linjc16/ctgov huggingface dataset:
Pain in America: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.

Conditions
-----------------
Orthopaedic Related Pain (Musculoskeletal Pain)

Intervention / Treatment
-----------------
* Behavioral: Control
* Behavioral: Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native English speakers Exclusion Criteria: Patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. Patients with a severe mental, visual, auditory or tactile impairment.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>This group will receive a 10 minute discussion | Behavioral: Control<br>* This group will receive a standardized 10 minute discussion.<br>|
| Active Comparator: Intervention<br>This group will receive a 10 minute standardized discussion | Behavioral: Intervention<br>* This group will receive a standardized 10 minute discussion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Nkem Musculoskeletal Pain Management Comprehension Test NMPMCT | Validated Questionnaire | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surveys |  | 5 minutes |
OCTA Study: Retinal Vascular Changes in Patients With SARS-CoV-2 Infection

Study Overview
=================
Brief Summary
-----------------
This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that have been affected by COVID-19.

Detailed Description
-----------------
To investigate the potential role of optical coherence tomography angiography in identifying the changes in retinal vessel density in patients that have been affected by COVID-19. The optical coherence tomography angiography represents a noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Official Title
-----------------
Optical Coherence Tomography Angiography in Patients Affected by SARS-CoV-2 Infection: a Pilot Study

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Optical coherence tomography angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 18 years diagnosis of previous COVID-19 absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. absence of significant lens opacities, low-quality OCT and OCT-A images. Exclusion Criteria: age younger than 18 years absence of previous diagnosis of COVID-19 presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. presence of significant lens opacities, low-quality OCT and OCT-A images.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Patients with COVID19<br>The patients with previous diagnosis of COVID19 | Diagnostic Test: Optical coherence tomography angiography<br>* Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.<br>|
| Control subjects<br>Healthy subjects without actual and previous ocular diseases | Diagnostic Test: Optical coherence tomography angiography<br>* Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography. | The parameter analyzed by optical coherence tomography angiography was: retinal vessel density | one month |
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty: WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis

Detailed Description
-----------------
Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis

Official Title
-----------------
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative

Conditions
-----------------
Muscles Ischemia

Intervention / Treatment
-----------------
* Procedure: Total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age = 55-85 years Osteoarthritis of knee joint (degree III or IV) Physical status (ASA I or II) Body mass index < 45 kg/m² Written informed consent Exclusion Criteria: Age <55 or > 85years Osteoarthritis knee joint (degree I or II) Physical status (ASA III or IV) Body mass index ≥ 45 kg/m² Unable to provide written consent Malignant disease Rheumatoid disease Infectious disease Coagulation disorder History of deep vein thrombosis or pulmonary embolism Peripheral arterial disease Immune deficiency Medication (Glucocorticoid, Aspirin, Heparin, Cumardine, Wafarin) Neurological dysfunction Liver insufficiency Coronary heart disease Immobility

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tourniquet<br>Total knee arthroplasty will be performed with tourniquet | Procedure: Total knee arthroplasty<br>* Total knee arthroplasty<br>|
| Experimental: non-tourniquet<br>Total knee arthroplasty will be performed without tourniquet | Procedure: Total knee arthroplasty<br>* Total knee arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Data | Measurement of intracellular proteolytic activity | During operation 60 min Ischemia/Shame-Ischemia Time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloodloss |  | 1 week postoperative | 
| Complications |  | 6 months postoperative | 
| Clinical Scores | WOMAC-Score, Knee-Score | 6 months postoperative | 
| Radiographic Scores | Prosthesis Position on radiographs | 1 Week postoperative | 
| Electrophysiological Evaluation of the N. femoralis | Nerve function analysis | 1 Week postoperative |
Phase 3 Study of OTO-201 in Acute Otitis Externa

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

Official Title
-----------------
A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa

Conditions
-----------------
Acute Otitis Externa, Swimmer's Ear

Intervention / Treatment
-----------------
* Drug: 12 mg ciprofloxacin
* Drug: Sham Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria includes, but is not limited to: Subject is a male or female age 6 months or older Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa Subject or subject's caregiver is willing to comply with the protocol and attend all study visits Exclusion Criteria includes, but is not limited to: Subject has tympanic membrane perforation Subject has eczematoid otitis externa Subject has diabetes mellitus

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

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTO-201<br> | Drug: 12 mg ciprofloxacin<br>* Single administration of OTO-201<br>* Other names: OTIPRIO;|
| Sham Comparator: Control<br> | Drug: Sham Control<br>* Simulated, single adminstration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Considered a Clinical Cure at Day 8 | Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3 | At Day 8 (1 week after dosing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Considered a Clinical Cure at Day 15 | Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3 | At Day 15 (2 weeks after dosing) |
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the use of microwave radiometry in a population of patients diagnosed with acute appendicitis and treated with appendectomy. The main purpose of the study is to report the results of microwave radiometry as a diagnostic tool in acute appendicitis and compare those results with the commonly used ultrasonography.

Detailed Description
-----------------
Patients diagnosed with acute appendicitis from the emergency department of Hippocration General Hospital and treated with appendectomy will be evaluated with microwave radiometry for changes in the temperature of the appendix before its removal. Subsequently, the results of microwave radiometry for the patients confirmed by the histopathology report to have acute inflammation of the appendix, will be compared with those of the ultrasonography used for the diagnosis of acute appendicitis.

