linjc16/ctgov huggingface dataset:
Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the pre-operative levels of sex-hormones can be used to identify the varicocele patients who can expect improvements in their semen parameters following varicocelectomy.

Official Title
-----------------
Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality?

Conditions
-----------------
Varicocele, Infertility, Semen Quality

Intervention / Treatment
-----------------
* Procedure: Hormone and semen measurements before varicocelectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Varicocele (grade 1-3) and surgery planned for this condition At least 18 years of age Exclusion Criteria: Fever within 3 months before the first semen sample Malformations of the uro-genital tract Karyotype other than 46, XY or Y micro deletions Endocrine disease Chronic disease Medications which reduce semen quality Epididymitis within 6 months before surgery

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hormone/semen measurements before and after varicocelectomy<br>We will measure sex-hormone and semen quality in patients both before and after varicocelectomy. The purpose is to asses if preoperative hormone levels are predictive for who will have improved semen quality after surgery. | Procedure: Hormone and semen measurements before varicocelectomy<br>* Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in semen parameters |  | February 2017 (anticipated duration of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hormone levels |  | February 2017 (anticipated end of the study) |
Post Marketing Surveillance Study on Emselex After Launch in Germany

Study Overview
=================
Brief Summary
-----------------
- Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.

Official Title
-----------------
Post-Marketing Surveillance Study Emselex

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

Intervention / Treatment
-----------------
* Drug: Darifenacin, Emselex (BAY79-4998)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are treated with Emselex for Overactive Bladder Exclusion Criteria: Exclusion criteria are the contraindications as specified in the German product information

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 |
| --- | --- |
| Group 1<br> | Drug: Darifenacin, Emselex (BAY79-4998)<br>* Patients from routine practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, Adverse drug reactions, physician's global assessment of tolerability |  | After 2-3 months of treatment (long-term 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incontinence |  | At end of study | 
| Urgency episodes |  | At end of study | 
| Micturitions / nycturitions |  | At end of study | 
| Physician's assessment of improvement/efficacy |  | At end of study | 
| Physician's assessment of patient's satisfaction with therapeutic effect |  | At end of study | 
| Physician's assessment of patient's ability to hold urine |  | At end of study | 
| Dose and treatment duration of Emselex |  | At end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder
Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers

Study Overview
=================
Brief Summary
-----------------
Patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from June 2013 to June 2014 were considered eligible for enrolment. Enrolled patients underwent a baseline unenhanced CT scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months. Finally, the patients underwent a follow-up unenhanced CT scan during hydration regimen.

Official Title
-----------------
Changes in Renal Papillary Density After Hydration Therapy in Calcium Stone Formers

Conditions
-----------------
Urolithiasis

Intervention / Treatment
-----------------
* Other: Oligomineral water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing endourological procedures for renal stones Recurrent stone disease Calcium oxalate stones (>50% of the stone made of calcium oxalate) Exclusion Criteria: Systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis) Non-calcium oxalate stones

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 |
| --- | --- |
| Other: Hydration<br>Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months | Other: Oligomineral water<br>* Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in renal papillary density | Renal papillary density measured with unenhanced CT scan | At baseline and after 12 months |
Verification of the Safety of Normal Food Before a Cerebral Arteriography

Study Overview
=================
Brief Summary
-----------------
Fasting is currently required before elective cerebral angiography, despite numerous arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose to assess frequency of nausea and vomiting among patients having taken their breakfast at home before day care angiography. The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

Detailed Description
-----------------
Fasting is currently required before elective cerebral angiography, despite numerous arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams unusefull regarding it's main goal : reducing nausea and vomiting. The investigators propose to assess frequency of nausea and vomiting among patients having taken their breakfast at home before day care angiography. The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

Official Title
-----------------
Verification of the Safety of Normal Food Before a Cerebral Arteriography

Conditions
-----------------
Cerebral Angiography

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, non fasting, day care hosptilalisation Exclusion Criteria: Childs, pregnancy, parenteral nutrition, nausea, vomiting before arteriography, arteriography under general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of vomiting during arteriographic procedure | The investigators check if there is vomiting or not during the examination noted by an electro radiology manipulator. Safety issue : Bronchus inhalation | fifteen minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea | The nausea will be evaluated using an analog visual scale (EVA) by an electro-radiology manipulator (MAR)at the exit of the intervention room | fifteen minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fasting, non fasting, cerebral angiography, nausea, vomiting
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).

