linjc16/ctgov huggingface dataset:
Faslodex Specific Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.

Detailed Description
-----------------
MC MD

Official Title
-----------------
Faslodex Specific Clinical Experience Investigation for Long-term Use

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Faslodex for the first time due to postmenopausal breast cancer Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Faslodex<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions. |  | 1 year | 
| Incidence of serious adverse events. |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions with injection site reaction, thromboembolic events and hepatic impairment |  | 1 year | 
| Progression-free survival |  | 6 month | 
| Progression-free survival |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postmenopausal breast cancer, Faslodex, cohort
Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol

Study Overview
=================
Brief Summary
-----------------
A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in healthy volunteers. This study aims at confirming this pharmacodynamic interaction in patients with post-surgery pain.

Detailed Description
-----------------
The study is a comparison of the analgesic action of paracetamol versus tropisetron + paracetamol in 30 patients who had surgery of the ear. The evaluation criteria will be the score on the visual analogue scale for pain evaluation.

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

Intervention / Treatment
-----------------
* Drug: Tropisetron
* Drug: paracetamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than 18 years Men or women Ear surgery Written consent given Exclusion Criteria: Paracetamol hypersensibility Tropisetron hypersensibility

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: Tropisetron|a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol|
|Drug: paracetamol|a comparison of the analgesic action of paracetamol versus tropisetron+paracetamol|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups |  | at 30 min, 1h, 2h, 3h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, serotonin, interaction, Patients with postsurgical pain, after ear surgery
Polymorphism of the Cytochrome P450-system in Renal Transplants

Study Overview
=================
Brief Summary
-----------------
In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A). All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared.

Detailed Description
-----------------
Primary endpoint is the serum creatinine in patients with and without polymorphysms rate of rejections in patients with and without polymorphysms

Official Title
-----------------
Polymorphism of the Cytochrome P450-system and the MDR-system in Renal Transplants Receiving the Immunosuppressive Drugs Tacrolimus, Sirolimus, Everolimus or Cyclosporine A

Conditions
-----------------
Function of Renal Transplant

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: sirolimus
* Drug: everolimus
* Drug: cyclosporin A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal transplant patients receiving one or more of the following drugs: tacrolimus sirolimus everolimus cyclosporin A fluvastatin Informed consent given by the patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tacrolimus|retrospective analyze of drug levels in comparison to polymorphism|
|Drug: sirolimus|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism|
|Drug: everolimus|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism|
|Drug: cyclosporin A|retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism|

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
-----------------
cyclosporin A, Tacrolimus, Everolimus, Sirolimus, Fluvastatin
Diagnostic Errors in Anaphylactic Shock

Study Overview
=================
Brief Summary
-----------------
Diagnostic accuracy and quality of management in anaphylactic shock is assessed in three conditions: expected, unexpected with no distractor, unexpected with distractor

Detailed Description
-----------------
participants: physicians taking part in voluntary workshops. Participants are allocated to teams of three design: prospective, randomized, single-blind setting: simulated anaphylactic shock intervention: participants are allocated to 3 versions of the scenario: 1) expected, 2) unexpected but no distractor, 3) unexpected with distractor

Official Title
-----------------
Context-dependent Diagnostic Accuracy in Anaphylactic Shock

Conditions
-----------------
Diagnostic Error

Intervention / Treatment
-----------------
* Other: Diagnostic context


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physicians taking part in voluntary simulator workshops Exclusion Criteria: Refusal to participate or to being videorecorded

Ages Eligible for Study
-----------------
Minimum Age: 24 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Expected<br>Anaphylactic shock occurs after the injection of a drug known to cause allergic reactions | Other: Diagnostic context<br>* A life-threatening situation occurs in 3 different contexts<br>|
| Active Comparator: Unexpected, no distractor<br>Anaphylactic shock occurs unexpectedly, but their is no medical distractor | Other: Diagnostic context<br>* A life-threatening situation occurs in 3 different contexts<br>|
| Active Comparator: Unexpected, with distractor<br>Anaphylactic shock occurs unexpectedly. Scenario is set up such, that a tension pneumothorax may be a likely explanation | Other: Diagnostic context<br>* A life-threatening situation occurs in 3 different contexts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct diagnosis of anaphylactic shock | Diagnosis of anaphylactic shock is explicitly stated by at least one team member within a time frame of 15 minutes after onset | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment of anaphylactic shock with epinephrine ≥ 0.3mg intravenously | Anaphylactic shock is correctly treated with epinephrine in an appropriate dose (≥ 0.3mg intravenously) within a time frame of 5 minutes after diagnosis | 5 minutes |
Prospective Pilot Study Validating the Canadian C-Spine Rule Pre-hospital

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety, level of performance and level of comfort with the Canadian C-Spine rule in a prehospital setting by emergency medicine undergraduates.

