linjc16/ctgov huggingface dataset:
Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas

Study Overview
=================
Brief Summary
-----------------
Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.

Official Title
-----------------
Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas (SAR-GEN_ITA): a Multicenter Prospective Study

Conditions
-----------------
Diagnosed or Relapsed/Refractory Sarcomas

Intervention / Treatment
-----------------
* Other: observation and biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma at first diagnosis. Patients with confirmed relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma Written informed consent signed by the patient, or parents or legal representative to perform molecular analysis of the tumor sample. Patients aged ≤24 years Pathological review of tumor samples. Availability of fresh tumor sample from newly diagnosed or relapsed/refractory cancer and 10 ml of EDTA peripheral blood sample. Centralization of paraffin-embedded tumor sample might be optional. Exclusion Criteria: 1. Known history of active HIV, HCV, or HBV infection 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient undergoing surgery biopsy or the quality of the data.

Ages Eligible for Study
-----------------
Maximum Age: 24 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observation and biopsy|biopsy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the genomic profiles of osteosarcoma, Ewing sarcoma and Synovial Sarcoma tumor samples in pediatric, adolescents and young adult patients at the time of diagnosis or relapse/progression |  | 2018-2021 |
Studying Cognition in SPG4

Study Overview
=================
Brief Summary
-----------------
Comparing the cognitive levels of patients with SPG4 mutations to healthy controls.

Detailed Description
-----------------
Comparing the cognitive levels of patients with SPG4 mutations to healthy controls by using the CANTAB® and MoCA.

Official Title
-----------------
Studying Cognition in SPG4 Compared to Healthy Controls

Conditions
-----------------
Hereditary Spastic Paraplegia, Cognitive Impairment

Intervention / Treatment
-----------------
* Diagnostic Test: CANTAB
* Diagnostic Test: MOCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with SPG4 with known SPAST-Mutation (patient group) or healthy control Age 18 to 70 years Written, informed consent Exclusion Criteria: Lack of ability for a written, informed consent Presence of gait disorder or other neurological condition (for healthy controls)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| SPG4 patients<br> | Diagnostic Test: CANTAB<br>* CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)<br>Diagnostic Test: MOCA<br>* Montreal cognitive assessment (MOCA) in German<br>|
| Healthy controls<br> | Diagnostic Test: CANTAB<br>* CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)<br>Diagnostic Test: MOCA<br>* Montreal cognitive assessment (MOCA) in German<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying cognitive affected domains by using CANTAB | Number of SPG4 patients with affections in the examined cognitive domains by using CANTAB | day 1 |
Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

Study Overview
=================
Brief Summary
-----------------
This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components

Official Title
-----------------
Assessment of Unstable Carotid Plaque Using PET and MR Imaging in Patient Referred to Endarterectomy: The CAROTEP Study

Conditions
-----------------
Carotid Artery Stenosis

Intervention / Treatment
-----------------
* Drug: Sodium fluoride F-18 PET imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old Health care system affiliation Referred to carotid endarterectomy Symptomatic patients: Carotid stenosis between 70 and 99% (NASCET criteria) TIA or minor stroke attack (RANKIN ≤ 3) Asymptomatic patients: Carotid stenosis between 70 and 99% (NASCET criteria) No symptoms Patient who has been informed of the study and has given his/her informed consent Exclusion Criteria: Contra indication to MRI Renal failure (clearance < 30ml/mn) Patient with active inflammatory disease History of cancer Pregnancy or lactation Patient with carotid disease treated by fibrinolysis Patient under guardianship, or unable to understand the purpose of the study

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: symptomatic<br> | Drug: Sodium fluoride F-18 PET imaging<br>* prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging<br>|
| Active Comparator: asymptomatic<br> | Drug: Sodium fluoride F-18 PET imaging<br>* prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid F18-NaF uptake | do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparaison of F18-NaF PET and Carotid MRI | comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination | baseline | 
| F18-NaF PET uptake | comparaison between F18-NaF uptake at pre-operative imaging | baseline | 
| histology | comparaison between histology at post-operative histologic analysis | baseline |
Gene Expression Profiling of Malignant Tumor Predict the Therapeutic Response of DC-CIK Immunotherapy

Study Overview
=================
Brief Summary
-----------------
To investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after DC-CIK immunotherapy.

Detailed Description
-----------------
The patients with malignant tumor are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) . Venous blood (4 ml) is collected from each subject and placed into tubes containing Ethylene Diamine Tetraacetic Acid(EDTA) before and after each treatment. Lymphocytes are sorted by Fluorescence Activated Cell Sorting(FACS) and stored at -80°C until processing. The T-Cell Receptor/B-Cell Receptor gene expression is detected by micro-array。 Estimate Immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. Response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines. Degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy. Compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the DC-CIK immunotherapy response.

Conditions
-----------------
Malignant Tumor

Intervention / Treatment
-----------------
* Biological: DC-CIK Immunotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed with malignant tumor; Age: 18-80 years; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; At least one measurable lesion according to the RECIST criteria; Adequate bone marrow, cardiac, liver, and renal function; Life expectancy ≥2 months; Not received other anti-tumor treatment Informed consent signed Exclusion Criteria: previous history of other malignancies; Uncontrolled central nervous system metastases; Serious or uncontrolled concurrent medical illness.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: gene expression profile<br> | Biological: DC-CIK Immunotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-Cell Receptor/B-Cell Receptor gene expression |  | 3 month |
Framing of Numerical Information in Cochrane Summaries

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.

Detailed Description
-----------------
The aim of the study was to conduct three different parallel randomized controlled trials to assess how the different framing of Cochrane summary information (positive vs negative framing of health information) affects affect the perception of the efficacy and intention for use of the described treatment.

Official Title
-----------------
Framing of Numerical Information in Cochrane Summaries: a Randomized Controlled Trial

Conditions
-----------------
Health Literacy

Intervention / Treatment
-----------------
* Other: Frame of numerical information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First year medical students Exclusion Criteria: Those who have failed first year and have to repeat it.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive frame<br>The numerical expressions were presented in a positive way: e.g. treatment was successful for 4 out of 10 persons. | Other: Frame of numerical information<br>* Each group received only one frame of information.<br>|
| Experimental: Negative frame<br>The numerical expressions were presented in a negative way: e.g. treatment was unsuccessful for 6 out of 10 persons. | Other: Frame of numerical information<br>* Each group received only one frame of information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of effectiveness | One item on Likert type scale from 1-10, higher score indicates the higher perceived effectiveness. | Immediately after reading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desire to use the described treatment | One item on Likert type scale from 1-10, higher score indicates the greater desire to use the described treatment. | Immediately after reading | 
| Desire that treatment is prescribed by family doctor | One item on Likert type scale from 1-10. Higher score indicates the greater desire that treatment is prescribed by family doctor. | Immediately after reading |
IgG-4 Levels in Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
This is an observational - non interventional study. The investigators will compare IgG4 levels of 80 healthy donors (from Israel blood bank - MDA) and 80 Systemic Sclerosis patients from Meir Medical Center.

Detailed Description
-----------------
IgG4 levels will be obtained from medical records of 80 SSc patients between the years 2000-2019. These will be compared to IgG4 levels from sera of 80 healthy donors (from Israel blood-bank - MDA). Correlations between IgG4 levels and the following will be made: age, sex, disease type (limited or diffused SSc), disease duration, medications.

Official Title
-----------------
Comparing IgG-4 Levels in Systemic Sclerosis Patients vs. Healthy Controls

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SSc patients Exclusion Criteria: other chronic co-morbidities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| SSc<br>74 SSc patients aged 18 - 85 | Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)<br>* IgG4 measurement in mg/dL<br>|
| Healthy controls<br>80 Healthy blood-donors aged 18 - 85 | Diagnostic Test: IgG4 measurement (non-interventional, just obtaining data from medical records)<br>* IgG4 measurement in mg/dL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG4 measurement | quantifying IgG4 in each group and in SSc subgroups based on disease type, organs involved, medications. | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SSc, IgG4
Phase 3 Study of KHK7580

Study Overview
=================
Brief Summary
-----------------
This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.

Official Title
-----------------
Phase 3 Study of KHK7580 (A Long-term Study of KHK7580 in Subjects With Secondary Hyperparathyroidism Receiving Hemodialysis)

Conditions
-----------------
Secondary Hyperparathyroidism

Intervention / Treatment
-----------------
* Drug: KHK7580


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Personally submitted written voluntary informed consent to participate in the study Stable chronic renal disease treated with hemodialysis 3 times weekly for at least 12 weeks before screening Intact PTH level of > 240 pg/ml at screening (except subjects receiving cinacalcet hydrochloride at screening) Exclusion Criteria: Change in dose or dosing regimen of cinacalcet hydrochloride or activated vitamin D drug or its derivative, phosphate binder, or calcium preparation within 2 weeks before screening; or start of treatment with such drugs within 2 weeks before screening; Parathyroidectomy and/or parathyroid intervention within 24 weeks before screening; Severe heart disease; Severe hepatic dysfunction; Uncontrolled hypertension and/or diabetes; Treatment with an investigational product (drug or medical device) in a clinical study or any study equivalent to clinical study within 12 weeks before screening; Primary hyperparathyroidism; Other conditions unfit for participation in this study at the discretion of the investigator or subinvestigator.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK7580<br> | Drug: KHK7580<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Adverse Event collection and assessment | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL |  | Up to 52 weeks | 
| Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline |  | Up to 52 weeks | 
| Mean percent change in intact PTH level from baseline |  | Up to 52 weeks |
Ototoxicity of Artemether / Lumefantrine (Coartem) and Other Antimalarials

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the potential side-effects of artemether / lumefantrine and other antimalarials on the auditory function.

Detailed Description
-----------------
Artemisinin based combination therapies (ACT) currently are the most promising treatment options for uncomplicated falciparum malaria. There have been controversial reports about possible ototoxicity of artemether / lumefantrine (Coartem®) from retrospective studies. In this investigation treatment of uncomplicated malaria with artemether / lumefantrine, quinine, where side-effects on hearing are known, or atovaquone / proguanil, where no such effects have been reported, are compared. Auditoy function is examined (Auditory Brainstem Response, Pure-tone Audiometry, Otoacustic Emissions) before treatment, after 7, 28, and, for determination of irreversibility, after 90 days.

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: artemether/lumefantrine
* Drug: quinine
* Drug: atovaquone/proguanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged above 5 years Uncomplicated falciparum malaria Axillary Temperature ≥37,5°C or history of fever within the previous 24 hours Ability to tolerate oral therapy Informed consent by the patient or by parent/guardian for children Residence in study area Exclusion Criteria: Known or suspected hearing deficits Adequate anti-malarial treatment within the previous 7 days Mixed infection Danger signs and signs of severe malaria as defined by the WHO Presence of severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) Concomitant disease masking assessment of response History of allergy or intolerance against study medications Pregnancy

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: artemether/lumefantrine|nan|
|Drug: quinine|nan|
|Drug: atovaquone/proguanil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |