linjc16/ctgov huggingface dataset:
Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal Pseudo-drusen-like Deposits: Case-control Study (PL-AMD)

Study Overview
=================
Brief Summary
-----------------
The rationale of this research is to determine if patients with lupus and presenting retinal pseudo-drusen-like deposits have genetic and complement-related similarities with AMD patients. Based on the results obtained, this study could lead to future research that could better target the treatment of patients with lupus or patients with AMD (Age related Macular Degeneration). The primary objective is to check if patients with lupus, treated or not with antimalarial drugs, with pseudo-drusen-like deposits have a different complement profile (functional exploration of complement, complement factors, genetic complement polymorphisms involved in AMD) compared to patients without pseudo-drusen-like deposits.

Official Title
-----------------
Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal Pseudo-drusen-like Deposits: Case-control Study (PLAMD)

Conditions
-----------------
Lupus Erythematosus, Lupus Erythematosus, Systemic, Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic lupus erythematosus Case patients : with pseudo-drusen-like deposit Control patients : without pseudo-drusen-like deposit Exclusion Criteria: Patient under a measure of legal protection

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case (with pseudo-drusen-like deposits)<br>Patients with lupus, treated or not with antimalarial drugs, with pseudo-drusen-like deposits | Procedure: Blood test<br>* Blood test for complement factors and genetic polymorphisms of AMD analysis<br>|
| Control (without pseudo-drusen-like deposits)<br>Patients with lupus, treated or not with antimalarial drugs, without pseudo-drusen-like deposits | Procedure: Blood test<br>* Blood test for complement factors and genetic polymorphisms of AMD analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of AMD genetic polymorphisms between case and control patients |  | Baseline | 
| Comparison of complement factors between case and control patients |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus Erythematosus, Systemic, Age Related Macular Degeneration, Pseudo-drusen-like deposits
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation

Study Overview
=================
Brief Summary
-----------------
This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.

Official Title
-----------------
High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Drug: icotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology) Positive EGFR 21 exon mutation or 19 exon deletion Age 18-75 years old with performance status of 0 to 2 With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria Adequate hematological, biochemical and organ functions. Exclusion Criteria: Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases. Evidence of interstitial lung diseases Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 21 icotinib (250mg)<br>Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity. | Drug: icotinib<br> <br> * Other names: conmana;|
| Active Comparator: 21 icotinib (125mg)<br>Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity | Drug: icotinib<br> <br> * Other names: conmana;|
| Experimental: 19 icotinib (125mg)<br>Patients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity | Drug: icotinib<br> <br> * Other names: conmana;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 20 months | 
| Objective response rates |  | 12 weeks |
Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Adults who undergo cataract surgery will be questioned after surgery about the eventual pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: type of anesthesia, duration of surgery, machines used, unexpected events, particularities noticed by the surgeon, etc. There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

Detailed Description
-----------------
Adults who undergo cataract surgery, excepting under general anesthesia, will be asked to rate a Visual Analog Scale grading the pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: Visual analog scale of pain according to the surgeon (before recording the patient), type of anesthesia, duration of surgery, machines used, time of ultrasound used for phakoemulsification, preoperoative visual acuity and intraocular pressure, biometry, iris color, preoperative donesis, preoperative capsular pseudoexfolliation, unexpected events, particularities noticed by the surgeon as Floppy iris syndrome, Lens-iris diaphragm retropulsion syndrome There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

Official Title
-----------------
Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery / RECHMPL20_0210

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Undergoing a cataract surgery during the period of inclusion, and by one of the surgeons of the study Majority 18 years and more Exclusion criteria: - General anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Pain during cataract surgery | Visual Analog Scale of pain | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the rate of intraoperative complications over the series | assess the rate of intraoperative complications over the series | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract surgery, Phakoemulsification, Pain, Biometry, Anesthesia
Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)

Study Overview
=================
Brief Summary
-----------------
In this study, all citizen of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate in a population-based health study, the HUNT study. Blood samples are drawn from the participants and assessed for celiac disease by a serological assay. Celiac disease is a chronic inflammatory disease of the small intestine due to dietary gluten in wheat, barley and rye. The diagnosis will be verified through endoscopic assessment and biopsies from the small intestinal mucosa. The aims of the study are 1) to establish the population-based prevalence of celiac disease; 2) to assess the consequences of the disease from patient reported outcomes, symptoms, deficiencies, and co-morbidity; 3) to study possible risk factors and environmental triggering events; 4) to identify genetic predictors and gene-environmental interactions.

Official Title
-----------------
Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Endoscopy and biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants of the forth round of the HUNT study Exclusion Criteria: None

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: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Endoscopy and biopsy<br>Participants of the HUNT study with a positive serological assay for celiac disease are invited to attain a diagnostic endoscopy with duodenal biopsies | Diagnostic Test: Endoscopy and biopsy<br>* Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of celiac disease | the proportion of cases in the general population of Nord-Trøndelag County, Norway | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
General population, Prevalence, Diagnosis, Prognosis, Etiology, Genes
Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.

