linjc16/ctgov huggingface dataset:
Pharmacokinetics of Levosimendan in Pediatric Intensive Care Units

Study Overview
=================
Brief Summary
-----------------
To describe pharmacokinetics of levosimendan in neonates and children supported or not with extracorporeal circulation devices (ECMO, CRRT)

Detailed Description
-----------------
Levosimendan is a calcium sensitiver wih inotropic effects. It's use in the context of acute or chronic heart failure in children has yet to be defined. Due to physical proprieties of levosimendan and metabolites, we hypothesized that concomitant use of extracorporeal devices such as ECMO will cause major pharmacokinetic variations. Furthermore, pharmacokinetics of levosimendan in children with multiple organ failure has to be specify.

Official Title
-----------------
Pharmacokinetics of Levosimendan, OR1855 and OR1896 in Neonates and Children With or Without Extracorporeal Membrane Oxygenation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children admitted in pediatric intensive care units with planned infusion of 0.2 mcg/kg/min of levosimendan over 24h in context of routine care Arterial line or central venous catheter inserted for blood sampling procedures in context of routine care. Exclusion Criteria: Absence of clear parental status or information

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- | --- |
| First parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Area under the plasma concentration versus time curve (AUC) ) | Area under the plasma concentration versus time curve (AUC) of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care | At the end of the study, after 2 years. | 
| second parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (distribution volume) | distribution volume of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care | At the end of the study, after 2 years. | 
| third parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (half-life time) | half-life time of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care | At the end of the study, after 2 years. | 
| fourth parameter of the pharmacokinetics of levosimendan, OR1855, OR1896 (Peak Plasma Concentration (Cmax)) | Peak Plasma Concentration (Cmax) of levosimendan, OR 1855 and OR 1896. Samples will be collected over a period in of 192h in context of routine care | At the end of the study, after 2 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levosimendan, pharmacokinetics, children, acute heart failure
Incidence of Parkinson's Disease Among Veterans

Study Overview
=================
Brief Summary
-----------------
This is a database study. Medical records will be reviewed in order to document a new or pending diagnosis of Parkinson's disease and in order to learn more about the disease process. Other than the time that it takes to complete a medical record authorization form, no other human subject participation will be needed.

Official Title
-----------------
Incidence of Parkinson's Disease Among Veterans

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
chart review
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 |
| --- | --- | --- |
CLaret Embolic Protection ANd TAVI - Trial

Study Overview
=================
Brief Summary
-----------------
This prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.

Conditions
-----------------
Frequency of Cerebral Perfusion Defects After TAVI, Size of Cerebral Perfusion Defects After TAVI

Intervention / Treatment
-----------------
* Device: TAVI (Medtronic CoreValve)
* Device: Claret-Filter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be scheduled to undergo an endovascular aortic valve prosthesis (Medtronic CoreValve®) implant procedure with the femoral artery as the intended access site for the valve delivery system. Exclusion Criteria: Patient is unsuitable for TAVI Prior Stroke or TIA in the last 12 month Carotic stenosis >70% Relevant stenosis of the brachiocephalic trunc or the right subclavian artery Expected Non-compliance for follow-ups Pregnancy Patient is already recruited for another 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cerebral Protection Filter<br>Patient is treated with Cerebral protection Filter. | Device: TAVI (Medtronic CoreValve)<br> <br> Device: Claret-Filter<br> <br> |
| Other: No Cerebral Protection Filter<br>Patient is not treated with Cerebral protection Filter. | Device: TAVI (Medtronic CoreValve)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and Size of Cerebral Embolism | Primary endpoint ist the rate and the size of cerebral embolism in postinterventional Magnetic Resonance Imaging (MRI). | 2 days after Intervention |
Proton Pump Inhibitor (PPI) Therapy for Newly Diagnosed Esophagitis

Study Overview
=================
Brief Summary
-----------------
This study is being done to for two reasons: To learn about the effects (good and bad) esomeprazole (an FDA approved drug for reflux esophagitis) has on your esophagus when taken correctly. To learn about the quality of life changes (good and bad) you may experience with this medication.

