linjc16/ctgov huggingface dataset:
Adaptation of a Premorbid Function Scoring System as a Predictor for Intensive Care Unit Mortality

Study Overview
=================
Brief Summary
-----------------
To evaluate whether a premorbid functioning scoring system such as the ECOG system can be adapted to predict ICU morbidity and mortality.

Official Title
-----------------
Adaptation of a Premorbid Function Scoring System as a Predictor for Intensive Care Unit Mortality

Conditions
-----------------
ICU Mortality, ICU Morbidity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged 18 years and older admitted to the Presbyterian Hospital intensive care units under the medical ICU service. Exclusion Criteria: -

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 |
| --- | --- | --- |
| Mortality | Data will be expressed as mean + SD. Non parametric data will be expressed as median with interquartiles. Student t-test will be used to compare the normally distributed data, and the Mann-Whitney U test will be used for non parametric data. Chi-Squared test will be used to assess for trend between the ECOG score and the 30-day mortality. The investigators will use logistic regression analysis to determine the factors (including the ECOG score) associated with the 30-day mortality. Significance will be accepted for p values < 0.05. | 30-day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
premorbid, scoring system, ECOG, ICU, morbidity, mortality
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

Study Overview
=================
Brief Summary
-----------------
A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

Official Title
-----------------
A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: ropinirole


Participation Criteria
=================
Eligibility Criteria
-----------------
Â Inclusion criteria: Patients diagnosed with Restless Legs Syndrome (RLS). Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement). Patients must give written informed consent prior to any specific study procedures. Exclusion criteria: Patients with a primary sleep disorder other than RLS. Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease). Other inclusion or exclusion criteria to be evaluated by the physician.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: ropinirole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLS, Restless Legs Syndrome
Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
The activated clotting time (ACT), global thrombosis test (GTT-3), platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI).

Detailed Description
-----------------
The activated clotting time (ACT), global thrombosis test (GTT-3) and platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI) - 20 smoking and 20 non-smoking.The measurements will take place: before coronary angiography (CA), 10 minutes after unfractionated heparin (HNF), 2h after CA, 6h after CA, 30 days after CA

Official Title
-----------------
Coagulation Profile in Patients Undergoing Coronary Intervention Measured With Activated Clotting Time, Global Thrombosis Test and Platelet Inhibition VerifyNow P2Y12 Test

Conditions
-----------------
Chronic Coronary Insufficiency, Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled do CA >18 years old Exclusion Criteria: pregnancy previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-smoking<br>Non-smoking patients undergoing coronary angiography or percutaneous coronary intervention | |
| Smoking<br>Smoking patients undergoing coronary angiography or percutaneous coronary intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACT change | Activated Clotting Time | Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT | 
| GTT-3 change | Global Thrombosis Test | Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT | 
| VerifyNow change | Platelet inhibition P2Y12 test | Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary angiography, activated clotting time, platelet inhibition
Use of 50% Nitrous Oxide / 50% Oxygen Premix During Liver Biopsy of Focal Lesion

Study Overview
=================
Brief Summary
-----------------
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of liver biopsy in order to relax him and to reduce his pain during this painful medical treatment. This single investigator centre and national clinical trial is done blindly : half of patients will receive 50% nitrous oxide / 50% oxygen premix and half of them a placebo gas (mixture of 50% oxygen and 50% nitrogen). 94 patients will be included in this clinical protocol.

Official Title
-----------------
Study of the Efficiency of Kalinox 170 Bar During Liver Biospy of Focal Lesion

Conditions
-----------------
Liver Biopsy

Intervention / Treatment
-----------------
* Drug: Kalinox 170 bar
* Drug: Mix of 50% oxygen and 50% nitrogen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient requiring a liver biopsy of focal lesion Age upper than 18 years OMS : 0 to 3 patient consent form signed Exclusion Criteria: patient unable to use Visual Analog Scale (VAS) OMS upper than 3 coagulation disorder contraindication linked to the experimental product patient already included in another clinical trial uncompatible with this trial

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Mixture of 50% nitrous oxide and 50% oxygen | Drug: Kalinox 170 bar<br>* Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour<br>|
| Placebo Comparator: B<br>Mixture of 50% oxygen and 50% nitrogen | Drug: Mix of 50% oxygen and 50% nitrogen<br>* Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measurement by using Visual Analog Scale (VAS) |  | At the end of the liver biospy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's acceptance and doctor's satisfaction |  | At the end of the liver biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver biopsy
Master Rollover Protocol for Continued Safety Assessment of Study Drug

Study Overview
=================
Brief Summary
-----------------
This study is for patients who have participated in a previous study and who continue to receive benefit to have continued access to study drug and/or treatment.

