linjc16/ctgov huggingface dataset:
eCoin for OAB Feasibility Follow-on Study

Study Overview
=================
Brief Summary
-----------------
This trial is a prospective, multicenter, single-arm follow-on study will evaluate the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects with urgency urinary incontinence (UUI) as defined by the American Urological Association (30). The follow-on study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient-reported outcomes through 24 weeks of eCoinTM therapy (which is the same as 28 weeks from study device reimplantation).

Official Title
-----------------
SUBCUTANEOUS TIBIAL NERVE STIMULATION FOR URGENCY URINARY INCONTINENCE: A FOLLOW-ON STUDY

Conditions
-----------------
Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence

Intervention / Treatment
-----------------
* Device: eCoin Tibial Nerve Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual participated in the eCoin Feasibility Study for Urgency Urinary Incontinence. Individual was implanted with the study device during the eCoin Feasibility Study for Urgency Urinary Incontinence. Exclusion Criteria: 1. In the opinion of the investigator, individual is not a good candidate for participation in the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eCoin Tibial Nerve Stimulation<br> | Device: eCoin Tibial Nerve Stimulation<br>* Subcutaneous stimulation of the tibial nerve using the eCoin device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |  | 12 weeks after device activation. | 
| Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 4 Months After Implantation. | Instances of a related adverse event. | 16 weeks after device implantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary. |  | 24 weeks after device activation. | 
| Safety in All Patients. All Adverse Events Will be Reported in All Patients Who Were Implanted 6 Months After Implantation. | Instances of a related adverse event | 28 weeks after device implantation. |
Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration

Study Overview
=================
Brief Summary
-----------------
the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration

Detailed Description
-----------------
phrenic nerve stimulation during swallowing

Official Title
-----------------
Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration

Conditions
-----------------
Velopharyngeal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stroke with aspiration Exclusion Criteria: obstructive rhinitis bronchial obstruction pace maker phrenic nerve paralysis

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?
-----------------
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
-----------------
aspiration, phrenic nerve, magnetic stimulation
Wound Healing After Emergency Appendicectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare two techniques of wound closure in open appendicectomies in adult patients: continuous, absorbable, intradermal suture and interrupted, non-absorbable sutures.

Official Title
-----------------
Wound Healing and Cosmetic Result After Emergency Appendicectomy in Adult Patients: a Prospective, Randomised Trial Comparing Two Methods of Wound Closure

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: appendicectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient with acute appendicitis Exclusion Criteria: Children

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery, absorbable stitches<br>wound healing after absorbable and nonabsorbable stitches are compared | Procedure: appendicectomy<br>* Wound healing after absorbable and nonabsorbable stitches are compared<br>|
| Active Comparator: surgery, nonabsorbable stitches<br> | Procedure: appendicectomy<br>* Wound healing after absorbable and nonabsorbable stitches are compared<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound heeling |  | 14 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic result |  | 1 year after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, appendicectomy, stitches, wound healing, cosmetic results
Gene Mapping for Quantitative Traits

Study Overview
=================
Brief Summary
-----------------
To conduct gene mapping studies for quantitative traits.

Detailed Description
-----------------
DESIGN NARRATIVE: The study built upon existing sib-pair methods for multipoint mapping of Quantitative Trait Loci (QTL)s. It greatly expanded upon the statistical methodology to identify and localize QTLs for complex traits by merging sib-pair methods with a powerful twin design which used phenotypic data on monozygotic (identical) and dizygotic (fraternal) twins to resolve phenotypic variability into genetic and non-genetic components, and partition human quantitative genetic variation into effects due to loci on specific chromosomal regions. This quantitative methodology was applied to risk factors for cardiovascular disease -- one of the most pressing health problems in Western society. Population-based samples of Dutch, Swedish, and Australian twins had been identified in previous studies, phenotypic measures on lipids, lipoproteins, and other important cardiovascular risk factors had been obtained, and blood had been banked in a valuable resource which was available for use in this study. In 500 DZ twin pairs, a series of 175 highly polymorphic microsatellite markers were detected using an automated process for detecting fluorescent signals. These data were analyzed using the new statistical methods both to confirm the effects of a series of candidate loci and to test for the effects of previously unknown QTLs. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta

Study Overview
=================
Brief Summary
-----------------
It is claimed that SBO may be responsible for bladder dysfunction in patients without known neurological disease. Subsequently, it was reported that the frequency of SBO in NE cases was higher than normal children. However, in controlled trials, SBO frequency was not different in NE patients compared to the normal population. Conversely, the incidence of dysfunctional bladder in the presence of SBO in NE patients was found to be higher and the response to treatment was worse than in non-SBO patients. The present study aimed to determine whether the frequency of SBO in patients with NE was higher than in healthy subjects, the effect of SBO on the severity of LUTS and whether treatment response of primary NE patients changed in the presence of SBO.

Official Title
-----------------
The Relationship Between Nocturnal Enuresis And Spina Bifida Occulta: A Prospective Controlled Trial

Conditions
-----------------
Enuresis, Nocturnal, Spina Bifida

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 6 to 15 years at least one night-time wetting weekly Exclusion Criteria: neurological disease, diabetes mellitus or insipidus, spinal surgery history, spina bifida skin findings, chronic renal insufficiency and secondary enuresis

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Enuresis nocturna<br>Patients aged 6 to 15 years with at least one night-time wetting weekly | |
| Normal population<br>Patients who were admitted to the urology clinic with a complaint of abdominal or lateral pain, who had no NE and had a direct abdominal x-ray examination | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dry bed days | Patients were called for check-up one and three months later. When waking in the morning they were given a form to mark as dry or wet, and dry bed days were examined at check-up. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lower urinary tract symptoms, nocturnal enuresis, spina bifida occulta, treatment response
Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.

