linjc16/ctgov huggingface dataset:
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Detailed Description
-----------------
Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Official Title
-----------------
High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)

Conditions
-----------------
Breast Fibroadenoma

Intervention / Treatment
-----------------
* Device: HIFU treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients >18 years of age Fibroadenomata diagnosed according to local hospital protocol; ultrasound alone on patients <25 and ultrasound plus core-biopsy in patients >25 (Graded B2 or less) Visible on ultrasound (Graded U2/U3) Definitive diagnosis of fibroadenomata confirmed by the Breast multi-disciplinary team meeting (MDT). Exclusion Criteria: Lesion with atypia or suspicion of phyllodes (Graded B3 or greater) Pregnant or lactating women History of laser or radiation therapy to the targeted breast

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIFU treatment<br>HIFU treatment in patient diagnosed with fibroadenoma | Device: HIFU treatment<br>* HIFU treatment in patients with fibroadenoma<br>* Other names: Echopulse;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in size of fibroadenomata as recorded on ultrasound imaging |  | Month 1, Month 3, Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | Month 1, Month 3, Month 12 | 
| Patient recorded outcomes measures | Patient questionnaires and VAS scales | Month 1, Month 3, Month 12 | 
| Mean treatment time |  | Treatment visit date | 
| Cost-effectiveness |  | 12 months |
Driving Ability Among People With Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is to assess the effect of MCI on driving ability by using on road driving test. The relationship between their driving outcome and their cognitive decline will be examined.

Detailed Description
-----------------
Each subject will be evaluated by test battery which is accepted to driving assessment and include: The Montreal Cognitive Assessment, Clock Drawing Task, Color Trail Test, Motor Free Visual Perception, Visual Spatial Search Task , Awareness Questionnaire and on road driving test. The difference between outcome measures of the on road test between the patient group and the control group will be tested. The correlation between outcome measures of the on road test and the cognitive tests will be examined.

Official Title
-----------------
Assessing the Effect of MCI on Driving Ability by Using on Road Driving Test. The Relationship Between Their Driving Outcome and Their Cognitive Decline Will be Examined

Conditions
-----------------
Mild Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of Mild Cognitive Impairment(given by a neurologist), valid driver's license and driving experience of at least a year. Exclusion Criteria: people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| mild cognitive impairment<br>men and women, aged 50 to 70. The inclusion criteria are:diagnosis of MCI (given by a neurologist), valid driver's license and driving experience of at least a year. the exclusion criteria are: people diagnosed with other neurological damage such as: dementia, CVA and head injury, people with sensory or motor impairment. | |
| Healthy people<br>Men and women, ages 50-70. the inclusion criteria are: healthy people with out neurological disease or psychiatric illness, have valid driver's license and driving experience of at least a year. | |

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
-----------------
mild cognitive impairment, Automobile Driving, cognitive aspects
Training at Different Intensities in Coronary Artery Disease -Effects on Myocardial Function

Study Overview
=================
Brief Summary
-----------------
The study investigated if aerobic endurance exercise of different intensity has different impact on the physical capacity and myocardial function in patients with coronary artery disease. Patients with stable CAD trained for 10 weeks, and oxygen consumption and myocardial function were measured before and after this period. Patients were randomly assigned to each exercise group.

Detailed Description
-----------------
Peak oxygen consumption was measured by gas-analysis. Myocardial function was measured by echocardiography. Exercise was performed on treadmills under close supervision of an exercise physiologist. Patients had to complete over 70% of sessions to be included in analysis. Three sessions were scheduled every week. Heart rate (HR) was about 85 % of max HR in the high intensity group, and about 65 % in the moderate intensity group.

Official Title
-----------------
Which Training Intensity is Most Effective in Improving Myocardial Function in Patients With Coronary Artery Disease?

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Behavioral: Exercise training for 10 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable coronary artery disease over 4 months since cardiovascular event Exclusion Criteria: heart failure inability to exercise

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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

| Intervention/Treatment |
| --- |
|Behavioral: Exercise training for 10 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen consumption |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Myocardial function measured by echocardiography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease, Exercise training, Intensity, Randomized, echocardiography, Aerobic Exercise
Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.