Official Title
-----------------
Master Rollover Protocol for Continued Safety Assessment of Study Drug

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: LY2503029
* Drug: LY3023414


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible patients must be currently receiving benefit in a concluded Lilly study for a compound that has opened an addendum in the continued access protocol. Exclusion Criteria: Patients must not be concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY2503029|Administered orally.|
|Drug: LY3023414|Administered orally.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Proof-of-principle Study of Oral Treatment of Non-alcoholic Steatohepatitis With a Novel PDE4 Inhibitor ASP9831

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period

Detailed Description
-----------------
The study includes an open-label sub-study prior to the main study

Official Title
-----------------
Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)

Conditions
-----------------
Non-Alcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Drug: ASP9831
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization Elevated serum ALT levels Exclusion Criteria: Hepatic cirrhosis Other known cause of liver disease Uncontrolled diabetes mellitis type 2, i.e. HbA1c > 8.5% Positive history of tuberculosis or a positive PPD skin test which is not explained by previous BCG vaccination History of excessive alcohol abuse within 5 years prior to screening or a current average alcohol intake of more than 20 g/day (2 units) for females or more than 30 g/day (3 units) for males Subject has used drugs associated with steatohepatitis within 6 months prior to screening (corticosteroids, high dose estrogens, methotrexate, amiodarone, anti-HIV drugs, tamoxifen)

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP9831 Low Dose<br> | Drug: ASP9831<br>* Oral<br>|
| Experimental: ASP9831 Higher Dose<br> | Drug: ASP9831<br>* Oral<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NASH, Chronic liver disease
Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the difference in stylet curvature affects the ease of tracheal intubation using C-MAC videolaryngoscope in infants under 1 year of age.

Official Title
-----------------
Comparison of Different Stylet Angles for Orotracheal Intubation Using C-MAC® Video Laryngoscopes in Infants

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Other: Style curve similar to natural curvature of endotracheal tube
* Other: Style curve similar to hockey stick shape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ① Infants under 1 year old scheduled for elective surgery under general anesthesia ② American Society of Anesthesiology physical status I, II Exclusion Criteria: Any pulmonary disease

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C-curve group (group C)<br>In group C, stylet curvature is made similar to the natural curvature of endotracheal tube. | Other: Style curve similar to natural curvature of endotracheal tube<br>* Stylet curvature is made similar to the natural curvature of endotracheal tube for intubation using C-MAC videolaryngoscope.<br>|
| Active Comparator: Hockey stick curve group (group H)<br>In group H, stylet curvature is made similar to hockey stick shape. | Other: Style curve similar to hockey stick shape<br>* Stylet curvature is made similar to hockey stick shape for intubation using C-MAC videolaryngoscope.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tube handling time | From glottis visualization to completion of tracheal intubation | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intubation time | From insertion of C-MAC blade to completion of tracheal intubation | during procedure | 
| Time to reaching glottis | From visualization of glottis to reaching the glottis of tube tip | during procedure | 
| The location of the initial tube tip | The location of the initial tube tip on the screen of C-MAC | during procedure | 
| Successful tracheal intubation | Incidence of successful intubation within 30 sec | during procedure, within 30 sec | 
| Additional manipulation of stylet angle |  | during procedure | 
| Number of external laryngeal manipulation |  | during procedure | 
| Easiness of tracheal intubation | Visual analogue scale (0-10, 0: extremely easy, 10: extremely difficult) | during procedure |
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess the feasibility and effectiveness of using a statewide immunization information system (IIS) to send seasonal influenza vaccine reminders from Local Health Departments (LHDs), targeting children with high-risk conditions.

Official Title
-----------------
Seasonal Influenza Vaccination Reminders for Children With High-risk Conditions

Conditions
-----------------
Seasonal Influenza Vaccination

Intervention / Treatment
-----------------
* Behavioral: Mailed influenza vaccination reminder notice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children, 24-60 months current or previous enrollment in Medicaid (Michigan) presence of at least 1 chronic condition, as indicated by the Michigan Care Improvement Registry (MCIR) resident of Kalamazoo, Ottawa, or Kent counties (Michigan) Exclusion Criteria: receipt of influenza prior to notification date ineligible for reminder/recall notification in the Michigan Care Improvement Registry (MCIR)

Ages Eligible for Study
-----------------
Minimum Age: 24 Months
Maximum Age: 60 Months

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mailed reminder notice<br>Seasonal influenza vaccination reminder sent by postal mail | Behavioral: Mailed influenza vaccination reminder notice<br>* Influenza vaccination reminder sent by postal mail<br>|
| No Intervention: No reminder notice<br>No seasonal influenza vaccination reminder sent by postal mail | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seasonal influenza vaccination | Receipt of 1 or more dose of seasonal influenza vaccine, either trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV) | up to 4 months following reminder notification | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invalid mailing address | Postal mailing address determined to be invalid for mail delivery, either by physical return of mailed reminder notification, or through the United States Postal Service's National Change of Address (NCOA) process | up to 4 months following reminder notification | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, vaccine, reminder / recall, immunization registry, immunization information systems
Postoperative Nausea and Vomiting: to Estimate the Incidence and Risk Factors in a Tertiary Teaching Hospital

Study Overview
=================
Brief Summary
-----------------
Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia. The aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Detailed Description
-----------------
Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia, in the literature it reaches up to 70% of the surgical patients and it occurs after local and general anesthesia with surgery. Locally in Jordan there was no proper clinical study to estimate PONV among surgical patients, the aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Official Title
-----------------
Postoperative Nausea and Vomiting: A Prospective Observational Study to Estimate the Incidence and Risk Factors Over One Year in a Tertiary Teaching Hospital

Conditions
-----------------
Postoperative Nausea and Vomiting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergoes anesthesia and surgery. Patients who suffer from postoperative nausea and vomiting for 24 hours. Exclusion Criteria: Patients who suffer from postoperative nausea and vomiting after 24 hours. Patients who undergoes Day-case surgery.
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 |
| --- | --- | --- |
| Postoperative nausea and vomiting |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, postoperative, nausea, vomiting