linjc16/ctgov huggingface dataset:
Long Term Follow up on Functional Gastrointestinal Disorder (FGID)

Study Overview
=================
Brief Summary
-----------------
Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who were referred to the Pediatric Clinic due to abdominal pain with the aims to learn more about symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases for a follow up using a validated questionnaire and analyse the long term prognosis and risk factors for prolonged severe symptoms.

Detailed Description
-----------------
Long term prognosis and risk factors in functional gastrointestinal disorder (FGID) is largely unknown. The investigators plan to retrospectively analyse a cohort of children who during the years 2010-2015 were referred to the Pediatric Clinic of Umeå University Hospital due to abdominal pain. The aims are to explore and descriptively describe the symptoms and effects of investigations performed. Furthermore, the investigators plan to contact the cases five years after the first contact for a follow up using a validated questionnaire of the ROME-III-criteria and analyse the long term prognosis and risk factors for prolonged severe symptoms.

Official Title
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Long Term Follow up on Functional Gastrointestinal Disorder (FGID)

Conditions
-----------------
Functional Gastrointestinal Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
At time of first visit the children had: At least 2 months of abdominal pain Age 3-18 years No organic gastrointestinal diseases No neuromuscular disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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 |
| --- | --- | --- |
| Percentage (%) of patients that fulfill the ROME-III criteria for FGID | Measured by the validated ROME-III questionnaire | 5 years after fist visit +/- 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICD 10-diagnosis following the primary investigation |  | 12 months after first visit | 
| Current ICD 10-diagnosis |  | 5 years after fist visit +/- 1 year | 
| Number (n) of visits for the primary investigations |  | 0-12 months after first visit |
Oxycodone in Treatment of Early Labour Pain Efficacy and Safety

Study Overview
=================
Brief Summary
-----------------
Oxycodone is used to treat early labour pain instead of meperidine. However, the efficacy and effects of oxycodone to the newborn has not been studied. In the present study, patient who has received oxycodone is asked about pain relief and after labour single venous blood sample from the parturient and umbilical cord are taken for the analysis of oxycodone.

Official Title
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Oxycodone in Treatment of Early Labour Pain Efficacy and Safety

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Other: oxycodone


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Oxycodone for pain relief age 18 years or more given informed consent Exclusion Criteria: no oxycodone age less than 18 years no informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Parturients with oxycodone<br>Parturients who were given oxycodone | Other: oxycodone<br>* oxycodone 0,1/kg up to 10 mg sc.<br>* Other names: Ocycodone administration;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured with numerical rating scale | Pain measured with numerical rating scale 0-10 (0=no pain, 10 = worst pain) | from the time of oxycodone administration up to the birth of newborn, maximum of 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor pain, oxycodone
Validation of a Model for Predicting Anastomotic Leakage

Study Overview
=================
Brief Summary
-----------------
This study will validate a machine learning model for predicting anastomotic leakage of esophagogastrostomy and esophagojejunostomy.

Detailed Description
-----------------
Anastomotic leakage is a fatal complication after total and proximal gastrectomy in gastric cancer patients. Identifying patients with high-risk of AL is important for guiding the surgeons' decision making, such as a more rigorous anastomotic operation， placing a jejunal feeding tube and dual-lumen flushable drainage catheter. We have developed a high-performance machine learning model based on 1660 gastric cancer patients, which showed good discrimination of anastomotic leakage. Hence, this multi-center prospective study will validiate the usability of the model for predicting anastomotic leakage in gastric cancer patients who receive total and proximal gastrectomy.

Official Title
-----------------
Validation of a Machine Learning Model for Predicting Anastomotic Leakage of Esophagogastrostomy and Esophagojejunostomy: A Multicenter Prospective Study

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion Criteria: Aged older than 18 years and younger than 85 years. Primary gastric adenocarcinoma confirmed by preoperative pathology. Expected curative resection via total or proximal gastrectomy. American Society of Anesthesiologists (ASA) class I, II, or III. Written informed consent. Exclusion Criteria: Pregnant or breastfeeding women. Severe mental disorder or language communication disorder. Other surgical procedures of gastrectomy is performed. Interrupted of surgery for more than 30 minutes due to any cause. Malignant tumors with other organs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Incidence of anastomotic leakage |  | Within 30 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine learning, anastomotic leakage, total and proximal gastrectomy
Preoperative Evaluation of Airway

Study Overview
=================
Brief Summary
-----------------
Evaluation of airway markers of patients who have undergone obesity surgery.

