Humaco, Puerto Rico

Product Surveillance Registry

Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG

This prospective, study has cross-sectional analysis of ERG functions in a group of diabetics with and without retinopathy. Both Chromatic ERG and Full field ERG (NOVA, Diopsys, Inc. Pine Brook, NJ) will be utilized in the study. Subsequently individuals with an outside normal limit outcome on at least one ERG test will be invited to be part of the longitudinal study. Individuals with abnormal ERG results will be asked to take the carotenoid vitamin supplement (ZeaVision DVS supplement) and the baseline data will be compared to the values at one, three- and six-month follow-up. The primary endpoint of a patient's follow-up will be at 6 months. The study will be performed at three sites. Western University of Health Sciences, Harpers Pointe Eye Associates (Externship site College of Optometry, Western University of Health Sciences) and Oklahoma College of Optometry, Northeastern State University, Tahlequah, Oklahoma. The clinical study plan will be reviewed and approved by Eye Care Center of the Western University of Health Sciences Institutional Review Board (IRB). Harpers Pointe Eye Associates will be covered under an externship site of Western University of Health Sciences. NSUOCO will apply for a separate IRB review at their own site.

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants

Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

Participants eligible for the study will be randomly allocated (1:1) to receive either dichoptic treatment while wearing the Luminopia headset or patching treatment of the fellow eye for amblyopia with clinical assessments at 13, and 26-weeks post-randomization. At the 26-week primary outcome visit, participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more, will be offered Luminopia dichoptic therapy and if they accept, followed forward with visits at 39- and 52-weeks post-randomization. The study will end for all other participants.

Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

At an enrollment visit, distance VA will be measured in trial frames with or without cycloplegia based on a cycloplegic refraction performed within 30 days. If still apparently eligible, children will be prescribed spectacles and will then return for a spectacle baseline visit, where they will wear their new spectacles for the first time for at least 10 minutes (but no more than 24 hours) and will be tested in those new spectacles to confirm final eligibility prior to randomization. Participants not found to be eligible in their new spectacles will end study participation. Participants eligible for the study will be randomly allocated to one of two treatment groups: Sequential (spectacles alone) and then patching if needed (monitored by ODM), or Simultaneous (spectacles and patching monitored by ODM). After randomization, follow-up visits will occur at 8-week intervals through 56 weeks. At each visit on or after the 8-week visit, participants will be classified as either: stable/worsening or improving; those stable/worsening are then classified as having either resolved or residual amblyopia, provided that the current and most recent previous visit were completed at least 6-weeks apart (target 8 weeks) and provided the required test and retest VA testing was completed. Participants who are stable/worsening and have residual amblyopia in the sequential group will start patching (monitored by ODM) and continue to be followed every 8 weeks. Participants in the simultaneous group, or in the sequential group after having advanced to patching, who are stable/worsening but have residual amblyopia will be released to treatment at investigator discretion. All participants continue 8-weekly visits until 56 weeks when Study participation ends.

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of Migraine

Blood Flow Restriction Training on Upper Extremity Grip Strength

Blood Flow Restriction (BFR) training, also known as occlusion training, is an innovative exercise technique that involves using a tourniquet or blood pressure cuff to partially restrict blood flow to the working muscles during resistance exercises. This unique approach allows individuals to achieve significant muscle strength and hypertrophy gains with lower resistance loads, making it a promising alternative to traditional high-intensity training methods. BFR training has been extensively studied in various populations, demonstrating its potential benefits for muscle growth, strength, and endurance across different muscle groups. While much research has focused on the effects of BFR training on large muscle groups like the quadriceps and biceps, there is a paucity of studies specifically investigating its impact on upper extremity grip strength. Grip strength is a fundamental measure of hand and forearm muscle function, playing a crucial role in various activities of daily living, occupational tasks, and sports performance. Understanding the effects of BFR training on grip strength could provide valuable insights into optimizing hand and forearm strength and functional capacity. The current study seeks to fill this research gap by examining the effects of Blood Flow Restriction (BFR) training on upper extremity grip strength in a healthy young adult population. By exploring this novel application of BFR training, we aim to contribute to the existing body of knowledge surrounding BFR's potential benefits for grip strength enhancement. The results of this study may have implications for athletes, rehabilitation programs, and individuals seeking efficient and effective ways to enhance their grip strength and overall upper extremity function.

Study Comparing Tapinarof Cream 1% to VTAMA ® (Tapinarof Cream 1%) in the Treatment of Plaque Psoriasis

To compare the safety of Test, Reference, and Placebo treatments in patients with Plaque Psoriasis. Patients in this randomized, double-blind, three-arm, placebo controlled, parallel-design, multi-site study will be randomly assigned in a 2:2:1 ratio to treatment with the test product, reference product or placebo control, respectively.