linjc16/ctgov huggingface dataset:
Burnout and Approach to Bereavement Initiatives in a Medical Intensive Care Unit (ICU)

Study Overview
=================
Brief Summary
-----------------
Given the stress, exhaustion and close interface with death that Intensive Care Unit (ICU) health care providers face, this study will evaluate burnout rates in intensive care unit (icu) physicians, nurses and ancillary staff. Investigators will also study the effect on a bereavement card on these burnout rates

Detailed Description
-----------------
This study will evaluate: Burnout rates among nurses and ancillary staff with the Abbreviated Maslach burnout inventory. This is a well validated tool that is used to evaluate symptoms of burnout such as denationalization, emotional exhaustion and lack of personal accomplishment. Burnout rates at the beginning of and at the end of the house staff's ICU rotation to gauge the effect of an ICU rotation on burnout rates amon medical trainees. Determine whether the introduction of a bereavement card will improve symptoms of burnout as gauged by the abbreviated maslach burnout inventory Staff perceptions and response to the introduction of a bereavement

Official Title
-----------------
Burnout and Approach to Bereavement Initiatives in a Medical Intensive Care Unit (ICU)

Conditions
-----------------
Burnout, Professional

Intervention / Treatment
-----------------
* Diagnostic Test: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health care providers who work in the Bellevue Hospital Medical ICU Exclusion Criteria: NA

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Health Care Providers<br>Bellevue hospital Medical Intensive Care Unit; 30 Nurses and 50 physcians | Diagnostic Test: Survey<br>* Burnout rates before and after the introduction of a bereavement card Burnout rates before and after an ICU rotation for physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burnout rate before introduction of bereavement card | Measured by Staff Response Questionnaire | 1 Year | 
| Burnout rate after introduction after introduction of bereavement card | Measured by Staff Response Questionnaire | 1 Year | 
| Burnout rates before ICU rotation for physicians | Measured by Staff Response Questionnaire | 1 Year | 
| Burnout rates after an ICU rotation for physicians | Measured by Staff Response Questionnaire | 1 Year |
Objective Measures in Implantable Hearing Devices

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure objectively the coupling from direct acoustic cochlear stimulation to the inner ear with a non-invasive technique of auditory evoked potentials.

Detailed Description
-----------------
A new technique, called Direct Acoustic Cochlear Stimulation, has very recently been introduced to restore hearing in patients with severe hearing loss due to the immobility of a small ossicle in the middle ear, the stapes. A piston-like prosthesis, which is placed up into the inner ear, is connected to an implantable mechanical stimulator, named DACS. Unfortunately, as with other active middle ear implants, until now the correct function of this technique cannot be checked during the surgery, leading to a possibly variable outcome of hearing. In this project, the objective auditory evoked potentials, like Auditory Steady-State Response (ASSR), will be used to measure the efficacy of this method of inner ear stimulation. This highly innovative, non-invasive research will provide valuable insight in a new promising way of inner ear stimulation and may give a unique possibility to measure the correct connection from an implantable hearing device to the inner ear.

Official Title
-----------------
Clinical Trial on Objective Measures in Implantable Hearing Devices for Subjects With Mixed Hearing Loss.

Conditions
-----------------
Mixed Hearing Loss

Intervention / Treatment
-----------------
* Behavioral: Auditory evoked potentials and audiometry
* Behavioral: Auditory evoked potentials


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults mixed hearing loss Exclusion Criteria: children

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mixed hearing loss<br> | Behavioral: Auditory evoked potentials and audiometry<br> <br> Behavioral: Auditory evoked potentials<br>* Different protocols for audiometry and auditory evoked potentials<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| auditory evoked potentials |  | 1 - 3 - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speech audiometry |  | 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hearing, Thresholds, Coupling to the inner ear
Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer's disease.

