linjc16/ctgov huggingface dataset:
French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

Study Overview
=================
Brief Summary
-----------------
CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.

Official Title
-----------------
French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

Conditions
-----------------
Immune Thrombocytopenia, Autoimmune Hemolytic Anemia

Intervention / Treatment
-----------------
* Other: no specific intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (18+ year-old) newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB Exclusion criteria: - opposition to data collection

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 |
| --- |
|Other: no specific intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Immune thrombocytopenia (ITP) and AIHA | Number of new cases | Baseline | 
| Natural evolution and events | Disease duration. Description of bleeding, infection, thrombosis events | Baseline and follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | platelet count >30 G/L and no bleeding | 15 years | 
| Complete rate | platelet count >30 G/L and no bleeding | 15 years | 
| Treatment lines | % of patients with each treatment by line of treatments | 15 years | 
| Adverse drug reactions | % of patients with adverse drug reaction reported by investigators | 15 years | 
| Bleeding | % of patients with bleeding during follow-up | 15 years | 
| Rescue treatment | % of patients with any treatment added during the exposure of ongoing treatment | 15 years | 
| Adherence to ITP management guidelines. | Percentage of patients who benefitted from the recommended examinations to detect secondary ITP and the percentage of patients who benefitted from the recommended first-line and second line treatments | 15 years | 
| Events | % of patients with other events of interest like cancer, death, infection, thrombosis | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry
Study of the Diaphragmatic Function by Transient Elastography (ELASTODIAPH)

Study Overview
=================
Brief Summary
-----------------
The study of diaphragmatic function is usually measured by the pressures and volumes generated by contraction of the diaphragm, which is often difficult (cumbersome technique, difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically analyze the diaphragm compared to other accessory respiratory muscle groups). In this study, the investigators aimed at analysing diaphragmatic function by measuring the shortening, stiffness, strain and thickening of the diaphragm by ultrasound.

Official Title
-----------------
Study of the Diaphragmatic Function by Transient Elastography : Comparison With Mechanical and Electrophysiological Variables

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteer Exclusion Criteria: chronic respiratory, neurologic or cardiac disease swallowing disorders pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: To compare diaphragm elastrography provided by ultrasound to diaphragm function indices provided by magnetic/electrical phrenic nerves stimulation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects<br>Only one arm is considered | Diagnostic Test: Ultrasound<br>* Volitional and non volitional respiratory tasks<br>* Other names: Magnetic and electrical phrenic nerve stimulation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transdiaphragmatic pressure | The transdiaphragmatic pressure is the sum of absolute values of gastric and oesophagal pressures | 2 hours |
Long-term Effects of Intensive Insulin Treatment in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment

Detailed Description
-----------------
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits. In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.

Official Title
-----------------
Stockholm Diabetes Intervention Study

Conditions
-----------------
Coronary Heart Disease, Stroke, Renal Failure

Intervention / Treatment
-----------------
* Drug: Intensive insulin treatment
* Drug: Standard insulin treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born 1930 or later Type 1 diabetes Nonproliferative retinopathy Normal serum creatinine Unsatisfactory blood glucose control Exclusion Criteria: Alcohol/drug abuse Proliferative retinopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 52 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: Intensive insulin treatment<br>Intensive insulin treatment | Drug: Intensive insulin treatment<br>* Mealtime insulin (Actrapid) Basal insulin (Monotard)<br>* Other names: Basal-bolus insulin treatment;|
| Active Comparator: Standard insulin treatment<br>Standard insulin treatment | Drug: Standard insulin treatment<br>* Insulin Mixtard<br>* Other names: Mixed insulin 2-3 times per day;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Mortality | All cause mortality and composite mortality from myocardial infarction, stroke and renal failure | Up to 28 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity of Cardiovascular Complications | Morbidity of: coronary heart disease, stroke and renal failure | Up to 28 years |
Phytoserms for Menopause Symptoms and Age-Associated Memory Decline

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of a soy based dietary supplement (phytoSERM) for hot flashes and age associated memory loss.

