linjc16/ctgov huggingface dataset:
Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Anti-adhesive effect and Safety of a mixed solid of poloxamer, gelatin and chitosan(Mediclore®) after axillary dissection for breast cancer

Detailed Description
-----------------
A Multicenter Double-blinded, Randomized Study

Official Title
-----------------
Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer A Multicenter Double-blinded, Randomized Study

Conditions
-----------------
Breastcancer, Surgery: Axillary Dissection

Intervention / Treatment
-----------------
* Device: adhesive barrier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients needed axillary dissection in breast cancer Written informed consent Patients without clinically significant lab the patients who are diagnosed 'positive for metastasis' by sentinel lymph node biopsy Exclusion Criteria: having enrolled another clinical trials within 1 month Immunosuppression or autoimmune disease Anticoagulant, general steroids within a week from surgery Incompatible medications Serious diseases (heart failure, renal failure, liver failure, uncontrolled hypertension, diabetes mellitus, coagulation deficiencies)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediclore<br> | Device: adhesive barrier<br>* After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.<br>|
| No Intervention: Not done<br>Standard treatment for surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sum of ROM(range of motion) | to compare the differences of sum of ROM between two groups comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction | 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sum of ROM(range of motion) | comparision of the differences of sum of ROM between two groups ROM: forward flexion and horizontal abduction | 24weeks | 
| pain assessment (numeric pain rating scale) | to compare the differences of the pain related with motions of upper limbs | 4weeks, 24weeks | 
| Scoring DASH(Disablities of the arm, shoulder and hand) | to compare the differences of the DASH score | 4weeks, 24weeks |
Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

Study Overview
=================
Brief Summary
-----------------
The anastomotic leak (AL) is a very serious complication in colorectal surgery not only because of its severity but its frequency. Other facet for study, besides the risk factor and prevention, is the AL early diagnostic, due to minimize the clinical consequences and severity; and avoid the failure-to-recue. Several studies analyze the Creactive protein (CRP) and Procalcitonine (PCT) usefulness in AL predictor before the clinical signs appear. At a prospective observational study carry on our center, it concluded that CRP at 3rd day after surgery over 15mg/dl was a very important AL predictor, even before the clinical changes appear. The aim of this study is minimize the severity complications and the mortality due to AL appears. The aim of this study is minimize the severity complications and the mortality due to AL by means of introduces an upgrade program in which a CT scan will be conduct in all the patients with high CRP levels at 3rd, 4th or 5th postoperative day, with the goal to know the AL early and make all the therapeutic step to minimize the consequences.

Official Title
-----------------
Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Other: Early diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age. Patients undergoing elective colorectal surgery due to neoplastic or non-neoplastic etiology. Patients with an anastomosis performed in the surgical act. Signed informed consent. Exclusion Criteria: Patients who require transfer to another center. Patients with fatal evolution: those who require urgent reoperation for an inarverted perforation, early leakage of anastomosis or death before the third postoperative day.

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

| Intervention/Treatment |
| --- |
|Other: Early diagnosis|Early diagnosis. Upgrade program implementation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of morbidity | Number of reoperations, readmissions for infections associated or other medical complications, terminal stomata | 1 year | 
| Severity of mortality | Number of related exits | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Compare hospital stay and ICU stay of patients undergoing elective colorectal surgery before and after the improvement program. |  | 1 year | 
| - Evaluate the difference in the incidence of anastomosis leak after the implementation of the improvement program |  | 1 year |
Biomarkers Predicting Atrial High Rate Episodes in Cardiac Implantable Electronic Device Recipients

Study Overview
=================
Brief Summary
-----------------
This study is sought to investigate any predictors including biomarkers for atrial high rate episodes (AHRE) occurrence in patients without prior history of atrial tachyarrhythmias receiving cardiac implantable electronic device (CIED).

Detailed Description
-----------------
Atrial high rate episodes (AHRE) are noticed up to 70% in patients receiving cardiac implantable electronic device (CIED) even in the absence of prior history of atrial tachyarrhythmias. AHRE is clinically important because it is considered to be associated with clinical atrial fibrillation, stroke, mortality, and heart failure hospitalization. Therefore, predictors of AHRE might be useful for early detection of AHRE susceptable CIED recipients. Biomarkers as well as clinical characteristics will be analyzed.

