linjc16/ctgov huggingface dataset:
Oraverse Versus Laser

Study Overview
=================
Brief Summary
-----------------
clinically assess the reversal of articaine 4% of two different concentration of vasoconcentration soft-tissue local anesthesia in pediatric dentistry using Diode Laser and Oraverse

Detailed Description
-----------------
Patients will be divided randomly into two groups (20 patients in each group) Group (1): Patients will be undergoing anesthesia revision by diode laser Group (2): Patients will be undergoing anesthesia revision by oraverse. Then each group will be subdivided into 2 subgroups (10 patients each) according to type of local anesthetic agent into: subgroup 1: Articaine 4% with 1:100000 epinephrin &Subgroup 2: Articaine 4% with 1:200000 epinephrin After 30 min of injection corresponding to approximate time of treatment, the patient in each group will be exposed to the reversal agent which may be diode laser or oraverse.

Official Title
-----------------
Comparative Study of the Effect of Diode Laser and Oraverse on Reversing the Effect of Articaine 4% Soft Tissue Anasthesia in Children

Conditions
-----------------
Reversal of Local Anesthesia in Children

Intervention / Treatment
-----------------
* Drug: OraVerse Injectable Product
* Device: diode laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who need to be treated under anesthesia by injecting mandibular first molar infiltration. Cooperative children aged 6 to 10 years old with the ability to understand and respond to the sensation of soft tissue -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser group<br>Patients will be undergoing anesthesia revision by diode laser | Device: diode laser<br>* patient exposed to diode laser<br>|
| Experimental: oraverse group<br>Patients will be undergoing anesthesia revision by oraverse | Drug: OraVerse Injectable Product<br>* injection of oraverse,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reversal of local anasthesia | patient free of lip numbness | 30 minute |
Myocardial Micro-damage in Relation to Active and Passive Fixation Pacemaker Electrodes

Study Overview
=================
Brief Summary
-----------------
Pacemaker electrodes are either equipped with tines (passive fixation) or with a screw (active fixation) for initial fixation in the patient´s heart. Both types of electrodes provide similar results in a long-term follow-up and the use of one or the other electrode type in many instances is mainly based on the implanter´s preference. The PACMAN-trial investigates whether the two lead types are associated with different amounts of myocardial micro-damage during implantation.

Official Title
-----------------
Effect of Passive Versus Active Fixation Leads on the Magnitude of Troponin Release After Pacemaker Implantation (PACMAN Trial)

Conditions
-----------------
Bradyarrhythmia

Intervention / Treatment
-----------------
* Device: Pacemaker implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: de-novo implantation of a pacemaker system Exclusion Criteria: AAI pacing or cardiac resynchronization therapy ICD indication temporary pacing lead revision right ventricular pacing aimed from alternative pacing sites (other than the apex) lead revision severe tricuspid valve regurgitation previous myocardial infarction, coronary intervention, stroke, cardioversion or ablation in the presence of elevated troponin levels dialysis

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 |
| --- | --- |
| Active Comparator: Ventricular pacemaker electrode<br>receives an active fixation ventricular pacemaker electrode | Device: Pacemaker implantation<br> <br> |
| Active Comparator: Passive fixation ventricular pacemaker electrode<br>receives a passive fixation ventricular pacemaker electrode | Device: Pacemaker implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high-sensitive Troponin T |  | 1 day |
Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele

Study Overview
=================
Brief Summary
-----------------
Varicocele is a major contributor in male infertility. The improvement of sperm parameters after varicocelectomy supports this contribution. The pathophysiological mechanisms of varicocele-induced male infertility are still under investigation. Cystatin C (Cys C) and endoglin are secreted glycoproteins that recently linked to several cellular changes common in varicocele like apoptosis and autophagy.

