linjc16/ctgov huggingface dataset:
Clinical Outcomes and Global Epidemiology -Data Coordinating Center

Study Overview
=================
Brief Summary
-----------------
The primary objective is to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. Secondary Objectives include the following: To determine the impact of inactive empiric antimicrobial therapy, defined as receipt of empiric antimicrobial therapy with no in vitro activity against the offending isolate for at least 24hrs, on the outcome (end points defined below) of patients with Acinetobacter bloodstream infection. To determine the impact of carbapenem resistance and pan-drug resistance (defined as resistance to all antimicrobials except colistin and/or tigecycline if these agents were tested) on the outcome of patients with Acinetobacter bloodstream infection. To assess the efficacy of varying definitive therapies on the outcome of patients with Acinetobacter bloodstream infection. To characterize the molecular epidemiology of Acinetobacter on a global level, as determined by pulsed-field gel electrophoresis (PFGE) and other techniques, and to assess whether patient outcomes are clonally related and to characterize the mechanisms of resistance in Acinetobacter on a global scale.

Detailed Description
-----------------
Medical records will be reviewed and information collected from charts to assess for independent predictors of in-hospital mortality (up to 28 days) in patients with Acinetobacter bloodstream infection. 24 sites will participate and all information will be loaded into a password protected database.

Official Title
-----------------
Clinical Outcomes and Global Epidemiology -Data Coordinating Center

Conditions
-----------------
Acinetobacter Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acinetobacter bloodstream infection Exclusion Criteria: Does not meet entry 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acinetobacter, bloodstream infection, Isolate
Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group. The investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging.

Official Title
-----------------
Correlation Between Middle Turbinate Histopathology and Computed Tomography Staging in Chronic Rhinosinusitis

Conditions
-----------------
Chronic Rhinosinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with chronic rhinosinusitis who failed conservative medical treatment, Patients who stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery. Exclusion Criteria: Immunosuppressed patients, Patients in whom no indication to excise the middle turbinate was found, AND Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).

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 |
| --- | --- | --- |
| inflammation of soft tissue and bony elements of the middle turbinate |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between middle turbinate histopathology and CT staging in chronic rhinosinusitis |  | two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic rhinosinusitis, Computed tomography, Histology, Middle turbinate, Morphometry, osteomyelitis, polyps
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term safety of YVOIRE classic s by incidence of adverse events including injection site local reactions and biodegradability

Official Title
-----------------
A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s Injected Into the Nasolabial Folds

Conditions
-----------------
Correction of Nasolabial Folds

Intervention / Treatment
-----------------
* Device: YVOIRE Classic s


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects whose age is over 18 years old Subjects whose WSRS grade is equal or greater than 2 Subjects must be willing and able to provide written informed consent Subjects who are scheduled to be treated with YVOIRE classic s for facial tissue augmentation to correct the nasolabial folds Exclusion Criteria: Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE classic s Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening Subjects who have received face lifting or plastic surgery on face within 9 months before screening Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites Subjects who tend to have hypertrophic scars Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders. Women in pregnancy or lactation

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| YVOIRE Classic s<br>Treatment with YVOIRE Classic s | Device: YVOIRE Classic s<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Device-related Adverse Events |  | Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years. |
Bevacizumab Effect on Blood Velocity

Study Overview
=================
Brief Summary
-----------------
Retinal blood flow velocity is affected by Bevacizump intravitreal injection. This effect is correlated to treatment success.

Detailed Description
-----------------
The purpose of the study was to carry out a pilot study on the short-term effect of intravitreal Bevacizumab (Avastin) injection on retinal blood-flow velocity and test whether the short-term haemodynamic changes could predict the longer term clinical result of the treatment.

Official Title
-----------------
The Effect of Intravitreal Bevacizumab (Avastin) Injection on Retinal Blood-Flow Velocity in Patients With Choroidal Neovascularization

Conditions
-----------------
Choroidal Neovascularization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CNV receiving Bevacizumab intravitreal injection Exclusion Criteria: Candidates in whom the retina could not be seen clearly because of media opacity or a poorly dilating pupil
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 |
| --- | --- | --- |
| Blood flow velocity change |  | 1 day following injection |
PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

Study Overview
=================
Brief Summary
-----------------
An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

Official Title
-----------------
An Open-label, PhaseⅢ Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: MRA(Tocilizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987 Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study Exclusion Criteria: Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug Subjected to any of the following within 4 weeks before administration of the study drug: Surgical treatment (operations,etc.). Plasma exchange method

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRA(Tocilizumab)<br>* 8mg/kg/4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of ACR 20％ improvement at the final visit |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of the frequency of ACR 20％, 50％ and 70％ improvement,time course of individual items within the ACR core set. |  | throughout study | 
| Time course of DAS28 to the final visit. |  | throughout study | 
| Time course of steroid sparing effect from first visit to final visit. |  | throughout study |
To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.

