linjc16/ctgov huggingface dataset:
Warfarin and Non-Steroidal Anti-Inflammatory Drugs (NSAID) Customized Alert

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that a newly formatted electronic alert that requires the prescriber to pause and enter a specific reason for override on this alert, will cause prescribers in the intervention group to be significantly less likely to prescribe the combination of warfarin and NSAID than prescribers in the control group.

Official Title
-----------------
The Effect of Customized Alerts Versus Generic Alerts for the Prescription of Warfarin and NSAID

Conditions
-----------------
Warfarin and NSAID

Intervention / Treatment
-----------------
* Behavioral: Electronic Alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All resident physicians (RP) and nurse practitioners (NP) involved in inpatient care at two hospitals of the University of Pennsylvania Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: customized electronic alert<br>This intervention was not targeted to patients with a disease but to the providers. The intervention was not a drug but a customized electronic alert, requesting the prescriber to specify a reason for override whenever the combination drugs of warfarin and NSAID were ordered together. | Behavioral: Electronic Alert<br> <br> |
| No Intervention: Standard practice<br>The control group was not patients but the providers. Providers in the control group continued with the standard practice of receiving passive alerts in the form of message boxes warning the provider not to prescribe the combination drugs warfarin and NSAID. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased rate of prescription of the combination of warfarin and NSAID |  | 17 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
warfarin, NSAID, The condition is the concomitant prescription of
Postpartum Anemia and Postpartum Depression

Study Overview
=================
Brief Summary
-----------------
Postpartum anemia (PPA) and Postpartum depression (PPD) are common afflictions affecting women after childbirth. Both disorders have a significant impact on women's health and functional status. Despite common symptoms and characteristics, a link between these entities has not been adequately studied. The objective of this study is to determine whether postpartum anemia is an independent risk factor for the development of postpartum depression. This prospective cohort study will include all women delivered by elective term cesarean delivery. Hemoglobin and iron levels will be measured, standardized questionnaires for assessment of PPD, functional status and lactation will be administered before discharge and at 3 & 6 weeks post partum. Hemoglobin levels at each time point will be analyzed for correlation with depressive symptoms, functional status and lactation success.

Official Title
-----------------
Is Postpartum Anemia an Independent Risk Factor for Development of Postpartum Depression?

Conditions
-----------------
Postpartum Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women after term elective cesarean section Exclusion Criteria: age < 16 years, preterm (< 37 weeks) delivery, multiple gestation, symptomatic anemia necessitating blood transfusion, significant fetal anomalies or infant not discharged with mother for other reason, preexisting severe chronic maternal illness, preexisting maternal depression and/or current use of antidepressants, other psychiatric illness (e.g. bipolar disease, schizophrenia) or preexisting hemoglobinopathy
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Incidence of postpartum depression |  | 0-6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Edinburgh Postnatal Depression Scale results |  | 0-6 weeks postpartum | 
| Functional status |  | 0-6 weeks postpartum | 
| Lactation success |  | 0-6 weeks postpartum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum anemia, postpartum depression
Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor

Study Overview
=================
Brief Summary
-----------------
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor

Official Title
-----------------
A Prospective, Randomized, Controlled, Comparitive Multicenter Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite® vs Competitor in Adult Subjects With Primary Open-Angle Glaucoma (POAG)

Conditions
-----------------
Glaucoma, Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: iStent Infinite
* Device: Competitor Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG) Exclusion Criteria: Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iStent Infinite<br>Subjects implanted with iStent Infinite system | Device: iStent Infinite<br>* Implantation of the iStent Infinite<br>|
| Active Comparator: Competitor Device<br>Subject implanted with competitor device | Device: Competitor Device<br>* Implantation of competitor device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Diurnal Intraocular Pressure | Change in Mean Diurnal Intraocular Pressure from Baseline over time | Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, MIGS
Intraosseous Access

Study Overview
=================
Brief Summary
-----------------
The investigators will compare the success rates and time to successful IO access during simulated adult resuscitation.

Official Title
-----------------
Comparison of NIO, BIG, EZ-IO, Jamshidi and Cook Intraosseous Devices in Adult Patients Under Resuscitation by Paramedics: a Randomized Crossover Manikin Trial.

