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NCT ID: NCT04846244 Active, not recruiting - Clinical trials for Axial Spondylarthritis (axSpA)

A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib

UPSTAND
Start date: April 30, 2021
Phase:
Study type: Observational

Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in axSpA participants. Upadacitinib is being developed for the treatment of axSpA. Approximately 650 adult participants with active-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific. Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. Participants will be followed for 12 months. There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

NCT ID: NCT04842877 Active, not recruiting - Lymphoma, B-Cell Clinical Trials

Study of Valemetostat Tosylate as a Single Agent in Patients With Relapse/Refractory B-cell Lymphoma

Start date: June 11, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, prospective, single arm, non-randomized, open-label, phase 2 clinical study to evaluate safety and efficacy of valemetostat tosylate (DS-3201b) in patients with relapsed or refractory B cell lymphoma with 6 cohorts of patients including 2 biology-driven cohorts. Up to 141 patients will be enrolled in 6 different cohorts (40 patients with aggressive B-cell lymphoma, 41 with follicular lymphoma (FL), 20 with Mantle Cell Lymphoma (MCL) and 20 with other indolent lymphomas, and 20 patients with Hodgkin lymphoma (HL)). FL patients with EZH2 mutant (gain of function mutations) will be enrolled in the cohort 2bis. At least 8 aggressive B-cell lymphoma patients with EZH2 mutant will be enrolled in the cohort 1. The primary endpoint is the overall response rate (ORR) determined by investigator assessment.

NCT ID: NCT04839484 Active, not recruiting - Nasolabial Fold Clinical Trials

LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of Lumina™ for the treatment of Nasolabial Folds (NLFs). Subjects will be randomized to receive treatment (Lumina™) in one NLF and control (Restylane® Defyne) in the contra-lateral NLF. 118 subjects will be treated.

NCT ID: NCT04839159 Active, not recruiting - Sickle Cell Disease Clinical Trials

Study of Biological Markers in Children With Sickle Cell Disease

Start date: May 10, 2012
Phase: N/A
Study type: Interventional

Sickle cell disease is associated with significant morbi-mortality hence the interest in an early and targeted care. At present, there is no plasmatic marker able to identify infants at higher risk of developping severe complications later in life. However, recent studies have demonstrated a correlation between certain complications of the disease and biomarkers of the endothelial dysfunction characterizing it. Investigators prospectively followed a cohort of children diagnosed with SCD through the universal neonatal screening using inflammatory and haemostatic plasmatic markers to study their annual evolution. Investigators then will evaluate potential associations between these biological markers and the occurrence of SCD related complications. A secondary objective of this study is to evaluate the repercussions of therapeutic intervention on these markers. .

NCT ID: NCT04837040 Active, not recruiting - Acromegaly Clinical Trials

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

PATHFNDR-1
Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

A randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as CRN00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (SRL) based treatment regimens.

NCT ID: NCT04831073 Active, not recruiting - Clinical trials for Type A Aortic Dissection

European Registry of Type A Aortic Dissection

ERTAAD
Start date: February 28, 2023
Phase:
Study type: Observational

Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

NCT ID: NCT04830228 Active, not recruiting - Clinical trials for Peripheral Artery Disease

BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions

BIONETIC-I
Start date: August 10, 2021
Phase:
Study type: Observational

BIOTRONIK cobalt chromium balloon-expandable Dynetic-35 stent in association with Passeo-35 Xeo peripheral dilation catheter for the treatment of peripheral iliac lesions

NCT ID: NCT04829318 Active, not recruiting - Clinical trials for Depressive Disorder, Major

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

ESCAPE-LTE
Start date: April 26, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants who have completed 32 weeks of esketamine nasal spray treatment in Study 54135419TRD3013 (NCT04338321).

NCT ID: NCT04822571 Active, not recruiting - Clinical trials for Femoroacetabular Impingement

Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males

CAM-FAI relia
Start date: March 23, 2021
Phase: N/A
Study type: Interventional

Femoroacetabular impingement is an orthopedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. The main study was initiated with the goal of exploring the etiology of FAI in a multidimensional and novel way that addresses the major gaps in literature. Within the main study a 3D motion capture protocol has been designed in line with the latest literature recommendations, which called for more hip ROM specific movements and athlete oriented 3D motion capture protocols that incorporate the spinopelvic complex. While the protocol surely contains movements that have been previously validated and published such as squats and lunges, a unique addition of high velocity soccer kicks and hop- lunges have been included. Such additions elevate the relevancy of the 3D motion analysis protocol, however they also pose questions on how reliable and accurate these additions are. This is especially important a 3D motion analysis has a very subjective component, which is the placement of the skin markers by the clinician. Errors or alteration to markers placement between different sessions or different subjects have been shown to significantly affect the quality of data. Furthermore, not all physical movement can be properly documented using motion analysis. The velocity at which the movement is preformed combined with how complex it is can affect the quality of data collected by the motion analysis system. Also another important component is the uniqueness of the population recruited for the main study. Most studies with highly dynamic motion protocols have been validated and published on adult populations. Thus the investigators cannot use their findings liberally to compare with the adolescent protocol, as differences in patterns of motion between adults and adolescence have been documented. Indeed, a need to test the reliability of the investigators' protocol among their own study groups is highly imperative.

NCT ID: NCT04821622 Active, not recruiting - Prostate Cancer Clinical Trials

Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.