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.
The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU. After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.
Aerobic fitness is an important part of sport training preparation for wheelchair rugby players. Currently, there are some test protocols on arm crank ergometer for spinal cord injury people. However, wheelchair propulsion seems to be better and more specific movement to assess aerobic fitness in wheelchair rugby player. Thus, this pilot study was designed to determine the reliability of the aerobic fitness test protocol on a wheelchair ergometer for wheelchair rugby players. Methods Ten wheelchair rugby players (C5/6 = 4, C6/C7 = 3, C7/th1 = 1 all with incomplete lesions, cerebral palsy (CP) = 1; dysmelia = 1; mean age = 32,90 yr. ± 5,17; body mass = 70,04 kg ± 12,53; body height = 177,70 cm ± 18,64) participated in the aerobic fitness test on the Lode Esseda wheelchair ergometer (LEM Software 10.12, Groningen, Netherlands). This test involved different considering players' International Wheelchair Rugby Federation (IWRF) class (class 0.5 = 4 players, classes 1.0-1.5 = 6 players, and classes 2.0-3.5 = 8 players) increments of workload every minute at constant velocity of 4.5 km/h. Peak oxygen uptake (V̇O2peak l/min, V̇O2peak ml/kg/min), minute ventilation (VE), and the test time achieved were collected (Cortex Metamax). The load [N, Watts] from the last fully achieved level in the test was noticed. Participants repeated the aerobic fitness test twice with 24h break. Each player had 10 minutes warm-up before the test. Differences (T-test for independent groups or Wilcoxon test) and correlations (Pearson test or Spearman test) between results from the first and the second repetition of the test (fully achieved load level in the test) were calculated to establish reliability. The intra-class correlation coefficients (ICC) and standard error of measurement (SEM) were added. The significance level was set at p<.05
Lumbar spine pain syndromes are one of the most common pain conditions in our society. The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Today, this method is used in many fields of medicine. Its primary purpose is to support the musculoskeletal system by using various types of applications. There is a lack of publications in the global literature on the effect of kinesiotaping of the external oblique muscles on lumbar spine pain. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.
This is a parallel, treatment, Phase 2, double-blind, 2 arm, 12-week Proof of Concept (PoC) study with 2 staggered cohorts (2 arms in each cohort) that is designed to assess the efficacy, safety, and tolerability of rilzabrutinib in adult participants (aged 18-70 years) with moderate-to-severe asthma who are not well controlled on ICS/LABA therapy. Study treatment includes investigational medicinal product (IMP) (rilzabrutinib or placebo) added-on to a background therapy of ICS/LABA (fluticasone/salmeterol [non-investigational medicinal product], standardized at screening). Background therapy of ICS/LABA will be withdrawn during the 12week randomized treatment period and resumed at the end of the IMP treatment period, as outlined below: - Screening period (4 weeks) - Randomized IMP treatment period (12 weeks ± 3 days) - Background therapy stabilization phase (4 weeks) - Background therapy withdrawal phase (4-5 weeks) - No background therapy phase (3-4 weeks) - Post IMP treatment safety follow-up period (4 weeks ± 3 days)
This study is open to people aged 18 to 65 who have post-traumatic stress disorder. The purpose of this study is to find out whether a medicine called BI 1358894 improves symptoms in people with post-traumatic stress disorder. Participants are put into 2 groups randomly, which means by chance. Participants take BI 1358894 or placebo as tablets every day for 2 months. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 4 phone calls from the trial staff. During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether their symptoms change. The doctors also regularly check participants' health and take note of any unwanted effects.
Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: - record information about the participants' hot flashes in an electronic diary - answer questions about the participants' symptoms The doctors will: - check the participants' health - take blood samples - ask the participants questions about what medicines the participants are taking and if the participants are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.
Deep tissue massage (DTM), based on deep palpation and elimination of fascia restrictions, can reduce symptoms resulting from fascial disorders. The goal of this study was the analysis of the DTM effect on respiratory parameters in healthy people. People of both sexes living in the city of Cracow were recruited to the study by the authors personally and through social media. An original questionnaire was completed in the presence of the examiner in order to collect the participants characteristics data. Questions about past diseases, previous surgical procedures or injuries, currently taken medications or the level of physical activity were asked to check the inclusion/exclusion criteria. The study involved a group of 40 people divided into two subgroups. The experimental group underwent a single DTM session. Classic massage was performed in the control group. Before and after treatment the lung vital capacity, chest circumference and oxygen saturation were measured and a spirometry test was performed. The main hypothesis assumed that static respiratory parameters should increase after the treatment session more in the experimental than in control group while the dynamic respiratory parameters would not differ significantly in both groups before and after treatment.
The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.
A survey of Polish respondents will aim to define migraine characteristics in Polish subjects. To achieve this, a structured questionnaire based mainly on American Migraine Prevalence and Prevention Study has been prepared to serve as a tool for data extraction. The obtained data should allow for defining disease parameters, burden and received treatments. Additionally questions regarding patients rhinological symptoms and COVID-19-related history were included.
This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.