linjc16/ctgov huggingface dataset:
Head Pulse for Ischemic Stroke Detection

Study Overview
=================
Brief Summary
-----------------
Accurate diagnosis of stroke due to large vessel occlusion (LVO) is an essential step in providing acute stroke care to a community. The gold-standard for diagnosis LVO is brain imaging, which is impractical in the pre-hospital setting. A non-invasive method to detect LVO is needed. Using highly sensitive accelerometers, one can measure the HeadPulse- tiny forces exerted on the skull from the cardiac contraction. This study tests the hypothesis that LVO alters the HeadPulse characteristically. Analysis of these data along with the subjects vascular status (LVO vs. non-LVO as measured by CT angiography) will be used to create a model that can predict LVO status in suspect stroke subjects.

Detailed Description
-----------------
Large vessel occlusion (LVO) ischemic stroke is a treatable disease at specialized centers. Clinical outcomes of patients with LVO is time-dependent. To maximize clinical benefit of thrombectomy, stroke systems of care need accurate methods to triage patients with LVO to comprehensive stroke centers or thrombectomy ready centers rather than closer primary stroke centers. EPISODE will evaluate whether measurements of the HeadPulse can predict the presence or absence of LVO based on recordings from a consecutive series of patients undergoing CTA for suspected stroke. Recordings from patients pre- and post-thrombectomy will also be compared to investigate whether a systematic change in cranial forces exists during LVO.

Official Title
-----------------
Measuring Cardiac Head Impulse to Detect Acute Large Vessel Ischemic Stroke

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: Cranial Accelerometry Measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected acute stroke CTA or MRA performed Exclusion Criteria: Any patient in whom obtaining a non-invasive recording is judged by the treating team to interfere with clinical assessment or treatment of the patient.

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 |
| --- | --- |
| Suspected acute stroke<br>Any patient with suspected acute stroke triggering a stroke code and had a brain imaging angiogram | Diagnostic Test: Cranial Accelerometry Measurement<br>* Measuring the HeadPulse using cranial accelerometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cranial accelerometry model | Difference in cranial accelerometry waveform analysis in LVO vs. non-LVO subjects | Through study completion, likely 2 years |
Comparison of the Efficacy and Safety of Two Topical Creams for Pediatric Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.

Official Title
-----------------
A Randomized, Investigator-Blind, Six-Week, Parallel Group, Multicenter Pilot Study to Compare the Safety and Efficacy of EpiCeram Skin Barrier Emulsion and Desonide Cream 0.05% in the Twice Daily Treatment of Pediatric Subjects With Moderate Atopic Dermatitis

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

Intervention / Treatment
-----------------
* Device: EpiCeram Skin Barrier Emulsion
* Drug: Desonide Cream 0.05%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 3 months of age and less than 13 years of age atopic dermatitis of moderate severity Exclusion Criteria: pregnant or lactating treatment of atopic dermatitis with topical product in the 14 days prior to Baseline treatment of atopic dermatitis with systemic product in the 30 days prior to Baseline serious or uncontrolled medical condition active infection significant use of inhaled, intranasal, or intraocular corticosteroid

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 12 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>EpiCeram Skin Barrier Emulsion | Device: EpiCeram Skin Barrier Emulsion<br>* topical cream, twice daily, 6 weeks<br>|
| Active Comparator: 2<br>Desonide Cream 0.05% | Drug: Desonide Cream 0.05%<br>* topical cream, twice daily, 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Three Item Severity Score | The average of the sum of scores for erythema, edema/papulation, and excoriation for two target lesions. Scoring on a scale of 0 to 3 (none to severe). Maximum score is 9. | Baseline to 6 weeks |
DiamondTemp Global Registry

Study Overview
=================
Brief Summary
-----------------
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

Detailed Description
-----------------
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.

