linjc16/ctgov huggingface dataset:
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate pain intensity over 8 weeks in acupuncture patients with chronic low back pain and to compare 2 different groups of patients which differ in the acupuncture method used to treat the pain.

Official Title
-----------------
Efficacy of Different Acupuncture Methods for Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Other: Acupuncture 1
* Other: Acupuncture 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of chronic low back pain (for at least 3 months) confirmed by a consultant indication for treatment of low back pain with acupuncture confirmed by a consultant at least 40 mm on a VAS pain scale Exclusion Criteria: acupuncture during the last 6 months start of a new therapy for low back pain within the last 4 weeks pregnancy substance or drug abuse

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture 1<br> | Other: Acupuncture 1<br>* Application of individualised acupuncture<br>|
| Active Comparator: Acupuncture 2<br> | Other: Acupuncture 2<br>* Application of standardised acupuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity over 8 weeks (area under the curve) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of back pain at week 8 and week 26 |  | baseline, week 8, week 26 | 
| Back function (FFbH-R) |  | baseline, week 8, week 26 | 
| QoL |  | baseline, week 8, week 26 | 
| Days with medication intake |  | baseline to end of week 8 | 
| Days with physical therapy because of back pain |  | baseline to end of week 8 | 
| Sick leave days |  | baseline, at week 8, at week 26 | 
| Number of therapy sessions |  | baseline to expected time frame 3 months | 
| Duration of therapy |  | baseline to expected time frame 3 months | 
| Adverse effects and severe adverse effects |  | baseline to expected time frame 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, acupuncture
Natural History of Pedal Puncture Wounds in Diabetics

Study Overview
=================
Brief Summary
-----------------
There are no evidence (research) based guidelines for treatment of early, closed puncture wounds of the feet in diabetics. Surgeons usually see only the limb- and life-threatening consequences of puncture wounds of the feet in diabetics, and are therefore tempted to advocate more aggressive, preemptive, invasive primary treatment for all such wounds, assuming, from this blinkered perspective that all such wounds progress to serious infection. This study is designed to determine the natural history of puncture wounds of the feet in diabetics, specifically, whether all become infected or whether some do heal without any surgical intervention. It requires administration of a questionnaire to 188 known diabetics attending 11 selected outpatient health care centers in the parish of St. James, Jamaica.

Official Title
-----------------
The Natural History of Pedal Puncture Wounds in Diabetics: a Cross-sectional Survey in the Parish of St. James, Jamaica.

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic 15 years and older Resident in the parish of St. James, Jamaica Exclusion Criteria: Impairment of conscious level or mental status such that autonomy is compromised

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Diabetics<br>Diabetics in the parish of St. James, Jamaica | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pedal puncture wounds |  | September, 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection in pedal puncture wounds |  | September, 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pedal puncture wounds, Infection in pedal puncture wounds, Diabetes education and pedal puncture wounds
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19

Study Overview
=================
Brief Summary
-----------------
Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known. The investigators will explore patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected. The investigators will determine whether this persistance varies according to the severity of the Covid-19 a treatment by steroids during the covid-19. This will help to anticipate whether a second wave of infection is possible in a non-naive population.

Detailed Description
-----------------
Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known. The investigators will explore adult patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected. The investigators will determine whether this persistance varies according to the severity of the Covid-19 (3 groups: no oxyegn therapy; oxygen therapy of less than 3L/min; oxygen therapy of 3L/min or more) a treatment by steroids during the covid-19. Immunocompromised patients will be excluded.

Official Title
-----------------
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19

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

Intervention / Treatment
-----------------
* Diagnostic Test: serology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive SARS-CoV-2 Exclusion Criteria: age under 18 immunocompromised at the onset of Covid-19

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: Prevention
Intervention Model: Sequential Assignment
Interventional Model Description: sample of patients 6 and 12 months after the acute disease
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Covid-19<br>only arm: Covid-19 proven by PCR | Diagnostic Test: serology<br>* blood sample of 10 ml twice (6 and 12 months after the Covid-19)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-SARS-CoV-2 neutralizing antibody titers | Titer in plamsa of neutralizing anti-SARS-CoV-2 antibody | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neutralizing antibodies, long-term persistence
A Survey of Factors Associated With the Successful Recognition of Agonal Breathing and Cardiac Arrest.