Conditions
-----------------
Intraosseus Access, Manikin, Resuscitation

Intervention / Treatment
-----------------
* Device: NIO Adult device
* Device: Bone Iniection Gun
* Device: EZ-IO
* Device: Jamshidi Intraosseous Needle
* Device: Cook Intraosseous Needle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Give voluntary consent to participate in the study paramedic more than 1 year experience in medicine Exclusion Criteria: Not meet the above criteria Wrist or Low back diseases

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: IO access<br>Performed intraosseus access device during simulated cardiopulmonary resuscitation | Device: NIO Adult device<br>* IO access-1<br>* Other names: NIO;Device: Bone Iniection Gun<br>* IO access-2<br>* Other names: BIG;Device: EZ-IO<br>* IO access-3<br>Device: Jamshidi Intraosseous Needle<br>* IO access-4<br>* Other names: Jamshidi;Device: Cook Intraosseous Needle<br>* IO access-5<br>* Other names: Cook;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to IO needle insertion | time from picking up a intraosseous access device, to successful IO needle insertion in the bone | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to IO needle stabilization | time from picking up a intraosseus access device to correct fixation IO needle | 1 day | 
| time to intraosseuss infusion | begining with picking up a intraosseuss access device and ending with the IV line tubing was connected to the inseted IO needle | 1 day | 
| Ease of use | To access subjective opinion about the difficulty of the procedure, participants were asked to rate it on a visual analogue scale (VAS) with a score from 1 (extremely easy) to 10 (extremely difficult). | 1 day |
Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

Study Overview
=================
Brief Summary
-----------------
Wide Pulse Pressure is frequently present in the normal, full-term neonatal population. This study will evaluate the frequency and persistence of wide pulse pressure in the neonatal population. Using a prospective study design in the Regular newborn and Observation nurseries of SIUH, North site. Healthy newborns that are between 0-72 hrs of age will have their blood pressures measured using the oscillometric method. This data will offer insight into whether the presence of wide pulse pressure in otherwise healthy newborn infants warrants further cardiovascular evaluation

Official Title
-----------------
Evaluation of the Frequency and Persistence of Wide Pulse Pressure in the Neonatal Population

Conditions
-----------------
Blood Pressure, Pediatrics, Infant, Newborn, Cardiology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants with gestational age > or = 35weeks and birth weight > 2500g, who are hemodynamically stable, have no cardiorespiratory abnormalities and have no evidence of sepsis. If a blood culture was drawn due to the presence of maternal risk factors (e.g. maternal fever, prolonged rupture of membranes), patients will be included only if the blood culture result is negative and in case of intrapartum antibiotic treatment, ancillary blood tests (CBC with differential, CRP) are also within the normal range Exclusion Criteria: Infants with gestational age < 35weeks or birth weight < 2500g and with evidence of neonatal sepsis either culture proven or clinically suspected.

Ages Eligible for Study
-----------------
Maximum Age: 72 Hours

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 |
| --- | --- |
| Newborns<br>Healthy newborns in Regular and Observation nurseries who are between 0-72 hrs of age. Infants with gestational age > or = 35weeks and birth weight > 2500g, who are hemodynamically stable, have no cardiorespiratory abnormalities and have no evidence of sepsis. If a blood culture was drawn due to the presence of maternal risk factors (e.g. maternal fever, prolonged rupture of membranes), patients will be included only if the blood culture result is negative and in case of intrapartum antibiotic treatment, ancillary blood tests (CBC with differential, CRP) are also within the normal range | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of wide pulse pressures in healthy newborn | This study will determine the incidence of wide pulse pressures in healthy newborn infants during the first days of life. | 15 mins a day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure, Pediatrics, Infant, Newborn, Cardiology
Analysis of Emergency Department Visits According to Incidence of Covid-19

Study Overview
=================
Brief Summary
-----------------
With lockdown, Emergency Departments (ED) visits decrease, principally for visits unrelated with Covid-19. In this study, the investigators aimed to find a correlation between ED visits and incidence rate of Covid-19 in a French metropolis.