Official Title
-----------------
A Prospective Pilot Study Validating the Canadian C-Spine Rule in a Pre-hospital Setting

Conditions
-----------------
Injury of Cervical Spine, Cervical Spine Fractures

Intervention / Treatment
-----------------
* Other: Canadian C-Spine rule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alert, stable, adult patients presenting with an acute possible injury to the cervical spine Alert: GCS ≥ 14 Stable: systolic blood pressure ≥ 90 mmHg respiratory frequency 12 - 20 / min adult ≥ 18 years old Acute: ≤ 4 Possible injury to the cervical spine: posterior neck pain following any mechanism no neck pain but visible injury above the clavicles no neck pain or visible injury above the clavicles but a mechanism that indicates a cervical spine injury Exclusion Criteria: Acute paralysis (quadriplegia, paraplegia) Penetrating trauma to the neck Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery) Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canadian C-Spine Rule<br> | Other: Canadian C-Spine rule<br>* Emergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed cervical spine injuries and fractures |  | At the first visit to the emergency department until 30 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the Canadian c-spine rule | Performance includes rule accuracy | Analyzed at the end of the pilot study in april 2011 | 
| Level of comfort | Level of comfort with the decision of the canadian c-spine rule as this is important for a possible implication in protocol | Analyzed at the end of the pilot study in april 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Canadian C-Spine Rule, Prehospital Emergency Care, Cervical Spine Injuries, Cervical Spine Fractures, Emergency Medicine Undergraduates
Associations of the Grades of Doctor and Neonatal Outcomes

Study Overview
=================
Brief Summary
-----------------
In China, the standardized training system for residents was built last year, and the associations of the grades of doctors and accoucheurs and neonatal outcomes remains unclear.

Detailed Description
-----------------
In China, the grades of doctors and accoucheurs are divided into four levels, and different levels may induce differences of neonatal asphyxia and death. The standardized training system for residents was built last year,the associations of the grades of doctors and accoucheurs and neonatal asphyxia,neonatal death before and after the training systems need to be assess.

Official Title
-----------------
Associations of the Grades of Doctor and Neonatal Outcomes: An Observational Prospective Study

Conditions
-----------------
Standardized Training System for Residents, Neonatal Outcomes

Intervention / Treatment
-----------------
* Procedure: attending obstetrician
* Procedure: associate obstetrician
* Procedure: chief obstetrician


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age (GA) is from 26 to 42 weeks Exclusion Criteria: major congenital malformations or complex congenital heart disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 100 Days

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| attending obstetrician<br>the low grade doctor who can do caesarean operation with no pregnant complications. | Procedure: attending obstetrician<br>* Attending obstetrician can do the caesarean operation without pregnant complications.<br>|
| associate chief obstetrician<br>The middle grade doctor who can do caesarean operation with no or mild or middle pregnant complications. | Procedure: associate obstetrician<br>* Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.<br>|
| chief obstetrician<br>the high doctor who can do all caesarean operation without limitations | Procedure: chief obstetrician<br>* Chief obstetrician can do all caesarean operation without limitations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal asphyxia | neonatal asphyxia was defined according to manual of neonatal care | within 28 days | 
| death | neonatal death | within 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley Scales of Infant Development | to assess the development using Bayley Scales of Infant Development | at 2 months and 2 years old |
A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections

Study Overview
=================
Brief Summary
-----------------
This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.

Official Title
-----------------
A Phase II Prospective, Open Label, Randomized, Active-controlled, Parallel Group, Multi-center 'Proof of Concept' Trial in Adult Patients With Complicated Skin or Skin Structure Infections Requiring Hospitalization.

Conditions
-----------------
Soft Tissue Infections

Intervention / Treatment
-----------------
* Drug: Standard care
* Drug: beta-lactam
* Drug: beta-lactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; skin or skin structure infection requiring hospitalization; clinical diagnosis of a skin or skin structure infection caused by bacteria known or suspected to be susceptible to the randomized study treatment; material from site of infection is clinically purulent or seropurulent. Exclusion Criteria: presenting with sustained shock (SBP<90mm Hg for > 2 hours, despite adequate fluid resuscitation); known or suspected concomitant bacterial infection requiring antibiotic treatment; skin infection or chronic non-healing ulcer of > 2 weeks duration; patients in whom surgery is the primary treatment.

