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Filter by:This protocol is part of a larger project, COMPRare (COMPlement-mediated Rare kidney diseases), which has been financed on behalf of the EJP RD (European Joint Programme on Rare Diseases) program of EU and is leaded by a scientific consortium from 7 European countries. The partners (P) of the consortium are: P1. Radboudumc Amalia Children's Hospital (The Netherlands) P2. Semmelweis University (Hungary) P3. Cordeliers Research Center (France) P4. Max Delbruck Center for Molecular Medicine (Germany) P5. Istituto di Ricerche Farmacologiche Mario Negri (Italy) P6. Lund University (Sweden) P7. Lille University (France) The general aim of the project is to define new diagnostic tools for complement activation in order to improve patients stratification and follow-up, thereby affecting time and choice of treatment in patients with aHUS and C3G. Particularly, the specific objectives of the COMPRare are: - To develop new standardized analytic assays thereby identifying specific complement prognostic biomarkers for early diagnosis, classification, improved monitoring and treatment of patients with aHUS and C3G; - To in-depth characterize patients' complement abnormalities in blood, in patient-derived cells and in kidney biopsies; - To identify strategies to classify VUS/LPV - To find new pathophysiological pathways involved in aHUS and C3G for further improving disease diagnosis, monitoring and treatment. The results of these studies will form the basis of personalized treatment with existing and upcoming complement inhibitory drugs for these rare complement-mediated kidney diseases.
This is a first-in-human, randomized, double-blind, placebo-controlled trial in healthy subjects. The trial consisted of two parts: part 1: single ascending dose (SAD) study and part 2: multiple ascending dose (MAD) study. Each part had multiple Intravenous infusion administration dose groups. Prior to the formal initiation of the dose-escalation trial, the safety, tolerability, and pharmacokinetics (PK) characteristics of a pretest dose (pilot dose) of 2 mg will be evaluated in 2 subjects (both administered BG136 for injection)
The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety & tolerability of three different doses against a placebo control.
The purpose of this randomized controlled trial, which included pretest and posttest, was to examine the effectiveness of pressure ulcer prevention and care education given to caregivers of patients treated in a palliative care clinic. The key questions it aims to answer are: - Does the routine clinical training given in the palliative care clinic have an effect on the knowledge level of patients' relatives about pressure ulcers? - Does the pressure ulcer education given to the relatives of patients treated in the palliative care clinic have an effect on the level of knowledge about pressure ulcers? Participants will participate in an educational activity on pressure ulcers. Researchers will compare whether pressure ulcer training given to palliative care patient relatives is effective compared to routine service training with lecture, question-answer and presentation method.
The main purpose of this study is to look if the study drug, tirzepatide, gets into the breast milk and if yes, how long it takes the body to get rid of it. The study drug will be given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study will be approximately 8 weeks, including screening.
The aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.
In this research study, the investigators are using examining how brain activity (electrical and blood flow) changes during tests of emotional processing and attention and memory in the magnetic resonance imaging (MRI) scanner. Investigators are also using non-invasive brain stimulation to probe different parts of the brain and measuring brain activity (electrical and blood flow). This study includes healthy participants and researchers hope this will help us develop improved brain-based treatments for emotional difficulties like depression.
In this trial, 32 healthy subjects are planned to be enrolled in fasting and 36 healthy subjects are planned to be enrolled in postprandial, and the fasting and postprandial trials will be randomized separately. According to the randomization table, subjects will be randomly assigned to one of the two groups (Group A: TRTR, Group B: RTRT). The washout period (dosing interval) between doses will be at least 5 days. Taking the washout period of 5 days as an example, all subjects will take the corresponding medication according to the randomization table on day 1 of the first cycle trial, day 6 of the second cycle trial, day 11 of the third cycle trial, and day 16 of the fourth cycle trial.
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion in healthy subjects.
The purpose of this study is to evaluate the safety and efficacy of 02 facial sunscreens (investigational products [IPs]) under controlled and normal conditions of use on the face for 28 and 56 days, respectively. This study will consist of 2 groups a) Group 1: will assess the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face in comparison with the control area (other side of face) and on the forearm, comparing 02 IPs versus control area (no product application) and 03 benchmarks; and through use of the IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, image capture (Colorface) and assessments of the efficacy perceived by the participant; b) Group 2: will evaluate the safety and efficacy of a facial sunscreen in improving skin hydration and barrier function, through 12h of single application on the face; and through use of IP under normal conditions for 28 +/- 2 days on the face, with assessments by instrumental measurements of corneometry, transepidermal water loss, imaging (Colorface) and assessments of the efficacy perceived by the participant; in addition to evaluating the improvement in uniformity of facial skin tone through the use of IP under normal conditions for 56 +/- 2 days, with assessments by image analysis (Colorface), dermatological clinical analyses (radiance and homogeneity of skin tone),assessments of perceived efficacy, and emotional testimony by the participant.