linjc16/ctgov huggingface dataset:
Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function

Study Overview
=================
Brief Summary
-----------------
The study aimed to explore and quantify functional and electrical activities in different pelvic floor muscle groups, to differentiate the electrophysiological role in different pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to develop treatment strategies for different pelvic floor muscle groups in different female pelvic disorders.

Detailed Description
-----------------
Female pelvic floor disorders including sexual dysfunction, urinary incontinence, fecal incontinence, and pelvic organ prolapse are relating to the function of pelvic floor structures. Essential components responsible for pelvic floor function include bony, muscular, and fascial structures of the pelvis. Among above components, pelvic floor muscles, either the superficial or deep group, are considered crucial in maintaining the morphology and functional integrity of the pelvic floor. Inspection and digital examination incorporating Oxford grading system during pelvic examinations are the most convenient and commonly methods applied to evaluate the function of pelvic floor muscles. Nevertheless, both methods cannot provide quantitative information of pelvic floor muscle contraction. With the introduction of pelvic floor manometry and electrophysiological testing, quantification of pelvic floor muscle contractions can be expected. The study aimed to explore and quantify functional and electrical activities in different pelvic floor muscle groups, to differentiate the electrophysiological role in different pelvic floor muscle groups relating to pelvic floor dysfunction or disorders, and further to develop treatment strategies for different pelvic floor muscle groups in different female pelvic disorders.

Official Title
-----------------
Correlates of Electrophysiological Activities in Different Pelvic Floor Muscle Groups and Female Pelvic Floor Function

Conditions
-----------------
Pelvic Floor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with pelvic floor dysfuntion Exclusion Criteria: Pregnant women Women with histories of diabetes, cerebrovascular diseases, neurological diseases, degenerative muscular diseases, or autoimmune connective tissue diseases。

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

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

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 |
| --- | --- | --- |
| Contraction of pelvic floor muscle | Chart review | Baseline |
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast

Study Overview
=================
Brief Summary
-----------------
In this study we compare two treatment options for ankle sprains. 100 patients were randomised between a flexible cast treatment and a removable and adjustable brace made out of the same materials. Follow-up was 4 months. Primary outcome were functional scores. Secondary outcome measures were patient satisfaction scores with treatment as well as treatment result.

Official Title
-----------------
Functional Treatment for Acute Ankle Sprains: Softcast Wrap Versus MOKcast. A Prospective Randomized Single-centre Trial

Conditions
-----------------
Acute Ankle Sprain, Ankle Ligament Rupture, Ankle Injuries

Intervention / Treatment
-----------------
* Other: Functional treatment for ankle sprain using ankle cast
* Other: Ankle sprain treated with removable ankle support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Grade 2 and 3 acute ankle sprains Exclusion Criteria: history of ankle sprains with persistent instability grade I lateral ankle sprains ankle fracture bilateral ankle sprains previous ankle ligament surgery neuromuscular disorders of the lower extremities rheumatoid arthritis, alcoholism, serious psychiatric or neurological illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOK<br>Adjustable and removable brace made out of Softcast material | Other: Ankle sprain treated with removable ankle support<br>* Ankle sprain functionally treated with removable and adjustable ankle support<br>|
| Active Comparator: WRAP<br>Softcast ankle cast | Other: Functional treatment for ankle sprain using ankle cast<br>* Functional treatment for ankle sprain using ankle cast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional scores according to Karlsson score | The modified KSS gives a score from 0-90 on perceived function of the ankle and foot, divided over eight topics relevant to daily function. The modified KSS at 4 months was the primary endpoint. | Follow-up of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Measured by Visual analogue scale (1-10) | follow-up of 4 months | 
| Satisfaction score | satisfaction scores with treatment as well as treatment result on scale 1-10 | follow-up of 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle Sprain, Ankle Distortion, Functional treatment, Brace treatment
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements; to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and to document the adverse effects of surgery in patients with cervical dystonia.

