Dnipo, Ukraine

Budesonide As a Treatment for Functional Dyspepsia

Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

A First-in-Human Open-label, Phase I/Ib Dose Escalation and Expansion Cohort Study of EOS006215 as Monotherapy and in Combination With Pembrolizumab or Other Anticancer Treatments in Participants With Advanced Solid Tumors

The study will be conducted in 2 parts: - Part 1 - Dose Escalation Phase I dose escalation cohorts for EOS006215 as monotherapy and in combination with anticancer treatments in participants with specific tumor types. - Part 2 - Dose Expansion Phase Ib dose expansion cohort(s) may be included to further evaluate the safety, tolerability, efficacy, PK and PD of EOS006215 as monotherapy or in combination with anticancer treatments in participants with specific tumor types.

Open Label Safety Study of Tradipitant in Idiopathic and Diabetic Gastroparesis

Protein Requirements After Bariatric Surgery

The study objective is to determine maintenance dietary protein requirements for adult males who have previously undergone Roux-en-Y-Bypass (RYGB) surgery, using the minimally invasive Indicator Amino Acid Oxidation (IAAO) method. The study hypothesis is that dietary protein requirements will be elevated in this population compared to young adults with no previous bariatric surgery. The null hypothesis states that there is no difference in dietary protein requirements between adults with previous RYGB surgery and adults without previous surgery. Protein requirements will be expressed relative to fat-free-mass (FFM) to account for obesity-related increases in lean mass. The primary endpoint of the study is the estimated average protein requirements (g/kg FFM/d) and the upper limit of the 95% confidence interval. The study comprises a nutritional experimental study using the IAAO method to determine protein requirements. Indicator amino acid oxidation is measured at seven incremental protein intake levels, each on a separate study day after two adaptation days. Protein intake requirements are calculated as the protein intake level where the indicator amino acid oxidation ceases to decline further despite a further increase in protein intake. This is referred to as the breakpoint. The sequences of protein intake levels are randomized for each study participant. Protein requirements are calculated, not per individual, but for the whole study population, when sufficient oxidation studies are included at each protein intake level. This implies that the same individual does not have to complete all the oxidation studies at the seven time points. The study will consist of one initial screening and planning visit, and 2 to 7 metabolic trial visits. Each participant can complete at least two, preferably more, and up to all 7 protein intake levels. Patients who previously consented to be included in a UZ Leuven Obesity Clinic repository (ClinicalTrials.gov Identifier NCT04614961; S-62590) will be pre-screened according to the study criteria. Thereafter patients who remain eligible will be contacted and will receive information regarding the study using the informed consent form. An invitation to participate in the study will also be circulated through patient support groups of obesity and bariatric surgery using their social network platforms (See addendum A). Patients who are interested in participation will be invited to contact the study coordinator. Patients who complete the pre-screening assessment and remain eligible will invited to a screening visit. Patients who remain eligible to partake will receive further information regarding the study procedures and will be provided with instructions and food items and utensils needed for the first 3-day metabolic experiment. Patients will also be provided with a multivitamin-mineral supplement suitable for patients following bariatric surgery to consume for the duration of the study. Habitual dietary intake will be self-reported using a 3-day food diary. For patients who do not meet all inclusion criteria, any newly identified raised blood glucose, blood pressure, abnormal liver function or decreased kidney function will be reported to the patient and their general practitioner. The study day will be repeated 7 times, each at a different intake level. The subjects will randomly receive one of seven protein intakes levels during each IAAO experiment (figure 1.). Simple randomization will be conducted using RedCap and allocation tables created in R to allocate a different protein level during each of the visits. Allocation will be concealed from participants. One investigator will be unblinded to allocation as he needs to calculate and physically prepare the study diets based on the specific protein intake level of the given study day. This will not interject bias as the study outcomes are metabolic processes measured by objective biochemical analysis. Adaptation days protocol Patients will be contacted, and experimental visits scheduled. The study protocol is based on the established IAAO method(26). On two adaptation days prior to the IAAO testing day, patient will consume a maintenance diet providing ad libitum energy intake and protein intake of at 1.5 g/kg ideal body weight. This amount of protein meets current upper-limit of protein requirements for individuals after bariatric surgery(16), and thereby to avoid a catabolic state during the adaptation period. The maintenance diet will be the participants habitual food intake with the additional of additional protein supplements as necessary. Participants will be allowed to consume one cup of coffee or tea and additional water as needed. Food intake during the 2 days will be recorded to measure protein and energy intake. Metabolic study days On the study days, patients will visit the ACRONIM study unit at UZ Leuven. Patients will be instructed to arrive for the study visit after a 12-hour fast overnight. On arrival, body weight and body composition will be measured as described above. Patient will receive eight hourly isocaloric meals, each providing 1/12 of their daily energy requirement, thus 67% of their total daily intake. The 7 test protein intake levels will be testes. It is important that there are at least 2 intake levels below and above the measured protein requirements to identify a breakpoint of amino acid oxidation . Therefore, we selected a range of intake levels which includes two intakes below requirements in healthy men and women, one which is aligned to healthy requirements, and four at higher levels, anticipating that the breakpoint will occur before the final two intake levels. The remainder of the diet will be provided as 40% fat and 40% carbohydrate to meet daily energy requirements of REE x 1.5. Protein is provided as a crystalline amino acid mixture with a similar amino acid profile to egg protein. The remainder of the diet will be made up of protein-free powder, flavouring, oil, and protein-free cookies. From the 5th meal the tracer protocol will commence. A primer dosage of 0.176 mg/kg NaH13CO3 and 1.86 mg/kg 1-13C phenylalanine will be provided with the fifth meal. With the next three meals, 1.2 mg/kg 1-13C phenylalanine will be added. The phenylalanine tracer will form part of a total dietary phenylalanine intake if 30.5 mg/kg/day, approximately three times the Recommended Daily Allowance (RDA,) to ensure sufficient supply for protein synthesis. The RDA for an amino acid is the amount of the amino acid required for protein synthesis, as previously determined by IAAO studies. Equally total tyrosine intake will be 40 mg/kg/day, well in excess of requirements, to minimize the conversion of phenylalanine to tyrosine for protein deposition. Both stable isotopes will be purchased from Cambridge Isotope Laboratories (Woburn, MA, USA). Breath and urine samples will be collected to measure phenylalanine oxidation and phenylalanine flux respectively. 3 x12ml breath samples will be collected at three time-points and 15ml urine samples at 2 time points prior to commencing the tracer protocol. From 2.5 hours after the start of the tracer protocol until the end of the experiment (hour eight). Breath samples will be collected 6 times (12ml x 3 each time) and urine two times (15ml each time). Breath samples will be stored at room temperature and urine samples will be frozen and stored at -20 ˚C. 13CO2 enrichment of expired air and Urine 13C phenylalanine enrichment will be measured with the use of Gas Chromatography-Mass Spectrometry (GC-MS). Whole-body phenylalanine flux during isotopic steady state will be calculated according to the model of Matthews et al. as was previously described for IAAO studies. Phenylalanine flux is measured as the dilution of ingested labelled phenylalanine, measured as 13C- phenylalanine in urine. The rate of appearance of 13CO2 in expired air (F13CO2) represents the oxidation of ingested phenylalanine. F13CO2 is calculated according to the model of Matthews et al., using a factor of 0.82 to account of carbon dioxide retained in the bicarbonate pool (32).

