linjc16/ctgov huggingface dataset:
Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Detailed Description
-----------------
Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours

Official Title
-----------------
Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Drug: Ceftobiprole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed Consent Between 18 and 75 years of age inclusive VAP - 48 hours after onset of mechanical ventilation BMI 18 - 35 inclusive Albumin < 3.3 g/dL or clinical evidence of edema Negative Pregnancy test Expected survival of at least 7 days Exclusion Criteria: Renal impairment (CrCl < 80 mL/min) Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams) History of seizures Sustained shock, unresponsive to sympathomimetics Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, >15% total body burn or significant third degree burn)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceftobiprole<br>Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days | Drug: Ceftobiprole<br>* Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated throughout the study. |  | Study Duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VAP
Evaluating Outcomes in the Placement of Boomerang Percutaneous Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures. Background: Very few publications have evaluated this relatively novel percutaneous closure device.

Detailed Description
-----------------
The purpose of this study is to document our experiences using the Boomerang closure device. Several different closure devices are used in the department of Radiology. A closure device is something that is placed in the artery in the leg just prior to removing the catheters from your leg at the end of the imaging or treatment procedure that is to be performed in the Department of Radiology. The devices used are all FDA approved. This study will compare the Boomerang device (a newer FDA approved device) to the other older devices currently being used. You may not have the Boomerang device used in your procedure; however, the Boomerang device is used in almost all of our patients undergoing a neuro imaging or treatment procedure. The neuroradiologist will determine which device if any is best for you based on the size of your artery, your medical condition etc. We will only collect data about you and your procedure if the Boomerang device is used.

Official Title
-----------------
Technical and Clinical Outcomes Following Placement of Boomerang Percutaneous Closure Device After Cerebral Angiography or Neurointerventional Procedures

Conditions
-----------------
Medical Device, Angiography

Intervention / Treatment
-----------------
* Device: Boomerang closure device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient that has a percutaneous Boomerang closure device placed after having a neuro-intervention Exclusion Criteria: Patients that do not have this medical device used post procedure

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 |
| --- | --- |
| Boomerang percutaneous closure unit<br>patients having a Boomerang percutaneous closure device after a Neurointerventional study | Device: Boomerang closure device<br>* Use of percutaneous of Boomerang closure device. Follow up outcomes evaluated after the use of Boomerang closure device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Satiety Effects of Beef Compared to Beans

Study Overview
=================
Brief Summary
-----------------
The satiety effects of beef will be compared to beans. Beef is hypothesized to be more satiating than beans.

Detailed Description
-----------------
Subjects will consume 2 different meatloaf lunches and satiety will be measured by visual analogue scales. They will consume an ad lib snack after 3 hours and food intake will be measured.

Official Title
-----------------
Satiety Effects of Beef Compared to Beans

Conditions
-----------------
Food Selection

Intervention / Treatment
-----------------
* Other: Other: Bean patty
* Other: Other: Beef patty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, non-smoking, BMI of 18-27, non-dieting, typically consumes breakfast/lunch Exclusion Criteria: distaste for beans, vegetarian, current smoker, restrained eating habits, recent weight change, history of significant disease of past medical history, pregnant, lactating irregular menstrual cycle

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bean patty<br>Bean Patty | Other: Other: Bean patty<br> <br> Other: Other: Beef patty<br> <br> |
| Active Comparator: Beef patty<br>Beef patty | Other: Other: Bean patty<br> <br> Other: Other: Beef patty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| satiety | Measure satiety by visual analogue scale (VAS) | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| food intake | assorted snacks provided to assess food intake variation between treatments | 180 minutes |
Evaluation of Thoracic Tumors With 18F-FMT and 18F-FDG PET-CT A Clinicopathological Study

Study Overview
=================
Brief Summary
-----------------
L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for positron emission tomography (PET). The aim of this study was to determine whether PET-CT with 18F-FMT provides additional information for the preoperative diagnostic workup as compared with 18F-FDG PET. Tumor uptake of 18F-FMT was compared with several immunohistochemical markers including L-type amino acid transporter 1 (LAT1).

Official Title
-----------------
Evaluation of Thoracic Tumors With 18F-FMT and 8F-FDG PET-CT: A Clinicopathological Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with indeterminate pulmonary nodule suspicious of lung cancer Exclusion Criteria: Patients with other malignancies and those who had received cancer treatment within the past 5 years were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| 1<br>PET study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluorine-18-α-methyltyrosine,, Positron emission tomography,, Fluorine-18-fluorodeoxyglucose,, Lung cancer,
Enhanced Tuberculosis Case Detection Among Substitution Treatment Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the prevalence of latent tuberculosis infection among injecting drug users and to conduct randomized controlled trial to evaluate a case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program in Estonia.

