linjc16/ctgov huggingface dataset:
Vaccination Against SARS-Cov2 (COVID-19) in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.

Study Overview
=================
Brief Summary
-----------------
Rheumatoid arthritis and spondyloarthritis (ankylosing spondylitis and psoriatic arthritis mainly) are chronic inflammatory rheumatism (RIC), frequently onset in young adults. The prevalence is respectively 0.3 to 0.8% and 0.4%. or about 600,000 people. The basic treatments (DMARDs), essential to control the progression of the disease, are classified into csDMARDs (chemical), the first of which is methotrexate, or bDMARDs (biological). These treatments are immunomodulators and there is an increased risk of severe infection under these therapies. Several vaccinations are therefore recommended by learned societies in patients receiving these treatments, in order to prevent certain infectious risks.In the current pandemic context, the vaccination of these patients against SARS-Cov2 is a major issue in their management and is recommended by the French society of rheumatology. However, many patients express doubts about this vaccination or refuse it. The factors associated with the vaccination will are not known. Better identifying them would make it possible to adapt the information to be given to our patients to promote their adherence.

Official Title
-----------------
Vaccination Against SARS-Cov2 in Chronic Inflammatory Rheumatism and Factors Determining Its Decision.

Conditions
-----------------
Rheumatoid Arthritis, Spondyloarthritis

Intervention / Treatment
-----------------
* Other: Non intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory patients Men or women of any age Follow-ups for chronic inflammatory rheumatism such as rheumatoid arthritis or spondyloarthritis Treated with methotrexate or biotherapy. Exclusion Criteria: Patients not treated with biotherapy or methotrexate. Patients in whom the assessment could not be performed reliably

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non intervention|Non intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the desire to be vaccinated against SARS-CoV2 | Percentage of patients with RIC and treated with DMARDs who favor vaccination against SARS-CoV2 ; determined with a questionnaire | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with the desire for vaccination against SARS-CoV2 | Identify the factors associated with the desire for vaccination against SARS-CoV2 ; determined with a questionnaire | At inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS COV 2 vaccination
Change in Biting Force After Botox Injection

Study Overview
=================
Brief Summary
-----------------
Implant rehabilitation is a successful treatment option for edentulous patients. Decreasing bone loss around implants is an important target for all implantologists. It has been shown that pathological forces, such as bruxism, may in fact result in bone loss and eventual implant failure. Botilinium Toxin is a material of many clinical uses. Beside its cosmetic applications, it has been used in the treatment of masseter muscle hypertrophy. Purpose: To investigate the effect of botilinium toxin injection on biting forces, and its ultimate effect on peri-implant bone changes.

Official Title
-----------------
Change in Biting Force After Botilinium Toxin Injection and Its Effect on Peri Implant Bone Changes

Conditions
-----------------
Bruxism

Intervention / Treatment
-----------------
* Drug: Botox Injectable Product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a partially edentulous mandible, Kennedy Class I configuration, who are indicated for rehabilitation with partial implant overdenture prostheses, and who complained of Bruxism. Exclusion Criteria: The presence of notable facial asymmetry. Severe malocclusion Pregnancy A history of any serious medical illness Drug allergy.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botox<br> | Drug: Botox Injectable Product<br>* Botox is a well known neurotoxin that is derived from the bacterium clostridium botulinium. Its therapeutic applications are variable and well documented, alongside its cosmetic applications. There are seven known serotypes of Botox, from A to G, but only two types; A &B, are available for medical and cosmetic uses.<br>|
| No Intervention: Control No Botox<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in biting force | Biting force measured using T-Scan | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone changes around implant | Bone changes using 3D CBCT | 12 months |
Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

Study Overview
=================
Brief Summary
-----------------
The primary objective is to admix a radiolabel with albuterol sulphate for incorporation into the Handihaler® device for inhalation studies. This will allow for the investigators to determine the regional lung deposition of drug inhaled from the standard Handihaler® device compared to a novel modification of the device to provide more effective dispersion and aerosolization of the coated albuterol powder. The new mechanism of action for proof-of-concept testing consists of a bead (5.1 mm; expanded polystyrene foam) coated with drug powder, as opposed to the standard lactose formulation-filled capsule.

