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NCT ID: NCT05064878 Recruiting - Clinical trials for CDKL5 Deficiency Disorder

A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder

Start date: March 8, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, parallel-group, placebo controlled, 2-part study to evaluate the efficacy and safety of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).

NCT ID: NCT05064397 Completed - Clinical trials for Chronic Cluster Headache

A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

CHRONICLE
Start date: September 17, 2021
Phase: Phase 3
Study type: Interventional

The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

NCT ID: NCT05064202 Not yet recruiting - Cardiogenic Shock Clinical Trials

Unloading in Heart Failure Cardiogenic Shock

UNLOAD HF-CS
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.

NCT ID: NCT05063786 Active, not recruiting - Clinical trials for Advanced Breast Cancer

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

ALPHABET
Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

NCT ID: NCT05063721 Completed - Clinical trials for Mitochondrial Myopathies

MABs Therapy m.3243A>G Mutation Carriers

MABS01
Start date: March 1, 2020
Phase: Phase 1
Study type: Interventional

Rationale: Mitochondrial disorders are progressive, often fatal multisystem disorders, in 20-25% of the cases caused by heteroplasmic mutations in the mitochondrial DNA (mtDNA). At this moment, there is no effective treatment known to influence the disease process or manifestation. Myogenic stem cell-based therapies complementing defective muscle cells and fibres, are highly promising to combat the myopathy and exercise intolerance which affect >50% of heteroplasmic mtDNA mutation carriers. Myogenic stem cells called mesoangioblasts (MABs), are currently the only myogenic precursors that fulfil all criteria to be used as advanced therapy medicinal product (ATMP) for systemic treatment. The researchers have demonstrated that MABs of most m.3243A>G carriers contain no or only a low amount (<10%) of the mtDNA mutation, allowing direct ex vivo expansion of patient-derived MABs. The overall aim is to induce muscle regeneration using these autologous MABs with a mutation load of <10%, as an advanced therapy medicinal product (ATMP). Objective: The phase I trial will consist of an intra-arterial injection (via catheter in femoral artery) of the autologous MABs in the left lower leg of 5 m.3243A>G patients.

NCT ID: NCT05063149 Recruiting - Premature Clinical Trials

Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

PROTEA
Start date: January 18, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first year of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.

NCT ID: NCT05063123 Withdrawn - AML Clinical Trials

Study to Assess an Interphase Cycle With Flotetuzumab.

HOVON162AML
Start date: January 2022
Phase: Phase 2
Study type: Interventional

Patients who have measurable residual disease (MRDpos, defined as MRD > 0.1% by flowcytometry or detectable mutant Nucleophosmin 1 (NPM1) by quantitative polymerase chain reaction (qPCR) after two cycles of intensive chemotherapy) prior to start conditioning for an allogeneic Hematopoietic Cell Transplantation (HCT) have a very high risk of relapse after transplantation. Important questions in the field are whether patients with MRD after intensive chemotherapy can be converted to MRD negativity (i.e. undetectable MRD, MRDneg) and whether this conversion impacts on the relapse rate after transplantation. This trial aims to develop effective "interphase" treatment for patients in morphological complete remission (CR) with MRD after at least 2 cycles of intensive chemotherapy and prior to start conditioning for an allogeneic HCT. Flotetuzumab, a bispecific antibody-based molecule against CD3 and CD123 in a dual-affinity re-targeting antibody (DART®) format is a new treatment modality based on immunomodulation. The rationale to use flotetuzumab in this study is: 1) its antileukemic activity reported in R/R AML; 2) its limited extra-medullary (i.e. tissue) toxicity; and 3) its short halflife.

NCT ID: NCT05062733 Recruiting - Complication Clinical Trials

SEBBIN Round, Anatomical and Biconvex Gluteal Implants

Start date: November 20, 2021
Phase:
Study type: Observational

This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device. The aim of the study is to gather additional data about the safety and effectiveness of the device.

NCT ID: NCT05062707 Recruiting - Breast Cancer Clinical Trials

Early Ageing During Therapy in AYA Cancer Patients

Start date: February 10, 2022
Phase:
Study type: Observational

Longitudinal cohort study; measurements before start of systemic therapy and one year later.

NCT ID: NCT05062447 Recruiting - Clinical trials for Adaptation, Emotional

Adaptive and Maladaptive Emotions in Patients With Cancer: Identification of Indicators

EMOCA
Start date: August 10, 2021
Phase:
Study type: Observational

Primary Objective: To identify indicators distinguishing between adaptive and maladaptive emotions in patients with cancer.