linjc16/ctgov huggingface dataset:
Uroflowmetry in Children With Enuresis Nocturnal

Study Overview
=================
Brief Summary
-----------------
Background: Enuresis nocturna is an important social and psychological problem in children. Uroflowmetry is an important test used to investigate lower urinary tract symptoms.. Objective:To evaluate the uroflowmetry (UFM) results of children with nocturnal enuresis (NE). Method: The uroflowmetry findings of healthy and visualized children without any urinary symptoms and who were prospectively admitted to the urology and pediatric surgery outpatient clinic with the complaint of Enuresis nocturna between January 2020 and July 2021 were compared. Information (anamnesis, physical examination, radiology results and laboratory tests) and uroflowmetry results of NE and healthy children included in the study were recorded.

Detailed Description
-----------------
SMale and Female,

Official Title
-----------------
How Valuable is Uroflowmetry in Children With Enuresis Nocturnal?

Conditions
-----------------
Enuresis

Intervention / Treatment
-----------------
* Device: uroflowmetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primer monosymptomatic enuresis nocturna Exclusion Criteria: Urinary infectious Diabetes Spina bifida, Epispadias, Hipospadias VUR Extrophia Vesica Epilepsy Cerebral Palsy

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>Enuresis nocturna with children | Device: uroflowmetry<br>* Qmax(ml/s),Qav(ml/s),Volume (ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uroflowmetry | ml/s | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enuresis nocturna, uroflowmetry, child
Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac manipulation during off pump surgery in patients who require the drug for inotropic support (improved heart function) and the associated hemodynamic variables (vital signs). Levosimendan is one of the first agents in a new class of drugs used to treat heart failure and works via a unique mechanism called calcium sensitization, that makes the heart beat more efficiently. Levosimendan also has unique effects on the blood vessels, as well as causing relaxation, an important therapeutic approach of heart failure therapy.

Detailed Description
-----------------
This is a non-randomized trial, and the patients will be assigned to one of three dose groups following cardiopulmonary bypass or prior to manipulation of the heart in the off pump group. A total of 30 patients will be enrolled into this study, 20 off-pump and 10 subjects on pump. Levosimendan is approved in Europe for the treatment of decompensated heart failure. It improved cardiac function without increasing energy demands. The subject's enrollment ends at Day 7 or day of discharge, whichever comes first.

Official Title
-----------------
Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Levosimendan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 21 years of age Less than 80 years of age ASA Class III-IV Scheduled for elective cardiac surgery Signed informed consent History of heart failure, and/or left ventricular ejection fraction <50% Exclusion Criteria: Emergency surgery Withdrawal of consent Uncontrollable ventricular arrhythmias Obstructive cardiomyopathy Confirmed pregnancy test for women of child-bearing potential

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics |  | day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamics |  | day of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, cardiac surgery, pharmacokinetics, pharmacodynamics
Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Schizotypal personality disorder patients will show cognitive improvements in 1) working memory 2) learning and memory 3) sustained attention 4) enhanced performance on the AX-CPT, N-back and Eriksen during pergolide treatment. There will be a significant diagnosis by drug administration of 0.3 mg of oral pergolide interaction for performance on the cognitive tasks, with the schizotypal personality disorder group demonstrating significantly improved peformance compared to the other personality disorder group after pergolide compared with placebo. Design: Randomized, double-blind, crossover study of pergolide vs. placebo. Half of subjects receive pergolide for eight weeks; half of subjects receive placebo for four weeks followed by pergolide for four weeks.

Official Title
-----------------
The Dopaminergic System in Schizotypal Personality Disorder: Pergolide for Cognitive Symptoms in Schizotypal Personality Disorder

Conditions
-----------------
Schizotypal Personality Disorder, Other Personality Disorders

Intervention / Treatment
-----------------
* Drug: Pergolide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for Schizotypal Personality Disorder (or meets full criteria bar one) or another personality disorder and shows impairment on markers of cognitive functioning. Medically healthy, not abusing drugs or alcohol, is at least two weeks medication-free and does not have significant neurological disease. - Exclusion Criteria: DSM-IV or RDC criteria for Schizophrenia or any Schizophrenia-related psychotic disorder or for Bipolar Disorder. Any other Axis I disorders must be transient and preceded by the personality disorder diagnosis, which should be primarily responsible for subject's functional impairment. -

