linjc16/ctgov huggingface dataset:
Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to prospectively assess the general safety profile of Dotarem

Official Title
-----------------
Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

Conditions
-----------------
General Safety Profile of DOTAREM

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient scheduled for a Dotarem®-enhanced MRI Exclusion Criteria: patient with a contra-indication to MR examination patient with a contra-indication to Dotarem® injection as per local SPC
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 |
| --- | --- | --- |
| Frequency of Adverse Events | Adverse Events were notified and described. | During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nephrogenic Systemic Fibrosis Incidence | For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis. | Follow-up of at least 3 months after magnetic resonance examination | 
| Image Quality | Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good. | Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) | 
| Diagnostic Quality | Diagnostic quality was assessed by the radiologist by answering the question could you come to a diagnostic ? (answer : yes or no). | Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour) |
Objective Evaluation of Shoulder Pathology and Surgery

Study Overview
=================
Brief Summary
-----------------
The goal of this study was to clinically validate a new device for the objective outcome evaluation of adult patients undergoing shoulder surgery for glenohumeral osteoarthritis and rotator cuff disease, using the activities of daily living described in the Simple Shoulder Test (SST) as a reference. The study was set up as a clinical trial including patients over an observation period of one year and a control group of subjects. Clinical evaluations will be made at baseline, 3 months, 6 months and 1 year after surgery by two independent observers. Miniature sensors each containing three 3D gyroscopes and three 3D accelerometers will allow computing new kinematic scores. They will be compared to the regular SST, DASH, ASES and Constant scores.

Conditions
-----------------
Glenohumeral Osteoarthritis, Rotator Cuff Disease

Intervention / Treatment
-----------------
* Device: Body fixed 3D sensors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old patients with a unilateral rotator cuff disease implying a transfixiant supraspinatus rupture of at least 1 cm2, as determined by Magnetic Resonance Imaging (MRI), or a unilateral glenohumeral osteoarthritis stage II or III according the radiologic criteria published by Koss informed and signed consent Exclusion Criteria: Patients who had a previous shoulder surgery (open or arthroscopic) Patients who had a contralateral shoulder pathology

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Body fixed 3D sensors|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Is the 4MGS a Useful Outcome Measure Post-PPCI

Study Overview
=================
Brief Summary
-----------------
This study aims to assess usual walking speed (4-metre gait speed) in patients undergoing primary percutaneous coronary intervention (PCI) for acute myocardial infarction and to assess whether this can predict future cardiovascular events and death.

Official Title
-----------------
Is the Four Metre Gait Speed a Useful Outcome Measure in Patients With Acute Myocardial Infarction After Primary Percutaneous Coronary Intervention?

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient hospitalised with an acute myocardial infarction who has undergone primary percutaneous coronary intervention Capacity to consent Able to walk Age over 18 years Exclusion Criteria: Significant co-morbidities that would limit exercise capacity or make exercise unsafe (e.g. neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)

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 rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of cardiovascular events |  | 1 and 5 years | 
| Need for repeat revascularisation |  | 1 and 5 years | 
| Health resource usage |  | 1 and 5 years | 
| All-cause mortality |  | 5 years | 
| Cardiovascular death |  | 1 and 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous coronary intervention
Intensive Care Therapy of Covid-19 Disease in Germany

Study Overview
=================
Brief Summary
-----------------
Multi-center retrospective and prospective observational study of Covid-19 patients with severe or critical illness treated on a German ICU

Official Title
-----------------
Intensive Care Therapy of Covid-19 Disease in Germany an Multi-center Observational Study

Conditions
-----------------
COVID, ARDS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years Covid-19 disease (positive SARS-CoV-2 PCR) Exclusion Criteria: -none

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 | ICU Mortality of patients | up to 150 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | Intensive care unit length of stay | up to 150 days |
Osteoarthritis Topical Treatment

Study Overview
=================
Brief Summary
-----------------
This is a phase 2a clinical trial performed to evaluate the efficacy of a topical treatment of ibuprofen compared to the use of a placebo topical treatment. A multi-center, double-blinded, randomized placebo controlled study. Study length: 14 days Dosing twice daily (b.i.d.)

Official Title
-----------------
A Pilot Study to Compare the Efficacy and Safety of a Novel 10% Ibuprofen Formulation Versus Placebo Alone Applied to the Knee in Patients With Painful Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Ibuprofen
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Male or female patients aged at least 40 years. Primary osteoarthritis in a single knee joint, grade II/III based on the Kellgren and Lawrence classification system. Radiographic evidence consistent with osteoarthritis carried out within 6 months before screening. pain is currently not adequately controlled with a simple analgesic or an NSAID OR would necessitate treatment, but is not yet treated. Main Exclusion Criteria: Concomitant presence of another type of continuous pain that is more severe in intensity in comparison with the osteoarthritis target joint pain Osteoarthritis causing significant pain in any joint other than the identified knee, or contralateral knee (≥ 20 mm pain) as confirmed by a separate VAS at visit 1 for any other painful joint concerned. Female patients who are pregnant or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Ibuprofen<br> | Drug: Ibuprofen<br>* 10% ibuprofen cream formulation at a dose of 200mg<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 2 grams of placebo cream for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) Pain scale |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, knee pain
Metabolic Syndrome Observation on a Regional Basis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the prevalence of Metabolic Syndrome in Italy on a regional basis, defined according to NCEP/ATPIII Guidelines criteria.

