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  • Relationship Between Immunosuppressive Treatment Status and Clinical Course of Parkinson's Disease

    Phase

    N/A

    Span

    187 weeks

    Sponsor

    Medical University of Warsaw

    Warsaw

    Recruiting

  • Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis

    Phase

    2

    Span

    101 weeks

    Sponsor

    KeyBioscience AG

    Warsaw

    Recruiting

  • Diagnosis, Treatment, and Outcome Assessment of Septic Cardiomyopathy Using an Integrated Mathematical Model

    This multicenter, prospective observational study will enrol adult patients treated for sepsis or septic shock in the intensive care unit (ICU). Eligible patients will be identified based on predefined inclusion and exclusion criteria and enrolled in the study after obtaining informed consent. The primary transthoracic echocardiography will be performed within 48 hours of enrollment to gather detailed echocardiographic data, while key hemodynamic measurements will be recorded simultaneously. A second transthoracic echocardiography will be conducted within 10 days of the initial evaluation. This follow-up assessment will occur during continued ICU care after discontinuation of vasopressor therapy or during hospitalization in the general ward, depending on the patient's clinical progression. The echocardiographic and hemodynamic parameters from both the initial and follow-up evaluations will be input into a mathematical formula designed to integrate these data into a single cardiovascular estimate. This integrated model will then be used to assess its ability to predict patient outcomes. Following hospital discharge, patients will be followed for up to one year. During this period, a long-term follow-up assessment will be conducted, during which patients will complete the SF-36 quality of life questionnaire. This follow-up will assess patients&amp;#39; overall health, functional status, frequency of healthcare visits, and need for nursing care. These data will provide insights into the long-term impact of sepsis and septic cardiomyopathy on survivors beyond the acute phase of their illness. This study will evaluate whether the use of an integrated model that combines clinical parameters with echocardiographic measurements can improve the accuracy of diagnosing septic cardiomyopathy and provide valuable predictions of clinical outcomes. Additionally, the study will assess the course of septic cardiomyopathy and its impact on one-year follow-up outcomes, including patient quality of life. A broadly applicable diagnostic approach could allow for timely treatment adjustments, reduce the burden of sepsis-related complications, and improve overall patient outcomes.

    Phase

    N/A

    Span

    211 weeks

    Sponsor

    Vilnius University

    Warsaw

    Recruiting

  • Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.

    Inclusion and exclusion criteria Inclusion criteria Patients treated with CartiONE for knee cartilage lesion more than 6 months prior to inclusion in this study. The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index knee surgery report, and posttreatment observations and re-intervention reports, if applicable. Exclusion criterion Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation. Statistics This is a retrospective, open label, non-randomized, single arm trial. Since different questionnaires for effectiveness and for quality of life (e.g., KOOS, EQ-5D,...) may have been used, the total score of the questionnaires ranging from the minimum total score (i.e. 0 or 1) to the maximum total score will be transformed into the range from 0 respective 1 to 100. Now they can be combined across patients and effectiveness questionnaires or across patients and quality of life questionnaires. Details will be provided in the Statistical Analysis Plan. There are two co-primary endpoints: Primary endpoint safety: Adverse events with particular focus on Treatment failure rate and on other AESIs Primary endpoint effectiveness: MOCART sub-score 1 "Volume fill of cartilage defect" Efficacy/Effectiveness: Key secondary endpoints: Non-inferiority in MOCART/MOCART 2.0 total scores when measured at two different visits, i.e., at the reference visit and later. Non-inferiority in mean "Radiologist's overall knee status assessment" when measured on a scale from 0 (extremely bad) to 100 (extremely good) at two different visits, i.e., at the reference visit and later. Other secondary endpoints: Improvement in other effectiveness questionnaire total scores Improvement in quality-of-life total scores Improvement in other questionnaires when applicable Exploratory endpoint: "Radiologist's overall knee status assessment" on a scale from 0 (extremely bad) to 100 (extremely good) of the two readers.

