linjc16/ctgov huggingface dataset:
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the radiographic outcomes of Total Ankle Arthroplasty in patients having a calcaneal stem.

Detailed Description
-----------------
The primary objective of this study is to determine the radiographic outcomes of patients who have received TAA with the calcaneal stem. Due to the fixation of the stem in the calcaneus, talar component position, osteolysis and bone quality are of interest to the FDA. Specifically, subsidence and/or migration of the talar component, osteolysis as a measure of wear, and bone quality of the talus, cuboid and navicular are to be evaluated in this study. Therefore, the radiographic outcomes of this study aim to assess these parameters

Official Title
-----------------
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation

Conditions
-----------------
Arthrodesis, Degenerative Arthritis, Rheumatoid Arthritis, Complications; Arthroplasty, Mechanical

Intervention / Treatment
-----------------
* Device: Radiographic evaluation of previously implanted patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites. Exclusion Criteria: Patients who will be recruited for participation in this study received the TAA with calcaneal stem between December 6, 2005 and November 13, 2007 at approximately 28 sites.

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 |
| --- | --- |
| Total Ankle Arthroplasty with calcaneal stem<br>Patients received the TAA with calcaneal stem between 12/6/05 & 11/13/07 at approximately 28 sites. | Device: Radiographic evaluation of previously implanted patients<br>* Radiographs of the ankle<br>* Other names: Radiographs of previously implanted patients;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Evaluation | Bone quality of the talus, navicular, and cuboid will be assessed on both the lateral and mortise views of the latest follow-up radiographs | Post operarative 1.2 -3.1 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Ankle Arthroplasty
Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome

Study Overview
=================
Brief Summary
-----------------
This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.

Official Title
-----------------
Follow up Protocol to the Open Label Phase I/II Study OPN-305-106: A Prospective, Open Label Phase I/II Study to Assess the Safety and Efficacy of Cycles of Intravenously Infused Doses of OPN-305 in Second-line and Third-line Lower (Low and Intermediate-1) Risk Myelodysplastic Syndrome (MDS)

Conditions
-----------------
Myelodysplastic Syndrome

Intervention / Treatment
-----------------
* Drug: OPN-305


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of the OPN-305-106 study Principal Investigator adjudicated efficacy response defined as either transfusion independence, stable disease, minor HI-E response or major HI-E response and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine. Provide written informed consent for the follow up protocol. Exclusion Criteria: Refusal to provide written informed consent Withdrawal from the OPN-305-106 study prior to the final EOT visit Plan to be included into another interventional investigational study. Progression of disease

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: OPN-305<br> | Drug: OPN-305<br>* Patients will receive study drug every 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and types of Serious Adverse events |  | monthly through study completion, an average of 18 months | 
| monitor ongoing efficacy responses | To monitor ongoing efficacy responses defined as transfusion independence. Transfusion independence is defined as 56 consecutive days where no RBC transfusions are given | monthly through study completion, an average of 18 months |
Role of Point of Care Ultrasound in Endotracheal Tube Placement

Study Overview
=================
Brief Summary
-----------------
Role of point of care ultrasound in endotracheal tube placement in children

Detailed Description
-----------------
Role of point of care ultrasound in confirmation of endotracheal tube placement in children

Official Title
-----------------
Role of Point of Care Ultrasound in Confirmation of Endotracheal Tube Placement in Children

Conditions
-----------------
Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Intervention / Treatment
-----------------
* Device: Point of care Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children below 18 years needing endotracheal intubation. Exclusion Criteria: Age more than 18 years. Patients with significant neck or lung pathology. Patients with elective intubation

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point of care Ultrasound<br>Point of care Ultrasound for placement of endotracheal tube | Device: Point of care Ultrasound<br>* Point of care Ultrasound<br>* Other names: POC Ultrasound;|
| No Intervention: Traditional<br>Traditional method of insertion of endotracheal tube | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with correct placement of endotracheal tube | The number of patients with correct placement of endotracheal tube | 6 months |
Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain

Study Overview
=================
Brief Summary
-----------------
According to the WHO, therapeutic education is intended to help patients acquire or maintain the skills they need to optimally manage living with a chronic disease. Low back pain is frequent and therapeutic education could be a promising option. The purpose of the study is to evaluate the impact of a therapeutic education program for patients suffering from low back pain.