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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on tests of sustained attention, episodic memory and working memory at baseline and after 2, 4, 6 and 8 weeks on the study medication |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale, Positive and Negative Symptom Scale and Clinical Global Impression scale at baseline and then weekly through the end of the trial |  |  |
OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
Smartphone apps have the potential to measure standard metrics of visual function. In addition, new tests may serve as digital biomarkers to detect early progression of disease, assess risk of developing disease or expand the patient's clinical picture. Smartphones are inherently advantageous to reduce the reliance on specialist bulky and costly equipment that currently only exists in specialist clinics. While there are some smartphone apps available for vision monitoring, very few have any clinical evidence to support reliability, validity and diagnostic accuracy. The OKKO Health app (www.okkohealth.com) is a smartphone app available on Apple iOS and Android platforms, consisting of short games with applied vision science technology to measure visual function in an engaging way. The app has one game per function, each on average 1-2 minutes. There are 4 game modes available testing visual acuity, contrast sensitivity, colour sensitivity and hyperacuity. This study will aim to validate these measures of visual function against gold standard clinical tests.

Official Title
-----------------
OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with AMD in at least one eye Willing to travel to the clinic in Exmouth/Bristol Able to hold and use a smartphone Exclusion Criteria: Significant ocular pathology other than AMD Unable to provide written informed consent

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Visual acuity collected in the OKKO Health app and via ETDRS chart | Day 1 | 
| Contrast sensitivity | Contrast sensitivity collected in the OKKO Health app and via Pelli Robson chart. | Day 1 | 
| Colour sensitivity | Colour sensitivity collected in the OKKO Health app and via City University colour test/Mollon-Reffin colour vision test. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual distortion | Visual distortion assessed using the OKKO Health app and Amsler chart. | Day 1 | 
| Optical coherence tomography (OCT) | Scans obtained from OCT. | Day 1 |
Melanocortin 4 Receptor Mutations and Obesity-associated Diseases

Study Overview
=================
Brief Summary
-----------------
Mutations in the melanocortin 4 receptor (MC4R) are the most common form of monogenic obesity, and can explain 2-6% of severe obesity. Studies have shown that mutations in MC4R are associated with increased fat mass, height-for-age, appetite and insulin resistance among children. In adults, mutations in MC4R are less penetrant for these phenotypes but it has been observed that individuals with MC4R mutations have a smaller than expected blood pressure for their degree of obesity. The purpose of this study is to explore the association between functional MC4R mutations and obesity, insulin resistance and blood pressure.

Official Title
-----------------
Mutations in the Melanocortin 4 Receptor and Obesity-associated Diseases

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 years Men and women BMI > 30 kg/m^2 Exclusion Criteria: Uncontrolled type 2 diabetes Bariatric surgery Use of anti-obesity medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>No intervention | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obesity | Obesity measured as BMI | Baseline | 
| Blood glucose | Blood glucose measured at baseline | Baseline | 
| MC4R mutations | MC4R mutations detected by sequencing of the coding region of the MC4R gene | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, MC4R, Blood pressure, Blood glucose
Management of Prostate Cancer in Central China

Study Overview
=================
Brief Summary
-----------------
Some recent reports indicate that incidence of prostate cancer is increasing rapidly in China. However, no large-scale survey of prostate cancer has been done in central China, few data are available regarding its management. The investigators aimed to analyze the management of prostate cancer and compare the outcome of patients with such a survey. The investigators collected data of patients diagnosed with prostate cancer from the 2003 and 2008 in central China. Data were disaggregated by rural and urban hukou. The survival rate of patients was analyzed using Kaplan-Meier method. Prognostic factors were analyzed using the log-rank test and Cox proportional hazards model.

