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Banskabystrica, Slovakia

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  • SCAD : a Registry of Spontaneous Coronary Artery Dissection

    Observational, multicentre, international retrospective and prospective cohort study. Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled. Patient data will be collected at the following time-points: - First SCAD event visit (retrospectively on chart review) - First follow-up: at time of enrolment - Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion Approximately 30 countries and 120 sites will participate in this registry.

    Phase

    N/A

    Span

    353 weeks

    Sponsor

    European Society of Cardiology

    Banska Bystrica

    Recruiting

  • Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

    The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event. Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments: 1. Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 2. Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet 3. Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin. The study will be conducted at approximately 700 sites in approximately 40 countries globally.

    Phase

    3

    Span

    165 weeks

    Sponsor

    AstraZeneca

    Banska Bystrica

    Recruiting

  • A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

    The drug being tested in this study is TAK-279. TAK-279 is being tested to treat participants with moderately to severely active Crohn's disease. The study will look at the efficacy and safety of TAK-279. The study will enroll approximately 268 participants. During the Induction Period participants will be randomly assigned to one of the following treatment groups in a ratio of 1:1:1:1 to receive TAK-279 or placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. TAK-279 Dose 3 4. Placebo This multi-center trial will be conducted globally. The overall study duration is approximately 60 weeks including a 4-week safety follow-up period.

    Phase

    2

    Span

    177 weeks

    Sponsor

    Takeda

    Banska Bystrica

    Recruiting

  • Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia

    Phase

    3

    Span

    119 weeks

    Sponsor

    Arrowhead Pharmaceuticals

    Banska Bystrica

    Recruiting

  • A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

    The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active CD. The drug is tested and approved in adults in approximately 70 countries. Participants to be enrolled must have failed response to, lost response to, or been intolerant to at least 1 of the current standard of care (SOC) induction and maintenance therapies for CD including exclusive and/or partial enteral nutrition therapy, immunomodulators (e.g., azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists. The study will enroll approximately 120 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as: - Participants 10 to 15 kg, Vedolizumab 150 mg - Participants >15 to <30 kg, Vedolizumab 200 mg - Participants ≥30 kg, Vedolizumab 300 mg At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to one of the 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and by weight groups. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows: - Participants ≥30 kg, Vedolizumab 300 mg (High dose) or 150 mg (Low dose) - Participants >15 to <30 kg, Vedolizumab 200 mg (High dose) 100 mg (Low dose) - Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) or 100 mg (Low dose) The dose will remain blinded to the participant and study doctor during the study (unless there is an urgent medical need). All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion to the high dose in their weight group based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed during Maintenance Period. This multi-center trial will be conducted worldwide. After the Week 54, participants may be eligible to continue receiving vedolizumab in extension study MLN0002-3029. Participants who do not maintain corticosteroid-free clinical response at week 54 will undergo an end-of-study (EOS) or ET visit, and a safety visit 18 weeks after the last dose of vedolizumab followed by 2 years of long term follow-up (up to 104 weeks), in addition these participants will then be eligible to enter study MLN0002-3029 for an observational LTFU period of 2 years after the last dose of study drug.

    Phase

    3

    Span

    212 weeks

    Sponsor

    Takeda

    Banska Bystrica

    Recruiting

  • Cirrhosis Registry of Hospitalized Patients

    On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate. After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution [FDR]) Mortality data are uploaded from the national registry of dead on regular basis

    Phase

    N/A

    Span

    809 weeks

    Sponsor

    F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

    Banska Bystrica

    Recruiting

  • Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

    Explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

    Phase

    2

    Span

    308 weeks

    Sponsor

    Pfizer

    Banska Bystrica

    Recruiting

  • Fecal Microbial Transplantation in Severe Alcoholic Hepatitis

    - FMT via upper GI tract is provided to CS non-responders (NR) or non-eligible (NE) adult patients hospitalized with SAH (determined by the Lille-model). - Modified version of the Sarin FMT protocol is used with microbiota material procured from unrelated healthy donors.

    Phase

    3

    Span

    248 weeks

    Sponsor

    F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

    Banska Bystrica

    Recruiting

  • Transfer Factor Efficacy in the Management of Cirrhosis-associated Immune Dysfunction

    Most of mortality from advanced chronic liver disease (ACLD) is mediated by so- called specific complications of end-stage liver disease (ESLD); one of the most important is infection (25-30%). Infection is responsible for considerable proportion of ESLD-related mortality. Important in pathogenesis of infections in ESLD is CAIDS (cirrhosis - associated immune dysfunction syndrome), recently re-named to CAID (Cirrhosis-Associated Immune Deficit). TRANSFER FACTOR (TF) is supposed to act at several points in CAID - cascade. This gave rise to hypothesis, that TF could be of benefit in AD/ACLF. Characteristics of TF It has been shown that transmission fo T-Lymphocyte reactivity is transmissible not only by T-cells alone, but also by hommogenate of peripheral white blood cells. Later it became clear that for the transmission of cellular immunity is responsible dialysable fraction of T-lymphocytes homogenate (with small molecular weight of 10 kDa; consists of amino acids, small peptides, nucleotides etc). This homogenate was named Transfer - factor (TF). One dose of lyophilized drug contains: Leucocyti dialysatum 200 x 10 6 (contains various IFNs, ILs, chemokines, endorfins, heat shock protein etc) - stimulates T H 1 response - induces production of IL-1, IL-2 - activates chemotaxis of immunocompetent cells - increases fagocytic activity - activates antigen-presentation by APCs The aim of this study is to assess the efficacy of transfer factor in decreasing rate and/or severity of infections in ACLF.

    Phase

    2/3

    Span

    213 weeks

    Sponsor

    Martin Janičko

    Banska Bystrica

    Recruiting

  • Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis

    Total study duration per participant will be up to 58 weeks, including a screening period of up to 4 weeks, a treatment period up to 52 weeks and a post-treatment follow-up period of 2 weeks.

    Phase

    2

    Span

    212 weeks

    Sponsor

    Sanofi

    Banska Bystrica

    Recruiting

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