Mostar

Researchers are evaluating the safety and effectiveness of a once-daily oral medication called AP1189, at a dose of 100 mg, compared to a placebo in participants who have respiratory insufficiency expected to be caused by respiratory viral infections such as SARS-CoV-2, Influenza A or B, or RSV. This study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to include 96 hospitalized participants. The goal is to assess AP1189 as an add-on treatment to the standard care provided for these respiratory infections. Participants will be randomly assigned in equal numbers to receive either AP1189 tablets or matching placebo tablets once daily for 14 days, alongside their standard of care treatment. The study monitors participants during this 14-day treatment period to evaluate treatment outcomes and safety. During the study, participants will be assessed for a composite outcome including death, need for invasive mechanical ventilation or ECMO, cardiovascular organ support, or new renal failure within 28 days. The study includes clinical evaluations, oxygen saturation measurements, and safety monitoring during and after treatment. Overall participation lasts at least 28 days to capture these outcomes and monitor participant health.

Researchers are evaluating the pharmacokinetics PK, safety, and tolerability of aumolertinib in European adults diagnosed with locally advanced or metastatic non-small cell lung cancer NSCLC that has specific activating mutations in the EGFR gene. This Phase 1, open-label, multicenter study focuses on participants whose tumors have mutations such as ex19del, L858R, or T790M. The goal is to better understand how aumolertinib and its metabolites behave in the body and their safety profile in this population. Participants receive aumolertinib orally at a dose of 110 mg once daily under fasting conditions in 21-day treatment cycles. The study has two parts Part A involves detailed PK assessments with visits for blood sampling on specific days within the first two treatment cycles to analyze drug levels. Part B allows participants to continue aumolertinib treatment beyond Cycle 2 until disease progression, intolerable side effects, or other discontinuation reasons determined by the investigator. During the study, participants will undergo safety evaluations and tumor assessments according to clinical needs. Blood samples for PK analysis are collected at multiple time points during the early treatment cycles. After stopping treatment, participants will have an End of Treatment visit within 7 days and a safety follow-up visit approximately 28 days after the last dose. The primary outcomes include measuring drug concentration peaks and exposure over 24 hours, while secondary outcomes focus on adverse events throughout the study, which may last about 18 months on average.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

This research aims to evaluate whether administering XEMBIFY every two weeks alongside Standard Medical Treatment SMT over a one-year period can reduce the number of major bacterial infections each year in adults with low antibody levels hypogammaglobulinemia who have B-cell Chronic Lymphocytic Leukemia CLL, Multiple Myeloma MM, or Non-Hodgkin Lymphoma NHL. The study compares this treatment to a placebo plus SMT to determine its impact on infection rates. Participants are randomly assigned to one of two groups. One group receives a loading dose of XEMBIFY subcutaneously at 150 mgkgday for five consecutive days starting in Week 1, followed by biweekly doses of 300 mgkg until Week 51. The other group receives a placebo injection on the same schedule. Both groups continue to receive the standard medical treatments and supportive care they require throughout the study. During the study, participants will have regular assessments including monitoring the frequency of infections, hospitalizations, and antibiotic use. Researchers will measure the annual rate of major bacterial infections and track the time to first infection among other outcomes up to Week 51. Participants are observed closely throughout the treatment year to evaluate safety and effectiveness, with the entire study lasting approximately one year per participant.

Grade I ankle sprains are common injuries particularly among athletes, women, teenagers, and physically active people. They often lead to complications like chronic ankle instability or osteoarthritis. This research aims to evaluate treatments for Grade I ankle sprains, focusing on therapeutic exercises and rehabilitation. The Bowen technique, which has been effective for other musculoskeletal problems, is being studied for its potential benefit for these ankle sprains. Participants are divided into two groups. One group receives cryotherapy, therapeutic exercises, use of braces, and the Bowen technique. The other group receives cryotherapy, therapeutic exercises, use of braces, and manual massage. These interventions are part of conservative treatment methods targeting recovery from ankle sprains. During the study, participants will be assessed mainly by measuring their subjective pain intensity over three weeks. The research team will monitor recovery progress and any changes in pain levels. This observational study involves adults aged 18 years and older, and the total participation duration centers around the three-week pain assessment period.

Researchers are evaluating the efficacy and safety of Imeroprubart in adults with active Chronic Inflammatory Demyelinating Polyneuropathy CIDP, a condition affecting the peripheral nerves. This Phase 2b, multi-center, randomized, double-blind, placebo-controlled study aims to understand how well Imeroprubart works compared to placebo in treating CIDP. The study is sponsored by Immunovant Sciences GmbH and focuses specifically on adults meeting diagnostic criteria for typical or variant forms of CIDP. Participants will receive either Imeroprubart or a matching placebo by subcutaneous injection once weekly. The treatment period includes an initial 24-week phase Period 1 with Imeroprubart or placebo, followed by an extension to 52 weeks Period 2 for continued evaluation. Imeroprubart dosing is given once weekly via subcutaneous injection. Placebo is provided similarly during the first 24 weeks. During the study, participants will be monitored through clinical assessments including relapse status by Week 24, as well as measurements of disability, grip strength, muscle strength, and symptom scores. Electrodiagnostic tests support diagnosis at baseline. Safety and efficacy will be closely observed during treatment, with follow-up visits scheduled to assess outcomes. The total participation duration covers at least 24 weeks for the primary outcome assessment, with ongoing monitoring as defined by the study protocol.