Detailed Description
-----------------
The plan is to have 50 people take part in this study at Mayo Clinic Rochester. This research study is looking at people who have a new condition called erosive reflux esophagitis. Esophagitis is defined as mucosal damage produced by the abnormal reflux of gastric contents into the esophagus. Acid reflux, over time, can wear away or erode the lining of your esophagus. This condition is called erosive esophagitis. The treating physician may start you on prescription strength acid reducing group of medications called Proton Pump Inhibitors (PPI). PPI medications can provide 24-hour relief from your painful heartburn symptoms and it can help you heal the erosions in the esophagus that acid reflux may cause.

Official Title
-----------------
How Does Proton Pump Inhibitor Therapy Impact Quality of Life in Patients Newly Diagnosed With Erosive Reflux Esophagitis?

Conditions
-----------------
Erosive Esophagitis, Reflux Esophagitis, GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Have either mild-to-moderate erosive reflux esophagitis Meet criteria for GERD symptoms. Exclusion Criteria: Patients already on esomeprazole therapy, have previously failed to respond to esomeprazole, or are intolerant to PPI therapy. Patients expected to travel outside of the United States during the initial 8 weeks of PPI therapy. Pregnant women will be excluded as PPI's are not thought safe for the fetus (Pregnancy Category C). - Children younger than 18 years of age will be excluded. Other vulnerable populations, such as those with diminished mental acuity, will be excluded.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erosive Esophagitis, Reflux Esophagitis, GERD
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

Study Overview
=================
Brief Summary
-----------------
To demonstrate the efficacy/safety of Fosamax Plus D

Official Title
-----------------
A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women

Conditions
-----------------
Osteoporosis Postmenopausal

Intervention / Treatment
-----------------
* Drug: alendronate sodium (+) cholecalciferol
* Drug: Comparator: Alendronate sodium (Fosamax)
* Dietary Supplement: Comparator: Calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study Patient has been diagnosed with osteoporosis Patient has been postmenopausal for more than 6 months Patient has no contraindication to taking oral bisphosphonates Patient is eligible for dual energy x-ray absorptiometry in spine or hip Exclusion Criteria: Patients with esophageal dysfunction Patients who can not sit or stand at least 30 minutes Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months

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

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

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>Alendronate sodium/Cholecalciferol | Drug: alendronate sodium (+) cholecalciferol<br>* Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks<br>* Other names: Fosamax Plus D;Dietary Supplement: Comparator: Calcium<br>* 500 mg oral tablet calcium once daily, for 16 weeks<br>|
| Active Comparator: 2<br>Alendronate sodium | Drug: Comparator: Alendronate sodium (Fosamax)<br>* Alendronate sodium; tablet, once weekly, for 16 weeks<br>Dietary Supplement: Comparator: Calcium<br>* 500 mg oral tablet calcium once daily, for 16 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment |  | Baseline and 16 weeks |
A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

Study Overview
=================
Brief Summary
-----------------
This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.

Official Title
-----------------
Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With Those Of Amoxicillin-Clavulanic Acid In Patients Presenting With An Exacerbation Of Chronic Bronchitis

Conditions
-----------------
Bronchitis, Chronic

Intervention / Treatment
-----------------
* Drug: Amoxicillin/clavulinic acid
* Drug: Azithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Outpatients presenting with an exacerbation of chronic bronchitis including: chronic bronchitis with obstructive respiratory disorders documented by a forced expiratory volume of below 80% and higher than 35% of the theoretical value, within the previous 12 months; and thought to be of infectious origin Exclusion Criteria: Exclusion Criteria: Patient not presenting with the associated signs of an exacerbation Patient presenting with clinical signs suggestive of pneumonopathy at inclusion Patient requiring hospitalisation in intensive care

Ages Eligible for Study
-----------------
Minimum Age: 36 Years
Maximum Age: 74 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 |
| --- | --- |
| Active Comparator: Group 2<br> | Drug: Amoxicillin/clavulinic acid<br>* amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days<br>|
| Active Comparator: Group 1<br> | Drug: Azithromycin<br>* Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess clinical efficacy (clinical recovery or clinical failure) |  | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbations |  | Day 30 to Day 90 | 
| Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum) |  | continuous |
Effect of PlayStation Distraction in the Dental Setting

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to assess whether the behavior, anxiety, and dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction.

