linjc16/ctgov huggingface dataset:
The Genetics of Pulmonary Fibrosis

Study Overview
=================
Brief Summary
-----------------
This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis.

Detailed Description
-----------------
The purpose of this study is to explore genetic factors associated with the development of pulmonary fibrosis. The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis. To investigate the genetics of pulmonary fibrosis, the investigators plan to enroll individuals with pulmonary fibrosis and their family members.

Official Title
-----------------
Idiopathic Pulmonary Fibrosis, a Disease Initiated by Mucociliary Dysfunction

Conditions
-----------------
Idiopathic Pulmonary Fibrosis (IPF)

Intervention / Treatment
-----------------
* Other: Blood draw
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years old Family member diagnosed with IPF Exclusion Criteria: - No family member with IPF

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| People with IPF<br> | Other: Blood draw<br>* Blood draw<br>Other: Questionnaire<br>* Pulmonary Fibrosis Questionnaire<br>|
| Family members without IPF<br> | Other: Blood draw<br>* Blood draw<br>Other: Questionnaire<br>* Pulmonary Fibrosis Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify and explore genetic loci and related environmental exposures in individuals with familial pulmonary fibrosis and their relatives. | The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis. | Baseline |
Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy

Study Overview
=================
Brief Summary
-----------------
This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy. For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.

Official Title
-----------------
Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: MRI exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosis of pharmaco-resistant focal epilepsy Patient candidate for surgery to resect the epileptogenic zone Patients affiliated to a social security scheme or beneficiaries of such a scheme Patients with French as their mother tongue Patients who have given signed informed consent before performing any procedure related to the study. Exclusion Criteria: Contraindication to performing an MRI: Intellectual disability objectified by a Mini Mental Score (MMS) score <24 in the year preceding inclusion, Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous, Participation in other research protocols underway with exclusion period or in the previous week, Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: epileptic Patients<br> | Other: MRI exam<br>* MRI before and after resection surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy. | The outcome measure is the hemispheric lateralization index (IL) before surgery measured by functional MRI | One hour and thirty minutes |
To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension

Detailed Description
-----------------
Non-interventional study based on newly collected data. The study will consist of a baseline visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated Micatrio® Combination Tablets. The patients will be followed up until discontinuation of Micatrio® Combination Tablets treatment or the end of study. All patients administrated Micatrio® Combination Tablets after the launch at the sites contracted with the sponsor will be registered.

Official Title
-----------------
The Special Drug Use-results Survey on Long-term Use of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed Dose Combination Tablets in Patients With Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: T80/A5/H12.5 FDC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert Patients who have never been treated with Micatrio® Combination Tablets before enrolment Exclusion criteria: Patients who are participating/planned to participate in a clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| T80/A5/H12.5 FDC<br>Patients with hypertension | Drug: T80/A5/H12.5 FDC<br>* Drug<br>* Other names: MICATRIO;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Patients With Any Suspected Adverse Drug Reactions | An Adverse drug reaction (ADR) is defined as an AE for which either the investigator or the sponsor (or both) assess the causal relationship to Micatrio Combination Tablets as related. The frequency of patients with any suspected ADR is presented as total number of participants with an ADR reported. | from first intake of Micatrio combination tablet until last intake +1 day (week 52) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Clinic Diastolic Blood Pressure at Week 52 | Change from baseline in clinic diastolic blood pressure (DBP) millimeters of mercury [mmHg] at Week 52 | At baseline and week 52 | 
| Change From Baseline in Clinic Systolic Blood Pressure at Week 52 | Change from baseline in clinic systolic blood pressure (SBP) millimeters of mercury at Week 52 | At baseline and week 52 |
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the ocular tolerance of T1225 1% and 1.5% eye drops versus vehicle after one instillation twice-daily (morning and evening), in one eye, during 3 days (from Day 0 to Day 2). To assess azithromycin tear, conjunctiva and plasmatic concentrations, after a 3-day treatment period

Detailed Description
-----------------
The aim of the present study was to compare ocular tolerance and safety after repeated instillations of T1225 1% and 1.5% eye drops and vehicle and to assess the residual azithromycin concentrations in tear, ocular conjunctiva and plasma samples, approximately 12 hours after the last Investigational Medicinal Product instillation.

Official Title
-----------------
Study of the Ocular Safety After Repeated Instillations of T1225 1% or 1.5% Eye Drops in Healthy Volunteers

Conditions
-----------------
Eye Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: Azithromycin (T1225)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged from 18 to 45 years old; Written informed consent; Healthy volunteers without any subjective ocular symptom; Normal ocular examination in both eyes (corrected visual acuity >= 6/10, normal slit lamp examination, tear prism height > 0.1mm, tear break-up time (BUT) >= 10 seconds, lissamine green test score < 4); Registered, or agreed to be registered, in the national register of healthy volunteers Exclusion Criteria: Ocular trauma, infection or inflammation within the last 3 months; number of corneal stained punctuations Ocular trauma, infection or inflammation within the last 3 months; number of corneal stained punctuations >= 5; blepharitis, conjunctivitis, uveitis; contact lenses; topical ocular treatment within the last month; ocular laser within the last 3 months; ocular surgery, including LASIK and PRK, within the last 12 months; systemic macrolide within the last month; medication during the study (except: paracetamol and contraceptives).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Azithromycin (T1225)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular pharmacokinetic in tears |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance |  |  |
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.