Detailed Description
-----------------
Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for cervical dystonia. At present there are only anecdotal reports of benefit. The objective of this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded manner. Our hypothesis is that in patients refractory to medical management, bilateral pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up. The research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the completion of the trial.

Official Title
-----------------
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation of Cervical Dystonia

Conditions
-----------------
Cervical Dystonia

Intervention / Treatment
-----------------
* Device: Deep brain stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, male or female Diagnosed with cervical dystonia by a movement disorders neurologist Has cervical dystonia alone, not generalized or multifocal Has had adequate trials of medical therapy Exclusion Criteria: Cognitive impairment Abnormalities on pre-operative magnetic resonance imaging (MRI) Medical conditions precluding general anaesthetic or surgery Unstable psychiatric disease Previous brain lesions to treat cervical dystonia

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Deep brain stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in neck postures/movements |  |  | 
| Improvement in quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document adverse effects of surgery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical dystonia, Deep brain stimulation
Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

Study Overview
=================
Brief Summary
-----------------
The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres. In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.

Official Title
-----------------
Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

Conditions
-----------------
Rugby Professionals, Concussion

Intervention / Treatment
-----------------
* Diagnostic Test: OCT A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professional rugby player Exclusion Criteria: impossibility to realise OCT

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: OCT A|OCT (Optical Coherence Tomography) and Retinophotography made at the beginning and end of the Rugby season.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average thickness difference of the RNFL on each eye in micrometers measured by OCT, between the beginning and the end of the season |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinophotography, OCT, Optical nerve
Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)

Study Overview
=================
Brief Summary
-----------------
The general rules of antibiotic prophylaxis in surgery or interventional medicine include the choice of an antibiotic active on the bacteria most frequently encountered in surgical site infections. This antibiotic must cover, the bacteria present on the skin and recognized as responsible for surgical site infections. The aim of this study is to identify bacteria found in skin flora in the inguinal region of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Flora found will allow to evaluate the impact of skin preparation and antibiotic prophylaxis protocols as they are currently practiced.

Official Title
-----------------
Prevalence of Cutaneous Enterococci at Femoral Insertion Site in Transcatheter Aortic Valve Implantation (TAVI)

Conditions
-----------------
Aortic Valve Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for aortic valve replacement by TAVI procedure with trans femoral approach Patient with pre-TAVI assessment performed at Clinique Pasteur Patient affiliated or beneficiary of a social security scheme Patient accepting to participate and having given his no objection Exclusion Criteria: TAVI procedure by non-trans femoral approach Protected patients: Adults under guardianship or other legal protection; Pregnant or breastfeeding woman; Hospitalized without consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Enterococci prevalence | Proportion of patients with Enterococcus feacalis and other Enterococci in inguinal flora before TAVI | At Day 0 at TAVI intervention time (preoperative) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin flora of the groin | Bacteria profile of inguinal skin | At Day 0 at TAVI intervention time (preoperative) before skin disinfection | 
| Skin flora of the groin | Bacteria profile of inguinal skin | At Day 0 at TAVI intervention time (preoperative) after skin disinfection | 
| Infectious events | Occurrence of infective endocarditis or other infectious adverse events | From day of TAVI to 1 year after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enterococci, Infective endocarditis, Antibiotic prophylaxis, TAVI
Assessment of a Personalized Health Care Intervention for Frequent Headache

Study Overview
=================
Brief Summary
-----------------
The research project is a component of a mentored research career enhancement award. The purpose of the award is to help the PI and his collaborators prepare for future research grant opportunities through the Patient Centered Outcomes Research Institute (PCORI). The research project is a feasibility study with the following specific aims; 1) to assess outcomes associated with a personalized health plan for frequent headaches; 2) to identify measurable outcomes that are meaningful to patients with frequent headaches; and 3) to create a patient stakeholder group to inform patient-centered outcomes research for frequent headaches. Specific Aim #1 will be achieved by recruiting and enrolling 40 established patients at the Duke Family Medicine Center who have frequent headaches. The intervention consists of 3 study visits with the PI, 2 clinical consultations with subjects' established primary care provider at the Duke Pickens Family Medicine Center, and participation in 2 focus groups. Personalized health plans might consist of a combination of medical management, lifestyle changes, nutrition counseling, or other therapeutic modalities as appropriate. Data analysis will be descriptive; no formal hypotheses will be tested.

