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NCT ID: NCT05524883 Recruiting - Clinical trials for Duchenne Muscular Dystrophy (DMD)

Safety, Tolerability, Pharmacodynamic, Efficacy, and Pharmacokinetic Study of DYNE-251 in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

DELIVER
Start date: August 12, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this study is to evaluate the safety, tolerability, and dystrophin protein levels in muscle tissue following multiple intravenous (IV) doses of DYNE-251 in participants with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The study consists of 3 periods: a multiple-ascending dose (MAD) / placebo-controlled period (24 weeks), an open-label period (24 weeks) and a long-term extension period (96 weeks).

NCT ID: NCT05524571 Recruiting - Thyroid Eye Disease Clinical Trials

Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease

Start date: January 5, 2023
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of batoclimab 680 milligrams (mg) subcutaneous (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24.

NCT ID: NCT05524051 Recruiting - Clinical trials for Acute Kidney Injury Following Cardiac Surgery

A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

Start date: March 3, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.

NCT ID: NCT05523934 Recruiting - Clinical trials for Complex Regional Pain Syndromes

Retrospective Analysis of capsaïcin Patch in Complex Regional Pain Syndrome

Start date: September 16, 2022
Phase:
Study type: Observational

Complex regional pain syndrome is a painful syndrome often secondary to a traumatic lesion. Treatment is difficult, of long duration with variable outcomes. Patch of capsaïcin has been proposed as adjuvant to a multimodal treatment. Capsaïcin may act by its effect on transient receptor potential vanilloid 1. Efficacity and outcome studies with this treatment are lacking. The aim of this retrospective study is to evaluate pain intensity over time assessed by visual analog scale in patient with complex regional pain syndrome treated with capsaïcin patch in addition to their usual treatment.

NCT ID: NCT05523544 Recruiting - Clinical trials for Personality Disorders

The Effects of Schema Therapy in Outpatient Forensic Mental Health Care: a Single Case Multiple-baseline Study.

STOFSCED
Start date: August 25, 2022
Phase: N/A
Study type: Interventional

Forensic psychiatry aims at reducing recidivism risk by treating mental or psychiatric problems. In forensic psychiatry approximately between 42 and 84% of the patients have PDs. Individuals with PDs have an increased risk of violence and a higher recidivism risk than offenders without PDs. Consequently, in outpatient forensic mental health settings, PDs are both assessed and treated. Treatment of PDs with ST was demonstrated to be effective in regular mental health care. For forensic patients, ST was adjusted by adding specific modes. This adjustment showed promising results. However, this study was limited to closed forensic psychiatric hospitals where patients were admitted mandatorily. In recent years, there has been a development in the field of personality and PDs with more attention for personality functioning (PF) as the core of personality pathology. This is described in Criterion A of the Alternative Model for Personality Disorders (AMPD) in the DSM-5 section III. Some instruments that measure PF, for instance the SIPP-118 are applicable to measure the change in PF as an effect of treatment. In forensic outpatient mental health, as far as we know, no specific instrument has been identified as a routine outcome monitoring during PD treatment. This study will examine the outcome of ST for PDs in forensic outpatient mental health. To our knowledge this has not been studied before. We will examine three primary outcomes. A first outcome is measured in terms of changes towards more adaptive schemas and modes. A second outcome is defined in terms of reducing recidivism risk. Thirdly, we will investigate whether the concept of severity of PF as described in Criterion A of the AMPD in the DSM-5 is useful to monitor the effect of ST treatment for these patients. Because having a PD is known to correlate with experiencing a lesser quality of life and having other psychological problems, these concepts are secondary outcome variables for the effect of treatment. Since the number of patients admitted for ST is limited, ST a long-term treatment is and patients must be willing to participate in a study, a Single Case Experimental Design (SCED) with a limited number of patients (N=8) seems to be the most applicable design.

NCT ID: NCT05523167 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

ALKIVIA
Start date: October 12, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

NCT ID: NCT05521828 Recruiting - Oocyte Donation Clinical Trials

Luteal Phase Ovarian Stimulation With Follitropin Delta and Dydrogesterone

LadyDe
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The last decade has shown a progressive scientific interest for new strategies to improve the outcomes of controlled ovarian stimulation (COS). Given the fact that interovulatory period has been described to have multiple waves of follicular recruitment, luteal phase ovarian stimulation (LPOS) has been proposed as new protocol for COS, with satisfactory ovarian response and pregnancy outcomes. On the other hand progestin-primed ovarian stimulation (PPOS) is today considered an innovative protocol aiming to achieve multi-follicle recruitment and block the luteinizing hormone (LH) surge through progesterone administration in place of the traditional down regulating or gonadotropin-releasing hormone (GnRH) antagonist. This protocol has been shown to be equally effective as LH suppression with GnRH antagonist reporting equivalent oocyte retrieval rates, endocrine profiles, viable embryo numbers, and pregnancy outcomes. Due to the feasibility and patients-friendly characteristics of PPOS in oocytes donors, the current study aims to investigate the impact on the number of cumulus-oocyte complexes (COCs) when a PPOS protocol is associated to both conventional follicular phase stimulation and LPOS for vitrification of oocytes in oocyte donors. Moreover, it aims to determine whether LPOS using PPOS protocol has comparable outcomes to conventional follicular phase stimulation with PPOS protocol, in oocyte donor patients.

NCT ID: NCT05519085 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

SUCCESSOR-1
Start date: September 20, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.

NCT ID: NCT05518149 Recruiting - Clinical trials for Depressive Disorder, Major

A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)

VENTURA-LT
Start date: September 22, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).

NCT ID: NCT05518123 Recruiting - Migraine Clinical Trials

Efficacy and Tolerability of Rimegepant for the Prevention of Migraine in Adults With History of Inadequate Response to Oral Preventive Medications

Start date: November 7, 2022
Phase: Phase 4
Study type: Interventional

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications