape, CT imaging
Biomarkers for Identification of COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
Acute lung injury represents the most severe form of the viral infection sustained by coronavirus disease 2019 (Covid-19) also named as SARS-CoV-2, a new virus emerged in December 2019 in Wuhan (China). The diagnosis is clinical and patients develop flu-like syndrome with fever and cough; patients with clinical symptoms can perform a swab test, including molecular and/or antigen swab, for diagnosis of positivity to Covid-19. Even if diagnosis and treatment are well described, to date, this viral pandemic infection induces an increased mortality in the world. The aim of the present project is to evaluate specific biomarkers that could be used for patient stratification and for tailor therapy in COVID-19 infected patients.

Official Title
-----------------
Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection

Conditions
-----------------
Coronavirus

Intervention / Treatment
-----------------
* Diagnostic Test: Biomarkers expression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 18 and 75 years, extremes included, male or female In conscious patients, ability to understand and the willingness to sign a written informed consent document; in unconscious patients informed consent will be signed from parents or legal tutors. Exclusion Criteria: Patients that don't sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 75 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 |
| --- | --- |
| Covid-19 positive patients<br>all drugs used for standard treatment | Diagnostic Test: Biomarkers expression<br>* Evaluation in biomarkers expression between 2 groups<br>|
| Covid-19 negative patients<br> | Diagnostic Test: Biomarkers expression<br>* Evaluation in biomarkers expression between 2 groups<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers expression | Change in biomarkers (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) in covid-19 positive patients vs covid-negative patients | up to 30 days | 
| Liver Biomarkers expression | Change in CYP450 expression in covid-19 positive patients that develop adverse drug reactions or drug inefficacy | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarkers expression (microRNAs, oxidative stress, Neuron-Specific Enolase, IL-2, IL-6, TNF-alfa, leukocytes, subtypes lymphocytes) after treatment | Changes in biomarkers in covid-19 patients before and after standard treatment | 60 days |
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging

Study Overview
=================
Brief Summary
-----------------
MRI 3D UTE Hyper-Cones & ZTE for PET/MR lung attenuation correction & for lung diagnostic imaging

Detailed Description
-----------------
The primary objective is to clinically test the feasibility of 3D UTE Hyper-Cones & ZTE in capturing lung density of patients with lung diseases at reasonable clinical imaging times compared to standard MR lung protocols (LAVA-Flex, PROPELLER). Secondly, we want to investigate if Hyper-Cones & ZTE can be used for lung imaging such as vessels and air-pathways, oncological patients, lung nodules and lung infiltration & parenchyma pathophysiology such as chronic obstructive pulmonary disease.

Official Title
-----------------
MRI 3D UTE Hyper-Cones & ZTE for PET/MR Lung Attenuation Correction & for Lung Diagnostic Imaging

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: PET/MR image acquisition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent and signature clinical PET/CT planned and performed at Wagi site in Schlieren male or female patients from 18 to 80 years of age. Exclusion Criteria: - same exclusion criteria as for the clinical PET/CT exam (i.e. pregnant women). Additional exclusion criteria: - standard exclusion criteria for clinical MRI (evaluated by clinical standard determined by MRI questionnaire).

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET/MR (single arm)<br>PET and MR sequence acquisition on SIGNA PET/MR device | Diagnostic Test: PET/MR image acquisition<br>* Acquisition of PET and MR sequences on SIGNA PET/MR device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning. | Confirm that lung density map extraction is feasible through Hyper-Cones & ZTE scanning. | 1 year |