linjc16/ctgov huggingface dataset:
Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection

Study Overview
=================
Brief Summary
-----------------
Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study aims to determine the difference in H. pylori infection rate of EGC patients before and after ER , and discuss the causes leading to the difference, which can provide references for improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.

Detailed Description
-----------------
Gastric cancer is the fourth most commonly diagnosed cancer in the world and the second leading cause of cancer-related deaths. Nowadays, endoscopic resection（ER） is widely accepted as the primary treatment for early gastric cancer (EGC) without lymph node metastasis，which includes endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).However, recurrence rate after endoscopic resection for EGC still achieves 6.7%-14%. However, there is no comparative analysis about H. pylori infection rate before and after ER yet.

Official Title
-----------------
Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection

Conditions
-----------------
Early Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high grade dysplasia(HGD) and EGC patients treated by endoscopic resection(including EMR and ESD) in Ren Ji hospital Exclusion Criteria: Suspect of advanced gastric cancer Lesions with light grade dysplasia History of gastric surgery Poor gastrointestinal preparation Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| difference in H. pylori infection rate before and after ER | Information on the H pylori infection status before ER will be collected from the medical records of each patient. A positive result on at least one rapid urease test, urease breath test or Giemsa staining is deemed to be indicative of H pylori infection .Each specimen after ER will be detected H pylori infection status in two weeks. Then we analyze the difference in H. pylori infection rate before and after ER. | in two weeks after endoscopic resection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic resection, H. pylori infection
Retrospective Observational Study To Update 5-Year Survival Of Subjects Who Participated In Axitinib Trial A4061012

Study Overview
=================
Brief Summary
-----------------
The primary objective of this observational study is to retrospectively collect current survival data for patients originally included in axitinib A4061012 [NCT00076011] study to estimate the 5-year survival rate in subjects with metastatic renal cancer cell treated with axitinib.

Detailed Description
-----------------
Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919]. Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919]. 5-year survival information to be updated.

Official Title
-----------------
Retrospective Observational Study Of Subjects With Cytokine-Refractory Metastatic Renal Cancer Treated With Axitinib (AG-013736) To Estimate 5-Yr Survival

Conditions
-----------------
Carcinoma, Renal Cell

Intervention / Treatment
-----------------
* Drug: axitinib: observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects participating in this observational study originally participated in study A4061012 [NCT00076011] and may have also participated in study A4061008 [NCT00828919] Exclusion Criteria: Subjects who withdrew from the original study A4061012 [NCT00076011] or the continuing access study A4061008 [NCT00828919]

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Interventional Study<br>Subjects participating in this observational study originally participated in study A4061012 [NCT00076011], and may have also have participated in study A4061008 [NCT00828919]. | Drug: axitinib: observational study<br>* Non-interventional observational study<br>* Other names: AG-013736;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall survival is the duration from first dose of study medication to death. For participants who are alive, overall survival is censored at the last contact. | Baseline until death or up to Year 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retrospective trial, 5-year survival, metastatic renal cancer cell
Discovering the Antecedents of Rheumatoid Arthritis Flare

Study Overview
=================
Brief Summary
-----------------
Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.

Detailed Description
-----------------
80% of patients living with rheumatoid arthritis can expect fluctuations in their symptoms over time. Dramatic increases in disease activity are considered flare. This study will follow patients with increased risk for flare prospectively for one year. Serial questionnaires and disease activity scores will be compared to blood samples to better understand the molecular phenotype of rheumatoid arthritis flares.

