linjc16/ctgov huggingface dataset:
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

Study Overview
=================
Brief Summary
-----------------
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

Official Title
-----------------
A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation.

Conditions
-----------------
Heart Failure, Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional MR 2+ - 4+ with left ventricular enlargement Symptomatic heart failure 20% - 50% LVEF Exclusion Criteria: mitral regurgitation of organic origins recent cardiac interventions severe comorbidities

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 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: 1<br>Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant. | Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant<br>* Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of implanted patients who maintain a sustained 1 grade reduction in MR and reduction of mitral annulus anterior posterior dimension |  | 30 days | 
| percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Mitral Regurgitation
Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports

Study Overview
=================
Brief Summary
-----------------
This is a prospective, descriptive and observational study of the anticancer center practice

Official Title
-----------------
Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with any cancer, requiring a central venous catheter No contraindication for any surgery with local or complete anaesthesia Exclusion Criteria: Previous Xylocaine or Lidocaine allergy Clinic superior vena cava syndrome

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 population<br>Patient with cancer requiring a long-term central venous catheter | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and collection of complications for the patients requiring an implantable central venous access ports substitution/change |  | Until the implantable central venous access ports removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief description of the different risk factor for morbidity |  | Until the implantable central venous access ports removal | 
| Assessment of the implantable central venous access ports ease-of-use for nurses according to the modalities of implementation and patient features |  | Until the implantable central venous access ports removal | 
| Assessment of the patient quality of life |  | Before central venous access ports implementation, at the first day of chemotherapy, and during the cycle 4 of chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Implantable central venous access ports, cancer
Tuberculosis Volatile Organic Compounds

Study Overview
=================
Brief Summary
-----------------
The Pulmonary Colonization Test is a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of mycobacterial organisms in the lower respiratory tract. It consists of: A breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and Tedlar bag, as well as for the collection of a separate sample of room air. Analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography. Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection. Analysis of the volatile organic compounds in sputum culture by short acoustic wave/gas chromatography. This study will test the hypothesis that the investigators can identify the presence of mycobacteria in an individual by sampling the breath of patients with active tuberculosis and by sampling head space above culture media of sputum provided. This study will test the hypotheses: that the investigators can identify positive cultures for mycobacterium tuberculosis through sampling of the headspace above the cultures prior to standard laboratory culture identification that the investigators can identify control of tuberculosis by sampling exhaled breath

Official Title
-----------------
Detection of Mycobacteria in Lungs and Culture Using an Ultra-fast Gas Chromatograph

Conditions
-----------------
Pulmonary Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected tuberculosis infection or disease Positive tuberculosis skin test Positive sputum culture for TB X-rays indicated possible tuberculosis infection or disease ability to give breath and sputum samples at regular intervals Exclusion Criteria: Heavy smoker History of or active pulmonary disease other than tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tuberculosis Patients<br>Suspected Tuberculosis patients | |
| Control<br>Healthy volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of tuberculosis from bacterial plates | Tuberculosis will be identified form culture plates by the volatile organic compound signature | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mycobacterium tuberculosis, Pulmonary tuberculosis, Electronic nose, Gas chromatography
Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
Iodine supplementation during pregnancy is recommended by the high health authority and by the World Health Organization during pregnancy. We would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

Detailed Description
-----------------
Physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. The iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. The general French population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. However, according to French studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. To maintain euthyroidism, the mother must increase her T4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d The thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. Our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.

Official Title
-----------------
Evaluation of Iodine Supplementation in Women With Pregnancy Associated With Gestational Diabetes

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Other: Evaluation of iodine supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant woman with gestational diabetes age ≥ 18 years subject informed of the study and not having opposed it. Exclusion Criteria: already known pathology of the thyroid

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Evaluation of iodine supplementation|survey of iodine supplementation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iodine supplementation | µg/day | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iodine intake, iodine supplementation, gestational diabetes
Study of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of exogenous glucagon-like peptide-1 on the immune system i.e on the regulation of immune cells important in diseases such as obesity and diabetes. The hypotheses are: Glucagon-like peptide-1 has an immunological effect observed by studying immune cells in the blood Treatment with glucagon-like peptide-1 increases the number of immune cells in the blood Treatment with glucagon-like peptide-1 leads to a more anti-inflammatory cytokine profile in the blood

Official Title
-----------------
Regulation of Immune Cells in Obese Patients With Type 2 Diabetes Mellitus Treated With Liraglutide (Victoza)

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes BMI > 27 kg/m2 Planed start of treatment with liraglutide Age > 18 years Exclusion Criteria: Infection or active inflammatory disorder Immunomodulating treatment (i.e nonsteroidal antiinflammatory drugs, glucocorticoids) Smoking Alcohol consumption > 14 beverages/week Former bariatric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br>Patients with type 2 diabetes undertaking treatment with liraglutide | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of specific immune cells in blood detected by flow cytometry |  | Before and 12 weeks after initiation of liraglutide treatment |
Post Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems

Study Overview
=================
Brief Summary
-----------------
Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement)

