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NCT ID: NCT04804553 Recruiting - Clinical trials for Active Juvenile Psoriatic Arthritis

Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis

PEAPOD
Start date: March 17, 2022
Phase: Phase 3
Study type: Interventional

The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.

NCT ID: NCT04801979 Completed - Clinical trials for Adults Without Disabilities

Normative Values and Reference Equations of a New Incremental Step Test for the Assessment of Exercise Capacity for Portuguese Adults

Start date: May 30, 2021
Phase:
Study type: Observational

According to the official guidelines, a range of settings for cardiorespiratory rehabilitation, including the community- and home-based models, are considered to answer to the inadequate number of rehabilitation services, especially at hospitals, and, also, to respond to the patients' needs. For these settings outside the hospitals, new strategies for the assessment of exercise capacity and exercise training are essential. The modality of stepping can be a promising tool because it is inexpensive, portable, and reflects one of the main activities of daily living (stair climbing). The development of a new field test implies the establishment of normative values and reference equations generated from data of populations without disabilities to aim to characterize a defined population at a specific period of time, and evaluate and compare an individual's performance within a population.

NCT ID: NCT04798261 Recruiting - Pulmonary Embolism Clinical Trials

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Start date: June 25, 2021
Phase:
Study type: Observational

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).

NCT ID: NCT04797351 Completed - Bipolar Disorder Clinical Trials

Bi-REAL - DBT Skills Online Group Intervention for Bipolar Disorder

BI-REAL
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Bipolar disorder (BD) is a serious mental disorder characterized by episodes of mania/hypomania and/or depression. Compared to the general population, these individuals present functional impairment, and life interference subclinical symptoms even between mood episodes, and higher mood instability and suicide rates with a lower quality of life. Given the chronic and phasic course of this disorder, patients are great consumers of health services and in Portugal there is no specialised psychotherapeutic approach to Bipolar Disorder, having pharmacological treatment alone as the main therapeutic response, and a considerable number of patients are not fully stabilized with drug treatments, experiencing residual symptoms. Although studies suggest that certain psychological therapies can be helpful for people experiencing full mood disorder episodes, or to reduce risk of future episodes, there are no gold standard and evidence-based psychological therapies for BD, and recent systematic reviews on psychosocial interventions for BD identify Dialectical-Behavior Therapy (DBT) as promising. Our research is sustained in a recovery based perspective, which means we intend to develop a sense of hope, understanding, empowerment and work towards a meaningful and satisfying life, focusing on less clinical outcomes. Recovery is a concept that looks beyond the traditional clinical definitions which focus on reduced symptomatology, hospitalisation and medication compliance, and focuses on having a better sense of living even though you might have some clinical symptomatology. DBT was developed as an approach for highly emotionally and behaviourally dysregulated people, and it has been referred as promising in BD patients. DBT aims to give individuals who experience quick and intense shifts in mood, skills to manage and regulate their emotions. People with Bipolar Disorder can benefit from skills to regulate their emotions and interpersonal efficacy, which is frequently affected by mood changes, and therefore have a life worth living, feeling skillful and empowered to deal with challenges. Our study aimed to develop a 12 session DBT-skills group adapting the sessions and skills to be used with this client group (Bi-REAL - Respond Effectively and Live mindfully). This study aims to test acceptability, feasibility and efficacy of this 12 session DBT skills pilot randomized group intervention for patients with Bipolar Disorders.

NCT ID: NCT04796337 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

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

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

NCT ID: NCT04796311 Completed - Acute Pancreatitis Clinical Trials

Imunomodulation in Acute Pancreatitis

Start date: February 26, 2021
Phase:
Study type: Observational

Acute pancreatitis is an acute inflammatory pathology of the pancreas with activation of both innate and adaptive immune system, including T and B lymphocytes and release of inflammatory cytokines. We aim to characterize the circulating profile of T and B cells, its regulatory populations and B cell maturation, as well as inflammatory cytokines, in a prospective way of 50 patients with acute pancreatitis admitted to Hospital da Luz Lisboa. Blood samples will be collected at hospital admission, 48h, one month and 6 months after hospitalization of patients, relating these values to the severity of acute pancreatitis. Patients with acute pancreatitis in the previous 6 months, diabetes mellitus, pregnant women, uncontrolled comorbidity and terminal neoplasms will be excluded. A control group of 30 ambulatory individuals observed at the Hospital da Luz Lisboa will be recruited. Laboratory evaluation will be performed at the Immunology Laboratory of NOVA Medical School.

NCT ID: NCT04793958 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

NCT ID: NCT04793919 Recruiting - Clinical trials for Acute Promyelocytic Leukemia

Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia

Start date: October 9, 2019
Phase: Phase 2
Study type: Interventional

The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.

NCT ID: NCT04791904 Completed - Clinical trials for Decompressive Craniectomy and Cranioplasty

Predictive Factors for Cranioplasty Complications - A Decade Experience

Start date: September 1, 2020
Phase:
Study type: Observational

This is a single-center, observational retrospective study. This study aims to identify predictive factors of complications for patients submitted to cranioplasty after decompressive craniectomy for all types of etiologies. All patients submitted to cranioplasty since 2008 will be analyzed.

NCT ID: NCT04790916 Terminated - Clinical trials for Autoimmune Hepatitis

Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH)

Start date: April 19, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the effect of RO7049665 on time to relapse following forced corticosteroid (CCS) tapering as measured by the hazard ratio between RO7049665 7.5 milligrams (mg) and placebo arm.