Detailed Description
-----------------
The tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. The tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. Control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus. The formalin-fixed and paraffin embedded tissue samples were stained with Verhoeff van Gieson and Movat's pentachrome. Samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. In case of discrepancy investigators evaluated the samples together to gain consensus.

Official Title
-----------------
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.

Conditions
-----------------
Pelvic Organ Prolapse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery for pelvic organ prolapse hysterectomy due to other benign reasons than pelvic organ prolapse Exclusion Criteria: surgery due to malignancy
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with pelvic organ prolapse<br>Patients, who were operated on because of pelvic organ prolapse. | |
| Patients without pelvic organ prolapse<br>Patients, who had hysterectomy due to other reasons than pelvic organ prolapse. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The elastin content in tissue samples in patients with or without pelvic organ prolapse. |  | september 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The collagen content in tissue samples in women with or without pelvic organ prolapse. |  | September 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic organ prolapse, Connective tissue, Elastin, Collagen
Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule. YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation. Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2

Official Title
-----------------
Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 45 years old, healthy adult male subject >55 Kg(Body weight) and < ideal body weight ± 20% Exclusion Criteria: AST or ALT > 1.25 * Upper normal range (Lab) Total bilirubin > 1.5 * Upper normal range Systolic BP >140 OR <100, Diastolic BP >90 OR <65

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lyrica capsule(Pregabalin 150mg)<br> | Drug: Pregabalin<br>* Pregabalin 300mg a day<br>|
| Experimental: YHD1119 A(Pregabalin SR 300mg)<br> | Drug: Pregabalin<br>* Pregabalin 300mg a day<br>|
| Experimental: YHD1119 B(Pregabalin SR 300mg)<br> | Drug: Pregabalin<br>* Pregabalin 300mg a day<br>|
| Experimental: YHD1119 C(Pregabalin SR 300mg)<br> | Drug: Pregabalin<br>* Pregabalin 300mg a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss |  | 36 hr | 
| AUCtau |  | 36 hr | 
| Safety monitoring | Laboratory findings Adverse event | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast AUCinfinity Tmax,ss t1/2 |  | 36 hour | 
| AUCinfinity |  | 36 hr | 
| Tmax,ss |  | 36 hr | 
| t 1/2 |  | 36 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C
Quality Project Malnutrition Intensive Care

Study Overview
=================
Brief Summary
-----------------
Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score.

Detailed Description
-----------------
Malnutrition is a great problem in healthcare, its related to mortality, infections and length of stay. Observational study to investigate nutrition state in all admitted patients in ICU. Measurement by BIVA and SNAQ score. All patients were asked for their nutrition state by SNAQ and the BIVA measurement is done by a trained doctor.

Official Title
-----------------
Quality Project Malnutrition Intensive Care

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Other: BIVA measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission ICU Exclusion Criteria: none

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 |
| --- |
|Other: BIVA measurement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malnutrition | percentage of patients with malnutrition at admission on the ICU | day 1 in Intensive Care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| malnutrition in elective and acute patients | Is there a difference in malnutrition between elective patients and acute patients | day 1 in Intensive Care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIVA measurement, SNAQ score
Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.

Official Title
-----------------
Safety and Efficacy of Switching to the Travoprost/Timolol Maleate Fixed Combination (DUOTRAV®) From Prior Mono or Two-Drug Therapy in Germany

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

Intervention / Treatment
-----------------
* Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Age related. Other protocol-defined exclusion criteria may apply.

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: DuoTrav<br>One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks | Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)<br>* One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks<br>* Other names: DUOTRAV®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline) |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure at 12 weeks from other prior therapies (baseline) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma
Epidemiology and Cost-effectiveness of Out-Of-Hospital Cardiac Arrest in Finland

Study Overview
=================
Brief Summary
-----------------
Observational study of all out-of-hospital cardiac arrest during 6 months in regional areas of Helsinki University Hospital and Kuopio University Hospital from activation of EMS system until follow up to 6 months of survival.Simultaneous observation of out-of-hospital cardiac arrest primary survivors admitted to all Finnish ICUs.

Official Title
-----------------
FinnResusci: Epidemiology and Cost-effectiveness of Out-Of-Hospital Cardiac Arrest in Finland

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-of-hospital cardiac arrest patients Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group study<br> | Other: No intervention<br>* Observational study, no interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive at hospital discharge (time frame: Hospital discharge day) | alive at hospital discharge | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPC (time frame: 1 year after cardiac arrest) | Neurologic outcome (Cerebral Performance Category) at one year after out of hospital cardiac arrest. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Arrest, Intensive Care Unit, Emergency Medical Service