linjc16/ctgov huggingface dataset:
Noninvasive Transcutaneous Glucometer Development

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assist in the development of a noninvasive device for the accurate measurement of blood glucose levels.

Detailed Description
-----------------
The feasibility of measuring blood glucose concentration in patients with diabetes mellitus using near infrared (NIR) spectroscopy and multivariate data analysis techniques has been established using general purpose, scientific-grade infrared spectrophotometers under the 90-049 UNM HRRC protocol. Now that the concept of painless, bloodless, and reagent-less clinical laboratory tests has been shown to be viable, the challenge is to bring this technology to the patients who need it. We must develop a device that is portable, affordable, and rugged - all while improving accuracy. We must also improve our understanding of the nature of glucose in whole, intact skin. Since the light beam cannot discriminate plasma glucose in skin blood vessels from glucose in the larger skin interstitial fluid space, the exact nature of the glucose in all tissue compartments contributing to the light-beam signal must be elucidated. The noninvasive measurement can be no more accurate than the reference measurement on which it was based. Finally, we have found that the accuracy of the noninvasive measurement also worsens as a function of time from the initial measurement. This effect is independent of instrumentation drift and is due to physical changes in the patient's skin such as variation of hydration, collagen, vascularity, glycation end-products, etc. To account for these sources of physiologic interference they must be evaluated independently and then compared to errors of the noninvasive predictions over time.

Official Title
-----------------
Noninvasive Transcutaneous Glucometer Development

Conditions
-----------------
Healthy, Prediabetic State (IGT), Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Healthy Type I diabetics Type II diabetics Impaired glucose tolerance Exclusion Criteria: Minor status (<18 years of age) Pregnant

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 |
| --- | --- | --- |
Radiomic Analysis for Predicting Treatment Response and Clinical Outcomes in Malignancies

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to undertake a retrospective analysis of CT and MRI scans for patients undergoing radiation treatment to develop radiomic signatures to predict treatment response and clinical outcomes.

Detailed Description
-----------------
Imaging in oncology has widespread application with modalities like ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) having a well-established role particularly in diagnosis, staging, assessment of treatment response, and surveillance. With the applications of radiomics in oncology, the potential of imaging as a non-invasive biomarker in treatment response, as well as genotypic characterization, has been recognized. Radiomics has the potential to tailor way towards precision oncology with the development of biomarkers that can guide personalized treatments. In this study, the investigators aim at developing CT and MRI radiomic signatures as potential biomarkers to predict treatment response and clinical outcomes for patients treated with radiation having breast, brain, head and neck, and gynecological malignancies.

Official Title
-----------------
Radiomic Analysis of CT and MRI Scans for Predicting Treatment Response and Clinical Outcomes in Patients With Breast, Brain, Head-neck and Gynecological Malignancies

Conditions
-----------------
Brain Cancer, Breast Cancer, Head and Neck Cancer, Gynecologic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast, head and neck, brain, and gynecological malignancies Treated with radiation at Odette Cancer Centre between 2010 and 2019 Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast malignancies<br>Those diagnosed with breast malignancies | |
| Head and Neck malignancies<br>Those diagnosed with head and neck malignancies | |
| Brain malignancies<br>Those diagnosed with brain malignancies | |
| Gynecological malignancies<br>Those diagnosed with gynecological malignancies | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of imaging biomarkers in predicting treatment response for breast, brain, head-neck, and gynecological malignancies | Development of imaging biomarkers in predicting treatment response | 1 year | 
| Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity) for breast, brain, head-neck, and gynecological malignancies | Development of imaging biomarkers in predicting clinical outcomes (survival/toxicity) | 1 year |
Pre-discharge vs. Early Post-discharge Stress Testing and GRACE Score for Safe Discharge of ACS-patients With a Negative Hs-troponin T Result

Study Overview
=================
Brief Summary
-----------------
New high-sensitivity cardiac troponin (hs-cTn) assays allow earlier detection of acute myocardial infarction (AMI). Furthermore, elevated values were associated with an increased risk of recurrent AMI or death. Therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. Other criteria for an early invasive strategy include a GRACE risk score >140 points or other cardiovascular risk factors. Hs-cTn assays allow discrimination of patients at very low and high risk. Studies confirmed safety of early discharge protocols in patients with unstable angina (UAP). The aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with UAP and to 2) review the optimal timing of stress-testing. Therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. Endpoints are major adverse cardiovascular events within 30 and 90 days.