Detailed Description
-----------------
Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study

Official Title
-----------------
An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Tramiprosate (3APS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study. Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal). Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver. The patient must be presenting a reasonably good nutritional status. Signed inform consent from the patient or legal representative. Exclusion Criteria: Patients will not be eligible to participate in the study if they meet any of the following criteria: The patient participates in another drug trial during the study. The patient with a clinically significant and/or uncontrolled condition or other significant medical disease. The patient is unable to swallow medication tablets.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tramiprosate (3APS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the long-term safety of Tramiprosate (3APS). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide additional long-term data on the efficacy of Tramiprosate (3APS). |  |  |
Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The rationale for this study is to determine if Campath-1H can be used in liver transplant recipients to induce a state of immunological unresponsiveness that would not only eliminate the need for calcineurin inhibitors maintenance therapy, but also reduce corticosteroids utilization, decreasing the incidence of acute cellular rejection and perhaps reduce the severity of histologic recurrence of certain autoimmune diseases responsible for causing liver failure. The investigator propose a randomized prospective open label trial in 50 liver transplant recipients who will received a calcineurin inhibitors free immunosuppressive protocol that consist of a single dose of Campath-1H as an induction therapy in association with maintenance mycophenolate mofetil (CellCept®) and low dose steroids. The second group will receive a standard immunosuppressive regimen, which consists of IV steroid induction therapy and maintenance steroids, together with tacrolimus at a full therapeutic dose with no induction antibody therapy.

Official Title
-----------------
Mycophenolate Mofetil Maintenance Therapy for Liver Transplantation Following Campath-1H Induction

Conditions
-----------------
Primary Liver Transplant

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects; Ages 45 years and older; Are to receive a liver transplant. Exclusion Criteria: Recipients of a multi-organ transplant; known hypersensitivity to daclizumab, CellCept®, or prednisone; therapy with an investigational medication within 4 weeks of study entry; history of malignancies within the past 5 years and/or lymphoma, excluding adequately treated skin carcinoma (basal or squamous cell), or other than exclusion #9; history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study; history of HIV infection; females who are pregnant or nursing; subject is receiving systemic corticosteroids for other medical conditions for which the physician feels that discontinuation of corticosteroids is contraindicated; T2 or higher hepatocellular carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mycophenolate mofetil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effectiveness of Oral Anticoagulants in Elderly Patients With Non-Valvular Atrial Fibrillation and Heart Failure

Study Overview
=================
Brief Summary
-----------------
Observational study of elderly individuals diagnosed with Non-Valvular Atrial Fibrillation and Heart Failure who are beginning oral blood thinners

Official Title
-----------------
Real-World Comparative Effectiveness Research Among Elderly Non-valvular Atrial Fibrillation (NVAF) Patients With Heart Failure (HF) Using Oral Anticoagulants

Conditions
-----------------
Atrial Fibrillation, Heart Failure

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Were age greater than or equal to 65 years as of the index date Had greater than or equal to 1 diagnosis of AF prior to or on the index date Had greater than or equal to 1 diagnosis claim of HF during the 12 months prior to or on the index date Had 1 or more pharmacy claim for oral blood thinners Exclusion Criteria: Claims indicating diagnosis or procedure for hip/knee replacement surgery within 6 weeks prior to index date Pharmacy claim for warfarin, apixaban, dabigatran, edoxaban or rivaroxaban during the 12-month baseline period Greater than 1 oral anticoagulants prescription claim on the index date and/or with a follow-up less than 1 day Had medical claim indicating VTE in the 12 months prior to index date Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Elderly individuals with NVAF and HF who are taking OAC's<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stroke/systemic embolism (SE) |  | Approximately 195 weeks | 
| Incidence of major bleeding |  | Approximately 195 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of miocardial infarction (MI) |  | Approximately 195 weeks | 
| Incidence of all cause mortality |  | Approximately 195 weeks | 
| Incidence of all cause hospitalization |  | Approximately 195 weeks | 
| Incidence of major adverse cardiac event |  | Approximately 195 weeks |
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Compared to Ultra for Presbyopia

Study Overview
=================
Brief Summary
-----------------
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, confirmatory, randomized, bilateral, 2-way crossover, double masked (subject and investigator), repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses according to unique randomization schedules that will be provided to each Investigator If vision is unsatisfactory in the original dispensed lenses, additional lens powers may be trialed.

Official Title
-----------------
1-Week Dispensing Evaluation of Kalifilcon A Daily Disposable Multifocal Contact Lenses Compared to Ultra for Presbyopia Contact Lenses

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: kalifilcon A Daily Disposable Multifocal
* Device: samfilcon A for Presbyopia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 40 years or older on the date the Informed Consent Form (ICF) is signed and have the capacity to read, understand and provide written voluntary informed consent. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Be willing and able to follow instructions. Have signed a statement of informed consent. Exclusion Criteria: Participating in a conflicting study. Considered by the Investigator to not be a suitable candidate for participation.

