linjc16/ctgov huggingface dataset:
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

Study Overview
=================
Brief Summary
-----------------
Primary outcome variable is healing at the final follow up visit.

Detailed Description
-----------------
The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.

Official Title
-----------------
Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair

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

Intervention / Treatment
-----------------
* Device: Fistula Plug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure Likely cryptoglandular origin Must be at least 18 years of age Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable Patients willing and able to submit to postoperative follow-up evaluations Exclusion Criteria: Crohn's Disease Evidence of on-going local infection History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT Superficial fistulas without any muscle involvement Fistulae of traumatic origin, including obstetric Intersphincteric fistulas that would be candidate for fistulotomy Horseshoe or multi-tract fistulas Ano-vaginal or recto-vaginal fistulas Anastomotic fistulas (ileo-anal, colo-anal) A wound-healing or autoimmune disorder (including insulin-dependent diabetics) Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate History of prior or current pelvic radiation Difficulty comprehending or complying with the study (in surgeon's opinion)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GORE® BIO-A® Fistula Plug<br>All patients in study receive the GORE® BIO-A® Fistula Plug. | Device: Fistula Plug<br>* Bioabsorbable fistula plug<br>* Other names: GORE® BIO-A® Fistula Plug;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fistula Closure |  | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Drainage Post Procedure |  | Follow up out to 12 months post procedure |
Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

Official Title
-----------------
Effect of Liraglutide on Glycaemic Control in Japanese Subjects With Type 2 Diabetes.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy 7.0 % =< HbA1c < 10.0 % Body Mass Index (BMI) < 30.0 kg/m^2 Exclusion Criteria: Subjects treated with thiazolidinediones or insulin Subjects with any serious medical conditions

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 14 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment |  |  | 
| Body weight after 14 weeks. |  |  | 
| Safety and tolerability |  |  |
Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI before and after bariatric surgery. Administration of glucose as well as fructose is followed by functional brain MRI, and findings are correlated with serum glucagon-like peptide 1 (GLP-1) levels as an endogenous satiety signal in obese humans.

Official Title
-----------------
Glucose and Fructose Stimulated Brain Activity in Obese Subjects Before and After Bariatric Surgery

Conditions
-----------------
Exploratory Behavior

Intervention / Treatment
-----------------
* Dietary Supplement: Tap water
* Dietary Supplement: Glucose
* Dietary Supplement: Fructose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: right-handed morbidly obese patients scheduled for bariatric surgery Exclusion Criteria: Diabetes mellitus cardiovascular disease neurologic or psychiatric disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PLACEBO<br>Single intragastric instillation of 300ml tap water via nasogastric tube | Dietary Supplement: Tap water<br>* 300ml tap water via nasogastric tube<br>|
| Active Comparator: GLUCOSE<br>Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube | Dietary Supplement: Glucose<br>* 300ml tap water with 75g glucose via nasogastric tube<br>|
| Active Comparator: FRUCTOSE<br>Single intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube | Dietary Supplement: Fructose<br>* 300ml tap water with 25g fructose via nasogastric tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional magnetic resonance imaging (fMRI) in healthy, obese volunteers while they performed a working memory task: changes in cerebral blood flow |  | changes from baseline to one hour after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plasma glucose |  | Changes from baseline to one hour after treatment | 
| Changes in plasma insulin |  | Changes from baseline to one hour after treatment | 
| Changes in Plasma GLP-1 |  | Changes from baseline to one hour after treatment |
Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen

Study Overview
=================
Brief Summary
-----------------
Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro

Detailed Description
-----------------
Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer under or after therapy with a specific immuntherapy with Pollinex quattro

Official Title
-----------------
Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen

Conditions
-----------------
Rhinitis, Allergic, Seasonal

Intervention / Treatment
-----------------
* Other: Quality of life under or after therapy with Pollinex quattro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort Therapy with Polinex quattro Exclusion Criteria: Age <18 years.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group study<br>Single Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro | Other: Quality of life under or after therapy with Pollinex quattro<br>* To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaire (DLQI) |  | during year one, year two, year three of therapy or within 6 months after completion of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pollinosis, quality of life, specific immunotherapy
Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network

Study Overview
=================
Brief Summary
-----------------
During confinement, food intake can become compulsive, physical activity is significantly reduced, sleep is altered with exacerbated anxiety and stress levels and increased family violence. In some at-risk patients, mental health may even deteriorate. The temptation is great for all to take refuge in food or in front of screens. The main elements that can impact weight changes during this period of confinement are stress and anxiety, lack of physical activity, changes in eating habits, sleep disturbance and alcohol consumption. The investigators wish to study the impact of confinement on pre-post confinement weight loss kinetics in adults included in weight reduction programs (RNPC).

Official Title
-----------------
Evaluation of Changes in Weight, Sleep, and Other Psycho-behavioural Parameters During Covid-19 Confinement in Subjects Monitored by the RNPC Network

Conditions
-----------------
Obesity, Comorbidities, Confinement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 25 kg/m² and/or waist circumference > 80 cm in women and 94 cm in men Persons registered in the RNPC program Be legally able to give consent after adequate information and submission of the information note Person affiliated to social security Exclusion Criteria: Being unable to understand, follow objectives and methods due to cognition or language problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and parturient; subject under administrative or judicial control, persons who are protected under the act.