Official Title
-----------------
Estrogen Receptor-beta phytoSERMs for Management of Menopause and Age-Associated Memory Decline

Conditions
-----------------
Hot Flashes, Memory Loss

Intervention / Treatment
-----------------
* Dietary Supplement: PhytoSERM tablet
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-menopausal women ages 45 - 60 (inclusive) must have a vasomotor symptom (e.g., hot flash) and a memory complaint Exclusion Criteria: history of clinically significant stroke current evidence or history in past 2 years of epilepsy, seizure, focal brain lesion, head injury with loss of consciousness or any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse Known allergy to soy derived products; hypersensitivity to estrogens or progestins

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PhytoSERM 50 mg tablet<br>Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks | Dietary Supplement: PhytoSERM tablet<br> <br> |
| Experimental: PhytoSERM 100 mg tablet<br>Dietary supplement: PhytoSERM tablet to be taken once per day for 12 weeks | Dietary Supplement: PhytoSERM tablet<br> <br> |
| Placebo Comparator: Placebo tablet<br>Dietary supplement: placebo tablet to be taken once per day for 12 weeks | Dietary Supplement: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability | as measured by assessment of AEs, co-morbid events, laboratory measures, symptoms and cognitive performance | 12 weeks | 
| efficacy | change from baseline in neuropsychological (cognitive, functional) test results | 12 weeks | 
| efficacy | change from baseline in vasomotor symptoms | 12 weeks |
Blood Donation--Immune Sequelae and Recruitment

Study Overview
=================
Brief Summary
-----------------
To determine if there were immune sequelae related to the long-term donation of blood or blood products.

Detailed Description
-----------------
DESIGN NARRATIVE: The study had two objectives. The first objective was to investigate changes in immune function which may have occurred as a result of blood, plasma, or platelet donations. Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors. To ascertain whether donation of blood or blood products altered specific immune parameters, studies were conducted on white blood cell (WBC) receptors known to be involved in normal host defense mechanisms, lymphocyte subpopulations, plasma proteins, and complement activation products from 30 individuals in each of four separate donor groups: whole blood donors, bulk plasma donors, plasma donors stimulated with incompatible RBC, and platelet donors. Donor immune data were compared with results in nondonor controls and were also correlated with demographic data, donation history, laboratory data, and clinical findings. The second objective of the study was to determine if changes in an individual donor's immune status occurred over time. A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings. New donors were enrolled in donation groups and followed longitudinally for a period of up to two years. The study was extended through January, 1997 on FY 1995 funds.

Conditions
-----------------
Blood Disease, Blood Donors

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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 |
| --- | --- | --- |
Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.

Official Title
-----------------
Contrast-Enhanced Spectral Mammography: Potential to Improve Diagnostic Accuracy

Conditions
-----------------
Breast Screening

Intervention / Treatment
-----------------
* Diagnostic Test: Contrast-Enhanced Spectral Mammography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention. Exclusion Criteria: Age <30 years old Screening mammography with only calcifications abnormalities Male patients Pregnant or lactating patients Patients with any allergy to iodinated contrast Patients with eGFR < 45 Patients that may be treated with radioactive iodine

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Contrast-Enhanced Spectral Mammography (CESM)<br>Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up. The radiologist will interpret the low energy images and record their findings. | Diagnostic Test: Contrast-Enhanced Spectral Mammography<br>* A standard dose of contrast material for other contrast mammography examinations and for body CT scanning, 1.5 ml/kg of Iohexol350 will be injected intravenously (IV) using a power injection (3-4 ml/s) with a maximum does of 150 ml. The IV injection is performed while the patient is in a sitting position. The mammogram will be performed in a standing position.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of CESM compared to mammography | The radiologist will interpret the low energy images and record their findings. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mammography, Contrast-Enhanced Spectral Mammography, 19-116
BioMonitor Master Study

Study Overview
=================
Brief Summary
-----------------
The BioMonitor is an implantable cardiac monitor used to automatically detect and record episodes of arrhythmia in patients with bradycardia, tachycardia, asystole and atrial fibrillation. The study will be conducted to support regulatory approvals outside of Europe. This BioMonitor Master study is designed to investigate the clinical efficacy and safety of the BioMonitor.

Official Title
-----------------
Master Study of the Implantable Cardiac Monitor BioMonitor

Conditions
-----------------
ATRIAL FIBRILLATION, Syncope

Intervention / Treatment
-----------------
* Device: BioMonitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected cardiac arrhythmia OR Previous AF diagnosis OR AF diagnosis before or after ablation procedure OR Stroke of unknown origin. Exclusion Criteria: Implanted ICD or cardiac pacemaker Allergy to patch electrodes

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 |
| --- | --- |
| Implantable cardiac monitor diagnostics<br>Patients has standard indication for implantable cardiac monitor diagnostic. | Device: BioMonitor<br>* Implantable cardiac monitor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SADE free-rate | SADE free-rate > 90% at 3 month follow-up | at 3 month follow-up | 
| Rate of appropriate QRS detection | Rate of appropriate QRS detection > 90% (based on comparison with Holter ECG recording) | at 6 week follow-up |
Tampere Traumatic Head and Brain Injury Study

Study Overview
=================
Brief Summary
-----------------
Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.

Detailed Description
-----------------
Aims of the study: To improve clinical assessment of mTBI in the acute phase To assemble better knowledge of diffusion tensor imaging as a diagnostic tool in mTBI To improve neuropsychological evaluation of mTBI Main focus on psychosocial functioning / outcome / correlates E.g. Resilience, PTSD

Official Title
-----------------
Tampere Traumatic Head and Brain Injury Study

Conditions
-----------------
Traumatic Brain Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: WHO's mtbi criteria Inhabitant of Pirkanmaa hospital district Age between 18 and 60 years Exclusion Criteria: Detrimental alcohol use Drug addiction Chronic neurological disease Earlier brain injury Diagnosed psychiatric disease Hearing or sight deficiency Native language other than finnish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- | --- |
Clinical Research Outside of Teaching Hospitals (RECHNONU)

Study Overview
=================
Brief Summary
-----------------
The very most part of clinical research in France takes place in teaching hospitals. Advantages to develop it in others hospitals are numerous: access to innovative treatments, improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and reduced selection bias. The objectives of the study are to report the current situation of clinical research outside of teaching hospitals in France.

Detailed Description
-----------------
The very most part of clinical research in France takes place in teaching hospitals. Advantages to develop it in others hospitals are numerous: access to innovative treatments, improvement of healthcare quality, hospitals' attractiveness, increased inclusion rates and reduced selection bias. The objective the study is report the current situation of clinical research outside of teaching hospitals in France. A three-stage survey was conducted between January and October 2012 in non-teaching hospitals of North-eastern France. First questionnaires were sent to administrative and medical boards of all hospitals with more than 100 beds, then to head doctors of every department in hospitals with more than 300 beds and finally meetings were organized with clinical research actors of 20 selected hospitals.

Official Title
-----------------
Clinical Research Outside of Teaching Hospitals : Current Situation in North-eastern France

Conditions
-----------------
Medical Staff, Hospital

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-teaching hospitals established in north-eastern France Exclusion Criteria: more than 100 beds for the second stage only: less than 300 beds
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 |
| --- | --- | --- |
| Description of the clinical research in non-teaching hospitals of north-eastern France | Self-Assessment Questionnaire | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificities of each centers in clinical research | Self-Assessment Questionnaire | 1 year | 
| Problems to solve for developing clinical research | semi-structured interview | 1 year |