linjc16/ctgov huggingface dataset:
Non-Contact Respiratory Rate Monitoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare thermographic estimates of respiratory rate to manual counting (visual inspection) and thoracic impedance-based methods. Thermographic methods rely on detection of temperature changes in the nose and mouth that occur as room temperature air passes through the nose and mouth during ventilation, and may offer a non-invasive means of measuring respiratory rate without requiring any patient contact.

Official Title
-----------------
Evaluation of Non-Contact Respiratory Rate Monitor in Post-Surgical Subjects

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Device: Themography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Underwent surgery at the University of Virginia Able to provide verbal consent to participate in the study Exclusion Criteria: Unable to provide verbal consent to participate in the study Youth Prisoners

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-Surgical<br>Patients who underwent surgery and were admitted to the PACU | Device: Themography<br>* Using a FLIR camera, a thermographic recording will be taken of the patient while breathing. Simultaneously, the research investigator will record the thoracic impedance-based respiratory rate as well as manually count respirations in one minute.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement between manually calculated respiratory rate and thermographic respiratory rate | Agreement between manually calculated respiratory rate and thermographic respiratory rate using the Limits of Agreement approach | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-surgical
Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.

Conditions
-----------------
Refractive Errors

Intervention / Treatment
-----------------
* Device: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week. The subject must have best corrected visual acuity of 6/7.5 or better in each eye. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must read and sign the statement of informed consent The subject must be between 18 and 43 years of age Exclusion Criteria: On medication known to affect accommodation Active ocular surface pathology Had eye surgery Significant ocular tissue anomaly Any medical condition that may be prejudicial to the study Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 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 |
| --- | --- |
| Wearers of contact lenses without UV Protection<br>Subjects who have worn a soft contact lens without UV protection for the past five years or more. | Device: No Intervention<br>* No Intervention<br>|
| Wearers of contact lenses with UV Protection<br>Subjects who have worn a soft contact lens with UV protection for the last 5 years or more. | Device: No Intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Pigment Optical Density (MPOD) after 5 years of contact lens wear | The MPOD will be assessed at a single visit will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history. | Approximately 40 minutes | 
| Amplitude of Accommodation after 5 years of contact lens wear | Measured with autorefractor at a single visit and will be compared between wearers of contact lenses with UV protection and those wearers of lenses without UV protection, based on their 5 year wear history. | Approximately 40 minutes |
Relation Between PRST Score, Skin Conductance and BIS

Study Overview
=================
Brief Summary
-----------------
Determine the relation between PRST (pressure, rate, sweating, tears) score, skin conductance (SC) and Bispectral index (BIS) values during anesthesia

Detailed Description
-----------------
Probability of >0 points in the PRST as a function of BIS and number of fluctuations in mean skin conductance (NFSC) will be recorded during the anesthesia.

Official Title
-----------------
The Relation Between PRST Score, Skin Conductance and BIS Values During Anesthesia

Conditions
-----------------
Awakeness, Pain

Intervention / Treatment
-----------------
* Other: monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minor elective surgery General anaesthesia Exclusion Criteria: autonomic neuropathy presence of a pacemaker medication with anticholinergic drugs use of ketamine, clonidine

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: Other
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: monitoring|The bispectral index (BIS) and skin conductance (SC) monitors will be connected when patient will be positioned on the operating table. A BIS value greater than 60 will be considered an indicator of light anaesthesia. The SC monitoring will be achieved using the MEDSTORM AS 2005 monitor. Number of fluctuations in mean skin conductance (NFSC) of >0.1 s-1 in a period of 15 s might be counted as a significant change and indicates an increase in the sympathetic outflow. General anaesthesia will be performed and laryngeal mask will be inserted. Blood pressure, heart rate, BIS, SC, and PRST (pressure, rate, sweating, tears) score will be recorded.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between NFSC, PRST and BIS | Correlation between NFSC-PRST and, BIS-PRST will be assessed. | anesthesia induction (while giving induction agent to the patient), surgical incision (when the surgeon makes the first incision), extubation (when LMA is removed) |
The Effect of Computerized Alcohol Screening and Brief Intervention (CASI) on Alcohol Consumption in Adolescent Patients in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to examine the effectiveness of the Computerized Alcohol Screening and Brief Intervention (CASI) in adolescent patients in the Emergency Department at the UC Irvine Medical Center. This research study will evaluate the effectiveness of the brief intervention compared to standard of care (no intervention). Brief interventions have a high potential impact in ED. Computerized alcohol screening and brief intervention (CASI) is a fast and easy to use tool for patients and healthcare providers. CASI provides the Alcohol Use Disorders Identification Test (AUDIT-C)4, from the World Health Organization and CRAFFT3, followed by a brief intervention and customized alcohol intake recommendations for the patient. This study will also determine the effectiveness of the brief intervention in reducing alcohol use/abuse in adolescents between 12-17 years of age. The overall goal of this study is to identify at risk alcohol use/abuse in adolescents and provide an intervention at an early stage. The current data to support alcohol and screening and brief intervention in adolescents is limited. The researchers hope that this research study will add to the overall body of knowledge in support of using the emergency department as a tool in public health, as it relates to the individual patients morbidity and mortality (pancreatitis, cirrhosis) and to the societal costs of alcohol use (lost days of work, motor vehicle collisions).