Official Title
-----------------
Osservatorio Regionale Sulla Sindrome metabolicA

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged between 18 and 75 years Signed Informed consent Laboratory analysis (lipidic profile and glycemia) performed in the last year Exclusion Criteria: Pregnancy or breast feeding Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Prevalence of Metabolic Syndrome in Primary Care Population |  | July 2009 - March 2010 | 
| Concomitant presence of other CV risk factors |  | July 2009 - March 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic syndrome, lipids, waist circumference, HDL, hypertension
Venous Air Embolism in Cesarean Delivery, Especially Placental Previa

Study Overview
=================
Brief Summary
-----------------
Effects of placenta previa on incidence and severity of venous air embolism in patients during cesarean delivery

Conditions
-----------------
Cesarean Delivery With Placental Previa

Intervention / Treatment
-----------------
* Procedure: cesarean delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteer with cesarean delivery Exclusion Criteria: the one who rejects to participate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| placental previa<br> | Procedure: cesarean delivery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| read sonography records during the surgery | Three sono views will be recorded rapidly for later interpretation of the stage of air embolism. The midesophageal (ME) 4-chamber view will be continuously monitored during surgery and videotaped. When a bubble is detected in the right atrium (RA), the probe will be turned to the right side and the angle was adjusted to the ME bicaval view to confirm its entrance from the inferior vena cava. Then, the angle will be rapidly re-adjusted to view the ME right ventricle (RV) inflow-outflow view to confirm the extent of air embolism through the right ventricular outflow tract (RVOT). | After 1 or 2 weeks of surgery |
Evaluation of the Pediatric Igel Airway in 250 Children

Study Overview
=================
Brief Summary
-----------------
Once a child has been anaesthetised and is fully asleep, a special airway tube called a laryngeal mask is often inserted into their mouth to help with their breathing. This tube is removed just before the child wakes up. A new type of airway tube, called an i-gel airway, has been developed for children, which is hoped will be easier to insert, safer once in position, and will be less likely to cause a sore throat after the anaesthetic than a standard laryngeal mask. The adult i-gel airway has been available for adults since 2007, and early trials have shown very encouraging results.

Official Title
-----------------
A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants

Conditions
-----------------
Anesthesia, Child, Infant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children weighing 5 -30kg Classified by the American Society of Anesthesiology (ASA) as grade 1-2, Scheduled for elective surgery under general anaesthesia, in whom a LMA or PLMA would otherwise be used for airway maintenance and in whom neuromuscular blocking drugs will not be used. Exclusion Criteria: Inability of patient or parents to understand the study or consent process Neck pathology Previous or anticipated airway problems Pathology of airway, respiratory tract, upper gastrointestinal tract Increased risk of regurgitation or aspiration Weight >30kg or <5 kg ASA 3 and above, Emergency surgery

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- |
| Children<br>between 10 and 30 kgs | |
| Infants<br>between 5 - 10 kg | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children? |  | during anaesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post-operative sequelae |  | during anaesthesia and up to 24 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anesthesia, child, infant, laryngeal mask
Efficacy and Safety of Grass-SPIRE Registration Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season

Official Title
-----------------
A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis

Conditions
-----------------
Rhinitis, Conjunctivitis

Intervention / Treatment
-----------------
* Drug: Grass-SPIRE
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years Score of ≤ 21 on RCAT questionnaire Rye grass specific IgE of ≥ 0.7 kU/L Positive skin prick test to Rye grass whole allergen extract Exclusion Criteria: History or findings of significant disease Asthma requiring GINA Step 3 or higher treatment History of severe drug allergy, severe angioedema or systemic allergic reaction Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years Contraindications for administration of epinephrine

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 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: Grass-SPIRE<br>Eight intradermal injections of Grass-SPIRE | Drug: Grass-SPIRE<br> <br> |
| Placebo Comparator: Placebo<br>Eight intradermal injections of Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Score of symptoms and allergy medication | Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication | Approximately 66 weeks | 
| Safety of Grass-SPIRE | Measurement of adverse events | Approximately 66 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Scores | Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects | Approximately 66 weeks | 
| Rescue Medication Use | Use of allergy medication to help allergy symptoms | Approximately 66 weeks | 
| Quality of Life | Assessment of Quality of Life measured by responses to a questionnaire | Approximately 66 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rhinitis, Conjunctivitis, Grass, Allergy
Quantification of Cannabinoids and Comparison to Post-Surgical Pain Medication Requirements and Surgical Outcomes

Study Overview
=================
Brief Summary
-----------------
To determine how daily cannabis use affects surgical outcomes.

Detailed Description
-----------------
To determine if patients who are daily cannabis users that are undergoing inpatient abdominal surgery for the treatment of cancer are different from non-cannabis users regarding phytocannabinoid and endocannabinoid levels, pain scores, pain medication requirements, and surgical complications.

Official Title
-----------------
Quantification of Endo- and Phytocannabinoids With Comparison to Pain Medication Requirements and Surgical Outcomes for Patients Undergoing Abdominal Surgery for Cancer

Conditions
-----------------
Post-Surgical Pain, Post-Surgical Complication, Cancer, Cannabis Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 21 years old Undergoing abdominal surgery for the treatment of cancer Report no cannabis use in the last year or daily cannabis use Exclusion Criteria: patients with chronic pain, chronic pain syndrome on opioids female patients who are pregnant or lactating patients who report use of illicit substances

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Daily cannabis users<br>Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report daily cannabis use | |
| Cannabis non-users<br>Patients undergoing inpatient abdominal surgery for the treatment of cancer who self-report no cannabis use | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | Postoperative opioid consumption among daily cannabis using and non-cannabis using patients undergoing abdominal surgery for cancer | 30 days | 
| Correlation of postoperative opioid consumption | Correlation between serum phytocannabinoid and endocannabinoid levels, pain scores, and postoperative opioid consumption | 30 days | 
| Correlation of postoperative complications | Correlation between 30-day post-operative complications, preoperative, and postoperative phytocannabinoid and endocannabinoid levels | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannabis, Post-Surgical Complications, Post-Surgical Pain, Abdominal Surgery