linjc16/ctgov huggingface dataset:
A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Study Overview
=================
Brief Summary
-----------------
Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm that typically arises in the abdomen but can develop at other anatomic sites, most commonly in the extremities. These tumors have a relatively high local failure rate after primary treatment using surgery and/or radiotherapy, and although rarely giving rise to distant metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may recur adjacent to the site of surgical resection, underscoring the limitations of surgery in the palliative setting. Therefore, effective medical therapies for AF are needed to maintain quality of life and prolong survival.The goal of the current study was to better define the activity of imatinib in the treatment of AF and to determine the molecular basis for response/nonresponse

Official Title
-----------------
A Phase II Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

Conditions
-----------------
Fibromatosis

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent; Age ≥ 10 years; Eastern Cooperative Oncology Group Performance status ≤ 2; Histologically confirmed desmoid tumor; Disease progression after local treatment Measurable target lesion (RECIST criteria) ; Adequate hematological, renal and liver functions : Exclusion Criteria: Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. Pregnant or lactating female Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 10 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: imatinib<br>Imatinib 400 mg/day until disease progression | Drug: Imatinib<br>* Imatinib 400 mg/day until disease progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-progressive rate | non-progressive rate at 16weeks | 16weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 16 weeks |
Effect of Different Intensities of Exercise on Daily Energy Expenditure With Physical Activity in Overweight Boys

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is evaluate the effect of different intensities of exercise (moderate vs. intense) on the daily energy expenditure in overweight adolescents.

Detailed Description
-----------------
The specific objectives are: Assess and quantify the existence of compensatory effect of exercise on subsequent physical activity. Compare the amount of daily physical activity in adolescents subjected to different protocols of training intensity.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: physical activity-moderate
* Behavioral: Intense physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overweight 6th and 7th grades students consent form signed by parents / tutors Exclusion Criteria: diabetes mellitus hypertension or reported cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: physical activity-moderate<br>participants will be walking during 60 minutes in a moderate pace | Behavioral: physical activity-moderate<br>* cross -over of moderate and intense physical activity<br>Behavioral: Intense physical activity<br>* cross -over of moderate and intense physical activity<br>|
| Experimental: intense physical activity<br>participants will be running during 60 minutes in na intense pace. | Behavioral: physical activity-moderate<br>* cross -over of moderate and intense physical activity<br>Behavioral: Intense physical activity<br>* cross -over of moderate and intense physical activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy expenditure | measured by triaxial accelerometry | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical activity, energy expenditure, compensatory mechanisms, adolescent
Geranium Oil and Its Components for the Relief of Numbness-OB 100

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations.

Detailed Description
-----------------
This is a pilot study to define the time course, the incidence of sensation restoration and the improvement in nerve conduction in people with numbness by using topical geranium oil.

Official Title
-----------------
Geranium Oil and Its Components for the Relief of Numbness-OB 100

Conditions
-----------------
Nerve Conduction, Numbness

Intervention / Treatment
-----------------
* Other: Geranium Oil with component PN-34


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Neuropathy with the inability to feel touch in a standard nylon filament test Signed informed consent Exclusion Criteria: Pregnant or nursing Known allergies to geranium oil or geranium oil fractions Open sore in the area of numbness Migraine headaches or headaches to strong smells

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geranium Oil and component PN-34<br> | Other: Geranium Oil with component PN-34<br>* Geranium oil as a topical application to the body that is numb, time to determine how long it takes for the feeling to return, if it does so, and if the return of feeling is maintained by daily topical application of oil over 12 weeks. This including the process of absorption, distribution and localization.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to numbness relief and restoration of sensation |  | 12 weeks |
Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids

Study Overview
=================
Brief Summary
-----------------
Cell-based immune therapy using modified macrophages is a promising therapeutic approach in breast cancer. The objective of this cohort study is to collect tumor samples to develop patients' derived organoids to test the antitumor activity of newly developed CAR-macrophages. Other biological samples will be collected such as blood to analyze the host inflammatory status.

Official Title
-----------------
Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids (CARMA)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 years or more Histologically confirmed breast cancer at any stage Requiring surgery or tumor biopsy as standard of care Any or no systemic treatment Signed informaed consent Health insurance coverage Exclusion Criteria: Opposed to biospecimen collection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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 |
| --- | --- | --- |
| Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers |  | 24 months | 
| Antitumor activity of the CAR-macrophages compared to non-modified macrophages |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients |  | 24 months |
VRH Pain Reduction During Burn Wound Care and Physical Therapy

Study Overview
=================
Brief Summary
-----------------
Using Virtual Reality Hypnosis to relief pain and anxiety for burn patients.

Detailed Description
-----------------
The purpose of the study is to examine whether there is more effective relief of pain and anxiety during wound care procedures in burn-injured patients that are treated with Virtual Reality Hypnosis with post-hypnotic suggestion.

