linjc16/ctgov huggingface dataset:
Food Intake and Blue Dishware in Residents Living With Dementia

Study Overview
=================
Brief Summary
-----------------
Blue dishware was alternated with white dishware for lunch and dinner for residents living with dementia. Food consumption occurred in the home dining room and food was weighed before and after consumption to determine proportion consumed. Eating challenges were also noted. Within-participant comparisons were made to determine if food intake and eating challenges improved with the blue dishware condition.

Official Title
-----------------
Food Intake and Blue Dishware in Residents Living With Dementia in Retirement Homes

Conditions
-----------------
Food Preferences, Eating Behavior

Intervention / Treatment
-----------------
* Other: Blue dishware


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: living in a residential care environment with dementia informed consent of POA and assent of person living with dementia Exclusion Criteria: did not come to the dining room to eat required eating assistance did not live on the study unit

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: participant meals were randomized to blue or white dishware conditions, matched for food choices
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: White dishware<br>standard white dishware used in the home | Other: Blue dishware<br>* blue dishware is used for plates and bowls<br>|
| Experimental: blue dishware<br>specially designed blue dishware, plates and bowls | Other: Blue dishware<br>* blue dishware is used for plates and bowls<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precent of Food consumed of food served (grams consumed/grams provided) | gram weight of food intake as weighed on a calibrated scale | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Meals with an Eating challenge based on an Eating challenges Checklist | change in eating challenges from a prespecified list | 8 weeks |
Sleep Disorders in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Fatigue is a frequent and disabling symptom in patients with multiple sclerosis (MS). The pathophysiology of this sign is not fully understood. Some data suggest that the fatigue is associated with sleep disorders. The aim of this study is to determine the polysomnographic parameters in MS patients with fatigue in comparison to MS patients without fatigue.

Official Title
-----------------
Study of Sleep Disorders and Fatigue in Patients With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with multiple sclerosis Expanded Disability Status Scale score < or = 5 Fatigue (Modified Fatigue Impact Scale > 45), with a disease duration > 3 months Exclusion Criteria: Depression Cognitive disorders EDSS > 5 Epilepsia Obesity Drug inducing sleep disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
-----------------
multiple sclerosis, fatigue, sleep disorders
Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
Background: The cardiac resynchronization therapy (CRT) has been shown to improve symptoms and outcome of patients with congestive heart failure (HF), and depressed left ventricular ejection fraction (LVEF < 35 %). The rate of non-responders to CRT is estimated at 30 %. Yet, the impact of frailty on the response to CRT has not been studied, until now. Purpose : To assess the impact of frailty in the elderly, on the response to CRT.

Detailed Description
-----------------
Methods : Frailty is evaluated before implant ,and defined as <14/17 points using the ONCODAGE score, in 150 patients of > 70 years age, selected for CRT according to the ESC 2013 guidelines. The response to CRT, estimated at 9 months, is defined as an improvement of at least 5 % of the LVEF and the absence of HF hospitalization or cardiovascular death.

Official Title
-----------------
Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy

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

Intervention / Treatment
-----------------
* Other: Frailty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of > 70 years age, Selected for CRT according to the ESC 2013 guidelines Exclusion Criteria: patients included in other clinical trial which can interfere with the results of this one

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 |
| --- | --- |
| CRT<br>Patients over 70 years age, selected for CRT according to the ESC 2013 guidelines. | Other: Frailty<br>* CRT device is implanted in all patients selected for the study. Frailty is evaluated before implant and defined as <14/17 points using the ONCODAGE score<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non response on CRT |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seric albumin | To assess the impact of seric albumin on the response to CRT | 9 months | 
| seric gammaglutamyltranferase | To assess the impact of seric gammaglutamyltranferase on the response to CRT | 9 months | 
| mortality |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
frailty, Heart failure, cardiac resynchronization therapy
Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache

Study Overview
=================
Brief Summary
-----------------
Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. It is also possible that how we take care of your pain in the Emergency Department will influence the level of pain you experience one or two days from now. This study seeks to answer these questions.

