linjc16/ctgov huggingface dataset:
Community Acquired Sepsis Cohort

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to constitute a prospective cohort of all the patients presenting to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic syndrome of community origin.

Detailed Description
-----------------
Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications of infectious diseases. In this context, the optimization of the management of septic patients from their reception in the emergency services must be a priority. However there are no predictors of progression or severity in patients admitted to emergencies despite the recommendations emphasizing the need for screening and early therapeutic management. Many scores have been proposed for intensive care unit but they remain difficult to extrapolate to other services because they are very comprehensive and require information that is difficult to obtain for emergency physicians.

Official Title
-----------------
Community Acquired Sepsis Cohort

Conditions
-----------------
Severe Septic Syndrome, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years old Patient hospitalized during the study period for community infectious diseases at the CHU of Rennes Exclusion Criteria: Written objection from the patient to the computer processing of his data Pregnant women Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

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 |
| --- | --- | --- |
| Assessment of morbidity in patients with septic syndrome of community origin | Study of prognostic factors | Day 90 | 
| Internal validity, severity score |  | Day 90 | 
| Internal validity, triage score by orientation nurses |  | Day 90 | 
| Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality |  | Day 90 |
A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy

Study Overview
=================
Brief Summary
-----------------
The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients. Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.

Official Title
-----------------
A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of the Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Laparoscopic Prostatectomy )

Conditions
-----------------
Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Fesoterodine
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged 30 to 90 years old with prostate adenocarcinoma who have already made their treatment selection of RARP, and only men with an AUA symptom score greater than 7 will be included. All subjects must be able to read and comprehend fully the informed consent. Exclusion Criteria: Men with prostate neoplasms other than adenocarcinoma Subjects receiving other treatments for prostate cancer will be excluded. Any subject with a preexisting bladder disease will be excluded. Subjects with acute urinary retention and/or deceased gastrointestinal motility. Subjects with glaucoma. Subjects with hepatic or renal impairment. Subjects taking CYP3A4 Inhibitors (e.g.ketoconazole, itraconazole, clarithromycin). Subjects with myasthenia gravis Subjects who are unwilling or unable to complete the subject questionnaires Subjects, who in the opinion of the investigator, would be non-compliant with the majority of the visits scheduled or study procedures.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: Fesoterodine 4mg<br>Fesoterodine 4mg, Oral once daily for three months | Drug: Fesoterodine<br>* 4 mg<br>|
| Placebo Comparator: Placebo<br>Placebo Oral once daily for three months | Drug: Placebo oral tablet<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male adult subjects, aged 30-90 years, RARP, American Urological Association symptom score greater than 7 will be included
Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.

Official Title
-----------------
Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring

Conditions
-----------------
Laxity of Skin

Intervention / Treatment
-----------------
* Device: AuraLevée treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 21 to 70 years old, For females, at least 9 months post-partum, Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator, For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study, Apparently healthy, Informed consent signed by the subject. Exclusion Criteria: History of skin hypersensitivity, Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex), Use of non-steroidal anti-inflammatory drugs within past 2 weeks, Suffering from hormonal imbalance which may affect weight or cellulite, Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants, Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site, The current or recent use (within the past 12 months) of isotretinoin, Pregnancy or breast feeding, Infectious diseases (such as HIV) present, Are a tobacco smoker, Insulin dependent diabetic subjects, Oxygen dependent subjects, Subjects with severe chronic illness, scleroderma, or lupus, Subjects with open sores or scars in the treatment region, or Subjects with ischemia in the treatment region.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AuraLevée treatment|A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in cosmesis | Improvement in cosmesis will be assessed by scoring photographs taken before and 1 and 3 months after treatment. Circumference changes will be measured and compared. | 1 and 3 months |
Scan-Rescan Sub-Study of MS PATHS

Study Overview
=================
Brief Summary
-----------------
The primary objective of this sub-study is to calculate the reproducibility and other technical performance measures of various magnetic resonance imaging (MRI) image analysis algorithms in order to assess their suitability for detecting changes due to multiple sclerosis (MS) in a real-world setting in participants with MS. The secondary objective of this sub-study is to use the primary endpoint results to calibrate measurements across scanners within each MS PATHS center.

