linjc16/ctgov huggingface dataset:
Impact of Postoperative Pyuria on Treatment Outcomes After PVP

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to identify serial changes in the incidence of postoperative pyuria after the Photoselective Vaporization of the Prostate (PVP), to determine whether the presence of postoperative pyuria could be correlated with surgical outcomes after surgery and to identify predicting factors that influence on persistent pyuria after the PVP.

Official Title
-----------------
Does Postoperative Pyuria Influence Treatment Outcomes After Photoselective Vaporization of the Prostate (PVP)?: A Short-term Serial Follow-up Study

Conditions
-----------------
Prostatic Hyperplasia, Pyuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men who underwent photoselective vaporization (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment sterile urine on urinalysis and urine culture before surgery absence of indwelling urethral catheter before surgery Exclusion Criteria: previous diagnosis of prostate carcinoma or bladder cancer co-existence of urinary stone any antibiotic treatment within 2-weeks before surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No pyuria<br> | |
| Persistent pyuria<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the subtotal storage symptoms score of the International Prostate Symptom Score (IPSS) |  | 1-week, and 1-, 3- and 6-months after the surgery |
Mealtime Interactions and Risk of Toddler Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to conduct 18-, 24-, and 36-month assessments with mother-toddler dyads who participated in a study that is testing the effects of a multicomponent lifestyle intervention as a means to prevent excessive gestational weight gain in obese women. Specifically, dyads will be invited to participate in home-based assessments to videotape an evening meal, have anthropometric measures taken, and complete study questionnaires. The overall goal is to understand factors related prospectively to responsive feeding between mothers and toddlers at 18 months; determine whether responsive feeding at 18 and 24 months predicts change in zBMI and adiposity from 18-36 months; and explore which factors are most strongly predictive of child zBMI change from birth to 36 months.

Official Title
-----------------
Mealtime Interactions and Risk of Obesity in Toddlers

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother participated in clinical trial #NCT01545934 Child 18-36 months old Exclusion Criteria: Child chronic health conditions that could affect feeding or growth (diagnosed feeding disorders, use of feeding tube) or could influence the mealtime interaction (significant food allergies or dietary restrictions, diagnosed psychiatric disorders, or pervasive developmental delays).

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 36 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Behavioral: Lifestyle Intervention<br>The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy. | |
| No Intervention: Standard Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responsive feeding | The Responsiveness to Child Feeding Cues Scale will be used to code maternal responsive feeding. Primary outcomes are: a) maternal responsiveness to toddler fullness cues. | 18- and 24-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Weight Status | zBMI will be computed at each time point | birth, 6-, 12-, 18-, 24- and 36-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
toddler obesity, responsive feeding, behavioral weight control, pregnancy weight gain, early life risk factors
Protective Effects of EPI-743 on Noise-Induced Hearing Loss

Study Overview
=================
Brief Summary
-----------------
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.

Official Title
-----------------
A Phase 2A Randomized, Placebo Controlled, Double Blind Study of the Protective Effects of EPI-743 (VincerinoneTM) on Noise-Induced Hearing Loss

Conditions
-----------------
Noise-induced Hearing Loss

Intervention / Treatment
-----------------
* Drug: EPI-743
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults ages 18-30 Abstention from use of Idebenone, CoQ10, Vitamin E and foods or beverages at least 30 days prior to treatment initiation Non-smokers Abstention from alcohol from day 0 and throughout the duration of study Normal audiology exam Subject must be able to swallow size 0 capsules Exclusion Criteria: Allergy to EPI-743 or sesame oil or nuts Any medical disordere that would prevent subject participation Any prescription meds other than for contraception or seasonal allergies Any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, ADHD, hx. of migraines, neurological, kidney) Fat malabsorption syndromes Anticoagulation thereapy within 30 days of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EPI-743<br>EPI-743 400 mg P.O. TID | Drug: EPI-743<br>* EPI-743 (2 capsules 200 mg each) taken at a dose of 400 mg P.O. TID for 9 days with noise exposure for 4 hours on Day 8.<br>* Other names: EPI743;|
| Placebo Comparator: Placebo<br>Sesame Oil, NF in sealed gelatin capsules to match the test product | Drug: Placebo<br>* 2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.<br>* Other names: Matching placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure tone audiometry |  | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recovery following acute noise exposure |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hearing, noise, oxidative stress
Prostate Cancer Diagnosis Through NMR Spectroscopy of Semen and Prostatic Secretions

Study Overview
=================
Brief Summary
-----------------
To develop the hypothesis that quantitative NMR spectroscopy of human semen can be used to diagnose prostate cancer.