    Phase

    N/A

    Span

    96 weeks

    Sponsor

    Cartilage Repair Systems BV

    Warsaw

    Recruiting

  • Impact of Knee Extension Brace on Quadriceps EMG During ASLR

    The study will be conducted on a group of healthy individuals aged 18 - 35 years. After an interview confirming that the subject does not have exclusion criteria and written consent to participate in the study, anthropometric measurements will be taken of height and weight using a scale and tape measure. The subjects will be informed in detail about the procedure and the form of the measurements, the way in which they are to be taken, and will be familiarised with the the measuring instruments and their principles of operation. Then, in accordance with the study protocol, specific measurements will be taken of the rectus femoris, medial vastus and lateral vastus muscles using surface EMG of a non-invasive nature. Study participants will undergo the following measurements: 1. Measurement of the MVC (maximum voluntary contraction) of the quadriceps of the thigh, in a sitting position with the lower leg flexed to 90 degrees. 2. Measurement of muscle activity during elevation of the straightened lower limb in a supine position without an orthosis. 3. Measurement of muscle activity during straight leg raise in supine position with knee brace. Ad.a. Measurement of quadriceps excitability of the dominant lower limb using surface EMG in a seated position with the trunk stabilised and the lower leg flexed to 90 degrees, stabilised in the distal part (without taking the foot) against a stationary object so as to execute maximal volitional isometric quadriceps muscle tension. Upper limbs crossed over the chest. Ad.b. Measurement of right quadriceps excitability using surface EMG in supine position without orthosis. The subject raises the test limb by touching the anterior surface of the tibia to a pole set at 20 cm at the command 'raise leg', then lowers the limb at the command 'lower leg'. During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times. Ad.c. Measurement of quadriceps excitability of the dominant lower limb using surface EMG in supine position with knee extension brace on. Measurement performed in three variants: 1. The test subject raises the test limb by touching the front surface of the tibia to a pole set at a height of 20 cm on the command 'raise leg', then lowers the limb on the command 'lower leg'. During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times. 2. The test subject is asked to apply maximum tension to the quadriceps (thigh muscle) (command 'press the knee against the ground, bring the toes together, straighten the foot and flex the quadriceps maximally"), then maintaining the tension he/she raises the limb touching the front surface of the tibia to the pole placed at the height of 20 cm on the command "raise the leg", then lowers the limb on the command "lower the leg". During the task there is a 1 second moment of holding the leg straight as the tibia touches the pole. This action is repeated three times. 3. Before the test, the test subject is verbally instructed to 'Try, despite the orthosis holding you upright, to bend the knee and raise the leg so that the quadriceps do not tense'. Then, on the command 'raise leg', the test subject raises the limb by touching the front surface of the tibia to a pole set at 20 cm, on the command 'lower leg' he lowers the limb. During the task there is a 1 second moment of keeping the leg straight as the tibia touches the pole. This activity is repeated three times. The time for the full test is approximately 15-20 minutes per participant. Statistical analysis will be performed using Statistica and/or JASP software. The study will be carried out with a minimum of 20 adults aged 18 - 35 years. The exact number of participants in the study, will be determined after performing an a-priori sample size estimation after collecting data from the first 10 people examined. Eligibility of subjects will include a subject and physical examination by a physiotherapist. Inclusion criteria: age between 18-35 years, no contraindications to physical exercise, ability to perform the required commands without pain or discomfort, full range of motion of the knee joint. Exclusion criteria: those with a history of knee and/or hip surgery, damage to ligamentous structures of the knee joint in the past treated conservatively or meniscus treated conservatively, muscle and tendon injury of the knee joint area in the past 3 months.