Detailed Description
-----------------
Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month. Each value will be compare to evaluate whether the groups of patient improve.

Official Title
-----------------
Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Drug: Folrex
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute stroke < 24 hours. Patients with impairment up to 4 on NIHSS scale. Family support. Informed consent. Exclusion Criteria: Presence of another disease not well controlled. Patient with dementia.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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<br>In this group we will use Placebo cream, in the early rehabilitations in the upper extremity | Drug: Placebo<br>* Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation<br>|
| Experimental: Folrex<br>In this group we will use Folrex cream, in the early rehabilitations in the upper extremity | Drug: Folrex<br>* Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it will be done at the beginning, at fifth day and at month (4 weeks). |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index |  | 4 weeks | 
| National Institutes of Health Stroke Scale (NIHSS) |  | 4 weeks |
Specimen Banking From Patients With Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The primary objective of the protocol is to develop a comprehensive specimen banking program from patients with lung cancer for future translation research, which will enable the investigators to detect lung cancer earlier, develop better therapies and explore screening and prevention strategies.

Detailed Description
-----------------
The aims of the study are as follows: 1) to continue to unravel the complex biology of lung cancer 2) to identify early detection and prognostic markers to guide therapeutic decision 3) to define markers of response and/or resistance to drug therapy, and 4) to identify new therapeutic and prevention targets.

Official Title
-----------------
Specimen Banking From Patients With Lung Cancer

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are undergoing further testing for the diagnosis or treatment of lung cancer. Oral and written informed consent Exclusion Criteria: 1. Any individual who does not give oral and written consent for participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Diagnosis/treatment of lung cancer<br>Specimen Banking | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of a comprehensive specimen banking program from patients with lung cancer for future translational research. | No statistical analysis will be applied to the overall collection of samples. Rather, each project that utilized tissue bank resources will require an appropriate statistical plan to be submitted along with the initial tissue request. | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer
Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether cloxacillin lock is effective in prevention of double lumen infection.

Detailed Description
-----------------
Double lumen infection is one of the causes of morbidity and mortality in hemodialysis patients. Many strategies used to prevent it and one of them is antibiotic lock. Thus we select chronic hemodialysis patients and divided them into 2 groups. One group received cloxacillin and heparin as catheter lock and the second group received only heparin lock.

Official Title
-----------------
Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients

Conditions
-----------------
Double Lumen Infection, Hemodialysis

Intervention / Treatment
-----------------
* Drug: cloxacillin
* Drug: heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis for 3 months at least 2 time dialysis/week Exclusion Criteria: active infection acute renal failure

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>cloxacillin 100 mg/ml + heparin 1000iu/ml as catheter lock at the end of hemodialysis | Drug: cloxacillin<br>* cloxacillin 100mg/ml as catheter lock at the end of hemodialysis<br>Drug: heparin<br>* heparin 1000iu/ml as catheter lock at the end of hemodialysis<br>|
| Active Comparator: 2<br>heparin 1000iu/ml as catheter lock at the end of hemodialysis | Drug: heparin<br>* heparin 1000iu/ml as catheter lock at the end of hemodialysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catheter infection |  | 6 months |
Rituximab for Refractory or Relapsed Focal Segmental Glomerulosclerosis or Minimal Change Disease

Study Overview
=================
Brief Summary
-----------------
Various studies have been conducted to identify effective treatment strategies for primary focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) so far. In the light of these studies, corticosteroids and calcineurin inhibitors have been the treatment of choice and mycophenolic acid derivatives have been seen as a second line agent. However, treatment options in refractory or relapsed cases are still under debate. Recently, rituximab has become an alternative in those patients. Therefore, a study based on registry data was conducted to evaluate the efficacy and safety of rituximab in adult patients suffering from a relapsed or refractory primary FSGS or MCD.

Official Title
-----------------
Efficacy and Safety of Rituximab in Adult Patients With Refractory or Relapsed Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease

Conditions
-----------------
Focal Segmental Glomerulosclerosis, Minimal Change Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having biopsy-proven focal segmental glomerulosclerosis or minimal change disease. Showing resistance to or relapsing after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives. Having a history of rituximab use (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after aforementioned agents. Exclusion Criteria: Not providing or withdrawing consent.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Patients with primary focal segmental glomerulosclerosis or minimal change disease who were treated using rituximab (375 mg/m2/wk for 1-4 weeks) following resistance to or relapse after at least one set of prior therapies including corticosteroids, calcineurin inhibitors or mycophenolic acid derivatives. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Remission | Proteinuria <0.5 g/day, confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine. | 12 months | 
| Partial Remission | Proteinuria <3.5 g/day and a 50% or greater reduction from peak values, confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
focal segmental glomerulosclerosis, minimal change disease, rituximab
Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the prevalence of menstrual cycle related pain complains in adolescents and young adults.

Detailed Description
-----------------
An internet questionnaire with 12 items was used: Adolescents start of menstruation characteristics of menstrual cycle pain related to menstrual cycle (questions based on well-known pain-complaints related to the presence of endometriosis) analgetics influence on school carrier influence on social life Young adults idem as for adolescents influence of pain on an eventual sexual relationship

Official Title
-----------------
Prevalence of Menstrual Cycle Related Pain Complains in Adolescents and Young Adults

Conditions
-----------------
Dysmenorrhea, Pelvic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3rd year high school girls 1st year university young females Exclusion Criteria: pre-menarcheal girls

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adolescents<br>3rd year high school girls (14-16 years old) | |
| young adults<br>1st year university young females (18 - 20 years old) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of menstrual cycle related pain complains |  | 3rd year high school & first year university | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between level of pain complains and characteristics of menstrual cycle |  | 3rd year high school & first year university | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adolescents, young adults, dysmenorrhea, pelvic pain