linjc16/ctgov huggingface dataset:
Efficacy and Safety of TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

Detailed Description
-----------------
The investigators select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.

Official Title
-----------------
Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Exemestane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Karnofsky ≥ 70 Provision of informed consent Pathological confirmation of invasive ductal carcinoma and estrogen receptor is positive Tumor stage(TNM):T2-4bN0-3M0 Premenopausal woman Not previously received treatment with bisphosphonate Laboratory criteria: PLT ≥ 100*109/L WBC ≥ 4000/mm3 HGB ≥ 10g/dl GOT,GPT,ALP ≤ 2*ULN TBIL,DBIL,CCr ≤ 1.5*ULN Exclusion Criteria: Pregnant or lactation woman History of organ transplantation With mental disease With severe infection or active gastrointestinal ulcers With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) With heart disease Experimental drug allergy
Sexes Eligible for Study
-----------------
Female

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: Exemestane<br>Exemestane for neoadjuvant chemotherapy | Drug: Exemestane<br>* Exemestane for neoadjuvant chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic assessment | therapeutic assessment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions and disease-free survival | Adverse reactions and disease-free survival | 2 years |
Postoperative Score Predictive of the Prognosis of Acetabular Fractures

Study Overview
=================
Brief Summary
-----------------
Acetal fractures are joint fractures that occur in the hip. These fractures affect the functional prognosis of the hip in the short, medium and long term. In the acetabulum fractures operated on, there is a radiological score in the literature allowing the prognosis to be predicted depending on the quality of the postoperative reduction. This score is based on the quality of postoperative reduction assessed on pelvic radios. In addition, the thresholds for poor / good results were determined empirically.

Official Title
-----------------
Postoperative Score Predictive of the Prognosis of Acetabular Fractures

Conditions
-----------------
Acetabular Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient whose age is ≥ 18 years Patient operated on for an acetabular fracture at the GHPSJ between January 2004 and December 2014 Patient with a minimum postoperative follow-up of 2 years French-speaking patient Exclusion Criteria: Patient treated conservatively. Patient under guardianship or curatorship Patient deprived of liberty Patient under legal protection Patient objecting to the use of his medical data as part of this study

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 |
| --- | --- | --- |
| Total hip replacement | This ouctome corresponds to the total hip prosthesis. | Year 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications | This ouctome corresponds to the postoperative complication rate. | Year 2 | 
| Delay of total hip replacement | This ouctome corresponds to the delay of total hip replacement. | Year 2 |
Observing the Changes of Fibroblast Growth Factor 23 in Patients of Tumor Induced Osteomalacia

Study Overview
=================
Brief Summary
-----------------
Fibroblast froth factors (FGFs) are humoral factors identified by their ability to stimulate cell proliferation1. They play different roles in the regulation of cell proliferation, differentiation and function. Most FGF family members act as paracrine factors. But FGF19(FGF19) subfamily members, including FGF19, 21, and 23, work as endocrine factors to regulate bile acid, carbohydrate and phosphate metabolism2. Of these, FGF23 plays an important role in phosphate and bone metabolism3. FGF23 gene encodes 251 amino acids, including a 24-amino acid signal peptide4. The secreted FGF23 is a protein consisted of 227 amino acids. It works by binding to a Klotho-FGF receptor 1c (FGF1c) complex5. FGF suppresses the expression of type 2a and 2c sodium-phosphate cotransporters, which mediate phosphate reabsorption in proximal tubules.6 FGF23 decreases 25-hydroxyvitamin D-1α-hydroxylase expression and enhances 25-hydroxyvitamin D-24-hydroxylase expression6. Therefore, FGF23 reduces serum 1,25-dihydroxyvitamin D〔1,25(OH)2D〕, which stimulates intestinal calcium and phosphate absorption. FGF23 decreases serum phosphate through the above mechanisms FGF23 over-expression might result in hypophosphatemic rickets and osteomalacia. Tumor induced osteomalacia (TIO) is a paraneoplastic syndrome usually caused by benign phosphaturic mesenchymal tumors. Symptoms are nonspecific, such as general weakness, fatigue, and bone pain. Sometimes fracture may occurs. The responsible tumors are sometimes small and difficult to detect. Tumors secrete FGF23. FGF23 reduced phosphate reabsorption in the proximal tubules and decrease 1,25(OH)2D levels, which result in hypophosphatemia and then osteomalacia. The investigators would like to observe the changes of FGF23 in patients who receive operation or medical treatment and hope this will benefit future treatment.

