linjc16/ctgov huggingface dataset:
Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid

Study Overview
=================
Brief Summary
-----------------
Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin in European countries, including France. Immunologically, BP is characterized by the production of autoantibodies directed against two major components of the hemidesmosome, BP180 and BP230. The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its serum level at diagnosis have been correlated with disease activity. The anti-BP230 autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis did not correlate with disease activity. Up to now, no clinical or immunologic factors have been identified to predict outcome of patients with good or poor prognosis bullous pemphigoid as defined by long complete remission off therapy and recurrent disease requiring maintenance therapy for years. The usefulness of BP180 or BP230 ELISA scores for monitoring BP patients during treatment also remains unclear.

Detailed Description
-----------------
Aim of the study were : To study association between the serum level of cytokines (IL-17 and IL-23) and of the protease MMP-9 and the relapse of bullous pemphigoid.

Official Title
-----------------
Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid

Conditions
-----------------
Bullous Pemphigoid

Intervention / Treatment
-----------------
* Other: Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with bullous pemphigoid patients not yet receiving treatment for bullous pemphigoid aged > 18 years Exclusion Criteria: - Patients with relapse of bullous pemphigoid

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 |
| --- | --- |
| bullous pemphigoid<br>Patients with bullous pemphigoid. | Other: Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse of bullous pemphigoid. | The relapse of bullous pemphigoid is defined as he reappearance of at least 3 new daily blisters along with pruritus and/or erythematous, eczematous or urticarial plaques | Month 12 |
Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Study Overview
=================
Brief Summary
-----------------
To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Official Title
-----------------
Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Vardenafil (Levitra, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20 years and older- Males with erectile dysfunction Stable heterosexual relationship Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use Other exclusion criteria apply according to the Summary of Product Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Arm 1<br> | Drug: Vardenafil (Levitra, BAY38-9456)<br>* Vardenafil 10 mg orally on demand prior to intercourse<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment Question |  | 12 weeks | 
| Other diary responses |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Comparing Active and Passive Ankle-foot Prostheses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform a biomechanical study of a prototype prosthetic foot and evaluate if it provides a physiological generation of power at the ankle in transtibial amputees. The prosthetic foot is a prototype system that generates power via actuators (i.e. robotic system).

Detailed Description
-----------------
Subjects will be studied during level-ground walking. A camera-based motion capture system will be used to study the biomechanics of motion and evaluate if the pattern of ankle power generation by the prosthetic foot is physiological. In addition, the metabolic cost of ambulation will be monitored during walking at constant speed over a period of several minutes. The data will allow us to assess if the prosthetic foot leads to a decreased metabolic cost of ambulation compared to passive prosthetic feet.

Official Title
-----------------
Comparing Active and Passive Ankle-foot Prostheses

Conditions
-----------------
Trans-tibial Amputation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: weigh more than 200 lbs are high level ambulators corresponding to levels E to F of the Special Interest Group of Amputee Medicine (SIGAM) mobility grade have the ability to follow multi-step commands. Exclusion Criteria: score level D on the SIGAM mobility grade have experienced 1 or more falls in the last month before the study have a residual limb length which does not allow for seven inches clearance of bracket attachment for the PowerFoot the residual limb must be stable in volume (no change in socket or socket padding in last 6 months) and without pain that limits function the sound-side (contralateral) lower extremity must be free of impediments that affect gait, range of motion, or limb muscle activity Any diagnosed cardiovascular, pulmonary, neurological, and/ or orthopedic conditions that would interfere with subject participation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| Amputees<br>Adults with history of traumatic unilateral transtibial amputation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle power generation | Ankle power derived using a camera-based motion capture system during walking | During the session trial (approx 10 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic cost of ambulation | Oxygen consumption during level-ground walking | During the session trial (approx 10 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prosthesis, amputees, gait
Incidence and Clinical Course of Colonoscopy Related Perforation

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the incidence and clinical course of colonoscopy related perforation based on the result of a prospective registry.

Detailed Description
-----------------
In each endoscopy unit from participating hospital, there is a alarm system focusing on the development of perforation. Therefore, perforation cases will not be missed from the registry.

Official Title
-----------------
Incidence and Risk of Poor Outcomes After Colonoscopy Related Perforation: Result From a Prospective Data Registry

Conditions
-----------------
Perforation Colon

Intervention / Treatment
-----------------
* Procedure: colonoscopy perforation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have a perforation after colonoscopy Exclusion Criteria: Patients who refuse to be registered.

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 |
| --- |
|Procedure: colonoscopy perforation|The development of perforation after colonoscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation | Number of participants who take surgical treatment after perforation | 1 month |
Application CT and MRI in Cerebral Venous Sinus Thrombosis

Study Overview
=================
Brief Summary
-----------------
Cerebral venous thrombosis (CVT) is a rare disease, and with poor prognosis. Computed tomography (CT) andmagnetic resonance imaging (MRI) are the most commonly used image modalities for patients with non-specific neurologic symptoms. We are going to assess the accuracy of CT and MRI in the differential diagnosis of CVT and cerebral venous sinus thrombosis (CVST).

