linjc16/ctgov huggingface dataset:
Materialise X-ray Knee Guides for Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the positioning of customized guides designed from patients X-Rays (Materialise X-Ray Knee Guides) using computed tomography in primary total knee arthroplasty.

Official Title
-----------------
Prospective Monocentric Clinical Investigation Using the Materialise X-ray Knee Guides for Total Knee Arthroplasty

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Device: X-Ray Knee Guide group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physically and mentally able and willing to comply with the protocol Be treated for a primary total knee arthroplasty Are fluent in Dutch or French Sign the Informed Consent Form Comply with the indications listed in the Instructions for Use Be able to undergo a CT scan Exclusion Criteria: Fulfilling one of the contraindications mentioned in the Instructions for Use Pregnant A prisoner Reported to have mental illness or belonged to a vulnerable population

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: X-Ray Knee Guide group<br>Total knee arthroplasy using Materialise X-Ray Knee Guides | Device: X-Ray Knee Guide group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between planned and achieved tibial and femoral components position as assessed by 3D imaging processing methods |  | 2 Months post-operatively |
EYE-SYNC Concussion Classification Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.

Official Title
-----------------
EYE-SYNC Concussion Classification Study

Conditions
-----------------
Concussion, Mild, Concussion; Eye, Concussion, Brain, Concussion, Severe, Brain Injuries, Concussion, Cerebral

Intervention / Treatment
-----------------
* Device: EYE-SYNC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women actively engaged in competitive athletics Eye tracking measurements and SCAT5 evaluations are collected within 3-day window Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury Exclusion Criteria: Prior enrollment (subjects may only enroll once) POOR eye tracking data quality Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: Difficulty Remembering ≥ 4 or Confusion ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS) EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores < 2.0

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Concussion Evaluation<br>Adult athletes receiving a clinical evaluation for a suspected concussion after head injury | Device: EYE-SYNC<br>* Evaluation of oculomotor performance using visual presentation and eye tracking analysis<br>* Other names: SCAT-5;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics | A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard. | 3 days |
Retrospective Review a Comprehensive Case Database of HoLEP Procedure Performed by a Single Surgeon

Study Overview
=================
Brief Summary
-----------------
Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in conjunction with the prescription of the anticholinergic drugs.

Detailed Description
-----------------
Eighty men with urodynamically proven BPO underwent HoLEP at our hospital. All patients were evaluated preoperatively with International Prostate Symptom Score (IPSS), International Continence Society male questionnaire short form (ICS-SF), 3-day frequency - volume charts (FVC), transrectal ultrasonography, and uroflowmetry with postvoid residual urine volume. The patients were divided into two groups; BPO without DO (Non-DO group) and BPO with DO (DO group). We assessed the patients postoperatively at 2 weeks, 1, 3 and 6 months after surgery.

Official Title
-----------------
Retrospective Review of a Comprehensive Case Database of HoLEP (Holmium Laser Enucleation of Prostate) Procedure Performed by a Single Surgeon

Conditions
-----------------
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 yrs or greater International prostatic symptom score >= 12 Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20) Exclusion Criteria: Patients with urologic malignancies such as prostate cancer and bladder cancer Patients underwent urethral, prostate surgery Patients with urethral stricture or bladder diverticulum or bladder neck contracture

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HoLEP group<br>Holmium Laser Enucleation of Prostate Group | |

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
-----------------
Holmium Laser Enucleation of Prostate
Evaluation of a Lifestyle Intervention for Employees With Prediabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of a worksite lifestyle intervention for diabetes prevention among employees with prediabetes.

Detailed Description
-----------------
The lifestyle intervention includes a 16-week group-based program which targets weight reduction through the adoption of a lower fat diet and greater physical activity.

Official Title
-----------------
Evaluation of a Lifestyle Intervention for Employees With Prediabetes

Conditions
-----------------
Prediabetes, Overweight, Obese

Intervention / Treatment
-----------------
* Behavioral: Lifestyle counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years old overweight or obese prediabetes with elevated glucose value Exclusion Criteria: recent cardiovascular event use of corticosteroids concurrent participation in a structured weight loss program pregnant or lactating

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Diabetes Prevention Program lifestyle intervention | Behavioral: Lifestyle counseling<br>* 16-week nutrition, physical activity and behavioral intervention<br>|
| No Intervention: Usual Care<br>Usual care from primary care physician | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Change in body weight | 4 months | 
| Body Weight | Change in body weight | 7 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lifestyle risk reduction
Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system to measure potential circulatory compromise.

Detailed Description
-----------------
The objective of this study is to demonstrate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system, The Ox-Imager Mini. Potential circulatory compromise will be imaged in healthy volunteers using both the subject and predicate devices (Ox-Imager CS) in a Vascular Occlusion Test (VOT) model. The VOT model is an established paradigm to introduce transient ischemia in skin and the the subjects will be imaged during this time. The primary endpoint will be to measure significant decrease in tissue oxygen saturation after occlusion for both predicate and subject devices.

