There are about 9702 clinical studies being (or have been) conducted in Poland. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.
To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia
Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.
During the last 10 years many studies concerning the impact of physical training on whole-body insulin sensitivity have been published, but there is a lack of an extended investigation on the potential clinical benefits of novel circuit training-based on strength and endurance exercises-relating to the optimization of insulin sensitivity and vascular endothelial function. It is of interest to precisely determine the physiological and biochemical effects of circuit training. An important aspect of the planned research will be the analysis of the effects of physical training on the released during muscle contraction myokines capable of modulating various metabolic processes. We hypothesized that in studied participants 12 weeks of the novel form of training would result in improving insulin sensitivity and vascular endothelial function mainly via myokines released by contracting skeletal muscles. The following questions will be asked: (1) whether the 12-week circuit training (combined strength and endurance exercises) performed by women with insulin resistance, improves insulin sensitivity, carbohydrate and lipid metabolism and promotes the efficiency of endothelial defense mechanisms? (2) whether the 12-week circuit training (combined of strength and endurance exercises) changes the concentrations of transcription factors regulating lipid and carbohydrate metabolism or the synthesis and/or secretion of myokines and adipokines in women with insulin resistance? (3) whether the 12-week strength training, interspersed with bouts of endurance exercise has a positive effect on cytokine profile? (4) whether there is a relationship between changes in body composition, HOMA-IR, and the level of myokines caused by physical training? (5) whether the 12-week circuit training reduces low back pain symptoms, plantar stifness and improve functioning of the patient in everyday life? A group of 80 women, aged 25 to 45 years, with diagnosed insulin resistance will participate in the planned study. Participants will be enrolled in the research program based on medical qualification. Before the intervention all women will have venous blood collected to determine fasting glucose, hemoglobin glycosylated (HbA1C) and insulin levels and insulin resistance by the homeostasis model assessment of insulin resistance (HOMA-IR) will be calculated. The inclusion criteria will be as follows: (1) women, age: 25-45 years, menstruating, (2) BMI 18,5-29,9 kg/m2, (3) insulin resistance based on HOMA-IR (cut-off point 2.5), (4) HbA1C ≤ 6.5%, (5) not contraindicated to physical activity. Participants meeting the inclusion criteria will be randomly divided into two groups. The first group of women will undergo circuit training, consisting of exercises performed on 7 machines arranged in a circuit. Thanks to the use of adequate software the machines will automatically adjust their parameters, such as seat height or resistance to the exercising person, and the training progress will be individually monitored. The planned training will last for 3 months, during which the patients will exercise 3 times a week for 30 minutes (2 circuits will be done during each session). The planned duration of the training session will be controlled (one minute for strength exercises, four minutes for endurance exercises and a 30-second break between each exercise). In the training group, one-repetition maximum exercise test (1RM) will be performed to determine the appropriate training load and later after the program to verify the increase in muscle strength. The range of maximum heart rate (HRmax) will also be determined in all exercising women. The second group of women, who will be asked to maintain their current level of physical activity and their diet for a period of 3 months will serve as a control group. Before and after the training program in all participants of the study pulse wave velocity, anthropometric parameters and body composition will be assessed. Concurrently venous blood will be taken to determine biochemical indicators related to carbohydrate and lipid metabolism, insulin resistance, vascular endothelium function, inflammation and adipocytokines and myokines. In both groups of women, the questioners concerning dietary intake and the level of daily physical activity will be administered. Results will be subjected to analysis involving descriptive, and advanced statistic method among them analysis of correlations, regression, variance and cluster analysis. All calculations and statistics will be performed using TIBCO Statistica 13.3 software (TIBCO).
This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death ligand 1 (PD-L1)-refractory/relapsed patients with unresectable Stage III or IV melanoma. The contributions of BNT111 and cemiplimab will be delineated in single agent calibrator arms. Patients will be randomized in a 2:1:1 ratio to Arm 1 (BNT111 + cemiplimab) and calibrator Arm 2 (BNT111 monotherapy), and Arm 3 (cemiplimab monotherapy). Patients in single agent calibrator arms (Arms 2 and 3), who experience centrally verified disease progression under single agent treatment, may be offered addition of the other compound to the ongoing treatment after re-consent.
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
This is a prospective, randomized, placebo-controlled, double-blind, multicenter phase III registration clinical study to observe, compare and evaluate the efficacy and safety of Toripalimab combined with Lenvatinib versus placebo combined with Lenvatinib as the 1st-line therapy for advanced HCC. Eligible subjects will be randomized at a ratio of 2:1 to receive Toripalimab combined with Lenvatinib (experimental group) or Placebo combined with Lenvatinib (control group).