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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who meet at least one of the following three laboratory criteria for malnutrition: TSerum Albumin: ≤3.5 mg/dl Pre-Albumin: <15 mg/dl Transferrin: <200 mg/dl
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upvisit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)
Awards & highlights
No Placebo-Only Group
Study Summary
This trial looks at whether giving extra nutrients to patients who are deficient in them can help improve recovery following joint replacement surgery.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 2 (2 wks pre) visit 3 (surgery day) visit 5 (4 weeks post)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in the patients' albumin, pre-albumin, and/or transferrin levels
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutritional supplementationExperimental Treatment1 Intervention
Given Ensure Max Protein Nutrition shake 2 weeks before surgery and continued 2 weeks after surgery.
Group II: No Nutritional supplementationActive Control1 Intervention
Treatment as usual
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ensure
2020
Completed Phase 2
~260
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,335 Previous Clinical Trials
794,744 Total Patients Enrolled
17 Trials studying Osteoarthritis
3,757 Patients Enrolled for Osteoarthritis
Ran SchwarzkopfPrincipal InvestigatorNYU Langone
1 Previous Clinical Trials
160 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have an eating disorder.Patients ≥ 55 years of age but ≤ 95 years of age.You have had septic arthritis before.Patient are current candidates for elective primary total hip and total knee arthroplasty.You have severe kidney or liver disease.You are allergic to taking pills or supplements by mouth.You cannot take medicine or supplements by mouth.
Research Study Groups:
This trial has the following groups:- Group 1: Nutritional supplementation
- Group 2: No Nutritional supplementation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have registered to take part in this research effort?
"Affirmative. The clinical trial, which was initially posted on July 6th 2021, is currently in need of participants according to the information hosted on clinicaltrials.gov. 125 patients are required between two medical facilities."
Answered by AI
Are there any vacancies for individuals in this research program?
"Affirmative, the information available on clinicaltrials.gov confirms that this trial is still in need of participants, which it began to search for since July 6th 2021. The most recent update was made on October 11th 2022 and 125 people are required from 2 sites."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Pennsylvania
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
Rothman Orthopedic Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Email
Most responsive sites:
- Rothman Orthopedic Institute: < 24 hours
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