Detailed Description
-----------------
Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele

Official Title
-----------------
Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele

Conditions
-----------------
Varicocele, Infertility, Male

Intervention / Treatment
-----------------
* Procedure: Varicocelectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile men Varicocele Poor sperm parameters Exclusion Criteria: Men with systemic diseases Infertile men due to other causes than varicocele

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Varicocelectomy<br>Subinguinal varicocelectomy under general anesthesia and complete aseptic condition | Procedure: Varicocelectomy<br>* Subinguinal varicocelectomy under general anesthesia and complete aseptic condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quality of Semen | According to WHO 2010 guidelines regarding semen analysis Sperm concentration (to be more than 15 million sperm per milliliter). Sperm motility (not less than 60% progressive motility). Sperm morphology (not less than 6% normal morphology). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male infertility, Varicocele, Cystatin C, Endoglin
A Phase II Study of KUC-7483 in Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of KUC-7483 in overactive bladder patients.

Official Title
-----------------
A Randomized, Double Blind, Placebo Controlled, Phase II Study of KUC-7483 in Patients With Overactive Bladder

Conditions
-----------------
Overactive Bladder (OAB)

Intervention / Treatment
-----------------
* Drug: KUC-7483
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a symptom of overactive bladder for more than 6 months. Patients who meet the following condition during the 3-day bladder diary period. the mean number of micturitions per 24 hours is ≥8 times the mean number of urgency episodes per 24 hours is ≥1 time Exclusion Criteria: Patients who are diagnosed as stress urinary incontinence are predominant. Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3<br> | Drug: KUC-7483<br> <br> |
| Placebo Comparator: 1<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of micturitions per 24 hours |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean number of urgency episodes per 24 hours |  | 12 weeks | 
| Change from baseline in mean number of incontinence episodes per 24 hours |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Urgency, Overactive bladder, Frequency, Micturition, Urge urinary incontinence, β3-agonist
Improving Cardiac Secondary Prevention

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether providing individuals with personalized information on cellular aging, including telomere dynamics, will stimulate them to adhere to cardiac prevention strategies and improve exercise capacity.

Official Title
-----------------
Improving Cardiac Secondary Prevention Through Personalized Biomarker Knowledge

Conditions
-----------------
Myocardial Infarction, Secondary Prevention

Intervention / Treatment
-----------------
* Behavioral: Education regarding telomere length


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Individuals who have sustained a myocardial infarction and entered the cardiac rehabilitation program Exclusion Criteria: Individuals with genetic mutations that affect telomere length Individuals who may not have the mental capacity to understanding the ramifications of risk biomarkers

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants receive standard care in cardiac rehabilitation program | |
| Experimental: Knowledge transfer group<br>Participants receive standard care in cardiac rehabilitation program plus education regarding telomere length | Behavioral: Education regarding telomere length<br>* Teaching concepts of cellular aging and telomere length<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise capacity based on cardiopulmonary exercise testing | Online VO2 maximum | after 6-month cardiac rehabilitation program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to supervised exercise sessions | Proportion of prescribed supervised on-site exercise sessions attended | 6 months | 
| Activity assessment | Garmin recording | 6 months |
Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of standard treatment with parenteral ampicillin and oral amoxicillin compared to initial daily therapy with ceftriaxone followed by 3 times weekly suppressive treatment for salmonella infections in AIDS patients.

Official Title
-----------------
Prospective Comparison of Ampicillin / Amoxicillin Versus Ceftriaxone for the Treatment of Salmonella Infections in AIDS Patients

Conditions
-----------------
HIV Infections, Salmonella Infections

Intervention / Treatment
-----------------
* Drug: Ceftriaxone sodium
* Drug: Ampicillin sodium
* Drug: Amoxicillin trihydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Type I hypersensitivity to beta-lactam antibiotics. Not expected to survive 12 weeks. In a coma or with other central nervous system (CNS) impairment. Patients with the following are excluded: Type I hypersensitivity to beta-lactam antibiotics. Not expected to survive 12 weeks. In a coma or with other central nervous system (CNS) impairment. Prior Medication: Excluded within 48 hours of study entry: Treatment with an antibiotic active in vitro against Salmonella. HIV infection, AIDS, or AIDS related complex (ARC). Salmonella bacteremia or positive stool culture in patient with 3 or more stools per day.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ceftriaxone sodium|nan|
|Drug: Ampicillin sodium|nan|
|Drug: Amoxicillin trihydrate|nan|

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
-----------------
Salmonella Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Amoxicillin, Ceftriaxone
Use of Armodafinil for Fatigue in Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

Detailed Description
-----------------
The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment. Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life. They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.

Official Title
-----------------
Use of Armodafinil (R-modafinil) for Fatigue in Sarcoidosis

Conditions
-----------------
Sarcoidosis, Fatigue, Sleepiness

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sarcoidosis using standard criteria 15. Disease for more than one year On stable, systemic therapy Complain of fatigue which has been present for more than six months. Over 18 years of age Provide written informed consent. Exclusion Criteria: Pregnancy Change in therapy for sarcoidosis in prior three months History of ventricular arrythmias

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Armnodafinil<br>Armodafinil | Drug: Armodafinil<br>* Dosage 150-250 mg<br>* Other names: Nuvigil;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis. |  | Prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of Armodafinil (Nuvigil) on pulmonary function in sarcoidosis. |  | Prospective | 
| To determine the safety and tolerability of Armodafinil (Nuvigil) in sarcoidosis. |  | Prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoidosis, Fatigue
Increasing Spontaneous Non-exercise Activity (The Sitting Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see if one's liking and awareness of different types of activities is related to one's activity pattern.

Official Title
-----------------
Increasing Spontaneous Non-exercise Activity (The Sitting Study)

Conditions
-----------------
Sedentary Lifestyle

Intervention / Treatment
-----------------
* Other: Activity Liking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary lifestyle Exclusion Criteria: 5% weight loss within the past 2 months Active job or lifestyle Participation in an exercise program Pregnant and/or lactating Uncontrolled hypertension Alcohol or drug abuse Presence of acute illness Major limitation of physical movement

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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 |
| --- | --- |
| Other: Activity Liking<br>Subjects will look at images of people doing different types of activities (e.g., walking, skiing, watching television) and rate their liking of the activity. | Other: Activity Liking<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liking of activity | Visual Analog Scale rating and operant responses for sedentary and physical activities | Baseline, week 1, week 2 |
Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.

Detailed Description
-----------------
This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.

Official Title
-----------------
Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.

Conditions
-----------------
Overactive Bladder

Participation Criteria
=================
Eligibility Criteria
-----------------
OAB subjects (n=10 Phase I and n=10 Phase II) Inclusion Criteria: Female Age 18-75 years Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit. At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary. InterStim® treatment naïve or being revised with a new lead Exclusion Criteria: Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I) Revision of only the IPG (without replacement of the tined lead) More than one InterStim® device being placed (undergoing bilateral stimulation) Controls (n=10) Inclusion: Female Age 18-75 years Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence) American Urological Association (AUA) symptom score of ≤4 Exclusion: -History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Implanted subject<br>Subjects with Interstim implanted | |
| Controls<br>Subjects without Interstim implanted | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve Growth Factor (NGF) levels | pg/ml | 4 weeks |
Reducing Youthful Dangerous Driving

Study Overview
=================
Brief Summary
-----------------
To examine the effectiveness of four motivational counseling groups and a directed observational experience in the emergency room in comparison to education and community volunteering only, in reducing high risk driving behaviors

Conditions
-----------------
Injuries

Intervention / Treatment
-----------------
* Behavioral: Enhanced community service
* Behavioral: Group MI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 16-20 years Court referred for driving offense Speak English Exclusion Criteria: Age over 20 years Not court referred Not English speaking

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 20 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: Group MI<br>Four group counseling sessions and a directed observational visit to the emergency department of a busy urban hospital | Behavioral: Group MI<br>* Four group counseling sessions and two directed observational visits to an emergency department<br>|
| Active Comparator: Enhanced community service<br> | Behavioral: Enhanced community service<br>* Two educational sessions and volunteering at a local community service site<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of traffic offenses |  | 12 months post intervention completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported high risk driving behaviors |  | 12 months post intervention completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Counseling, Crime, Adolescent