Official Title
-----------------
Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache

Conditions
-----------------
Tooth Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years, pain in any tooth Exclusion Criteria: duration of pain > 96 hours oral trauma within 96 hours of presentation facial or neck swelling pericoronitis visual impairment to less than finger counting within three feet

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 |
| --- | --- |
| Injectable pain medication<br>Patients who receive an injectable form of pain medication. | |
| Oral pain medication<br>Patients who receive oral pain medication only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Pain Scale | Is there any change in patient report of pain using the Visual Analog Pain Scale before and after treatment. | Before and After treatment of tooth pain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for additional treatment | Does patient require addtional/repeated analgesia or rescue medication? | while in the Emergency Department |
Safety and Feasibility of Kefir Administration in Critically Ill Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and feasibility of kefir administration in critically ill adults.

Official Title
-----------------
Safety and Feasibility of Kefir Administration in Critically Ill Adults

Conditions
-----------------
Critically Ill

Intervention / Treatment
-----------------
* Dietary Supplement: Kefir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill adult patients receiving antibiotics. Functional GI tract (able to tolerate oral diet or tube feeding). Exclusion Criteria: Received antibiotics for >72 hours prior to enrollment. Known immunosuppression (due to medications including chronic steroids, TNF-alpha inhibitors, monoclonal antibodies, immunosuppressive antimetabolites, etc.). Compromised gut integrity (bowel resection, GI malignancy, GI bleed, inflammatory bowel disease). History of CDI within 60 days. Liver failure or pancreatitis. Dairy intolerance or milk allergy. Patients consuming probiotics at baseline. Artificial heart valve. Extremely poor prognosis and not expected to survive the treatment period.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kefir administration in critically ill adults<br>Critically ill subjects will receive Kefir throughout the length of their ICU course in an ascending dosing regimen | Dietary Supplement: Kefir<br>* Oral route (via feeding tube in intubated patients). Serving size 240mL to be given in an ascending dosing regimen if tolerated starting at 60 mL/day, 120 mL/day until single 240 mL/day; if evidence of intolerance, dose will be reduced to previously tolerated dose.<br>* Other names: Lifeway Foods® Original Kefir Unsweetened Whole Milk;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of adverse effects related to kefir administration including vomiting, aspiration, diarrhea, interactions with medications or tube feeds, bacteremia secondary to a bacterium in kefir | 30 days | 
| Feasibility of Kefir administration | Number of subjects to have more than 75% of doses given when subject is allowed to have PO/feeding tube administration and are tolerated | 30 days |
Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.

Official Title
-----------------
Opioids Versus Extra Strength Acetaminophen for the Management of Moderate Persistent Non-cancer Pain

Conditions
-----------------
Arthritis, Pain, Cognitive Impairment

Intervention / Treatment
-----------------
* Drug: long acting oxycodone
* Drug: extra strength acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 65 Pain at least 3 months duration Pain greater in lower extremity than other anatomical site with ambulation Pain self-report of moderate intensity of higher on an average day Community-dwelling Ambulatory Physician states participants have decision-making capacity to enroll into the trial Participants with cognitive impairment have a reliable caregiver Inadequate pain relief from NSAIDS and/or acetaminophen in the past Exclusion Criteria: Current cancer requiring chemotherapy History of addiction to opioids or other controlled substance Consumes more than 2 alcoholic drinks a day Severe balance disturbance Intra-articular steroid injection in the past 6 weeks

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen<br> | Drug: extra strength acetaminophen<br>* 1,000 mg twice daily<br>|
| Active Comparator: Long Acting Oxycodone<br> | Drug: long acting oxycodone<br>* 10mg twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Self-report on the Brief Pain Inventory and WOMAC |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discontinuation of Study Drug, Short Physical Performance Battery |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Analgesia, Cognitive impairment, Randomized controlled trial, Physical function
Participate While Pregnant Survey

Study Overview
=================
Brief Summary
-----------------
The main goal for this study is to assess concerns and barriers to research participation by pregnant women through an anonymous online survey (www.pbrc.edu/ParticipateWhilePregnantSurvey).

Detailed Description
-----------------
Participants will complete an online survey distributed through HIPAA compliant REDCap database. Collected data will consist of general multiple choice responses and optional write-in responses (e.g. providing a personal response for elaboration an Other option). No private health information will be collected.

Official Title
-----------------
Research Participation in the Pregnant Population: A Survey Study

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual may complete this survey.

