linjc16/ctgov huggingface dataset:
Prevalence of Fibromyalgia in Israel

Study Overview
=================
Brief Summary
-----------------
The prevalence of fibromyalgia syndrome in the Israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. In the current study the investigators aim at estimating the prevalence of fibromyalgia in this population. For this purpose a two - stage process will be used. First, a population survey will be conducted by telephone, screening for widespread pain and fatigue in the general population. This survey will use the London Fibromyalgia Epidemiology Study Screening Questionnaire. Second, a sample of patients attending the rheumatology clinic will be surveyed with this tool and will be examined in order to determine the actual proportion of patients fulfilling ACR criteria for fibromyalgia. This will enable us to calculate the positive predictive value of the London Fibromyalgia Epidemiology Study Screening Questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the population.

Official Title
-----------------
Prevalence of Fibromyalgia in Israel

Conditions
-----------------
Fibromyalgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals over 18 who consent to answer the survey questions

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of fibromyalgia in the Israeli population |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic data on fibromyalgia patients |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Fatigue
Bilateral Dual TAP Block: Description of a Novel Four-point Approach

Study Overview
=================
Brief Summary
-----------------
A prospective study of 30 patients with severe postoperative pain following abdominal surgery, in which the dual TAP block technique has been used successfully to achieve pain relief. A description of ultrasound technique, effectiveness, duration and potential side effects of the pain treatment, with possible recommendations for future use.

Detailed Description
-----------------
This prospective cohort study is designed to describe a novel ultrasound-guided bilateral dual transversus abdominis plane (BD-TAP) block and to evaluate the postoperative analgesic efficacy in a selection of patients having undergone major abdominal surgery under general anaesthesia where neuraxial anaesthesia and/or intravenous administration of analgesics had failed or was unwanted by the patient, or if the placement of an epidural catheter was deemed impossible by the anaesthetist in charge. 30 consecutive patients planned for the study. BD-TAP to be performed bilaterally with a high frequency linear ultrasound probe, with bupivacaine. Success rate, decline in VAS score, postoperative demand of opioids and block performance time to be recorded.

Official Title
-----------------
Ultrasound-guided Bilateral Dual Transversus Abdominis Plane (BD-TAP) Block: Description of a Novel Four-point Ultrasound-guided TAP Block Approach

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Bilateral dual TAP block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pain VAS >5 following abdominal surgery, in which conventional pain treatment or epidural block is either ineffective or contraindicated Exclusion Criteria: Hypersensitivity to local anaesthetics

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Active pain treatment<br>Bilateral dual TAP block | Procedure: Bilateral dual TAP block<br>* Bupivacaine 2.5 mg/ml 15 ml per injection. 4 injections per patient according to dual TAP block procedure<br>* Other names: TAP block;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain VAS after the intervention compared to pre-intervention VAS |  | 10-20 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain medication required following intervention |  | First 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, abdominal surgery, bilateral dual TAP block
A Study Into the Effectivity and Safety of Firmagon, Prescribed for Treatment of Patients With Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.

Official Title
-----------------
Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma in the Netherlands

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy Exclusion Criteria: - Patients with a contraindication for prescription of Firmagon®
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| To estimate the progression-free survival (PFS) failure rate |  | Maximum 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To enhance the knowledge on known undesirable effects under routine conditions and to obtain further knowledge about so far unknown and rare undesired effects |  | Every 3 months (during 3 years) | 
| To prescribe the change in patient's quality of life (QoL) during therapy. |  | From study start and after 6 months | 
| To assess the improvement of IPSS from baseline after 3 months of Firmagon therapy and at end-of-therapy |  | From study start, after 3 months and at end of treatment | 
| To assess the reduction of prostate volume (neoadjuvant therapy) |  | Fom baseline after 3 months |
In-stent Restenosis and Pericoronary Fat Attenuation Index

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the predictive value of fat attenuation index (FAI) and related radiomics characteristics of pericoronary fat in patients after percutaneous coronary intervention (PCI) for the occurrence of in-stent restenosis (ISR) during the follow-up period (9 to 24 months). The results of this study are expected to provide an early assessment of the inflammation around the coronary lesion segment in patients after PCI, and provide a basis for early targeted intensive drug therapy in clinical practice.

Official Title
-----------------
Construction and Evaluation of Clinical Prediction Model of In-stent Restenosis After Percutaneous Coronary Intervention by Pericoronary Fat Attenuation Index and Radiomics Characteristics

Conditions
-----------------
In-stent Restenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with coronary heart disease who have undergone PCI; Patients followed up coronary angiography 9 to 24 months after PCI; Patients received chest CT examination during inpatient/outpatient follow-up; Exclusion Criteria: Patients with diseases of the immune system; Patients with history of tumor diseases; Patients with chronic/acute infectious diseases; Image quality is not sufficient for analysis;
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ISR<br>Patient developed in-stent restenosis 9-24 months after stenting | |
| no ISR<br>Patients were free of in-stent restenosis 9-24 months after stenting | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat attenuation index (FAI) | The pericoronary FAI was defined as the mean CT attenuation of the pericoronary adipose tissue (-190 to -30 HU). Peri-stent FAI was measured around the stent segment of all 3 major epicardial coronary vessels. | 2022.8.15-2023.8.14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pericoronary fat attenuation index
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to allow Groupe SEBBIN to communicate to competent authorities and to the scientific community data relative to the safety and effectiveness of SEBBIN silicone gel-filled breast implants.

