linjc16/ctgov huggingface dataset:
Blood Eosinophil Measurements in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
This study will assess the within-day variation of blood eosinophils in patients with Chronic Obstructive Pulmonary disease (COPD) in stable state and determine if there is a correlation between the blood eosinophils and certain clinical parameters.

Detailed Description
-----------------
COPD is a heterogeneous disease, resulting in different phenotypes with varying clinical and pathophysiological characteristics. One of these pathophysiological features is chronic airway inflammation which can be eosinophilic of nature. Blood eosinophils could be an accessible biomarker for this eosinophilic inflammation. Eosinophil counts can fluctuate due to their short half-life in blood and due to a diurnal rhythm. More needs to be known about this diurnal rhythm and the different confounding factors and sources of within-subject variability of this biomarker.

Official Title
-----------------
Blood Eosinophil Measurements Throughout the Day in Patients With Stable Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients willing and able to give informed consent for participation in the study. Age 18 years or older. Diagnosis of COPD according to GOLD (Global Initiative for Chronic Obstructive Lung Disease): post-bronchodilator Tiffeneau index <0.7), in a stable state of the disease. A smoking history of >10 pack-years Exclusion criteria: Clinical diagnosis of asthma. Use of systemic corticosteroids (oral, intravenous or infiltration) up to six weeks before inclusion. Pregnancy. A recent exacerbation of COPD (<4 weeks).

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 |
| --- | --- |
| Single-arm trial<br>Patient receiving blood sampling, spirometry and Feno | Other: Blood sampling<br>* Blood sampling, Spirometry, Fraction exhaled Nitric Oxide<br>* Other names: Spirometry and Fraction exhaled Nitric Oxide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-day within-subject level changes of blood eosinophils | Describe the within-day within-subject levels of blood eosinophils and determine the within-day within-subject variability of blood eosinophils | 12 hours |
Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor

Study Overview
=================
Brief Summary
-----------------
Pain evaluation remains a clinical problem. Pain Monitor allows pain evaluation using the measurement of skin conductance. Withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the Pain Monitor.

Official Title
-----------------
Pain During Chest Tube Withdrawal: Evaluation Using Pan Monitor in Patients With or Without Epidural Anesthesia

Conditions
-----------------
Chest Pain

Intervention / Treatment
-----------------
* Procedure: Chest drain withdrawal
* Device: Pain Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing removal of a chest tube after lung surgery, patients able to indicate the pain score. Exclusion Criteria: pregnancy, lactation , insulin-dependent diabetes with dysautonomia, central or peripheral neurological disease, agitation, inability to understand the protocol, inability to use the Pain Monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities, contra-indication to oral morphine , respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations recent administration of neostigmine or of atropine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Epidural analgesia<br>Postoperative patients with epidural analgesia | Procedure: Chest drain withdrawal<br> <br> Device: Pain Monitor<br> <br> * Other names: Measurement of Pain Monitor index;|
| Oral analgesics<br>Postoperative patients with oral analgesics | Procedure: Chest drain withdrawal<br> <br> Device: Pain Monitor<br> <br> * Other names: Measurement of Pain Monitor index;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain monitor evaluation of pain | Comparison between Pain monitor index and auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain) | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Evolution of Pain monitor index and of auto-evaluation of pain (numerical scale from 0 -no pain- to 10 - maximal pain) during the chest tube withdrawal | 1 hour |
Gene Expression Monitoring of Mononuclear Cells (MNC) Subpopulations and Immunological Status and Metabolome Defining of Healthy Population

Study Overview
=================
Brief Summary
-----------------
Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+ cells)and should provide a reference for comparison with transcriptomic data of any disease state.Furthermore, metabolome and immunological status are defined on same samples.

