linjc16/ctgov huggingface dataset:
Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

Study Overview
=================
Brief Summary
-----------------
Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.

Official Title
-----------------
Multi-center, Open-label, Single-arm Study to Assess the Safety and Contraceptive Efficacy of a Levonorgestrel-containing Intravaginal Ring During a Treatment Period of One Year in Healthy Women 18 to 35 Years of Age

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Levonorgestrel (BAY98-7196)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy female subject requesting contraception and willing to use the IVR Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months) History of regular cyclic menstrual periods Subject is willing and able to attend the scheduled study visits and comply with study procedures Exclusion Criteria: Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator Undiagnosed abnormal genital bleeding Wish for pregnancy during the study Major surgery scheduled during the study period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levonorgestrel (BAY98-7196)<br>Vaginal ring containing 170 mg levonorgestrel | Drug: Levonorgestrel (BAY98-7196)<br>* Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate (Pearl Index) | Pearl Index = Number of pregnancies per 100 woman-years of exposure | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative failure rate | Probability of getting pregnant | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy prevention
Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test Before Immunosuppressive Therapies?

Study Overview
=================
Brief Summary
-----------------
Hepatitis B virus (HBV) infection is a challenging health problem. According to the World Health Organization, an estimated 240 million individuals (3.7%) suffered from chronic HBV infection worldwide. After acute hepatitis B virus (HBV) infection, the disappearance of hepatitis B surface antigen (HBsAg) had generally been believed to signify viral elimination. However, it now becomes clear that those subjects may have occult HBV infection which is defined as the presence of HBV DNA in the liver in the absence of HBsAg in the serum. Occult HBV infection usually accompanies antibody against hepatitis B core antigen (anti-HBc) and/or antibody against HBsAg (anti-HBs), but some cases might not have these serological markers (seronegative occult HBV infection) .

Detailed Description
-----------------
In a recent systematic review, nearly 40% of HBsAg carriers and 5% of antiHBc-positive but HBsAg-negative patients developed HBVr during TNF inhibitor therapy. Considering the lifelong use of multiple antirheumatic drugs, we need more specific guidelines for the management of rheumatic disease patients who are scheduled to receive biological and/or non-biological DMARDs.

Official Title
-----------------
Is Hepatitis B Surface Antigen (HB s Ag) Enough Alone as a Screening Test for Hepatitis B Virus Infection in Rheumatic Disease Patients Before Starting Immunosuppressive Therapies??

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Other: HBV core antibodies testing. • Real time PCR testing.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Any patients with rheumatic disease with hepatitis B surface antigen negative. Exclusion Criteria: • Overt co-morbid condition. Any malignancy e.g. HCC
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: rheumatic disease with HBs-ag positive<br>• HBV core antibodies testing. • Real time PCR testing. | Other: HBV core antibodies testing. • Real time PCR testing.<br>* HBV core antibodies testing in HBV surface antigen negative patients. Real time PCR testing for those having positive HBc antibodies.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with occult HBV. | Number of patients having occult HBV. | 1 year |
To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.

Official Title
-----------------
Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study

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

Intervention / Treatment
-----------------
* Drug: Tocilizumab
* Drug: DMARDs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301 Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301 Willing to give written informed consent Exclusion Criteria: History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study ALT or AST > ULNⅹ2.5 Platelet count < 100ⅹ103/ μL WBC < 3,000/mm3 Absolute neutrophil count < 1,000/mm3 Absolute lymphocyte count < 500/mm3 Total bilirubin > ULNⅹ2

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tocilizumab 8mg/kg + DMARDs<br> | Drug: Tocilizumab<br>* intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks<br>Drug: DMARDs<br>* DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety results | All AE/ADR during study Physical examination including vital signs and ECG Clinical laboratory results | 48weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy |  | 48weeks | 
| Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy |  | 48weeks | 
| Change of individual parameter in ACR core set |  | 48weeks | 
| Change of individual parameter in DAS28 |  | 48weeks | 
| Change of individual parameter in Rheumatoid factor |  | 48 weeks |
SCCOR Minorities Observational Study

