linjc16/ctgov huggingface dataset:
Cough Peak Flow for Extubation Prediction

Study Overview
=================
Brief Summary
-----------------
Successful weaning from mechanical ventilation in ICU patients depends on patient ability to breathe spontaneously and on cough efficiency. Previous studies found that cough peak flow (CPF) at 60 L/min threshold predicted extubation failure. These studies measured CPF using a dedicated flow-meter that required patient disconnection from the ventilator, limiting the generalizability of this procedure. This study aimed to predict extubation outcome in a consecutive series of patients by measuring CPF from the ventilator flow-meter. CPF measurements were done by freezing ventilator screen and scrolling the cursor to the maximal value of CPF during expiration and Tidal Volume (TV) in preceding inspiration. The objective was to assess the performance of CPF to predict early extubation outcome.

Official Title
-----------------
Assessing Cough Peak Flow (CPF) Using Ventilator built-in Flow-meter to Predict Extubation Success: A Single Centre Study

Conditions
-----------------
Extubation in ICU Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Intubation > 24h Eligible for scheduled weaning trial and then scheduled extubation Mechanical ventilation from Evita XL ventilator (Dräger, Germany) Patient's agreement to participate Exclusion Criteria: - Withdrawal decision of life supporting care

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 |
| --- | --- | --- |
| Early extubation success rate (EES rate) | Defining a relation between the CPF/TV ratio before extubation and early extubation success rate | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scheduled weaning trial success rate | Defining a relation between the CPF/TV ratio before weaning trial and scheduled weaning trial success rate | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cough peak flow, scheduled weaning trial, scheduled extubation, prognosis
Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.

Detailed Description
-----------------
This study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 15 days and subjects eligibility will be evaluated after informed consent signature. Urea breath test (UBT) will be performed in addition to routine baseline evaluations (physical, lab test, etc). Treatment: subjects will be treated for 10 days. A confirmation of eligibility visit will take place on Day 0 and an end-of-treatment visit will take place between days 9-14. Follow-up: approximately one month post-treatment, eradication of H. pylori will be confirmed through UBT

Official Title
-----------------
Pilot Study Assessing the Safety, Tolerability, Compliance and Efficacy of Twice Daily Dosed Pylera Plus Omeprazole as a First Line Treatment of Helicobacter Pylori Infection

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: OBMT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive H. pylori status through UBT testing Exclusion Criteria: Documented allergy to any of the drugs contained in the treatment regimen Severe renal insufficiency, renal failure or azotemia Previous surgery of the upper gastrointestinal tract Hepatic failure Pre-existing peripheral neuropathies Use of any experimental drug within 30 days prior to randomization

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: OBMT|Omeprazole 20 mg twice daily, in combination with bismuth subcitrate potassium (40 mg), metronidazole 125 mg and tetracycline 125 mg HCl. All patients must take 6 capsules of Pylera, in addition to 1 omeprazole twice daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H. pylori status confirmed by Urea Breath Test |  | at 6 and 10 weeks following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | at the end of treatment, one and two months post-treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori infection, Quadruple therapy, Safety, Efficacy, Tolerability, BID dosing
Blood Cultures's Profitability in Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the blood cultures' profitability in intensive care unit and create a validated prediction rule for extractioning in critical patients.

Detailed Description
-----------------
Implementing a predictive rule blood cultures to determine the probability of positive or negative result, improving the profitability of the diagnostic test.

Official Title
-----------------
Blood Cultures's Profitability in Intensive Care Unit

Conditions
-----------------
Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been extracted blood culture sample Exclusion Criteria: Under-aged, pregnants, Major burns.

