linjc16/ctgov huggingface dataset:
Evaluation Of A Novel Methodology In The Assessment Of Urethral Function Using SS-RBX.

Study Overview
=================
Brief Summary
-----------------
SS-RBX will be used to evaluate pharmacodynamic changes in urethral function using a novel methodology

Official Title
-----------------
Measurement Of Urethral Function In Women With Stress Urinary Incontinence - Evaluation Of The Sensitivity Of Urethral Reflectometry Compared To Urethral Pressure Profilometry, Using [S,S]-Reboxetine To Detect Pharmacological Augmentation Of Urethral Pressure.

Conditions
-----------------
Urinary Incontinence, Stress

Intervention / Treatment
-----------------
* Drug: SS-RBX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Stress urinary incontinence Exclusion Criteria: Bladder outflow obstruction Neurological disease

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

Sexes Eligible for Study
-----------------
Female

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

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: SS-RBX|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the utility of urethral reflectometry in the detection of pharmacologically induced pressure changes in the female urethra. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of [S,S]-Reboxetine on urethral function in women with SUI. |  |  |
Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Hypotension after induction of general anesthesia and before surgical stimulation is a prevalent anesthesia-related side effect. The post-induction hypotension disrupts organ perfusion and may cause organ damage particularly acute kidney injury, cerebrovascular stroke, and myocardial ischemia. Post-induction hypotension occurs with greater frequency and severity in the elderly. This is because of aged-related diminished cardiac reserve and impaired autonomic homeostasis. Pleth variability index (PVI) is a software program that measures the dynamic changes of the PI that occurs during a complete respiratory cycle. Our primary outcome is to determine the predictive ability and the optimal cut-off value of pre-anesthesia PVI for predicting elderly patients who are at risk of developing post-induction hypotension

Official Title
-----------------
Pre-anesthesia Pleth Variability Index as a Predictor for Post-induction Hypotension in Elderly Patients Undergoing General Anesthesia: A Prospective Cohort Study

Conditions
-----------------
Post-induction Hypotension

Intervention / Treatment
-----------------
* Device: Pleth variability index for prediction of post-induction hypotension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ASA physical status I or II patients will receive general anesthesia Exclusion Criteria: Patients with a history of cardiorespiratory disorders patients with uncontrolled hypertension or cardiac dysrhythmias Patients with renal or hepatic diseases. Patients with long-standing diabetes and peripheral vascular diseases.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pleth variability index for prediction of post-induction hypotension|The use of the baseline Pleth variability index values for prediction of occurrence of post-induction hypotension|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy (Area under receiver operating characteristic curves) of pre-induction PVI for prediction of post-induction hypotension |  | before induction of general anesthesia |
Open Label Safety Study of a Birch Pollen Allergen Extract

Study Overview
=================
Brief Summary
-----------------
This trial is performed to assess safety of a sublingual birch pollen extract.

Official Title
-----------------
A Multicentre Open Label Safety Study of a Sublingual Specific Immunotherapy With a Solution of Birch Pollen Allergen Extract in Patients With Clinically Relevant Birch Pollen Allergy

Conditions
-----------------
Rhinoconjunctivitis

Intervention / Treatment
-----------------
* Drug: Biological: AL0206st


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allergic rhinoconjunctivitis attributable to birch pollen Positive SPT Positive EAST Exclusion Criteria: Serious chronic diseases Other perennial allergies Partly controlled asthma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Solution of birch pollen allergen extract<br>In total up to 4 drops (dose for maintainace therapy)are administered under the tongue. | Drug: Biological: AL0206st<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with at least one adverse event | Between Visit 03 and Visit 05 (June 2008 - January 2009) | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic reactions | The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase. | Entire treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type I - Allergy, rhinoconjunctivitis
Efficacy of Therapy With the Spironolactone Pills Compared to Minoxidil Lotion in Female Pattern Hair Loss

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.