Official Title
-----------------
Gene Expression Monitoring of Peripheral Blood Mononuclear Cells Subpopulations (CD4+ Cells, CD56+ Cells and CD4+CD25+ Cells) and Immunological Status and Metabolome Defining of Healthy Population

Conditions
-----------------
Gene Expression, Metabolomics, Immunological Status

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 20-70 years healthy Exclusion Criteria: acute or chronic diseases pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Healthy volunteers<br> | Other: Blood sampling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MNC subpopulations, Gene Expression, Metabolomics, Immunological Status
Psychological Impact of Quarantine in Chronic Pain Patient During COVID-19 Outbreak

Study Overview
=================
Brief Summary
-----------------
In the context of quarantine with COVID-19, we will study the experience and psychological impact of pain in adult patients living with chronic pain. We will evaluate the link between the question of physical and psychological confinement in the experience of pain in this particular situation

Official Title
-----------------
Psychological Impact of Quarantine in Chronic Pain Patient During COVID-19 Outbreak

Conditions
-----------------
Sars-CoV2, Chronic Pain

Intervention / Treatment
-----------------
* Other: questionnaire assesment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with chronic pain Patient in confinement Patient with sufficient understanding of the French language Exclusion Criteria: Non adult patient patient without quarantine

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 |
| --- | --- |
| patient with chronic painful<br> | Other: questionnaire assesment<br>* questionnaire assesment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale questionnaire |  | 1 week from baseline on | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (SF36) |  | 1 week from baseline on | 
| self-reported questionnaire for painful |  | 1 week from baseline on | 
| qualitive questionnaire |  | 1 week from baseline on | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychological impact, COVID-19
Risk of Recurrent Venous Thrombosis: A Validation Study of the Vienna Prediction Model

Study Overview
=================
Brief Summary
-----------------
Because of a high recurrence risk after unprovoked venous thromboembolism (VTE) indefinite anticoagulation is recommended, but confers a considerable bleeding risk. It is important to identify patients, in whom the recurrence risk is lower than the expected bleeding risk, and who will not benefit from long term anticoagulation. By use of a scoring model (Vienna Prediction Model), patients can be stratified according to their recurrence risk based on their sex, location of VTE and D-Dimer. Before implementation in routine care, an independent validation is required. Patients with unprovoked VTE will stop anticoagulation after 3-7 months and the recurrence risk will be estimated by use of the Vienna Prediction Model. Low risk patients with a score of <180 will be included and will be left untreated. Patients with a high score will not be included and their management will follow current guidelines. Follow-up will be two years and the endpoint will be recurrent symptomatic VTE.

Official Title
-----------------
Identification of Patients at Low Risk of Recurrent Venous Thromboembolism After Stopping Anticoagulant Treatment: A Prospective Multicenter Cohort Study (Validation of the Vienna Prediction Model)

Conditions
-----------------
Venous Thromboembolism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years symptomatic uni- or bilateral proximal (including the trifurcation area, popliteal, superficial femoral, deep femoral, common femoral and iliac vein) or distal DVT of the leg and/or symptomatic PE. VTE not provoked by one of the following temporary risk factors: surgery, trauma,pregnancy, cancer, immobilisation. Exclusion Criteria: History of previous VTE; anticoagulation for longer than 6 months; reasons for long-term anticoagulation other than VTE; poor patient compliance; no consent 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| venous thromboembolism<br> | Other: no intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent venous thromboembolism |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
risk of recurrent
Far Infrared Radiation Treatment for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
A study to determine the use of far infrared radiation for the treatment of prostate cancer.

Detailed Description
-----------------
Our initial assessment indicates that electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to cure a number of diseases, including prostate cancer.

Official Title
-----------------
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with Prostate, Bladder or Testicular Cancer. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Radiation: Far Infrared Radiation<br>* Far Infrared Radiation (5μm to 20μm wavelength) for 30 to 40 minutes each treatment session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is to determine the therapeutic effects of far infrared radiation on Prostate Cancer. |  | 2 years and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary end point of the study is to evaluate the therapeutic effects of far infrared radiation on other types of cancer (Bladder and Testis). |  | 2 years and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumors or cancer of the prostate, Cancer of Prostate, Cancer of the Prostate, Neoplasms, Prostate, Neoplasms, Prostatic, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer
Neurophysiological Characterization of Postherniotomy Pain

Study Overview
=================
Brief Summary
-----------------
Sensory function is different in persistent postherniotomy pain patients than in operated controls, suggesting this to be a neuropathic pain syndrome. By performing quantitative sensory testing, the specific changes in pain patients will be revealed, thereby aiding in designing future treatment trials. MRI scans of the groin regions in pain patients and control patients will be evaluated by senior MRI specialists assessing potential pathology to the region (Mesh, inflammation, edema, funicle etc.) Assessors will be blinded to clinical status, and surgery.

