linjc16/ctgov huggingface dataset:
Assessment of Prototype Hand-held Fundus Camera

Study Overview
=================
Brief Summary
-----------------
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.

Detailed Description
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We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.

Official Title
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Assessment of Prototype Hand-held Fundus Camera

Conditions
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Evaluate Performance of New Fundus Camera

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Greater than 21 years of age Ability to give informed consent Willingness to spend up to 2 hours for photos 5 patients presumed to be normal 5 patients with abnormalities of the posterior pole of the retina or the optic nerve will be studied Exclusion Criteria: Any known pathology felt by the Principal Investigator to be significant so as to preclude participation as a normal subject Monocular subjects Potential subjects may be excluded based on the Principal Investigator's judgement that they are not good subjects to photograph Children and vulnerable subjects will not be included in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera | Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher. Scale Image scored as follows Unacceptable: cannot see fundus detail Unacceptable: fundus detail visualized, but inadequate for meaningful analysis Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use Good: fundus detail visualized, meaningful analysis possible, std photo superior Excellent: fundus detail visualized as well as std photo Superior: fundus detail of higher quality than std photo | estimated 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Fundus photography
An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn how well an instrument called an Actiwatch-2 can determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is, a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures and records the amount of movement a person makes each minute. After being worn overnight, data are transferred from the Actiwatch to a computer, and a program estimates whether a person is awake or asleep by analyzing the recorded movement data. The enrollment target is 80 participants. Although other actigraphy equipment has been used to monitor sleep in children, the Actiwatch-2 has not been validated in the pediatric population.

Official Title
-----------------
An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children

Conditions
-----------------
Sleep Monitoring

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Children (ages 6 months to 18 years) who are undergoing a medically necessary sleep study [polysomnography (PSG)] in the OHSU Sleep Disorders Laboratory ASA classification I and II (children in good health) Exclusion Criteria: ASA classification III, IV (children with a chronic or severe disease). Children with developmental delay. Children born extremely prematurely (before 32 weeks gestation), as these children and their parents may react differently to experimental procedures Children who do not speak English or whose parents do not speak English.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum 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 |
| --- | --- |
| Main group<br>pediatric patients receiving overnight sleep study | |

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
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actigraphy, polysomnography, pediatrics, sleep, To validate Actigraphy against polysomnography
A Real-World Registry to Investigate the Performance of LenSx® Laser in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the performance of LenSx® Laser in femtosecond laser-assisted cataract surgery (FLACS) in real-world medical practice in Chinese patients.

Detailed Description
-----------------
All subjects will undergo FLACS using the LenSx® Laser system. The recommended postoperative visits will follow the current standard of care in China.

Official Title
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A Prospective, Single-Arm, Multicenter, Registry Study to Investigate the Performance of Femtosecond Laser-Assisted Cataract Surgery in Chinese Cataract Patients

Conditions
-----------------
Cataracts

Intervention / Treatment
-----------------
* Device: LenSx® Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese; Will undergo LenSx® Laser-assisted cataract surgery and phacoemulsification in at least one eye; Must sign written informed consent; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Contraindications listed in LenSx® Laser System Operator's Manual; Pregnant, nursing, or planning a pregnancy; Concurrent enrollment in another investigational drug and/or device study or participation in such a study within 30 days prior to surgery day; Other protocol-specified exclusion criteria may apply.

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 |
| --- | --- |
| LenSx<br>Phacoemulsification cataract surgery in at least 1 eye using LenSx® Laser technology | Device: LenSx® Laser<br>* Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of a round anterior capsulotomy |  | Surgery (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate of lens fragmentation without additional segmentation after LenSx Laser procedure |  | Surgery (Day 0) | 
| Completion rate of intraocular lens (IOL) implantation |  | Surgery (Day 0) | 
| Completion rate of corneal incisions |  | Surgery (Day 0) | 
| Best-corrected distance visual acuity (BCDVA) |  | Up to Day 30 | 
| Percentage of patients with BCDVA of 20/20, 20/25, 20/40 or better at each visit |  | Up to Day 30 |
Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma

Study Overview
=================
Brief Summary
-----------------
This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer.

Official Title
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Longterm Outcome of Photodynamic Therapy Compared With Biliary Drainage Alone in Patients With Unresectable Cholangiocarcinoma

Conditions
-----------------
Cholangiocarcinoma

Intervention / Treatment
-----------------
* Procedure: Photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial. Exclusion Criteria: 1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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 |
| --- | --- |
| Control Group<br>Group that be administrated biliary drainage only | |
| PDT Group<br>Group that be administrated photodynamic therapy and biliary drainage | Procedure: Photodynamic therapy<br>* Each patient to whom PDT was offered underwent a specific, detailed educational process by a dedicated team member(P.B., P.J., or K.E.), after which informed consent was obtained.Porfimer sodium (Photofrin; Axcan Pharma Inc, Quebec, Canada)was used as a photo sensitizing agent, administered intravenously at a dose of 2 mg/kg body weight 48 hours before illumination.A diode laser system (InGaAIP Laser Diode; Diomed Inc, An-dover, MA) with a maximum power output of 2000 mW and a wavelength of 633+-3 nm was used as a light source, delivered through a 3.0-m length fiber having a 2.5-cm-long cylindrical diffuser at its distal end (Pioneer Optics, Windsor Locks, CT).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bili duct neoplasms, bile duct cancer, photodynamic therapy, biliary drainage
Fibroscan Study in HCC

Study Overview
=================
Brief Summary
-----------------
In patients with HCC undergoing therapy 1. We aim to determine the prognostic significance of liver stiffness in patients with HCC 2. We aim to determine the rate and severity of complications of treatment and its association with liver stiffness in patients with HCC

