linjc16/ctgov huggingface dataset:
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to find the Effects of Anesthetics Used in Hypotensive Anesthesia on Stapes Reflex and Distortion Product Auto Acoustic Emission.

Detailed Description
-----------------
This study was aimed at evaluating the effects of dexmedetomidine and esmolol on stapes reflex and distortion product auto acoustic emission. the stapes reflex and auto acoustic emission are of considerable diagnostic significances in otolaryngology this are objective methods for the assessment of auditory function.

Official Title
-----------------
The Effects of the Drugs Used in Hypotensive Anaesthesia on Cochlea

Conditions
-----------------
Anesthesia; Adverse Effect, Reflex, Abnormal, Tinnitus, Spontaneous Oto-Acoustic Emission

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: esmolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 age American Society of Anaesthesiologists physical status classification (ASA)1-2 tympanoplasty surgery patients with normal stapes reflexes Exclusion Criteria: hypertension drug allergy cardiac problems pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: dexmedetomidine<br>0,4-0,8 µg./kg./h dexmedetomidine | Drug: Dexmedetomidine<br>* 1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion<br>* Other names: precedex;|
| Active Comparator: esmolol<br>100- 300 µg./kg./min esmolol | Drug: esmolol<br>* 500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion<br>* Other names: breviblock;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distortion product auto acoustic emission | distortion product measurements will be performed in 1001, 1501, 2002, 3003, 4004, 6006, 7996 Hz frequencies and change from baseline in distortion product measurements at postoperative 1 day | postoperative 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stapes reflex | stapes muscle reflex measurements will be performed by electrical impedance. data will be taken as graphics. ıf there is an amplitude on graphic the data will be assumed as stapes reflex positive.Change from Baseline in stapes muscle reflex at postoperative 1 day | postoperative 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine, esmolol, stapes reflex
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This is a single center, observational study of posaconazole PK sampling in lung transplant recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and one 10ml blood sample for a total collection of 28ml of blood obtained over the entire study. In addition, the investigators will collect medical record information and any excess BAL samples available during the study (tests done as part of the patient's clinical care and the samples would have been discarded once diagnosis was made).

Detailed Description
-----------------
PK blood samples will be obtained around a clinical dosing of posaconazole

Official Title
-----------------
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

Conditions
-----------------
Lung Transplant Infection, Fungal Infection

Intervention / Treatment
-----------------
* Other: collection of blood samples for PK testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant Exclusion Criteria: must meet inclusion criteria

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 'collection of blood samples for PK testing'<br>collection of PK samples around a dosing of Posaconazole | Other: collection of blood samples for PK testing<br>* PK samples collected around dosing of posaconazole<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the levels of posaconazole post dosing | pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels | 24 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
posaconazole, PK blood sampling
Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. Patients receive potassium phosphate or potassium citrate tablets twice a day for 3 years.

Conditions
-----------------
Hypercalciuria, Kidney Calculi

Intervention / Treatment
-----------------
* Drug: potassium citrate
* Drug: potassium phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- Creatinine clearance at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: potassium citrate|nan|
|Drug: potassium phosphate|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
-----------------
hypercalciuria, nephrolithiasis, rare disease, renal and genitourinary disorders
Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis

Study Overview
=================
Brief Summary
-----------------
This is a study to to compare traditional fibre wound swabs to more recently developed flocked swabs for the identification of Group A streptococcal pharyngitis in children presenting to a children's emergency department.

Conditions
-----------------
Streptococcal Infection, Pharyngitis

Intervention / Treatment
-----------------
* Device: Flocked swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need for a bacterial throat culture

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Flocked swab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of Group A streptococcus via culture of organism |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Flocked swab, Group A streptococcus pharyngitis
An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Study Overview
=================
Brief Summary
-----------------
To determine the safety profile of Androxal in men with secondary hypogonadism.

Detailed Description
-----------------
This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Official Title
-----------------
An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

Conditions
-----------------
Secondary Hypogonadism

Intervention / Treatment
-----------------
* Drug: Androxal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Successful completion of either ZA-301 or ZA-302 Exclusion Criteria: • Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Androxal<br>Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2. | Drug: Androxal<br> <br> * Other names: enclomiphene citrate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone levels | Values of total morning testosterone levels at each visit | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follicle Stimulating Hormone and Leutinizing Hormone | Values of Follicle Stimulating Hormone (FSH) and Leutinizing Hormone (LH) at each visit | 26 weeks | 
| Diabetic Parameters | Changes in HbA1c, fasting plasma glucose (FPG), insulin, and homeostasis model assessment-insulin resistance (HOMA-IR) for those subjects with Type II diabetes | 26 weeks | 
| Change in weight and body mass index (BMI) | Change in weight and BMI | 26 weeks |
Overactive Bladder (OAB) Drink Advice Study

Study Overview
=================
Brief Summary
-----------------
The researchers want to investigate how fluid intake influences the symptoms of OAB. The researchers will recruit 45 patients with OAB and randomize them (blind) in 3 groups (low/normal/high fluid intake). Patients will follow this drink pattern for 2-5 days, while filling in an standard micturation diary for 2 days. This micturation diary is coupled to: collection of multiple urine samples, urine pH measurements, and a Perception of Intensity of Urgency Scale (PPIUS) scoring table. All this is collected by the patients themselves. Urine samples will be analysed for osmolality by the clinical chemistry department.

