linjc16/ctgov huggingface dataset:
Learning Curve CUSUM of LV Ejection Fraction by Visual Estimation in Novice Practitioners

Study Overview
=================
Brief Summary
-----------------
This retrospective, cross-sectional cohort study was conducted to investigate the novice practitioners' learning curve of visual estimation of LV ejection fraction (%) through a echocardiographic video files at the academic emergency department (ED) in tertiary urban hospital.

Detailed Description
-----------------
Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file. They received echocardiography interpretation skill training which included one hour of lecture. Twenty echocardiography videos files were provided during training session, they were instructed how to estimate EF by looking at the LV contractility without taking any measurement. This procedure took less than 2 minutes in each case. An evaluation form was completed by each EP. EF is estimated qualitatively (Normal / Global hypokinesia), RWMA and quantitatively (%) by EP with echocardiographic certification(cardiologist). An each echocardiography has been performed with M7R® model ultrasound machine was reported by experienced echocardiographers as using MSM. The echocardiography results were reported blinded to our study. A participant estimated the EF based on a complete assessment of LV wall motion including parasternal long-axis, short-axis, and apical four chamber view except for MSM. And, participants wrote down EF(%) and a region of WMA as visual assessment and checked Normal wall motion or Global hypokinesia in EF reporting paper.

Official Title
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CUSUM Analysis in the Assessment of Novice Practitioners' Visual Estimation in LV Ejection Fraction With Echocardiographic Images

Conditions
-----------------
Echocardiography

Intervention / Treatment
-----------------
* Device: Echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: EM residents who have no experience of echocardiography Exclusion Criteria: They do not want to participate this study
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 |
| --- | --- |
| Novice practitioners<br>Residents in Emergency department who has no experiences of echocardiography prior to the study. | Device: Echocardiography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Learning curve | Rate of concordance | 2 hours |
Morphine Gel for Bedsores

Study Overview
=================
Brief Summary
-----------------
This study tests the effectiveness of a morphine-containing gel for reducing pain caused by pressure ulcers, also known as bedsores or pressure sores. We will apply the gel containing morphine, or the gel alone, directly onto painful pressure ulcers and compare the results.

Detailed Description
-----------------
In this study, we will apply a morphine-containing gel (or placebo) directly onto painful pressure ulcers. We will take participants off of any opioid-containing medications upon entry into the study. This allows us to measure any morphine that may enter into the bloodstream from the topically applied gel. The purpose of this study is to examine the efficacy of the gel for pressure ulcer analgesia, as well as the systemic absorption of morphine from the topically applied gel. We will document the amount of pain medications taken by participants to determine whether the gel decreases the need for these drugs.

Official Title
-----------------
Morphine-Infused Gel for Pressure Ulcer Analgesia

Conditions
-----------------
Decubitus Ulcer

Intervention / Treatment
-----------------
* Drug: Pain relief for pressure ulcers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of a Stage II pressure ulcer. Pressure ulcer must be painful. Primary Care physician must approve participation. Thinking ability must be clear and intact. Willing to change pain medication to oxycodone. Exclusion Criteria: Allergy to morphine, oxycodone or intrasite gel. Use of codeine- or morphine-containing medications. Use of pain medications for anything other than the pressure ulcer.

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: Pain relief for pressure ulcers|nan|

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
-----------------
Analgesia, Bedsore, Morphine gel, Pressure ulcer, Pain, Ulcer
Differing Levels of Positive Anti-Neutrophil Cytoplasm Antibody (ANCA) Test and Their Correlation With Vasculitis or Malignancy or Chronic Inflammation

Study Overview
=================
Brief Summary
-----------------
A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a high probability for vasculitis has high sensitivity and specificity for vasculitis. A positive ANCA test result in those patients who do not have a high probability for vasculitis requires extensive follow-up because those patients eventually present with malignancy or other inflammatory diseases. The investigators wish to investigate the correlation between the differing levels of positive ANCA tests and their relationship to vasculitis, malignancy and inflammatory diseases.

