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NCT ID: NCT04285892 Active, not recruiting - Clinical trials for In Vitro Maturation of Oocytes

Embryo Developmental Potential in a Novel 2-step IVM System

CAPA-IVM-Sib
Start date: May 1, 2020
Phase: N/A
Study type: Interventional

In vitro maturation is a valid option for PCO(S) patients in the daily ART clinic, however maturation and embryologic development are not yet matching the efficiency levels obtained by standard COS treatment. To further enhance embryo quality after IVM, it was hypothesized to keep the connection and communication between oocyte and cumulus cells intact for a prolonged pre-maturation culture before IVM was initiated. This has been investigated and established using a meiotic blocker C-type Natriuretic peptide (CNP). The CNP peptide is present in high concentrations in the growing follicle, is produced by the mural granulosa cell compartment and binds to the Natriuretic peptide receptor 2 (NRP2) present in the cumulus cells. Binding of CNP on NRP2 leads to intracellular cGMP increase in cumulus cells, which travels through the transzonal projections to the oocyte. In the oocyte, cGMP will block the resumption of meiosis. Using CNP as natural inhibitor of meiosis, a new medium was designed to allow oocyte and surrounding cumulus cells to communicate and hence gain in competence for an additional culture period: the pre-maturation phase or Capacitation phase (CAPA). This system was devel-oped in mouse, tested in human in UZ Brussel on research material (toelating federaal EC: CFE-FCE ADV_073_ZUBrussel, toelating lokaal EC: 2016/411 BUN 143201630723) and used in a clinical setting in Vietnam.

NCT ID: NCT04281485 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy

Start date: November 5, 2020
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of gene therapy in boys with DMD. It is a randomized, double-blind, placebo-controlled study with two thirds of participants assigned to gene therapy. The one third of participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.

NCT ID: NCT04280718 Active, not recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

ADHERE+
Start date: September 18, 2020
Phase: Phase 2
Study type: Interventional

This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.

NCT ID: NCT04272931 Active, not recruiting - Clinical trials for Colorectal Cancer Liver Metastases

DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

DRAGON
Start date: May 8, 2020
Phase: N/A
Study type: Interventional

Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2).

NCT ID: NCT04272034 Active, not recruiting - Cervical Cancer Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

Start date: March 26, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

NCT ID: NCT04269590 Active, not recruiting - Parkinson Disease Clinical Trials

Triggering Motor Memory Consolidation in PD: Complex Practice of Fine Motor Tasks and Brain Activity During Learning

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is characterized by severe motor symptoms, including upper limb dysfunction, that is only partially alleviated by medication. PD is also a motor learning disease due to the degradation of the striatum, involved in the consolidation of motor memory. We showed earlier that motor practice improves writing deficits and that there is long term potential when it is applied in a focused manner. However, retention difficulties were also apparent. What is currently unclear, is which learning method leads to optimal retention in PD and how it is expressed in underlying neural network changes. In healthy controls, retention is improved by incorporating dual task (DT) conditions or by loading cognition during learning. Our own work showed that DT training also led to better retention than single task (ST) learning, at least in a subgroup of PD. Using a combination of behavioral assessment, functional magnetic resonance imaging and upper limb task training, this project aims to understand how to boost the robustness of practice in PD. Throughout, we will contrast ST with DT learning. As complex practice can now easily be delivered via novel technology, this study will set out future avenues for rehabilitation targeted at specific neural circuitry.

NCT ID: NCT04269577 Active, not recruiting - Parkinson Disease Clinical Trials

Motor Learning in Parkinson's Disease: Underlying Effective Connectivity and Influential Factors

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) is characterized by severe motor symptoms that can only be partially alleviated by medication. It was shown previously that rehabilitation is an important therapeutic supplement for micrographia in early disease. However, what is unknown is how motor learning impacts on the underlying neural networks in patients with different disease progression and how this interacts with dopaminergic medication. Furthermore, difficulties with upper limb motor control has a severe impact on the daily lives of PD patients since fine motor skills become increasingly important for the use of smartphones and tablets. Therefore, the current project will include a newly developed Swipe-Slide Pattern test, resembling the pattern codes used to unlock smartphones and tablets. This task will be used to determine learning-induced neuroplasticity of cortico-striatal effective connectivity across disease stages in PD. Using a combination of behavioral assessment and functional magnetic resonance imaging, the investigators aim to contribute to the understanding of upper limb motor learning in patients with PD for the development of individualized rehabilitation programs.

NCT ID: NCT04269200 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

DUO-E
Start date: May 5, 2020
Phase: Phase 3
Study type: Interventional

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.

NCT ID: NCT04266301 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

STIMULUS-MDS2
Start date: April 14, 2013
Phase: Phase 3
Study type: Interventional

This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.

NCT ID: NCT04259138 Active, not recruiting - Colitis, Ulcerative Clinical Trials

Determination of the Optimal Treatment Target in Ulcerative Colitis

VERDICT
Start date: February 18, 2020
Phase: Phase 4
Study type: Interventional

Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development. Participants with active UC will be randomized in a 5:4:1 (initially 2:3:5) ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as: - Group 1: corticosteroid-free symptomatic remission - Group 2: corticosteroid-free endoscopic + symptomatic remission - Group 3: corticosteroid-free histological + endoscopic + symptomatic remission An interim analysis was performed to assess the proportion of subjects that reached their assigned treatment target after 50 subjects in each group had reached the first 32-week assessment. The interim analysis and projections made based on target achievement rates for all subjects included in the interim analysis resulted in a recommendation to adjust the randomization ratio from 2:3:5 to 5:4:1 for Groups 1, 2 and 3 respectively as of May 5th, 2023. This change was necessary in order to complete the study with approximately 100 subjects achieving treatment target within each group.