linjc16/ctgov huggingface dataset:
Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria

Study Overview
=================
Brief Summary
-----------------
Background: Erythropoietic protoporphyria (EPP) is characterized by development of painful skin symptoms upon exposure to visible light dye to accumulation of the photoactive substance protoporphyrin IX (PpIX) in the skin.This study aimed to quantify the actual light exposure of patients with EPP during everyday life. The investigators further aimed to establish the associations between symptoms and light exposure, use of protective clothes, and erythrocyte PpIX concentration.

Official Title
-----------------
Light Exposure Patterns and Symptoms Among Patients With Erythropoietic Protoporphyria

Conditions
-----------------
Erythropoietic Protoporphyria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with erythropoietic protoporphyria Informed consent Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| Actual light exposure | Actual light exposure of patients with erythropoietic protoporphyria | from April through June 2017 |
Gastric Ultrasound in Paediatric Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Anesthesia for emergency surgery is a situation at risk of pulmonary aspiration of gastric contents. It has been previously reported that bedside two-dimensional ultrasonography can be a useful tool for anesthesiologists to determine gastric contents and volume in adults and children. In this prospective study, preoperative qualitative ultrasound assessment of gastric contents is performed for each children admitted for emergency surgery, in order to plane in case of empty stomach an intravenous or inhalation technique induction rather than an rapid sequence induction.

Official Title
-----------------
Ultrasound Assessment of Gastric Contents : the Way to Best Induce Children for Emergency Surgery

Conditions
-----------------
General Anesthesia

Intervention / Treatment
-----------------
* Device: Gastric ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged from 0 to 18 years old Parental consent Exclusion Criteria: Gastric tube contraindication Parental refusal

Ages Eligible for Study
-----------------
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastric Ultrasound<br>Preoperative qualitative ultrasound assessment of gastric contents will be performed | Device: Gastric ultrasound<br>* Preoperative qualitative ultrasound assessment of gastric contents will be performed for each children admitted for emergency surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adapted changes in induction technique according to ultrasound assessment of gastric contents |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound, antrum, pulmonary aspiration, emergency surgery
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

Official Title
-----------------
Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: simvastatin (+) ezetimibe
* Drug: Comparator: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are naïve to lowering lipid agent Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks. Exclusion Criteria: Impaired kidney function Increased liver enzyme levels Pregnant women Hypersensitivity to ezetimibe and other statin agents

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: 1<br> | Drug: simvastatin (+) ezetimibe<br>* simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks)<br>* Other names: Vytorin®;|
| Active Comparator: 2<br> | Drug: Comparator: atorvastatin<br>* atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)<br>* Other names: Lipitor®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment | Primary objective is to evaluate the proportion of patients achieving LDL-C target <100 mg/dl recommend in National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) after 6 weeks of treatment(vytorin 10/20 vs. atorvastatin 10 mg) | After 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment | If patients didn't achieve LDL-C <100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. | After 12 weeks of the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypercholesterolaemia
A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.

Study Overview
=================
Brief Summary
-----------------
The main objectives of the study were to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays. to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.

Official Title
-----------------
A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.

Conditions
-----------------
vonWillebrand's Disease

Intervention / Treatment
-----------------
* Biological: Optivate® (Human Coagulation Factor VIII)
* Biological: Haemate P® (Human Coagulation Factor VIII)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optivate®<br> | Biological: Optivate® (Human Coagulation Factor VIII)<br> <br> |
| Active Comparator: Haemate P®<br> | Biological: Haemate P® (Human Coagulation Factor VIII)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0-48h) for VWF: RCo |  | Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose |
SD01 Registry (SD01 ICD Lead)

Study Overview
=================
Brief Summary
-----------------
This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.

Official Title
-----------------
SD01 Registry (SD01 ICD Lead)

Conditions
-----------------
Ventricular Fibrillation, Ventricular Tachycardia, Heart Failure

Intervention / Treatment
-----------------
* Device: SD01 ICD lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet a standard indication for ICD/CRT-D therapy First ICD/CRT-D implantation or upgrade from pacemaker Signed informed consent form Willing to participate for the whole duration of the registry Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger Patient has legal capacity and ability to consent Exclusion Criteria: Meet a standard contraindication for an ICD/CRT-D therapy Age <18 years Pregnant or breast-feeding women Cardiac surgery planned within the next six months Enrollment in another cardiac clinical investigation with active treatment arm Mechanical tricuspid valve prosthesis or severe tricuspid valve disease Dexamethasone acetate intolerance

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 |
| --- | --- |
| SD01 ICD lead<br> | Device: SD01 ICD lead<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SADE-free rate |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, CRT-D, Lead
BIO|CONCEPT.Renamic Neo Study

Study Overview
=================
Brief Summary
-----------------
The BIO|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.

Official Title
-----------------
BIO|CONCEPT.Renamic Neo

Conditions
-----------------
Medical Devices

Intervention / Treatment
-----------------
* Device: Renamic Neo programmer device, including software; PK-222-L ECG cable


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is planned for de novo implantation or already has a BIOTRONIK active, implantable device. Patient is able to understand the nature of the study and provides written informed consent. Exclusion Criteria: Patient is implanted with a Stratos pacemaker. Patient is planned for implant exchange or upgrade. Patient is pregnant or breast feeding. Patient is less than 18 years old.