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

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kalifilcon A Daily Disposable Multifocal<br>kalifilcon A Daily Disposable Multifocal Low Add Power (LA) and High Add Power (HA) | Device: kalifilcon A Daily Disposable Multifocal<br>* kalifilcon A Daily Disposable Multifocal low add and high<br>|
| Active Comparator: samfilcon A for Presbyopia<br>B+L ULTRA for Presbyopia Low Add Power (LA) and High Add Power (HA) | Device: samfilcon A for Presbyopia<br>* Ultra for Presbyopia Low and High Add Contact Lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Mean Binocular logMAR Visual Acuity at Distance (6m) | One week | 
| Near Visual Acuity | Mean Binocular logMAR Visual Acuity at Near (40cm) | One week |
Correlation Between Refraction and Biometric Parameters

Study Overview
=================
Brief Summary
-----------------
To document the refractive status of Chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.

Detailed Description
-----------------
In this study, we will analyze the refractive status of schoolchildren and compare the ocular biometrics, including spherical equivalent refraction (SER), pupil distance (PD), corneal curvature (CC), high order aberration (HOA), and central corneal thickness (CCT) between boys and girls. Additionally, we investigate the correlation between the SER in diopters and the other biometric parameters, including PD, CC, HOA, CCT, and body mass index (BMI).

Official Title
-----------------
Correlation Analysis of Refraction and Biometric Parameters in Chinese Schoolchildren

Conditions
-----------------
Refractive Errors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schoolchildren aged from 6 to 15 years Exclusion Criteria: with previous histories of cataracts, keratitis, strabismus, or other visual impairments with history of previous eye surgery with unreliable auto-refraction values unwilling to participate

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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 |
| --- | --- | --- |
| refractive error in diopters and biometric Parameters | Multiple regression analysis will be performed to evaluate the correlations between SER and the other biometric parameters | up to 1 year |
The Lolland-Falster Health Study

Study Overview
=================
Brief Summary
-----------------
The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. The population study aims at examining complexities of environmental, hereditary, lifestyle, and social factors as determinants and predisposing factors for morbidity, health, and quality of life. The study will cover physical, mental, and social dimensions and examine family patterns and subgroups. The study will provide baseline information for later follow-up.

Official Title
-----------------
The Lolland-Falster Health Study

Conditions
-----------------
Urinary Incontinence, Personality, Impaired Health, Disease, Wellbeing, Mental Disorders, Atherosclerosis, Renal Insufficiency, Chronic, Skin Diseases, Coronary Disease, Ear Diseases, Nose Diseases, Pharyngeal Diseases, Chronic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals registered in Lolland or Guldborgsund municipality Exclusion Criteria: Adults with incapacity guardianship Incapacity to give informed consent Individuals with address protection Severe physical immobility Non-Danish and Non-English speaking

Ages Eligible for Study
-----------------
Maximum Age: 110 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 | Self-administered questionnaires, clinical examination, and biospecimen | Cross-sectional, measured once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Self-administered questionnaires, clinical examination, and biospecimen | Cross-sectional, measured once | 
| Risk factors | Self-administered questionnaires, clinical examination, and biospecimen | Cross-sectional, measured once |
Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.

Detailed Description
-----------------
Oral lichen planus is a mucosal inflammatory disease of unknown origin. It can be very painful especially if erosions appear on the oral mucosa. In this study the efficacy of pimecrolimus compared to placebo in treatment of erosive oral lichen planus will be investigated. To this end the subjective pain and the amount of affected mucosa will be monitored before and after treatment.

Official Title
-----------------
Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Conditions
-----------------
Lichen Planus, Oral

Intervention / Treatment
-----------------
* Drug: Pimecrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically and histologically confirmed diagnosis of erosive oral lichen planus Spontaneous or meal related oral pain No topical therapy 2 weeks prior to study start No systemic therapy 4 weeks prior to study start Signed informed consent Exclusion Criteria: Pregnant or breast-feeding women Known allergy to macrolide antibiotics Known current active malignant disease or in patient's history Known immunodeficiency or HIV infection Participation at another clinical trial within the last 6 months

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: Quadruple


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's and investigator's global assessment after 4 and 8 weeks |  |  | 
| Pimecrolimus blood level after 4 weeks |  |  |