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NCT ID: NCT05470985 Recruiting - Crohn Disease Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

Start date: August 22, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.

NCT ID: NCT05470595 Recruiting - Clinical trials for Large Cell Neuroendocrine Carcinoma of the Lung

A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung

LCNEC-ALPINE
Start date: January 18, 2022
Phase: Phase 2
Study type: Interventional

This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

NCT ID: NCT05468320 Recruiting - Clinical trials for Thrombotic Thrombocytopenic Purpura

Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura

MAYARI
Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.

NCT ID: NCT05466669 Recruiting - Liver Cirrhosis Clinical Trials

Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis

Start date: March 9, 2022
Phase:
Study type: Observational

Prediction of hepatic encephalopathy after insertion of a transjugular intrahepatic portosystemic stent shunt (post-TIPS HE) are critical for patient selection prior to TIPS insertion, and a currently unmet, clinically highly relevant need. In this prospective multicenter observational cohort study, the investigators aim to evaluate the ability of Stroop EncephalApp and the simplified Animal Naming Test (S-ANT1) in comparison to the goldstandard PHES to predict the occurence of post-TIPS HE in patients with decompensated liver cirrhosis. Moreover, secondary aims of this study include the detection of potential blood based biomarkers for prediction of post-TIPS HE and the predictive value of frailty and quality of life/sleep prior to TIPS insertion.

NCT ID: NCT05466110 Recruiting - Low Back Pain Clinical Trials

Spinal Cord Stimulation Versus Instrumentation for FBSS

PROMISE
Start date: March 20, 2023
Phase: N/A
Study type: Interventional

Low back pain affects people of all ages and has become the leading cause of living with disability worldwide. Patients, suffering from persistent pain after spinal surgery in the absence of any clear spinal pathology are defined of having a "failed back surgery syndrome (FBSS)" and treatment of FBSS remains a great controversy in the spinal community. Apart from conservative treatment, spinal fusion remains as therapeutic option. Furthermore, minimal invasive Neuromodulation techniques might be a promising alternative. Aim of this randomized interventional multi center study is to compare treatment success in FBSS patients with either spinal cord stimulation (SCS) or fusion surgery, 12 months after intervention according to the Oswestry Disability Index (ODI) and other scales and scores. Radiological and health economic outcome also will be analysed for thorough comparison of techniques. Additionally, the safety of the interventions needs to be compared.

NCT ID: NCT05464472 Recruiting - Cognition Disorder Clinical Trials

Impact of Transcatheter Aortic Valve Implantation (TAVI) on Cognitive Functions

KogniTa
Start date: May 31, 2021
Phase:
Study type: Observational

Interventional implantation of the aortic valve (Transcatheter Aortic Valve Implantation; TAVI) may alter neurocognitive functions. We aim to differentiate the changes in cognitive functions after a TAVI.

NCT ID: NCT05463562 Recruiting - Bipolar Disorder Clinical Trials

Multimodal Biomarkers of Electroconvulsive Therapy in Severe and Treatment-resistant Depression

DetECT
Start date: February 24, 2022
Phase:
Study type: Observational

Electroconvulsive therapy (ECT) is a widespread and safe stimulation method that has been used successfully for decades in psychiatric diseases such as severe or therapy-resistant depression. Unfortunately, ECT still has stigmas attached to it. The latter often leads to reservations among those affected and perturbs optimal and guideline-based therapy. Despite the demonstrated effectiveness of ECT, prediction of treatment response is still not possible. This is due to the limited knowledge about the biological mechanisms of action of ECT, especially on an individuum level. Thus, the DetECT study intends to recruit 134 inpatient subjects of the Max Planck Institute of Psychiatry with severe and/or treatment resistant depression receiving ECT to perform weekly psychometry and blood draws before and after ECT sessions one, seven, and twelve. The subsequent biopsychological analysis comprises omics, physiological, neurocognitive, and psychometric measurements. The multimodal data collected will be used to identify data-driven clusters associated with ECT mechanisms and outcome.

NCT ID: NCT05463380 Recruiting - COVID-19 Clinical Trials

Hospitalised COVID-19 Patients Cohort Study in the EuCARE Project

EuCARE-HOSP
Start date: February 23, 2022
Phase:
Study type: Observational

The WP3 hospitalized cohort in EuCARE is an observational multicentre study including collection of retrospective (historical) and prospective data from hospitalized COVID-19 patients followed at 12 clinics from 11 countries from 4 continents. In a subset of patients, peripheral blood, viral isolates and/or viral sequences are collected for analysis in WP2 with regards to neutralising antibodies, cellular immunity and SARS-CoV-2 diagnostics. Data and results from analysis of biological material will be analysed by biostatistical methods and with artificial intelligence in WP5. This analysis will focus on the impact on clinical outcome of viral variants / viral sequences as well as the vaccines used and the vaccination schedules.

NCT ID: NCT05462873 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors

Start date: April 4, 2023
Phase: Phase 1
Study type: Interventional

To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

NCT ID: NCT05462522 Recruiting - Systemic Sclerosis Clinical Trials

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis

Start date: January 16, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.