European Registry of Next Generation Imaging in Advanced Prostate Cancer

This registry is intended to collect real-world data on patient demographics, medical history, clinical endpoints, histological tumour characteristics and imaging explorations of the patients with prostate cancer at high risk for harbouring metastatic deposits at the hormone-sensitive stage, who require imaging exploration (conventional, NGI, or their combination) either at the diagnostic workup of a "naïve" patient or at biochemical relapse/progression after local treatment. Stage 1: cross-sectional observation 1. To identify the proportion of patients for whom an imaging work-up with NGI at baseline may result beneficial, according to physician criteria. 2. Assess management prompted by NGI vs. conventional imaging in usual clinical practice. 3. To identify the proportion of patients for whom conventional imaging is considered informative enough for making a clinical decision, according to physician criteria. 4. Stratification of metastatic prostate cancer patients by the number, volume, and location of deposits, according to the different imaging tools employed. 5. Reclassification of HSPC (M0 vs low vs. high volume) based on NGI respect to CI when both imaging modalities are used. Stage 2: longitudinal observation 1. Evaluation of survival outcomes and their relationship with the imaging pathway undertaken (overall and per subgroup of imaging modality). 2. Identification of prognostic factors related to treatment response and disease progression.

A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer

A Study to Evaluate the Safety, Tolerability, and Effects on Blood and Urine Markers of Single Ascending Dose of GSK4771261 in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease

Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain.

This study comprises a prospective cohort study with three objectives. Objective 1 is to investigate whether the reliance on lumbar versus ankle proprioception during standing and body perception at the lower back (i.e., "proprioceptive factors"), anxiety, fear of movement, pain catastrophizing, depression, stress, and coping with stressful situations (i.e. "fear-related factors"), and inflammatory markers (i.e., "inflammatory factors") change over time and differ between women with and without PLPP in the 3rd pregnancy trimester, 6 weeks postpartum, and 9 months postpartum. We hypothesize that women with PLPP show (1a) a maladaptive reliance on ankle proprioception and/or disturbed body perception at the lower back, (1b) higher levels of fear of movement, anxiety, stress, depression, pain catastrophizing and poorer coping with stress, and (1c) greater immune activation and a disturbed balance of pro- vs. anti-inflammatory markers compared to pain-free women. Objective 2 is to determine whether the proprioceptive, fear-related, and inflammatory factors are correlated in women with PLPP. Based on previous findings (52-55), we hypothesize that anxiety correlates with higher concentrations of IL-6 and IL-12, and lower concentrations of IL-2 and IL-10. We will also examine whether maladaptive reliance on ankle proprioception and disturbed body perception at the lower back correlate with fear of movement, anxiety, and concentrations of inflammatory markers in women with PLPP. Objective 3 (= primary objective) is to investigate whether the proprioceptive, fear-related, and inflammatory factors predict the presence of PLPP in the 3rd trimester, 6 weeks postpartum and 9 months postpartum. Based on (our own) research (20,26,33,38,39,56), we hypothesize that a maladaptive reliance on ankle proprioception and disturbed body perception at the lower back, higher levels of anxiety and fear of movement, and immune activation and disturbed balance of pro- and anti-inflammatory markers in the 1st trimester predict having PLPP in the 3rd trimester. We also expect that the presence of these factors in the 3rd trimester predicts the persistence of PLPP 6 weeks and 9 months postpartum.

Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types