Conditions
-----------------
Alcohol Consumption

Intervention / Treatment
-----------------
* Behavioral: CASI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Ages 12-17 Exclusion Criteria: - Intoxicated

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ADOLESCENT<br> | Behavioral: CASI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Study Overview
=================
Brief Summary
-----------------
Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

Detailed Description
-----------------
To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

Official Title
-----------------
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy: A Randomized Controlled Trial

Conditions
-----------------
Nephrolithiasis

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin
* Drug: Levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patient 18 years or older Stones ≥ 2 cm and/or mild to moderate hydronephrosis Sterile mid urine stream Exclusion Criteria: Patients with a stent, nephrostomy tube or indwelling catheter Renal failure Fever before surgery Previous manipulation/procedure Concomitant bladder stone or tumour Patients with active UTI Contralateral renal/ureteric stone

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
Interventional Model Description: Efficacy of ciprofloxacin therapy in sepsis avoidance.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ciprofloxacin<br>ciprofloxacin tablets | Drug: Ciprofloxacin<br>* drug adminstration to ameliorate sepsis incidence<br>* Other names: quinolones;|
| Active Comparator: levofloxacin<br>levofloxacin tablets | Drug: Levofloxacin<br>* levofloxacin pill<br>* Other names: quinolones;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ciprofloxacin versus levofloxacin duration before PCNL | To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine | Compare the difference between C&S of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone, in predicting the upper urinary tract infection and urosepsis. | 12 months | 
| predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL. | assess the risk factors for SIRS and sepsis in PCNL. | 12 months |
Comparing ASHC and CDSMP Outcomes In Arthritis

Study Overview
=================
Brief Summary
-----------------
The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural counties in North Carolina. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.

Official Title
-----------------
Comparing ASHC and CDSMP Outcomes In Arthritis

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

Intervention / Treatment
-----------------
* Behavioral: Arthritis Self management program
* Behavioral: Chronic Disease Self Management Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African american adults with arthritis Caucasian adults with arthritis Exclusion Criteria: -

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arthritis self management program<br> | Behavioral: Arthritis Self management program<br> <br> * Other names: AFSMP;|
| Experimental: Chronic Disease Self Management Program<br> | Behavioral: Chronic Disease Self Management Program<br> <br> * Other names: Healthy Living;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life, measured at 4 and 12 months, |  | 4 months, 12 months | 
| Health care utilization measured at 4 and 12 months |  | 4 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self management behaviors measured at 4 and 12 months |  | 4 months, 12 months | 
| Self efficacy for arthritis management, measured at 4 and 12 months |  | 4 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthritis, chronic disease, self management, self efficacy
Zenith® Low Profile AAA Endovascular Graft

Study Overview
=================
Brief Summary
-----------------
This extended investigation is to provide continued physician access to the device and collect confirmatory safety and effectiveness data.

Official Title
-----------------
Clinical Investigation Plan for the Zenith® Low Profile AAA Endovascular Graft

Conditions
-----------------
Abdominal Aortic Aneurysms, Iliac Aneurysms, Aorto-iliac Aneurysms

Intervention / Treatment
-----------------
* Device: Zenith Low Profile AAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Subject has at least one of the following Aortic or aortoiliac aneurysm Iliac aneurysm Aneurysm with a history of growth Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Life expectancy less than 2 years Pregnant of breastfeeding or planning on becoming pregnant with 60 months Unwilling to comply with the follow-up schedule

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

| Intervention/Treatment |
| --- |
|Device: Zenith Low Profile AAA Endovascular Graft|Treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair|

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
-----------------
Low Profile, Abdominal Aortic Aneurysms, Endovascular
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

Study Overview
=================
Brief Summary
-----------------
National french registry of patients with tetralogy of Fallot and implantable cardioverter defibrillator.

Detailed Description
-----------------
Inclusion criteria: patient with tetralogy of Fallot > 18 years implantable cardioverter defibrillator (ICD) primary or secondary prevention All french centers performing ICD implantation are annually contacted to include all patients with tetralogy of Fallot and ICD. Retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with prospective follow up and annual update. All events are centrally adjudicated with collection of all baseline ECG and reviewing of endocavitary EGM.

Official Title
-----------------
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator

Conditions
-----------------
Tetralogy of Fallot, Implantable Defibrillator User, Congenital Heart Disease, Sudden Cardiac Death, Ventricular Arrythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tetralogy of Fallot implantable cardioverter defibrillator Exclusion Criteria: age < 18 years

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 |
| --- | --- | --- |
| Ventricular arrhythmias | Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation | through study completion, an average of 1 year | 
| Complications of ICD | Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tretalogy of fallot, implantable cardioverter defibrillator, congenital heart disease, sudden cardiac death, ventricular arrhythmia
Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleft Lip Repair by Modified Millard Cheiloplasty

Study Overview
=================
Brief Summary
-----------------
Evaluation of the effect of botulinum toxin type-A injection prior to surgical correction of complete unilateral cleftlip repair by modified millard cheiloplasty

Official Title
-----------------
Evaluation of the Effect of Botulinum Toxin Type-A Injection Prior to Surgical Correction of Complete Unilateral Cleftlip Repair by Modified Millard Cheiloplasty

Conditions
-----------------
Esthetic Outcome of Injection of Botulinum Toxin Type-A in Cleft Lip Repair

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary cleft lip Exclusion Criteria: Cleft palate

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 6 Months

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Scar Length<br> | Drug: Botulinum toxin type A<br>* Botulinum toxin type-A injection<br>|
| Vancouver scar scale<br> | Drug: Botulinum toxin type A<br>* Botulinum toxin type-A injection<br>|
| Scar width<br> | Drug: Botulinum toxin type A<br>* Botulinum toxin type-A injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Length |  | 6 months |