Study Overview
=================
Brief Summary
-----------------
The SCCOR Minorities study will recruit minority participants from the COPDGene cohort, in whom the University of Pittsburgh has already obtained baseline and five year data, in order to enhance bone mineral density and vascular function data collection from minority smokers. Dual X-ray absorptiometry (DXA) scans will be obtained to measure bone mineral density. Non-invasive vascular studies will be performed to measure endothelial function. Questionnaires regarding symptoms and activity levels will be administered and a blood sample will be obtained in participants in which blood samples are not already available from the COPDGene study visits.

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive, Emphysema

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American male and female subjects participating in COPDGene study Exclusion Criteria: caucasians pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Dual Xray Absorptiometry measurement of lumbar spine and hip bone mineral density. |  | As this is a cross-sectional collection of data, the outcome will be measured once at the first and only study visit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of carotid artery intimal thickness with ultrasound |  | As this is a cross-sectional collection of data, the outcome will be measured once at the first and only study visit. |
Pyrotinib Plus Vinorelbine in HER2+ Metastatic Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the patterns and treatment outcomes of pyrotinib plus vinorelbine in the real world.

Official Title
-----------------
Pyrotinib Plus Vinorelbine in Metastatic HER2-positive Breast Cancer Patients- a Multicenter Retrospective Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman, age > 18 years old diagnosed with HER2 +Metastatic Breast Cancer pyrotinib plus vinorelbine for at least one cycle, starting from 2018.05-2020.05 available medical history Exclusion Criteria: medical history was incomplete

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 |
| --- | --- |
| Pyrotinib plus vinorelbine<br>Patients used pyrotinib plus vinorelbine as treatment for metastatic breast cancer. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 
| Adverse events | Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyrotinib
Prenatal Corticosteroids and Antioxidants in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Premature infants are highly susceptible to oxidative stress because of the immaturity of their antioxidant defense system. The use of prenatal glucocorticosteroids administered to the mother improves respiratory function and overall outcome. The investigators hypothesize that prenatal glucocorticosteroids favor the expression and competence of the antioxidant defense system.

Detailed Description
-----------------
This is an observational study recruiting extremely low gestational age neonates (<28 weeks gestation) whose mothers received or not full scheduled prenatal glucocorticosteroids. Healthy term newly born infants acted as controls. At birth cord blood were drawn for the following analytical determinations: reduced and oxidized glutathione; malondialdehyde; superoxide dismutase; catalase; glutathione peroxidase; glutathione reductase; glutathione s-transferase. In addition, first urine voided was collected for ortho-tyrosine/phenylalanine and 8-hydroxy-2-oxo-deoxyguanosine/2-deoxyguanosine determination. Analytical data and clinical outcomes are compared.

Official Title
-----------------
Prenatal Corticosteroids Enhance the Antioxidant Defense System in Extremely Low Gestational Age Neonates

Conditions
-----------------
Oxidative Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age <28 weeks Registered used or not of prenatal glucocorticosteroids by the mother Exclusion Criteria: Use of pro-or-antioxidant drugs by the mother during gestation Major congenital malformations Prenatal inflammation (E.G.:chorioamnionitis) Chromosomopathies Uncertainty about gestational age
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PRENATAL CORTICOSTEROIDS<br>Extremely low gestational age neonates (<28 weeks gestation) whose mothers received full course of betamethasone before delivery. | |
| NON PRENATAL CORTICOSTEROIDS<br>Extremely low gestational age neonates (<28 weeks gestation) whose mothers did not receive full course of betamethasone before delivery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of glutathione redox status in cord blood. |  | at birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of antioxidant activity. |  | at birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antioxidant enzymes, Glutathione, Oxidative stress, Prematurity, Respiratory distress, Non enzymatic antioxidant defense system, Enzymatic antioxidant defense system
Thoracic Computed Tomography Scan for Diagnosis of Aspirated Foreign Bodies.

