Clinical Trials Logo

Filter by:
NCT ID: NCT06095427 Completed - Healthy Clinical Trials

A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection

Start date: March 9, 2021
Phase: Phase 1
Study type: Interventional

This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics (PD) between the test product L06006 and the reference products US-Prolia and EU-Prolia in healthy male subjects. A total of 300 healthy male subjects aged 28 to 65 years (both inclusive) will be randomized 1:1:1 to receive a single subcutaneous (s.c.) injection of either LY06006 or US-Prolia or EU-Prolia on Day 1 and then be followed for 36 weeks.

NCT ID: NCT06095388 Recruiting - Clinical trials for Mucopolysaccharidosis III-A

Phase I/II Study of JR-441 in Patients With Mucopolysaccharidosis Type IIIA

Start date: October 4, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase I/ II, open-label, randomized, 2-arm study, designed to evaluate the safety and explore efficacy of the study drug in development for the treatment of MPS IIIA patients.

NCT ID: NCT06095232 Recruiting - Pregnancy Related Clinical Trials

Pilot Study to Investigate Dietary Changes During Pregnancy

Start date: August 19, 2023
Phase:
Study type: Observational

The aim of this pilot study is to investigate dietary choices and composition during pregnancy and fluctuating sex hormones during the natural menstrual cycle in women. In particular, the investigators are interested in the relationship between diet choice, cognitive performance and diversity of the gut microbiome. The study will be conducted in a longitudinal/cross-sectional design. Primiparous pregnant women will be investigated during four different time periods (during the 1st-3rd trimester and during the postpartum period). Women with a natural regular menstrual cycle will be assessed during two different hormonal phases of the cycle (early follicular, luteal) and undergo the same study design as pregnant women. Participants will conduct online tasks related to cognitive performance, food approach/avoidance behavior and risk assessment, fill out online questionnaires related to diet, mood, sleep and mental-wellbeing. In addition, participants will log their daily food intake for three days in a food diary and send in a stool sample in order to analyse gut microbiome composition.

NCT ID: NCT06095115 Active, not recruiting - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 in Adolescent and Adult Participants With Moderate to Severe Plaque Psoriasis

ICONIC-LEAD
Start date: October 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is see how effective is JNJ-77242113 in participants with moderate to severe plaque psoriasis.

NCT ID: NCT06095102 Active, not recruiting - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 for the Treatment of Participants With Plaque Psoriasis Involving Special Areas (Scalp, Genital, and/or Palms of the Hands and the Soles of the Feet)

ICONIC-TOTAL
Start date: October 12, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to see how effective JNJ-77242113 is in participants with plaque psoriasis affecting special areas (scalp, genital, and/or palms of the hands and the soles of the feet).

NCT ID: NCT06094439 Recruiting - Metabolomics Clinical Trials

Targeted Metabolomics and Spent Embryo Culture Medium

Start date: September 1, 2023
Phase:
Study type: Observational

More than 8 million babies have been born through in vitro fertilization (IVF). Non-invasive observation of embryos in vitro to better understand their development is becoming increasingly important. Morphology has been used as standard from the beginning, but has the disadvantage of subjectivity. Now the emphasis in basic and clinical research is on developing rapid, quantitative, non-invasive tests. Hence comes the idea of metabolic profiling of spent embryo culture medium (SECM) as a biomarker. This could be useful for understanding and improving the nutritional environment of oocytes and embryos. The goal of our study is to determine metabolic profiles of the SECM in combination with morphological assessments to better understand the nutritional requirements of the embryo. The goal would be to optimize media specifically, depending on patient and embryo characteristics ("personalized medicine") ("the embryo in vitro as patient").

NCT ID: NCT06094270 Recruiting - Colonoscopy Clinical Trials

Artificial-intelligence-based Reporting Technology for Endoscopy Monitoring and Imaging System

ARTEMIS
Start date: December 19, 2023
Phase:
Study type: Observational

Properly documenting withdrawal time in colonoscopy is essential for quality assessment and cost allocation. However, reporting withdrawal time has significant interobserver variability. Additionally, current manual documentation of endoscopic findings is time-consuming and distracting for the physician. This trial examines an artificial intelligence based system to determine withdrawal time and create a structured report, including high-quality images (AI) of detected polyps and landmarks.

NCT ID: NCT06094127 Recruiting - Clinical trials for Thoracic Aortic Aneurysm

Zenith Thoracic Alpha (ZTA) Post-Market Data Collection

Start date: July 6, 2023
Phase:
Study type: Observational [Patient Registry]

This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.

NCT ID: NCT06094101 Recruiting - Rhabdomyosarcoma Clinical Trials

Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)

PerVision
Start date: September 19, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor. This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities. It is an interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study evaluating a personalized peptide vaccine. Primary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.

NCT ID: NCT06093334 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Imaging of Chemotherapy-induced Morphological and Functional Lung Changes in Childhood ALL and HD

MinimALL
Start date: October 17, 2023
Phase: N/A
Study type: Interventional

With increasing cure rates of childhood cancer there is growing recognition of late effects of treatments. However, there is a lack of non-invasive and child-friendly procedures that can indicate possible late damage. This study uses morphologic and free-breathing phase-resolved functional low-field (PREFUL) magnetic resonance imaging (MRI) to identify persistent pulmonary toxicity after treatment for childhood acute lymphoblastic leukemia (ALL), Hodgkin's disease (HD) and allogeneic stem cell transplantation. Furthermore, cardiopulmonary testing is performed by means of a pulmonary function test, echocardiography with strain analysis and spiroergometry.