linjc16/ctgov huggingface dataset:
Epidemiological Study in Children and Adolescents With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with associated ALT levels , active HBeAg negative disease and decompensated CHB in the pediatric population. Family history and history of HBV transmission is essential to assess the course of the disease and can be used to determine the best mode of treatment This information will be used to assist with the feasibility and design of studies for the Novartis clinical pediatric development program, as the current epidemiology of ediatric CHB is not accurately known in Western countries or the rest of the world making pediatric studies difficult to plan and conduct. This study forms part of the Novartis Pediatric Investigational Plan, a post marketing approval commitment to the EMEA Pediatric Committee.

Official Title
-----------------
A Cross-sectional, Multi-center, Epidemiological Study in Western and Asian Countries in Children and Adolescents With Chronic Hepatitis B

Conditions
-----------------
Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepatitis, Virus Diseases, Digestive System Diseases, Hepatitis B, Chronic, Hepatitis B, DNA Virus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female, 2 to less than 18 years of age. Documented chronic hepatitis B defined by all of the following: Clinical history compatible with chronic hepatitis B,Detectable serum HBsAg at the time of the study and at least one other documentation of HBsAg positive at least 6 months prior to inclusion HBeAg-positive or HBeAg-negative Serum ALT of all levels subject or subject's parent or legal guardian must be willing and able to provide written informed consent for participation in the study. Exclusion criteria: Patients ≥ 18 years of age Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
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 |
| --- | --- |
| pediatric<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obtain epidemiological data in children and adolescents with chronic hepatitis B that will assist the feasibility and design of studies for the Novartis telbivudine clinical pediatric development program |  | 2 yrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis B, HBV, chronic hepatitis B, pediatric
Impact of Rapid Detection of MRSA

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the impact of the Alere&#8482; PBP2a test combined with pharmacist review of antimicrobial therapy, on clinical outcomes and cost in hospitalized patients with sterile site S. aureus infection.

Official Title
-----------------
Clinical and Economic Impact of a Rapid Test for Detection of Methicillin-resistant Staphylococcus Aureus (MRSA) From Sterile Sites (the Alere&#8482; PBP2a)

Conditions
-----------------
Staphylococcus Aureus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Inpatients (adults and children) at Mayo Clinic, Rochester with sterile source S. aureus cultures (both control and intervention periods) Above, with rapid PBP2a testing (intervention period only). Exclusion criteria: Patients with polymicrobial cultures (i.e., growth of S. aureus plus other organisms in the culture). Patients who have not provided MN authorization to use their medical records for research. Patients who have had the FilmArray Blood culture identification diagnostic test performed on an index S. aureus blood culture. Patients who have had a sterile source S. aureus culture within the prior 30 days.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| control<br>Patients with growth of S. aureus from sterile site cultures between Sept 15, 2012 - Dec 31, 2012. No rapid testing was performed, and standard bacterial culture and susceptibility testing was done. | |
| intervention<br>Patients with growth of S. aureus from sterile site cultures between Sept 15, 2013 - Dec 31, 2013. Rapid PBP2a testing was performed along with pharmacist notification of service if modification to therapy needed based on rapid test results. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (hours) to optimal antimicrobial therapy for patients with MSSA and MRSA infections in the pre-intervention and post-intervention periods |  | within first 7 days of culture result | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (in hours) to identification of MRSA. |  | within first 3 days of culture result | 
| Vancomycin days of therapy following S. aureus culture result |  | during the 2 weeks following culture result | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MSSA, MRSA
Evaluation of Endometrial Stromal Cell Apoptosis in Adenomyosis

Study Overview
=================
Brief Summary
-----------------
Our previous results revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It implies that the formation of adenomyosis might be due to abnormal endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. In addition, in vitro coculture of macrophages and endometrial stromal cells (ESC) increase the expression of IL-6 mRNA in ESC, which might further enhance the proliferation of ESC and subsequently result in the formation of ectopic endometrial implants in adenomyosis. Besides, another possible mechanism is the abnormal apoptosis of ESC in adenomyosis. In endometriosis, apoptotic endometrial cells were found to be decreased, which possibly accounts for the formation of endometriosis. However, there have not been reports investigating the apoptosis of ESC in adenomyosis. In this study, we try to investigate apoptotic ESC with flow cytometry in women with and without adenomyosis. Annexin V, bcl-2, and caspase-3 were measured to represent the degree of apoptosis in ESC.

