linjc16/ctgov huggingface dataset:
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits the T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety of pimecrolimus Cream 1% with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

Official Title
-----------------
Pimecrolimus Cream 1% Plus Topical Corticosteroid in Patients (2-17 Years of Age) With Severe Atopic Dermatitis

Conditions
-----------------
Dermatitis, Atopic

Intervention / Treatment
-----------------
* Drug: Pimecrolimus plus topical corticosteroid (TCS)
* Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe atopic dermatitis 5% of total body surface area (TBSA) affected Exclusion Criteria: Concurrent skin diseases (infections) Immunocompromised Recently received phototherapy or systemic therapy

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 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: 1<br>Pimecrolimus 1 % cream plus topical corticosteroid (TCS) | Drug: Pimecrolimus plus topical corticosteroid (TCS)<br>* Pimecrolimus 1 % cream plus topical corticosteroid (TCS) twice daily<br>* Other names: Elidel;|
| Placebo Comparator: 2<br>Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS) | Drug: Pimecrolimus vehicle (Placebo) plus topical corticosteroid (TCS)<br>* twice daily administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events of clinical interest (e.g. skin infections, skin irritation) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all other adverse events |  |  | 
| Time to relapse of atopic dermatitis |  |  | 
| Time to treatment success according to the Investigators Global Assessment (IGA - a measure of disease severity) |  |  | 
| Efficacy measured by IGA (treatment success and improvement) |  |  | 
| Efficacy measured by improvement in Eczema Area and Severity Index (EASI - a measure of disease severity and extent |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic dermatitis, T-cell, pimecrolimus, children, topical corticosteroids
Aquatic Verses Land Exercise to Decrease Fall Risk

Study Overview
=================
Brief Summary
-----------------
Compare the effect of aquatic,land and no exercise on fall risk factors in women diagnosed with osteoporosis

Detailed Description
-----------------
Background and Purpose: Fall prevention through exercise is an ongoing goal of researchers and clinicians. This study compared the effects of aquatic exercise (AE), land exercise (LE) and no exercise (NE) on fall risk factors. Subjects: Seventy-three women, 60 or older, with osteoporosis (OP). Method: Randomized clinical trial comparing balance, posture, strength, mobility, function, falls, and quality of life. Results: Significant differences (p<0.05) were found for participants' ratings of global change (AE and LE > NE), tandem balance (AE > LE) and function (LE > AE). Joint pain and falls occurred more often during LE. Discussion and Conclusion: Participants experienced significant global improvement with both AE and LE. Less joint pain, reduced falls and improved balance were found in AE, however LE was more effective in improving functional ability at home. Clinicians should consider the individual's specific impairments and risk factors when recommending exercise programs on land or in water.

Official Title
-----------------
The Effect of Water Verses Land Exercise to Decrease Fall Risk in Older Women With Osteoporosis

Conditions
-----------------
Osteoporosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 60 or older diagnosed with osteoporosis female Exclusion Criteria: has not been involved in regular exercise in past 2 months does not have any medical or neurological condition that would significantly limit activities of daily living, such that involvement in an exercise program would jeopardize safety

Ages Eligible for Study
-----------------
Minimum 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength |  |  | 
| balance |  |  | 
| mobility |  |  | 
| function |  |  | 
| quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
accidental falls, osteoporosis, risk factors
Effects of Imatinib Mesylate in Polycythemia Vera

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera. The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.

Detailed Description
-----------------
Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Official Title
-----------------
Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

Conditions
-----------------
Polycythemia Vera

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea Age >18 years Signed written informed consent form Exclusion Criteria: Pregnancy or breast-feeding Creatinine >3 max NV Bilirubin >3 max NV AST/ALT >3 max NV Concomitant and severe psychiatric disorder Concomitant neoplastic 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: Imatinib Mesylate<br>400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness) | Drug: Imatinib Mesylate<br>* 400 mg/die for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Haematocrit to less than 45%. |  | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response duration |  | 6-12 months | 
| Safety profile |  | 6-12 months | 
| Reduction in platelet count and spleen size |  | 6-12 months | 
| Reduction of incidence phlebotomies. |  | 6-12 months | 
| Symptoms improvement in patients. |  | 6-12 months |
Transient Infrared Imaging for Early Detection of Skin Cancer

Study Overview
=================
Brief Summary
-----------------
The hypothesis or study goal is to determine whether functional dynamic infrared imaging can be used for melanoma and other skin cancer screening and/or diagnosis.

Official Title
-----------------
Transient Infrared Imaging for Early Detection of Skin Cancer

Conditions
-----------------
Skin Cancer

Intervention / Treatment
-----------------
* Device: Infrared Imaging Device- ALIAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All lesion in easily accessible places Lesion less than 3.5 cm Exclusion Criteria: Any minors Lesion close to vital organs

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Infrared Imaging Device- ALIAS|Infrared Camera|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To detect skin cancers with >90% sensitivity and >50% specificity using infrared imaging | We are developing a screening algorithm than can compute data from infrared pictures and give us a threshold below which all the cases are benign and above which is malignant. Our primary outcome is to detect all the malignant cases with more than 90% sensitivity and all the benign cases with more than 50% specificity, | 5 years |
Epidural Contrast Flow Patterns of TESI Using the Inferior-Anterior Position as the Final Needle Tip Position.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the contrast flow patterns in the epidural space using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how well this approach correlates with appropriate contrast flow patterns and with analgesia at follow up. This knowledge may prove useful in guiding physician practice patterns in the non-surgical management of low back pain. Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior) epidural contrast spread based on inferior-anterior needle-tip position, particularly with appropriate needle tip position.