Official Title
-----------------
Post Operative Pain After Pulpectomy of Primary Molars With One Shap Rotation File Versus Wave One Reciprocating File

Conditions
-----------------
Pulp Necroses

Intervention / Treatment
-----------------
* Other: Pulpectomy using single file system ( One Shape file)
* Other: Pulpectomy using single file system ( WaveOne Gold file)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of more than 4 years Healthy children Primary molars with irreversible pulp damage Exclusion Criteria: Presence of periapical radiolucency realtes to primary molar Uncooperative child

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wave One Gold<br>Receporcating single file used for preparation of root canals in primary molars | Other: Pulpectomy using single file system ( WaveOne Gold file)<br>* Rotary file instrument for pulpectomy of primary molars ( WaveOne Gold file)<br>|
| Experimental: One shape<br>Rotation single file used for preparation of root canals in primary molars | Other: Pulpectomy using single file system ( One Shape file)<br>* Rotary file instrument for pulpectomy of primary molars ( One shape file)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Assessment of pain using 4 piont intensity scale 1 means no pain, 2 means slight pain, 3 means moderate pain and for means sever pain at 6,12, 48,72 hours and 1 week | 1 week |
Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.

Study Overview
=================
Brief Summary
-----------------
Randomized controlled trial comparing specialized AF Clinic with 'care as usual' Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.

Official Title
-----------------
The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: AF Clinic
* Other: Care as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed atrial fibrillation Exclusion Criteria: Age < 18 years unwillingness to participate

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AF Clinic<br> | Other: AF Clinic<br>* Treatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment<br>|
| Active Comparator: Care as Usual<br> | Other: Care as Usual<br>* Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. |  | minimum of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality, all cause hospitalizations, Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness. |  | minimum of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, disease management program, integrated chronic care program, guideline, stroke, heart failure, quality of life, costs
The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial

Study Overview
=================
Brief Summary
-----------------
At the start of the controlled ovarian stimulation as a part of the IVF/ICSI treatment patients are informed about this trial. In case they gave informed consent and they have a progesterone level between 1 and 1.5 ng/ml at the day of the hCG injection, they will be randomised. One group of patients will have a fresh embryo transfer, in the second group all embryos will be cryopreserved and transfered in a subsequent (natural or artificial) cycle. The aim of this study is to compare clinical pregnancy rate between the two groups.

Official Title
-----------------
The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial

Conditions
-----------------
Clinical Pregnancy Rate

Intervention / Treatment
-----------------
* Procedure: Freeze all


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF/ICSI treatment progesterone > 1 ng/ml and ≤ 1.5 ng/ml Exclusion Criteria: > 40 years AMH ≤ 1 ng/ml Conditions influencing pregnancy rate (e.g. hydrosalphinx, uterus malformation, hyperprolactinemia and other endocrine conditions; with the exception of controlled thyroid function disease) no available progesterone value on the day of hCG-injection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fresh embryo transfer<br>fresh embryo transfer (standard of care) | |
| Experimental: Freeze all<br>Vitrification of all embryos and replacement of a thawed embryo in a subsequent cycle | Procedure: Freeze all<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 7 gestational weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | 25 gestational weeks | 
| Live birth rate |  | Delivery |
Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma

Study Overview
=================
Brief Summary
-----------------
Around 1/3 of patients with COPD have elevated eosinophil levels. However, the role of eosinophils in COPD has not been yet understood and is probably different in COPD and in asthma. The aim of this study was to assess the expression of selected surface markers on eosinophils and to assess the gene expression in eosinophils in COPD and asthma patients. We are planning to enrol 12 COPD, 12 asthma and 12 control subjects. Patients will undergo routine clinical assessment, spirometry, blood sampling and sputum induction. Eosinophils will be isolated from blood and sputum. Surface markers on eosinophils will be assessed in flow cytometry, gene expression will be assessed by RNAseq.

Official Title
-----------------
Phenotype Assessment of Blood and Airway Eosinophils in Patients With COPD and Asthma

Conditions
-----------------
COPD Asthma, Eosinophilic Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of COPD according to GOLD 2019 or asthma according to GINA 2021 Peripheral blood eosinophil count ≥ 100 / μL Age ≥40 years (COPD), ≥18 years (asthma) History of cigarette smoking: ≥10 pack-years (for COPD) Stable disease period (at least 3 months without exacerbation) Exclusion of parasitic diseases Informed consent to participate in the study Exclusion Criteria: COPD and asthma overlap Use of systemic corticosteroids in the 3 months prior to the study Respiratory infection or exacerbation in the 3 months prior to the study Acute and chronic respiratory failure Concomitant diagnoses: systemic connective tissue diseases, malignant neoplasms, severe and / or uncontrolled cardiovascular diseases Use of immunosuppressive or immunomodulating drugs in the 3 months preceding the study Contraindications to sputum induction No consent to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients<br> | |
| asthma patients<br> | |
| control subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| expression of surface markers | expression of CD125, CD62L, CD66b, CD193, CD11b, CD14 | performed up to 3 months after blood and sputum collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
eosinophil, COPD, asthma