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

| Intervention/Treatment |
| --- |
|Device: Renamic Neo programmer device, including software; PK-222-L ECG cable|Patients were enrolled either for implantation including subsequent pre-hospital discharge or for a follow-up visit only. ICM patients were included for follow-ups only. Implants were programmed and interrogated by using the investigational devices.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Device Effects (ADE) and Device Deficiencies (DD) Per Number of Implantations and Per Number of PHD/Follow-up Cases | The number of Adverse Device Effects (ADE) and Device Deficiencies (DD) that occured in patients, users or other persons during the use of the Renamic Neo programmer at implantation, pre-hospital discharge and during the on-site follow-up was evaluated. The investigator was asked to report any ADEs or DD that occurred during implantations and follow-ups. All Adverse Device Effects (ADE) related to the investigational device and only Device Deficiencies (DD) that were determined to bear the potential for a medical occurrence were prespecified to be collected. | Patients participated from (I) implantation until the pre-hospital discharge (usually 1-2 days) or (II) only for the in-office follow-up (usually 1 day). |
The Effect of Physostigmine on Cognitive Functioning in the Immediate Period After Sedation for Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the administration of physostigmine in combination with sedation for colonoscopy can minimize the cognitive decline at the time of hospital discharge

Detailed Description
-----------------
Physostigmine, a tertiary cholinesterase inhibitor, which prevents the breakdown of ACh by inhibiting the enzyme acetylcholinesterase (AChE), crosses the blood-brain barrier (BBB), and elevates brain ACh levels. Physostigmine has been shown to improve attention, and performance in working memory. It has also been shown to produce analgesia following systemic or central administration. Patients undergoing colonoscopy under sedation of propofol and fentanyl show cognitive decline in the immediate period following the procedure. In this study, half the patients will receive physostigmine in combination with the sedation, and their cognitive functioning at the time of hospital discharge will be assessed by standard neuropsychological tests, and compared to that of patients without physostigmine.

Conditions
-----------------
Cognitive Dysfunction

Intervention / Treatment
-----------------
* Drug: Physostigmine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over18 years old ASA I-III Fluency in Hebrew, Russian, or Arabic Absence of serious hearing or vision impairment Exclusion Criteria: History of head trauma, neurological diseases, alcoholism, drug abuse, consumption of psychotropic drugs or antidepressants Heart failure (NYHA > 3) Liver failure Respiratory problems (asthma, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physostigmine<br>Colonoscopy sedation with or without physostigmine | Drug: Physostigmine<br>* Intravenous bolus of physostigmine 1 mg, 3-5 minutes before completion of the colonoscopy procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive functioning assessed by standard neuropsychological tests |  | At time of hospital discharge following colonoscopy procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, Cognitive decline, Physostigmine, Colonoscopy
Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. We will assess the effects of exercise training on coronary endothelial function, vascular structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression of diabetes candidate genes.

Official Title
-----------------
Long- But Not Short-term Exercise Training Improves Coronary Endothelial Dysfunction in Diabetes Mellitus Type 2 and Coronary Artery Disease

Conditions
-----------------
Type 2 Diabetes Mellitus, Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent preserved left ventricular function (left ventricular ejection fraction ≥ 50%) a physical work capacity ≥ 50 W at least one significant coronary stenosis > 50%, whereas either the left anterior descending (LAD) or circumflex artery (RCX) has to be free from disease or stenoses ≤ 25% for the assessment of intracoronary flow measurements Exclusion Criteria: diseases further affecting endothelial function untreated hypertension (systolic blood pressure > 160 mm Hg or a diastolic blood pressure of > 90 mm Hg) cigarette smoking during the previous six months LDL-cholesterol > 4.3 mmol/l ventricular tachyarrhythmias chronic obstructive pulmonary disease severe renal or hepatic dysfunction valvular heart disease myocardial infarction within the previous 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week) | Behavioral: Exercise training<br>* 4 weeks in-hospital exercise training (6x15 min bicycle/day, 5 days/week) followed by a 5 months ambulatory exercise program (30 min ergometer/day, 5 days/week, plus 1h group exercise/week)<br>|
| No Intervention: B<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.

Official Title
-----------------
A Randomized, Double-blind, Double-dummy, Multi-center Study to Investigate the Safety and Efficacy of Olmesartan Medoxomil Compared With Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: olmesartan medoxomil
* Drug: losartan potassium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg) able to give written informed consent Exclusion Criteria: known or suspected secondary hypertension history of chronic hepatic diseases obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease cardiac arrhythmia unstable angina pectoris congestive heart insufficiency (New York Heart Association classification III-IV) bilateral renal artery stenosis isolated renal artery stenosis post renal transplantation history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment retina bleeding/effusion insulin dependent diabetes mellitus uncontrolled non-insulin dependent diabetes mellitus

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>olmesartan medoxomil | Drug: olmesartan medoxomil<br>* oral tablets, once daily for 8 weeks<br>|
| Active Comparator: 2<br>losartan potassium | Drug: losartan potassium<br>* capsules, once daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of trough seated diastolic blood pressure from baseline to 8 weeks |  | Baseline to 8 weeks |
Microglial Cells Activation Imaging Using PET-CT With 18F-DPA714

Study Overview
=================
Brief Summary
-----------------
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in brain injury and degeneration. It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels Neurologic deterioration. It is however hard to evidence microglial activation in vivo: first, the investigators need very high-resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results. 18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to explore the clinical feasibility used PET-CT with 18F-DPA714 to monitor microglial cells activation of brain in several different disease. This study might reveal significant neuroinflammatory process in the brain. The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.

Official Title
-----------------
In Vivo Assessment of Neuroinflammation With 18-FDPA714 PET/CT

Conditions
-----------------
Microglial Cells Activation Imaging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Positron emission tomography scans were acquired more than twice Written informed consent was provided by the patients and their health care proxies - Exclusion Criteria: Contraindication for PET examination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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 |
| --- | --- | --- |
| Standardized Uptake Value (SUV) | Measures of specific binding of 18F-DPA-714 measures of specific binding of the tracer | 2 years |