Study Overview
=================
Brief Summary
-----------------
To access CT Scan as a diagnostic tool for foreign bodies aspiration.

Detailed Description
-----------------
Comparison with gold standard diagnostic tool, the endoscopy

Official Title
-----------------
Management and Assessment of Thoracic CT Scan for Diagnosis of Aspirated Foreign Bodies in Children

Conditions
-----------------
Aspirated Foreign Body of Lower Respiratory Tract

Intervention / Treatment
-----------------
* Procedure: Thoracic CT Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 6 months and 16 years suspicion of a foreign body aspiration health care assurance information of parents Exclusion Criteria: emergency situation certainly of foreign body presence delay for CT Scan realization longer than 24 hours no speaking French parents parents refusal.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 16 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Thoracic CT Scan | Procedure: Thoracic CT Scan<br>* Perform a CT Scan and an endoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between CT Scan and endoscopy results |  | 12 HOURS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| X Ray radiation induced by CT Scan |  | TWO YEARS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT Scan, Endoscopy, Aspiration, Foreign Bodies
Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age

Study Overview
=================
Brief Summary
-----------------
Show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

Detailed Description
-----------------
In the literature, a relationship has been demonstrated between local inflammation in the aortic wall and increased arterial stiffness. Arterial stiffness is commonly represented by pulse wave velocity (PWV) measured using an applanation tonometer. It would seem that this parietal inflammation precedes arterial stiffness and consequently, arterial hypertension . Arterial stiffness is an important factor of cardiovascular morbidity and mortality and therefore represents a major public health interest in prevention in the face of the continuous aging of our population . This study will consist in studying on a population divided into three age groups, less than 40 years old, 40 to 60 years old and more than 60 years old, the relationship between thoracic aortic parietal inflammation evaluated using the Standard Uptake Value parameters (SUV) and Hounsfield units (HU) measured on 18F-FDG PET/CT scans performed between 09/04/2018 and 11/06/2020 and arterial stiffness parameters. We will seek to show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

Official Title
-----------------
Relationship Between Aortic Parietal Inflammation on 18F-FDG PET Scan and Arterial Stiffness as a Function of Age

Conditions
-----------------
Arterial Stiffness

Intervention / Treatment
-----------------
* Diagnostic Test: Measure of aortic inflammation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent whole-body 18F-FDG PET/CT included in the PACTEP study Patient with an assessment of arterial stiffness by applanation tonometer Exclusion Criteria: patients without an assessment of arterial stiffness by applanation tonometer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Measure of aortic inflammation|Standard Uptake Value (SUV) measures of aortic wall|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to etablish a relationship inflammation of aortic wall and arterial stiffness | Standard Uptake Value | 1 day |
Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

Study Overview
=================
Brief Summary
-----------------
By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal holes in the eardrum as an alternative to surgery.

Official Title
-----------------
Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation

Conditions
-----------------
Tympanic Membrane Perforation

Intervention / Treatment
-----------------
* Biological: Platelet Rich Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet criteria for tympanoplasty procedure Willing to comply with the protocol and attend all study visits Able to provide written informed consent Exclusion Criteria: Patients who have previously undergone middle ear or lateral skull base surgery Patients who would not qualify for a tympanoplasty Any type of platelet disorder, cancer, or ongoing systemic infection Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of steroids to the ear drums Type I diabetes or other autoimmune pathology

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRP Treatment<br>Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise. | Biological: Platelet Rich Plasma<br>* Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.<br>* Other names: PRP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of patients requiring surgery | Number of participants that are able to avoid surgery for their perforation. | 6 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to healing | Size of perforation | 6 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet Rich Plasma, TM perforations, Hearing loss, Hole in the eardrum