linjc16/ctgov huggingface dataset:
2 Hour Dispensing Evaluation of Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Commercially Available Biotrue ONEday Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The objective of this 2 hour study is to evaluate the clinical performance of Biotrue ONEday lenses with an alternate packaging solution (EPG03) compared to commercially available Biotrue ONEday lenses. This novel contact lens packaging solution contains known elements in the ophthalmic industry and is safe for use.

Official Title
-----------------
2 Hour Dispensing Evaluation of Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Commercially Available Biotrue ONEday Contact Lenses

Conditions
-----------------
Contact Lens Wearer

Intervention / Treatment
-----------------
* Device: Biotrue ONEday lenses with an alternate packaging solution (EPG03)
* Device: Biotrue ONEday lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have 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 in the opinion of the Investigator. Considered by the Investigator to not be a suitable candidate for participation.

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: Biotrue ONEday lenses with an alternate packaging solution (EPG03)<br> | Device: Biotrue ONEday lenses with an alternate packaging solution (EPG03)<br>* Biotrue ONEday lenses with an alternate packaging solution (EPG03)<br>|
| Active Comparator: Biotrue ONEday lenses<br> | Device: Biotrue ONEday lenses<br>* Commercially available Biotrue ONEday lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalized logMAR Visual Acuity |  | 2 hours |
A Clinical Study With the Medical Device PowerSpiral for Deep Enteroscopy

Study Overview
=================
Brief Summary
-----------------
The objective of the SAMISEN study is to assess the performance and safety of diagnostic and therapeutic procedures with the newly designed Olympus Motorized Spiral Enteroscope (PowerSpiral).

Detailed Description
-----------------
The main objective of this registry is to collect data on the safety and performance of the new motorized PowerSpiral device during Post-market Clinical Follow-up. It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. As clinical performance and efficacy is equally important for the user this study also collects efficacy and handling data of the new device.

Official Title
-----------------
Safety and Performance of the Motorized Spiral Endoscope (PowerSpiral) in Subjects Indicated for Small-bowel Enteroscopy: A PMCF Registry

Conditions
-----------------
Small Bowel Disease

Intervention / Treatment
-----------------
* Device: Deep enteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Patients with small bowel disease indicated for deep enteroscopy Exclusion Criteria: Age under 18 years Female and of child-bearing age who is currently pregnant or planning to become pregnant within the study period Any contraindication to standard enteroscopy Concurrent participation in another competing clinical study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Deep enteroscopy|A deep enteroscopy conducted with the new medical device PowerSpiral.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect Serious Adverse Events and Device Deficiencies to demonstrate safety of the Motorized Spiral Endoscope (PowerSpiral) in daily medical practice. | It is assumed that the new device and its safety profile is non-inferior to preceding generations of balloon assisted enteroscopes. Endoscope (PowerSpiral) in a typical clinical setting within the Intended Use | up to 12 days | 
| Diagnostic Yield | Defined as the percentage of procedures that either confirmed a diagnosis from previous studies, or established a new definitive diagnosis at the anatomical location identified in previous studies or findings that could explain the clinical symptoms. | up to 12 days | 
| Therapeutic Yield | Defined as the percentage of patients with any endoscopic intervention / therapy with the exception of biopsies. | up to 12 days |
A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with Alzheimer's disease.

Official Title
-----------------
A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Drug: ABT-089


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Current diagnosis of probable Alzheimer's disease. ADAS-cog score of at least 12 and MMSE score of 10 to 26. Non-smoker Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person. Fluent in English. EXCLUSION CRITERIA: Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks. Has clinically significant or uncontrolled medical condition other than Alzheimer's disease. Nursing home resident.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: ABT-089|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMSE |  |  |
The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study

Study Overview
=================
Brief Summary
-----------------
Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases are of unclear cause, often occuring in families. We believe that mutations in specific already-identified genes contribute to DCM in Quebec and that certain mutations may account for a significant proportion of cases due to the well-documented founder effect. Two hundred patients with DCM followed in our Heart Function Clinic will be approached for one blood sample at their routine clinic visit to test this hypothesis. The samples will be tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.