Official Title
-----------------
Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Usual practice
* Other: Education program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain Treatment with transcutaneous electrical nerve stimulation (TENS) Exclusion Criteria: Contra-indication of TENS Patients with mental disorders Lack of autonomy or patients living alone at home without help Concomitant inclusion in another research on the treatment of pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>The control group will follow usual practice. | Other: Usual practice<br> <br> |
| Experimental: Education program<br>The Education program group benefit in addition of a therapeutic education program including nursing follow-up at 1, 3 and 6 months. | Other: Usual practice<br> <br> Other: Education program<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | EIFEL functional disability scale (Gagnon et al, Annals Phys Med Rehab, 2009, 1, 3-16). | 6 months | 
| Quality of life | DRAD questionnaire (Lawlis et al, Spine 1989;14:511-6.) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Numerical scale | 6 months | 
| Neuropathic pain | DN4 questionnaire | 6 months | 
| Social impact | Changes in the employment status | 6 months | 
| Evaluation of the program | Self-administered questionnaire | 6 months |
Antiphospholipid Antibodies and Early Severe Preeclampsia.

Study Overview
=================
Brief Summary
-----------------
The Antiphospholipid Syndrome is an immune disease where the presence of antibodies directed against cell membrane phospholipids (antiphospholipid antibodies) can cause an hypercoagulable state that causes thrombosis and obstetric complications (miscarriages, stillbirths). Since 1999 the Sapporo Criteria for Antiphospholipid Syndrome diagnosis includes the development of severe preeclampsia before 34 weeks of gestation, but this was done without solid evidence of a relation between the two. Our study will try to add information to this particular point.

Official Title
-----------------
Antiphospholipid Antibodies and Early Severe Preeclampsia (< 34 Weeks of Gestation). A Case-Control Study.

Conditions
-----------------
Severe Preeclampsia, Antiphospholipid Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age between 24-34 weeks Diagnosis of severe preeclampsia Exclusion Criteria: Known antiphospholipid syndrome. Known presence of antiphospholipid antibodies. Patients with systemic lupus erythematosus.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases-Early Severe Preeclampsia<br>Patients with severe preeclampsia before 34 weeks of gestation | |
| Controls<br>Patients with normal pregnancies at term. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lupus anticoagulant | Number of cases positive for Lupus Anticoagulant. | 15 months | 
| Anticardiolipin antibodies | Number of cases with high/medium levels of IgG/IgM of anticardiolipin antibodies. | 15 months | 
| B2 Glycoprotein I | Number of cases with levels of B2 Glycoprotein 1 > 99% | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibodies, anticardiolipin, Antibodies, B2 Glycoprotein I, Lupus Anticoagulant, Severe Preeclampsia
IBD-OPERA Database, UC Protocol

Study Overview
=================
Brief Summary
-----------------
The investigators believe that patients with ulcerative colitis are able to report details of their own medical history accurately and record changes in clinical status effectively over time. Using an internet-based database the investigators will ask patients to report their own disease history, and the investigators will compare their reports to the medical record.

Official Title
-----------------
IBD-OPERA Database: Inflammatory Bowel Disease - Outcomes, Preferences, Education, Resource Utilization, Assessment Database

Conditions
-----------------
Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MD documented diagnosis of ulcerative colitis current of past prescription for anti-TNF medication at least 18 years of age access to medical records to verify information 20% of participants will be patients diagnosed within 1 year of inclusion Exclusion Criteria: unwilling or unable to provide informed consent for study participation unable to access or use internet less than 18 years of age diagnosis of crohn's disease or IBD-U illiterate or does not possess minimum level of literacy required to complete questionnaire

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 |
| --- | --- |
| Cohort 1<br>First 50 patients | |
| Cohort 2<br>2nd group of 50 patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of patient self reporting | The validity of patient self report on details of their ulcerative colitis compared to chart review. Validity is defined as a match between patient self report and medical records. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative colitis
Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.