    Phase

    N/A

    Span

    48 weeks

    Sponsor

    Józef Piłsudski University of Physical Education

    Warsaw

    Recruiting

    Healthy Volunteers

  • Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

    Phase

    N/A

    Span

    93 weeks

    Sponsor

    Institute of Mother and Child, Warsaw, Poland

    Warsaw

    Recruiting

  • Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS)

    Phase

    N/A

    Span

    133 weeks

    Sponsor

    University of Glasgow

    Warsaw

    Recruiting

  • Polish Version Fatigue Severity Scale

    Fatigue is one of main symptoms in multiple sclerosis, amyotrophic lateral sclerosis, post-polio syndrome, stroke, parkinsonism as well as in the chronic fatigue syndrome. It has profound effect on quality of life and professional and social functioning and in multiple sclerosis it is described as the worst symptoms by the 50% of patients. It is defined as the difficulty in initiating and maintaining a sustained mental or physical activity. Not infrequent it is misdiagnosed as sleepiness or other symptom. Fatigue severity scale (FSS) is a time efficient and easy to apply instrument to assess the impact of fatigue on patient's life. It has been translated and validated in Turkish, Russian, Hindi, Portuguese, and many other languages. FSS is a short, nine-item self-report questionnaire. Each item is a Likert scale, scored from one to seven, where seven refers to the most severely expressed aspect of fatigue. The aim of this study is to validate the Polish-language version of the Fatigue Severity Scale (pFSS). This version has been created according to widely accepted, respective standards, including translation by two independent native Polish-language speakers with acquired knowledge of English and backward translation by two independent native English-language speakers with acquired knowledge of Polish as well as with the pretesting on ten patients.

    Phase

    N/A

    Span

    126 weeks

    Sponsor

    Jakub Antczak

    Warsaw

    Recruiting

    Healthy Volunteers

  • The Effect of a Multispecies Probiotics on Autism Symptoms and the Quality of Life in Children

    This study is a randomized, double-blind, placebo-controlled clinical trial. One hundred and eight children aged 7 to 15 years diagnosed with Autism Spectrum Didorder will be randomly assigned in a 1:1 ratio to receive either a multispecies probiotics or a placebo for 12 weeks. The probiotic mixture contains 5 x 10^9 colony forming units per dose consisting of Bacillus subtilis W201, Bifidobacterium infantis W17, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus rhamnosus W140, Lactococcus lactis W19, Propionibacterium freudenreichii W200. The two co-primary outcomes will be the assessment of core autism symptoms using the Autism Symptom Rating Scales (ASRS) and quality of life measured by the Quality of Life in Autism Part A questionnaire (QoLA-A). The secondary outcomes will include evaluations of sleep impairments using Children Sleep Habit Questionnaire - Abbreviated (CSHQ-A), parental stress levels using Parenting Stress Index-III (PSI-III), gastrointestinal symptoms using Gastrointestinal Symptom Rating Scale (GSRS), and urinary p-cresol levels. These outcomes will be assessed twice: at baseline and after 12 weeks of intervention.

    Phase

    N/A

    Span

    104 weeks

    Sponsor

    Medical University of Warsaw

    Warsaw

    Recruiting

  • Blood Pressure Changes After Bariatric Surgery

    Pathogenesis of blood pressure reduction associated with weight loss is not established. We hypothesize that monitoring of blood pressure changes after weight loss, with concomitant evaluation of cardiac output and selected biochemical parameters related to blood pressure regulation may help in the understanding of weight loss-associated decrease in blood pressure. The study protocol include measurement of blood pressure (bedside and 24h blood pressure monitoring), assessment of the cardiac function and biochemistry 1-2 days before laparoscopic sleeve gastrectomy and at the time of routine surgical follow-up visits after surgery ie. one week, one month, six and twelve months. Blood pressure measurements will be performed using automatic oscillometric monitors (OnTrak , Spacelabs,USA). Cardiac evaluation will include an echocardiographic assessment of the systolic and diastolic left ventricular function as well as cardiac output measurement using Doppler method. Biochemistry measures, in addition to routine blood tests needed for surgical follow-up, will include fasting insulin, high sensivity C-reactive protein, cystatin C, and NT-proBNP.

    Phase

    N/A

    Span

    247 weeks

    Sponsor

    Medical University of Warsaw

    Warsaw, Mazowieckie

    Recruiting

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