Official Title
-----------------
Prospective Intervention Study of Drink Advice in Overactive Bladder Syndrome (OAB)

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

Intervention / Treatment
-----------------
* Dietary Supplement: water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OAB patients Exclusion Criteria: benign prostatic hyperplasia neurogenic detrusor overactivity urine tract infection anticholinergics intravesical botulin toxin cardiac failure renal insufficiency sacral neurostimulation percutaneous neurostimulation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: normal fluid intake<br>1500 ml /day (+/- 300 ml) for 2,5 days | Dietary Supplement: water<br>* drinking water / normal dietary fluids for oral intake<br>|
| Active Comparator: high fluid intake<br>2400 ml/day (+/- 300 ml )for 2,5 days | Dietary Supplement: water<br>* drinking water / normal dietary fluids for oral intake<br>|
| Active Comparator: low fluid intake<br>fluid intake 900 ml/day (+/- 300ml) for 2,5 days | Dietary Supplement: water<br>* drinking water / normal dietary fluids for oral intake<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine osmolality |  | 2 days | 
| PPIUS urge-score |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine pH |  | 2 days | 
| PPIUS urge score |  | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAB, urine, osmolality, urge, fluid intake, PPIUS, urge score, bladder
Dysfunctional Uterine Bleeding After Tubal Sterilization

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will compare the frequency and amount of bleeding after tubal sterilization and salpingectomy

Detailed Description
-----------------
Dysfunctional uterine bleeding is common after tubal sterilization. The investigators will compare the frequency and amount of bleeding after two techniques eithe tubal sterilization by pomeroy's method during cesarean section or complete salpingectomy

Official Title
-----------------
Dysfunctional Uterine Bleeding After Tubal Sterilization and Salpingectomy

Conditions
-----------------
Contraception, Dysfunctional Uterine Bleeding

Intervention / Treatment
-----------------
* Procedure: Pomeroy's tubal sterilization
* Procedure: Salpingectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-40 Patient completed her family Patient on cesarean delivery Exclusion Criteria: Tubal sterilization by other methods Salpingectomy by laparoscopy Patient wishing fertility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tubal sterilization Pomeroy's method<br> | Procedure: Pomeroy's tubal sterilization<br>* Both Fallopian tubes will be grasped by allis forceps and a kokher forceps will be applied below the allis forceps then excision of tubal part above kokher and transfixation of both ends away from each other during cesarean section<br>|
| Active Comparator: Salpingectomy<br> | Procedure: Salpingectomy<br>* Both fallopian tubes will be completely removed during cesarean section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Dysfunctional bleeding | percentage of cases suffering of dysfunctional bleeding | 1 year after cesarean section | 
| Amount of bleeding | number of sanitary pads during bleeding | 1 year after cesarean section | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dysfunctional uterine bleeding, Tubal sterilization, Salpingectomy, Cesarean section
Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement

Study Overview
=================
Brief Summary
-----------------
Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.

Official Title
-----------------
Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement

Conditions
-----------------
Micropenis

Intervention / Treatment
-----------------
* Device: Hyaluronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males, 21 to 65 years of age, Seeking enhancement of their penile width and girth. Exclusion Criteria: Patient with a history of psychological or psychiatric illness, Congenital or acquired penile malformation, Previous plastic surgery or non-invasive treatments of their penis, Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy. Patients with a history of allergic reactions to hyaluronic acid derivatives Individuals with penises measured less than 6 cm in length in the flaccid position Individuals with penises greater than 12.5 cm in length in the flaccid position. Individuals with uncircumcised penises

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>This is a prospective, single-arm, single-center study | Device: Hyaluronic Acid<br>* Injectable<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in penile width and girth | Three-dimensional (3D) surface images taken by a digital stereophotogrammetry system at the baseline will be compared to the images taken at 1 year post-treatment follow up. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of increase in penile width and girth | For how long duration the treatment will produce a measurable difference in penile size. | 1 year |
A Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Objective of this study is to investigate the safety, pharmacokinetics and efficacy of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.

Official Title
-----------------
A Phase II Clinical Study of KDT-3594 in Japanese Patients With Early Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: KDT-3594


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese patients Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale Exclusion Criteria: Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease. Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score < 24 points

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: KDT-3594<br> | Drug: KDT-3594<br>* oral administration, dose titration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | The numbers of events and subjects, the incidence regarding adverse events. | 8 weeks | 
| Plasma concentrations of KDT-3594 and its metabolites | Plasma concentrations of KDT-3594 and its metabolites during treatment period. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change from baseline (Week 0) in MDS-UPDRS total score | 8 weeks |