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NCT ID: NCT04105127 Not yet recruiting - Malocclusion Clinical Trials

Pain and Discomfort With Anterior Versus Posterior Builds-up

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

Orthodontic build-ups are made by composite/resin material bonded to the palatal or occlusal surfaces of teeth (usually molars or incisors). Their primary purpose is to prevent heavy contact of the upper teeth with lower fixed appliances in patients with overbite reduction to avoid brackets detachment. These appliances disarticulate the posterior teeth, deprogram the masticatory muscles and allow for eruption, extrusion, and uprighting of the posterior teeth. Build-ups are usually placed in the first months of the fixed orthodontic treatment and contribute to increasing the perception of pain. In the orthodontic daily practice, the pain is the most frequent symptom during treatment and is the one that most frightens/worries the patients. Literature shows that fear of pain is one of the primary reasons that patients fail to seek orthodontic care. Pain has a negative effect on patients' compliance, oral hygiene, and missed appointments. Its effects on patients' daily lives is a major reason for discontinuance of orthodontic treatment. In the literature the prevention of pain and management of orthodontic builds-ups is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice. So, the aim of the present study is to investigate and analyze the perception of pain and function impairment with different type of build-ups (anterior or posterior) to identify an efficient clinical management protocol and an effective pain and discomfort prevention strategy.

NCT ID: NCT04093947 Not yet recruiting - Obesity Clinical Trials

Characteristics of Subjects With Overweight or Obesity at the Onset of Hypertension

Start date: October 1, 2019
Phase:
Study type: Observational

The study aims to investigate the characteristics of subjects with hypertension at onset among a cohort of apparently healthy subjects, with overweight or obesity (BMI ≥ 25 Kg / m2), and free of any drug treatment at the baseline. The evaluation includes anthropometric (weight, height, BMI, waist circumference), haematochemical (hormones, metabolic and routine) parameters and the screening for hypertension with ABPM. The diagnosis of hypertension is made in accordance with the 2017 guidelines of the American College of Cardiology / American Heart Association ACC / AHA.

NCT ID: NCT04078542 Not yet recruiting - Cough Clinical Trials

Prevalence and Main Features of Chronic Refractory Cough.

ASSESS-CRC
Start date: January 1, 2020
Phase:
Study type: Observational

Cough is among the most common causes of medical consultation in primary care.[1] Chronic cough, arbitrarily defined as symptom persisting more than 8 weeks, has been variably reported in different settings and geographical area, with an overall prevalence of 10-20% in the general population, that increases up to 40-50% in pneumology specialist clinics.[2,3] While acute cough is generally caused by the common cold and typically lasts one to three weeks, chronic persisting cough can underlie more serious disease processes. Moreover, it can impair quality of life,[4] possibly leading to tiredness, urinary incontinence, and eventually syncope. It also has psychosocial effects such as embarrassment and negative impact on social interactions. A careful clinical history may provide important diagnostic clues that allow therapeutic trials without the need of further investigations.[5] Smoking history, medication list and presence and character of sputum should be carefully detailed. Identification of the causes of productive cough is generally straightforward and strategies for intervention and treatment are well defined.[5] Conversely, chronic dry or poorly productive cough represents a greater diagnostic challenge. Several studies have shown that in nonsmokers with normal chest radiography who are not taking ACE-inhibitor, chronic cough is usually due to asthma, rhinosinusitis or gastro-esophageal reflux (GER).[6] Many dedicated algorithms have been identified to guide the diagnostic phase and to sequentially coordinate the execution of further diagnostic deepening and/or empirical treatments, based on cost-effectiveness principles.[5,7-9] Among these, the European Respiratory Society (ERS) recommendations[5] are widely applied in clinical practice and broadly parallel those released by the American College of Chest Physicians[7]. This notwithstanding, a proportion of cases do not reach a definite diagnosis and resolutive treatment[7]. This condition is termed chronic refractory cough (CRC), chronic idiopathic cough, or unexplained chronic cough.[7,10] It can be diagnosed when patients have no identified causes of chronic cough (unexplained or idiopathic chronic cough) or when the cough persists after investigation and treatment of cough-related conditions. Because patients with unexplained chronic cough often receive specific therapies, such as inhaled corticosteroids or proton pump inhibitors, they can also be classified as having CRC. The real prevalence of CRC is not well-know and many cases of CRC may be actually misdiagnoses due an incomplete application of recommended work-up. In the present study we aim to estimate the prevalence of chronic cough in different care settings, together with the prevalence of CRC according to a systematic and integrated approach. The careful application of the recommendation defined by ERS guidelines will allow to detect truly refractory cases of chronic cough.