Detailed Description
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The investigators evaluated the airway parameters recorded preoperatively for patients with BMI> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.

Official Title
-----------------
Evaluation of Airway on Undervent Bariatric Surgery Patients

Conditions
-----------------
Obesity, Difficult Intubation

Intervention / Treatment
-----------------
* Other: obese patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>30kg/m2 18<age <65 elective surgery planned ASA II-III Exclusion Criteria: BMI<30kg/m2 18>age >65 ASA IV

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: Screening
Intervention Model: Sequential Assignment
Interventional Model Description: retrospective clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: obese patient<br>BMI>30 kg/m2 and underwent bariatric surgery | Other: obese patients<br>* underwent bariatric surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway evaluation for menagement in obese patient | preoperative airway measurements routinely performed (mallampati score, thyromental distance, neck circumference ..)for each patient will be evaluated | 3 year | 
| mallampati score | Class I : Visualization of the soft palate, fauces; uvula, anterior and the posterior pillars. Class II : Visualization of the soft palate, fauces and uvula. Class III : Visualization of soft palate and base of uvula. Class IV: Only hard palate is visible. Soft palate is not visible at all. | 3 year | 
| thyromental distance | TMD was measured as straight distance between thyroid notch and lower border of mental prominence.(cm) | 3 year | 
| neck circumference | Neck Circumference was measured in the midway of the neck, between mid-cervical spine and mid anterior neck, to within 1 mm, using non-stretchable plastic tape with the subjects standing upright. | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
difficult airway, obese patient,
The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision. This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.

Official Title
-----------------
The PCI Choice Trial: a Pilot Randomized Trial of a Decision Aid for Patients With Stable Coronary Artery Disease

Conditions
-----------------
Stable Angina

Intervention / Treatment
-----------------
* Other: Decision Aid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of stable angina - As judge by clinician, eligible for medication therapy or PCI - agree to be available for follow-up survey 3 months after treatment decision Exclusion Criteria: has major communication barrier (severe hearing/vision impairment, dementia, cannot communicate with clinician in English)

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: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PCI Choice decision<br>Decision Aid intervention is provided to clinician to share with patient | Other: Decision Aid<br> <br> |
| No Intervention: Usual Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings | Efficacy in improving measures of patient knowledge and involvement, decision making quality, treatment choice and clinician satisfaction of the decision aid. | Baseline to Three Months |
Long-tErm Follow-uP of antithrombotIc Management Patterns In Acute CORonary Syndrome Patients in Asia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting.

Official Title
-----------------
Long-Term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent has been provided. Diagnosis of STEMI, NSTEMI or UA Hospitalization for the first time within 48 hours of onset of symptoms. Exclusion Criteria: UA, STEMI, NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons. Current participation in a randomised interventional clinical trial.

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| short- and long-term medication and treatment prescribed by physicians in real-life setting |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical outcome (Cardiovascular events) |  | up to 3 years | 
| cost of hospitalization |  | up to 3 years | 
| quality of life (EQ-5D questionnaire) |  | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long-term follow up, Antithrombotic management patterns, Acute Coronary Syndrome, Asia, quality of life
Pompe Disease QMUS and EIM

Study Overview
=================
Brief Summary
-----------------
Study Objectives: Determine the correlation between quantitative muscle ultrasound (QMUS), electrical impedance myography (EIM) and currently accepted measures of physical function. Determine the reliability of EIM measures performed in the home through use of a hand held device. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.

Official Title
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Electrical Impedance Myography and Muscle Ultrasound: Longitudinal Measures in Pompe Disease

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Device: Muscle ultrasound
* Other: Electrical Impedance Myography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetically confirmed diagnosis of Pompe disease. Exclusion Criteria: Age <18 years Inability to provide informed consent.