Official Title
-----------------
Testing Interactions to Adjunctive Pain Control Techniques

Conditions
-----------------
Burn

Intervention / Treatment
-----------------
* Behavioral: using VR hypnosis/distraction and audio hypnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 7 years Able to complete subjective evaluations of pain English-speaking Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder Able to communicate orally Exclusion Criteria: Age less than 7 years Incapable of indicating subjective evaluation of pain Non-English-speaking Demonstrating delirium, psychosis, or Organic Brain Disorder Unable to communicate verbally Significant developmental disability Extreme susceptibility to motion sickness

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm one uses Virtual Reality Hypnosis post hypnotic suggestions to reduce pain durng wound care procedures. | Behavioral: using VR hypnosis/distraction and audio hypnosis<br>* a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control<br>|
| Experimental: 2<br>Arm two uses Virtual Reality distraction that is administered at times other than during burn care procedure to control for both for attention and high technology. | Behavioral: using VR hypnosis/distraction and audio hypnosis<br>* a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control<br>|
| Experimental: 3<br>Arm three use Audio administered Hypnosis without the visual technology. | Behavioral: using VR hypnosis/distraction and audio hypnosis<br>* a between subject comparison using VR hypnosis and VR distraction and audio hypnosis for pain control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| we use GRS, VAS, McGill,and nurse GRS to measure the pain. |  | once a day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality Hypnosis
Effect of Diet and Exercise in Breast Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
This study seeks to see if a 12-week diet and exercise program improves exercise ability, energy level, and quality of life.

Official Title
-----------------
Fit for the Fight: Effect of a Multidisciplinary Diet and Exercise Program on Body Weight, Quality of Life and Inflammation in Survivors of Triple-negative Breast Cancer

Conditions
-----------------
Breast Cancer, Obesity

Intervention / Treatment
-----------------
* Behavioral: aerobic exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ER/PR/HER2neu negative breast cancer at least 3 months after end of treatment BMI at least 25 Exclusion Criteria: stage IV cancer

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: aerobic exercise|3 times per week for 12-weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | aim for loss of 10% of BMI | 12 weeks | 
| quality of life | Fatigue, disease-specific symptoms, depression and energy level all assessed by standardized questionnaires | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| markers of inflammation | blood draws at beginning and end of study to analyze any effect on inflammation | 12 weeks |
Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine

Study Overview
=================
Brief Summary
-----------------
Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description
-----------------
Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.

Official Title
-----------------
Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO)

Conditions
-----------------
Diphtheria, Tetanus, Acellular Pertussis

Intervention / Treatment
-----------------
* Biological: Boostrix®
* Biological: Td (Tetanus diphtheria) vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum 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 |
| --- | --- |
| Boostrix cohort<br> | Biological: Boostrix®<br>* Single dose<br>|
| Historical Td cohort<br> | Biological: Td (Tetanus diphtheria) vaccine<br>* Single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of medically-attended neurological events. |  | 30 days following vaccination with Boostrix. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of medically-attended hematologic events |  | 30 days following vaccination with Boostrix | 
| Occurrence of allergic reactions. |  | 30 days following vaccination with Boostrix | 
| Occurrence of new onset chronic illnesses |  | 6-month period following vaccination with Boostrix | 
| Occurrence of neurological and hematological events and allergic reactions |  | Within the second 30-day period following vaccination with Boostrix | 
| Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Boostrix
Post-mortem Genetic Testing

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.

Official Title
-----------------
Post-mortem Genetic Testing for Cardiac Ion Channelopathy in Unexplained Still Births

Conditions
-----------------
Cardiac Ion Channelopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unexplained still births, No cause of death after detailed autopsy Exclusion Criteria: Lack of parental consent

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 42 Weeks

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 |
| --- | --- | --- |
| Incidence of cardiac ion channelopathy mutation |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiac ion channelopathy in 1st degree relatives of index case |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ion channelopathy,, Still birth, Sudden death
Nocturnal Insulin-Glucose in Hospital: Tight Control

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 Diabetes Diabetes duration > 3 years Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year A1c 6-9% No ketoacidosis during the previous 12 months Glomerular Filtration Rate (GFR) > 60 ml/kg/min m2 Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice Exclusion Criteria: Gastroparesis Hypoglycemia unawareness Uncorrected visual impairment Deafness BMI> 35 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit. |  | During the closed-loop period for each patient: 12 hours |
Impact of Pharmacist in Cardiology Service

Study Overview
=================
Brief Summary
-----------------
The coverage of the diabetes is a multidisciplinary care, with practitioners' implication(hospital and liberal), and other medical and paramedical profession: doctor, pharmacist, male nurse, nutritionist, etc. In fact there is a real importance of link between hospital and general medecine outside. That's why the pharmacist's presence during the hospitalization seems to be a good alternative to make the link between hospital and the outside pharmacist where patient take his treatment. Hospital pharmacis proceed to a treatment conciliation at the entrance and at discharge. By this conciliation the aim of the study is to show and quantify the impact of pharmacist presence on therapeutic target .

Official Title
-----------------
Presence of a Clinical Pharmacist in a Cardiology Department: What Impact on the Management of Diabetic Patients Within Care Pathways? Example of Inpatient Cardiac Patients at GHPSJ

Conditions
-----------------
Cardiomyopathy, Diabetic

Intervention / Treatment
-----------------
* Other: pharmacist assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 2 patient hospitalized in cardiology service Hospitalization more than 24 hours with insuline or/and oral anti diabetic Exclusion Criteria: diabètes type 1 iatrogenic hyperglycaemia hospitalization for cardia angiography

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pharmacist assessment intervention group<br>St Joseph Hospital pharmacist assess every diabetic patient hospitalized in cardiology service in term of antidiabetic treatment during the hospitalization | Other: pharmacist assessment<br>* St Joseph Hospital pharmacist assess every diabetic patient hospitalized in cardiology service in term of antidiabetic treatment during the hospitalization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of biological test glycosylated haemoglobin evolution between the entrance and discharge |  | 5 days |