linjc16/ctgov huggingface dataset:
Clinically Indicated Magnetic Resonance Imaging in Patients With Cardiac Devices

Study Overview
=================
Brief Summary
-----------------
Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.

Detailed Description
-----------------
This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.

Official Title
-----------------
Clinically Indicated Magnetic Resonance Imaging of Patients With Permanent Pacemakers (PPM) and Implantable Defibrillators (ICD)

Conditions
-----------------
Arrhythmias, Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an emergent or absolute need for MR imaging and PPM or certain ICD's Exclusion Criteria: Pacemaker dependent patients with ICD's Patients with other contraindication to MRI

Ages Eligible for Study
-----------------
Minimum Age: 9 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 |
| --- | --- |
| MRI and Cardiac Devices<br>Clinically indicated MRI (all types) in patients with implanted pacemakers and ICD | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Malfunction | Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline | immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months) | 
| Patient Safety | Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI) | assessed during MRI and immediate post MRI (up to 2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance | We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images | Immediately post MRI (up to 2 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, pacemakers, Defibrillator
MTF Image Modifications

Study Overview
=================
Brief Summary
-----------------
Human visual acuity and contrast sensitivity are highly dependent on various different parameters. Each should be optimized for perfect visual performance. However, in real life our eyes lack such parameters, which might lead to unsatisfying results even after spectacle correction or contact lenses. A promising approach would be to design intra ocular lenses (IOL), which are implanted into the eye for example in the course of cataract extraction and are able to compensate for the human eyes' aberrations. For example cutoff frequency, edge-sharpness or specific contrast for selected structure sizes would need to be considered. Since, an aberration free optical system is almost impossible and since the impact of each single parameter is not yet known, IOL design parameters would have to be chosen very carefully. Furthermore, image quality of IOLs still is tested ex vivo by ray tracing for example, but this does not guarantee perfect function after implantation, as our visual system has complex image precessing units form the retina to the brain. The present study picks one of these parameters and seeks to assess its impact on visual quality in-vivo. By subjectively grading different images with objective changes to image quality by variations of the modulation transfer function (MTF), the potential influence and thus on our subjective visual impression shall be assessed.

Official Title
-----------------
A Pilotstudy Investigating the Impact of Image Modifications on Subjective Image Quality

Conditions
-----------------
Visual Acuity, Modulation Transfer Function, Contrast Sensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged between 18 and 35 years, nonsmokers Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, emmetropia or ≤ 1 diopter Exclusion Criteria: Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug (except oral contraceptives) Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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, young subjects<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective image quality |  | 1 study day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective image sharpness |  | 1 study day |
TNF Alpha in Refractory Asthma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate whether the administration of etanercept to patients with severe asthma improved their asthma related quality of life and a measure of the degree of reactivity of the airways

Detailed Description
-----------------
Although steroid dependent asthma represents a small population of patients with asthma, they consume a disproportionately large amount of the health resource burden attributed to asthma. Treatment options in this group are extremely limited; the development of effective treatments for this group of patients should be a priority, not only for increasing individual patient quality of life but for long term reduction of health spending. This randomised, double blind, placebo controlled, cross over trial will investigate the efficacy of a soluble TNF receptor, etanercept, in severe, steroid dependant asthma.

Official Title
-----------------
The Efficacy of a Soluble Ligand Binding Tumour Necrosis Factor Receptor, Etanercept, in Severe, Steroid Dependant Asthma: a Randomised Controlled Study