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 |
| --- | --- |
| Experimental: 1<br> | Drug: beta-lactam<br>* 750mg iv q8h<br>|
| Experimental: 2<br> | Drug: beta-lactam<br>* 1500mg iv q8h<br>|
| Active Comparator: 3<br> | Drug: Standard care<br>* As prescribed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate. |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical cure |  | Event driven | 
| Time to resolution of signs and symptoms of skin or soft tissue infection |  | Event driven | 
| Bacteriological outcome |  | Event driven | 
| Adverse events; laboratory abnormalities |  | Throughout study |
Fluorescent Cholangiography During Acute Cholecystitis

Study Overview
=================
Brief Summary
-----------------
This study compares the visualizationrate of fluorescent and X-ray cholangiography during laparoscopic cholecystectomy for acute cholecystitis

Official Title
-----------------
Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis

Conditions
-----------------
Acute Cholecystitis

Intervention / Treatment
-----------------
* Procedure: Cholangiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis with ≤ 5 days of complaints (in Denmark the national consensus for surgical window) Exclusion criteria Laparoscopic operation converted to open operation prior to completed fluorescent and X-ray cholangiography Allergy towards iodine, Iohexol or indocyanine green Legally incompetent (any reason) Cholangitis (as defined above)15 Withdrawal of inclusion consent at any time

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluorescent cholangiography<br>Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green | Procedure: Cholangiography<br>* All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography<br>|
| Active Comparator: X-ray cholangiography<br>Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol | Procedure: Cholangiography<br>* All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualizationrate | Percentage of patients with visualization of the structure: the cystic duct - common hepatic duct - common bile duct junction. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualizationrate | Percentage of patients with visualization of the structure2: right and left hepatic ducts, common hepatic duct, common bile duct, cystic duct | 1 hour | 
| Bile duct stones | Percentage of patients with visualization of bile duct stones | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluorescence, Cholangriography, Cholecystectomy
Post-Market Study of Alcon Intraocular Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate clinical and functional performance in real-world conditions in participants who have been implanted with Acrysof IQ Vivity (Extended Vision) IOLs compared with Alcon Aspheric Monofocal IOLs.

Detailed Description
-----------------
This observational study will enroll subjects who have been implanted with an Alcon aspheric monofocal or monofocal toric IOL no less than 4 months prior to study procedures. This study will be conducted in Australia.

Official Title
-----------------
Clinical and Functional Performance of Acrysof IQ Vivity Versus Aspheric Monofocal IOLs

Conditions
-----------------
Visual Acuity

Intervention / Treatment
-----------------
* Device: Vivity IOL
* Device: Aspheric monofocal IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: In good general health at the screening visit; Implanted in both eyes at least 4 months ago with either Vivity/Vivity toric IOL or an Alcon aspheric monofocal/monofocal toric IOL (Acrysof IQ/Clareon); Best Corrected Distance Visual Acuity (BCDVA) of 20/25 or better with both eyes together; BCDVA of 20/40 or better in each eye; Key Exclusion Criteria: Clinically significant Posterior Capsular Opacity (PCO) as assessed via slit-lamp exam per investigator opinion; History of ocular surgery other than cataract surgery and Nd:YAG laser surgery; History of amblyopia.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| Vivity IOL<br>Subjects previously implanted with Vivity or Vivity toric IOL | Device: Vivity IOL<br>* Commercially available extended vision IOL<br>* Other names: Acrysof IQ Vivity or Vivity toric IOL;|
| Aspheric Monofocal IOL<br>Subjects previously implanted with an aspheric monofocal or monofocal toric IOL | Device: Aspheric monofocal IOL<br>* Commercially available aspheric IOL<br>* Other names: Clareon monofocal or monofocal toric IOL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binocular photopic best-corrected distance visual acuity (BCDVA) | Visual acuity will be measured using a standard visual acuity chart at a distance of 4 meters under photopic (well-lit) conditions and reported in logarithm Minimum Angle of Resolution (logMAR) units. Visual acuity will be measured binocularly (both eyes together). | At least 4 months post-operative |