Study Overview
=================
Brief Summary
-----------------
During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation. The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter. However, before being used extensively, such device needs to be evaluated concerning its accuracy. The aim of the present study is to assess the reliability of this device.

Official Title
-----------------
Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.

Conditions
-----------------
Shock

Intervention / Treatment
-----------------
* Device: EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute circulatory failure defined as : systolic blood pressure<90mmHg or mean arterial pressure <65mmHg and blood lactate > 2mmol/L Exclusion Criteria: Pregnant women

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)|continuous measurement of venous lactate through a central venous catheter by microdialysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement | Agreement between sequential arterial blood lactate measurement and continuous venous lactate obtained by microdialysis | Every 4hours for 48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interchangeability | Interchangeability of the variations of the two methods using the trend interchangeability method | Every 4hours for 48hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactic Acid
The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the effect of glucagon-like peptide-1 on cardiac output and transpulmonary gradient in patients undergoing right heart catheterisation for clinical reasons.

Official Title
-----------------
The Effect of Glucagon-Like Peptide-1 (GLP-1) on Pulmonary Vascular Resistance (PVR) in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Glucagon-Like Peptide 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Able to give informed consent On the waiting list for heart transplant Left Ventricular Dysfunction awaiting catheterisation Exclusion Criteria: Nicorandil, glibenclamide, Dipeptidyl Peptidase-4 inhibitor, Glucagon-Like Peptide-1 receptor agonist or insulin Women of child bearing age and breast feeding women Cardiac pacemaker or other implanted metallic device Unable to give informed consent

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: GLP-1<br> | Drug: Glucagon-Like Peptide 1<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulmonary Vascular Resistance with Glucagon-Like Peptide-1 |  | 30 minutes |
Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up

Official Title
-----------------
Evaluation of Non Traditional Cardiovascular Risk Factors in Chronic Kidney Disease Patients Starting Dialysis

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Biological: Plasma osteoprotegerin level
* Biological: Plasma fibroblast growth factor 23 level
* Procedure: Vascular calcification score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who has signed the written consent form Patient with chronic renal failure starting dialysis therapy Exclusion Criteria: Pregnancy Patient with chronic renal failure not yet on dialysis therapy

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiovascular risk evaluation<br>Measurement of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 2 year follow-up | Biological: Plasma osteoprotegerin level<br>* dosage of plasma osteoprotegerin<br>Biological: Plasma fibroblast growth factor 23 level<br>* dosage of plasma fibroblast growth factor 23<br>Procedure: Vascular calcification score<br>* measurement of vascular calcification score by X-ray of the lateral abdominal aorta<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of vascular calcifications during a 2 year follow up according to plasma osteoprotegerin level at inclusion | osteoprotegerin will be measured in picomol/L; vascular calcifications will be measured at inclusion and after the 2 year follow up | 2 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of vascular calcifications during a 2 year follow up according to plasma fibroblast growth factor 23 level at inclusion | fibroblast growth factor 23 will be measured in RU/milliliter; vascular calcifications will be measured at inclusion and after the 2 year follow up | 2 years after inclusion | 
| Occurence of cardiovascular events during a 2 year follow up |  | 2 years after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic kidney disease starting dialysis, cardiovascular risk, bone mineral metabolism markers
The Heidelberg Engineering ANTERION Imaging Agreement Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess image quality of acquired biometry images of the eye

Detailed Description
-----------------
The conducted study is a non-interventional study for an imaging device used in the aid of ophthalmology diagnosis. Because the study is not interventional, the study is not an Applicable Clinical Trial per Clinicaltrials.gov definition.

Official Title
-----------------
The Heidelberg Engineering ANTERION Imaging Agreement Study

Conditions
-----------------
Eye Abnormalities, Normal Eyes

Intervention / Treatment
-----------------
* Device: ANTERION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 22 years or older Able and willing to undergo the test procedures, sign informed consent, and follow instructions Able to fixate With eye pathology status for each of the two eye populations. A. Eye with normal anterior segment B. Eyes with anterior segment abnormalities identified with the slit lamp exam including but not limited to: glaucoma surgeries: trabeculectomy, laser peripheral iridotomy and drainage devices corneal surgeries: corneal inlays and corneal transplants pterygium and corneal scar Exclusion Criteria: Subjects which were enrolled in the B-2018-1 Study Physical inability to be properly positioned at the study devices or eye exam equipment Contact lenses worn during imaging

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Eyes with normal anterior segment<br> | Device: ANTERION<br>* Biometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center<br>|
| Eyes with anterior segment abnormalities<br> | Device: ANTERION<br>* Biometry images will be acquired on the ANTERION and the reference device and the image quality and the identification of abnormalities will be assessed by a reading center<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality | Comparison of the B-Scan image quality between the ANTERION and the reference device | 30 days | 
| Agreement in identification of abnormality | Agreement in identification of abnormality from OCT B-Scan images between ANTERION and the reference device | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Evaluate any adverse events found during the clinical study | 1 day |