Study Overview
=================
Brief Summary
-----------------
The overall goal of this pilot study is to design and conduct a survey of 9-1-1 call takers in the province of Ontario, Canada to better understand the factors associated with the successful identification of cardiac arrest (including victims with agonal breathing) over the phone. Specific objectives are: To conduct iterative semi-structured interviews to identify behavioural factors influencing identification of cardiac arrest by 9-1-1 call takers; To develop a survey instrument about behavioural factors influencing the ability of 9-1-1 call takers to identify cardiac arrest based on a systematic review of the literature, the results of the semi-structured interviews, and theoretical constructs from the Theory of Planned Behaviour; and To conduct a survey among Ontario 9-1-1 call takers using the survey instrument, and to identify factors and strategies that might be targeted by Knowledge Translation interventions.

Official Title
-----------------
A Survey of Factors Associated With the Successful Recognition of Agonal Breathing and Cardiac Arrest by 9-1-1 Call Takers.

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 9-1-1 call-takers, male or female, full or part-time, employed in an eligible Ambulance Communication Centre Exclusion Criteria: Ambulance Communication Centre Managers, support staff or administrative staff
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>Full and part-time 9-1-1 call takers employed at Ambulance Communication Centres in the Canadian provinces of Ontario, Nova Scotia, New Brunswick, as well as the city of Montreal, Quebec, Canada. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intention to Give CPR Instructions | Median intention to give CPR instructions when agonal breathing is present | During a call with a victim potentially in cardiac arrest | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
agonal breathing, cardiac arrest, 9-1-1 call taker, survey
Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
Study Design : randomized, open label, single-dose, 2-way cross-over design Phase : Phase I

Official Title
-----------------
An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers

Conditions
-----------------
Healthy Adult Volunteers

Intervention / Treatment
-----------------
* Drug: G3041
* Drug: SEVIKAR®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers between the ages of 19 to 55 years old 19 ≤ BMI ≤ 27 having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination doctor determines to be suitable as subjects within 4 weeks ago before administration Exclusion Criteria: Hypersensitivity(or history of hypersensitivity) to amlodipine and olmesartan Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT Excessive drinking(exceed alcohol 140g/week) Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day) Smoking over 10 cigarettes per day

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: G3041<br>Amlodipine orotate 10mg/Olmesartan medoxomil 40mg | Drug: G3041<br> <br> Drug: SEVIKAR®<br> <br> |
| Active Comparator: SEVIKAR®<br>Amlodipine besylate 10mg/Olmesartan medoxomil 40mg | Drug: G3041<br> <br> Drug: SEVIKAR®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast, Cmax |  | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax, t1/2, AUCinf, CL/F, Vz/F |  | Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h | 
| ΔAUEC24, ΔEmax, tEmax |  | 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h |
Long-term Mortality in Diabetics Undergoing Major Surgery

Study Overview
=================
Brief Summary
-----------------
Patients with CAD and diabetes mellitus have a better prognosis than patients with CAD and no diabetes mellitus. In acute coronary syndrome patients with an insulin therapy had a better survival than patients with oral antidiabetics. But there is not known wether perioperative therapy with insulin or oral antidiabetics is associated with higher risk for higher perioperative cardiac morbidity and mortality and worse long-term survival.

Detailed Description
-----------------
Diabetes mellitus is an important risk factor for arteriosclerosis in general and for coronary artery disease. Patients with CAD have a worse prognosis if they have diabetes mellitus. But it is not known whether the treatment of Dm has an influence on mortality or morbidity. In face of the high number of patients with Dm and the therapeutic consequences this prospective study wants to compare short-time and long-time morbidity in Patients with Dm undergoing major non-vascular surgery. Inclusion criteria are medically treated Dm (insulin or oral antidiabetics) and major non cardiac surgery. The normal perioperative treatment of the study is not changed by the study itself.