Official Title
-----------------
Reproducibility of Brain Volume and Lesion Measurements in Multiple Sclerosis: a Scan-Rescan Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Participants (or participant's legal representative) has the ability to understand the purpose and risks of the sub-study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and l local participant privacy regulations. Diagnosis of relapse-onset MS (relapsing-remitting or secondary progressive). First MS symptom within the past 1 to 30 years. Key Exclusion Criteria: Initiation of any MS disease-modifying treatment within 4 weeks prior to Visit 1. Steroid treatment or suspected MS relapse within 6 weeks prior to Visit 1. Note: Other protocol specified inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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 |
| --- | --- | --- |
| Overall Reproducibility of Brain Volume |  | Baseline up to Day 7 | 
| Overall Reproducibility of Lesions |  | Baseline up to Day 7 | 
| Intrascanner Reproducibility of Brain Volume |  | Baseline up to Day 7 | 
| Intrascanner Reproducibility of Lesions |  | Baseline up to Day 7 | 
| Interscanner Reproducibility of Brain Volume |  | Baseline up to Day 7 | 
| Interscanner Reproducibility of Lesions |  | Baseline up to Day 7 | 
| Intra-class Correlation Coefficients (ICCs) Across Repeated Magnetic Resonance Imaging (MRI) for Brain Lesions |  | Baseline up to Day 7 | 
| Kappa Coefficients Across Expert Manual Segmentation for Brain Lesions |  | Baseline up to Day 7 | 
| Sensitivity and Specificity for Lesion Detection |  | Baseline up to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Coefficients of Equation Parameters for Models to Map Brain Volume and Lesion Measurements between Scanners |  | Baseline up to Day 7 |
Canadian Pegvisomant Compassionate Study In Acromegalic Patients

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: 1) to provide SOMAVERT for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of SOMAVERT.

Official Title
-----------------
A Multi-Center, Open-Label Study For The Compassionate Use Of Pegvisomant In Acromegalic Patients Refractory To Conventional Therapy and For Patients Who Received The Product During The Clinical Development Program.

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Pegvisomant treatment
* Procedure: Medical History, demographics
* Procedure: Sign and symptoms: questionnaire
* Procedure: Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT
* Procedure: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have participated and completed the previous Pegvisomant studies or have shown to be unresponsive to other conventional therapies Exclusion Criteria: ALT/AST>3 times the ULN or have hepatic disease have severe visual field loss, cranial nerve palsies or intracranial HTN that requires surgery to decompress the tumor unwilling to self-administer the medication.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegvisomant treatment|nan|
|Procedure: Medical History, demographics|nan|
|Procedure: Sign and symptoms: questionnaire|nan|
|Procedure: Blood tests: IGF-1, AST/ALT/ALP/TBIL, GTT|nan|
|Procedure: MRI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's IGF-1 levels normalize signs and symptoms of acromegaly normalize |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pegvisomant demonstrates continued safety and efficacy |  |  |
Efficacy and Safety Study of Kinerase® for Treatment of Cutaneous Facial Photodamage

Study Overview
=================
Brief Summary
-----------------
The purpose of the K.I.S.S. study is to evaluate the efficacy of Kinerase® Cream (Kinetin 0.1%) in Thai patients, on the basis of the severity and clinical signs of facial photodamage.

