Clinical trials

This randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Participants will be randomized to Nuvicol II, Nuvicol SII, or placebo and will consume one capsule daily for 4 months. Pain, quality of life, knee muscle function, concomitant analgesic medication use, cartilage degradation biomarkers, safety laboratory variables, and adverse events will be assessed during follow-up.

This prospective multicenter cohort study aims to compare clinical and functional outcomes between hamstring tendon and quadriceps tendon autografts in anterior cruciate ligament (ACL) reconstruction in female athletes. Participants will be followed for two years after surgery to evaluate graft failure rates, return to sport, knee stability, and patient-reported outcomes.

The cross-cultural adaptation will be performed according to the internationally recommended methodology, using the following guidelines: translation, back-translation; revision by a committee, questionnaire diffusion and data collection and analyzing. The psychometric properties will be evaluated by administering the questionnaire to approximately 300 participants. Reliability will be estimated through stability and homogeneity assessment

Randomized, controlled, triple-blind clinical trial with three parallel arms based on the product consumed (low-dose experimental product, high-dose experimental product, and placebo product) and conducted at a single center to measure the efficacy of a product (Xanthigen®) on overweight or obesity during 16 weeks of consumption.

This study aims to evaluate cardiovascular risk factors, clinical characteristics, and outcomes in adult patients attending an outpatient cardiology clinic. The research focuses on identifying predictors of adverse cardiovascular events, optimizing risk stratification, and improving preventive strategies in routine clinical practice. Data will be collected from patients receiving standard cardiology care without altering their treatment. The results are expected to contribute to better understanding of cardiovascular risk profiles and to support improvements in clinical decision-making and patient management.

Randomized, controlled, double-blind clinical trial with two parallel arms based on the product consumed (experimental product and placebo product) and conducted at a single center, to measure the efficacy of the liquid NUTIFOOD product (nutritional product with carob extract) on carbohydrate metabolism.

This study investigates the effects of an adapted aikido exercise program on the health of adults with unilateral wrist and/or hand dysfunction. The un- derlying assumption is that regular practice of adapted aikido may improve physical, psychological, and quality-of-life parameters in this population com- pared with a non-exercising control group.

Randomized, placebo-controlled, double-blind, multicenter clinical trial with two parallel study arms (experimental and placebo) to assess the efficacy of genistein extract consumption over 18 months on cognitive decline in patients with prodromal Alzheimer's disease.

A controlled, randomized clinical trial is proposed to demonstrate the effectiveness of the experimental product in controlling hepato-pulmonary inflammation and neurovascular encephalic inflammation, which may constitute the etiopathogenic basis of persistent COVID. In addition, an individualized training program will be implemented for each participant in order to improve chronic symptoms and, consequently, their quality of life.

This study evaluates whether a liquid carob extract can improve blood glucose levels in individuals with prediabetes. Participants are selected according to predefined health criteria and randomly assigned to two groups: one group receives the carob extract and the other receives an inert liquid (placebo). Blood samples are collected and glucose-related parameters are measured throughout the study to assess changes over time. The objective is to determine whether this extract may contribute to better glycemic control and help prevent progression to diabetes.

Cross-cultural adaptation, validity and Reliability of Berg Balance Scale in Albanian population

This randomized, double-blind clinical trial aims to evaluate the effect of a probiotic supplement on gut microbiota composition and glycemic control in adults with type 1 diabetes mellitus. A secondary comparison will be made with a healthy control group. Participants will be assigned to receive either a probiotic or a placebo for 98 days. Stool samples and metabolic parameters will be collected at baseline and after the intervention period. The study seeks to better understand how modulation of the intestinal microbiota may influence glucose regulation in people with type 1 diabetes.

Introduction. The development of hemophilic arthropathy causes degenerative joint damage that leads to functional impairment, limiting physical activity and causing disability in patients with hemophilia. Objectives. i) To assess the level of physical activity in patients with hemophilia; ii) To identify the best predictive model for physical activity in adult patients with hemophilic arthropathy. Material and method. Multicenter cross-sectional cohort study. Eighty-eight patients will be recruited. The dependent variable will be physical activity (International Physical Activity Questionnaire). Secondary variables will be kinesiophobia (Tampa Kinesiophobia Scale), functionality (Functional Independence Scale in Hemophilia), pain intensity, and clinical, anthropometric, and sociodemographic variables.

Introduction. Faced with the risk of injury relapse, and as athletes train and compete, they generate anxiety that limits their ability to push themselves to the maximum, influencing their performance. Objectives. i) To identify the state and trait anxiety of non-professional athletes with previous hamstring injuries; ii) To evaluate the main prognostic factors of anxiety in these athletes; and iii) To analyze the best predictive model of anxiety in soccer players with previous hamstring injuries. Material and method. Ambispective cross-sectional cohort study. 88 players will be recruited. The primary variable of the study will be anxiety (State-Trait Anxiety Inventory), with the number of recurrences of the study injury being the dependent variable. The secondary variables, estimated as modifying or confounding, will be the main sociodemographic variables (age, type of school/work activity), clinical (number of hamstring injuries, number of relapses of injury in the same location, duration of injury in weeks, date of last injury), sports (weekly training load, seasons competing, regular starting line-up) and anthropometric (weight).

Introduction. Meniscal lesions are common and are associated with the development of osteoarthritis of the knee. Work activities that cause mechanical stress can lead to acute or chronic injuries. The surgical treatment for this injury is meniscectomy. Physiotherapy is a widely accepted first-line treatment for patients with meniscus tears. Objective. To assess the clinical and functional status of patients who have undergone meniscus surgery with and without post-surgical physiotherapy. Material and method. Multicenter ambispective cohort study. 89 patients who have undergone meniscectomy will be recruited. The primary variable of the study will be functionality (Time Up \& Go), with the prescription of a post-surgical physiotherapy treatment being the dependent variable. The secondary variables, estimated as modifying or confounding, will be range of motion (goniometry), pain intensity (visual analog scale) and kinesiophobia (Tampa scale).

To translate and validate the Upper Limb Functional Index into Albanian for use in the Albanian-speaking population.