linjc16/ctgov huggingface dataset:
ICI-VPH: Impact of HPV Immunisation Schedules Against HPV

Study Overview
=================
Brief Summary
-----------------
This randomised clinical trial aims to determine whether an immunization schedule comprising two doses of Gardasil administered six months apart is non-inferior to a schedule comprising three doses administered at 0, 6 and 60 months for the prevention of HPV-16 and HPV-18 infections that persist for at least six months, up to ten years after the initial vaccination. The study hypothesis is that the two-dose schedule would offer similar protection as that of a three-dose schedule against persistent HPV-16/18 infections.

Official Title
-----------------
ICI-VPH: Impact Des Calendriers d'Immunisation Contre Les HPV

Conditions
-----------------
Human Papillomavirus Infections

Intervention / Treatment
-----------------
* Biological: Quadrivalent HPV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having received two doses of Gardasil in 2008-2009, 2009-2010,2010-2011 or 2011-2012 according to 0, 6 months Schedule (between 4 and 12 months) Resident of the regions chosen for the study Exclusion Criteria: Being considered immunosuppressed at time of vaccination (9-10 years-old) or at recruitment visit Being pregnant at recruitment visit

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 16 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2 dose of quadrivalent HPV vaccine<br>The participants who have already received 2 doses of the quadrivalent HPV vaccine (0, 6 months schedule) 5 years before recruitment will not receive an additional dose. | |
| Experimental: 3 doses of quadrivalent HPV vaccine<br>The participants will receive a 3rd dose of quadrivalent HPV vaccine at recruitment visit, which is 5 years after having received two doses of vaccine given 6 months apart in grade 4 (0, 6, 60 months Schedule) | Biological: Quadrivalent HPV vaccine<br>* One dose of Gardasil administered in the intervention group<br>* Other names: Gardasil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of persistent HPV-16/18 infections |  | 5 years after recruitment visite | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titres of antibodies and seropositivity for HPV types 6, 11, 16 and 18 |  | 5 years after recruitment visit |
Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus

Official Title
-----------------
Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus, Carotid Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Cilostazol
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 30 and 80 years Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%) Carotid plaque on 3D ultrasound Exclusion Criteria: Acute bleeding or bleeding tendency Diagnosed with heart failure Suggestive of ischemia on ECG Uncontrolled hypertension Recently diagnosed with peptic ulcer disease Taking other antiplatelet agents Hypersensitivity to salicylic acid Aspirin induced asthma Severe kidney, liver, heart disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cilostazol group<br>Cilostazol 200 mg or maximal tolerate dose | Drug: Cilostazol<br>* Cilostazol 200 mg/day<br>|
| Active Comparator: Aspirin group<br>Aspirin 100 mg | Drug: Aspirin<br>* Aspirin 100 mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of carotid artery atherosclerosis | Plaque composition | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of carotid artery atherosclerosis 1 | Changes in carotid intima-media thickness after treatment | 6 months | 
| Change of carotid artery atherosclerosis 2 | Changes in carotid artery stenosis after treatment | 6 months | 
| Change of carotid artery atherosclerosis 3 | Plaque volume in carotid artery | 6 months |
Atazanavir for HIV Infected Individuals: An Early Access Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to provide atazanavir to patients infected with human immunodeficiency virus (HIV) whose antiviral medications are no longer working to control HIV activity within the body and who are unable to create a new treatment regimen using other available anti-HIV drugs, because of either side effects or treatment failure previously taken. The safety of this treatment will also be studied.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Atazanavir (BMS-232632)


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria: Patients eligible for inclusion into the EAP are those that are a virologic failure due to resistance, intolerance and/or adherence problems with current anti-HIV medications; OR have multiple toxicities or intolerance to their anti-HIV medication but are not a virologic failure; OR have severe elevated lipids in the blood (e.g., cholesterol, triglycerides) that do not respond to lipid-lowering medication. Key exclusion Criteria: Restrictions apply regarding the use of atazanavir with specific medications which may have a potential to cause possible side effects when taken together. Patients will also be excluded for any of the following reasons: 1) pregnancy or breast feeding, 2) elevated liver enzymes, 3) significant cardiovascular disease, or 4) other restrictions as indicated in the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atazanavir (BMS-232632)|nan|

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
-----------------
treatment experienced
Diagnosis and Natural History Study of Patients With Neurological Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve understanding of neurological conditions. Patients participating in this study will continue receiving medical care, routine laboratory tests, and diagnostics tests (X-rays, CT-scans, and nuclear imaging), from their primary care physician. Doctors at the NIH plan to follow these patients and offer advice and assistance to their primary care physicians.