Official Title
-----------------
Comparison in Survival in Patients With Insulin-dependent and Non-insulin-dependent Diabetes Mellitus With Known or Suspected Coronary Artery Disease Undergoing Major Non-cardiac Surgery

Conditions
-----------------
Diabetes Mellitus, Coronary Heart Disease, Major Non-cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetes mellitus with insulin or oral antidiabetics proven coronary artery disease or very high risk for it major non-vascular surgery Exclusion Criteria: emergency no 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death and/or major adverse cardiac events |  | 12 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin-dependent diabetes mellitus, non-insulin-dependent diabetes mellitus, coronary artery disease, long-term mortality
Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long term urinary, sexual, cosmetic and psycho-social outcomes of adult patients operated for hypospadias during childhood

Official Title
-----------------
Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences

Conditions
-----------------
Hypospadias

Intervention / Treatment
-----------------
* Other: Urethral stenosis assesment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients operated for hypospadias during childhood (before the age of 15) at the University Hospital of Besançon (France) Exclusion Criteria: Patients with a non-operated hypospadias Opposition to participate Legal incapacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 23 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br> | Other: Urethral stenosis assesment<br>* Auto-questionnaires + Clinical examination + Flow metry and post-mictional residue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood | Proportion of adult patients with urethral stenosis following a repair surgery performed during childhood, assessed with flowmetry (maximal urinary flow) | Day 1 |
Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration

Study Overview
=================
Brief Summary
-----------------
Determine if the use of platelet rich fibrin (PRF) improves the rate and quality of healing for intraoral mucosal and epithelial soft tissue defects.

Official Title
-----------------
Role of Platelet-Rich Fibrin in Intraoral Soft Tissue Regeneration of Head and Neck Surgery Patients: A Prospective Clinical Trial

Conditions
-----------------
Mucosal Ulceration

Intervention / Treatment
-----------------
* Procedure: Platelet Rich Fibrin Application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Three categories of patients will be included in this study: Osteoradionecrosis (ORN) or medication related osteonecrosis of the jaw (MRONJ) patients who present to clinic with exposed bone and no clinical sign of infection. Patients having an excisional biopsy in clinic performed under local anesthesia resulting in a defect that cannot be easily repaired without compromising normal anatomy or function. These situations include excisions which would result in primary closure under tension or with distorted anatomy, require a local flap, or require healing by secondary intention. Patients presenting to the post-operative clinic with intraoral surgical wound dehiscence or an intraoral surgical wound healing by secondary intention. Exclusion Criteria: Patients under 18 years of age. Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Fibrin (PRF) Group<br>Patients randomized to this group will receive treatment with a PRF graft. | Procedure: Platelet Rich Fibrin Application<br>* Platelet Rich Fibrin application at first post-op visit.<br>|
| No Intervention: No Platelet Rich Fibrin Group<br>Participants in the observational control group will be managed at the time of the complication by standard of care methods. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rate of healing in intraoral mucosa and epithelium soft tissues | Improved healing times of PRF patients compared to control group. | 3 months post-operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platelet rich fibrin (PRF)
Intubation and Extubation Over 48 Hours Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how often ventilator associated pneumonia happens in the current intensive care units, and how types of endotracheal tube affect its occurrence.

Official Title
-----------------
Observational Study of Intubation and Extubation Over 48 Hours Mechanical Ventilation

Conditions
-----------------
Pneumonia, Ventilator-Associated, Critical Illness

Intervention / Treatment
-----------------
* Device: Choice of endotracheal tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 20 years old Mechanically ventilated over 48 hours in the ICU Exclusion Criteria: Mask ventilation Tracheostomy

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Ventilator associated pneumonia<br> | Device: Choice of endotracheal tube<br>* Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration<br>* Other names: Special cuff with aspiration means Taper Guard;|
| No pneumonia<br> | Device: Choice of endotracheal tube<br>* Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration<br>* Other names: Special cuff with aspiration means Taper Guard;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence and timing of ventilator associated pneumonia | From tracheal intubation to ICU duscharge | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-free days | During ICU stay | one month | 
| Duration of ICU stay and hospital stay | From tracheal intubation to ICU or hospital discharge | three months | 
| ICU and hospital mortality | From tracheal intubation to hospital discharge | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiration, Artificial, Pneumonia, Ventilator-Associated, Critical Illness