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NCT ID: NCT03470545 Completed - Clinical trials for Obstructive Hypertrophic Cardiomyopathy

Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

EXPLORER-HCM
Start date: May 29, 2018
Phase: Phase 3
Study type: Interventional

This is a multicenter, international, double-blind study of the administration of mavacamten in participants with symptomatic obstructive HCM (oHCM). Approximately 220 participants will be randomized to receive placebo or mavacamten.

NCT ID: NCT03470337 Completed - Clinical trials for Thrombophlebitis Leg

Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Start date: September 1996
Phase: Phase 3
Study type: Interventional

Oral enzyme therapy in patients with acute superficial vein inflammation (thrombophlebitis) can serve as an additional treatment option besides standard therapy with compression stockings, common pain medication and physical treatments. This randomized, double-blinded trial compares efficacy and safety with placebo.

NCT ID: NCT03470025 Completed - COPD Clinical Trials

Improving Psychosocial Well-being in COPD Patients in Rehabilitation

IMPROVE
Start date: January 10, 2018
Phase: N/A
Study type: Interventional

Because of a lack of clinical trials, there is currently a paucity of evidence on the most effective strategies to identify and address psychological co-morbidity in COPD, or on targeting these interventions to specific patient groups. The relationship between physiological disease impairment and patient's disease experience is weak. Some patients have highly impaired Quality of life (QoL) despite relatively minor lung function impairment, and others have good QoL despite severe lung function impairment. It is likely that psychological and behavioral factors may be relevant; moreover the coping strategies used by patients and their relationship to individual psychological factors have been incompletely explored. Pulmonary Rehabilitation (PR) is part of integrated COPD patient management and its potential impact on QoL should be underlined: several studies have found that physical exercise has a beneficial effect on depression symptoms [GOLD, 2017]. Before initiating PR a comprehensive and careful assessment should be performed: treatment goals, specific healthcare needs, smoking status, nutritional health, self-management capacity, health educational, psychological health status and social circumstances, medical history and comorbidities, and exercise capabilities and limitations. Moreover, PR has beneficial effects on mood status and daily activities. Sustaining Pulmonary Rehabilitation benefits and regular exercise over the long term is difficult without any maintenance strategy. The main aim of this study is to assess the Effect of the Psychological Intervention (PI) on Quality of life, psychological status and well-being, and the maintenance of Pulmonary Rehabilitation benefits, in COPD patients. A PI based on psychoeducation and psychological and emotional support may be a key to improve Quality of life and to bring COPD patients to show a greater awareness of their health status.

NCT ID: NCT03469713 Completed - Clinical trials for Renal Cancer Metastatic

Nivolumab Plus Stereotactic Body Radiotherapy in II and III Line of Patients With Metastatic Renal Cell Carcinoma

NIVES
Start date: July 14, 2017
Phase: Phase 2
Study type: Interventional

NIVES study is an ongoing phase II, single arm, multicenter study. In this trial pts received SBRT to one non-brain measurable lesion and concomitant NIVOLUMAB, an anti-programmed cell death (PD-1). Combining SBRT with NIVO may enhance the antitumor immune responses and improve clinical outcomes, how it was demonstrated for other solid tumors with a phenomenon known as the abscopal effect . It was planned to enrolled a total of 68 pts within 12 months. The objective of the current analysis is to describe the first report of safety profile of NIVO in combination with SBRT.

NCT ID: NCT03468023 Completed - Clinical trials for Radius Fracture Distal

Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial

SLA-Ver
Start date: March 15, 2017
Phase: N/A
Study type: Interventional

This study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radius fractures.

NCT ID: NCT03467165 Completed - Osteoarthritis Clinical Trials

MRgFUS in the Treatment of Hand and Hip Osteoarthritic Pain

Start date: April 27, 2019
Phase: N/A
Study type: Interventional

This project aims at performing a pilot study to provide data on safety and potential efficacy of Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) in the treatment of pain caused by trapeziometacarpal osteoarthritis (OA) and/or scaphotrapezial OA, and by hip OA, while exploring the potential application of MRgFUS to two different and central joints burdened by OA.

NCT ID: NCT03467152 Completed - Clinical trials for Dementia With Lewy Bodies

Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies

Start date: May 4, 2018
Phase: Phase 2
Study type: Interventional

This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

NCT ID: NCT03466723 Completed - Parkinson Disease Clinical Trials

miRNAs Profiling in Parkinson's Disease

Start date: February 14, 2019
Phase:
Study type: Observational [Patient Registry]

microRNAs (miRNAs) regulate fundamental cell processes. Dysregulation of miRNA expression and function is reported in various diseases including cancer, metabolic disorders as well as neurological disorders. Circulating miRNAs have been proposed to mirror physiological and pathological conditions suggesting their use as biomarkers for various diseases. The study will focus on a case-control study cohort (N=1000) of subjects recruited at the IRCCS Neuromed for which a deep clinical characterization and genome-wide sequencing data are available. This study will enable to identify novel circulating biomarkers for Parkinson's disease (PD). Further, the project will give new insights on the involvement of miRNAs in the etiology of PD and in the understanding of the genetics of the disease thus opening avenues for novel therapeutic strategies.

NCT ID: NCT03465839 Completed - General Surgery Clinical Trials

Bedside Nursing Handovers in the Surgical Context

Start date: July 26, 2018
Phase: N/A
Study type: Interventional

Nursing handovers are performed 2-3 times a day for each patient, with an approximate average of 2 million nursing deliveries per year in a hospital of medium size. Nursing handovers are considered essential for the continuity and safety of care. If the relevant clinical information is not shared in a precise and timely manner, it may worsen the patients' outcomes with an increase in adverse events, delays or inappropriate treatment until the omission of procedures. The modality of nursing delivery presents, therefore, a gap of vulnerability where vital information could not be considered and systematically shared. Patients should be involved in their care to promote a patient-centred approach. The involvement of patients in handovers is effective compared to other delivery methods. To date, however, the best mode to deliver handovers was still unclear due to a systematic lack of studies to identify the best practice of nursing handovers. The studies in the literature lack of sound methodologies due to not randomized designs. Thus an intervention to improve quality of handovers and to implement bedside handovers in surgical wards will be performed. The following hypotheses were made: - The introduction of nursing bedside handovers will improve the quality of the information exchanged. - The educational intervention training intervention will positively modify the nursing handovers. - There is a relationship between the qualitative level of nursing handovers and working status (expert vs novice) of the nurses. - There is a relationship between the qualitative level of nursing handovers and the patients' characteristics.

NCT ID: NCT03465722 Completed - GIST Clinical Trials

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Start date: March 26, 2018
Phase: Phase 3
Study type: Interventional

This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.