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: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: QMUS<br>All patients will undergo serial quantitative muscle ultrasound. | Device: Muscle ultrasound<br>* Ultrasound images of limb muscles will be collected.<br>|
| Other: EIM<br>All patients will undergo serial electrical impedance myography measures. | Other: Electrical Impedance Myography<br>* A painless current passes through the skin and surface electrodes are used to record the impedance through muscle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in muscle ultrasound echointensity as compared to baseline |  | Baseline, 1-2 years | 
| Percent change in muscle electrical impedance myography as compared to baseline |  | Baseline, 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability of muscle ultrasound and electrical impedance myography measures |  | 1-2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular Ultrasound, Electrical Impedance Myography
Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the Bag Squeeze to Manage Pain for Patients Undergoing Cystoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether utilization of the bag squeeze technique during flexible cystoscopy changes pain scores using a study questionnaire designed by the team which comprises a validated Lingard pain rating scale.

Official Title
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Pain Management for Cystoscopy: A Prospective Randomized Study Focused on Understanding the Role of the Bag Squeeze to Manage Pain for Patients Undergoing Cystoscopy

Conditions
-----------------
Pain, Procedural

Intervention / Treatment
-----------------
* Procedure: Bag Squeeze
* Procedure: No Bag Squeeze


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Undergoing flexible cystocopy at University Health Network that have undergone a flexible cystocopy and did not demonstrate difficulty during exploration (meatal stenosis or urethral stricture), simultaneous removal or ureteral stents or bladder biopsies or have a chronic history of pelvic pain Exclusion Criteria: - Patients that do not meet the inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A- Bag Squeeze<br>Participants will receive a bag squeeze of irrigation fluid (500 ml/ 2 cups of %0.9 saline solution) during the insertion of the cystocopy tube during their cystoscopy. | Procedure: Bag Squeeze<br>* Participants will receive a bag squeeze of irrigation fluid (500 ml/ 2 cups of % 0.9 saline solution) during the insertion of the cystocopy tube during their cystocopy.<br>|
| Other: Group B- No Bag Squeeze<br>Participants will receive a standard cystoscopy procedure. | Procedure: No Bag Squeeze<br>* Participants will receive a standard cystocopy procedure as per standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Rating | Participants will be asked to rate their pain on the study-specific Lingard pain scale post-cystocopy. The Lingard pain scale is an outcome measure scaled from 0 (no pain) to 10 (pain as bad it could be). The higher the reported rating out of 10, the more pain the participant has experienced. | The outcome measure will be assessed for up to 4 hours after consent and completion of clinical procedure. |
COVID-19 Risk Stratification

Study Overview
=================
Brief Summary
-----------------
The investigators seek to derive and validate a clinically useful risk score for patients with Coronavirus Disease 2019 to aide clinicians in the safe discharge of patients.

Detailed Description
-----------------
The investigators a-priori plan the following analysis: Derivation and Retrospective Validation. Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 beginning March 1, 2020 until approximately 1000 patients are included. Use 75% of this cohort to develop a simple risk-score that prognosticates a patient's suitability for discharge (no supplemental oxygen, no intensive care unit, and no death). Use multivariable logistic regression with forward selection informed by clinical judgement to choose variables a priori that emphasizes readily available data and easy calculation for use at the point of care. Use 25% of this cohort to retrospectively validate the risk-score. Prospective Validation. Select all adult patients with a positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 as soon as the derivation cohort in step 1 is assembled. Include approximately 250 patients. Use this sample to prospectively validate the risk-score developed in part 1.

Official Title
-----------------
COVID-19 Risk Stratification

Conditions
-----------------
Coronavirus, Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive reverse transcription polymerase chain reaction for severe acute respiratory syndrome coronavirus 2 Age 18 and older 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronavirus Disease 2019 positive, suitable for discharge<br>Patients with Coronavirus Disease 2019 who do not require supplemental oxygen, do not require intensive care unit-level care, and do not die. | |
| Coronavirus Disease 2019 positive, not suitable for discharge<br>Patients with Coronavirus Disease 2019 who do require supplemental oxygen, do require intensive care unit-level care, or do die. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suitable for discharge | Patient with COVID-19 who does not require supplemental oxygen, does not require intensive care unit-level care, and does not die. | Duration of participation in cohort, expected to be between 1 day and 20 days. |