Official Title
-----------------
Quantitative Sensory Testing in Persistent Postherniotomy Pain Patients

Conditions
-----------------
Postoperative Pain, Postherniotomy Pain, Neuropathic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients >18 yrs Inguinal herniotomy >1 yr previously No sign of hernia recurrence Unilateral chronic groin pain lasting more than 3 months Moderate/severe pain related impairment of everyday activities. Exclusion Criteria: Other causes of persistent pain in groin region (hip, other surgical procedures)

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pain-free control<br>Pain-free controls from previous prospective study (KF 01294867), operated >2 years previously | |
| Pain Patients<br>Patients with persistent postherniotomy pain lasting >1 year and pain related impaired daily function | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory function |  | actual | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Groin hernia, pain, chronic, quantitative sensory testing, Persistent postoperative pain
Syph-Check Syphilis Antibody Point of Care (POC) Test

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the performance of a rapid membrane test in a clinic or doctor's office setting to identify potential patients infected with syphilis and compare the results to currently licensed laboratory based tests.

Detailed Description
-----------------
The overall objectives of this study are to determine the performance characteristics of a candidate rapid point-of-care test (Syph-Check cassette format) for Treponema pallidum antibodies in serum, plasma and finger stick whole blood obtained from females and males attending sexually transmitted diseases (STD) clinics, family planning / reproductive health clinics, and physician's office; and to compare the performance of this new, rapid test to currently licensed laboratory based tests, the non-treponemal RPR and a Treponemal ELISA or TPPA test.

Official Title
-----------------
One-Step Syphilis Point of Care Test for Rapid Immunoassay Screening of Antibodies to Treponema Pallidum

Conditions
-----------------
Screening for Syphilis Infections

Intervention / Treatment
-----------------
* Device: Syph-Check POC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women will be eligible who: are 18 years of age or older; Routine presumed uninfected for screening visit, or show symptomatic signs of infection or are asymptomatic but are suspected of infection, and either/or have other STD disease conditions and infections, will be identified. Pregnant women in the first and third trimester Exclusion Criteria: are under 18 years of age unwillingness to give consent

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I<br>known syphilis infected patients | Device: Syph-Check POC<br>* Rapid membrane test for syphilis antibodies<br>* Other names: syphilis;|
| U<br>presumed uninfected patients | Device: Syph-Check POC<br>* Rapid membrane test for syphilis antibodies<br>* Other names: syphilis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the sensitivity and specificity of the POC test versus accepted laboratory tests |  | end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent positive agreement data will include supplemental test results identified by infection categories and treatment as possible |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
syphilis
Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in children between 6 and 21 years with type 1 diabetes.

Official Title
-----------------
Comparison of Efficacy and Safety of Insulin Detemir and Insulin Semilente®MC in Children, Adolescents and Young Adults With Type 1 Diabetes on Basal-Bolus Regimen.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes Current intensified insulin treatment Injection of insulin Semilente®MC at bedtime for at least 6 weeks BMI maximum 32 kg/m^2 HbA1c > 5.5 % and < 12.0 % Exclusion Criteria: Current treatment with premixed insulin(s) Impaired hepatic or renal function Recurrent major hypoglycaemia

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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

| Intervention/Treatment |
| --- |
|Drug: insulin detemir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  | after 16 and 32 weeks, respectively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| HbA1c results at the end of each treatment period |  |  | 
| Blood glucose |  |  | 
| Standard Laboratory Safety Parameters |  |  | 
| Hypoglycaemia |  |  |