Official Title
-----------------
Observing the Changes of Fibroblast Growth Factor 23 in Patients of Tumor Induced Osteomalacia

Conditions
-----------------
Hypophosphatemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with tumor induced osteomalacia. people without osteomalacia such as healthy people, people under dialysis, people with poor nutrition. Exclusion Criteria: people younger than 20 years old or older than 85 years old. people who are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Tumor induced osteomalcia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FGF23, P |  | at the time TIO is diagnosed |
Healthy Data: Improving Health Information Quality Using Intelligent Systems

Study Overview
=================
Brief Summary
-----------------
Electronic Health Record Systems (EHR) play an integral role in healthcare practice, enabling health organisations to collect, access and manage data more consistently. There is also a great deal of interest in using EHR data to improve decision-making and accelerate medical interventions. However, like all information systems, they are prone to data quality problems such as incomplete records, values outside normal ranges and implausible relationships. These problems are expected to become more prevalent as more organisations adopt electronic health record systems, aggregate, share and explore health data. The investigators believe current efforts to improve health data quality can be made more effective if backed by appropriate technology in the form of a readily accessible intelligent tool. Building on this, the investigators developed an Artificial Intelligence (AI) tool for automating data quality assessment of health data. In this study, the investigators evaluate the AI tool using a real-world dataset.

Detailed Description
-----------------
The main aim of this study is to assess the reliability and utility of an AI tool in identifying data quality dimensions of interest for secondary use of health data, including completeness, conformance and plausibility. In assessing this tool, this study will retrospectively analyse data captured during routine clinical care and identify records containing listed data quality dimensions. This study will also assess the consistency of the AI tool in generating and executing data quality checks.

Official Title
-----------------
Collection of Electronic Health Records (EHR) for Validation of Artificial Intelligence Based Tool for Data Quality Assessment

Conditions
-----------------
Data Quality

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No specific exclusion criteria Exclusion Criteria: No specific exclusion criteria
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 |
| --- | --- | --- |
| Data quality dimensions prevalence | The number of patient records identified by the AI tool with completeness, conformance and plausibility violations | 12 months, between 01/01/2020 and 31/12/2020 | 
| Consistency of AI tool | Consistency of AI tool in generating measures for detecting data quality dimensions | 2 months, through study completion | 
| Validity of AI tool detection | Validity of data quality dimensions identified by the AI tool | 2 months, through study completion |
Marginal Zone Lymphoma Cohort in Korea

Study Overview
=================
Brief Summary
-----------------
Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study

Detailed Description
-----------------
Marginal zone lymphoma (MZL) is a distinct subgroup of non-Hodgkin's lymphoma (NHL), which is typically characterized by an indolent clinical course and long survival duration. MZL is responsible for approximately 7 8% of all NHL. In Korea, MZL accounts for 21% of all B-cell lymphoma and is the second most frequent histologic subtype following diffuse large B-cell lymphoma. Annually, an estimated 500 patients are newly diagnosed with MZL. According to the previous large-scale analyses, MZL is usually a quiet indolent malignancy, which generally presents with limited stage of disease. Localized disease may be controlled with local treatment, and a high response rate can be achieved. Advanced MZL is associated with less favorable survival, and appears to be incurable with the currently available therapy. Transformation to large cell aggressive lymphoma may occur in the first recurrence or in subsequent relapses. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study especially related with Rituximab use (ex, Hepatitis B virus (HBV) reactivation)

Official Title
-----------------
Hepatitis B Virus Reactivation in Patients With Marginal Zone B-cell Lymphoma After Rituximab Containing Treatment: Consortium for Improving Survival of Lymphoma (CISL) Marginal Zone Lymphoma Cohort Study (MARCO)

Conditions
-----------------
Lymphoma, B-Cell, Marginal Zone

Intervention / Treatment
-----------------
* Other: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pathological confirmed marginal zone lymphoma No history of chemotherapy enable to routine staging w/u and sampling including HBV serology informed consent Exclusion Criteria: mixed with other type lymphoma refuse informed consent co-existing cancer needed treatment prior organ transplantation accompany with immunodeficiency

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Rituximab|Cohort observation study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment | Rate of HBV reactivation | up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV, marginal zone lymphoma, Cohort, Rituximab
Safety Study of HSV2 DNA Vaccine to Treat Patients With Recurrent Genital Herpes Caused by HSV-2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing. The study will also test the ability of vaccine to cause particular immune responses in the body and evaluate the effect it has on herpes outbreaks

Detailed Description
-----------------
Herpes simplex virus type 2 (HSV-2) infection is a serious public health problem, with up to 20% of the US population infected. Following primary infection, HSV-2 establishes a latent infection that can lead to recurrent disease when the virus reactivates. Genital lesions are often experienced with viral recurrence and these can be uncomfortable and painful, resulting in significant anxiety and social distress. There are no commercial vaccines available for therapy of HSV-2 infection.The aim of a therapeutic vaccine would be to enhance such natural responses by boosting the appropriate cellular immune response to HSV-2 in those latently infected individuals who experience frequent and unwanted reactivations. The purpose of this study is to evaluate the safety and tolerability profile of the pPJV7630 HSV-2 DNA vaccine as administered by Particle Mediated Epidermal Delivery (PMED )