Official Title
-----------------
Discovering the Antecedents of Rheumatoid Arthritis Flare

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2010 criteria for Rheumatoid Arthritis Swelling of at least one joint and or elevated acute phase reactants Greater than or equal to 40 years old or less than or equal to 65 year old female sex cyclic citrullinated peptide antibody + in the past 12 months Exclusion Criteria: hemoglobin < 9 white blood cell count < 3.5 Diagnosis of any active malignancy within the last 3 years besides non-melanomatous skin cancer Diagnosis of diabetes and requires insulin HIV+, Hep B S Ag+, Hep C polymerase chain reaction + Untreated latent tuberculosis Diagnosis of any additional systemic autoimmune connective tissue disease Inability to reliably complete study requirements History, physical, social or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
| RNA transcripts that correlate with rheumatoid arthritis disease activity | Blood drawn at various times throughout one year will be correlated with fluctuations in RA disease activity. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis
Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Epithelial ovarian cancer is the most lethal gynecological malignancy in developed countries and the fifth most common cause of cancer-related death in women. Poor prognosis is due to challenges in early diagnosis and development of inevitable resistance to chemotherapy in majority of patients despite of good initial treatment response. The purpose of this prospective study is to analyze variation in microRNA expression in prediction of primary treatment response and the role of microRNAs in development of chemoresistance in epithelial ovarian cancer. • Objectives: To screen microRNAs from prospectively collected plasma, urine and tumor samples from patients diagnosed with epithelial ovarian cancer. Samples are analyzed for microRNA expression and differential expression is correlated with primary treatment response, progression-free survival and overall survival. • Methods: Plasma, urine and tumor samples are collected at primary surgery (open surgery or diagnostic laparoscopy) or interval debulking surgery, at 1st, 3rd and 6th neoadjuvant or adjuvant chemotherapy and at progression for high-throughput screening of microRNA expression by array technology.

Detailed Description
-----------------
Inclusion criteria: patients operated for a suspected ovarian malignancy in the Department of Obstetrics and Gynecology in Tampere University Informed consent obtained

Official Title
-----------------
Molecular Mechanisms Leading to Chemoresistance in Epithelial Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age, informed consent. Exclusion Criteria: Informed consent not provided, age under 18 years.

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

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

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 |
| --- | --- | --- |
| miRNA expression profile as measured by miRNA array | Expression profile calculated with bioinformatical analysis | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Time from diagnosis to disease relapse | 5 years | 
| Over-all survival | Timo from diagnosis to death | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chemoresistance, miRNA, microRNA
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of nemolizumab in systemic sclerosis patients. To evaluate also the safety and pharmacokinetics.

Official Title
-----------------
An Open-label, Phase 2 Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Systemic Sclerosis

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

Intervention / Treatment
-----------------
* Drug: nemolizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Systemic Sclerosis according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) 2013 criteria Systemic Sclerosis patients with moderate to sever skin sclerosis Exclusion Criteria: Patients witg a disease considered inappropriate for participation in clinical trials, such as serious cardiac / hepatic / renal / pulmonary / hematologic disease Patients with a diseases that could interfere with assessment of Systemic Scleorosis Patients with body weight less than 30.0kg Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: nemolizumab<br> | Drug: nemolizumab<br>* nemolizumab will be administered subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in modified Rodnan Skin Score (mRSS) at Week 24 |  | Baseline and week 24 |
Immunopathology of Autoimmune Hemolytic Anemia

Study Overview
=================
Brief Summary
-----------------
Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied. The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls. The role of treatments, such as steroids, will also be determined in patients with warm AIHA.

Official Title
-----------------
Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study

Conditions
-----------------
Autoimmune Hemolytic Anemia

Intervention / Treatment
-----------------
* Biological: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA) Secondary AHAI (infections, hematological diseases, systemic diseases) Naive of treatment for hemolytic anemia or in relapse Older than 16 Able to understand written and spoken French who have provided written informed consent INCLUSION CRITERIA for CONTROLS Persons without auto-immune disease, cancer or active infection. Older than 16 Able to understand written and spoken French who have provided written informed consent Exclusion Criteria: Cold agglutinin disease Pregnancy Persons without national health insurance Exclusion Criteria for Controls: Subjects treated with corticosteroids or immunosuppressants Pregnancy Persons without national health insurance