Official Title
-----------------
Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol

Conditions
-----------------
Circulatory; Change

Intervention / Treatment
-----------------
* Device: The Ox-Imager Mini (Desaturation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Exclusion Criteria: History of congestive heart failure Patients with existing wound or ulcer. Rheumatoid arthritis Pregnant or lactating women

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Vascular Occlusion Test
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desaturation<br>Vascular Occlusion Test | Device: The Ox-Imager Mini (Desaturation)<br>* Vascular Occlusion Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant decrease in StO2 during occlusion | significant decrease in StO2 during occlusion | immediate | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tissue oxygen saturation
S.E.S Shoulder Arthroplasty Data Collection

Study Overview
=================
Brief Summary
-----------------
This observational study intends to collect efficacy and safety data on S.E.S shoulder system

Detailed Description
-----------------
The S.E.S.® shoulder system has been developed to provide a complete solution for all the indications for Shoulder Arthroplasty, Arthritis, Rotator Cuff Arthropathy, Proximal Humeral Fracture, minimising bone resection and restoring the natural anatomy of the patient.

Official Title
-----------------
A Prospective, Multicentre Study Evaluating the Clinical Performance of the S.E.S Shoulder Prosthesis

Conditions
-----------------
Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A pre-operative level of pain and function the same as for conventional joint replacement A likelihood of obtaining relief of pain and improved function Full skeletal maturity Ability to follow instructions Good general health for age Willing to return for follow-up evaluations Exclusion Criteria: Glenohumeral joint infection, osteomyelitis Neuro-muscular complications Inability to co-operate with and complete the study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| S.E.S prosthesis<br>Consecutive series of patients with a S.E.S prosthesis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constance and oxford Scores |  | 6m, 1yr, 2yr, 3yr, 4yr and 5 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication |  | Any time | 
| Patient Satisfaction |  | 6m,1yr,2yr,3yr,4yr and 5yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder Replacement
5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)

Study Overview
=================
Brief Summary
-----------------
Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Official Title
-----------------
Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial

Conditions
-----------------
LARS - Low Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Drug: Ramosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mid and low rectal cancer (AV<15cm) stage II, III, preop long-course CCRT, then ileostomy repair about 1 12 months after operation (no stomy) about 1 6 months after ileostomy repair major LARS Exclusion Criteria: recurred rectal cancer stage IV IBD uncontrolled preoperative fecal incontinence or constipation

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Ramosetron<br> | Drug: Ramosetron<br>* Ramosetron, 4 weeks<br>|
| Active Comparator: Loperamide<br> | Drug: Ramosetron<br>* Ramosetron, 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major Low Anterior Resection Syndrome (LARS) | LARS score (0-20, no, 21-29, minor, 30-42, major) | 0 weeks | 
| Difference of improvement of major Low Anterior Resection Syndrome (LARS) | LARS score (0-20, no, 21-29, minor, 30-42, major) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC QLQ-C30 score | Quality of life surveillance | 0 weeks | 
| EORTC QLQ-C30 score | Quality of life surveillance | 4 weeks |
Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

Study Overview
=================
Brief Summary
-----------------
The trajectory of atrial fibrillation (AF) patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the AF incidence, mortality and case-fatality, the investigators implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident AF.

Official Title
-----------------
Natural History and Patient Journey in Atrial Fibrillation: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.

Conditions
-----------------
Atrial Fibrillation, Epidemiology

Intervention / Treatment
-----------------
* Other: The study does not have an intervention, but observe the AF incidence of the UK disease-free population


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The investigators identify individuals aged 18 years or older and registered in the current primary care practice for at least one year. Exclusion Criteria: Individuals are excluded if they had a prior history of AF before study entry.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The study does not have an intervention, but observe the AF incidence of the UK disease-free population|The study does not have an intervention, but observe the AF incidence of the UK disease-free population.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Atrial fibrillation | AF incidence in the population | Jan 1st 1998 - May 31st 2016 | 
| Mortality of Atrial fibrillation | Mortality among AF patients | Jan 1st 1998 - May 31st 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, healthcare contacts, Electronic Health Records, epidemiology, comorbidity, health inequality
Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
This study is designed to assess the effectiveness of nasal continuous positive airway pressure in reducing respiratory distress in children with bronchiolitis

Detailed Description
-----------------
In this study, after taking consent from caretakers, patients of brochiolitis will be randomly assigned to either a standard care group or a nasal continuous positive airway pressure group. Both groups will be followed for respiratory distress. Respiratory distress will be compared by using Seattle sore of respiratory distress.

Official Title
-----------------
Effectiveness of Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Comparison to Standard Care in Children With Bronchiolitis: A Randomized Clinical Trial

Conditions
-----------------
Bronchiolitis Acute Viral, Bronchiolitis, Bronchiolitis Acute, Bronchiolitis, Viral, Nasal Continuous Positive Airway Pressure

Intervention / Treatment
-----------------
* Device: nasal continuous positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children presenting with history of cough, and tachypnea and wheezing on clinical examination Exclusion Criteria: Patients needing mechanical ventilation at the time of admission Patients whose caretakers refuse written informed consent Patients having consolidation on chest X-Ray

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 2 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 |
| --- | --- |
| No Intervention: standard care<br>In this arm, oxygen inhalation will be provided without positive end expiratory pressure | |
| Experimental: nasal continuous positive airway pressure<br>In this arm, positive end expiratory pressure will be provided by nasal continuous positive airway pressure | Device: nasal continuous positive airway pressure<br>* positive end expiratory pressure will be applied by nasal continuous positive airway pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in seattle score | seattle score will be noted and compared for both groups | after 12 hours |