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NCT ID: NCT04295304 Terminated - Clinical trials for Retinitis Pigmentosa

NR600 System Retinal Prosthesis for Patients With Retinal Degenerative Diseases

NR
Start date: January 17, 2020
Phase: N/A
Study type: Interventional

The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment

NCT ID: NCT04295252 Recruiting - Cardiogenic Shock Clinical Trials

Altshock-2 REGISTRY

Start date: July 1, 2020
Phase:
Study type: Observational [Patient Registry]

The study will provide data on profile, management, outcome, and evolution over time of cardiogenic shock patients admitted to the Intensive Coronary Care Units

NCT ID: NCT04295031 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Metformin in Older Adults With Type 2 Diabetes (AMEMET)

AMEMET
Start date: October 9, 2019
Phase:
Study type: Observational

Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the daily metformin prescribed dose and the impact of renal function and concomitant medication in diabetic patients over 65 years.

NCT ID: NCT04294979 Recruiting - Multiple Sclerosis Clinical Trials

Exercise Therapy in Multiple Sclerosis

RehaMS
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

Exercise or active rehabilitation is a non-pharmacological approach increasingly used for people with Multiple Sclerosis (MS), in support of disease-modifying therapies (DMTs), with the aim of improving the quality of life and engagement in daily activities. Exercise improves several disease outcomes, like cardiovascular and neuromuscular functions and walking abilities. However, its disease modifying potential is poorly explored. Exercise might target two relevant disease hallmarks that are interconnected, such as the dysregulated immune system and the inflammatory synaptopathy. Exercise might act through the activation of the autonomic part of the vagus nerve, which is an important modulator of both the innate and adaptive immune system, through the so-called cholinergic anti-inflammatory pathway-CAP. This study aims to address the effect of exercise in reducing peripheral inflammation that drives the synaptic pathology and neurodegeneration occurring in the brain of MS patients. Patients will undergo a therapeutic exercise program, consisting of 3 hours of treatment per day, 6 days/week for a total of 6 weeks. The treatment will include both passive and active therapeutic exercises targeted to restore or preserve muscular flexibility, motor coordination and ambulatory function. The day of recruitment (time 0) patients will undergo neurological and mood examination and blood withdrawal to analyze peripheral markers of immune function. Moreover, transcranial magnetic stimulation (TMS) will be used to measure synaptic transmission, while the heart rate variability (HRV) test will be performed to explore vagal function. The effect of exercise will be evaluated at the end of rehabilitation (after 6 weeks-time 1), on the above parameters. A follow up will be included (time 2, 8 weeks after the end of the treatment) to address long-term effects on neurologic and mood measurements as well as peripheral marker levels.

NCT ID: NCT04294940 Withdrawn - Clinical trials for Acute Coronary Syndrome

Impact of a Digital Solution (CardiCare™) on Cardiorespiratory Fitness Improvement in Patients Discharged From a Phase 2 Cardiac Rehabilitation Following an Acute Coronary Syndrome

Start date: December 2021
Phase: N/A
Study type: Interventional

Coronary heart disease is a partial inability of the coronary arteries to supply the heart muscle due to their narrowing. There is angina and myocardial infarction. Coronary heart disease is the first cause of non-communicated deaths and years of life lost. After hospital discharge, a few days following the acute care of a coronary heart disease, a formal Cardiac Rehabilitation programme (CR) is usually provided. CR is a comprehensive programme involving exercise training, risk factor modification, education and psychological support. It is generally sequenced in 4 phases. Phase 1 begins at the hospital and consists of early mobilisation and education. Most phase 2 CR models are based upon supervised ambulatory outpatient programmes. Maintenance (phase 3 and 4) follows the ambulatory programme in which physical fitness and risk factor control are supported in a minimally supervised setting. Despite high-grade recommendations and abundant clinical evidence, a CR program is not always implemented and the patients are not systematically referred after discharge from a phase 1 CR. Furthermore, compliance to pharmacological treatments and changes in lifestyle and diet are hugely neglected following a phase 2 CR and an important number of patients resume a sedentary lifestyle. A growing body of evidence supports the use of digital tools such as smartphones and tablets in helping the patients achieve their goals in terms of physical exercise, risk-factor reduction and diet improvement. Ad Scientiam has developed CardiCare™, a mobile application intended to provide a personalised physical training plan contributing to stabilise or improve cardiorespiratory fitness through improvement of VO2max. The mobile application CardiCare™ is to be used by patients after an acute coronary syndrome, graduated from a phase 2 cardiac rehabilitation program in a cardiac rehabilitation centre and entering in phase 3 CR. The mobile application CardiCare™ consists of several modules: - A physical activity recommendation engine, providing personalised weekly activity schedule, self-adapting to the patient's clinical characteristics, physical capacity and sport preferences through a proprietary algorithm - Self-administered questionnaires to assess perceived exertion, chest pain, weight variations, patient's quality of life - Passive monitoring of the patient's physical activity through Apple's HealthKit and Google's Fit - Informational content about cardiovascular diseases, risk factor reduction and chest pain action plan The investigator's work hypothesis is that, compared to standard care, CardiCare™ will stabilise or improve the cardiorespiratory fitness (VO2max) acquired post-CR.

NCT ID: NCT04294927 Recruiting - Ovarian Cancer Clinical Trials

TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

TUBA-WISP-II
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

NCT ID: NCT04294810 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

SKYSCRAPER-01
Start date: March 4, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

NCT ID: NCT04294667 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

PHOENYCS GO
Start date: August 12, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.

NCT ID: NCT04294654 Completed - Clinical trials for Major Depressive Disorder

Vortioxetine in Patients With Depression and Early Dementia

MEMORY
Start date: February 28, 2020
Phase: Phase 4
Study type: Interventional

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia

NCT ID: NCT04294550 Completed - Cancer Clinical Trials

Study on Quality of Life in Advanced Cancer Patients With Opioid-induced Constipation Treated With Naloxegol

Start date: September 1, 2018
Phase:
Study type: Observational

Opioid-Induced Constipation (OIC) is often associated with a compromised quality of life of patients in palliative care (PC) setting. Among the Peripherally-Acting Mu-Opioid Receptor Antagonists, Naloxegol is the most effective to treat OIC and to improve OIC-related aspects of quality of life in patients with non-cancer pain. This observational study aims to assess the impact of a 4-weeks Naloxegol therapy on the quality of life in advanced cancer patients with OIC assisted by a home PC program. The study is enrolling cancer patients with OIC (defined according to Rome IV criteria) not relieved by first-line laxatives, starting the therapy with 25 mg/day of Naloxegol. The main parameters evaluated at the beginning of the therapy (T0) and after 28 days (T28) are: Patient Assessment of Constipation Quality-of-Life (PAC-QoL, 4 subscales: physical discomfort, psychosocial discomfort, worries and concerns, satisfaction), evaluation of objective (number of weekly evacuations) and subjective constipation (Bowel Function Index, BFI, normal score<30), pain assessment by NRS.