Official Title
-----------------
A Single-Dose Comparative Bioavailability Study of Two Formulations of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release Tablets Under Fed Conditions

Conditions
-----------------
Allergies

Intervention / Treatment
-----------------
* Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)
* Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 53 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 |
| --- | --- |
| Experimental: 1<br>Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA) | Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)<br> <br> |
| Active Comparator: 2<br>Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA) | Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 10 days |
Post-market Safety Reassessment of Ulinastatin for Injection

Study Overview
=================
Brief Summary
-----------------
Investigate the application of ulinastatin(UTI) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) Analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin. Evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.

Detailed Description
-----------------
In order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. This trial is an observational study. The investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in ICU. This study would be expected to provide evidence for appropriate medication to administration department of health authority.

Official Title
-----------------
Post-market Safety Reassessment of Ulinastatin for Injection

Conditions
-----------------
Adverse Reaction to Drug

Intervention / Treatment
-----------------
* Drug: ulinastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ulinastatin treated Exclusion Criteria: Not applicable
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| general department<br>Patients using ulinastatin in department beyond ICU would be labelled as general department group. | Drug: ulinastatin<br>* We wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin.<br>* Other names: bikunin;|
| ICU<br>Patients using ulinastatin in ICU would be labelled as ICU group. | Drug: ulinastatin<br>* We wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin.<br>* Other names: bikunin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | participants will be followed for the duration of using ulinastatin, an expected average of 7 days |
Time for Lunch: The Impact of Lunch Time Constraints on Child Eating Behaviors

Study Overview
=================
Brief Summary
-----------------
Recent peer-reviewed observational evidence suggests that school children receive anywhere from 10-33 minutes of seated lunch time and that students with less time to eat discard higher amounts of milk, entrée (i.e. protein items), grains, and vegetables. This waste is a missed nutritional and food security opportunity and also negatively impacts the environment. The purpose of this study is to estimate the impact that lunch time constraints have on child food selection, consumption and waste behaviors using a crossover trial design, where the duration of seated lunch times are randomly allocated to be either 10 minutes or 20 minutes each day.

Official Title
-----------------
Time for Lunch: The Impact of Lunch Time Constraints on Child Eating Behaviors

Conditions
-----------------
Time Constraints During School Meals

Intervention / Treatment
-----------------
* Behavioral: Lunch period length


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be enrolled in local summer camp Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shortened lunch period<br>The amount of seated lunch time will be 10 minutes. | Behavioral: Lunch period length<br>* We are randomly allocating a 10 minute or 20 period of seated lunch time.<br>|
| Experimental: Longer lunch period<br>The amount of seated lunch time will be 20 minutes. | Behavioral: Lunch period length<br>* We are randomly allocating a 10 minute or 20 period of seated lunch time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food item selection | The type and number of school meal components selected by students to eat for lunch. | Ranges from 5 days to 20 days, depending upon how long each participant elects to enroll in the summer camp | 
| Food item consumption | The weight of each school meal component that was consumed by each child during lunch. Each measured in grams. | Ranges from 5 days to 20 days, depending upon how long each participant elects to enroll in the summer camp | 
| Food item waste | The weight of each school meal component that was discarded by each child during lunch. Each measured in grams. | Ranges from 5 days to 20 days, depending upon how long each participant elects to enroll in the summer camp |
E-learning: Teaching of Blindness Prevention

Study Overview
=================
Brief Summary
-----------------
E-learning material increases the student knowledge level before the traditional class of blindness prevention and help to fix this information a short period (one month) after the class.

Official Title
-----------------
E-learning as a Complement to Traditional Teaching of Blindness Prevention

Conditions
-----------------
Teaching Technique

Intervention / Treatment
-----------------
* Other: E-learning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being a medical student matriculated in the course of ophthalmology. This course is taught to fourth-year students at State University of Campinas. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Traditional teaching<br>A traditional class of blindness prevention. | Other: E-learning<br>* A traditional class of blindness prevention plus an additional e-learning material. The e-learning material included a PDF article about blindness prevention. This material was e-mailed one week before the traditional class.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate pretest score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-month posttest score |  |  | 
| Immediate posttest score. |  |  |