Conditions
-----------------
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Intervention / Treatment
-----------------
* Other: Follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with borderline positive ANCA test results Exclusion Criteria: Pregnant

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive ANCA<br>Patients with borderline positive ANCA results. | Other: Follow-up<br>* Follow-up of of patients with borderline positive ANCA test results<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline Positive ANCA | Borderline positive ANCA results of 12-19 U/ml is indication of possible malignancy or inflammatory diseases | Two weeks |
Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to show how the body absorbs, metabolises and excretes the drug [14C]AZD0530. As for all clinical trials, safety and tolerability of the drug will be evaluated.

Official Title
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An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: [14C] AZD0530


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Regular Daily Bowel movements Veins suitable for cannulation or repeated venepuncture Exclusion Criteria: Presence of any clinically significant illness Abnormal vital signs History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [14C] AZD0530|Solution, Oral, once|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530 |  | Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG |  | From time of consent to last visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers, ADME
Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures

Study Overview
=================
Brief Summary
-----------------
Researchers are assessing whether use of a virtual reality experience, used during the procedure, can reduce anxiety and improve satisfaction related to the procedure, especially when no or little sedation is being used.

Official Title
-----------------
Use of Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures Involving no or Minimal Sedation

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Device: Virtual Reality (VR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing invasive EP procedures with plan for no or minimal conscious sedation Exclusion Criteria: Patients unable to consent

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects undergoing electrophysiology procedure<br>Subjects will wear a virtual reality (VR) headset for a total of 40 minutes separated over 2 sessions during an electrophysiology procedure they are already scheduled to undergo. | Device: Virtual Reality (VR)<br>* 20 minutes of wearing a virtual reality headset with a choice of 4 environments based on their preference and another 20 minutes with a less immersive condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject anxiety | Measured using a survey question asking participants to rank their anxiety level over the last 20 minutes using a scale of 5 being extremely good (ie, less anxiety); 1 being extremely bad (ie, more anxiety). | 20 minutes | 
| Subject comfort | Measured using a survey question asking participants to rank their comfort over the last 20 minutes using a scale of 5 being extremely positive; 4 being somewhat positive; 3 being neutral; 2 being somewhat negative; 1 being extremely negative | 20 minutes |
Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

Study Overview
=================
Brief Summary
-----------------
Prevenar 13 is safe for administration to Filipinos.

Detailed Description
-----------------
Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.

Official Title
-----------------
A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study

Conditions
-----------------
Pneumococcal Disease

Intervention / Treatment
-----------------
* Biological: Prevenar 13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prescribed with the vaccine Exclusion Criteria: Patients with hypersensitivity to the vaccine

Ages Eligible for Study
-----------------
Minimum Age: 6 Weeks

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 |
| --- | --- |
| Prevenar 13 patients<br> | Biological: Prevenar 13<br>* Prevenar 13 vaccine as prescribed by the physician based on approved product indication<br>* Other names: Pneumococcal 13-valent Conjugate Vaccine (13vPnC);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs. | Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period |
Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football

Study Overview
=================
Brief Summary
-----------------
A total genotype risk score was generated based on the findings of previous research for non-contact injury, non-contact muscle injury, tendon injury, ligament injury, fracture injury and apophysitis injury. This score was then compared with the incidence of injury between those with high, medium and low risk scores for each injury. The influence of different rates of growth, stages of physical maturation and loading exposure were then also included in the risk model to see if any interaction effects could be observed between genetic risk score and susceptibility to injury in different categories of growth, maturation and loading exposure.