Detailed Description
-----------------
The objective of this protocol is to provide diagnosis and follow Experimental Therapeutics Branch (ETB) patients not currently entered on another research protocol. No investigational treatments will be administered on this protocol, and the NIH physicians will be playing largely a consultative role to the patient's primary physician.

Official Title
-----------------
Diagnosis and Natural History Protocol for Patients With Neurological Conditions

Conditions
-----------------
Alzheimer's Disease, Dementia, Movement Disorder, Multiple System Atrophy, Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients may be included on this protocol if they have an identifiable neurological disorder or represent a diagnostic puzzle. These disorders would include patients with Parkinson's disease, Alzheimer's disease, multiple system atrophy, progressive supranuclear palsy, restless legs syndrome, other cognitive and movement disorders, and diagnostic puzzles. Patients 18-90 years of age, inclusive, are eligible.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's, Movement Disorders, Alzheimer's, Screening, Diagnostic Puzzles, Alzheimer Disease, Progressive Supranuclear Palsy, PSP, Restless Leg Syndrome, RLS, Parkinsonism, PD
Measurements Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Compared To Standard Dose Protocol

Study Overview
=================
Brief Summary
-----------------
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol

Detailed Description
-----------------
Evaluation of accuracy and reliability of 2D and 3D measurements of the spine and lower limbs in adults based on biplanar radiographs with MicroDose protocol compared to a standard dose protocol Part 1: retrospective evaluation of 50 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 2: prospective evaluation of 100 patients: lower limb images with MicroDose protocol and lower limb images with standard dose protocol Part 3: prospective evaluation of 150 patients: spine images with MicroDose protocol and spine limb images with standard dose protocol

Official Title
-----------------
Two-dimensional And Three-dimensional Measurements Of Torsion And Length Of Lower Limbs And Spine Based On Biplanar Radiographs: Microdose Imaging Protocol Compared To Standard Dose Imaging Protocol

Conditions
-----------------
Underdevelopment; Congenital Malformation, Lower Limb, Scoliosis

Intervention / Treatment
-----------------
* Radiation: Biplanar x-ray images


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion: All patients referred for biplanar radiographs of spine and lower limb (from 18 to 99 years of age) Exclusion Criteria: Exclusion criteria: no informed 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 |
| --- | --- |
| Limb Torsion<br>adult patients, lower limb assessment retrospectively limb length and limb axis, torsion biplanar x-ray images | Radiation: Biplanar x-ray images<br>* biplanar x-ray images with microdose and low-dose protocol<br>|
| Limb Length and Axis<br>adult patients, lower limb assessment prospectively limb length and limb axis biplanar x-ray images | Radiation: Biplanar x-ray images<br>* biplanar x-ray images with microdose and low-dose protocol<br>|
| Spine<br>adult patients, spine assessment prospectively Cobb angles, plumbline biplanar x-ray images | Radiation: Biplanar x-ray images<br>* biplanar x-ray images with microdose and low-dose protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D- and 3D- measurements (torsion angles, scoliotic and kyphotic angles, length etc.) on biplanar radiographs with and without MicroDose-protocol and comparison of image quality parameters |  | 12 month |
Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging.

Detailed Description
-----------------
Cardiac magnetic resonance (CMR) imaging is a wide available technique for the diagnosis of myocardial ischemia. However, myocardial first-pass perfusion evaluation has been limited due to the moderate accuracy of the currently available qualitative and semiquantitative methods used to assess myocardial perfusion, and due to the lack of efficient absolute quantitative methods. Some CMR techniques and post-processing mathematical models have been developed for quantitative measurement of myocardial blood flow reserve with perfusion CMR under pharmacological stress. Measurement of these parameters with CMR have been shown to increase the accuracy of CMR in diagnosing myocardial ischemia, but most of these methods present technical challenges and have unreasonably time consuming post-processing. The aim of this study is to validate a full automated post-processing software for first pass perfusion CMR images that results in automated generated quantitative perfusion color maps.

Official Title
-----------------
Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance

Conditions
-----------------
Myocardial Ischemia

Intervention / Treatment
-----------------
* Other: myocardial perfusion with magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals with normal 12-lead electrocardiogram at rest. Exclusion Criteria: systolic blood pressure below 90 mmHg; bradycardia (< 45 heart beats/minute); intake of caffeine or caffeine-containing drink/medicine 24 hours prior to the examination; impaired renal function assessed by venous blood sample.