Official Title
-----------------
Prevalence of Latent Tuberculosis and Enhanced Tuberculosis Case Detection Among Injecting Drug Users Receiving Methadone Substitution Treatment

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Other: Case management approach in referral to health care services


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in substitution treatment program, Age 18 years or more, Able to read and write in Estonian or Russian, Able to provide informed consent

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active referral<br>Case management intervention group - study personnel scheduled the TB doctor appointment for the participant, reminded to keep it, and transportation to the clinic was organized when needed. | Other: Case management approach in referral to health care services<br>* Case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program<br>|
| No Intervention: Passive referral<br>Participants were instructed to schedule an appointment with TB services themselves. | Other: Case management approach in referral to health care services<br>* Case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis, Injecting drug users, Case management
Study of Nesiritide in Diastolic Heart Failure.

Study Overview
=================
Brief Summary
-----------------
We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.

Detailed Description
-----------------
In previous studies, patients with systolic heart failure were given nesiritide and had reduced heart filling pressures. The FDA has approved nesiritide for these patients. Between one-third and one-half of patients with heart failure have diastolic heart failure. Few of these patients have been studied while receiving nesiritide. A study is needed to test nesiritide on this specific type of heart failure. Patients will undergo a heart catheterization and heart biopsy. Patients will then be transferred to the intensive care unit for monitoring. An echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. At the completion of the infusion, a repeat echocardiogram will be obtained.

Official Title
-----------------
A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.

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

Intervention / Treatment
-----------------
* Drug: neseritide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elevated heart filling pressure. Ejection fraction >45%. Blood pressure >90. Physician feels that the patient needs intravenous medication for heart failure. - Exclusion Criteria: Patients receiving intravenous medication. Patients with significant heart disease or who are unstable. Patients with kidney failure or severe heart valve disease. -

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

| Intervention/Treatment |
| --- |
|Drug: neseritide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart catheterization, echocardiogram, nesiritide
Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
The study consists in determine the transpulmonary pressure in morbidly obesity patients that require mechanical ventilation. both gender only adults Medical intensive care patients.

Detailed Description
-----------------
We are studying adult patients with morbid obesity with respiratory failure requiring mechanical ventilation. We are measuring transesophageal presssures to estimate ideal PEEP and evaluate hemodynamic parameters.

Official Title
-----------------
Transpulmonary Pressures in Mechanical Ventilated Patients With Morbid Obesity

Conditions
-----------------
Mechanical Ventilation Complication, Respiratory Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both gender morbid obesity hemodynamically stable Exclusion Criteria: pregnant patients cirrhotic patients with esophageal varicose

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transpulmonary pressures<br>Esophageal balloon to measure transpulmonary pressures. PEEP adjustment as per transpulmonary pressures. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transpulmonary pressure | We will record the changes in transpulmonary pressure after adjusting PEEP (measure in cmH2O). | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamics | we will review hemodynamic changes while adjusting PEEP (BP, HR). | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transpulmonary pressure - morbid obesity
Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples. Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice. The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.

Official Title
-----------------
Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma

Conditions
-----------------
Stage IV Skin Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of melanoma and BRAFV600 Signed Informed Consent Form Unresectable phase III or phase IV melanoma The patients should be starting a treatment for melanoma (either first line or subsequent lines)
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 |
| --- | --- | --- |
| Rate of patient in which BRAF V600 in blood samples is present/absent |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with BRAFV600 present in tumor sample vs blood sample |  | two years |
Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD1981

Official Title
-----------------
An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD1981


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedure Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg Exclusion Criteria: Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life History or presence of any clinically significant disease or disorder in the opinion of the investigator Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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: 1<br> | Drug: AZD1981<br>* Oral tablet, 250 mg, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables and Radioactivity |  | Frequent sampling occasions during study days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) |  | Frequent sampling occasions during study days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADME, Healthy volunteers
Efficacy of Topical Cyclosporin for Ocular Rosacea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea

Detailed Description
-----------------
The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids

Official Title
-----------------
Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Drug: Cyclosporine 0.05%
* Drug: Ocular lubricant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at least 18 years old, but younger than 65 Diagnosis of acne rosacea Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia and hyperemia of at least 2+ Schirmers test of greater than 5mm in at least 1 eye If patient currently using lid hygiene must maintain regimen during study Stop oral antibiotics at least 4 weeks prior Exclusion Criteria: Use of topical cyclosporin within last 90 days Visual acuity of 20/100 or better in both eyes Pregnant or lactating females Active ocular infection Scarring of central cornea Eyelid defects,abnormal lid positioning or lagophthalmos Flax seed or Fish oil supplements within last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: Restasis<br> | Drug: Cyclosporine 0.05%<br> <br> |
| Active Comparator: 2: Refresh Endura<br> | Drug: Ocular lubricant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hyperemia |  | 6 months |