linjc16/ctgov huggingface dataset:
Tissue Banking Study - Polycythemia Vera or Essential Thrombocythemia (PV & ET) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to isolate and characterize stem cells of patients with Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are not working the way they should be and why they seem to be sensitive to regulatory factors in the blood, such as clotting.

Detailed Description
-----------------
Specific Aim 1: Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function. Specific Aim 2. Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC.

Official Title
-----------------
Treatment Strategies for Myeloproliferative Neoplasms by Targeting the Tumor Suppressor P53

Conditions
-----------------
Polycythemia Vera, Essential Thrombocythemia

Intervention / Treatment
-----------------
* Procedure: Blood specimen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: polycythemia vera or essential thrombocythemia agree to give blood for study Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PV or ET<br>subject who has polycythemia vera or essential thrombocythemia | Procedure: Blood specimen<br>* 4 green top tube 40 cc of blood draw<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem cell function | Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function. | at one time study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD34+ cells assays | Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC. After treatment with RG7112 and IFNα at the various doses, p53, MDM2, MDMX, phosphor-p38, and phosphor-STAT1 levels in MPN CD34+ cells will be measured using monoclonal antibody staining and flow cytometric and immunofluorescence analyses. | at one time study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue banking
FDG PET-Scan Analysis of Evolutivity of Non-surgical Aneurysm of Abdominal Aorta

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to determine if the evolutivity of global and segmentary captation of FDG-F18, which can be measured in the wall of abdominal aorta aneurysm, is predictive of the 9 month evolution of diameter and volume of the aneurysm, measured globally and segmentary in angioscan.

Official Title
-----------------
ANALYSE EN MORPHO-TEP AU FDG DE L'EVOLUTIVITE DES ANEVRISMES ABDOMINAUX AORTIQUES NON CHIRURGICAUX UNE ETUDE MULTICENTRIQUE DE L'INTER-REGION NORD-EST

Conditions
-----------------
Medically-treated Aneurysm of Abdominal Aorta

Intervention / Treatment
-----------------
* Other: PET-Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AAA with a minimum diameter of 40 mm, calculated with a standardized method No indication for an immediate surgery or endoprothesis implantation Age above 18 (except for patient under supervision) Patient having read the information letter and signed the informed consent Exclusion Criteria: - AAA should have no other specific cause than atherosclerosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non surgical aneurysm of abdominal aorta<br>PET-Scan | Other: PET-Scan<br>* PET-Scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between overall baseline 18-FDG uptake intensity of the aneurysm and its 9-month maximal diameter and/or volume in patients with diameter change greater than 4 mm/year | Composite primary outcome. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between initial 18-FDG uptake of individual aneurysmal segments and their 9-month diameter change. |  | 9 months | 
| Contribution of overall 18-FDG uptake to the predictive values of other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values) |  | 9 months | 
| Association between overall 18-FDG uptake and other baseline characteristics of the aneurysm (diameter, volume, thickness and wall stress, clinical and biological values). |  | 9 months | 
| Association between 9-month overall 18-FDG uptake change and variation of plasmatic biomarkers of inflammation, proteolysis and coagulation. |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aneurysm of abdominal aorta, 18F-fluorodesoxyglucose (FDG-F18)
Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake in Boys

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize exercise increases short term appetite and food intake, and interferes with satiety and satiations to a preload in normal weight, boys.

Detailed Description
-----------------
The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was investigated in normal weight (NW), boys were randomized into 4 treatments. Each boy consumed either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or sedentary activity. Subjects exercised at 25% above their ventilation threshold (VeT).

Official Title
-----------------
Effect of Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake After a Glucose Drink in Normal Weight Boys

Conditions
-----------------
Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight

Intervention / Treatment
-----------------
* Other: Dietary Supplement: water with noncalorie sweetener
* Other: Activity: With noncalorie sweetener or glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy boys with no emotional, behavioral or learning problems Exclusion Criteria: Girls

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedentary activity, noncaloric beverage<br> | Other: Dietary Supplement: water with noncalorie sweetener<br> <br> |
| Experimental: Sedentary activity, glucose beverage<br> | Other: Dietary Supplement: water with noncalorie sweetener<br> <br> |
| Experimental: Exercise activity, noncaloric beverage<br> | Other: Activity: With noncalorie sweetener or glucose<br> <br> |
| Experimental: Exercise activity, glucose beverage<br> | Other: Activity: With noncalorie sweetener or glucose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| food intake (kcal) |  | at 30-35 min after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite |  | 0-80 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Girls
Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of HPIPC for the treatment of symptoms of PAD