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

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic asthma Methacholine PC20<8mg/ml Exclusion Criteria: History of poor treatment concordance History of tuberculosis Radiographic evidence of previous tuberculosis Recent tuberculosis contact Respiratory tract infection within 3 months Current Smoker or Ex-smoker with more than 5 pack years Symptomatic co-morbid condition Contra-indication to etanercept Pregancy Breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methacholine PC20 |  |  | 
| Juniper asthma quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net change in post-bronchodilator FEV1 |  |  | 
| FEF25-75 |  |  | 
| FVC |  |  | 
| symptom visual analogue score |  |  | 
| exhaled nitric oxide concentration |  |  | 
| computed alveolar nitric oxide concentration |  |  | 
| sputum differential inflammatory cell counts |  |  | 
| sputum supernatant mediator concentration. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Refractory
The Effct of Chitooligosaccharide on Immune Function in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
Functional properties of chitooligosaccharides have been studied for antitumor activity, immunostimulating effects, antimicrobial activity, free radical scavening activity, adn angiotensin I converting enzyme inhibitory activity. Recent in vitro, and in vivo toxicity and absorbability studies have demonstrated that chitooligosaccharides have high absorbability and are essentially non-toxic. In the present study, we prepared a chitooligosaccharide with high absorbability and evaluated its effects on activation of immune function and cardiovascular funciton(lipid, atrial stiffness, etc) in healthy adults. This study was a 8-week, randomized, double-blind clinical trial. The 30 volunteers were divided into a control group(n=10), half dose chitooligosaccaride(FACOSTM) intake group(n=10), and full dose FACOS intake group(n=10). Peripheral blood mononuclear cells(PBMCs) were isolated and cultured in 12 well plate for 48 hours. Cytokine production by PBMCs pre- and postintervention were measured simultaneously after stimulation with lipopolysaccaride.

Conditions
-----------------
Immunity

Intervention / Treatment
-----------------
* Drug: FACOS (functional food)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults(the ages between 20 50 year) Exclusion Criteria: food allergy and allergy skin disease severe liver and kidney disease pregnant, lactating women cancer, stroke, etc.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FACOS (functional food)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in subjects with concordant versus discordant left ventricular (LV) lead position as compared to the site of latest mechanical activation.

Official Title
-----------------
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be scheduled to undergo implant of a Cardiac Resynchronization Therapy (CRT) system with approved standard indication per accepted guidelines as a new implant or an upgrade from an existing Implantable Cardioverter Defibrillator (ICD) or pacemaker with no prior left ventricular lead placement Be in sinus rhythm at the time of enrollment Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations Exclusion Criteria: Have persistent or permanent atrial fibrillation Be in New York Heart Association (NYHA) IV functional class Have prior left ventricular (LV) lead implant Be pacemaker-dependent Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months Have had a recent Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months prior to enrollment Have had intravenous inotropic support in the last 30 days Exhibit Cheyne-Stokes respiration Be less than 18 years of age Be pregnant or planning to become pregnant during the duration of the investigation Be currently participating in any other clinical investigation

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 |
| --- | --- |
| Concordant<br> | |
| Discordant<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation |  | This outcome measure will be assessed after an off-line analysis immediately after implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Cardiac Resynchronization Therapy (CRT) as defined by percent change in end-systolic volume (ESV) at 6-month follow-up relative to baseline. |  | 6 months after implant |
A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)

Study Overview
=================
Brief Summary
-----------------
The participants of this study will have AUL spasticity and have a need for botulinum toxin type A injections. AUL spasticity is where people develop tightening or stiffness of the muscles in the arms. Botulinum toxin type A is used for the treatment of spasticity in addition to physiotherapy. This study will ask participants to describe their experience living with AUL spasticity. This information will be used to assess the Arm Activity Measure (ArmA). ArmA is a scale designed to assess upper limb function in people with AUL spasticity. This study could suggest changes to the ArmA to improve its suitability for people with AUL spasticity or even the development of a new scale.

Official Title
-----------------
Non-interventional Study to Assess the Arm Activity Measure Questionnaire (ArmA) by Patients With Adult Upper Limb (AUL) Spasticity.