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 |
| --- | --- |
| Healthy volunteers<br>Healthy subjects with normal 12-lead electrocardiogram at rest. | Other: myocardial perfusion with magnetic resonance imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of global myocardial first pass perfusion in mL/min/g measured in automatic post-processed color maps compared with myocardial blood volume measured in the coronary sinus (mL/min) divided by the total left ventricle mass (g) |  | Through study completion, an average of 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial ischemia, magnetic resonance imaging, perfusion, software
Rasch-analysis of Clinical Severity in FSHD

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to make a standardized and scalable Rasch-built clinical severity scale to help in finding genetic and environmental modifiers of disease in Facioscapulohumeral muscular dystrophy (FSHD).

Official Title
-----------------
Rasch-analysis of Clinical Severity in FSHD

Conditions
-----------------
Facioscapulohumeral Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Genetic confirmation of FSHD (either FSHD-1 or FSHD-2) Exclusion Criteria: Do not understand English Unable to provide informed consent

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 |
| --- | --- |
| FSHD<br>Participants with FSHD-1 or FSHD-2. No intervention is given to participants. Participants will undergo series of tests and procedures in order to make a standardized and scalable Rasch-built clinical severity scale. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSHD Clinical Severity Scale | Measure severity of FSHD. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brooks scale | Measures upper extremity function.Scores on the scale range from 1-6. A score of 1 means the person can elevate their arms above their head while arms remain straight. 6 means the person cannot elevate their arms to their mouth and do not have useful function of their hands. | 1 day | 
| Vignos scale | Measures lower extremity function. Scores on the scale range from 1-10. A score of 1 means the person can walk and climb stairs without assistance. A score of 10 means the person is bedridden. | 1 day | 
| Iowa Oral Performance Instrument (IOPI) | IOPI measures lip and tongue strength by measuring the amount of pressure a person can exert on the tool. | 1 day | 
| Manual muscle testing | Measure person's range of motion. Scored on a scale with range of 0-5. Score of 0 means no movement. Score of 5 means the person has a full range of movement. | 1 day | 
| Quantitative strength testing |  | 1 day | 
| Functional testing |  | 1 day | 
| Reparatory function testing |  | 1 day | 
| Patient-reported outcome |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FSHD, muscular dystrophy
Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy

Study Overview
=================
Brief Summary
-----------------
In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .

Detailed Description
-----------------
Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till the end of surgery .

Official Title
-----------------
The Effect of Levosimendan Versus Its Combination to Magnesium Sulphate on Spinal Cord Protection Guided by NIRS in Infants Undergoing Coarctectomy: A Randomized Controlled Study.

Conditions
-----------------
Aortic Coarctation

Intervention / Treatment
-----------------
* Drug: Saline Solution
* Drug: Levosimendan
* Drug: Magnesium Sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction Exclusion Criteria: Parents or guardian refusal. Age more than12 months. Significant left ventricular dysfunction Patient with Heart block Patient with pre-existing CNS disorder eg seizure Patient with renal or hepatic dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>Control group will received saline | Drug: Saline Solution<br>* Placebo<br>* Other names: Nacl 0.9 %;|
| Active Comparator: Group L<br>Levosimendan group will received levosimendan infusion | Drug: Levosimendan<br>* Levosimendan<br>|
| Active Comparator: Group M<br>Levosimendan and Magnesium sulphate group will received both drugs | Drug: Levosimendan<br>* Levosimendan<br>Drug: Magnesium Sulfate<br>* Magnesium Sulfate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Infrared Spectroscopy value | After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate. | Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta) |
An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)

Study Overview
=================
Brief Summary
-----------------
This protocol involves a qualitative study of the needs/preferences of people with diabetes and health coaches regarding a telehealth coaching platform for glycemic control in people with diabetes.

Official Title
-----------------
An Artificial Intelligence Assisted Telehealth Intervention to Promote Self-Management in Patients With Type 2 Diabetes Mellitus (Qualitative Interview)

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Semi-structured Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health Coaches Group: (i) age between 18 and 80 years (ii) fluent in English (iii) work in or carry expertise in physical activity, nutrition/diet or health behavior. People with Diabetes Group (Patient/Caregiver Dyads): (i) age between 18 and 80 years (ii) fluent in English (iii) have Type-II diabetes. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Interview with People with Diabetes<br>One-on-One interview with people with diabetes | Behavioral: Semi-structured Interview<br>* One-on-one semi-structured interviews<br>|
| Interview with Health Coaches<br>One-on-One interview with health coaches | Behavioral: Semi-structured Interview<br>* One-on-one semi-structured interviews<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Users' Expectation from a Health Coaching System | This interview with participants help produce knowledge on the users' expectations from a health coaching system | 60 minutes |