Official Title
-----------------
Efficacy of Therapy With the Anti-androgen Spironolactone Compared to Topical Minoxidil in Female Pattern Hair Loss

Conditions
-----------------
Female Pattern Hair Loss

Intervention / Treatment
-----------------
* Drug: Spironolactone
* Drug: Minoxidil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be premenopausal women older than 18 with female pattern hair loss. Exclusion Criteria: Androgen excess Other scalp or hair disorders Contraindications to spironolactone treatment, especially pregnancy, electrolyte imbalances, history of breast cancer, or intake of interfering drugs Contraindications to minoxidil treatment, especially patients who are allergic to this treatment or have a history of low blood pressure or irregular heart beats

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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Spironolactone|This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.|
|Drug: Minoxidil|This study evaluates the efficacy of therapy with the anti-androgen spironolactone compared to topical minoxidil in female pattern hair loss.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hair density |  | after 3, 6 and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of subjects who experience side effects |  |  | 
| subject assessment of treatment effect |  |  |
Effect of Amlodipine Monotherapy or Combined With Terazosin on Lower Urinary Tract Symptoms and Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to investigate the efficacy and safety of low dose amlodipine alone, or combined with low dose terazosin in male patients with both lower urinary tract symptoms and hypertension.

Conditions
-----------------
Lower Urinary Tract Symptoms, Hypertension

Intervention / Treatment
-----------------
* Drug: amlodipine
* Drug: terazosin
* Drug: amlodipine plus terazosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men 50 years or older with LUTS [defined as International Prostate Symptom Score (IPSS) >= 10]. Stage 1 or 2 essential hypertension (SBP >= 140 mm Hg and < 180 mm Hg and/or DBP >= 90 mm Hg and < 110 mm Hg) Exclusion Criteria: A history of postural hypotension Secondary hypertension Prostate cancer Prostate surgery or other intervention Use of any agents to influence the LUTS symptoms in the last 4 weeks Other severe diseases

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Experimental: 1<br> | Drug: amlodipine<br>* amlodipine 5mg once daily for 28 days<br>|
| Active Comparator: 2<br> | Drug: terazosin<br>* terazosin 2 mg once daily for 28 days<br>|
| Experimental: 3<br> | Drug: amlodipine plus terazosin<br>* amlodipine 5 mg plus terazosin 2 mg once daily for 28days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy outcomes were reductions in blood pressure and International Prostate Symptoms Score (IPSS) and sub-scores. |  | 28th day after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amlodipine, Terazosin, Lower Urinary Tract Symptoms (LUTS), Essential hypertension, International Prostate Symptom Score (IPSS), Quality Of Life (QOL)
Applicability of Syncope Guidelines in Cataluña

Study Overview
=================
Brief Summary
-----------------
The aim of SYNCAT study is to study the level of adherence of the centers in Cataluña tu the Syncope Guidelines ESC2009 for the diagnosis and treatment of syncope and the impact that following them can have in the prognosis of these patients.

Detailed Description
-----------------
The aim of SYNCAT study is to analyze the level of adherence of Syncope Guidelines ESC2009 for the management, diagnosis and treatment of syncope in a specific territory with similar health structure, the region of Cataluña in Spain that includes aprox. 7,000,000 inhabitants, including different complexity level of hospitals and the impact that following guidelines can have in the prognosis of these patients.

Official Title
-----------------
Observational Study of the Application of the ESC2009 Syncope Guidelines in Cataluña

Conditions
-----------------
Brief Loss of Consciousness

Intervention / Treatment
-----------------
* Diagnostic Test: Transient Loss of Consciousness (T-LOC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each patient that comes from the Emergency room and/or in office doctors visit (Internal Medicine, Cardiology, Neurology...) with Transient Loss of Conscience (T-LOC) Exclusion Criteria: Patients younger than 15 years old Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Transient Loss of Consciousness (T-LOC)<br>Transient Loss of Consciousness (T-LOC). Treatment according to normal clinical practice. | Diagnostic Test: Transient Loss of Consciousness (T-LOC)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients That Adhere to the 2009 Syncope Guidelines (ESC2009) | To analyze the number of patients that an etiologic diagnose was established according to the New Syncope Guidelines ESC2009 in the hospital care, in a particular community with hospitals with different levels of care in a specific region of Spain. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TLOC
Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

Study Overview
=================
Brief Summary
-----------------
This expanded access program will provide continued access to cerdulatinib to eligible participants who experienced clinical benefit from cerdulatinib in Study 13-601 (NCT01994382) and who otherwise meet the eligibility criteria.