Official Title
-----------------
Multicenter Post-marketing Survey of SEBBIN Group Silicone Gel-filled Breast Implants

Conditions
-----------------
Breast Implant; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient is at least 18-year-old. The patient is genetically a woman. The patient is candidate to a breast augmentation or breast reconstruction with silicone gel-filled breast implants. The patient gets all information regarding the study and signs the informed consent relative to the use of her personal data. Exclusion Criteria: The patient is pregnant or breastfeeding. The patient has silicone implants somewhere else than in the breast. The patient was diagnosed with one of the following pathologies: Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease. Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease. Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease. The patient has a pathology that could delay healing (does not apply to the reconstruction group). The patient has cancer (does not apply to the reconstruction group). The patient has anatomical or physiological conditions that could lead to postoperative complications.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | complication rate | At 10 years of follow-up |
Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol

Study Overview
=================
Brief Summary
-----------------
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.

Detailed Description
-----------------
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential. The project aims to : develop the bio-sensor necessary to measure islet membrane electric potential develop interface between bio-sensor and user correlate analysis data collected by bio-sensor with metabolic results of islet graft

Official Title
-----------------
Quality Control of Pancreatic Islet Intended to Islet Graft

Conditions
-----------------
Pancreatic Islet Quality Control

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP Exclusion Criteria: Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-score | Beta-score in continuous variable, using the last Beta-score known before the second islet graft. Beta-score is a composite score that reflects pancreatic islet graft function after transplantation and measured from the following criteria: severe hypoglycemia, HbA1c, stimulated C-peptide, fasting glucose, insulin dose or oral diabetes, glycemic variability. | 6 months in average before second islet graft | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Islet Transplantation
FLI Normative Study

Study Overview
=================
Brief Summary
-----------------
Single center, cross sectional observational research design to collect normative data on the acquisition of listening skills in normally-hearing children aged 0-6 years of age.

Detailed Description
-----------------
The primary objective is the assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P). The FLI-P has been developed to address a substantial gap in the current tools available to measure the development of auditory skills in children. The FLI-P provides a measure of listening skills acquisition in children from birth to six years of age (0 - 72 months). The FLI-P will be administered by an investigator who has received appropriate training in its use or completed by parents/caregivers themselves. The FLI-P assessment will be conducted using an application running on a Personal Computer, tablet or online device. There are no specific medical or surgical procedures involved in this clinical investigation and the FLI-P is a non-interventional application.

Official Title
-----------------
Normative Data for the Functional Listening Index - Paediatric

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Other: Functional Listening Index


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged between 0 and 6 years of age. Pass on the Newborn Hearing Screen Status conducted during the New South Wales Statewide Infant Screening - Hearing (SWISH) Program. No current parental or professional concern regarding hearing status. Exclusion Criteria: Pre-existing diagnosis of additional needs. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of the study. Unwillingness or inability of the subject to comply with all investigational requirements.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 6 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normally-hearing<br>Children with normal hearing | Other: Functional Listening Index<br>* Functional Listening Index questionnaire to assess acquisition of listening skills.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Listening Index | The assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P). | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional Listening Index
Effectiveness of Transcranial Direct Current Stimulation for TKR

Study Overview
=================
Brief Summary
-----------------
Transcranial direct current stimulation (tDCS) is a technique of noninvasive cortical stimulation allowing significant modification of brain function used. Clinical application of this technique could be helpful for pain, Parkinson's disease, dystonia, cerebral palsy and dementia etc. And tDCS is safe with only mild, transient adverse effects. But there is few studies focused to postoperative states. The aim of this project is to reveal the effect of tDCS for postoperative pain after total knee replacement surgery,

Official Title
-----------------
Effectiveness of Transcranial Direct Current Stimulation for Postoperative Pain in Total Knee Replacement Surgery

Conditions
-----------------
Transcranial Direct Current Stimulation, Post Operative Pain

Intervention / Treatment
-----------------
* Device: apply tDCS
* Device: Sham tDCS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have scheduled elective spine surgery. Exclusion Criteria: Who has Cognitive dysfunction before surgery. Who already has delirium before surgery. Who has pain disorder ( like CRPS) Who cannot reveal the one's pain.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active tDCS<br>intervention : Intensity 2mA, 30minues, 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS | Device: apply tDCS<br>* Intensity 2mA, 20minues, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC<br>|
| Sham Comparator: sham tDCS<br>Intensity 2mA, 8 seconds (but looks same as an intervention 30mins), 7 times (post operation in 30min, in 4hrs, and 1 time a day from POD#1 to POD #7) apply tDCS (sham mode) | Device: Sham tDCS<br>* Intensity 0mA, 40 seconds, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | the decrease of pain scale in postop state with Visual Analog Scale. | 1hour, 6hours, 24 hours, 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Delirium | Incidence of Delirium | postop day 1,3,6 | 
| Consumption of PCA | The consumption of opioid. | 24 hours |
Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler (ACTIFER)

Study Overview
=================
Brief Summary
-----------------
The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.

Official Title
-----------------
Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler

Conditions
-----------------
Tissue Doppler, Left Atrial Closure

Intervention / Treatment
-----------------
* Procedure: Trans thoracic echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman over 18 years-old Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device Patient in sinus rhythm Subject affiliated or beneficiary of a social security scheme Patient having signed the informed consent Exclusion Criteria: Patient participating in another clinical study Patient in permanent ACFA Patient with a mitral prosthesis (biological or mechanical), Patient with a history of mitral annuloplasty Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Patient 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?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device<br> | Procedure: Trans thoracic echocardiography<br>* trans thoracic echocardiography at the beggining and at the end of the placement of the Saint Jude Medical AMULET type prosthesis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lateral e' speed | measured by tissue Doppler | 1 day |