Official Title
-----------------
Predictors of Atrial High Rate Episodes in Patients Implanting Cardiac Implantable Electronic Device Based on Biomarkers

Conditions
-----------------
Atrial High Rate Episode, Cardiac Implantable Electronic Device

Intervention / Treatment
-----------------
* Device: implantable cardiac electronic device recipients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving cardiac implantable electronic device Exclusion Criteria: patients who disagree for blood sampling to analyze not commonly used clinical biomarkers patients not followed-up at least 12 months after implanting device

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Patients receiving cardiac implantable electronic device<br>Patients receiving cardiac implantable electronic device for any clinical indication | Device: implantable cardiac electronic device recipients<br>* implantable cardiac electronic device recipients for any clinical indication<br>* Other names: cardiac resynchronization therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of atrial high rate episode |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors predicting the occurrence of atrial high rate episode | factors including biomarkers such as FGF-23 and soluble ST-2, and single nucleotide polymorphism | 12 months |
Vibro-Acoustography Imaging in Finding Breast Microcalcifications and Lesions in Women

Study Overview
=================
Brief Summary
-----------------
RATIONALE: New diagnostic procedures, such as vibro-acoustography imaging, may be an effective method of finding microcalcifications and lesions in the breast. PURPOSE: This clinical trial is studying how well vibro-acoustography imaging works in finding breast microcalcifications and lesions in women.

Detailed Description
-----------------
OBJECTIVES: To further develop a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging. To demonstrate and evaluate the capability of VA imaging in detecting microcalcifications and lesions inside the human breast. OUTLINE: Participants undergo vibro-acoustography (VA) imaging of the breast using ultrasonography over 90 minutes. Participants may also undergo further imaging using clinical ultrasonography.

Official Title
-----------------
In Vivo Breast Imaging by Vibro-acoustography

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Meets one of the following criteria: Healthy participant Proven microcalcifications and/or lesions in the breast Hormone status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified Not pregnant or nursing No condition that does not allow proper use of study imaging devices PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br> | |
| diseased<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further development of a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging |  | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer
Topical Antifungal Treatment for Tinea Pedis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.

Official Title
-----------------
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis

Conditions
-----------------
Tinea Pedis

Intervention / Treatment
-----------------
* Drug: 33525
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate erythema, moderate scaling, and mild pruritus Exclusion Criteria: Pregnancy and allergies

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Experimental: Active<br>Product 33525 | Drug: 33525<br>* Daily for 14 days<br>|
| Placebo Comparator: Placebo<br>Product 33525 Placebo | Drug: Placebo<br>* Daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving complete clearance | Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving effective treatment | Clinical Cure and Mycologic Cure | Day 42 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinea Pedis, Antifungal
Ex-Vivo Reversion of Platelet Inhibition Induced by Prasugrel

Study Overview
=================
Brief Summary
-----------------
The purpose of this ex-vivo study is to estimate the optimal platelet quantity necessary to reverse the antiplatelet effects of prasugrel.

Conditions
-----------------
Acquired Platelet Disorder

Intervention / Treatment
-----------------
* Other: Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute coronary syndrome Prasugrel loading dose 6-24h before inclusion Exclusion Criteria: Clopidogrel loading dose GPIIbIIIa use within 10 days before inclusion Known congenital thrombopathy and/or congenital coagulation defect

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 |
| --- | --- |
| Study patients<br>Acute coronary syndrome patients with a recent loading dose of prasugrel (6-24h) | Other: Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet reactivity assessed by light transmittance aggregometry (LTA) after ex-vivo normal platelet addition |  | within the first 6-24 hours after antiplatelet drug loading dose |
Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.

Study Overview
=================
Brief Summary
-----------------
Childhood obesity is a major public health issue since it is a risk factor of adulthood obesity, cardiovascular disease, psychological disorders, and other chronic conditions. RéPPOP is a two year personalized pathway for multidisciplinary care for overweight and obese children, close to patients' homes. Short and medium-term assessments of Rhône RéPPOP care for overweight and obese children show encouraging results. Long-term assessment is needed to confirm these results. The present study aims to assess the long-term efficiency of Rhône RéPPOP care for overweight and obese children by comparing BMI Z-scores at the start and the end of RéPPOP care to the current BMI. This data will be collected through a telephonic questionnaire by the scientific manager. The study's secondary objectives are to evaluate patients and their families' lifestyle changes and to improve RéPPOP practices.