Official Title
-----------------
Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: Microwave radiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of appendicitis Surgical removal of appendix Pathological confirmation of appendicitis Exclusion Criteria: -
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: Microwave radiometry<br>Patients diagnosed with acute appendicitis will undergo a measurement of the temperature of the appendix with the use of microwave radiometry in a room temperature of 20 -24 degrees celsius. | Procedure: Microwave radiometry<br>* Microwave radiometry of the right lower quadrant in a room temperature of 20-24 degrees celsius, in order to record changes in the temperature of the inflamed appendix.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appendix Temperature | Microwave radiometry will assess the temperature of the appendix for the patients diagnosed with appendicitis before they undergo surgical removal of the appendix. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis, Appendicitis, Microwave radiometry, Ultrasonography
Developing a Program for Transition to Adult Care for Youth With Chronic Conditions : a Mixed Method Study

Study Overview
=================
Brief Summary
-----------------
Investigation in 3 steps the transition of young people with chronic diseases. FIRST STEP: qualitative survey. Interviews with carers, young people and parents. Chronic Diseases studied: epilepsy, HIV, sickle cell disease, obesity. SECOND STEP: Delphi consensus survey. Vote on internet : carers, patients' associations, young people and family. Chronic Diseases studied: all. THIRD STEP: validation survey. Vote on internet : young people. Chronic Diseases studied: all.

Official Title
-----------------
Developing a Program for Transition to Adult Care for Youth With Chronic Conditions : a Mixed Method Study

Conditions
-----------------
Transition Care

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Youth with chronic diseases after transfer to adult care Parents or guardians of these youth. Professionals caregivers from pediatric services and adult services involved in transition Exclusion Criteria: -
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 |
| --- | --- | --- |
| Agreement rate for each component of the transition program defined |  | 2 years |
Study of Oglemilast for the Prevention of Asthma.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.

Official Title
-----------------
Efficacy and Safety of Oglemilast in the Prevention of Exercise-Induced Bronchospasm

Conditions
-----------------
Exercise-Induced Asthma

Intervention / Treatment
-----------------
* Drug: Oglemilast
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable mild asthma patients who exhibit at least a 20% decrease in FEV1 following exercise. Exclusion Criteria: pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oglemilast<br> | Drug: Oglemilast<br>* Oglemilast, 15mg once per day, oral administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Dose-marched placebo, once per day, oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of oglemilast over 2 weeks as determined by adverse events, physical examinations, vital signs, electrocardiograms, and laboratory examinations. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oglemilast, asthma, exercise, prevention, prophylaxis
Clinical Test for Armed-used Blood Pressure Monitor With Preformed Cuff

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the blood pressure level of the patient using a preformed cuff ranged 22 cm-36 cm.

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cuff circumference:22cm-36cm Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 23 Years
Maximum Age: 84 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 |
| --- | --- |
| blood pressure monitor<br>Cuff circumference:22cm-36cm | |
| stethoscopy<br>Cuff circumference: 22cm-36cm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of blood pressure |  | 10S | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BP
Physical Activity of Asthmatic Children

Study Overview
=================
Brief Summary
-----------------
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the comportment of children and its family toward exercise and practice of sports. There no scientific argument to advice a reduction of physical activity in asthmatic children, but previous studies showed that physical activity is reduced in asthmatic children. The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families.

Detailed Description
-----------------
Physical activity is mandatory to the optimal development and health of children. The presence of asthmatic manifestations may influence the behaviour of children and its family with a significant reduction of exercise and practice of sports. There no scientific argument to advice such a reduction of physical activity in asthmatic children. The aim of this observational study is to evaluate the existing factors leading to this reduction of physical activity in asthmatic children and their families. To evaluate the factors explaining this behaviour the investigator design an observational study, based on a questionnaire. The evaluation of the number of sujets to complete this study is 50 asthmatic children. The whole population will be considered as the same group. This study may be further completed by a comparative and new study including asthmatic and non-asthmatic children.

Official Title
-----------------
Physical Activity of Asthmatic School Children and Teenagers: Evaluation and Perspectives

Conditions
-----------------
Physical Activity, Asthma, Child Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatic children coming for regular follow-up Good control of asthma Exclusion Criteria: Previous pathologies with significant impact on physical activity

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Asthmatic children<br>Asthmatic children aged 6 to 17 year old coming to follow-up at asthma clinic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity of children | Score | inclusion visit |
A Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine

Study Overview
=================
Brief Summary
-----------------
This study will examine the influence of the basal insulins detemir and glargine on risk of cardiovascular death and death from all causes in patients treated by their general practitioner in United Kingdom (UK). The data for this study will be drawn from the Clinical Practice Research Datalink (CPRD) Register.

Official Title
-----------------
Retrospective Cohort Study of All-Cause and Cardiovascular Mortality in Type 2 Diabetes Patients Using Basal Insulin Detemir and Glargine

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis (ever) of type 2 diabetes Prescription (ever) of basal insulins glargine or detemir Insulin-naïve until initiation of basal insulins glargine or detemir Aged 40 years or older at start of observation period Exclusion Criteria: Diagnosis of type 1 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Cohort 1<br>New users of basal insulins glargine and detemir | Drug: Insulin detemir<br>* No treatment will be given to the patients in relation to this study. Patients have been included in this study because they have been treated with insulin glargine or detemir prior to study initiation (2004 - 2018) and according to routine clinical practice at that time. The decision to initiate treatment with commercially available insulin detemir and glargine has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age at all cause death or censoring | Years | Observation period 2004 - 2018 | 
| Age at death of cardiovascular disease | Years | Observation period 2004 - 2018 |