Kaliningrad

Researchers are evaluating the effectiveness and safety of BCD-248 as a treatment for patients with relapsed or refractory multiple myeloma. This open-label Phase 2 study focuses on individuals who have previously received at least two lines of therapy, including specific treatments like proteasome inhibitors, immunomodulatory drugs, and anti-CD38 therapy. Participants must have measurable disease and documented progression according to established criteria. The study treatment involves administering BCD-248 subcutaneously. Patients eligible for the trial will receive this investigational drug during the study period. There are no comparator groups mentioned, and the treatment is given as a single intervention. This trial does not mention additional phases or extension periods. Participants will be monitored for their overall response rate to treatment up to 24 weeks, based on criteria set by the International Myeloma Working Group. Assessments include disease evaluations and safety monitoring. The study involves careful screening to ensure participants meet specific health and prior treatment requirements, with follow-up to track treatment outcomes and adverse events throughout the study duration.

Researchers are studying patients with colorectal cancer to understand how the location of the tumor affects risks like death, leakage at the surgical connection site, and other complications after surgery. They also look at cancer recurrence and survival rates specific to colorectal cancer. This study focuses on measuring these outcomes to better understand treatment results based on tumor position within the colon or rectum. Various surgical procedures are used depending on tumor location. These include right and left hemicolectomy, sigmoid colon resection, anterior and low anterior resection of the rectum, abdominoperineal resection for tumors invading certain muscles, and total colectomy for multiple tumors. Each surgery targets a specific part of the colon or rectum where the tumor is found. Participants will undergo surgery and be monitored for outcomes such as anastomotic leakage within 3 months and mortality over 3 years. The study includes follow-up visits to assess early and late postoperative complications, cancer recurrence, and survival. Researchers will collect data during these visits to evaluate treatment effectiveness and safety over time.

The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material. For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).

Researchers are evaluating the effectiveness and safety of varying doses of Grammidin with anesthetic, a metered dose topical spray, in treating acute infectious and inflammatory diseases of the throat. This Phase 2 study compares Grammidin with anesthetic to Septolete Total lozenges in adults aged 18 to 75 who experience sore throat symptoms due to conditions like acute pharyngitis, nasopharyngitis, or exacerbation of chronic pharyngitis. Participants receive different doses of Grammidin with anesthetic spray or Septolete Total lozenges. The study involves a randomized, parallel-group design to compare these treatments. The primary measure of success combines pain intensity and throat assessment scores over the first 8 days of treatment, with visits scheduled accordingly. During the study, participants report sore throat severity using the Visual Analog Scale and other clinical symptom scales. Researchers monitor symptom changes from Day 1 to Day 8 and assess safety throughout. Patients must meet specific criteria such as symptom duration and pregnancy testing, and they are followed closely to measure treatment effects and any adverse events during this period.

Researchers are evaluating the effectiveness and safety of Raphamin in treating adults aged 18 to 75 years with acute rhinosinusitis, a condition characterized by symptoms such as facial pain and nasal congestion. This multicenter, double-blind, placebo-controlled, randomized clinical trial enrolls patients within 48 hours of symptom onset during the seasonal peak of acute respiratory viral infections. The study uses the Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) to assess symptom severity and quality of life. Participants are randomly assigned to receive either oral Raphamin or a placebo following the same dosing schedule for five days. The trial includes a screening and randomization period of up to one day, a five-day treatment phase, and a follow-up period lasting up to 14 days. Patients attend three in-person visits on days 1, 4, and 7, with an additional phone visit on day 14. During these visits, symptom assessments, physical examinations, and diary reviews are conducted to monitor treatment adherence and safety. Patients keep an electronic diary twice daily to record body temperature and symptom changes according to the MSS. Investigators evaluate symptom progression, adherence, safety, and any complications including the use of antibiotics or hospitalizations. The primary outcome is the percentage of patients showing improvement in acute rhinosinusitis symptoms by day 4. Symptomatic and concomitant disease therapies are allowed except for prohibited medications. Overall, participants are observed for up to 14 days to assess treatment impact and safety.

Researchers are investigating the effectiveness and safety of using recombinant non-immunogenic staphylokinase (Fortelyzin4) administered directly into the artery at the site of the clot in patients with acute limb ischemia (ALI) compared to traditional surgery. This phase 3 clinical trial focuses on patients with ALI of degrees I to II b, aiming to find better treatment options since intravenous thrombolysis is ineffective for this condition. Previous studies with Fortelyzin4 in heart attack and stroke patients showed promising results with fewer bleeding complications and no immune reactions. The study compares two treatment approaches: intra-arterial thrombolysis with Fortelyzin4, a fibrin-selective clot-busting drug given as a lyophilisate solution, and surgical methods including endovascular intervention, open surgery, or bypass surgery following national guidelines. Patients will be randomly assigned to either receive Fortelyzin4 directly at the clot or undergo one of the surgical procedures. The trial is open-label and conducted at multiple centers. Participants will be monitored to see if they avoid amputations within 30 days after treatment. Researchers will assess safety and effectiveness through clinical evaluations and track adverse events. Informed consent and contraceptive use during and after the study are required for participants. The study includes follow-up to measure outcomes and ensure participant safety over the trial period.