Official Title
-----------------
Epidural Contrast Flow Patterns of Transforaminal Epidural Steroid Injections Using the Inferior-Anterior Position as the Final Needle Tip Position.

Conditions
-----------------
Lumbosacral Radiculopathy, Lumbar Herniated Nucleus Pulposus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older History of lumbosacral radiculopathy or lumbar herniated nucleus pulposus Scheduled for TFESI at GW Spine and Pain Center Exclusion Criteria: Pregnant or plan on becoming pregnant Have undergone TFESI in the past year Opioid habituation Lumbo-sacral stenosis Lumbar surgery Lumbar spondylolisthesis

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 |
| --- | --- |
| Transforaminal Epidural Steroid Injection<br>Patients with a history of lumbosacral radiculopathy or lumbar herniated nucleus pulposus, scheduled for Transforaminal Epidural Steroid Injection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast flow patterns | Contrast flow patterns will be used as the primary outcome measure. The statistical test to be employed is to compare the proportions of patients in the study who experienced posterior flow, anterior flow and if that anterior flow had spread to more than 1 vertebral level in either direction, what that direction was, and the presence or absence of vascular flow. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score | VAS Pain Score - The statistical test to be employed is Wilcoxon Signed Rank Test to compare if there is a difference in pain score at appointments 1 months and 3 months post-injection relative to pre-injection. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transforaminal Epidural Steroid Injections
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

Study Overview
=================
Brief Summary
-----------------
In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.

Detailed Description
-----------------
All not-well controlled asthma patients would include the study. We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses We will evaluate the efficacy/safety for these not-well controlled patients.

Official Title
-----------------
Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Seretide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asthma not well control Exclusion Criteria: COPD

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Symbicort<br>We will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period. Intervention drug: Seretide fixed doses therapy | Drug: Seretide<br>* Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety<br>* Other names: Symbicort compared with Seretide;|
| Experimental: Seretide<br>In non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year | Drug: Seretide<br>* Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety<br>* Other names: Symbicort compared with Seretide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage of asthma total and well control | F/U clinical asthma control status and percentage of Acute exacerbation | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of asthma acute exacerbation |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SMART, asthma, fixed dose
Common Sensing and Right Ventricular Automatic Capture (COGNATE)

Study Overview
=================
Brief Summary
-----------------
This study will collect data on features for future pacemakers via an external non-implantable system.

Detailed Description
-----------------
COGNATE is an acute, confirmatory prospective, multi-center study designed to gather data on Brady and CRT-P indicated patients, with no restrictions on the type/brand of leads. This study will enroll up to 80 patients in up to 12 centers. Total duration of the study is expected to be 9 months.

Official Title
-----------------
Common Sensing and Right Ventricular Automatic Capture

Conditions
-----------------
Bradycardia, Chronotropic Incompetence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled to receive either Pacemaker (dual chamber) or CRT-P devices based on physician discretion Patients who are willing and capable of participating in all testing associated with this Clinical Investigation Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Patient enrolled in any concurrent study, without Boston Scientific CRM written approval, that may confound the results of this study Patients with a prosthetic mechanical tricuspid heart valve Women who are pregnant

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bradycardia, pacemaker
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

Study Overview
=================
Brief Summary
-----------------
QuickOptTM optimization method provides a quicker, simpler and reliable alternative to standard echocardiography methods for optimization of sensed AV, paced AV and V-V delays in patients with CRT-P devices

Official Title
-----------------
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: QuickOpt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system Patient is able to provide written informed consent for study participation Exclusion Criteria: Patient has limited intrinsic atrial activity (≤ 40 bpm) Patient has persistent or permanent AF Patient has a 2o or 3o heart block Patient is unable to provide analyzable echocardiogram images Patient's life expectancy is <12 months Patient is <18 years old Patient is pregnant Patient is on IV inotropic agents

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: QuickOpt<br>QuickOpt is an optimization algorithm to program the AV, PV and VV delays | Device: QuickOpt<br>* The QuickOpt algorithm will suggest values for programming AV, PV and VV delay.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the aortic velocity time integral value derived by the QuickOptTM optimization method with that derived by the standard echocardiography optimization methods |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for each optimization method considered in this study |  | 1 day | 
| Effects of any spontaneous cardiac events during the QuickOpt optimization process and these events are not limited to premature ventricular complex (PVC), pacemaker-mediated tachycardia (PMT), atrial fibrillation (AF) and far-field R-wave oversensing |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT, heart failure, optimization, Timing cycle optimization methods
The Radiation Oncology Registry and Biosample Repository

Study Overview
=================
Brief Summary
-----------------
The goal of this study is two-fold: to establish a tissue banking respository (defined as blood, urine, soft tissue, tumor specimen, and normal tissue from areas surrounding tumor specimens), and to prospectively assess health related quality of life (QOL) over time in patients with a pathologically confirmed diagnosis of neoplasia receiving radiotherapy or photodynamic therapy (PDT)

Official Title
-----------------
Registry and Biosample Repository

Conditions
-----------------
Patients With Pathologically Confirmed Neoplasia That Have Been, Selected for Definitive Photodynamic Therapy, Proton, or Photon Radiation Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone age 18 and above with a cancer diagnosis Able to sign consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- | --- |
| Health Assessments |  | 10 years |