Official Title
-----------------
A Phase I, Two-Center, Open-Label, Dose-Escalating Study to Investigate the Safety, Tolerability and Immunogenicity of pPJV7630, a Therapeutic DNA Vaccine for Herpes Simplex Virus Type 2 (HSV-2), in Patients With Recurrent Genital Herpes Caused by HSV-2

Conditions
-----------------
HSV-2

Intervention / Treatment
-----------------
* Biological: pPJV7630 administered by PMED


Participation Criteria
=================
Eligibility Criteria
-----------------
Otherwise healthy subjects with recurrent genital herpes due to HSV-2 infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: pPJV7630 administered by PMED|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events at all visits |  |  | 
| vaccine site evaluations |  |  | 
| laboratory parameters pre and post vaccination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HSV recurrences post vaccination |  |  | 
| immunogenicity of vaccine post vaccination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA vaccine, immunotherapy, Herpes Simplex Virus Type 2 (HSV2), Particle Mediated Epidermal Delivery
CPET in Myocardial Ischemia

Study Overview
=================
Brief Summary
-----------------
The investigators goal is to determine whether cardiopulmonary exercise testing (CPET) can be utilized in the diagnosis of myocardial ischemia. For the study participants the investigators will recruit patients who have been referred to myocardial perfusion PET/CT scan in Kuopio University Hospital. The participants will perform the CPET on a cycle ergometer on separate day after the perfusion scan. The investigators will compare the results of the PET/CT scan and CPET and evaluate if the possible perfusion defects detected in PET/CT correlate with the gas exchange parameters in CPET. The patients who receive invasive coronary treatment (coronary bypass surgery or percutaneous coronary intervention) will be invited to perform additional CPET ja PET/CT tests six months after the treatment. The goal will be to determine whether the recovery of myocardial perfusion can be assessed with gas exchange parameters in CPET.

Official Title
-----------------
Accuracy of Cardiopulmonary Exercise Testing in the Diagnosis of Myocardial Ischemia

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Procedure: Invasive coronary treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral to coronary perfusion PET/CT scan in Kuopio University Hospital Exclusion Criteria: Age under 18 years Pregnancy or breastfeeding Handicap Imprisonment Care under forensic psychiatry

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
Interventional Model Description: Patients who receive invasive coronary treatment will undergo additional coronary perfusion PET/CT and CPET tests six months after the treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Coronary perfusion PET/CT patients<br> | Procedure: Invasive coronary treatment<br>* Coronary artery bypass surgery or percutaneous coronary intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of myocardial ischemia assessed by the myocardial perfusion positron emission tomography | Regional myocardial perfusion below 2.3 ml/g/min measured by the quantitative positron emission tomography is a marker of myocardial ischemia | 6 months | 
| Presence of myocardial ischemia assessed by the cardiopulmanary exercise test | Criteria for myocardial ischemia that must be fulfilled are 1) Double sloping in the oxygen consumption/work rate trajectory, peak oxygen consumption below limit of the lowest normal, and abnormal oxygen pulse trajectory during the cardiopulmonary exercise test. | 6 months |
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To compare the effects of low-dose versus high-dose subcutaneous ( SC ) aldesleukin ( interleukin-2; IL-2 ) on immunologic and virologic markers in HIV-infected patients. To compare the effects of monthly versus bimonthly administration of SC IL-2 on these markers. Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit.

Detailed Description
-----------------
Interleukin-2 is a protein that is naturally produced by lymphocytes. In an initial study, patients in an earlier stage of HIV-1 infection tended to tolerate SC IL-2 better than those with more advanced infections, and those with higher baseline CD4+ counts tended to derive the greatest benefit. Patients are randomized to one of four treatment arms; patients receive either low-dose or high-dose SC IL-2 for 5 days either on a monthly or bimonthly schedule for approximately 6 months.

Official Title
-----------------
Subcutaneously Administered Aldesleukin ( Interleukin-2; IL-2 ) Therapy in HIV-Infected Patients

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Aldesleukin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV positivity. CD4 count >= 500 cells/mm3. No history of AIDS-defining opportunistic infection, or malignancy other than mucocutaneous Kaposi's sarcoma. Concurrent Medication: Required: Concurrent FDA-approved antiretroviral therapy (AZT, ddI, ddC, d4T). Prior Medication: Required: FDA-approved antiretroviral therapy for at least 6 weeks prior to study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Significant cardiac, pulmonary, thyroid, renal, or CNS disease. Prior Medication: Excluded: Prior IL-2. Systemic corticosteroids, chemotherapy, or experimental therapy within 4 weeks prior to study entry.

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


Arms and Interventions

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interleukin-2, AIDS-Related Complex