Official Title
-----------------
DiamondTemp Global Registry

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Device: DiamondTemp™ Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥ 18 years of age or minimum age as required by local regulations Planned procedure using commercially available DiamondTemp™ Ablation System Willing to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements Exclusion Criteria: Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager Subject with exclusion criteria required by local law

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 |
| --- | --- |
| Treatment Arm<br>Patients enrolled and treated with the DiamondTemp™ Ablation System | Device: DiamondTemp™ Ablation System<br>* A cardiac ablation will be performed using the DiamondTemp™ Ablation System.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Recurrence at 12 Months | Estimate the 12-month freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the DiamondTemp™ Ablation System. | 12 Months | 
| Freedom from Device / Procedure Related Adverse Events | Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months. | 12 Months |
Absolute Myocardial Perfusion Measurement in the Transplanted Heart

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to detect AR and CR in the transplanted heart by quantitative assessment of myocardial blood flow and its constituents by myocardial contrast echocardiography (MCE). Further we investigate the collateral circulation in these patients.

Detailed Description
-----------------
Heart transplantation has become an accepted therapy for end-stage heart failure. Acute allograft rejection (AR) remains a major cause of mortality in heart transplant recipients. Chronic rejection (CR) determines the long-term prognosis after cardiac transplantation and is responsible for more than one third of late deaths. Different non-invasive methods have been evaluated for the detection of AR, but the gold standard remains endomyocardial biopsy (EMB). Very little is known about the impact of CR on the collateral circulation in transplant patients. Since the collateral circulation of the heart is mainly part of the microcirculation, it can be hypothesized that it is less developed than in normal coronary atherosclerosis without microvascular lesions. The quantification of CR with non-invasive techniques has remained difficult. In this context, there is a need for a reliable non-invasive test to avoid regularly invasive evaluation. Based on the above considerations we propose that both AR and CR can be accurately detected and differentiated using non-invasive quantitative myocardial contrast echocardiography (MCE).

Official Title
-----------------
Absolute Myocardial Perfusion Measurement in the Transplanted Heart: a New Method for Accurate Detection of Allograft Rejection. A Pilot Study

Conditions
-----------------
Cardiac Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with heart transplantation, age 18-82 years EMB or EMB and coronary angiography Written informed consent to participate in the study Exclusion Criteria: Known adverse reaction to adenosine or echo contrast (SonoVueâ) Second or third degree AV block, unprotected sick sinus syndrome, atrial fibrillation with uncontrolled ventricular rate Asthma, severe pulmonary arterial hypertension (systolic pulmonary artery pressure >50mmHg assessed by echocardiography) Severe obstructive pulmonary disease

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of GnRH Administration During Luteal Support in Frozen-thawed Transfer Cycles

Study Overview
=================
Brief Summary
-----------------
GnRH administration during the luteal phase was found to significantly increase pregnancy rates in women undergoing fresh-cycle IVF cycles. We aim to investigate the effect of GnRH administration during the luteal phase in women undergoing frozen-thawed IVF cycles.

Conditions
-----------------
Pregnancy Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Frozen-thawed IVF cycles Exclusion Criteria: Hydrosalpings Uterine myomas

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | 1 year |
Feasibility@48: Cross Sectional Study of Intensive Care Unit Mobility Practices Across the United Kingdom

Study Overview
=================
Brief Summary
-----------------
Intensive Care Unit (ICU) patients commonly experience muscle loss at a rate of 2-3% day. Traditionally, critically ill patients have been managed in bed, however current research suggests that prolonged bedrest cause mechanical silencing of the muscles and exacerbates this muscle wasting. This ICU acquired weakness (ICUAW) leads to poor functional outcome and higher mortality. Research suggests that early out-of-bed mobilisation should occur within 48-hours of ICU admission to militate against this risk, however, this is only achieved in 30% of cases. Common barriers to mobilisation are unstable blood pressure, ventilation, sedation and fatigue. It is plausible that 48-hours is an unrealistic timeframe for mobilisation. The aim of this study is to explore the mobility practices on a given day in UK adult ICUs. The objectives are to: Determine the level of mobility that is achieved by each patient on adult ICUs, on a given day in the UK. Determine the typical physiological profile of patients on ICU that are both able and unable to participate in antigravity exercise Determine the proportion of adult ICU admissions that achieve out of bed mobilisation in the first 48-72 hours Explore clinician decision making about mobilisation This is a multi-centre cross-sectional study on one-day only. Over a 24-hour period data will be collected for all ICU patients at the participating centres. The lead physiotherapist will record the highest level of mobility achieved that day, and the physiological parameters from clinical observations. The reasons for the level of mobility achieved will be ranked in order of importance. These data are routinely collected. Data will be anonymised. Data will be analysed to determine feasibility of mobilisation at 48hours and develop a flow diagram of mobilisation decision-making.