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 |
| --- | --- |
| blood cultures<br>Admitted patients in critical care who need blood cultures | |
| blood cultures Getafe<br>Data collection of patients included in study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of positive, negative and contaminated blood cultures |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of positive, negative and contaminated blood cultures after training program | the effect of applying a blood culture extraction protocol is measured | 9 months |
A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide

Official Title
-----------------
A 12-week, Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg

Conditions
-----------------
Hypertension, Diabetes

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus. Patients who are eligible and able to participate in the study Exclusion Criteria Severe hypertension Uncontrolled diabetes type I and II History or evidence of a secondary form of hypertension History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 12 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic blood pressure after 12 weeks |  |  | 
| Change from baseline in systolic and diastolic blood pressure after 6 weeks |  |  | 
| Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks |  |  | 
| Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension,, diabetes,, aliskiren,, blood pressure,, valsartan,, hydrochlorothiazide
OUT OF THE ICU SHIFTING

Study Overview
=================
Brief Summary
-----------------
Numerous studies dealt with the hospital doctors' work but little is known about the work of ICU doctors, especially concerning the medical time spent outside the Intensive Care Unit (ICU) which is a significant workload that has never been evaluated to date. The main objective of our study was to evaluate the time spent by ICU doctors outside the unit, for the management of their patients during the IHT and for the care of patients in other departments. Secondary objectives were to describe the organization and distribution of medical time outside the intensive care unit. In this observational study, which took place during 5 years, from January 2012 to December 2016 in the medical ICU of the Nouvel Hôpital Civil at the University Hospitals of Strasbourg, every day after the morning medical staff, the anonymized information were collected in a register.

Official Title
-----------------
SHIFTING OF ANESTHESIS PHYSICIANS OUT OF THE INTENSIVE CARE UNIT

Conditions
-----------------
Hospital Rapid Response Team Activation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old Physician anesthetist of Intensive Care Unit of new civil hospital in Strasbourg Physician anesthetist who has agreed to participate in the study Exclusion Criteria: Refusal to participate in the study

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily time spent by physicians outside their service | Evaluation of the daily time spent by intensive care physicians outside their department for the care of patients | The period from 2012 to 2017 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anaesthetist, ICU, Intensif care unit
Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the validity of the Human Activity Profile and Godin self-report questionnaires of physical activity in persons seeking metabolic surgery.

Detailed Description
-----------------
This cross-sectional study will collect subject's medical history, anthropometric measurements, physical activity data through an accelerometer worn on the wrist and indirect physical activity measures via the Human Activity Profile and Godin self-report questionnaires. We will collect clinical information from the medical record including predictors of physical activity level in obesity such as nutritional lab and co-morbid conditions.

Official Title
-----------------
Validity of Physical Activity Questionnaires in Persons Pursuing Bariatric Surgery

Conditions
-----------------
Bariatric Surgery Candidate, Obesity

Intervention / Treatment
-----------------
* Behavioral: Physical Activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >19 BMI > 30 Able to speak and understand English Consent to provide access to medical records for medical history Will receive weight loss procedure (sleeve gastrectomy or gastric bypass) at Nebraska Medicine Consent to wear an activity tracker device for 7 days after designated visits. Exclusion Criteria: • Age < 19

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Physical Activity|Self-report questionnaires assessing physical activity level.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Activity Profile Questionnaire | Self-report questionnaire - indirect measure of physical activity | Baseline - Single time point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Godin-Shephard Leisure Time Physical Activity (Godin) questionnaire | Self-report questionnaire - indirect measure of physical activity | Baseline - Single time point | 
| Accelerometer | Direct measure of physical activity | Baseline - Single time point | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity, accelerometer, bariatric surgery, obesity
Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

Study Overview
=================
Brief Summary
-----------------
This study is a single-center, prospective, observational clinical study to evaluate the Application of saliva EBV-DNA Detection in EBV Infection Related Diseases

Official Title
-----------------
A Prospective Study on the Application of Saliva EBV-DNA Detection in EBV Infection Related Diseases