Official Title
-----------------
Total Genotype Score, Growth, Maturation and Loading Exposure as Risk Factors for Injury in Elite Male Youth Football

Conditions
-----------------
Apophysitis, Fractures in Children, Muscle Strain, Ligament Injury, Tendon Injuries, Genetic Predisposition

Intervention / Treatment
-----------------
* Genetic: Total Genotype Risk Score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elite male football players Exclusion Criteria: Female non-elite

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elite male youth footballers<br>Elite male youth footballers at an English championship / premier league football club | Genetic: Total Genotype Risk Score<br>* A total genotype risk score has been generated based on the results of previously observed genetic association studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture Injury Risk | Did the risk of fracture differ between total genotype risk score categories? was this affected by maturation? | 8 Years | 
| Non-Contact Injury Risk | Did the risk of non-contact injury differ between total genotype risk score categories? was this affected by maturation, and loading? | 8 Years | 
| Non-Contact Muscle Injury Risk | Did the risk of non-contact muscle injury differ between total genotype risk score categories? was this affected by maturation, and loading? | 8 Years | 
| Tendon Injury Risk | Did the risk of tendon injury differ between total genotype risk score categories? was this affected by maturation, and loading? | 8 Years | 
| Ligament Injury Risk | Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation? | 8 Years | 
| Apophysitis Injury Risk | Did the risk of ligament injury differ between total genotype risk score categories? was this affected by maturation? | 8 Years |
Perioperative Nutrition in Gastric Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to demonstrate the influence of peri-operative nutrition on the preservation of lean body mass after gastric bypass, as well as it's influence on postoperative complications.

Detailed Description
-----------------
Outcome measures: Lean body mass Length of hospital stay Weight loss Postoperative complications Cost

Official Title
-----------------
Perioperative Nutrition in Gastric Bypass Surgery for Morbid Obesity

Conditions
-----------------
Postoperative Complications, Gastric Bypass

Intervention / Treatment
-----------------
* Dietary Supplement: Glucose load (Nutricia)
* Other: Post operative early enteral feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: RYGBP surgery planned Age over 18 Informed consent Exclusion Criteria: Previous bariatric surgery

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: Nutrition<br>Pre-operative Glucose load and post-operative immediate enteral nutrition | Dietary Supplement: Glucose load (Nutricia)<br>* Pre-operative glucose load: 800 ml of PreOp (Nutricia) 12 h before surgery; 400 ml of PreOp (Nutricia) 2 hours before surgery<br>* Other names: PreOp, Nutricia;Other: Post operative early enteral feeding<br>* Enteral feeding starting 6 hours post surgery<br>|
| No Intervention: Control<br>No pre-operative glucose load. No early post-operative nutrition | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative body mass composition |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications |  | 30 days | 
| Length of stay |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RYGBP, Early nutrition, Lean body mass, Length of stay, Body Composition
Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional, retrospective clinical observation study focusing on the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease.

Detailed Description
-----------------
This study was a cross-sectional, retrospective clinical observation study investigating the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease through the Parkinson's disease sleep-related scale. At the same time, the effects of nocturnal symptoms on the quality of life of patients with Parkinson's disease were studied. About 1,500 Parkinson's patients will be recruited into the study who come from Shanghai, China.

Official Title
-----------------
Nocturnal Symptoms and Quality of Life in Patients With Parkinson's Disease in Shanghai

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Nocturnal symptoms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease patients diagnosed according to the diagnostic criteria of MDS Signing informed consent Exclusion Criteria: clinically suspected Parkinson's disease, has not been diagnosed; suspected or diagnosed as secondary Parkinson's syndrome (vascular, drug, traumatic, encephalitis, toxic, etc.); suspected or diagnosed as atypical Parkinson's syndrome (progressive supranuclear palsy, multiple system atrophy, cortical basal ganglia degeneration, etc.); There is a clear history of stroke, moderate to severe traumatic brain injury, hydrocephalus, brain surgery or history of brain tumors; severe cognitive impairment or psychiatric symptoms; Can not cooperate with the completion of the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's disease patients<br>Parkinson's disease patients with or without nocturnal symptoms | Other: Nocturnal symptoms<br>* Parkinson's disease patients with or without nocturnal symptoms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nocturnal symptoms in patients with Parkinson's disease | the incidence and influencing factors of nocturnal symptoms in patients with Parkinson's disease | January 31, 2020 |