linjc16/ctgov huggingface dataset:
Cost Effectiveness and Efficacy of Kyphoplasty and Vertebroplasty Trial

Study Overview
=================
Brief Summary
-----------------
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.

Official Title
-----------------
Cost Effectiveness and Efficacy of Kypho and Vertebro Plasty Trial

Conditions
-----------------
Osteoporotic Vertebral Compression Fractures

Intervention / Treatment
-----------------
* Procedure: Kyphoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
> or = 50 years of age Compression fracture (T4-L5)within previous 12 mo. Pain from compression fracture No malignant tumor No back surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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: vertebroplasty<br>vertebroplasty | Procedure: Kyphoplasty<br>* kyphoplasty<br>|
| Active Comparator: kyphoplasty<br>kyphoplasty | Procedure: Kyphoplasty<br>* kyphoplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back specific functional status(Roland) |  | 12 mo | 
| Pain |  | 12 mo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health status outcome measure(SF-36) |  | 12 mo |
An Observational Study of Stroke Patients.

Study Overview
=================
Brief Summary
-----------------
The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.

Detailed Description
-----------------
There is in general a focus on misuse of health resources. An increasing amount of guidelines is produced to reduce the variation in treatment of patients with the same diagnosis. Many recommendations are weak but seems though to have considerable impact on in hospital care. The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent supplementary CT and MRI. The intention is to study these issues in a larger population including an evaluation of utility of the different examinations and evaluations.

Official Title
-----------------
An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.

Conditions
-----------------
Quality of Care, Cerebrovascular Disorders, Hyperglycemia, Hypertension, Troponin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and I64) Hospitalized between January 1 and December 31, 2015 Exclusion Criteria: Previous hospitalization with a diagnosis of stroke in 2015. Foreigners and patients from other regions of Norway.

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 |
| --- | --- | --- |
| Number of supplementary computer tomography and magnetic resonance imaging of the brain. | Number | 3 months | 
| The number of blood sugar measurements | Number | 72 hours after admission to hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin measurement, | frequency and level of max value | 72 hours | 
| Number of blood pressure measurement | Number | 72 hours | 
| Transfer to tertiary center | Number | 72 hours |
Efficacy and Safety of Insulin Aspart vs. Human Insulin During Pregnancy by Women With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial was conducted in Europe, Middle East, North America and South America. The aim of this trial was to compare the use of an intensified insulin treatment with insulin aspart (NovoRapid®) versus human insulin (Actrapid®) in pregnancy.

Official Title
-----------------
A Randomised, Parallel-group, Open-label, Multinational Trial Comparing the Safety and Efficacy of Insulin Aspart (NovoRapid®) Versus Human Insulin (Actrapid®), Used in a Multiple Injection Regimen, in the Treatment of Pregnant Women With Type 1 Diabetes, Focusing on Maternal Hypoglycaemia and Pregnancy Outcomes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: human insulin
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Treated with insulin for at least 12 months Either plan to become pregnant in the immediate future, willing to undertake pre pregnancy counselling, and has a screening HbA1c lesser than or equal to 12.0%, or Pregnant with normal singleton pregnancy, gestational age for at least 10 weeks at the time of randomisation, confirmed by ultrasound scan. Exclusion Criteria: Previous birth of child with a major congenital malformation More than 2 previous multiple miscarriages or stillbirths Severe hyperemesis gravidarum, requiring hospitalisation, according to Investigator judgement Subjects being treated for infertility Proliferative retinopathy or maculopathy requiring acute treatment Drug or alcohol abuse Impaired renal, hepatic or cardiac function

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

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

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: human insulin|nan|
|Drug: insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk of major maternal hypoglycaemia |  | after 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk of major and minor hypoglycaemia |  |  | 
| Diabetic complications |  |  | 
| Obstetric complications |  |  | 
| Other Adverse Events |  |  |
A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

Detailed Description
-----------------
To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Official Title
-----------------
A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea

Conditions
-----------------
Papulopustular Rosacea

Intervention / Treatment
-----------------
* Drug: azelaic acid 15% gel
* Drug: azelaic acid 15% gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules Exclusion Criteria: Mild or severe rosacea Rosacea with marked ocular manifestations Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia History of hypersensitivity to propylene glycol

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Azelaic acid 15 % gel once daily | Drug: azelaic acid 15% gel<br>* 15% gel, topically applied once daily for six weeks<br>|
| Active Comparator: 2<br>Azelaic acid 15 gel twice daily | Drug: azelaic acid 15% gel<br>* 15% gel, topically applied twice daily for six weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's global assessment scored on a seven point scale |  | Measurements made during the course of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy |  | Parameters measured during the course of treatment |
Dead Space Monitoring With Volumetric Capnography in ARDS Patients

Study Overview
=================
Brief Summary
-----------------
This studies´ objective is to describe how different PEEP levels affect dead space measured by Bohr´s formula.

Detailed Description
-----------------
In ARDS patients PEEP has contradictory effects on ∆P (driving pressure of the airway) hat depends on the balance between lung recruitment and overdistension. Some authors showed that incremental levels of PEEP did not much affect dead space in ARDS patients. These studies used different methods for the assessment of dead space. Such technique also overestimates the dead space. We believe that the right way to measure dead space is applying the original Bohr's equation using the mean PACO2 value. Therefore, the aim of this observational study was to describe the effect that PEEP has on Bohr's dead space and its sub-components in mechanically ventilated patients with ARDS. This observational study was performed in the Intensive Care Unit of a University Hospital. Protocol design The protocol started recording the data during baseline protective ventilation. After 15 minutes of data recording, we studied four levels of PEEP - 0, 6, 10 and 16 cmH2O - which were randomly assigned by a randomization table. Respiratory, hemodynamic, arterial blood gas analysis and volumetric capnographic parameters were recorded. We analyzed the last 2 minutes of each protocol steps consisting in more than 30 breaths or data-points.