Detailed Description
-----------------
global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart Rate

Official Title
-----------------
Effect of PlayStation Distraction on Children's Behavior and Pain in the Dental Setting

Conditions
-----------------
Global Behaviour Measure

Intervention / Treatment
-----------------
* Behavioral: Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 6-8 years. Patients who required a minimum of 2 visits for restorative treatment. Exclusion Criteria: Patients with reduced audiovisual capabilities. Patients with psychological disorders.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. | Behavioral: Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.<br>* videogame can be considered as a method of distraction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global behavior during the treatment | we will use the Frankl Scale | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental perception of patient's anxiety | we will use the Modified Corah Anxiety Scale Questionnaire | 14 days | 
| Self-reported anxiety during the treatment | we will use the Venham Picture Test | 14 days | 
| Dental pain during the treatment | We will use the Wong-Baker Faces Scale | 14 days | 
| Heart rate during the treatment measures in different time points | We will use the the pulse oximeter | 14 days | 
| Degree of acceptance of the distraction method by the pediatric patient | Did you enjoy seeing the cartoon film during the dental visit? (Yes/No) | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Audiovisual distraction, Pediatric dentistry
Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children

Study Overview
=================
Brief Summary
-----------------
Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain. Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children.

Official Title
-----------------
Vitamin D vs Placebo in the Treatment of Vague Musculoskeletal Pain in Children

Conditions
-----------------
Hypovitaminosis D

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D
* Other: Placebo candy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 5-14 healthy vague musculoskeletal pain without diagnosis Exclusion Criteria: medications (steroids, seizure medications, birth control pills or shot) endocrinopathies

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 14 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: Vitamin D<br> | Dietary Supplement: Vitamin D<br>* 2000-3000 IU Vitamin D daily x 6 weeks<br>* Other names: Rainbow Light;|
| Placebo Comparator: Placebo<br> | Other: Placebo candy<br>* candy gum drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lessening of musculoskeletal pain level and frequency |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of serum 25 OH Vitamin D level |  | 6 weeks | 
| Decline of serum parathyroid hormone levels |  | 6 weeks |
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF

Study Overview
=================
Brief Summary
-----------------
Open-label therapy will be administered to up to 220 patients, following completion of either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.

Detailed Description
-----------------
Open-label therapy will be administered subcutaneously. Patients enrolled will continue to receive Interferon gamma-1b therapy three times per week and will be evaluated at 6-week intervals. Patients not taking Interferon gamma-1b at enrollment will re-initiate therapy with subcutaneous Interferon gamma-1b under a dose-escalation scheme, reaching full dose after 2 weeks.

Official Title
-----------------
An Open-Label Study of the Safety of Subcutaneous Recombinant Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Disease

Intervention / Treatment
-----------------
* Drug: Interferon gamma-1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Enrollment in Protocol GIPF 002 Part B or GIPF-004 Completion of the End of Treatment Visit in Protocol GIPF-002 Part B or the Study Completion Visit in GIPF-004 Able to understand and sign a written informed consent form and comply with the requirements of the study Exclusion criteria: pregnancy or lactation lack of adherence to either GIPF-002 or GIPF-004 study protocols and treatment regimens if Principal Investigator deems patient is unsuitable for study
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: Interferon gamma-1b|200 mcg, SQ, 3x per week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse events up to the end of study |  | 3.5 years | 
| Survival status at end of study |  | 3.5 years | 
| Serum antibodies to Interferon gamma-1b after the last injection. |  | 3.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic, Pulmonary, Fibrosis, IPF, Lung, Actimmune, Interferon, Gamma, InterMune