Official Title
-----------------
Evaluation of a Dry Powder Aerosol Dispersion Mechanism by Radiolabeling Techniques

Conditions
-----------------
Adult Healthy Volunteers

Intervention / Treatment
-----------------
* Device: modified Handihaler DPI
* Device: standard Handihaler DPI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers adults Exclusion Criteria: chronic illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified Handihaler DPI<br> | Device: modified Handihaler DPI<br>* subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.<br>|
| Placebo Comparator: standard Handihaler DPI<br> | Device: standard Handihaler DPI<br>* subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional delivery of dry powder to the lung | To compare the in vivo performance,i.e. the fraction of drug loaded in device that is delivered to the lung, of the novel system in comparison with a standard marketed dry powder inhaler (DPI) using radio-imaging techniques. The fraction delivered to the lung will be determined by gamma camera imaging of the lungs following inhalation of the radiolabeled powder from the standard vs. new device. | 1-5 minutes post inhalation |
Combination Weekly Taxotere™ With Iressa™ /Placebo in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if combination therapy of weekly Taxotere™ with Iressa™ will increase the objective responses in measurable leasions in metastatic breast cancer

Official Title
-----------------
A Randomised Phase II Study: Treatment With Daily p.o. Iressa™ (ZD1839) or Placebo in Combination With Weekly IV Infusion of Docetaxel in Patients With Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed mammary carcinoma Exclusion Criteria: prior taxane chemotherapy for metastatic disease or prior treatment with tyrosine kinase inhibitors inhibiting the EGF receptor. Prior hormone treatment or one type of anthracycline based treatment regimen without taxane for metastatic disease is allowed prior to inclusion. If the patient has been treated in the adjuvant or neoadjuvant setting with taxanes, inclusion is allowed when the first cycle of trial medication is started 12 months after the last course of adjuvant treatment

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

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

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: Gefitinib|nan|
|Drug: Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumour response (CR + PR) per RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression and response duration |  |  | 
| Exploratory outcomes: Objective tumour response in relation to ER, PgR, erb-B1 and erb-B2 receptor status and reduction in the number of malignant cells present in bone marrow |  |  |
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)

Official Title
-----------------
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Procedure: Fibrin glue injection in fistula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old CD confirmed by endoscopy and histology. CDAI should be 250 or less at least one perianal fistula (between anus or low rectum and perineum, vulva or vagina) draining for more than 2 months duration Exclusion Criteria: treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3 months presence of a perianal abscess (>1cm) assessed by magnetic resonance imaging (MRI) or endo-anal ultrasonography performed within the last month, presence of anal or rectal stenosis, surgery during the previous month (except seton removal), previous fibrin glue injection, pregnancy.

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Fibrin glue injection in fistula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission | Clinical remission was defined as the absence of any draining by fistula openings occurring spontaneously or after gentle finger compression , the absence of perianal pain and the absence of perianal abscess. | 8 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Clinical Remission |  | 4 weeks after Inclusion | 
| Occurrence of perianal abcess |  | During whole study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients, CD complicated, least, One perianal fistula, Draining, 2 months duration
The Bleeding With Antithrombotic Therapy Study 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the incidence and severity of bleeding complications in patients with cerebrovascular and cardiovascular diseases treated with oral antithrombotic therapy.

