linjc16/ctgov huggingface dataset:
eVent in the Human Patient Simulator

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators are testing the expert system called eVENT. eVENT provides expert advice about the patient's breathing. The investigators have developed and tested a prototype of eVENT and now want to test how it works in practice. To do this the investigators plan to use computer based simulations and test it when used by anesthesiologists in a full size human simulator. If these tests are successful the investigators will then be ready to evaluate eVENT on real patients.

Detailed Description
-----------------
The development of new sensors or the intelligent synthesis of existing signals (smart sensors) cannot reliably prevent adverse events unless the investigators assimilate the data produced from these devices and provide it to the clinician in a format that is easy to comprehend. The expert system that the investigators are developing will provide intelligent synthesis of data. The clinician focus can then be directed toward the patient rather than continual observation of the monitors. Clinicians need an expert system to augment vigilance and situation awareness, and to aid in decision making to prevent patient harm. The development of an expert system to assist the everyday anesthesiologist in the operating room is a significant challenge that is in urgent need of being addressed. Assistance is required in interpreting the overwhelming stream of physiological data, intelligently extracting key features from these data, and bringing them to the attention of the clinician.

Official Title
-----------------
eVENT: An Expert System for Detecting Critical Events During Anesthesia (Human Patient Simulator Study)

Conditions
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Efficacy of the Expert System's Ability to Help Detect Critical Events

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Staff anesthesiologist, fellows and 3rd - 5th year residents will be able to participate in this study. Subjects willing to provide informed consent. Exclusion Criteria: Inability/failure to provide informed consent. Presence of any of the following conditions oPrevious participation in similar experiment oTaken sedative medication within last 24 hours Inability/failure to obtain 75% or above in the post-training quiz on the correct use of the eVent. Evaluation will be immediately discontinued at request of subject at any point during the study.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
expert system, decision support system, human patient simulator, anesthesia
Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.

Official Title
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Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions

Conditions
-----------------
Chronic Postsurgical Pain

Intervention / Treatment
-----------------
* Procedure: vaginal or laparoscopic hysterectomy


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions Age 18-69 years Gender: female ASA status 1-3 Exclusion Criteria: Body Mass Index over 35 Diabetes mellitus Liver disease Preoperative use of opioids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hysterectomy<br>Patient who previously underwent vaginal or laparoscopic hysterectomy | Procedure: vaginal or laparoscopic hysterectomy<br>* vaginal hysterectomy or laparoscopic hysterectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of persistent postsurgical pain as measured at 6 months after surgery. |  | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity, location, characteristics of persistent postsurgical pain. |  | five years | 
| Effect of postsurgical pain on activity, sleep. |  | five years |
Naltrexone for Early Problem Drinkers

Study Overview
=================
Brief Summary
-----------------
Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence. Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.

Official Title
-----------------
Targeted Naltrexone for Early Problem Drinkers

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: naltrexone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence). Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women. Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment. Willing to provide a collateral informant for interviews regarding the patient's drinking during the study. A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment. Willing to provide a signed informed consent to participate in the study. Exclusion Criteria: Have a current clinically significant physical disease or abnormality. Have a serious psychiatric illness. Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence. A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms. Used opioids or other psychoactive medications regularly in the month prior to study enrollment. History of hypersensitivity to naltrexone (Revia).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).

Official Title
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Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients With Haemophilia A

Conditions
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Congenital Bleeding Disorder, Haemophilia A

Intervention / Treatment
-----------------
* Drug: turoctocog alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%) Body weight between 10 to 120 kg Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086) Exclusion Criteria: Known or suspected hypersensitivity to trial product(s) or related products Previous participation in this trial defined as withdrawal Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject) Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 56 Years

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

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: N8<br> | Drug: turoctocog alfa<br>* A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve |  | Infusion, 48 hours | 
| Incremental recovery |  | Infusion, 30 minutes | 
| In vivo t1/2 |  | Infusion, 48 hours | 
| Total clearance (CL) |  | Infusion, 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal concentration (Cmax) |  | 15 minutes after trial drug administration | 
| Number of adverse events |  | up to 48 hours after trial drug administration |
Taking on Diabetes to Advance You (TODAY)

Study Overview
=================
Brief Summary
-----------------
The program will consist of diabetes self-management sessions, led by an occupational therapist. The sessions will be held in an individualized format. Sessions will focus on diabetes education, self-management education, and education on behaviors and adaptive techniques to optimize participation in daily life with type II diabetes. As occupational therapists, the investigators and facilitator, aim to focus on establishing healthy habits, roles, and routines for individuals with type 2 diabetes.