Detailed Description
-----------------
Any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form.

Official Title
-----------------
Prostate Cancer Diagnosis Through NMR Spectroscopy of Semen and Prostatic Secretions

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any willing subject who meets the male gender requirements, who is competent, agrees to participate, and is able to understand the consent form. Exclusion Criteria: Not sepcified.
Sexes Eligible for Study
-----------------
Male

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
prostate, NMR Spectroscopy
French-Canadian Version of the Wheelchair Skills Program (WSP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to develop French Canadian versions of the Wheelchair Skills Program (WSP). Translating a measurement instrument in the field of biomedical sciences requires not only the language to be taken into account but also the cultural context. We will determine the measurement properties of the WST-F and complete the randomized controlled trial on the efficacy of the WSTP-F.

Official Title
-----------------
Translation, Validation and Evaluation of the Efficacy of the French-Canadian Version of the Wheelchair Skills Program (WSP)

Conditions
-----------------
Disabled Persons

Intervention / Treatment
-----------------
* Procedure: Wheelchair skills traing program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eighteen (18) or older; use a manual wheelchair at least four (4) hours per day; in the rehabilitation process (including training in manual wheelchair use); have enough ability to develop skills included in the wheelchair skills training program; are willing to take part in the study; French-speaking individual capable of understanding enough of the English language to sign this form after carefully reading it competent to give informed consent or have a proxy with power of attorney; have the verbal endorsement of the clinical therapist (if any) to participate; have the permission of the attending physician or occupational therapist to participate; are alert and cooperative. Exclusion Criteria: have an unstable medical condition (e.g. angina, seizures), as indicated by the attending physician, hospital or rehabilitation centre staff, enhanced registered nurse or self-report; have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by the attending physician, hospital or rehabilitation centre staff, enhanced registered nurse or self-report.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Wheelchair skills traing program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| French version of the Wheelchair Skills Test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wheelchairs, skills, french
The Effects of Dehydration on the Performance of Judoka

Study Overview
=================
Brief Summary
-----------------
Dehydration is a common phenomenon in judo that can lead to negative performance such as a decline in strength, a decline in anaerobic performance, a reduced body fluid balance, glycogen depletion and worsened psychological parameters. Therefore, we want to simulate several judo combats and look at the performances whether they change during a competition day. We also want to see if the results are different in a dehydrated versus euhydrated state.

Official Title
-----------------
The Effects of Dehydration on the Performance of Judoka

Conditions
-----------------
Dehydration

Intervention / Treatment
-----------------
* Other: Dehydration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: judoka minimum 18 years men and women only dehydration: sauna, warm bath, sweat suit Exclusion Criteria: injured sick not underaged (18 years)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dehydrated<br>The participants will be dehydrated (at least 2% of their body weight) before performing the Sterkowicz test. | Other: Dehydration<br>* Participants will be dehydrated (2% of their body weight) using sauna.<br>|
| No Intervention: euhydrated<br>The participants will be normally hydrated (= euhydration) before performing the Sterkowicz test (i.e. no specific intervention will be implemented). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sterkowicz test | Sterkowicz test | Up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | Heart rate will be determined using the Polar H1 (Polar, Kempele, Finland) | Up to 3 weeks | 
| Body weight | Body weight will be assessed to the nearest 0.002 kg using the WLT 60/120/X/L3 scale (All Scales Europe, Veen, The Netherlands) | Up to 3 weeks | 
| Borg Rating of Perceived Exertion Scale | The Borg Rating of Perceived Exertion scale is a numerical scale (to determine exertion) that ranges from 6 to 20, where 6 means no exertion at all and 20 means maximal exertion. | Up to 3 weeks | 
| body temperature | Body temperature will be determined using the Adtemp 421 Digital Ear Thermometer (American Diagnostics Corporations, Hauppauge, New York, United States of America) | Up to 3 weeks |
Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis

Conditions
-----------------
Candidiasis, Oral

Intervention / Treatment
-----------------
* Drug: micafungin
* Drug: caspofungin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Esophageal candidiasis confirmed by endoscopy Negative pregnancy test for female patients of childbearing potential Exclusion Criteria: Pregnant or nursing female patient Evidence of liver disease Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug Known to be non-responsive to therapy in any prior systemic antifungal clinical trail Experienced > 2 episodes of esophageal candidiasis requiring systemic antifungal therapy History of anaphylaxis attributed to echinocandin class of antifungals

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Daily dose | Drug: micafungin<br>* IV<br>* Other names: FK463;|
| Active Comparator: 2<br> | Drug: caspofungin<br>* IV<br>|
| Experimental: 3<br>Every other day dose, alternating with placebo | Drug: micafungin<br>* IV<br>* Other names: FK463;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative incidence of success, defined as complete clearing of esophageal lesions |  | End of Therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall therapeutic response |  | End of Therapy | 
| Mycological response |  | End of Therapy | 
| Clinical response |  | End of Therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Micafungin, Esophageal Candidiasis, caspofungin
CHIPs or College Health Intervention Projects

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to test the efficacy of brief clinician advice in reducing the frequency of high-risk drinking and alcohol-related harm in a population of college students seeking care at five university health care clinics. High-risk drinking is defined as 1) 8 or more episodes of heavy drinking (5 or more drinks in a row) in the past 28 days for male and female students, and/or 2) 50 drinks for male and 40 drinks for female students in the past 28 days, and/or 3) 15 drinks for male and 12 drinks for female students in the past 7 days, and/or 4) One or more episode(s) of heavy drinking which includes 15 or more drinks in a row.

Official Title
-----------------
Primary Care Alcohol Intervention in College Students

Conditions
-----------------
Alcohol Abuse

Intervention / Treatment
-----------------
* Behavioral: counseling
* Other: Brief Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who screen positive for high risk drinking on the Health Screening Survey (HSS) and Baseline interview Exclusion Criteria: Students who will be leaving campus due to graduation or for an extended absence prior to the first face to face intervention Female students who are pregnant at the time of randomization Students who are currently suicidal at the time of the baseline interview Students under 18 years of age Students who drink more than 200 drinks in 28 days (referred for treatment).

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief clinician advice<br> | Behavioral: counseling<br>* Physicians discussed high-risk/binge drinking with college-aged individuals in a health care setting.<br>Other: Brief Intervention<br>* Physicians discussed effects of high-risk/binge drinking with college-aged individuals in a health care setting.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in binge/high-risk drinking in college-aged students. |  | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| c) fr. of accidents, d) fr. of campus vandalism and interaction police; e) academic perf; f) fr. of unwanted sex; g) fr. of high-risk sex; h) fr. of physical altercations i) ER visits and hospital days; and j) cost vs. benefit of the intervention. |  | 6-months |
Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.

Conditions
-----------------
Skin Aging

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe crow's feet lines Female or male, 18 years of age and above and in good general health Women of childbearing potential must agree to use an effective method of birth control during the course of the study Exclusion Criteria: Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A Muscle weakness or paralysis, particularly in the area receiving study treatment Active skin disease or irritation at the treatment area Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart Treatment with botulinum toxin type A for crow's feet lines in the last 3 months Chemical peel during the 9 months prior to treatment Use of prescription retinoid products during the 3 months prior to treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose A<br>Dose A: Botulinum toxin type A | Drug: Botulinum Toxin Type A<br>* Botulinum toxin type A, Dose A applied to the lateral canthal area<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments |  | Up to 24 months | 
| Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments |  | Up to 24 months |