Official Title
-----------------
Role of Pre-discharge vs. Early Post-discharge Stress Testing and Implementation of the GRACE Risk Score for Safe Discharge of Patients With an ACS and a Negative High Sensitivity Troponin T Result Within 3 Hours After Presentation to a Chest Pain Unit

Conditions
-----------------
Major Adverse Cardiovascular Events, Troponin T, GRACE Score

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients presenting to the emergency department (chest pain unit) typical angina pectoris absence of symptoms since presentation at least 18 years low GRACE risk score (<140 points) informed consent, signed agreement Exclusion Criteria: conditions with need for immediate workup mental disorders dementia pregnancy, breast feeding

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 |
| --- | --- |
| Pre-discharge stress testing<br>Stress-testing (e.g. treadmill exercise test, stress-echochardiography) | |
| Post-discharge stress testing<br>Stress-testing (e.g. treadmill exercise test, stress-echochardiography) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular event |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular event |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress testing, Troponin T, GRACE score, Outcome
Osteoarthritis in Terms of ICF Components

Study Overview
=================
Brief Summary
-----------------
Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. The first aim of this study was to link and allocate items of The Western Ontario and McMaster Universities (WOMAC) OA index with ICF Comprehensive Core Set for osteoarthritis. The second aim was to examine the relationship between the quality of life and each ICF component's scores determined based on clinical data of WOMAC in OA.

Official Title
-----------------
Investigation of Individuals With Osteoarthritis in Terms of ICF Components Based of ICF Comprehensive Core Set for Osteoarthritis and Quality of Life

Conditions
-----------------
Osteoarthritis, Quality of Life, OUTCOME MEASURES

Intervention / Treatment
-----------------
* Other: Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with OA according to American College of Rheumatology clinical criteria for OA of the knee or hip;[14,15] being in the age range 18-65; and absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology). Exclusion Criteria: comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus); previous lower extremity surgery; Intra-articular steroid or hyaluronic acid injection in the last three months cognitive impairments; pregnancy; and illiteracy.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Evaluation|health status and quality of life were evaluated|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Western Ontario and McMaster Universities (WOMAC) OA Index: | The WOMAC Index is a self-administered, disease-specific questionnaire consisting of 24 items which are widely used in the evaluation of hip and knee OA. It consists of 24 items: pain (5 items), stiffness (2 items), and physical function (17 items). High score indicates worse pain, stiffness, and functional limitations. | 15 min | 
| Nottingham Health Profile (NHP): | NHP is a widely used measure of perceived distress of patients in physical, emotional and social domains. It consists of 38 items which are physical mobility (8 items), pain (8 items), sleep (5 items), emotional reactions (9 items), social isolation (5 items) and energy level (3 items). Questions have yes or no answers. Higher score indicates greater distress | 15 min |
Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients

Study Overview
=================
Brief Summary
-----------------
These days, there is higher proportion of elderly cancer patients. Most of them have comorbidities, borderline performance status and nutritional status. The discontinuation of chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric assessment might be beneficial in selection of suitable elderly patients for chemotherapy administration.

Detailed Description
-----------------
The patients with the age more than 70 years old who scheduled for chemotherapy were enrolled. Geriatric assessment was performed before starting chemotherapy. The toxicity will be recorded prospectively. Predisposing factors of grade 3 and 4 toxicity will be reported.

Official Title
-----------------
Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients: A Prospective Study

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 70 years of age plan to receive first cycle of chemotherapy histologically or cytologically proved of cancer Exclusion Criteria: patients who have concurrent chemoradiotherapy patients who received local chemotherapy

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| cancer patients receiving chemotherapy<br>Patients who are older than 70 years old receiving chemotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity |  | from starting chemotherapy to 1 month after last dose of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of grade 3 or 4 chemotherapy toxicity in elderly |  | from starting chemotherapy to 1 month after last dose of chemotherapy | 
| Factors associated with good quality of life during receiving chemotherapy |  | from starting chemotherapy to 1 month after last dose of chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly cancer patients, chemotherapy toxicity
Salivary Catecholamines in Aphthous Stomatitis (Canker Sores)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine how compounds produced in patients with canker sores affect wound healing.