Official Title
-----------------
Kinerase® Interactive Skin-care Study: A Multicentre, Phase IV, Single-arm, Open-label Trial to Evaluate the Efficacy and Safety of Kinetin, N6-furfuryladenine, 0.1% for Treatment of Cutaneous Facial Photodamage

Conditions
-----------------
Skin Roughness, Mottling, Blotchiness, Pigmentation, Fine Wrinkles

Intervention / Treatment
-----------------
* Other: Kinerase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects older than 35 years of age and less than 65 years of age. Subjects with mild, moderate or severe facial photodamage as assessed by a 10-point scale. Subjects willing to sign an informed consent and adhere to all protocol requirements. Exclusion Criteria: Male and female subjects with suspected porphyria, systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug-induced photosensitization. Subjects with chronic or recurring skin disease or disorder. Subjects with any active infectious skin disorder (Herpes simplex, molluscum contagiosum, and facial warts). Subjects with skin cancer of the facial tissues. Subjects who have received any laser/ intense pulsed light (IPL) / chemical peel in the 2 months preceding the screening visit. Subjects with a history of topical and/or oral isotretinoin use, 6 months prior to the screening visit. Subjects who have been on topical Retin-A or Renova in the 2 months prior to the screening visit. Subjects who have used topical alpha-hydroxy acid skin care products in the month preceding the screening visit. Subjects currently on any anti-aging products and who wish to continue use of their products. Subjects requiring concurrent treatment that would interfere with the study assessments. Pregnant or lactating female subjects.

Ages Eligible for Study
-----------------
Minimum Age: 35 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinerase<br> | Other: Kinerase<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the physician's evaluation and patient's self-evaluation at 12 weeks. |  | 12 weeks | 
| To assess the physician's evaluation and patient's self-evaluation at 4 weeks. |  | 4 weeks | 
| To assess the physician's evaluation and patient's self-evaluation at 8 weeks. |  | 8 weeks |
Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
To determine whether once a day administration of Mesalamine is at least as safe and efficacious and administration of multiple doses a day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Detailed Description
-----------------
Is taking total dose in mg/kg once a day, as safe as taking total dose divided in mg/kg spreadout during the day in preventing clinical relapse of ulcerative colitis in children and adolescence.

Official Title
-----------------
A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Asacol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 6 to 18 years, Must be able to swallow tablets, and Biopsy proven ulcerative colitis Exclusion Criteria: Allergy or hypersensitivity to Mesalamine or other salicylates Use of rectal medications

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asacol once a day dosing<br>Asacol total dose in mg/kg given once a day | Drug: Asacol<br>* Asacol is given once a day versus twice or three times a day<br>* Other names: Mesallamine;|
| Active Comparator: Asacol BID/TID dosing<br>Asacol total dose split BID or TID | Drug: Asacol<br>* Asacol is given once a day versus twice or three times a day<br>* Other names: Mesallamine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Once Daily Dosing Works as Well a Multiple Dosing a Day. | subject tolerated once a day dose Only 1 subject enrolled which was the control arm standard dose twice a day. No subjects enrolled to take dose once a day Therefore, primary outcome cannot be reported | overall study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Medication Compliance. | Not applicable : unable to measure secondary outcome because no one was enrolled in once a day dose arm. Therefore, no comparisons can be made to see if once a day dosing would have higher compliance than taking medication BID or TID | overall study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mesalamine, Ulcerative Colitis
Is Ultrasonography Comparable to MRI for the Detection of Morton Neuroma of the Foot?

Study Overview
=================
Brief Summary
-----------------
Patients with Morton neuroma of the foot will undergo either ultrasonography or MRI. The results will be compared. In case of surgery, the pathology report will be compared with the ultrasonographic or MRI findings. Which is the most reliable and specific: ultrasonography or MRI?

Official Title
-----------------
Is Ultrasonography Comparable to MRI for the Detection of Morton Neuroma of the Foot?

Conditions
-----------------
Morton Neuroma

Intervention / Treatment
-----------------
* Procedure: Ultrasonography or MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morton neuroma of the foot Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasonography or MRI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability and specificity of ultrasonography and MRI for detection of Morton neuroma of the foot |  |  |