linjc16/ctgov huggingface dataset:
A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil compared with placebo.

Official Title
-----------------
A Randomized, Double-Blind, Parallel-Design, Placebo-Controlled Study to Evaluate the Effects of 5 mg Tadalafil (IC351, LY450190) and 50 mg Sildenafil Administered Once Daily for 6 Months on Visual Function in Healthy Subjects or Subjects With Mild Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: tadalafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects or males with mild erectile dysfunction (ED). Between the ages of 30 and 65 years, inclusive. Exclusion Criteria: Phosphodiesterase type 5 (PDE5) inhibitor therapy (tadalafil, sildenafil, or vardenafil) within 6 weeks of the start of the study. Diagnosis of diabetes mellitus. Any chronic illness or medication that is a risk factor for eye disease or any medication that causes retinal toxicity or affects visual function. Certain chronic medical conditions including unstable angina pectoris, severe renal [kidney] insufficiency, clinically significant hepatobiliary [liver, bile duct] disease, cancer, and AIDS/HIV. A history of clinically significant chronic ophthalmologic disease or any significant visual abnormality identified at the start of the study.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tadalafil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dark-adapted bright flash b-wave amplitude on electroretinography (ERG) testing at baseline, 3 & 6 months on drug, and 4-6 weeks after discontinuation of drug. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Five other ERG waveform components; intraocular pressure; visual acuity; peripheral vision; color discrimination; and inspection of anterior chamber, lens, and retinal anatomy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Study Overview
=================
Brief Summary
-----------------
Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.

Official Title
-----------------
Intraoperative and Postoperative Analgesia for Laparoscopic Surgery.

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: morphine
* Drug: intrathecal analgesia (morphine)
* Drug: general anesthesia (fentanyl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic (general) Surgery Age>18 ASA<4 Morning surgery Exclusion Criteria: Patient refusal contra-indication for treatment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>General anesthesia + I.V pca | Drug: general anesthesia (fentanyl)<br>* general anesthesia alone<br>|
| Experimental: 2<br>General anesthesia + spinal analgesia + I.V pca | Drug: morphine<br>* Single dose: 0.1-0.5 mg<br>Drug: intrathecal analgesia (morphine)<br>* 0.1-0.5 mg of morphine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good analgesic method with minimal side effect. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Laparoscopic surgery (general surgery).
Interface Selection for Adaptive Servo Ventilation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.

Official Title
-----------------
Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study

Conditions
-----------------
Central Sleep Apnea, ASV

Intervention / Treatment
-----------------
* Device: Switch from oronasal to nasal mask during ASV treatment
* Device: Switch from nasal to oronasal mask during ASV treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with central sleep apnea, not responding to treatment with CPAP Indication for treatment with ASV Exclusion Criteria: Patients < 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oronasal - Nasal<br>Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night. | Device: Switch from oronasal to nasal mask during ASV treatment<br>* One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.<br>|
| Other: Nasal - Oronasal<br>Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night. | Device: Switch from nasal to oronasal mask during ASV treatment<br>* One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea/hypopnea index | Effect on respiratory events | Two nights | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mask comfort VAS | Subjective mask comfort | Two nights | 
| Device leaks data | Evaluation of leaks (data of ASV device) | Two nights | 
| Sleep efficiency | polysomnographic evaluation | Two nights | 
| Sleep architecture | Polysomnographic evaluation of different sleep stages | Two nights |
Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

Study Overview
=================
Brief Summary
-----------------
Our group has discovered that routine vaccinations in childhood may have non-specific and sex-differential effects on overall mortality. The effects are so large that they may have marked effects on overall mortality and seriously distort female-to-male mortality rates in high-mortality settings. We recently experienced periods during which oral polio vaccine (OPV) was lacking. Hence, some children did not get the recommended OPV at birth. We were following all infants as a part of a vitamin A supplementation trial. Surprisingly, we discovered that not receiving OPV was associated with significantly lower mortality in boys, but not in girls. We bled a subgroup of the children. Receiving OPV at birth significantly dampened the immunological response to BCG given at birth in both sexes. Based on these observations, receiving OPV at birth may have two negative effects, first, it may increase male mortality, and second, it may interfere with immunity against tuberculosis. OPV at birth is given for logistic reasons, to boost polio immunity. There have been no polio cases in Guinea-Bissau for the last 10 years. Hence, there is every reason to test in a randomised trial whether not receiving OPV at birth is associated with 1) mortality, morbidity and growth and 2) immunological response to BCG.

Official Title
-----------------
Investigating the Mortality and the Morbidity Impact of Oral Polio Vaccine at Birth

Conditions
-----------------
Infant, Newborn, Healthy

Intervention / Treatment
-----------------
* Biological: Oral polio vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Normal birth weight, no overt illness or gross malformations - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Oral polio vaccine | Biological: Oral polio vaccine<br> <br> |
| No Intervention: B<br>No oral polio vaccine | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality by sex |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity, growth, immunology |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mortality, Morbidity, Growth, Immunology
Effect of Dietary DHA Supplementation on Sperm Quality

Study Overview
=================
Brief Summary
-----------------
The aim of this study is evaluated the effect of dietetic supplementation with DHA on human sperm quality, antioxidant capacity and sperm DNA damage.

Official Title
-----------------
Effect of Dietary DHA Supplementation on Sperm Quality.

Conditions
-----------------
SPERM

Intervention / Treatment
-----------------
* Dietary Supplement: Sunflower oil
* Dietary Supplement: Docosahexanoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of male factor. Exclusion Criteria: Metabolic and genetic diseases. Oncological patients. Patients with anticoagulants treatment.
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sunflower oil<br> | Dietary Supplement: Sunflower oil<br>* 1500 mg sunflower/day for 10 weeks<br>|
| Experimental: Docosahexanoic acid<br> | Dietary Supplement: Docosahexanoic acid<br>* 1500mg/day for 10 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm concentration | million of spermatozoa per milimitre | 5 weeks | 
| Sperm motility | Percentage of motile sperm. | 5 weeks | 
| Sperm morphology | Percentage of sperm with normal morphology | 5 weeks | 
| Total capacity antioxidant | Total antioxidant capacity (TAC)is a colorimetric assay that measure the combined antioxidant activities of all its non enzymatic constituents in seminal plasma. | 5 weeks | 
| Sperm DNA damage. | DNA fragmentation analysis was evaluated by TUNEL test and measured by flow cytometry | 5 weeks | 
| Fatty acids measure. | Fatty acid analysis in seminal plasma and spermatozoa were evaluated by gas chromatography.The percentage of each fatty acid class was expressed as percentage of total fatty acids. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm in ejaculate | Million of spermatozoa in eyaculate. | 5 weeks | 
| Volume of ejaculate. | Eyaculated milliliters. | 5 weeks | 
| Sperm viability | Porcentage of sperm whitout membrane damage | 5 weeks |
The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.

Study Overview
=================
Brief Summary
-----------------
Transcleral cyclophotocoagulation has been used to treat glaucoma secondary to silicone oil

Official Title
-----------------
The Effect of Direct Cyclophotocoagulation Using Endolaser in Silicon Induced Glaucoma: a Pilot Study.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Cyclophotocoagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . Patients above 18 years of age. .Silicon filled for more than 2 months. .IOP more than 21 mmHg on triple topical antiglaucoma eye drops. Exclusion Criteria: . History of glaucoma prior to the initial retinal surgery. . Immediate rise of IOP after SOI. . History of previous laser application to the ciliary body. . Any contraindications for silicone oil removal.