Conditions
-----------------
Dilated Cardiomyopathy (DCM)

Intervention / Treatment
-----------------
* Other: blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Followed at MUHC Heart Function Centre Documented EF of less than or equal to 35% and an enlarged heart with a left ventricular end-diastolic size of greater than 6 cm. Patient's written consent Exclusion Criteria: Patients with a known underlying condition that results in a weakened and enlarged heart Patients unable to read and understand the consent form Patients who do not wish to participate

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

| Intervention/Treatment |
| --- |
|Other: blood test|looking at DNA|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Motion Characteristics of the Foot and Ankle as Measured by Durometer Readings

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the motion characteristics of the foot and ankle with a durometer as a method of measurement.

Detailed Description
-----------------
This study will assess and establish the motion characteristics of the foot and ankle with the use of a durometer as a measure of motion patterns. The durometer is a device commonly used in materials testing that measures displacement through the use of a piezoelectric sensor configured to detect motion a in the form of a reflected wave back from the surface being tested.

Conditions
-----------------
Foot Motion Characteristics

Intervention / Treatment
-----------------
* Behavioral: Durometer analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Logan student, staff, or faculty with no history of ankle injury; 2. Age 18 - 60 yoa Exclusion Criteria: 1. Logan student, staff, or faculty with no history of ankle surgery 1. No visual or vestibular condition that would affect balance; 2. Systemic illness that have an adverse effect on balance; 3. Local infection, injury or other malignancy affecting the lower extremity; 4. Any unstable joints of the lower extremity; 5. Any manipulation to the foot ankle joints within 48 hours; 6. Prescription or herbal muscle stimulants, relaxants, etc.; 7. Pregnancy

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Durometer analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Hepatitis C Elimination in the Netherlands

Study Overview
=================
Brief Summary
-----------------
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.

Official Title
-----------------
Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients

Conditions
-----------------
Chronic Hepatitis c

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ever diagnosed with (possible) chronic HCV in the 15-year period prior to initiation of the study, defined as having had a positive anti-HCV or HCV RNA test Lost to follow-up, defined as the lack of a scheduled outpatient care appointment after the last known positive HCV test result Exclusion Criteria: Younger than 18 Deceased Not residing in the Netherlands Unknown current address Severe comorbidity or short life expectancy that limits patients from benefiting from retrieval

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 lost to follow-up (LTFU) patients successfully re-linked to care |  | End of study, on average 2.5 years after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of LTFU patients in the investigated time period |  | 15 years prior to study initiation | 
| Case ascertainment rate | Established contact (via telephone or in writing) with a patient who is eligible for retrieval | End of study, on average 2.5 years after initiation | 
| Awareness of HCV diagnosis among LTFU patients | Number of patients who were aware of their HCV diagnosis when they are invited for re-evaluation | End of study, on average 2.5 years after initiation | 
| Number of patients who never had an outpatient appointment with a hepatologist or infectious disease specialist after initial positive HCV test |  | End of study, on average 2.5 years after initiation | 
| Number of viraemic patients at time of re-evaluation |  | End of study, on average 2.5 years after initiation | 
| Liver fibrosis stage of retrieved patients |  | End of study, on average 2.5 years after initiation | 
| Reasons for becoming LTFU |  | End of study, on average 2.5 years after initiation | 
| Time of being LTFU | Defined as years since last (HCV-)related hospital visit | End of study, on average 2.5 years after initiation | 
| Mode of HCV transmission |  | End of study, on average 2.5 years after initiation | 
| Sustained virological response | Defined as the absence of HCV RNA at least 12 weeks after treatment | End of study, on average 2.5 years after initiation |
Family Satisfaction (FS) in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
There is increasing awareness that high-quality care in the intensive care unit also includes care of visiting family members according to their needs. The investigators therefore want to assess family satisfaction using a questionnaire that was specially developed for this setting and recently validated for German-speaking participants.

Detailed Description
-----------------
Family members who visit patients on the ICU (intensive care unit) are not just onlookers. They experience the process of care along with their loved ones. Increasingly, the satisfaction of family members with ICU care, decision-making and information, and their empowerment to contribute towards patient care as near relatives, is being perceived as an important aspect of the general quality of ICU care. Family satisfaction is assessed using the 34-item FS-ICU questionnaire which was recently validated for German-speaking participants. The aim of this pilot survey is to identify opportunities for improvement of family satisfaction.