Official Title
-----------------
Dead Space Monitoring During PEEP Titration in Patients With Hypoxemia Secondary to Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome, Capnography

Intervention / Treatment
-----------------
* Other: PEEP titration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 18 years requirement of invasive mechanical ventilation for more than 4 hours and less than 12 hours severe hypoxemia (PAFI < 200) secondary to ARDS or post-operatory atelectasis Exclusion Criteria: -requirement of invasive mechanical ventilation prior to enrollment in this study

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

| Intervention/Treatment |
| --- |
|Other: PEEP titration|Exposure to different PEEP levels|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dead space variation | How dead space, measured by Bohr´s formula, varies with different PEEP levels during a recruitment manouver | 60 min |
Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the change in muscle volume around the hip in patients with unilateral femoro-acetabular impingement (FAI) after arthroscopy.

Detailed Description
-----------------
We performed a retrospective review of magnetic resonance imaging (MRI) data of FAI patients who underwent hip arthroscopy between January 1, 2016, and July 1, 2018. Image J with an embedded region-of-interest (ROI) tool was used to calculate the cross-sectional area (CSA) of muscles on MRI. Wilcoxon signed-rank test was used to determine the differences between preoperative and postperative hip muscle CSA. The correlations of change in muscle CSA with age, gender, BMI, pain level, preoperative symptom duration, and multiple validated patient-reported outcomes were also analyzed with a spearman rank correlation test.

Official Title
-----------------
Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy

Conditions
-----------------
Femoro-acetabular Impingement (FAI)

Intervention / Treatment
-----------------
* Procedure: hip arthroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Age 18-50 years; (2) symptoms, physical examination, imaging evidence in accordance with FAI; (3) symptoms that were not alleviated by nonsurgical treatment; (4) the operation is performed by the same senior operator. Exclusion Criteria: (1) bilateral symptoms; (2) revision surgery; (3) advanced osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease and operation; (6) osteonecrosis of hip; (7) sacroiliac joint disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: hip arthroscopy|hip arthroscopy was performed when symptoms were not alleviated by nonsurgical treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle volume after hip arthroscopy | hip muscle cross-sectional area of patients with unilateral FAI | at least two years after hip arthroscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
femoro-acetabular impingement, hip muscle volume, cross-sectional area, arthroscopy, MRI images
The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the accuracy of clinician interpretation.

Official Title
-----------------
The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation

Conditions
-----------------
Coagulation Disorder, Blood

Intervention / Treatment
-----------------
* Device: Novel ROTEM interpretation software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current residents and attending physicians in the University of Utah Department of Anesthesiology who have a range of experience and exposure to thromboelastography Exclusion Criteria: Refusal to consent or no longer an active member of the University of Utah Department of Anesthesiology

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The sensitivity/specificity and diagnostic accuracy of clinicians will be compared before and after the use of novel ROTEM app. The performance of more experienced clinicians will be compared to those with little to no experience in ROTEM. Analysis will be done using a mixed effects model to account for clustering of measurements within clinician groups. Inter-rater reliability analysis will be done to assess the similarity within clinician groups using the ICC.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Software Tutorial<br>Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software. | Device: Novel ROTEM interpretation software<br>* Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | sensitivity/specificity of clinician responses compared to a reference standard | 1 year of data collection |
Reduction of Post Intravitreal Injection Bleeding and Pain by Ice

Study Overview
=================
Brief Summary
-----------------
Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern. Prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.

Detailed Description
-----------------
cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.

Official Title
-----------------
Reduction of Post Intravitreal Injection Bleeding and Pain by Ice

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: ice pack
* Other: room temperature pack


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving intravitreal injection 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ice<br>Patients were randomly assigned to receive an ice 5 minutes prior the IViT | Other: ice pack<br>* ice pack was placed on eyelid 5 minutes prior to IVIT<br>|
| Placebo Comparator: placebo<br>Patients were randomly assigned to a room temperature patch (placebo) 5 minutes prior the IViT | Other: room temperature pack<br>* room temperature pack was placed on eyelid 5 minutes prior to IVIT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | Visual Analogue Scale (VAS) is a Likert-type scale (1-10). The VAS is a reliable tool in evaluating and quantifying ocular discomfort | change between VAS pain score at baseline and 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| size of subconjunctival hemorrhage | subconjunctival hemorrhage in mm | change between subconjunctival hemorrhage at baseline and 10 minutes |
Safety and Efficacy Study of Bimosiamose Cream to Treat Psoriasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Bimosiamose Cream is safe and effective in the treatment of plaque type psoriasis.

Official Title
-----------------
Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety and Efficacy of Bimosiamose 5% Cream for the Treatment of Patients With Chronic Plaque Type Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Bimosiamose Cream
* Drug: Placebo Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of plaque type psoriasis PASI score of 5-15 At least 18 years of age Written informed consent Exclusion Criteria: Active skin infection More than 20% Body Surface Area (BSA) affected by psoriasis Use of certain anti-psoriasis medication or treatments

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 |
| --- | --- |
| Active Comparator: Bimosiamose Cream<br> | Drug: Bimosiamose Cream<br> <br> |
| Placebo Comparator: Placebo Cream<br> | Drug: Placebo Cream<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |