linjc16/ctgov huggingface dataset:
Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections

Study Overview
=================
Brief Summary
-----------------
To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.

Detailed Description
-----------------
This is a cluster randomized, crossover-controlled trial with wards as the units of randomization. The trial will predominantly take place in ICU's but may include any acute care ward that has active surveillance for MRSA and or VRE in place (i.e., Bone Marrow transplant units, Oncology wards, etc.) Units will be randomly assigned to utilize two bathing routines in a random order. Each bathing routine will be utilized on all admitted patients to the unit for a six month study period for a total study duration of 12 months. The two bathing routines will include either the use of the Comfort® Bath Washcloth System (control) or the use of 2% Chlorhexidine Gluconate Cloth. Randomized units will either start with 2% Chlorhexidine Gluconate Cloth for six months and then switch to Comfort™ Bath Washcloth for the remaining six month period or the reverse order. Data collection will include all surveillance and clinical cultures for MRSA and or VRE and all bloodstream infections.

Official Title
-----------------
Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE

Conditions
-----------------
Nosocomial Bacteremia, MRSA Colonization, MRSA Infection, VRE Colonization, VRE Infection

Intervention / Treatment
-----------------
* Procedure: Bathing with Chlorhexidine Impregnated Washcloths


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to study units during the proposed study interval are eligible for inclusion in the study Exclusion Criteria: Patients with known allergies to chlorhexidine gluconate or any other ingredients in the product Patients with burns that include a high percentage of disrupted body surface area Use in patients undergoing lumbar punctures or contact with the meninges Patients with large open skin wounds; and Children less than 18 years old

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 |
| --- |
|Procedure: Bathing with Chlorhexidine Impregnated Washcloths|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
-----------------
MRSA, VRE, BSI
Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Nasal Intubation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether nasal intubation assisted by GlideScope videolaryngoscopy is faster, easier, and less traumatic than nasal intubation with conventional direct laryngoscopy.

Official Title
-----------------
Comparison of GlideScope Videolaryngoscopy to Direct Laryngoscopy for Nasal Intubation

Conditions
-----------------
Nasal Intubation

Intervention / Treatment
-----------------
* Device: GlideScope videolaryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient who is at least 18 years old patient requires nasal intubation for surgical indications operator has performed at least 10 prior GlideScope intubations (oral or nasal) Exclusion Criteria: cervical spine abnormalities known difficult airway requires rapid sequence induction any other patient in whom the attending anesthesiologist believes usage of the GlideScope is contraindicated

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: GlideScope videolaryngoscope|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to intubation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ease of intubation (VAS) |  |  | 
| incidence of trauma |  |  | 
| number of failures |  |  | 
| severity of patient sore throat on post-operative day 1 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GlideScope, videolaryngoscopy, intubation, nasal, nasotracheal, laryngoscopy, anesthesia
Dose Ranging Study in Healthy Methadone Maintenance Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the effect of a single oral dose of MOA-728, an investigational drug, on the oral-cecal transit time in subjects who are taking methadone.

Official Title
-----------------
A Randomized, Double-blind, 4-period Crossover, Dose-ranging Study to Determine the Effects on the Oral-cecal Transit Time of Single Doses of MOA-728 and the Safety and Tolerability of Multiple Doses of MOA-728 in Stable Methadone Maintenance Subjects

Conditions
-----------------
Adult

Intervention / Treatment
-----------------
* Drug: MOA-728


Participation Criteria
=================
Eligibility Criteria
-----------------
Men or nonlactating and nonpregnant women, aged 18 to 65 years Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MOA-728|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral-cecal transit time will be evaluated. |  |  |
Observational Study of Botulinum Toxin Type A in Patients With Urinary Incontinence Associated With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This study will describe the prescription conditions of botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence due to neurogenic detrusor overactivity (NDO) or idiopathic overactive bladder (IOAB) as per standard of care in clinical practice in France.

Conditions
-----------------
Urinary Bladder, Overactive, Urinary Bladder, Neurogenic

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients who receive a Botox® injection for urinary incontinence. Exclusion Criteria: -Patients not residing in France.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Botox®<br>Patients prescribed botulinum toxin Type A (Botox®) injection for the treatment of urinary incontinence associated with neurogenic detrusor overactivity or overactive bladder as per standard of care in clinical practice. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A (Botox®) injection as prescribed as standard of care in clinical practice.<br>* Other names: onabotulinumtoxinA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Patients Prescribed Botox® in Clinical Practice |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatments Previously Prescribed |  | Day 1 | 
| Number of Sites Injected |  | Day 1 | 
| Total Dose of Botox® Used |  | Day 1 | 
| Types of Anaesthesia and Antibiotic Prophylaxis Used |  | Day 1 | 
| Cytobacteriological Examination of the Urine |  | Day 1 | 
| Total Number of Botox® Cycles in Non-naive Patients (previously received Botox®) |  | Day 1 | 
| Length of Botox® Treatment in Non-naive Patients |  | Day 1 | 
| Time Since Last Botox® Injection in Non-naive Patients |  | Day 1 | 
| Characteristics of Injector Sites (Locations) |  | Day 1 | 
| Characteristics of Injector Physicians |  | Day 1 | 
| Characteristics of Patients |  | Day 1 | 
| Number of Patients by Pathology History |  | Day 1 | 
| Number of Patients by Medical and Surgical History |  | Day 1 | 
| Reduction of Number of Daily Urinary Incontinence Episodes in Non-naive Patients |  | Day 1 | 
| Percentage of Continent Patients in Non-naive Patients |  | Day 1 | 
| Number of Adverse Events during the Visit |  | Day 1 |
Dorsal Penile Block for Post-Robotic Prostatectomy Foley Discomfort

Study Overview
=================
Brief Summary
-----------------
The indwelling urethral foley is a major source of discomfort following radical prostatectomy. Our hypothesis is that intra-operative dorsal penile nerve block with bupivacaine may decrease immediate post-operative foley discomfort.

Detailed Description
-----------------
Patients undergoing robot-assisted radical prostatectomy (RARP) will be randomized in a double-blind placebo controlled manner to undergo penile ring block injection at the time of skin incision closure. A visual analog scale (VAS) based questionnaire including newly developed foley discomfort scores will be administered at various time points post-operatively.

Official Title
-----------------
Randomized Trial to Determine the Effect of Dorsal Penile Block on Post-Robotic Prostatectomy Foley Discomfort

Conditions
-----------------
Prostate Cancer, Robotic Prostatectomy, Foley Catheter Discomfort

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 40 years and above, diagnosis of prostate cancer, electing to undergo robot-assisted radical prostatectomy Exclusion Criteria: allergy to bupivacaine or amide-type local anesthetics, chronic pain condition, recently or currently on narcotics, genital abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline injection<br>saline injection | Drug: Saline<br>* A total of 20 mL on injectable saline(0.9% NS) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.<br>|
| Active Comparator: Bupivacaine injection<br>penile block with bupivacaine | Drug: Bupivacaine<br>* A total of 100 mg bupivacaine (20 mL of 5 mg/mL solution) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pain/discomfort |  | postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized trial, robotic prostatectomy, prostate cancer, foley catheter discomfort
Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

Study Overview
=================
Brief Summary
-----------------
This prospective, randomize, controlled trial will compared cap-assisted water exchange with water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis that that cap-assisted water exchange is more efficient and causes a shorter insertion time.

Official Title
-----------------
A Randomized, Controlled Trial Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy

Conditions
-----------------
Colonoscopy, Intubation Time, Cap-assisted Colonoscopy

Intervention / Treatment
-----------------
* Device: cap-assisted water exchange
* Procedure: water exchange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing fully sedated colonoscopy performed by the investigators Exclusion Criteria: obstructive lesions of the colon massive ascites history of partial colectomy provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: water exchange<br>The air was turned off at the beginning of colonoscopy. Water was infused and suctioned at the same time during insertion. The air was turned on when the colonoscope reached the cecum. | Procedure: water exchange<br>* water was infused and suctioned at the same time during insertion of colonoscope<br>|
| Experimental: cap-assisted water exchange<br>Cap was mounted to the tip of the colonoscope when water exchange was performed. | Device: cap-assisted water exchange<br>* a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.<br>Procedure: water exchange<br>* water was infused and suctioned at the same time during insertion of colonoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cecal intubation time |  | when the colonoscope reaches the cecum, an average of 14 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of propofol |  | The end of colonoscopy, an average of 14 minutes | 
| adenoma detection rate | when histology analysis of the removed polyps are available | One week after colonoscopy |
Clinical Biological and Pharmacological Factors Influencing Stroke Outcome

Study Overview
=================
Brief Summary
-----------------
In a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. The aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.To answer to the question, we conduct a cohort study of stroke patients.

Detailed Description
-----------------
In the cohort, the severity of stroke (NIHSS) will be correlated with : clinical factors, pharmacological factors, biological factors (inflammatory markers, hemostasis...)

Official Title
-----------------
Characterization of Clinical, Biological and Pharmacological Markers of Stroke Outcome

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ischemic or hemorrhage stroke hemispheric stroke stroke dating from less 48h Exclusion Criteria: non hemispheric stroke malformative intracranial hemorrhage traumatic intracranial hemorrhage subarachnoidal hemorrhage

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 |
| --- | --- |
| stroke patient cohort<br>Patients with an hemispheric ischemic or hemorrhage stroke hospitalized during the 48h following the beginning of stroke | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of stroke measured by NIH severity score |  | inclusion, day7, month3, year3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical, pharmacological and biological (metabolic, inflammation, hemostasis...) cognitive status |  | inclusion and year3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammation, coagulation, neuroprotection, drugs, clinical neurology, pharmacology, biological factors
Non-Invasive Cooling of Fat Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

Conditions
-----------------
Reduction of Unwanted Fat

Intervention / Treatment
-----------------
* Device: Zeltiq Dermal Cooling Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects > 18 years of age. Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months. Subject has read and signed a written informed consent form. Exclusion Criteria: Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. Subject has used diet pills within the past 6 months. Subject is unable or unwilling to comply with the study requirements. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. Patient is pregnant or intending to become pregnant in the next 9 months. Patient is lactating or has been lactating in the past 9 months. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Zeltiq Dermal Cooling Device<br>* Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visible improvement in treated area |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction |  | 4 months |
Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers

Study Overview
=================
Brief Summary
-----------------
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.

Detailed Description
-----------------
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe other gastrointestinal-related symptoms, or tenesmus of <72 hours duration.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers

Conditions
-----------------
Acute Bacterial Gastroenteritis

Intervention / Treatment
-----------------
* Drug: prulifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of acute bacterial gastroenteritis Traveler from an industrialized country Capable of giving Informed Consent Exclusion Criteria: Fever (>100.3 degrees) Pregnant or Breast Feeding or Not using adequate birth control Known or Suspected (co-)Infection with non-bacterial pathogen Symptoms of acute gastroenteritis of >72 hours duration Bloody Diarrhea Concomitant antibacterial with activity against enteric bacterial pathogens History of IBD Unable/Unwilling to comply with study protocol Greater than two doses of an antidiarrheal medication within 24 hours > 2 doses of anti-diarrheal medication within 24 hours Antimicrobial treatment within 30 days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tablet | Drug: prulifloxacin<br>* Tablet<br>|
| Placebo Comparator: 2<br>Tablet | Drug: prulifloxacin<br>* Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Last Unformed Stool (TLUS) |  | End of Therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiologic eradication rates |  | End of therapy/study | 
| Clinical cure based on relief of signs and symptoms |  | End of therapy/study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traveler's, Diarrhea