Detailed Description
-----------------
Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group). Annexin V-PE, bcl-2-PE, and caspase-3-PE are stained, and flow cytometry is done to measure the degree of apoptosis in ESC. On the other hand, another half of ESC are cultured for 24h, and also Annexin V-PE, bcl-2-PE, and caspase-3-PE are stained, and flow cytometry is done.

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with adenomyosis at early- to mid-secretory phases Exclusion Criteria: postmenopausal malignancy

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 50 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenomyosis, apoptosis, flowcytometry
Collection of Blood and Urine Specimens From Volunteers Utilizing Health Examination Services

Study Overview
=================
Brief Summary
-----------------
In summary, the researchers want to construct a longitudinal data bank using voluntary health examination participants. Researchers in the National Taiwan University Hospital (NTUH) campus can utilize these data to clarify the effects of several genetic and environmental factors on various common diseases in Taiwan in the future.

Conditions
-----------------
Hypertension, Chronic Diseases, Diabetes, Obesity, Chronic Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons who sign informed consent Exclusion Criteria: Age below 18 years

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic diseases, such as hypertension, diabetes, obesity, chronic renal failure, and so on
Corellation of Mutations, TILs and Age in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Age may pertain to different tumor genotype characteristics which may interfere with treatment efficacy and prognosis. The investigators investigated the distribution and prognostic effect of mutations (mut) and tumor infiltrating lymphocyte (TILs) in young and elderly early breast cancer patients (pts).

Official Title
-----------------
Tumor Mutational Patterns and Infiltrating Lymphocyte Density in Young and Old Patients With Breast Cancer

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

Intervention / Treatment
-----------------
* Genetic: Corellation of Mutations, TILs and Age in Breast Cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with early breast cancer <35 years old or >65 years old Exclusion Criteria: NA

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women <35 with early breast cancer<br> | Genetic: Corellation of Mutations, TILs and Age in Breast Cancer<br> <br> |
| women>65 years old with early breast cancer<br> | Genetic: Corellation of Mutations, TILs and Age in Breast Cancer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the prevalence of gene mutations in women <=35 years old with early breast cancer. |  | Up to 13 years | 
| Assessment of the prevalence of gene mutations in women >65years old with early breast cancer. |  | Up to 13 years | 
| Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women <=35 years old with early breast cancer. |  | Up to 13 years | 
| Evaluation of Tumor Infiltrating Lymphocytes (TILs) density using descriptive statistics in women >65 years old with early breast cancer. |  | Up to 13 years | 
| Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women <=35 years old with early breast cancer |  | Up to 13 years | 
| Evaluation of the prognostic effect of gene mutations and Tumor Infiltrating Lymphocytes with respect to Overall Survival in women >65 years old with early breast cancer. |  | Up to 13 years |
Comparison of Diclofenac vs. Nepafenac Ophthalmic Drops: Patient Comfort

Study Overview
=================
Brief Summary
-----------------
In this study we test Diclofenac and Nepafenac and compared patients experience and comfort following administration of these ophthalmic drops.

Detailed Description
-----------------
In this study we will compare the ocular tolerability between preservative-free Diclofenac and Nepafenac drops. Using a standard comparative scale we will measured discomfort, itching, burning and pain in intervals of 1 sec, 5 sec, 1 min and 5 min post-administration. The results may aid both doctors and patients in decision regarding the post surgical anti-inflammatory treatment.

Conditions
-----------------
Post Surgical Management, Pain Management, Inflamation Management

Intervention / Treatment
-----------------
* Drug: Diclofenac
* Drug: Nepafenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient facing cataract surgery Exclusion Criteria: under 18 cognitive decline

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

Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac+Nepafenac<br>one drop Diclofenac in one eye one drop Nepafenac in other eye | Drug: Diclofenac<br> <br> Drug: Nepafenac<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's comfort | change in patient's comfort between both eyes at 1 min post administration | 1 min post administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient's comfort | change in patient's comfort between both eyes at 10 min post administration | 5 min post administration |
0.05 Versus 0.1 mg Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the efficacy of 0.05 mg and 0.1 mg spinal morphine in reducing postoperative morphine requirement in patients undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty.