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Willingness to Participate in Research While Pregnant | Survey question: What types of research would you be willing to participate in while you were pregnant? | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preferred Methods for Learning About a Research Study | Survey respondents were asked how they would prefer to learn about a research study with several answers cited. | Day 1 | 
| Comfort of Participating in Research While Pregnant | Survey question: Would you feel comfortable participating in a research study while pregnant? | Day 1 | 
| Concerns for Participating in Research While Pregnant | Survey question: What concerns might make you hesitant to participate in a research study while pregnant? | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Survey
Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment

Study Overview
=================
Brief Summary
-----------------
A randomized clinical trial with two groups. Group A Group B Group A is being treated with conventional Steroid combination ointment for the treatment of chronic Plaque Psoriasis. Group B is being treated with Cyanocobalamin in Avocado Oil cream for the treatment of chronic Plaque Psoriasis. Each group having 45 patients.

Detailed Description
-----------------
Outcome is being measured by PASI Score calculation with monthly follow up.

Official Title
-----------------
Comparison of Cyanocobalamin in Avocado Oil Cream With Steroid Combination Ointment in the Treatment of Chronic Plaque Psoriasi-A Randomized Clinical Trial in Tertiary Care Hospital

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Combination Product: Potent topical steroid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age bracket (18-60 years) Non psoriatic Arthritis No oral Retinoids Exclusion Criteria: pregnancy Malignancy Body surface area involving >50%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Steroid combination ointment in the treatment of chronic Plaque Psoriasis | Combination Product: Potent topical steroid<br>* Cyanocobalamin in Avocado Oil Cream<br>|
| Active Comparator: Group B<br>Cyanocobalamin in Avocado Oil cream in the treatment of chronic Plaque | Combination Product: Potent topical steroid<br>* Cyanocobalamin in Avocado Oil Cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and tolerability of steroids as compared to Avacado Oil Cream | Compariaon of Efficacy of Steroid combination ointment in the treatment of chronic Plaque Psoriasis | 12 weeks |
Validation of Muscle Strength Testing for Pectoralis Major

Study Overview
=================
Brief Summary
-----------------
This study wants to understand which direction of shoulder movement and what posture of shoulder are best for the procedure of muscle strength testing of the muscle pectoralis major(PM). We will use muscle activity signals (sEMG) and force measurement to analyze the contribution of two parts of PM in three different contraction direction with three different shoulder postures.

Official Title
-----------------
Validation of Muscle Strength Testing for Pectoralis Major

Conditions
-----------------
Pectoralis Major, Muscle Strength, Surface EMG, Force Measurement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young male subjects which could expose the area of anterior chest to paste the sEMG electrodes Exclusion Criteria: Injury and uncomforted one week before the test

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| sEMG | Surface EMG signal were collected. | 6/1/2012 |
Uterocervical Angle: a Screening Tool That Estimates the Latent Phase Duration in Post Term Pregnancies

Study Overview
=================
Brief Summary
-----------------
To evaluate the performance of uterocervical angle (UCA) in the prediction of latent phase duration in post term pregnancies

Official Title
-----------------
Anterior Uterocervical Angle for Latent Phase Duration in Post Term Pregnancies

Conditions
-----------------
Post Term Pregnancy

Intervention / Treatment
-----------------
* Other: latent phase duration
* Other: uterocervical angle (UCA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with singleton pregnancies Post term pregnancies Patients with vertex presentation, Patients with intact membranes Patients with no uterine contractions Exclusion Criteria: women with BMI >30, multiparity and multiple pregnancies, patients with macrosomia (>4500 gr), patients with major fetal congenital abnormality or fetal death and any contraindications to vaginal birth (e.g. active genital herpes), patients with abnormal Pap smears, patients with a history of previous cesarean section, myomectomy, hysteroscopic surgeries, dilatation and curettages, loop electrosurgical excision procedures, and cervical conization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: uterocervical angle<br>uterocervical angle is the angle between lower segment of uterus and cervix | Other: latent phase duration<br>* latent phase duration in post term pregnancies<br>Other: uterocervical angle (UCA)<br>* uterocervical angle is the angle between lower segment of uterus and cervix<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction of latent phase duration by uterocervical angle in post term pregnancies | In patients diagnosed with late term pregnancy, the uterocervical angle and cervical length were measured by transvaginal ultrasound (TVUS) at the time of admission to the delivery room before labor induction. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relative success of UCA in active phase and duration of labor prediction in post term pregnancies | 5 months | 5 months |