Official Title
-----------------
Feasibility@ 48: A Cross Sectional Multi-centre Study of Intensive Care Unit (ICU) Mobility Practices Across the United Kingdom.

Conditions
-----------------
Critical Illness, Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are admitted to a participating ICU on the study day will be included Exclusion Criteria: None

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 |
| --- | --- | --- |
| The proportion of patients achieving a ICU mobility scale more than 3 on the day of the study |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physiotherapy, Rehabilitation, Mobilisation
Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level

Study Overview
=================
Brief Summary
-----------------
The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the cardiac computed tomography angiography (cardiac CTA) may induce a higher level of ROS in the peripheral blood. Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease (CAD). In total, twenty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families after the arrangement of cardiac CTA. It then will be retrieved just before the performance of cardiac CTA. For each enrolled case, peripheral blood will be sampled three times (once before and twice after the performance of cardiac CTA). Totally 60 blood samples will be collected from 20 study subjects within 3 months (January 1   March 31, 2009). ROS level in the collected blood samples will be then measured, compared, and analyzed.

Official Title
-----------------
Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level

Conditions
-----------------
Radiation Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who are arranged for cardiac CTA examination because of suspect coronary artery disease. Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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
-----------------
radiation injury, computed tomography, reactive oxygen species, free radicals
Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Study Overview
=================
Brief Summary
-----------------
Breast lesions are a common condition, diagnosed by imaging and palpation. In order to reduce the number of biopsies performed to the definitive diagnosis of a breast lesion, an imaging method with a high degree of accuracy is needed. Ultrasound imaging with microbubbles contrast media allows the diagnosis of vascularization of the lesion, according to timing. Our hypothesis is that a highly vascularized lesion that enhances in an early timing is most likely to represent a malignant lesion and thus, deserves biopsy for a definitive diagnosis. Females over 18 years age, with a focal lesion in breast will be suitable to perform this examination.

Official Title
-----------------
Breast Lesions Characterization on Contrast Enhanced Ultrasound With Histopathological Correlation

Conditions
-----------------
Malignant Neoplasm, Overlapping Lesion of Breast

Intervention / Treatment
-----------------
* Drug: Sonovue, Bracco


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female with a diagnosed breast focal lesion Exclusion Criteria: Allergic conditions to contrast media, asthma, R-L shunt

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microbubbles contrast media for US<br>Sonovue, Bracco, microbubbles contrast media | Drug: Sonovue, Bracco<br>* Intravenous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor vascularization |  | one year |
Contact Lenses and Myopia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine if multifocal contact lenses affect accommodation and/or binocular vision when worn by pediatric patients. This will be accomplished through subjective and objective accommodative and binocular experiments in children wearing single vision and multifocal soft contact lenses.

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7 to 15 years of age Refractive error between -1.00 and -8.00 D sphere, with less than or equal to 1.00 D astigmatism Corrected visual acuity of 20/25 or better in each eye Exclusion Criteria: Ocular or systemic disease known to affect accommodation or vision Convergence or accommodative disorder, or any strabismus Use of oral or topical medications known to affect accommodation

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 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 |
| --- | --- |
| Multifocal contact lenses<br>Coopervision Proclear Multifocal | Device: Contact lenses<br> <br> |
| Single vision contact lenses<br>Coopervision Proclear Sphere | Device: Contact lenses<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accommodative response | Accommodative response will be measured subjectively and objectively using the push-up technique and photorefraction. | Up to two hours | 
| Binocular posture status | Binocular posture will be measured using Modified Thorington, | Up to two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatrics, Contact lenses