Official Title
-----------------
The Comparison of 0.05 vs. 0.1 Milligram Spinal Morphine for Reducing Morphine Requirement After Vaginal Hysterectomy With/Without Anterior and Posterior Vaginoplasty

Conditions
-----------------
Pain, Vaginal Hysterectomy

Intervention / Treatment
-----------------
* Drug: Spinal morphine 0.05 mg
* Drug: Spinal morphine 0.1 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female ASA physical status 1-3 Undergoing vaginal hysterectomy with/without anterior and posterior vaginoplasty Be able to operate patient-controlled analgesia (PCA) Exclusion Criteria: Allergy to the study drugs History of bleeding tendency Infection at the back Refuse to spinal anesthesia History of CAD or CVA

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal morphine 0.05 mg<br>Patient received spinal morphine 0.05 mg | Drug: Spinal morphine 0.05 mg<br>* Patient received spinal morphine 0.05 mg<br>* Other names: opioids;|
| Active Comparator: Spinal morphine 0.1 mg<br>Patient received spinal morphine 0.1 mg | Drug: Spinal morphine 0.1 mg<br>* Patient received spinal morphine 0.1 mg<br>* Other names: Opioids;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total amount of morphine that the patient required during the first 24-h postoperative. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal morphine 0.05 mg, Spinal morphine
Organ Preservation Media Investigation

Study Overview
=================
Brief Summary
-----------------
Kidney transplantation remains limited by four problems: 1) a too high rate of delayed graft function, 2) early loss of kidneys from chronic rejection, 3) donor kidney shortages, and 4) the need for immunomodulating treatments. Improved cold storage methods can significantly impact on the first 3 of these 4 major problems. The device to be tested is a modification of the existing Viaspan organ preservation solution. The modification of this solution combines four compounds: Bovine neutrophil peptide-1 (BNP-1), Substance P (SP), Insulin-like growth factor-1 (IGF-1), and Nerve Growth Factor (NGF). This solution will be added to Viaspan for preservation of donor kidneys. Preclinical data indicates that trophic factor deprivation during cold storage is a significant and previously unrecognized mechanism of injury in cold stored kidneys. The aim of this study is improved graft function, decreasing early graft loss due to rejection, and decreasing the donor organ shortage.

Official Title
-----------------
Organ Preservation Media Investigation

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Device: Modified Viaspan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first renal transplant, PRA's <20% Exclusion Criteria: PRA's greater than 20% Subjects who are receiving a non-primary renal transplant Subjects under the age of 18 Pregnant or nursing women

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Modified Viaspan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Texture Features and PDL1 in CT-PET 18 FDG

Study Overview
=================
Brief Summary
-----------------
Search correlation between texture features in CT-PET 18 FDG and overexpression of PDL1 in non-small cell lung carcinomas during the inital staging. The hypothesis is that overexpression of PDL1is correlated with at least one texture feature among those selected. 84 CT-PET 18 FDG at the initial staging of a non small cell lung carcinoma (adenocarcinoma or squamous cell carcinoma), whose the biopsed site was the primitive site or the drainage lymphadenopathy, without previous treatment, were recruited and analyzed by a software allowing to estimate texture features.

Official Title
-----------------
Correlation Between Texture Features With CT-PET 18 FDG and Overexpression of PDL1 in Non-small-cell Lung Carcinomas During the Initial Staging.

Conditions
-----------------
Non Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: adult patient ; first CT-PET 18 FDG realized for the inital staging ; absence of previous treatment for a thoracic neoplasm ; biopsy realized on the primitive site or local drainage lymphadenopathy ; primitive site viewable with morphological imagery ; availability of evaluation of PDL1's overexpression ; Exclusion criteria - Refusal to participate in this research

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 |
| --- | --- |
| Overexpression of PDL1<br>Overexpression of PDL1 | |
| Absence of overexpression of PDL1<br>Absence of overexpression of PDL1 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between at least one texture feature and overexpression of PDL1 | Correlation between at least one texture feature and overexpression of PDL1 | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Correlation between overexpression of PDL1, texture features, CT-PET 18 FDG, Non Small Cell Lung Carcinoma
Peripheral Blood CD34-positive Cells Enumeration as Predictor of Stem Cell Harvest

Study Overview
=================
Brief Summary
-----------------
Stem cell mobilization procedures after chemotherapy and G-CSf performed at our Institution between 2002 and 2013 were reviewed in order to define prognostic factors for optimal harvest

Official Title
-----------------
Peripheral Blood CD34+ Cells Count as Predictor of Stem Cell Harvest After Chemotherapy and G-CSF. A Single Center Experience

Conditions
-----------------
Blood Stem Cell Harvest Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mobilization with chemotherapy and G-CSF Years 2002-2013 Exclusion Criteria: mobilization with G-CSF alone mobilization with plerixafor

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Study group<br>All patients who underwent stem cell mobilization after chemotherapy and G-CSF at our institution between 2002 and 2013 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Stem cell harvest failure rate | Patients not able to harvest at least 2x10e6 CD34+/Kg in the specified time frame are considered failures | 7 days from hematological recovery |