Official Title
-----------------
A Randomized, Controlled Trial to Evaluate High Pressure Rapid Sequence, Intermittent Pneumatic Compression (HPIPC) for the Treatment of Intermittent Claudication, Pain and Ulcer Healing in Subjects With PAD

Conditions
-----------------
PVD, Arterial Ulcers

Intervention / Treatment
-----------------
* Device: High pressure intermittent pneumatic compression (HPIPC)
* Behavioral: Excercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intermittent claudication >6mo Ischemic ulceration or ulcer of mixed (venous) etiology ABI < 0.7 Ambulatory Able to comply Exclusion Criteria: Gangrene M.I. within 6mo Inability to walk Wound infection Systemic corticosteroids HBO, Apligraf, Dermagraft within 6mo Falsely elevated ankle to brachial index (ABI) Inflammatory condition affecting healing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: HPIPC<br>High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 45 minutes twice daily | Device: High pressure intermittent pneumatic compression (HPIPC)<br>* Apply therapy for 45 minutes twice daily<br>* Other names: Art Assist;|
| Active Comparator: Excercise<br>Walking on a graded treadmill for 45 minutes once daily | Behavioral: Excercise<br>* Treadmill walking 45 minutes once daily<br>* Other names: Walking on a treadmill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Reduction in Wound Surface Area |  | baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Improvement in Peak Walking Time | Percentage Improvement in the amount of time one can walk without pain | 16 weeks | 
| Perceived Improvement in Physical Function After 16 Weeks | Percent improvement in SF-36 Quality of life (QOL) questionnaire score at baseline and at week-16. The higher the score on the SF-36 questionnaire the better the QOL. | 16 weeks | 
| Wound Pain as Determined by a Visual Analog 10 Point Scale (VAS) for Pain. | Percent change (improvement)in mean VAS pain scores at baseline and at 16 weeks | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic ulcers, PAD, Intermittent Claudication Pain
Role of RDW as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient

Study Overview
=================
Brief Summary
-----------------
role of RDW as anon invasive method for predicting liver cell failure & portal hypertension in cirrhotic patient

Detailed Description
-----------------
Red blood cell distribution width (RDW) is a measure of the range of variation of red blood cell (RBC) volume. The RDW-SD (Standard deviation ) is an actual measure of size. Normal reference range of RDW-SD in adult human is 39-46 fL .Liver plays an important role in removing body toxins which affects RBCs ,so liver cirrhosis may affects the RDW. Cirrhosis is a chronic degenerative disease in which irreversible scarring of the liver occurs. It leads to liver failure. Child's score is used as an indicator for liver cell function Portal hypertension is an increase in the blood pressure within the portal venous system .Obstruction to blood flow that occurs in liver due to fibrosis and regenerating nodules reduce flow from the portal veins into the hepatic veins. It also impedes hepatic artery flow from the branches that feed into the sinusoids. This increase in arterial resistance leads to an increase in arterial flow into the portal vein via producing a new anastamosis. The net result of that is an increase in portal vein pressure and dilatation of portal vein. Direct measurement of portal pressure is invasive, inconvenient, and clinically impractical. The Hepatic Venous Pressure Gradient (HVPG) is used to measure portal pressure .Recently, portal vein diameter is used as indicator for portal hypertension .

Official Title
-----------------
Role of Red Cell Distribution Width as Anon Invasive Index for Predicting Liver Cell Failure and Portal Hypertension in Cirrhotic Patient

Conditions
-----------------
Predicting Liver Cell Failure & Portal Hypertension in LC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The study will include a total of 100 patient in Assiut university hospital diagnosed to be cirrhotic by abdominal US. They will be divided into 3 groups according to Child's score (A,B,C) Exclusion Criteria: Evidence of iron deficiency anaemia Patients within one month of hematemesis Thalassaemia

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Role of RDW (red cell distribution width) as a non invasive index for predicting liver cell failure and portal hypertension in cirrhotic patient | To develop a simple predictive method for liver cell failure and portal hypertension in cirrhotic patient using the routine hematological parameters (RDW in complete blood count ) & abdominal US | 3 years |
Effects of Rehabilitation on Muscle Fibre Composition and Capillaries in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
Pulmonary rehabilitation has been established as an evidence-based and recommended therapy in patients with chronic obstructive pulmonary disease (COPD). The aim of our study is to show a potential change in muscle fibre composition and in the amount of capillaries in quadriceps muscle from pre tob post 3-week rehabilitation. Pulmonary rehabilitation includes standardised exercise training, e.g. cycling and strength training for major muscle groups.