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: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: pilot
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cyclophotocoagulation|Transcleral cyclophotocoagulation is used to treat glaucoma secondary to silicone oil.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP lowering in patients with silicon induced glaucoma |  | 6 months |
Internet-Based Strategic Transdisciplinary Approach To Risk Reduction And Treatment

Study Overview
=================
Brief Summary
-----------------
I-START is a randomized controlled trial that will evaluate the efficacy of an internet-based program of behavioural counseling for adaptive lifestyle change to subjects diagnosed with hypertension. I-START will be evaluated using objective outcome indices: systolic and diastolic blood pressure, pulse pressure, and markers of vagal-heart rate (HR) modulation and baroreflex sensitivity. The Heart and Stroke Foundation of Canada Blood Pressure Action Plan(TM) (BPAP) will be adminisered over a 4-month period, and evaluated in a 2 (Intervention vs. Wait list Control) X 2 (Baseline vs. Post-Intervention) factorial design, blocking for 3 recruitment sites (Toronto, London, the Grey Bruce region of Ontario, Canada), and stratified for sex and age group (45-59, 60-74 years).

Official Title
-----------------
I-START: Internet-based Strategic Transdisciplinay Approach to Risk Reduction And Treatment

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Web-based lifestyle counseling messages
* Behavioral: Generic Information


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage 1 OR Stage 2 hypertension 46 -74 years of age able to read & write English or French living in private residence Exclusion Criteria: Cardiovascular disease Major psychiatric disorder (e.g. psychosis) Dependence on Alcohol or Drugs with in past year Diabetes >= 5 years

Ages Eligible for Study
-----------------
Minimum Age: 46 Years
Maximum Age: 74 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 |
| --- | --- |
| Active Comparator: 1<br>Waitlist control with generic Information about lifestyle and hypertension | Behavioral: Generic Information<br>* Waitlist control plus educational material on lifestyle behavior and hyptertension<br>|
| Experimental: 2<br>Web-based intervention of lifestyle counseling messages based on the transtheoretical model of readiness for change. | Behavioral: Web-based lifestyle counseling messages<br>* 10 email messages based on readiness-to-change over a 4 month period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lab Assessment of systolic and diastolic blood pressure as well as pulse pressure |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lifestyle Behavior: exercise and diet assessed by questionnaire |  | 4 months | 
| laboratory assessment of estimated vagal-heart rate modulation and baroreflex sensitivity |  | 4 months |
The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.

Official Title
-----------------
The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations: a Prospective Cohort Study

Conditions
-----------------
Surgery, Children, Only, Drug Effect, Vascular Malformations

Intervention / Treatment
-----------------
* Drug: Detralex
* Drug: Troxevasin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: venous malformation venous malformation Exclusion Criteria: allergy

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Per os+topical solution(1)<br> | Drug: Detralex<br>* Diosmin+ Hesperidin<br>|
| Per os+topical solution(2)<br> | Drug: Detralex<br>* Diosmin+ Hesperidin<br>Drug: Troxevasin<br>* Troxerutin<br>|
| Per os only<br> | Drug: Detralex<br>* Diosmin+ Hesperidin<br>|
| Topical solution only<br> | Drug: Detralex<br>* Diosmin+ Hesperidin<br>Drug: Troxevasin<br>* Troxerutin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coagulation testing | Coagulation testing | 1 month |
The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder

Detailed Description
-----------------
Children aged 5 - 10 years newly diagnosed with attention deficit hyperactivity disorder who report primary nocturnal enuresis, Investigators will obtain baseline data (from parents/caregivers) on their sleep habits and enuresis characteristics by questionnaire. After 6 weeks of methylphenidate therapy, prescribed for the attention deficit, a new questionnaire will be filled.

Official Title
-----------------
Does Methylphenidate, Prescribed for Attention Deficit Disorder, Influence Primary Enuresis in These Children?

Conditions
-----------------
Attention Deficit Hyperactivity Disorder, Enuresis

Intervention / Treatment
-----------------
* Drug: methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New diagnosis of attention deficit hyperactivity disorder History of primary nocturnal enuresis Normal neurological examination Exclusion Criteria: Anatomical abnormality of the genitourinary system Concommitant treatment, pharmacological/behavioral for enuresis Concommitant diurnal enuresis

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: methylphenidate|The drug will be prescribed as indicated for attention deficit disorder|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A reduction in nocturnal enuresis frequency |  | 6 weeks |