Researchers are studying advanced hepatocellular carcinoma HCC in patients who have Child-Pugh Class B7 cirrhosis and whose cancer has worsened after at least one prior treatment. This clinical trial aims to compare the safety and effectiveness of the drug namodenoson with a placebo in this group of patients. The trial is a Phase 3, multicenter, randomized, double-blind study designed to provide clear evidence on the benefits and risks of namodenoson for this condition. Participants will be randomly assigned to receive either namodenoson 25 mg or a matching placebo by mouth twice daily in 28-day cycles. Treatment continues until the disease progresses or side effects become unacceptable. Tumor imaging is performed every two cycles to monitor disease status. After stopping the study drug, patients will have a follow-up visit 28 days later, and those who agree will be monitored long-term for survival. If results allow, some patients may continue taking namodenoson openly beyond the blinded phase. During the study, participants will regularly visit the clinic for safety checks, laboratory tests, and tumor imaging. The main outcome measured is overall survival up to 60 months after randomization. Secondary outcomes include progression-free survival, objective response rate, and the nature of side effects. Pharmacokinetics of namodenoson will also be studied. Long-term survival data will be collected for those who consent to follow-up, ensuring thorough monitoring throughout the study period.

Researchers are evaluating the pharmacokinetic profile of naldemedine and its metabolite nor-naldemedine after a single oral dose in children aged 2 to 18 years who are receiving or about to receive opioid treatment. The study focuses on pediatric participants experiencing or expected to develop opioid-induced constipation, aiming to understand how the drug behaves in their bodies. This is a Phase 12 open-label study designed to assess safety, tolerability, and drug levels in this population. Participants are divided into three age cohorts 12 to under 18 years, 6 to under 12 years, and 2 to under 6 years. Each participant receives a daily dose of naldemedine, ranging from 0.05 mg to 0.2 mg based on body weight, for 7 days. The drug is given as an oral tablet 0.2 mg dose only or oral suspension all doses. Cohort 3 enrollment occurs after safety and pharmacokinetics data from the first two cohorts are reviewed. During the study, participants will have blood samples collected at multiple time points on Day 1, Day 2, and Day 7 for Cohort 1 to measure drug concentration and related pharmacokinetic parameters. Researchers will also monitor for any treatment-emergent adverse events and assess the ability to swallow tablets and the palatability of the oral suspension. The total participation spans at least 7 days of dosing with monitoring of safety and drug behavior throughout this period.

This research aims to evaluate how structured nursing care given before and after a transrectal prostate biopsy affects resilience and anxiety in men undergoing this procedure. The study is conducted at the University Clinical Hospital Mostar in Bosnia and Herzegovina and focuses on men suspected of having prostate cancer. It is a prospective, longitudinal interventional study assessing the effects of nursing support on emotional and physical outcomes. Participants receive a standardized nursing intervention that includes patient education, preparation for the procedure, communication, emotional support, and nursing care throughout the biopsy process. All participants undergo the same intervention as outlined in the study protocol. The study observes participants at three key time points before the biopsy, within 24 hours after the procedure, and 2 to 3 weeks later after they receive their biopsy results. During the study, resilience is measured using the Connor-Davidson Resilience Scale at all three time points, while anxiety is assessed with the Hamilton Anxiety Rating Scale before the biopsy and after results are given. Pain, lower urinary tract symptoms, and perception of nursing care are also evaluated at specified times. Histopathological results benign or malignant will be used for subgroup analysis. Participants are followed through these assessments over the study period, with about 100 to 110 expected to complete the study.

Researchers are evaluating the serum levels of vitamin B12, folic acid, and vitamin D in women of reproductive age living in Herzegovina. The study aims to find out whether current international guidelines for micronutrient supplementation during the preconception period and pregnancy accurately reflect the needs of this population. This observational, cross-sectional study is led by Professor Vajdana Tomi at the Faculty of Health Studies, University of Mostar, Bosnia and Herzegovina. The study will include 360 women aged 18 to 49 years, who will provide blood samples for analysis of vitamin B12, folic acid, and vitamin D levels. No treatments or interventions will be given. The study is conducted in three phases recruitment and sample collection, laboratory analysis using chemiluminescent microparticle immunoassays on the Alinity ci platform, and data evaluation followed by publication of results. The goal is to develop population-specific recommendations for micronutrient supplementation. Participants will attend a single visit for blood sampling to measure serum concentrations of the studied vitamins. Researchers will analyze the samples and use statistical software to assess the prevalence of micronutrient deficiency or excess. The study will monitor safety and adherence through informed consent and standard procedures. Results will guide personalized supplementation strategies for women planning pregnancy or already pregnant, with the total participation lasting one visit.