Official Title
-----------------
Comparisons of Management and Outcome of Prostate Cancer in Central China Between 2003 and 2008: A Multi-institutional Report

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with newly diagnosed prostate cancer were included in the study. Exclusion Criteria: Those with a history of prostate cancer who were treated for another disease were excluded from study.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| all patients<br>We selected 9 cities (Zhengzhou, Luoyang, Kaifeng, Anyang, Xinyang, Zhoukou, Shangqiu, Nanyang, Zhumadian) by probability proportional to size sampling from geographical regions in central China. All cases with complete follow-up data of histological-proven prostate cancer treated in 2003 and 2008 at 14 department of urology in the 9 cities were retrospectively collected. Only patients with newly diagnosed prostate cancer were included in the study. Those with a history of prostate cancer who were treated for another disease were excluded from study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | overall survival that was defined as the interval from the date of diagnosis to the Medicare date of death | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostatic Neoplasms, Prostate Cancer, Disease Management, Rural, Urban
Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients.

Official Title
-----------------
Efficacy and Safety of DWP450 Compared With Botox in Patients With Moderate to Severe Glabellar Line: Active Controlled, Double-blind, Randomized, Multi-center, Phase I/III Clinical Trial

Conditions
-----------------
Moderate to Severe Glabellar Line

Intervention / Treatment
-----------------
* Drug: Generic equivalent of Clostridium Botulinum A Toxin
* Drug: Botox (Clostridium Botulinum A Toxin)


Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWP450<br> | Drug: Generic equivalent of Clostridium Botulinum A Toxin<br> <br> |
| Active Comparator: Botox<br> | Drug: Botox (Clostridium Botulinum A Toxin)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment | At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment | At 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment | At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment | At 8, 12, 16 weeks |
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial

Study Overview
=================
Brief Summary
-----------------
Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually applied but there is no perfect choice. It depends on physician's skill and situation. The best regimen is patient-controlled analgesia, but it requires an expensive equipment. Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours. Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may provide good analgesia for 72 hours.

Official Title
-----------------
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial

Conditions
-----------------
Postoperative Pain Relief

Intervention / Treatment
-----------------
* Drug: transdermal fentanyl patch (50 mcg/hour)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age =>18 years scheduled for abdominal surgery Exclusion Criteria: ASA class > 3 Known allergy to fentanyl or morphine History of substance or alcohol abuse, and tolerance or dependence on opioids Combined epidural block Can't use PCA, abnormal renal / liver function

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

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transdermal fentanyl patch<br>Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery | Drug: transdermal fentanyl patch (50 mcg/hour)<br> <br> * Other names: Duragesic;|
| Placebo Comparator: Placebo<br>Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups. | 48 and 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transdermal fentanyl patch, postoperative pain,
Accuracy and Outcome of Computer-assisted Surgery for Bony Micro-vascular Reconstruction in the Head and Neck Region

Study Overview
=================
Brief Summary
-----------------
Background: Functional and aesthetic reconstruction of mandibular defects due to tumour invasion, osteoradio- or chemonecrosis or trauma are challenging. Surgeons aim to achieve a good anatomic and symmetric reconstruction with stable occlusion and condylar position. Classically this was obtained by (pre)bending a reconstruction plate, and providing osteotomies at the vascularized free flap. Today there is the availability of CAD-CAM software enabling a preoperative planning based on 3D models. This computer-assisted surgery (CAS) procedure is said to improve accuracy of the postoperative result, as well as a reduce ischemia time. However, there is a need for objective analysis of the accuracy of CAS, as well as the effective reduction in operating time and financial implication. Study design: Retrospective study. All patients undergoing bony reconstruction by free vascularised flap between January 2013 and August 2016 will be included. Accuracy will be measured between the planned and actual result, through segmentation of the mandible in Brainlab software. Parameters regarding ischemic time and financial cost will be obtained from the medical files.

Conditions
-----------------
Mandibular Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of all ages patients of both genders patients requiring mandibular reconstruction due to tumour invasion, osteoradionecrosis, osteochemonecrosis or trauma all patients undergoing bony reconstruction by free vascularised flap all patients treated between January 2013 and August 2016 all patients where CAS was applied Exclusion Criteria: all patients not eligible according to abovementioned criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAS group<br>computer-assisted surgery group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of planned and actual result, through segmentation of mandibles Brainlab software |  | 6 months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemia time |  | perioperative | 
| financial implication |  | preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD-CAM software, accuracy, head and neck region, mandibular reconstruction