Official Title
-----------------
Observational Study of Family Satisfaction in the Intensive Care Unit Using the German-language FS-ICU

Conditions
-----------------
Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all visiting family members who consent to participate Exclusion Criteria: no more than two family members per patient; prior participation
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 |
| --- | --- | --- |
| Family Satisfaction in the ICU (FS-ICU) Questionnaire- Overall Satisfaction Score | Overall satisfaction score is calculated as the mean of 24 Items concerning satisfaction with care, communication and decision-making. After transformation of Items the score has a scale reaching from 0 (highly unsatisfied) to 100 (highly satisfied). | From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Severity of Illness |  | From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months | 
| Patient Length of Stay on the ICU |  | From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months | 
| Patient Mortality |  | From beginning of ICU stay until death or discharge of patient, whatever came first, assessed up to 2 months |
Parental Perceptions on Prescription Opioid Use

Study Overview
=================
Brief Summary
-----------------
This study involves an anonymous survey given to parents regarding their perceptions on prescription opioid use for pain control in children undergoing orthopedic surgery.

Official Title
-----------------
Parental Perceptions on Prescription Opioid Use for Pain Control in Children Undergoing Orthopedic Surgery

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of patients between 1-18 years of age scheduled for orthopedic surgery at Nationwide Children's Hospital. Exclusion Criteria: Parents with children less than 1 or greater than 18 years of age or scheduled for surgery other than orthopedic. Non-English speaking parents.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents<br>Parents of children undergoing orthopedic surgery | Other: Survey<br>* REDCap survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort with child receiving opioids | Are you comfortable with your child receiving opioids (for example: Morphine, Fentanyl, Dilaudid) during and after surgery? | Baseline | 
| Danger of opioids | Do you believe prescription opioids are dangerous? | Baseline | 
| Safety of prescription opioids | Do you believe prescription opioids are safer than non-opioids such as acetaminophen (Tylenol), ibuprofen (Advil or Motrin), and aspirin? | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment status | Current employment status of parent | Baseline | 
| Education | Level of education of parent | Baseline | 
| Gender | Gender at birth of child | Baseline |
Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)

Study Overview
=================
Brief Summary
-----------------
This is a single-center study at the Cleveland Clinic Main Campus designed to study biomarkers in healthy individuals to identify novel mechanisms of platelet activation and how platelets drive vascular inflammation and thrombosis in diseases.

Detailed Description
-----------------
Our past studies have discovered novel platelet activation pathways that may be targets of therapeutic development. We have also defined an important role for a shift in platelet phenotype in vascular disease. Our studies use both in vivo animal models and validation using human platelets from isolated blood. Platelets from healthy individuals may be compared to patients with vascular diseases in the IRB approved protocol Vascular Lab Resource (IRB #19-1451) study which is actively recruiting patients at the Cleveland Clinic Main Campus and studies patients with vascular diseases.

Official Title
-----------------
Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 to 65 years old Healthy Male & Female voluntary participants Exclusion Criteria: Individuals who have taken anticoagulant or antiplatelet medications in past 10 days Individuals with hematopoetic diseases

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect blood samples | To establish a biorepository for normal healthy cohort of subjects | 10 years |
Remote Cognitive Assessment for Surgical Patients

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to evaluate the use of remote cognitive testing to identify patients who may have cognitive vulnerability and may benefit from cognitive care pathways. Participants in this study are asked to complete a smartphone battery of thinking, memory, speech, and motor function tests on their smartphone.

Detailed Description
-----------------
This study is evaluating cognitive function in older adults that are undergoing surgery using remote assessments. Participants complete a battery of neuropsychological assessments prior to their surgery date. The battery includes smartphone adaptions of tests of thinking, memory, speech, and movement. The participant has a one-hour remote visit, where the investigators will conduct a Montreal Cognitive Assessment (MoCA) and have the participant complete the smartphone assessments. After their surgery, participants are evaluated on the delirium rating scale.

Official Title
-----------------
Remote Evaluation of Cognitive Function for Older Adults Undergoing Surgery

Conditions
-----------------
Mild Cognitive Impairment, Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spine surgery with a duration greater than or equal to three hours Can speak, write, and understand English Ability to participate in remote visit Exclusion Criteria: Participating in other cognitive studies Having more than one surgery (planned multiday surgery) Emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 99 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 Patients that develop Postoperative Delirium (POD). | Postoperative Delirium is measured by clinical assessment using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), or the Nursing Delirium Screen Scale (Nu-DESC). A composite delirium score is calculated, and patient is included in the delirium group if either CAM-ICU or NuDESC screenings are positive during the hospital stay. Electronic medical records will also be evaluated for any delirium diagnosis. | Daily after surgery up to discharge from the hospital- an average of days to 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote Cognitive Assessment