Official Title
-----------------
Assessment of a Personalized Health Care Intervention for Frequent Headache

Conditions
-----------------
Frequent Headaches

Intervention / Treatment
-----------------
* Other: Personalized health plan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic headache Exclusion Criteria: patients who do not understand english language

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Development of personal health plan<br>Personal Health Plan | Other: Personalized health plan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily headache scores, | Subjects will report daily headache scores to the CRC. | Daily from baseline to 3 months | 
| Change in Quality of life |  | Baseline to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
frequent headaches, personalized health plan
Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Study Overview
=================
Brief Summary
-----------------
Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.

Official Title
-----------------
Fistuolotomy With or Without Marsupialization for Treatment of Simple Anal Fistula: a Randomized Controlled Trial

Conditions
-----------------
Anal Fistula

Intervention / Treatment
-----------------
* Procedure: Fistulotomy
* Procedure: Marsupialization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders Age: 18-65 years All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers). Exclusion Criteria: High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary. Recurrent anal fistulas. Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB. High risk patients according to ASA (American society of anesthesiologists ) Any degree of incontinence. Patients with previous anal surgery.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fistulotomy with Marsupialization<br>Lay open and Marsupialization of the fistula track | Procedure: Fistulotomy<br>* The fistula track is laid open after complete probing till the internal opening<br>Procedure: Marsupialization<br>* The laid open track will be marsupialized using interrupted absorbable sutures<br>|
| Active Comparator: Fistulotomy without Marsupialization<br>lay open of the fistula track | Procedure: Fistulotomy<br>* The fistula track is laid open after complete probing till the internal opening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete healing | The duration of time required to achieve complete wound healing | 8 weeks |
Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.

Study Overview
=================
Brief Summary
-----------------
Comparison of propofol and sevoflurane as a primary anesthetic for cardiac ablation of atrial fibrillation

Detailed Description
-----------------
A side effect of some volatile anesthetics, such as isoflurane and desflurane, is enhanced automaticity, accounting for secondary atrial pacemakers. Volatile anesthetics also have varying effects on the AV node and His-Pukinje system. These agents also prolong the QT interval and, for this reason, volatile anesthetics as a group have at times been avoided for atrial fibrillation ablation due to the fear that they may affect the efficacy of the ablation and increase recurrence. However, sevoflurane does not have the effects shown for other volatile anesthetics cardiac conduction. At this point there has not been a study comparing propofol, a non volatile anesthetic typically used in these cases, to sevoflurane, a volatile anesthetic, to determine if volatile anesthetics should be avoided during these procedures. This study will challenge the existing belief that sevoflurane increases the length of time to ablate atrial fibrillation and also decreases the efficacy of the ablation.

Official Title
-----------------
Comparison of Propofol and Sevoflurane as a Primary Anesthetic for Cardiac Ablation of Atrial Fibrillation.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: propofol
* Drug: sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have paroxysmal atrial fibrillation undergoing their first ablation. Exclusion Criteria: none

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol<br>Participants receiving propofol as anesthetic for cardiac ablation. | Drug: propofol<br>* Participant receives propofol as anesthetic for cardiac ablation.<br>|
| Active Comparator: sevoflurane<br>Participants receiving sevoflurane as anesthetic for cardiac ablation. | Drug: sevoflurane<br>* Participant receives sevoflurane as anesthetic for cardiac ablations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure duration | The duration of the procedure in minutes. | 1 day |