Official Title
-----------------
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following Cataract Surgery

Conditions
-----------------
Postoperative Complications, Cataract

Intervention / Treatment
-----------------
* Drug: Bromfenac
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract surgery Summed ocular inflammation score (anterior chamber cell score plus flare score) of >/= 3, 24 hours after the cataract extraction Agreed to avoid disallowed medications (meds) throughout the duration of the study Exclusion Criteria: Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye) Extraocular/intraocular inflammation in either eye Clinically significant (WHO CTC Grade 1 or greater) liver function tests

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromfenac<br>Topical bromfenac ophthalmic solution 0.1% | Drug: Bromfenac<br>* One drop in study eye every 12 hours for 14 days<br>|
| Placebo Comparator: Placebo<br>Vehicle of bromfenac | Drug: Placebo<br>* One drop in study eye every 12 hours for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Inflammation Score | Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none | Visit 4 (Day 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ocular Inflammation Score | Mean change from baseline in SOIS at each visit. | At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract Extraction, Anti-Inflammatory Agents, Non-Steroidal
A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic

Study Overview
=================
Brief Summary
-----------------
Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The new treatment intervention is based on the DIR Model. Parents will be coached at the start and then every 3-4 months for 1 year. Outcome will be measured at the first session and at the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating Scales, Functional Emotional Level, and parent satisfaction rating. Hypothesis of the study: Children who get additional treatment of DIR/floortime show much improvement in climbing the developmental ladder and declining in the autistic behaviors.

Official Title
-----------------
A One-year Prospective Follow-up Study of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders

Conditions
-----------------
Autism Spectrum Disorders

Intervention / Treatment
-----------------
* Behavioral: DIR/Floortime parent intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical criteria for Autistic Disorders according to DSM IV child is 2 - 6 years of age Exclusion Criteria: children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures) children who are geographically inaccessible for follow-up visits their parents are not literate or known chronic psychiatric or physical illness in the parents

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

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: DIR/Floortime parent intervention<br> | Behavioral: DIR/Floortime parent intervention<br>* Parent will be trained to observe their autistic child's cues, follow their child's lead and techniques to enhance his/her development.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Functional Emotional Assessment Scale (FEAS) Ratings (the child part) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Childhood Autism Rating Scale (CARS) Clinical rating of the children (6 point scale related to Greenspan's six Functional Development Level -FDL) Satisfaction of the effectiveness of the intervention of their child (Six-point Likert scale) |  | 1 year |
Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
Up to half of all patients with heart failure are found to have normal pumping function of the heart muscle, but show abnormalities in the way the heart muscle relaxes and fills with blood. These patients often have high blood pressure, and tend to have stiff arteries and stiff heart muscle. We wish to test the hypothesis that these patients have abnormal energy stores in their heart muscle.

Official Title
-----------------
Energetic Abnormalities in Heart Failure With Preserved Ejection Fraction

Conditions
-----------------
Heart Failure, Diastolic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical features consistent with heart failure LVEF ≥ 50%, with no evidence of significant valvular disease, no hypertrophic cardiomyopathy, and no evidence of pericardial constriction A peak VO2 < 80% predicted, with a pattern of gas exchange on metabolic exercise testing indicating a cardiac cause for limitation Exclusion Criteria: Objective evidence of lung disease on formal lung function testing Reversible myocardial ischaemia on contrast-enhanced myocardial stress Echocardiography, and evidence of exercise-induced mitral regurgitation Obesity (BMI >35) or a locomotor cause for exercise limitation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 |
| --- | --- |
| HfpEF<br>Patients with Heart Failure with preserved ejection fraction | |
| Control<br>Healthy Volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete echocardiographic assessment to assess resting diastolic function |  | 1 DAY | 
| Assessment of resting large artery function |  | 1 DAY | 
| Multiple Gated Acquisition Scan |  | 1 DAY | 
| Cardiac Magnetic Resonance Spectroscopy |  | 1 DAY | 
| Metabolic Exercise Testing (VO2max) |  | 1 DAY | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Energetics, Dynamic Diastolic filling Assessment, Heart Failure with Preserved Ejection Fraction, Arterial and Ventricular Stiffening