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Patients<br> | Biological: blood samples<br> <br> |
| controls<br> | Biological: blood samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+) |  | Change from baseline to 3 months | 
| physiological parameter : percentage of inhibiting LT proliferation inhibition |  | Change from baseline to 3 months |
A Follow-up Study on Total Endoscopic Thyroidectomy Bilateral Areola Approach

Study Overview
=================
Brief Summary
-----------------
Endoscopic thyroidectomy bilateral areola approach (ETBAA) is one of the most widely applied approach in China, meanwhile its safety and effectiveness has been broadly discussed since being introduced. However, these studies are generally with small sample size and short follow-up duration. The lack of long-term follow-up on oncological outcomes makes it inaccurate to evaluate the effectiveness of ETBAA versus OT. Thus, in this study, we evaluated long-term QoL and outcomes of patients with PTC underwent thyroidectomy via ETBAA versus OT.

Official Title
-----------------
A Follow-up Study on the Long-term Treatment Effect and Quality of Life of Thyroid Cancer After Total Endoscopic Thyroidectomy Bilateral Areola Approach

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Procedure: Endoscopic Thyroidectomy Bilateral Areola Approach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Female patients under 55 years old; 2) no lateral cervical lymph node or distant metastasis were detected before the operation; 3) postoperative pathology confirmed the diagnosis of papillary thyroid carcinoma. Exclusion Criteria: 1) Previous history of thyroid surgery; 2) lateral cervical lymph node dissection in the operation; 3) past or current history of underlying diseases including hyperthyroidism, hypertension, diabetes, coagulation dysfunction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Thyroidectomy Bilateral Areola Approach<br> | Procedure: Endoscopic Thyroidectomy Bilateral Areola Approach<br>* The endoscopic thyroidectomy achieves better cosmetic effects than open thyroidectomy, and is one of the most widely applied approach in China, meanwhile its safety and effectiveness has been broadly discussed since being introduced.<br>|
| No Intervention: Open Thyroidectomy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | measured by THYCA-QoL questionaire | 5 years |
Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.

Official Title
-----------------
Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.

Conditions
-----------------
Humoral and Cellular Immune Responses

Intervention / Treatment
-----------------
* Biological: IXIARO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults (18-40 years old) adults (≥60 years), both sexes willingness to sign written informed consent form Exclusion Criteria: age below 18 years or between 41-59 years old status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection previous immunization against yellow fever, japanese encephalitis (dengue or WNV) current acute infection (body temperature above 37,9°C)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: elderly<br>subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO | Biological: IXIARO<br>* 2 immunizations (0,5ml) with a 28 day interval<br>|
| Experimental: young<br>subjects 18 to 40 years old, receiving 2 immunisations with IXIARO | Biological: IXIARO<br>* 2 immunizations (0,5ml) with a 28 day interval<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination |  | 7 days after the 2 JE vaccinations |
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the diagnostic role of skin test in immediate reactions to iodinated radiocontrast media.

Official Title
-----------------
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media

Conditions
-----------------
Hypersensitivity

Intervention / Treatment
-----------------
* Procedure: Skin tests with radiocontrast media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with history of immediate hypersensitivity reactions to iodinated contrast media 15-70 years of age Exclusion Criteria: On antihistamine/ cannot discontinue antihistamine before the test Having asthma exacerbation Being pregnant Suffering from severe systemic disease/ in bad health

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Healthy controls<br> | Procedure: Skin tests with radiocontrast media<br>* Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media<br>|
| Active Comparator: Patients with immediate reactions<br> | Procedure: Skin tests with radiocontrast media<br>* Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of positive wheal and flare responses from skin test in patients with a history of immediate reactions to radiocontrast media |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood in vitro test from patients with a history of immediate reactions to radiocontrast media |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast media skin test, Skin test, hypersensitivity, contrast media