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NCT ID: NCT06015841 Recruiting - Parkinson Disease Clinical Trials

A Study to Evaluate the Effects of ACI-7104.056 Vaccination in Patients With Early Stages of Parkinson's Disease

VacSYn
Start date: July 24, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 vaccination in patients with early stages of Parkinson's disease.

NCT ID: NCT06015737 Not yet recruiting - Clinical trials for Cutaneous Lupus Erythematosus

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

LAVENDER
Start date: June 17, 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).

NCT ID: NCT06015282 Active, not recruiting - Influenza, Human Clinical Trials

The Celljuvant Study: A Phase 3 Immunogenicity and Safety Study of aQIVc Vaccine in Adults Aged 50 Years and Older

Start date: November 3, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIV1, or QIV2 in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIV1, and QIV2). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.

NCT ID: NCT06013995 Recruiting - Lupus Clinical Trials

A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus

Start date: September 21, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.

NCT ID: NCT06013969 Recruiting - Clinical trials for Generalized Pustular Psoriasis

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Start date: October 11, 2023
Phase: Phase 4
Study type: Interventional

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06013761 Recruiting - Epilepsy Clinical Trials

IF-MCT 16:8: Investigating the Influence of Intermittent Fasting With and Without MCTs in Patients With Drug-resistant Epilepsy

IF-MCT16:8
Start date: July 25, 2023
Phase: N/A
Study type: Interventional

The objective of the prospective monocentric pilot trial is to investigate the influence of intermittent fasting with or without a once-daily intake with medium chain triglycerides (MCTs) on the frequency of seizures in patients with therapy-refractory epilepsy. The effects of 12 weeks intermittent fasting according to the 16:8 method (IF 16:8) are compared to 12 weeks intermittent fasting with additional intake of exogenous MCTs (IF MCT 16:8) in a within-subject-crossover-design in 28 patients with drug-resistant epilepsy.

NCT ID: NCT06012435 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

Start date: February 21, 2024
Phase: Phase 3
Study type: Interventional

This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin (SGN-B6A), which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.

NCT ID: NCT06012162 Not yet recruiting - Clinical trials for Heart Transplantation

Genomics in Heart Transplants

Start date: January 2024
Phase:
Study type: Observational

A cross-sectional analysis of 200 heart transplant recipients, combining in-depth phenotyping and risk factor assessment (cardiac MRI, coronary angiogram with OCT, cardiorespiratory exercise tests, exogenic factors like nutrition, smoking, lipid profile) with short-read whole-genome sequencing to elucidate the interplay of established PRS from the literature and exogenic risk factors with respect to HTx outcomes will be carried out. Besides that, a long-read whole-genome sequencing of 100 newly transplanted recipients and their corresponding donors and extend latest bioinformatics methods developed by the study to analyze long-read data will be performed. This will enable a comprehensive and integrated analysis of structural variants, polygenic risk, high-penetrance variant genotypes, immunogenetic (major and minor histocompatibility), and individual lifestyle risk factors in a unique donor-recipient cohort, elucidating the extent of within-cohort variability and cross-correlations between the considered potential risk factors and an exploratory analysis of the utility of genetic risk scores in light of the study results will be carried out.

NCT ID: NCT06011642 Recruiting - Clinical trials for Psychological Disease

Reliability and Validity of a Digital Version of a Structured Interview for Children and Adolescents (Kinder-eDIPS)

Start date: December 3, 2021
Phase:
Study type: Observational

The Kinder-eDIPS is a digital version of the Kinder-DIPS (Diagnostisches Interview bei Psychischen Störungen im Kindes- und Jugendalter), a structured interview to assess a variety of the most frequent psychological disorders in children and adolescents. In this study, the reliability, validity and acceptance of the Kinder-eDIPS will be tested in both a clinical and a non-clinical sample.

NCT ID: NCT06011187 Recruiting - Outcome Clinical Trials

Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery

PEFLA
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Goal directed fluid therapy (GDFT) or "Personalized fluid therapy" may benefit high-risk surgical patients but these strategies are infrequently implemented. It has also been shown that without any goal or protocol for fluid resuscitation, large inter- and intra-provider variability exist that have been correlated with poor patient outcomes. Recently, an "Assisted Fluid Management" (AFM) system has been developed to help ease some of the work associated with GDFT protocol implementation. The AFM system may help increase GDFT protocol adherence while leaving direction and guidance in the hands of the care providers. This artificial intelligence-based system can suggest administration of fluid boluses, analyse the hemodynamic effects of the bolus, and continually re-assess the patient for further fluid requirements. To date, there are no large outcome study using this AFM system. The primary objective of this trial is thus to evaluate the impact of this AFM system to guide fluid bolus administration on a composite of major postoperative complications in high-risk patients undergoing high-risk abdominal surgery.