Karlovy Vary 1

Researchers are evaluating the effectiveness, safety, and tolerability of two different doses of remibrutinib compared to a placebo in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). This phase 3 study aims to determine how well remibrutinib works in treating this chronic skin condition characterized by painful abscesses and inflammatory nodules. The study lasts a total of 76 weeks and includes several phases: up to 4 weeks for screening, followed by a 16-week double-blind treatment period where participants receive either remibrutinib Dose A, Dose B, or a matching placebo. After this, there is a 52-week treatment period where all participants receive remibrutinib (Dose A or Dose B). Finally, a 4-week safety follow-up period occurs without treatment. Participants who stop treatment early are encouraged to stay in the study and complete the safety follow-up. During the study, participants will be regularly assessed for clinical response to treatment, focusing on the proportion achieving a 50% improvement in HS symptoms by week 16. Researchers will monitor safety and tolerability throughout the study, including during the follow-up period. Various evaluations such as physical exams and clinical assessments will be conducted to measure treatment effects and ensure participant safety over the entire 76-week duration.

Researchers are studying how well and safely orforglipron works in adult women who have stress urinary incontinence (SUI) and are overweight or have obesity. SUI is a condition where urine leaks during movements like coughing or exercising. This trial is part of a master protocol including two independent studies, and it is a Phase 3 clinical trial. Participants will be randomly assigned to receive either orforglipron tablets or a placebo, both taken orally once daily. The treatment period and study participation will last approximately 58 weeks, including screening and safety follow-up. The study compares the effects of orforglipron against placebo in this specific group of female patients. During the study, researchers will track changes in the frequency of incontinence episodes from the start to week 52. Participants will undergo screening, treatment, and safety monitoring throughout the trial. The study aims to assess the effectiveness and safety of orforglipron in reducing urinary leakage events over time.

Researchers are evaluating the safety and effectiveness of upadacitinib in treating adults and adolescents with moderate to severe hidradenitis suppurativa (HS) who have not responded to or cannot tolerate anti-tumor necrosis factor (TNF) therapy. HS is an inflammatory skin disease causing painful lesions in areas such as the underarms, groin, and anal/genital regions. This phase 3, double-blind study involves approximately 1328 participants worldwide and aims to monitor disease activity and adverse events over time. Participants will receive oral tablets of either upadacitinib or placebo once daily during Period 1 and Period 2, lasting a total of 36 weeks. In Period 1, participants are randomly assigned to one of two treatment groups, with a 50% chance of receiving placebo. Based on results and placement in earlier periods, participants enter Period 2 with six potential treatment groups. Eligible participants from these periods may continue into Period 3, a long-term extension lasting 68 weeks, continuing the same daily oral treatment. Following the treatment periods, participants will be followed for approximately 30 days. During the study, participants will attend regular outpatient visits for medical assessments, monitoring for side effects, and completing questionnaires. Researchers will measure the percentage of participants achieving a clinical response called HiSCR 50 from baseline to week 16 and track adverse events up to approximately week 108. The study may require a higher treatment commitment compared to usual care, but provides close monitoring of disease activity and safety throughout all study phases.

Hidradenitis suppurativa (HS) is a chronic and often painful skin disease that causes lumps, abscesses, and scars in areas like under the breasts, armpits, inner thighs, groin, and buttocks. Researchers are evaluating the investigational drug lutikizumab compared to placebo in adults and adolescents with moderate to severe HS. This study aims to assess the disease activity and safety of lutikizumab in a Phase 3 clinical trial involving about 1280 participants worldwide.

This research aims to improve early detection of Hepatitis C virus (HCV) infection among people who inject drugs (PWID) in the Czech Republic. It is a national, prospective, multicenter, non-interventional pilot project conducted in 18 clinical centers. The goal is to prepare, implement, and evaluate a screening process for early HCV detection and to develop new methods to integrate this screening into social healthcare systems. The project also seeks to reduce further transmission of HCV by identifying gaps in ongoing care for this population. Participants will undergo testing for hepatitis C antibodies to determine past exposure to the virus. Those who test positive for antibodies will receive further testing for HCV RNA and genotype to confirm active infection. Approximately 3,000 PWID will be enrolled to test the screening procedure and assess its effectiveness in real-world clinical settings. Participants will be screened and monitored until December 31, 2025, with researchers tracking the incidence of HCV in the screened cohort. The study will help create a methodology for continuous care from early diagnosis through treatment and propose system changes to make screening more efficient. The project is supported by European and Czech funding and registered by national authorities.

Overactive bladder (OAB) is a common health issue affecting many adults, with about 15-20% of the population experiencing it. This research aims to increase awareness and ensure that people with OAB symptoms are correctly referred to specialists such as gynecologists, urogynaecologists, or urologists for proper diagnosis and treatment. The study uses an online screening tool to identify individuals who might have OAB and need specialist evaluation. Participants will use a web platform or mobile app to complete validated questionnaires about their urinary symptoms, personal and family medical history, and quality of life. Those with positive screening results will be referred to a specialist who can access their screening data through the platform, perform further diagnostic tests if needed, confirm or rule out OAB, and decide on appropriate treatment. The study also includes a public relations campaign to encourage participation and improve awareness. During the study, participants will complete the online screening and may attend face-to-face specialist visits for diagnosis. Researchers will monitor the number of participants who complete the screening, the percentage of those with suspected OAB agreeing to follow-up, those diagnosed by specialists, and those who attend follow-up visits up to nine months. The data collected will help evaluate the screening process and its impact on quality of life, with attention to safety and privacy under GDPR.

This research aims to evaluate the safety and effectiveness of paramedics administering sufentanil intravenously to adults experiencing acute trauma pain without the presence or phone consultation of an emergency medical doctor. The study focuses on pain caused by injury and compares two approaches: sufentanil given by paramedics after consulting a remote physician versus sufentanil given based on paramedics' own competency without consultation. This observational study builds on previous findings but excludes distortions caused by the COVID-19 lockdown period. The study involves two treatment methods: one where paramedics administer sufentanil only after a phone consultation with a medical doctor, and another where paramedics independently administer sufentanil based on their training and competence. Both methods involve intravenous administration of the opioid analgesic sufentanil to patients with acute injuries to manage severe pain. Participants will be assessed for safety outcomes such as incidences of apnea, slow breathing (bradypnoea), nausea, and vomiting within 60 minutes after sufentanil administration until hospital handover. Pain relief effectiveness will be measured using numeric rating scales and visual analogue scales before administering sufentanil and again at hospital handover. The study monitors vital signs and pain levels during prehospital care to ensure patient safety and treatment efficacy.