Official Title
-----------------
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

Conditions
-----------------
Neural Tube Defects - Spina Bifida and Anencephaly

Intervention / Treatment
-----------------
* Drug: folic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months Exclusion Criteria: -women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: folic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of a Sepsis Prediction Algorithm on Clinical Outcomes

Study Overview
=================
Brief Summary
-----------------
In this clinical outcomes analysis, the effect of a machine learning algorithm for severe sepsis prediction on in-hospital mortality, hospital length of stay, and 30-day readmission was evaluated.

Detailed Description
-----------------
Materials and Methods: Clinical outcomes evaluation performed on a multiyear, multicenter clinical data set of real-world data containing 75,147 patient encounters from nine hospitals. Mortality, hospital length of stay, and 30-day readmission analysis performed for 17,758 adult patients who met two or more Systemic Inflammatory Response Syndrome (SIRS) criteria at any point during their stay.

Official Title
-----------------
Effect of a Sepsis Prediction Algorithm on Patient Mortality, Length of Stay, and Readmission

Conditions
-----------------
Severe Sepsis

Intervention / Treatment
-----------------
* Diagnostic Test: InSight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over the age of 18 presenting to the emergency department or admitted to an inpatient unit at the participating facilities were automatically included for clinical outcomes analysis Exclusion Criteria: Patients under the age of 18

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comparator<br>The comparator arm will involve patients monitored by InSight. | Diagnostic Test: InSight<br>* Clinical decision support (CDS) system for severe sepsis detection and prediction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Rate of in-hospital mortality based on SIRS criteria | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Duration of hospital length of stay in days based on SIRS criteria | 1 year | 
| 30-day readmissions | Rate of patient readmissions within 30 days | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dascena, Patient mortality, Length of stay, Readmissions, Algorithm, Diagnostic, Clinical outcomes
Vascular Risk After Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Nontraditional risk factors, such as inflammation, vitamin D deficiency, elevated PTH, insulin resistance, homocysteine, or uric acid, contribute to cardiovascular disease progression after kidney transplant. The purpose of this study is to evaluate which traditional and nontraditional cardiovascular disease risk factors best predict progression of cardiovascular disease (CVD) using carotid intima media thickness performed by ultrasound, in kidney transplant patients.

Detailed Description
-----------------
Cardiovascular disease remains the greatest cause of mortality after kidney transplant. Traditional risk factors, such as hypertension, diabetes, hyperlipidemia and smoking, contribute to vascular disease after transplant, but nontraditional risk factors may play a bigger role in vascular disease progression in this setting. This observational study will evaluate nontraditional risk factors for their contributions to vascular disease progression as determined by carotid intima media thickness and history of vascular disease events over time. The study requires annual checks of blood, urine, history, and carotid ultrasound for carotid intima media thickness

Official Title
-----------------
Vascular Risk After Kidney Transplantation

Conditions
-----------------
Cardiovascular Disease, Chronic Kidney Disease, Diabetes, Vitamin D Deficiency, Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant more than 6 months ago 19 years or older Exclusion Criteria: Estimated GFR <30 Previous small bowel, or lung transplant Pancreas transplant less than 6 months ago Cancer or any condition that would change weight dramatically in the near future such as malabsorption. Willing to return for testing annually for 3 years Women who are pregnant

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Carotid Intima Media Thickness (CIMT) | CIMT was defined by ultrasound. The mean and standard error of a 3 year change in CIMT was assessed (between baseline and three year follow up). | 3 years (baseline and three year follow up) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Transplant, Vascular Risk, inflammation, Diabetes, Insulin resistance, Chronic kidney disease
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

Study Overview
=================
Brief Summary
-----------------
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.

Official Title
-----------------
Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

Conditions
-----------------
Non Small Cell Lung Cancer, Bone Metastases, High NTX Level

Intervention / Treatment
-----------------
* Drug: zometa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Histologically confirmed non-small cell cancer One bone metastasis at least confirmed by image(X ray, CT or others) NTX > 50nM BCE/mM creatinine Life expectancy > 6 M ECOG <= 2 Signed ICF Exclusion Criteria: Women who are pregnant or in lactation Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: zometa<br>* zometa 4mg i.v. every 4 weeks for up to 2 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeleton-related event |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non small cell lung cancer, NTX, zometa