Detailed Description
-----------------
All patients older than 18 years were included in 9 ED during 51 weeks. Patients transferred between the centers participating in the study were excluded. The investigators count the number of visits per weeks, then the number of visits according to : reason for consultation Covid-like (cough, fever or dyspnea), reason for consultation with accordance to French Emergency Medicine Society (SFMU) reference diagnosis with accordance to SFMU reference orientation (home, medical unit, chirurgical unit, intensive care unit, psychiatric unit, death) Pearson's correlation test compare incidence rate per week with this counts and admission rate.

Official Title
-----------------
Analysis of Emergency Department Visits According to Incidence of Covid-19 in French Metropolis : a One-year Multicenter Observational Retrospective Study.

Conditions
-----------------
Emergency Service, Hospital, Epidemiology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 years old Exclusion Criteria: patient who are transferred between centers participating to the study.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-Covid-19 visit | Count of non-Covid-19 visit per week | 51 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for visits | Count of each reason for visits category according to SFMU reference | 51 weeks | 
| Admission rate | Admission rate per week | 51 weeks | 
| Diagnosis | Count of each diagnostic category according to SFMU reference | 51 weeks | 
| Orientation | Count of each orientation (home, medical unit, chirurgical unit, intensive care unit, death, psychiatric unit, other) | 51 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-Covid-19 visits, Emergency departments visits, Incidence of Covid-19
First Step With Singulair® Therapy (0476-323)

Study Overview
=================
Brief Summary
-----------------
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.

Official Title
-----------------
A 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma To Low Dose Inhaled Corticosteroid Treatment

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks
* Drug: Comparator: Fluticasone / Duration of Treatment: 6 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week) Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks Patient's forced expiratory volume in one second (fev1) is < 80% of predicted value Exclusion Criteria: Patient on combination therapy Patient on long acting beta2 agonists Patient on using moderate to high doses of ICS. (ICS >250 &micro g/day flovent&reg; or equivalent per day)

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks|nan|
|Drug: Comparator: Fluticasone / Duration of Treatment: 6 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian asthma guidelines criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control questionnaire |  |  |
GLP-1 and Hypoglycemia

Study Overview
=================
Brief Summary
-----------------
Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.

Official Title
-----------------
Hypoglycemia Associated Autonomic Dysfunction

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Glucagon-Like Peptide- 1 (GLP-1) infusion
* Other: Placebo Comparator: Saline Infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14 (7 males, 7 females) healthy controls age 30-60 yr. 14 (7 males, 7 females) people with type 2 DM age 30-60 yr. For type 2 DM: HbA1c 6-10.0% No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.) Body mass index >25kg • m-2 Exclusion Criteria: -

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucagon-Like Peptide -1 (GLP-1) infusion<br>Infusion of GLP-1 during experimental period | Drug: Glucagon-Like Peptide- 1 (GLP-1) infusion<br>* GLP-1 infusion during experimental period<br>* Other names: GLP-1;|
| Placebo Comparator: Saline Infusion<br>Saline infusion during experimental period | Other: Placebo Comparator: Saline Infusion<br>* Saline infusion (placebo) during experimental period<br>* Other names: Saline infusion;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plasminogen Activation inhibitor-1 (PAi-1) | measurements of change in PAi-1 at baseline and during the end of the glucose clamp period (2 hours) | change from baseline to end of clamp period | 
| Change in Flow mediated dilation (FMD) | flow mediated dilation of the brachial artery will be measured for change from baseline and end of glucose clamp ( 4 hours) | change from baseline and end of clamp | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GLP-1, hypoglycemia, Type 2 diabetes, endothelial function
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.

Detailed Description
-----------------
Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells. This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia. The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation. To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin. We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.

Official Title
-----------------
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation

Conditions
-----------------
Hyperinsulinemia

Intervention / Treatment
-----------------
* Drug: Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Between 40-65 years old. No medications. No medical problems. No serum cholesterol levels below 200 mg/dl. No contraceptives.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Insulin|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
-----------------
BQ-123, Endothelin, Insulin, Plethysmography, Vasoconstriction, Healthy Volunteer