Official Title
-----------------
Long-term Assessment of Rhône RéPPOP Care for Overweight and Obese Children.

Conditions
-----------------
Overweight, Childhood, Pediatric Obesity

Intervention / Treatment
-----------------
* Other: Collected data from Rhône RéPPOP database
* Other: telephonic questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All overweight and obese children included in RéPPOP care programs from 01/01/07 to 31/12/10 Exclusion Criteria: Refusal to respond to the telephonic questionnaire Subjects who withdraw their consent to participate in the study Subjects aged under 12 years

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Overweight and obese children<br>Overweight and obese children included in RéPPOP care programs between 2007 and 2010. | Other: Collected data from Rhône RéPPOP database<br>* BMI Z-scores at the start and the end of RéPPOP care programs.<br>Other: telephonic questionnaire<br>* Collected data though the telephonic questionnaire : current declared BMI Z-score.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of BMI Z-scores at the start and the end of RéPPOP care programs to the current BMI Z score. |  | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric Obesity, Overweight, Childhood
Comparing Clinical Benefits of Gamma Knife and Microvascular Decompression for Trigeminal Neuralgia

Study Overview
=================
Brief Summary
-----------------
Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression

Detailed Description
-----------------
A randomized prospective study conducted in The Neurosciences Hospital, Baghdad, from January 2016 to January 2018, patients had either GKR treatment or treated with MVD. The pain evaluated pre- and post-operatively using the Barrow Neurological Institute Pain Intensity scale (BNIPI), visual analog scale (VAS) and Brief Pain Inventory Facial (BPI-Facial) scoring systems. In GKR procedure, the trigeminal root entry zone targeted with a radiation dose of 80 Gy. MVD was performed using retro-sigmoid approach. Follow-up period for two years

Official Title
-----------------
Treatment of Primary Trigeminal Neuralgia: A Comparative Study of Microvascular Decompression and Stereotactic Gamma Knife Radiosurgery

Conditions
-----------------
Trigeminal Neuralgia

Intervention / Treatment
-----------------
* Radiation: Gamma knife


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary idiopathic trigeminal neuralgia Exclusion Criteria: secondary trigeminal neuralgia
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 |
| --- | --- |
| Active Comparator: Gamma knife group<br>Patients selected to be treated with gamma knife radiosurgery | Radiation: Gamma knife<br>* Microvascular decompression<br>* Other names: Surgery;|
| Active Comparator: MVD Group<br>Patients treated with microvascular decompression | Radiation: Gamma knife<br>* Microvascular decompression<br>* Other names: Surgery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barrow Neurological Institute Pain Intensity scale (1-5) | The pain evaluated pre- and post-operatively with the use of analgesic drugs the best is 1 indicates free of pain, the worst is 5. It is dependent score | Two years | 
| visual analog scale (0-10) | Pain severity described subjectively by the patient himself pre and post treatment , the 0 is free of pain and worst is 10. It is dependent score | Two years | 
| Brief Pain Inventory (1-7) | Assess pain severity as impact to functional activities, the 7 is normal live activity and the worst is 1. It is dependent score | ُTwo years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trigeminal neuralgia, treatment
Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort

Study Overview
=================
Brief Summary
-----------------
The NUMEVOX cohort is intended to follow-up the macro and microvascular dysfunction in relation to adipose tissue repartition in patients with metabolic syndrome associated to liver steatosis, sleep apnea. Duration of the follow-up is 3 years for each patient entering the cohort.

Official Title
-----------------
Impact of Adipose Tissue Repartition on the Time Course of Vascular Dysfunction - the NUMEVOX Cohort

Conditions
-----------------
Metabolic Diseases, Sleep Apnea, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age > 18 years old suspected of metabolic syndrome affiliated to french social health care Exclusion Criteria: age < 18 years old pregnancy no informed consent not eligible for the study (no MS, cancer)

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 |
| --- | --- |
| Metabolic syndrome (MS)<br>Patients suspected of metabolic syndrome without sleep apnea or liver steatosis | |
| MS with sleep apnea<br>Metabolic syndrome with sleep apnea | |
| MS with Liver steatosis<br>Metabolic syndrome with liver steatosis | |

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
-----------------
fatty liver, adipose tissue