Official Title
-----------------
the Application CT and MRI in the Diagnosis of Cerebral Venous Sinus Thrombosis

Conditions
-----------------
Magnetic Resonance Imaging, Cerebral Venous Sinus Thrombosis, Computer Tomographgy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A. The patients were diagnosed with cerebral venous thrombosis or cerebral venous sinus thrombosis; B. The patients completed at least cranial CT or MRI examination upon admission;C. The patients complete at least one of the CTV, MRV or DSA examination. Exclusion Criteria: A. Patients with severe cardiopulmonary insufficiency;B. Patients lost to follow-up;C. Patients with incomplete access to imaging data;D. Patients with cerebral venous sinus thrombosis that was not diagnosed at discharge.
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 |
| --- | --- | --- |
| specificity and sensitivity of CT | specificity and sensitivity of CT in the diagnosis of cerebral venous sinus thrombosis | 2022.01 | 
| specificity and sensitivity of MRI | specificity and sensitivity of MRI in the diagnosis of cerebral venous sinus thrombosis | 2022.01 |
Validation of French Version of LCADL and Dyspnea-12

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to develop and to validate a French version of the London Chest Activity of Daily Living (LCADL) and the Dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the Activity of Daily Living in COPD patients (stages severe and very severe).

Official Title
-----------------
Validation of the French Version of the London Chest Activity of Daily Living Scale (LCADL) and the Dyspnea-12 Questionnaire

Conditions
-----------------
Copd

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD with FEV1< 50% of predictive value Exclusion Criteria: FEV1> 50% of predictive value Patients with an exacerbation of COPD in the previous 30 days the inclusion

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 |
| --- | --- | --- |
| the Saint-Georges questionnaire, item Activity | by comparison with item activities of the Saint-Georges questionnaire for the LCADL | 15 days | 
| MMRC Dyspnea scale | by comparison with MMRC dyspnea scale for the dyspnea 12 | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyspnea
Promoting Appropriate Weight Gain Pregnant Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if engaging in group based phone counseling (GBPC) and an interactive physical activity monitoring system can help pregnant women gain an appropriate amount of weight during pregnancy.

Official Title
-----------------
Promoting Appropriate Weight Gain Pregnant Women

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Intervention
* Behavioral: Intervention 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-16 weeks pregnant Pre-pregnancy BMI between 22 kg/m2 to 45 kg/m2 Exclusion Criteria: Diabetes Pre-eclampsia Hypertension Other metabolic abnormalities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Participants in this group were informed to continue to receive usual care. | |
| Experimental: Intervention Arm<br>Received an interactive physical activity monitoring system (the Gruve®). | Behavioral: Intervention<br>* Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.<br>|
| Experimental: Intervention Arm 2<br>Received an interactive physical activity monitoring system (the Gruve®) and group based phone counseling (GBPC). | Behavioral: Intervention 2<br>* Participants received an interactive physical activity monitoring system, an electronic scale to report weekly body weight, weekly hour long conference calls with structured interactive educational lessons led by Health Educator, dietary recalls were completed at three different time points during their participation, and study personnel monitored physical activity levels weekly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excessive gestational weight gain | Proportion of excessive gestational weight gain based on weight gain guidelines. | During Pregnancy - 18-36 week gestational age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain | Total weight change during pregnancy | During Pregnancy - 18-36 week gestational age | 
| Infant fat mass | Infant fat mass | 1-4 days after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational weight gain, Physical activity
Community Glaucoma Screening Follow-up

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if one of three interventions improves follow-up rates for screening exam participants who are instructed to have a definitive eye exam.

Detailed Description
-----------------
To determine if one of three interventions: vouchers, telephone calls, and personal contacts, improves follow-up rates for screening exam participants who are instructed to have a definitive eye exam.

Official Title
-----------------
Community Glaucoma Screenings: Assessment of Interventions to Improve Follow-up

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Other: Voucher
* Other: Telephone Call
* Other: Contact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All who had an eye screening exam. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Voucher<br>Voucher for transportation reimbursement | Other: Voucher<br>* Vouchers given to reimburse transportation<br>|
| Active Comparator: Voucher and call<br>Voucher for transportation and telephone calls | Other: Voucher<br>* Vouchers given to reimburse transportation<br>Other: Telephone Call<br>* Telephone reminder calls<br>|
| Active Comparator: Voucher and call and contact<br>Voucher for transportation, telephone calls, and a contact at the senior center | Other: Voucher<br>* Vouchers given to reimburse transportation<br>Other: Telephone Call<br>* Telephone reminder calls<br>Other: Contact<br>* Contact at senior center to encourage follow up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitive follow-up eye exam |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Intervention, Follow up
Spinal Motor Evoked Potentials in Brain Surgery

Study Overview
=================
Brief Summary
-----------------
During neurosurgical resection of brain tumors within brain areas for motor control, it is important to monitor motor function. For this muscle motor evoked potentials are used. Those are elicited by transcranial and direct cortical stimulation. Motor responses are recorded from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used, but additionally motor activity is recorded from the spinal cord. This is called spinal motor evoked potentials. It is known that the relation between spinal and muscle motor evoked potentials helps to extent the resection of spinal cord tumors. This study implements the spinal motor evoked potential into brain tumor surgery and analyses the relationship between spinal and muscle motor evoked potentials. With this, detection of injury to the brain area for motor control might be discovered earlier and thus tumor resection can be performed safely.

Official Title
-----------------
Spinal Motor Evoked Potentials During Neurosurgical Procedures Within the Central Region

Conditions
-----------------
Brain Tumor, Glioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years tumor location adjacent to the motor cortex and corticospinal tract Exclusion Criteria: minor neurological degenerative diseases neurological immunological diseases drug abuse implanted medical devices such as cardiac pacemaker spine deformation

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 |
| --- | --- |
| Brain tumor<br>patients with glioma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-wave measurement | numeric assessment, amplitude and latency of D-wave | 24 hours | 
| Clinical motor status according to the MRC scheme | clinical motor status according to the MRC scheme | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle motor evoked potentials, spinal motor evoked potentials, D-wave, brain tumor surgery, intraoperative neuromonitoring