Official Title
-----------------
Effects of Pulmonary Rehabilitation on Muscle Fibre Composition and Capillaries in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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

Intervention / Treatment
-----------------
* Other: pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic obstructive pulmonary disease FEV1%pred. < 50% Exclusion Criteria: acute exacerbation exacerbation in the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: pulmonary rehabilitation<br> | Other: pulmonary rehabilitation<br>* 3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the amount of capillaries in muscle fibre type I |  | change from pre (day 1) to post rehabilitation (day 21) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the amount of capillaries in muscle fibre type IIa |  | Change from pre (day 1) to post rehabilitation (day 21) | 
| Change in the cross-sectional area of muscle fibre type I |  | Change from pre (day 1) to post rehabilitation (day 21) | 
| Change in the cross-sectional area of muscle fibre type IIa |  | Change from pre (day 1) to post rehabilitation (day 21) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
muscle fibre, capillary, rehabilitation, exercise training
The Incidence and Risk of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors

Study Overview
=================
Brief Summary
-----------------
Intermittent or continuous proton pump inhibitor (PPI) therapy are recommended for high-risk bleeding ulcers according to the French Society of Gastroenterology. The prevalence of incidence of vein infusion phlebitis after PPI intravenous infusion is high in geriatric acute ward (about 10% of severe vein infusion phlebitis). The primary of objective of the study is to determinate the prevalence of vein infusion phlebitis after PPI intravenous infusion in aging people. The secondary of objective of the study if to determinate the factors of risk of vein infusion phlebitis.

Detailed Description
-----------------
This is a multicenter observational study. 5 centers will participate to the study. Aging patients undergoing PPI intravenous infusion therapy will be proposed to be enrolled in the study. Paramedical observation will be performed during 5 days for each enrolled patients.

Official Title
-----------------
Risk Assessment and Incidence of Vein Infusion Phlebitis After Intravenous Infusion of Proton Pump Inhibitors

Conditions
-----------------
Vein Infusion Phlebitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged > 70 years; Undergo intravenous continuous or intermittent proton pump inhibitor therapy; Patients being informed and not opposed to the study. Exclusion Criteria: Existing vein infusion phlebitis before the PPI infusion by intravenous route; Under guardianship or curators; Covered by french AME health system.

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- | --- |
| Occurence of infusion phlebitis | The Visual Infusion Phlebitis Scale will be used to define. | at day-5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors of risk of vein infusion phlebitis | To determinate risk factors for vein infusion phlebitis. | Throughout of the study, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vein infusion phlebitis, proton pump inhibitor therapy, intravenous infusion, ulcer bleeding, aging
Biologic Glue for First Degree Perineal Tears

Study Overview
=================
Brief Summary
-----------------
The use of octyl-2-cyanoacrylate adhesive glue is not inferior to traditional suturing for first degree perineal tears repair

Detailed Description
-----------------
This is a prospective randomized trial, comparing the use of octyl-2-cyanoacrylate adhesive glue to traditional suturing, for the repair of first degree perineal tears.

Official Title
-----------------
Randomized Control Trial for the Comparison of Biologic Glue Versus Suturing for First Degree Perineal Tears

Conditions
-----------------
Grade 1 Perineal Tears

Intervention / Treatment
-----------------
* Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate
* Procedure: 3. traditional suturing with vicryl rapid 2X0


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women after instrumental or normal vaginal delivery with a diagnosis of first degree perineal tears Exclusion Criteria: excessive bleeding, chronic steroid treatment, immunosuppressive treatment, active infection, allergy to Dermabond or Histoacryl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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>use of octyl-2-cyanoacrylate adhesive glue for perineal tear grade 1 in 80 women | Device: 1. Dermabond Topical Skin Adhesive 2-Octyl Cyanoacrylate<br>* adhesive of perineal tears<br>|
| Active Comparator: 3<br>use of traditional suturing for perineal tear grade 1 in 50 women | Procedure: 3. traditional suturing with vicryl rapid 2X0<br>* suturing of perineal tears grade one with vicryl rapid 2X0<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional and cosmetic evaluation of perineal tear area. |  | At least six weeks after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain at least six weeks after delivery |  | At least six weeks after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adhesive glue, perineal tear, suture