Official Title
-----------------
The Bleeding With Antithrombotic Therapy Study 2

Conditions
-----------------
Cerebrovascular and Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: Any oral antithrombotics (antiplatelets or anticoagulants)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with cerebrovascular or cardiovascular diseases who start or continue taking oral antithrombotics (antiplatelets and/or anticoagulants) to prevent vascular events Patients who are able to receive MRI Provision of written informed consent either directly or by a suitable surrogate Exclusion Criteria: MRI contraindication Any condition that in the opinion of the responsible physician or investigator that renders the patient unsuitable for the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Any oral antithrombotics (antiplatelets or anticoagulants)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ISTH major bleeding |  | within 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically relevant non-major bleeding |  | within 2 years | 
| Hemorrhagic event details |  | within 2 years | 
| Ischemic events and those details |  | within 2 years |
European Quality Improvement Programme for Acute Coronary Syndromes

Study Overview
=================
Brief Summary
-----------------
The main hypothesis to be tested is that the use of a quality improvement programme will lead to measurable improvements in the management of care and use of evidence based treatments for patients presenting to hospital with non-ST elevation acute coronary syndromes.

Official Title
-----------------
Improving the Management of Non-ST Elevation Acute Coronary Syndrome: Systematic Evaluation of a Quality Improvement Programme

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Behavioral: Quality Improvement Programme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a good clinical history of ACS and at least one of the following: New or transient ST or T wave changes on the ECG consistent with acute myocardial ischaemia Elevation of troponin or other cardiac markers to levels indicative of myocardial necrosis according to local laboratory values Exclusion Criteria: Evidence of persistent ST elevation on the ECG Use of early reperfusion therapy Patients >80 years Patients transferred from another hospital

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QI<br>Quality Improvement Centres | Behavioral: Quality Improvement Programme<br>* Quality Improvement training programme<br>|
| No Intervention: Non-QI<br>No Quality Improvement Programme | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of 7 outcome measures to assess aggregate potential for improvement in care using the QI programme:1:risk stratification within 24 hrs, 2:early coronary angiography, 3:anticoagulation, 4:beta-blockers, 5:statins, 6:ACE-inhibitors, 7:Clopidogrel |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes at discharge including death and myocardial infarction |  | 10 months | 
| Estimated costs of care for patients |  | 10 months | 
| Estimated costs and economic evaluation of potential cost-effectiveness of QI programme |  | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute coronary syndromes, quality improvement
A Phase 2 Trial of ALIMTA (LY231514, Pemetrexed) Plus Oxaliplatin Administered Every 21 Days for First-Line Treatment of Patients With Advanced Colorectal Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the antitumor activity of ALIMTA plus Oxaliplatin combination therapy in patients with previously untreated advanced colorectal cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: ALIMTA
* Drug: Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary cancer of the colon or rectum Must have measurable disease Must be able to comply with study procedure Exclusion Criteria: Prior chemotherapy for advanced disease Pregnancy or lactation Candidates for surgical resection of one or more metastatic foci Second primary cancer Inability to take folic acid or vitamin B12

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ALIMTA|nan|
|Drug: Oxaliplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Antimicrobial Resistance in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
Cirrhotic patients are more vulnerable to bacterial infection, and infection is one of the most common causes of acute liver disease decompensation.

Detailed Description
-----------------
Cirrhotic patients are more vulnerable to bacterial infection which is a common cause of acute liver disease decompensation. The aim of this study will characterize the antimicrobial resistance and distribution of bacteria isolated from chronic hepatic patients with pulmonary infections, as well as to evaluate the antimicrobial susceptibility of bacteria isolated from sputum.

Official Title
-----------------
Antimicrobial Resistance Among Sputum Pathogens in Post Hepatitis Cirrhotic Patients

Conditions
-----------------
Cirrhosis

Intervention / Treatment
-----------------
* Diagnostic Test: Specimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Adults' older than 18 years with clinical evidence of liver disease Exclusion Criteria: Pregnancy Intensive care unite stay of more than 24 hours Malignancy Organ transplantation Acquired immune deficiency syndrome

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with Cirrhosis<br>Patient with clinical evidence of liver disease, portal hypertension, ultrasound or computed tomography results, laboratory data will be used to confirm liver disease | Diagnostic Test: Specimen<br>* Sputum will be collected in clean disposable containers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isolate Identification | Distribution of bacterial isolates from sputum of cirrhotic patients expressed by frequency of each isolate | One day | 
| Antimicrobial resistance | Antimicrobial susceptibility testing to antibiotics determined by kirby-bauer disk diffusion | One day |