Detailed Description
-----------------
The purpose of this study is to determine if salivary catecholamines are elevated in patients with the disease aphthous stomatitis. The results of this study will be combined with those performed in collaboration with a co-Investigator to understand the effects of catecholamines on mucosal wound healing and oral epithelial cell migration.

Official Title
-----------------
Salivary Catecholamines in Aphthous Stomatitis

Conditions
-----------------
Canker Sore

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older, both genders History of recurrent aphthous ulcers with 4 or more episodes per year Exclusion Criteria: History of salivary gland disease including Sjogren's disease, parotitis, and sialolithiasis History of benign or malignant salivary gland tumor History of celiac disease, ulcerative colitis or Crohn's disease Patients on medications that affect salivary flow such as anti-depressants and anti-cholinergic medications

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Individuals with a history of canker sores. | |
| 2<br>Individuals with no history of canker sores. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of Exercise Training Programs: Step and Stability Ball on Balance and Obstacle Avoidance in Older People

Study Overview
=================
Brief Summary
-----------------
Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the effect of two types of physical activity on stability parameters.

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Behavioral: Step physical activity program
* Behavioral: Stability Ball Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 65 Able to undergo physical activity for 45 minutes twice a week Exclusion Criteria: All Others

Ages Eligible for Study
-----------------
Minimum 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Step Physical Activity<br>A physical activity program that is based on the Step Apparatus Training Program | Behavioral: Step physical activity program<br>* Participants will take part in a biweekly, 8 week physical activity program that will include step exercises<br>|
| Active Comparator: Stability Ball<br>A physical activity program that is based on the Stability Ball | Behavioral: Stability Ball Program<br>* Participants will take part in a biweekly, 8 week physical activity program that will include stability ball exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability | Stability will be measured with the following tests: Timed Get Up and Go , One Leg Stand Test, Functional Reach Test,Tinetti Balance both before and after the 8 week physical activity program and the difference will be compared. | 3 months |
Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.

Official Title
-----------------
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain

Conditions
-----------------
Diabetic Peripheral Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: RGH-896
* Drug: RGH-896
* Drug: RGH-896
* Drug: pregabalin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female outpatients 18 to 75 years of age A diagnosis of painful diabetic neuropathy Controlled blood glucose Willingness to wash out all analgesic medications used for DPNP Female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception Female patients who are not pregnant Exclusion Criteria: Acute infections or cardiac problems Past use of pregabalin History of severe psychiatric disorder History of any amputation due to diabetes History of seizure disorder Active diabetic foot ulcers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: 1<br> | Drug: RGH-896<br>* 45 mg TID, capsules, 14 weeks.<br>|
| Experimental: 2<br> | Drug: RGH-896<br>* 30 mg TID, capsules, 14 weeks.<br>|
| Experimental: 3<br> | Drug: RGH-896<br>* 15 mg TID, capsules, 14 weeks.<br>|
| Active Comparator: 4<br> | Drug: pregabalin<br>* 100 mg, TID, capsules, 14 weeks.<br>* Other names: Lyrica;|
| Placebo Comparator: 5<br> | Drug: placebo<br>* TID, capsules, 14 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean daily pain rating |  | Baseline to Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% reduction in pain |  | Baseline to Week 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetic, peripheral, neuropathic, pain, chronic, diabetes
A Study of Mood and Stress After Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This is a study of factors, such as pain, family support, psychological history and alcohol/substance use, that may influence whether a person experiences depression after their spinal cord injury.

Detailed Description
-----------------
The objective of this study is to examine the degree to which vulnerability factors are mediated by stress to increase risk for depression after SCI in a sample of adults who sustained their injuries after the age of 18 years. Participants will complete a written survey (about pain, daily activities, social support and life experiences) and a telephone interview that will provide information about these factors.

Official Title
-----------------
A Survey of Vulnerability Factors, Current Stress and Depression Risk in Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a spinal cord injury Were age 16 years or older when injured Sudden onset of symptoms Exclusion Criteria: Under 19 years old Less than 1 year post-injury had a non-traumatic injury

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, quality of life, disability