Official Title
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A Study to Evaluate the Impact of Liver Stiffness on Treatment Outcome of Hepatocellular Carcinoma

Conditions
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Confirmed Diagnosis of Hepatocellular Carcinoma, Patients Who Are Scheduled to Undergo Transarterial Chemobolization, Systemic Therapy Surgery, Child's A to C Cirrhosis

Intervention / Treatment
-----------------
* Other: Fibroscan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HCC Patients who are scheduled to undergo therapy, either TACE systemic therapy or surgery For TACE cohort, patients undergoing first cycle TACE are eligible. For systemic therapy cohort, patients undergoing first-line systemic therapy are eligible. For surgery cohort, patient undergoing surgery are eligible. Prior surgery or loco-ablative therapy (e.g. Radiofrequency ablation, microwave, percutaneous ethanol injection) is allowed Child's A to Child's C liver function Exclusion Criteria: ECOG performance status > 2 Poorly controlled ascites

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE<br> | Other: Fibroscan<br> <br> |
| Experimental: Systemic Therapy<br> | Other: Fibroscan<br> <br> |
| Experimental: Surgery<br> | Other: Fibroscan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate and grade of treatment complications |  | 2 years | 
| Liver stiffness (kPa) |  | 2 years |
Falls From Sitting to Standing

Study Overview
=================
Brief Summary
-----------------
Background: When evaluating trauma patients, many centers perform computed tomography of the head, cervical spine, chest, abdomen, and pelvis, the so-called pan-scan. Here, we evaluate the utility of pan-scan in geriatric patients who sustained ground-level falls. Study Design: We performed a retrospective review of consecutive patients from the trauma registry of a large, urban Level 1 trauma center. Inclusion criteria were registration during the 2019 calendar year, age ≥ 65, mechanism of fall from either sitting or standing, and performance of pan-scan at time of assessment. Patient demographics, physical exam findings, CT results, injuries, and patient disposition were recorded. The sensitivity, specificity, positive and negative predictive values of the physical exam for significant injuries were calculated.

Official Title
-----------------
Falls From Sitting to Standing

Conditions
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Falls, Tomography of the Head, Cervical Spine, Chest, Abdomen, and Pelvis

Intervention / Treatment
-----------------
* Diagnostic Test: tomography pan scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria age >65 presented with fall from sitting or standing from 01/01/2019-12/31/2019 Exclusion criteria included age <65 years, falls from height, GCS less than 14, patients who did not undergo the complete pan-scan.

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: tomography pan scan|This is a retrospective chart review|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of physical exam compared to CT scan and identifying traumatic injuries | Sensitivity of physical exam compared to CT scan and identifying traumatic injuries. Sensitivity is a statistical measure which was calculated using our SAS software as described in methods. CT scan was used as the gold standard. Both physical exam and CAT scan were performed on initial presentation with a time frame on the order of minutes to hours. | 2 years | 
| Prevalence of injury. | Traumatic injuries were determined by CT scan, tabulated, and broken down by body region as well as injury type. These data were collected at the time of CT scan on initial presentation. These data presented as whole numbers and percentages. | 2 years | 
| Disposition from ED | Dispositions were determined by chart review, tabulated, and broken down by disposition location. These data collected at the time of admission | 2 years | 
| Disposition from hospital. | Dispositions were determined by chart review, tabulated, and broken down by disposition location, including patient expiration in some cases. These data were collected at the time of discharge | 2 years |
A System for Lengthening Contraction Training of Muscle

Study Overview
=================
Brief Summary
-----------------
Evaluation of a new exercise machine designed to improve strength and speed of movement in the leg muscles. Investigators are trying to learn whether a new training method results in greater strength improvements as compared to a traditional method.

Official Title
-----------------
A System for Lengthening Contraction Training of Muscle

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

Intervention / Treatment
-----------------
* Other: Exercise
* Other: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy able to exercise 3 times per week for 16 weeks at Mobility Research Center Exclusion Criteria: under- or overweight chronic disease that limits ability to exercise hips and legs limited by arthritis or pain presently engaged in a strenuous exercise program planned absence greater than one week.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSC-VLC<br>velocity-controlled variable resistance, lengthening contraction | Other: Exercise<br>* Velocity-controlled variable resistance protocols enable trainees to load their muscles more optimally along the entire ROM in either or both of the shortening (VSC) and lengthening (VLC) phases of a training repetition<br>|
| Active Comparator: SC<br>Constant weight shortening contraction | Other: Exercise<br>* Standard training of leg extension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg strength |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to rise from a chair |  | 16 weeks |
Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.

Official Title
-----------------
Noninvasive Hemodynamic Parameters Measurements as a Tool for Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Conditions
-----------------
Hypotension of Hemodialysis

Intervention / Treatment
-----------------
* Device: Continuous monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with EKSD undergoing chronic hemodialysis treatments for > 3 months. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study. Patients must satisfy a medical examiner about their fitness to participate in the study. Patients must provide written informed consent to participate in the study. Exclusion Criteria: Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development, or impaired cerebral function). Withholding the dialysis session for any reason prior to initiation. Minors under the age of 18.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous monitoring|Identifying intradialytic hypotension using a PPG-based wearable monitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with intradialytic hypotension | Using a PPG-based non-invasive wearable monitor to allow early detection of intradialytic hypotension | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determining the pathogenesis of intradialytic hypotension | Continuous monitoring of numerous hemodynamic parameters will allow to determine the pathogenesis | Through study completion, an average of 1 year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemodialysis, Intradialytic hypotension, Remote Monitoring