Official Title
-----------------
Taking on Diabetes to Advance You

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

Intervention / Treatment
-----------------
* Behavioral: Taking on Diabetes to Advance You (TODAY) Project


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes 18 or older patient at the Family Medicine Center in Fort Collins Exclusion Criteria: reading level below 6th grade inability to understand written or verbal instructions regarding questionnaires

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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: The investigators will utilize an evidence-based self-management program, and all individuals will be assigned to the prevention group to promote healthy lifestyles.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TODAY Project<br>All participants will attend individualized self-management sessions led by an occupational therapist. The classes will focus on promoting modifying daily activities, habits, roles, and routines to promote healthy lifestyles for individuals with type 2 diabetes. | Behavioral: Taking on Diabetes to Advance You (TODAY) Project<br>* This is an individualized educational intervention with activity components designed to assist in modifying habits, roles, and routines to promote healthy lifestyle patterns for individuals with type 2 diabetes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Diabetes Self-Management Questionnaire | 16-item self-report to assess self-care activities associated with diabetes | through the end of the intervention period, up to one year |
Prediction Tool for Premature Labour and Neonatal Outcome

Study Overview
=================
Brief Summary
-----------------
A register and prediction model will be developed to predict the outcome of preterm labour and birth.

Official Title
-----------------
Neonatal and Long Term Outcomes of Preterm Born Children in Flanders

Conditions
-----------------
Premature Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age of 24 weeks 0 days and 33 weeks and 6 days, and their preterm born children Exclusion Criteria: Patients who choose not to participate in the research. Intra-uterine prelabour fetal death. Fetuses or neonates with a major congenital disorder. Major is defined as a disorder that has an impact on neonatal respiratory and cerebral outcome and/or long-term outcome. Postpartum transfer/outborn.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| Register | A multicentre, multidisciplinary register will be created to provide a source of valuable information on obstetrical and neonatal practices and link them with obstetrical, neonatal and long-term outcomes of preterm labour and birth | 2017 - 2030 | 
| Prediction model | The prediction tool for true preterm labour (TPL) will be developed using individual risk factors, symptomatology, tocography, cervical change and a biomarker test, followed by a decision-making model, both based on individual data, evidence and experience. | 2017 - 2030 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The interval between starting corticosteroids and delivery | The interval between administration of antenatal corticosteroids and birth will be assessed and will be related to the short and long term outcome of preterm born children | 2012-2020 |
Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is To describe patient characteristics and drug usage among children that are prescribed esomeprazole for the first time and to compare them with patients who are prescribed other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time. To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs and H2-receptor antagonists.

Detailed Description
-----------------
Time Perspective: Other = Retrospective analysis of prospectively collected data Number of Anticipated Subjects: All subjects dispensed esomeprazole, other PPIs or H2-receptor antagonists for the first time during the study period

Official Title
-----------------
Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists

Conditions
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Hospitalized Cases of Angioneurotic Oedema, Pneumonia, Gastroenteritis, Failure to Thrive, Seizures, Acute Interstitial Nephritis and Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 0-18 years Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists Exclusion Criteria: Children with less than one year of history in PHARMO RLS before study cohort entry (if a child is <1 year at cohort entry, history from birth is required) Children using more than 1 acid suppressing drug concomitantly at cohort entry
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All first time users of esomeprazole<br> | |
| All first time users of other PPIs<br> | |
| All first time users of H2-receptor antagonists<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug utilization: Description of patient characteristics and drug usage |  | Study period 3 years | 
| Follow-up of safety outcomes: First occurrence of hospitalized angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acid suppressing drugs, pharmacoepidemiology, children
Pediatric Epilepsy Study

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.

Official Title
-----------------
A Multicenter, Rater-blind, Randomized, Age-stratified, Parallel-group Study Comparing Two Doses of Oxcarbazepine as Adjunctive Therapy in Pediatric Patients With Inadequately-controlled Partial Seizures.

Conditions
-----------------
Epilepsy, Epilepsies, Partial

Intervention / Treatment
-----------------
* Drug: oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: To enter this study, patients must: Have a diagnosis of partial seizures Be willing to be hospitalized Weigh a minimum of 6.6 pounds Be taking a stable dose of one to two concomitant anti-epileptic medications Have had a previous CAT scan/MRI confirming the absence of space occupying lesions or progressive neurological disease Have normal laboratory results EXCLUSION CRITERIA: To enter this study, a patient must not have or be: Seizures caused by metabolic disturbance, toxic exposure, or active infection A primary diagnosis of generalized epilepsy (exception - secondarily generalized seizures) A history of status epilepticus within 30 days Seizures not related to epilepsy Frequent use of additional anti-epileptic medications to treat increases in seizures (for example: rectal diazepam) Taking felbamate within 6 months Serum sodium levels <135 mEq/L Significant heart, breathing, kidney, stomach, liver, blood, or cancer disorder requiring treatment/therapy A history of chronic infection (e.g., hepatitis or HIV) Significant electrocardiogram (ECG) abnormalities A nursing mother taking anti-convulsant drugs Previously demonstrated sensitivity/allergic reaction to Trileptal or related compounds Used experimental medication within 30 days of entering this study

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 3 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in seizure frequency/24 hours (during the last 72 hours in the Treatment Phase compared to Baseline) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in seizure frequency/24 hours; change in seizure frequency/24 hours; response to treatment (at least a 50%, 75%, or 100% reduction seizure frequency/24 hours). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
partial seizures