Conditions
-----------------
EBV Infection

Intervention / Treatment
-----------------
* Diagnostic Test: Saliva Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: According to the HLH-04 diagnostic criteria, it meets the HLH diagnostic criteria. EBV infection occurs in cells with EBV-DNA copy number significantly increased in peripheral blood or tissue, or where EBV coding small RNA(EBER) is detected in tissue or peripheral blood. Or Straus' 1988 diagnostic criteria for CAEBV. Informed consent Exclusion Criteria: Patients who cannot cooperate with saliva collection Patients who are unwilling to cooperate with the project research according to the project research plan.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Saliva Testing|Saliva EBV-DNA Detection comparing with PBMC and plasma EBV-DNA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis | The sensitivity and specificity of saliva EBV-DNA detection level as a diagnosis for EBV infection-related diseases, and whether it can replace peripheral blood EBV-DNA monitoring | baseline | 
| Monitoring | The sensitivity and specificity of saliva EBV-DNA detection level as a monitoring method for EBV infection-related diseases, and whether it can replace peripheral blood EBV-DNA monitoring | 2 to 12 weeks after treatment |
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery

Study Overview
=================
Brief Summary
-----------------
The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.

Official Title
-----------------
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery - NO PEACKS

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In-patients with diagnosis of severe haemophilia A (FVIII < 1%), heavily pretreated (> 150 exposure days), without any history of inhibitors, a negative inhibitor test should be available, decision taken by the investigator to administer KOGENATE Bayer via continuous infusion during and after surgery.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222)<br>* Patients undergoing surgery and receiving continuous infusion with Kogenate Bayer according to local drug information.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of FVIII (in IU/kg) during continuous infusion, FVIII:C achieved compared to expected levels, reasons and number of unplanned bolus infusion, amount of blood loss, transfusion requirements |  | During continuous infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General tolerability and development of inhibitors |  | Within 14 days to 3 months after termination of continuous infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Continuous infusion, Surgery, Severe haemophilia A
Influence of Renal Function on the Circadian Variation of Cardiac Troponin

Study Overview
=================
Brief Summary
-----------------
Cardiac troponin is the preferred biomarker for the diagnosis of acute myocardial infarction. Whereas the diagnosis is based on an increase and/or decrease in the concentrations of cardiac troponins with at least one value above the 99th percentile value of the reference population together with the evidence of ischemia, serial sampling is needed. Knowledge of the variation in cardiac troponin levels over time in individuals in a normal rest state (not during an acute myocardial infarction), also called the biological variation, is important regarding the interpretation of the serial cardiac troponin levels. A recent study by our group showed a circadian rhythm in cardiac troponin levels. This circadian rhythm is important regarding the interpretation of the serial cardiac troponin levels. Increased cTnI and cTnT concentrations are common in subjects with renal impairment. The mechanism of the elevated concentration of cTn in these subjects is still unclear. It is hypothesized that impaired renal clearance contributes to elevated levels of cTn. However, it is not clear whether renal function affects the biological variation and circadian rhythm of cTn. The monitoring of the biological variation and circadian rhythm of cTn in subjects with impaired renal function creates the opportunity to assess the effect of renal clearance on the circadian rhythm of cardiac troponins.

Official Title
-----------------
Influence of Renal Function on the Circadian Variation of Cardiac Troponin

Conditions
-----------------
Chronic Kidney Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD stage 3 or 4 No dialysis No evidence of active, acute cardiovascular disease Exclusion Criteria: History of acute myocardial infarction in the last year History of pulmonary embolism in the last six months Anemia (Hb < 6.5 mmol/L)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Cardiac Troponins (cardiac troponin I (cTnI) and cardiac troponin T (cTnT)) |  | up to three months |
Treatment of Cholestatic Pruritus With Sertraline

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to find an effective and well-tolerated medical therapy for itching due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are currently being enrolled in the study. Persons participating in the study are given sertraline, a medication which is also often used for depression,to treat their itching. The dose is gradually increased as the effect on itching and any other potential side effects are carefully monitored.

Official Title
-----------------
Treatment of Cholestatic Pruritus With Sertraline

Conditions
-----------------
Pruritus, Liver Cirrhosis, Biliary, Hepatitis C

Intervention / Treatment
-----------------
* Drug: sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Itching for at least 3 months Primary biliary cirrhosis or hepatitis C Elevated alkaline phosphatase for at least 6 months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sertraline|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
-----------------
Cholestatic, Pruritus, Sertraline, primary biliary cirrhosis, hepatitis C