Official Title
-----------------
An Expanded Access Protocol for Patients Who Completed Study 13-601 and Continue to Clinically Benefit From Cerdulatinib

Conditions
-----------------
Relapsed/Refractory Chronic Lymphocytic Leukemia, Non-hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: cerdulatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant has completed Portola Study 13-601 and wishes to continue treatment with cerdulatinib. In the opinion of the Investigator, the potential benefit to the participant of continuing to receive cerdulatinib outweighs the risks. Female participants of childbearing potential and male participants must agree to continue to abstain from sexual intercourse or to remain on an effective method of contraception during treatment and for 90 days following the last dose of protocol therapy (examples of effective methods of contraception include oral contraceptives or double barrier methods, such as condom plus spermicide or condom plus diaphragm). Participant must be willing to give written informed consent and be able to adhere to dose and visit schedules. Exclusion Criteria: Participant requires chronic treatment with a strong CYP3A4 inhibitor or inducer. Participant has a known hypersensitivity to any of the components of cerdulatinib. Participant is female and is breast-feeding, pregnant, or intends to become pregnant. Participant is participating in any therapeutic clinical study.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cerdulatinib|Participants will receive oral cerdulatinib at the starting dose he or she was receiving at completion of Study 13-601 (30, 25, 20, or 15 milligrams [mg] twice daily [BID]).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Development of IVR and WEB Alcohol Interventions

Study Overview
=================
Brief Summary
-----------------
The primary aim of the present study is to study the effect of a brief automated alcohol intervention in University students, and if there is a difference in effect between automated brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to study if there is difference in effect between single and repeated interventions.

Official Title
-----------------
Development of IVR and WEB Alcohol Interventions

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

Intervention / Treatment
-----------------
* Behavioral: Single WEB intervention
* Behavioral: Repeated WEB intervention
* Behavioral: Single IVR intervention
* Behavioral: Repeated IVR intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females scoring 6 and above and males scoring 8 and above on AUDIT. Exclusion Criteria: Females scoring 5 and below and males scoring 7 and below on AUDIT
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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single WEB intervention<br>Web intervention recieved once. | Behavioral: Single WEB intervention<br>* Brief WEB intervention recieved once<br>|
| Experimental: Repeated WEB intervention<br>Web intervention recieved twice. | Behavioral: Repeated WEB intervention<br>* WEB intervention recieved twice.<br>|
| Experimental: Single IVR intervention<br>IVR intervention recieved once | Behavioral: Single IVR intervention<br>* IVR intervention recieved once<br>|
| Experimental: Repeated IVR intervention<br>IVR intervention recieved twice | Behavioral: Repeated IVR intervention<br>* IVR intervention recieved twice<br>|
| No Intervention: Control group<br>Untreated Control Group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALCOHOL USE DISORDERS IDENTIFICATION TEST (AUDIT) |  | September 2011 - October 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Drinking Questionnaire (DDQ) |  | September 2011 - October 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol consumption, Brief intervention, Automated techniques
A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.

Official Title
-----------------
A Phase II/III Randomized, Double-masked, Controlled, Parallel Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

Conditions
-----------------
Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Placebo ophthalmic solution
* Drug: DE-117 ophthalmic solution low
* Drug: DE-117 ophthalmic solution high
* Drug: Latanoprost ophthalmic solution 0.005%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma or ocular hypertension Exclusion Criteria: Patients at risk of progression of visual field loss Patients with severe visual field defect Patients with any diseases that preclude participation in this study for safety reasons

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo ophthalmic solution<br>Eyedrop | Drug: Placebo ophthalmic solution<br> <br> |
| Experimental: DE-117 ophthalmic solution low<br>Eyedrop | Drug: DE-117 ophthalmic solution low<br> <br> |
| Experimental: DE-117 ophthalmic solution high<br>Eyedrop | Drug: DE-117 ophthalmic solution high<br> <br> |
| Active Comparator: Latanoprost ophthalmic solution 0.005%<br>Eyedrop | Drug: Latanoprost ophthalmic solution 0.005%<br> <br> * Other names: Latanoprost;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | Week 4 |