Official Title
-----------------
A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: MORAb028


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules) Tumor accessible to intra-tumoral injections Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3 Exclusion Criteria: Are candidates for curative surgical excision or lymphadenectomy Prior non-surgical treatment within 4 weeks Known central nervous system (CNS) tumor involvement or metastases Hypersensitivity to MORAb-028

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MORAb 028<br> | Drug: MORAb028<br>* 1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of multiple intralesional administration of MORAb-028 | After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33) | Day 33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of intralesional administration of MORAb-028 |  | 22 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma
Comparison of Mesh Fixation Wit Cyanoacrylate vs Suture in Inguinal Hernia Surgery

Study Overview
=================
Brief Summary
-----------------
To compare fixation with glubran2 with suture during surgery por primary inguinal hernia. Hypothesis: Glue may induce less complications and chronic pain than suture

Official Title
-----------------
Cyanoacrylate vs Suture for Mesh Fixation in Inguinal Hernia Surgery

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Procedure: Inguinal mesh hernioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients Aged more than 18 years Primary inguinal hernia Exclusion Criteria: Inguinoscrotal hernia

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glue<br>Mesh fixation with glue | Procedure: Inguinal mesh hernioplasty<br> <br> |
| Active Comparator: Suture<br>Mesh fixation with suture | Procedure: Inguinal mesh hernioplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic pain after two years |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Male patients, Age > 18 year, Primary hernia, glue
Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.

Study Overview
=================
Brief Summary
-----------------
The primary aim of this non interventional study is to assess the independent prognostic role on overall survival of primary tumour 18F-FDG uptake value (SUVmax) measured on 18fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in patients with non-metastatic non-small cell lung cancers treated with curative intent, taking into account the other conventional prognostic factors (performance status, age, sex, disease stage).

Official Title
-----------------
Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.

Conditions
-----------------
Non Small Cell Lung Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically demonstrated NSCLC Stage I-III treated by curative treatment by surgery with or without chemotherapy (induction or adjuvant) or by chemoradiotherapy Inoperable patients treated by exclusive radiotherapy A whole-body (skull base to mid thighs) FDG-PET or a combined FDG-PET/CT on a dedicated machine, performed before any anticancer treatment FDG-PET or combined FDG-PET/CT has to be previously standardised according to the procedure described in appendix IV Written informed consent Accessibility to follow-up Age > 18 years Exclusion Criteria: Prior anticancer treatment (surgery, radiotherapy or chemotherapy) Stage IV NSCLC A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval) Uncontrolled diabetes mellitus (fast glycaemia above 130 mg/dl) Pregnancy and lactating woman Unavailability to send a copy of the PET or PET-CT (DICOM format) to the data centre

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 |
| --- | --- |
| I<br>Patients with non-small cell lung carcinoma treated with curative intent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | Survival will be dated from the date of PET scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | Period between the date of PET scan and the date of first progression or death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non small cell lung carcinoma, PET scan, Observational study, Non metastatic, treated, curative intent
Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
Several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily accessible biological marker of sepsis. Retrospective work in the adult emergency departments of Strasbourg University Hospitals has shown the good specificity of this biological sign for the diagnosis of infection. Our work aims to confirm the results by a more meaningful study. Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ED. Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion of an equivalent number of uninfected control patients. Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse

Official Title
-----------------
Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department

Conditions
-----------------
Eosinopenia

Intervention / Treatment
-----------------
* Other: Diagnosis of bacterial infection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: major patient patient suspected of infection and benefiting from the routine practice of NFS, whatever the indication during his / her visit to the emergency room. patient with or without criteria for bacterial infection patient affiliated to a social security scheme patient (or legal representative) who has agreed to participate in the study Exclusion Criteria: anti tumor chemotherapy immunosuppressive treatment corticotherapy antibiotherapy in progress malignant hemopathy evolutionary cancer refusal to participate in the study subjects under safeguard of justice subject under guardianship or curatorship