Conditions
-----------------
Spastic Hemiparesis, Muscle Spasticity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Participant has provided informed consent and is willing to take part in the study Participant is an adult aged at least 18 years Participant has a clinical diagnosis of spastic hemiparesis following stroke or traumatic brain injury (TBI) affecting one arm only Participant is at least 6 months post-stroke or TBI Participant has a need for botulinum toxin type A injections as part of their treatment for AUL spasticity Patient is considered to be in a stable state with regard to their therapeutic interventions (i.e., all treatments for the patient's condition have been stable for at least one month prior to assessment of eligibility) Participant has access to the internet, laptop, or tablet, and is willing to take part in either an online focus group or interview (caregiver assistance is acceptable) Participant is fluent in the English language and is able to discuss their condition Exclusion Criteria : Participant has any medical condition that prohibits their ability to communicate with the interviewer including severe dysphasia or an inability to read questionnaires. Participant has any other clinically relevant concern (e.g., significant psychiatric disorder or depression, history of alcohol and/or drug abuse) that in your opinion would interfere with their ability to provide written informed consent and/or participate. Participant has AUL spasticity is present in both arms

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 |
| --- | --- | --- |
| Number of participants answering to the questionnaire: for Part 1 15/15 subject |  | First interview/ at baseline |
Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms

Study Overview
=================
Brief Summary
-----------------
Stable heart transplant patients on Mycophenolate Mofetil (MMF) will sign a screening consent form in order to be evaluated with the gastrointestinal symptom rating scale (GSRS) questionnaire. Those who score three or more on at least two questions are eligible for the study. Once they sign a study consent they are randomized to one of two arms. It is thought that the severity of GI side effects will be reduced over time in patients who are in the Myfortic arm versus the severity of GI side effects over time in patients who remain on MMF treatment. Patients are evaluated by GSRS, The Psychological Well-Being Schedule, and the IT01/02 Checklist for the evaluation of GI symptoms and followed for one year (visits 1 month, 3 months, 6 months, 12 months).

Official Title
-----------------
Open-Label, Randomized Study Comparing the Patient Reported Severity of GI Side Effects of MMF Versus EC-MPS in Maintenance Heart Transplant Patients.

Conditions
-----------------
Heart Transplant Patients

Intervention / Treatment
-----------------
* Drug: Myfortic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable dose MMF for at least 4 weeks Over 18 years of age Heart transplant at least three months prior to study Exclusion Criteria: GI symptoms known not to be caused by MPA therapy Acute rejection episode in past 4 weeks History of malignancy since transplant Pregnancy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Usual medications (Cellcept) | |
| Active Comparator: 2<br>Patients taking Myfortic | Drug: Myfortic<br>* enteric coated Cellcept pills in applicable dose for patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in GSRS score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-rejection, GI side effects, heart transplant patients
Investigating the Accuracy of the Home Glucose Monitors in Hypoglycemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the accuracies and the capillary and venous comparabilities of five different home glucose monitors; Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart in an adult population.

Official Title
-----------------
Phase IV Study to Compare the Accuracy and Precission of Five Different Home Glucose Monitors;Optium Xceed, Contour Ts, Accu-chek Go, One Touch Select and Ez Smart

Conditions
-----------------
Hypoglycemia

Intervention / Treatment
-----------------
* Drug: Human insulin
* Drug: Human Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being under investigation for pituitary- adrenal functions Exclusion Criteria: Diabetes mellitus or any other chronic metabolic disease Taking medicine for any reason Anemia Polyctemia Compromised circulation Hypoxia
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: volunteers for insulin hypoglycemia test<br>None of the subjects had diabetes mellitus or any other metabolic diseases. They were not taking any medicine and they did not have anemia or polycythemia. Also none of the patients had any condition causing hypoxia or any compromise in peripheral circulation. | Drug: Human insulin<br>* The test was performed in the morning after an overnight fasting and the patients remained supine during the procedure. Two intravenous lines in both arms were established before the procedure. Venous blood was obtained for serum glucose before regular insulin (0.1 U/kg ) is injected and 30 and 45 minutes thereafter. If adequate hypoglycemia was not achieved at this period, a second dose of regular insulin (0.05U/kg) was injected intravenously. In subjects who had not reached the aimed hypoglycemia levels, the test was performed in another day with a higher initial insulin dosage (0.2U/kg).<br>Drug: Human Insulin<br>* 0.1U/kg IV pulse.<br>|

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
-----------------
Hypoglycemia, Home Blood Glucose Monitoring, Subjects are being investigated for the integrity of, pituitary-adrenal functions by insulin hypoglycemia test.