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NCT ID: NCT04873167 Completed - Clinical trials for Cardiovascular Risk Factor

Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes

NCT ID: NCT04873063 Completed - Clinical trials for Healthy Adult Male Volunteers

Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adult Male Volunteers

Start date: October 22, 2021
Phase: Phase 1
Study type: Interventional

Single-centre, randomized, double-blind, two-period, two-sequence, cross-over 7-day study. This study is the first safety/tolerability evaluation of a product -suppository formulation containing 6 mg BDP (once daily dosing), a second-generation oral or rectal corticosteroids with high topical anti-inflammatory efficacy in the gut and minimal systemic bioavailability (BA). BDP is marketed in different pharmaceutical formulations, including 3 mg suppositories, and approved for ulcerative proctosigmoiditis in the first attack or exacerbation phase at the dosage of 3 mg twice a day. For these reasons, a 6 mg suppository (Test - "T" product) is a scale-up of the 3 mg formulation (Reference - "R" product). For locally-applied-locally acting drug products that result in quantifiable systemic availability due to absorption from the administration site, relative systemic BA is informative for safety, but also with respect to efficacy. Therefore, safety/tolerability of T is evaluated through a comparison to R.

NCT ID: NCT04872374 Not yet recruiting - Clinical trials for Inflammatory Response

Effects of Parmigiano Reggiano on Skeletal Muscle Damage in Older Adults

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity. Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt. Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect. Therefore, the central hypothes is that PR consumed during RET can provide more energy substrates and improve muscle recovery. To date, no studies have studied its function on recovery from exercise nor in the elderly.

NCT ID: NCT04871958 Terminated - Diabetes Mellitus Clinical Trials

Individualized, Technological Interventions for Diabetes Care in the COVID-19 Ward

Initiator
Start date: March 19, 2021
Phase: N/A
Study type: Interventional

During the current Covid-19 pandemic, many hospitals worldwide have been overwhelmed and strategies based on new technologies have been considered to improve the outcomes in patients with diabetes and Covid-19 and to prevent healthcare workers' exposure. Point-of-care blood glucose measurements, with the need of frequent and intermittent blood glucose testing and the associated time burden for hospital staff workers, have evident limitations. To this respect, continuous glucose monitoring (CGM) might represent an effective tool in hospitalized patients. The latest CGM devices have alarms alerting clinicians (or patients) to abnormal blood glucose values. Furthermore, CGMs not requiring calibration with capillary glucose testing have the potential to decrease both nurse and patient burden. Insulin therapy is recommended in hospitalized patients with diabetes and Covid-19, conventionally by multiple daily insulin injections, i.e., rapid-acting insulin before meals and long-acting insulin once-a-day. Such a complex regimen demands also multiple daily fingerstick for glucose control. Use of continuous subcutaneous insulin infusion in hospital has been considered, and simple, less sophisticated pumps might be appro¬priate for prompt use by healthcare providers not specialized in diabetes treatment. V-Go® is a skin-patch insulin delivery device to be replaced every 24 h. It is fully mechanical, without tubing or electronics, and does not require any programming. It delivers a continuous basal infusion of rapid-acting insulin and allows for additional units before meals. Therefore, the implementation of CGM and automated insulin infusion in Covid-19 hospitals has the potential to improve clinical outcomes, protect frontline healthcare workers, and preserve personal protective equipment. However, because only observational retrospective data for CGM use and no data on insulin pump use are currently available, randomized controlled trials are needed to determine whether using these technologies in hospital is of significant help. The aims of this study are to explore, in patients with diabetes in COVID-19 wards, whether using continuous glucose monitoring with a glucose telemetry system and/or using a disposable insulin pump may improve blood glucose control and Covid-19 outcomes, and facilitate diabetes management.

NCT ID: NCT04871919 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Prospective Observational Study of Filgotinib in Subjects With Rheumatoid Arthritis

FILOSOPHY
Start date: May 11, 2021
Phase:
Study type: Observational

An observational study to describe the effectiveness, safety, and patient-reported outcomes in patients with moderate to severe active rheumatoid arthritis (RA) receiving filgotinib in real-world setting.

NCT ID: NCT04871763 Completed - Clinical trials for Orthodontic Appliance Complication

Assessment of Bacterial Loads of Essix Retainers in Patients Under Retention Therapy

Start date: May 12, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the bacterial loads present on essix retainers in patients' contention therapy. Patients are randomly divided into three groups, depending on the product used for the cleansing of the retainers: Geldis, Polident tablets and water. Microbiological samples were taken from the retainers at the baseline, after 1 and after 2 months, together with Bleeding Index, Plaque Index, BEWE Index and Schiff Air Sensitivity test.

NCT ID: NCT04871711 Completed - Chronic Hand Eczema Clinical Trials

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

DELTA 1
Start date: May 10, 2021
Phase: Phase 3
Study type: Interventional

This is a 16-week study in adult participants with chronic hand eczema (CHE). The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. The purpose is to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

NCT ID: NCT04871685 Active, not recruiting - Clinical trials for Respiratory Distress Syndrome

The ECOVITA Study - Validation of LUS Score in SARS-CoV-2 Disease, i.e COVID-19

ECOVITA
Start date: October 18, 2020
Phase:
Study type: Observational

Lung Ultrasound (LUS) has been revealing an extremely useful tool to identify and monitor complications from Sars-COV-2 disease. Recently, a research group has proposed a score, named LUS Score, able to optimize the use of this diagnostic technique. LUS Score is computed analyzing chest posterior and lateral spaces, considering the number of artefacts generated by the inflammed interstitium (B lines), the characteristics of the pleural line and the presence or not of consolidation areas. The comparison between LUS and chest tomography (CT), the current gold standard for the diagnosis of interstitial pneumonia by COVID-19, has confirmed from the preliminary data, the reliability of such technique. Hence, the validation on a really large sample size of the ultrasound tool performed by dedicated personnel with high expertise, may allow the validation both in the clinical practice and in emergency and ordinary wards.

NCT ID: NCT04871399 Recruiting - Colon Cancer Clinical Trials

Complete Mesocolic Excision in Comparison With Conventional Surgery for the Right Colon Cancer

CoME-In
Start date: July 13, 2020
Phase: N/A
Study type: Interventional

An Italian randomized controlled trial parallel-group in patients with a malignant tumor of the right or proximal transverse colon requiring right hemicolectomy.

NCT ID: NCT04871282 Active, not recruiting - Desmoid Tumor Clinical Trials

A Study of AL102 in Patients With Progressing Desmoid Tumors

RINGSIDE
Start date: March 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The current study is designed to evaluate the efficacy and safety of AL102 in patients with progressive desmoid tumors.