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 |
| --- | --- |
| Infected patients<br> | Other: Diagnosis of bacterial infection<br>* use of eosinopenia in the diagnosis of bacterial infection<br>|
| Control group<br> | Other: Diagnosis of bacterial infection<br>* use of eosinopenia in the diagnosis of bacterial infection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eosinopenia as a sepsis marker | Evaluation of the interest of eosinopenia in the diagnosis of infectious states in emergencies. | 102 month |
Antiretrovirals and Rate of Progression in Carotid Artery Intima-medial Thickness in HIV

Study Overview
=================
Brief Summary
-----------------
It is well known that HIV-infected subjects frequently experience hyperlipidemias, insulin resistance, and visceral adiposity, which are known to increase the risk of atherosclerosis. Several cohorts have shown an increased risk of heart disease in people with HIV. The effect of HIV treatment versus HIV itself on the incidence of heart disease is unclear. In this study the investigators will assess the effect on carotid IMT of the initiation of antiretroviral combinations that are known to have a minimal effect on lipids and insulin resistance. We will also assess the changes in several inflammation and cardiovascular markers,as well as endothelial activation markers,and how these changes relate to therapy-induced changes in immunologic, virologic and metabolic markers.

Official Title
-----------------
Assessment of the Use of a Metabolically-friendly Antiretroviral Regimen to Slow Down the Rate of Progression in Carotid Artery Intima-medial Thickness in Adults With HIV

Conditions
-----------------
HIV Infections, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for HIV positive group: HIV-1 infection Age at least 18 years Naïve to antiretroviral therapy CD4 cell count > 400 cells/mm3 For controls: Age at least 18 years, no known HIV infection, and no known medical condition requiring chronic use of prescription medications. Exclusion Criteria (both groups): Diabetes Pregnant or breastfeeding Women of child bearing age who refuse or are unable to use appropriate methods of contraception during the entire study period. Active infectious or inflammatory condition In jail or involuntarily incarcerated

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 |
| --- | --- |
| HIV positive<br>HIV infected treatment naive with CD4 cell count of at least 400 | |
| Healthy controls<br>Healthy controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Carotid IMT |  | Annualy for 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase or decrease in Inflammatory markers |  | Annually for 4 years | 
| Changes in Fasting lipids |  | Annually for 4 years | 
| Change in Insulin resistance by HOMA score |  | Annually for 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, IMT, coronary, Treatment Naive
Effects of Milk Fat Globule Membrane (MFGM) - Enriched Formula With Reduced Energy and Protein Content on Growth and Development

Study Overview
=================
Brief Summary
-----------------
Formula-fed infants differ from breast-fed infants in the growth pattern, risk for obesity and cardiovascular diseases, neurological development and morbidity in infections. The investigators' hypothesis is that a modified formula with reduced energy and protein content and enrichment with Milk Fat Globule Membrane (MFGM) containing bioactive proteins and phospholipids will reduce the difference between formula-fed and breast-fed infants.

Official Title
-----------------
Double-blinded Interventional Study on the Effects of MFGM-enriched Formula With Reduced Energy and Protein Content on Growth and Development

Conditions
-----------------
Infant

Intervention / Treatment
-----------------
* Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infants with birth weight 2500-4500 gr Fed with breastmilk only or formula only before 2 months of age Exclusion Criteria: Chronic illness

Ages Eligible for Study
-----------------
Maximum Age: 2 Months

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

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

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 |
| --- | --- |
| Experimental: 1<br>Modified formula | Dietary Supplement: Modified formula (MFGM-enriched formula with reduced energy and protein content)<br>* MFGM-enriched formula with reduced energy and protein content<br>|
| No Intervention: 2<br>Standard formula | |
| No Intervention: 3<br>Breastfed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Pletysmography (% body fat) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological development | Bayley Scales of Infant and Toddler Development, 3rd Ed (higher score - better outcome) | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body composition, Glucose tolerance, Intima-media thickness, Visual acuity, Neurological development