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NCT ID: NCT05683015 Recruiting - Psoriasis Vulgaris Clinical Trials

Therapeutic Drug Monitoring of Tildrakizumab in Psoriasis Patients

BIOLOPTIM-TIL
Start date: August 22, 2022
Phase: Phase 4
Study type: Interventional

Biologics such as tildrakizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study, the investigators aim to investigate the predictive value of early serum trough levels of tildrakizumab and determine the therapeutic window of tildrakizumab in psoriasis patients.

NCT ID: NCT05682326 Recruiting - Anaemia Clinical Trials

Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)

ASCEND-P
Start date: September 6, 2023
Phase: Phase 3
Study type: Interventional

This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis [ND] and Dialysis [D]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis [PD] or hemodialysis [HD]). The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks). Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than [<] 18 years, 6 to <12 years, 2 to <6 years, and 3 months to <2 years). Except for PK and dose change, which is within each age group only.

NCT ID: NCT05680766 Recruiting - Clinical trials for Irritable Bowel Syndrome

Feasibility Assessment of Cardiovascular Endurance Training for the Symptomatic Improvement of Irritable Bowel Syndrome Patients With a Sedentary and Non-active Lifestyle.

Start date: October 16, 2023
Phase: N/A
Study type: Interventional

This exploratory study's primary objective is the changes of irritable bowel syndrome (IBS) symptom severity by cardiovascular endurance training (CET) in relation to the baseline sedentary or non-active lifestyle. Secondary endpoints focus on the mechanisms associated with these changes. These mechanisms relate to dietary adaptations, changes in anxiety, depressive comorbidity, somatisation, alterations in the gut microbiome or metabolome, body composition and measures of cardiovascular fitness. Virtually all IBS guidelines mention lifestyle modifications as a management option. Research on the role of physical activity remains underassessed as compared to the other interventions. Therefore, an exploratory proof-of-concept study will investigate the influence of regular physical exercise on symptoms in a small group of IBS patients. This study will gather data on putative underlying mechanisms related to dietary factors, faecal microbiome and metabolome, mental well-being, body composition and cardiovascular fitness.

NCT ID: NCT05678218 Recruiting - Cholangiocarcinoma Clinical Trials

Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma

POELH-II
Start date: September 5, 2022
Phase:
Study type: Observational [Patient Registry]

The goal of this observational cohort study is to assess the yield of preoperative endoscopic ultrasound focussed on lymph nodes in patients with presumed resectable perihilar (pCCA), intrahepatic (iCCA) or mid-common bile duct (CBD) cholangiocarcinoma. The main questions it aims to answer is: 1. The number of patients precluded from surgical work-up due to positive regional or extraregional lymph nodes identified by endoscopic ultrasound guided tissue acquisition 2. Characteristics during endoscopic ultrasound of lymph nodes associated with malignancy

NCT ID: NCT05677971 Recruiting - Clinical trials for Alpha1-Antitrypsin Deficiency

Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein

Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), to test how well fazirsiran works compared with a placebo in improving measures of liver scarring including imaging and liver biomarkers (substances in the blood that the body normally makes and help show if liver function is improving, staying the same, or getting worse) as well as to check for side effects in participants treated with fazirsiran compared with those who received placebo. Participants will either receive fazirsiran or placebo. Liver biopsies, a way of collecting a small tissue sample from the liver, will be taken twice during this study.

NCT ID: NCT05677464 Recruiting - Obesity Clinical Trials

Prospective Multicenter Study With the Endomina® Triangulation Platform

PRETTi
Start date: June 8, 2020
Phase:
Study type: Observational [Patient Registry]

This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of "real life" routine clinical practice

NCT ID: NCT05677139 Recruiting - Asthma Clinical Trials

A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

Start date: December 13, 2022
Phase:
Study type: Observational

A study involving primary data collection within real-world settings of participants who initiate treatment with tezepelumab for severe uncontrolled asthma. This study will complement evidence obtained from randomized controlled trials and provide new data focusing on the holistic and patient reported outcome (PRO).

NCT ID: NCT05676372 Recruiting - Clinical trials for Peritoneal Metastases

Single-Cell Transcriptomics of the Peritoneal Microenvironment of Colorectal PC

SingleCell
Start date: June 16, 2020
Phase:
Study type: Observational

Single cell transcriptomics of CRC PC samples

NCT ID: NCT05675852 Recruiting - Clinical trials for Visual Neurosciences

Evaluation of Visual Parameters by Visual Evoked Potentials Captured by EEG

Start date: December 1, 2022
Phase:
Study type: Observational

This project will be based on an approach that has already proven itself in the field of the development of low-level visual functions such as visual acuity, vernier acuity and contrast sensitivity (Norcia & Tyler, 1985): scanning visual evoked potentials" (sVEP), a special case of steady-state visual evoked potentials (SSVEP). While SSVEPs consist of presenting a visual stimulus periodically, sVEPs are SSVEPs where the value of a parameter (e.g. the contrast of the stimulus) varies. This variation ("scanning") makes it possible to determine the threshold value where an electroencephalographic (EEG) response is perceived, and thus to evaluate visual parameters such as visual acuity, vernier acuity and contrast sensitivity. In this study we therefore record the amplitude of the EEG electrical signal during the presentation of low-level stimuli such as spatial frequency gratings or increasing or decreasing contrast.

NCT ID: NCT05673187 Recruiting - NSCLC Stage IV Clinical Trials

Adagrasib in Patients With KRASG12C-mutant NSCLC Who Are Elderly or Have Poor Performance Status

ADEPPT
Start date: June 12, 2023
Phase: Phase 2
Study type: Interventional

ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).