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 |
| --- | --- | --- |
| Analyse the variation in weight loss kinetics before, during and after confinement in patients enrolled in a weight reduction programme (RNPC) in France |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define the effects of containment on the variation in the kinetics of anthropometric parameters other than weight | Change in waist circumference, blood pressure, percentage of lean, fluid and muscle mass before and after the confinement period | 3 months | 
| Evolution of blood pressure before versus after confinement |  | 3 months | 
| Characterize clusters (homogeneous groups of patients) associated with particular dynamics of weight kinetics during confinement |  | 3 months | 
| Evaluate the impact of teleconsultation monitoring during containment on weight loss |  | 3 months |
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)

Study Overview
=================
Brief Summary
-----------------
Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

Detailed Description
-----------------
High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.

Official Title
-----------------
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: Atropine sulfate 0.01%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria One parent with myopia (<-3D in at least one eye) SE +1.00D to -1.50D Astigmatism < = 1.50D Distance vision logMAR 0.2 or better in both eyes Intraocular pressure of not greater than 21 mmHg No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride Exclusion Criteria: Any eye or systemic disease that affect vision or refractive error Conditions where topical atropine contraindicated Previous use of atropine or pirenzepine Known past/current amblyopia or strabismus

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 9 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
Interventional Model Description: Randomized control trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Premyopia atropine<br>On Atropine 0.01% | Drug: Atropine sulfate 0.01%<br>* Atropine 0.01%<br>|
| Placebo Comparator: Premyopia placebo<br>On placebo | Drug: Placebo<br>* placebo<br>|
| Active Comparator: Low myopia atropine<br>On Atropine 0.01% daily or every other day | Drug: Atropine sulfate 0.01%<br>* Atropine 0.01%<br>|
| Placebo Comparator: Low myopia placebo<br>On placebo | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical Equivalent | SE | 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length | AL | 3.5 years |
Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia

Study Overview
=================
Brief Summary
-----------------
The study aims to assess and compare the pain in women suffering from provoked vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18 months after treatment.

Conditions
-----------------
Vestibulodynia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vestibulodynia rated B2 according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification Patients previously treated no later than18 months ago for provoked vestibulodynia with botulinum toxin injections, in the University Hospital of Besançon. Exclusion Criteria: Major psychologic disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Long-term pain improvement after botulinum toxin injections | Assessment and comparison of pain using Visual Analogic Scale values before treatment,3 months after treatment and 18 months after treatment. | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, botulinum toxin, provoked vulvodynia
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Study Overview
=================
Brief Summary
-----------------
Correlate performance of LungLB Test with outcome of a scheduled biopsy.

Official Title
-----------------
Clinical Evaluation of LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules

Conditions
-----------------
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old with a CT identified indeterminate pulmonary nodule and scheduled for biopsy, at the time of consent. Planned biopsy nodule of interest: is solid ≤3 cm; or is nonsolid, ground glass opacity, of any size; or is part solid, where the solid component is no larger than 3cm (maximum diameter). Exclusion Criteria: Current and or prior diagnosis +/- treatment of non-lung cancer within the past 3 years. Current and or prior lung cancer diagnosis within 2 years following intent-to-cure surgery.

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Indeterminate Lung Nodule<br>Subjects that present with indeterminate lung nodules at time of biopsy. No intervention outside of standard of care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of LungLB test as compared to results from a tissue/FNA biopsy. |  | up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Clinical Variables With and Without LungLB Test Results | Evaluate the independent and associated contribution of readily available clinical variables including age, race, gender, socioeconomic level, environmental exposure, tobacco use, and radiology data combined with and without the LungLB test results and correlate with biopsy (tissue / FNA) outcome of indeterminate pulmonary nodules. | up to 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer, Circulating Genetically Abnormal Cells (CGAC), 4-color FISH, Increased/Decreased Risk, Early Lung Cancer Detection, Indeterminate Nodule
Dual Injection ESPB Versus Single Injection ESPB for Laparotomies

Study Overview
=================
Brief Summary
-----------------
To evaluate and compare the efficacy of single level injection erector spinae plane block versus double level injection Erector spinae plane block in laparotomies

Official Title
-----------------
Comparison Between the Efficacy of Ultrasound Guided Single Injection Erector Spinae Plane Block Versus Dual Injection Erector Spinae Plane Block for Postoperative Pain in Patients Undergoing Abdominal Surgery: Randomized Clinical Study

Conditions
-----------------
Regional Block, Post Operative Pain

Intervention / Treatment
-----------------
* Procedure: single level
* Procedure: dual level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age18-60. Both genders. abdominal surgery. ASA I-III. Exclusion Criteria: Drug allergy. Morbid obesity (BMI >40 kg/m2). Psychiatric disorder. Opiod dependence. patient refuse.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single ESPB<br>single injection at level T8 | Procedure: single level<br>* injection of 40 ml bupivacaine 0.25 at T8 (20 ml on each side)<br>|
| Experimental: dual ESB<br>dual injection at level T7 and T9 | Procedure: dual level<br>* injection of 40 ml of bupivacaine 0.25 at two level T7 and T9 (10 ml on each level of both side)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first analgesic request | time to request fentanyl | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting visual analogue pain scale | pain score at rest from 0-10 which 0 mean no pain and 10 the worst pain | 24 hours | 
| dynamic visual analogue pain scale | pain score at movement (cough) from 0-10 which 0 mean no pain and 10 the worst pain | 24 hours | 
| analgesic consumption | total fentanyl required first day postoperative | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESPB, pain, regional block