NCT ID: NCT04062760 Not yet recruiting - Acute Heart Failure Clinical Trials

Safety and Efficacy of Early, seQUential Oral dIuretic Nephron blockAde In Acute Heart Failure

SEEQUOIA-AHF
Start date: December 1, 2019
Phase: Phase 4
Study type: Interventional

The SEEQUOIA-AHF (Safety and Efficacy of Early, seQUential oral dIuretic nephron blockAde in Acute Heart Failure) trial is a multicenter, randomized, open-label, parallel-arm trial assessing the impact of early sequential nephron blockade (i.e. a regimen based on the combination of four oral diuretics with different sites of action along the nephron at low doses) compared to a conventional approach with a high-dose loop diuretic in the treatment of congestion in patients hospitalized with acute heart failure (AHF). In this study, after 24-72 hours of high-dose intravenous furosemide started at the time of hospital admission, patients admitted with AHF will be randomized to open-label oral treatment with either low-dose sequential nephron blockade or high-dose furosemide for 96 hours. The primary end-point will be the bivariate change in body weight and serum creatinine value at 96 hours since randomization. Secondary endpoints will include clinical (e.g., total change in body weight during hospitalization, change in dyspnea score at 96 hours since randomization, 30-day readmission rate) and laboratory (e.g., change in BNP or NT-proBNP at discharge vs randomization) parameters, and safety (e.g., change in serum creatinine value at discharge versus randomization and up to 30 days from discharge) issues.

NCT ID: NCT04053595 Not yet recruiting - Clinical trials for Perioperative/Postoperative Complications

Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization

Start date: June 2020
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the complications rate of high risk patients undergoing non-cardiac surgery that receive two different protocols of hemodynamic optimization. A group of patients receive a protocol based on dynamic parameters of fluid responsiveness; the other group of patients receive a protocol based of the optimization of oxygen extraction. The hypothesis is that a perioperative hemodynamic optimization protocol based on oxygen extraction is not inferior to a protocol based on dynamic parameters of fluid responsiveness considering the complication rate developed postoperatively.

NCT ID: NCT04053231 Not yet recruiting - Surgery Clinical Trials

Hepatocarcinoma Recurrence on the Liver Study - Part2

HERCOLES2
Start date: September 2019
Phase:
Study type: Observational [Patient Registry]

Rationale for the trial. To evaluate the impact of surgery on hepatocarcinoma recurrence. Thus, to evaluate the impact of different clinical, radiological, histopathological variables on recurrence after surgical treatment. The nature of this study will allow to observe, over time, the distribution of the considered collection variables, allowing a strictly observational monitoring of possible associations able to suggest models or interpretations, which can then be the basis for the construction of prospective and randomized studies.

NCT ID: NCT04032431 Not yet recruiting - Multiple Sclerosis Clinical Trials

Upper Limb Telerehabilitation With Virtual Reality in Multiple Sclerosis

TEAMS
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

This study aims to investigate the effectiveness of a home-based telerehabilitation program specifically designed for upper limbs, based on Virtual Reality (VR) in individuals affected by Multiple Sclerosis.

NCT ID: NCT03994874 Not yet recruiting - Clinical trials for Congestive Heart Failure

Peritoneal Ultrafiltration in Cardio Renal Syndrome.

PURE
Start date: July 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Randomized, controlled, unblinded, adaptive design clinical trial to evaluate the safety and efficacy of PolyCore (Polydextrin, L-Carnitine, D-xylitol) peritoneal ultrafiltration (PUF) in patients with heart failure and reduced ejection fraction (HFrEF).

NCT ID: NCT03985709 Not yet recruiting - Clinical trials for Osteoarthritis of Multiple Joints

Probiotic for Osteoarthritis

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

The gut microbiome appears to be a significant contributor to musculoskeletal health and disease. Microbiome composition and its functional implications have been associated with prevention of bone loss and/or reducing fracture risk. Genetic background, gender, dietary intake, and social factors are also important factors which contribute to the musculoskeletal health, as well as to the normal balance of intestinal microbiota. The link between gut microbiota and joint inflammation in murine models of arthritis has been established, and it is now receiving increasing attention in human studies. Recent papers have demonstrated substantial alterations in the gut microbiota in patients with rheumatoid arthritis (RA) and osteoarthritis (OA). These alterations resemble those established in systemic inflammatory conditions (inflammatory bowel disease, spondyloarthritides, psoriasis), which include decreased microbial diversity and lower abundances of bacteria belonging to the Firmicutes phylum that are known to have immunoregulatory properties.These new findings open important future horizons both for understanding disease pathophysiology and for developing novel biomarkers and treatment strategies. Further investigation into the mechanisms linking changes in the microbiome to alterations in bones and joints is necessary. Next Generation Sequencing, metatranscriptomic analysis, and metabolomic approaches may provide yet-greater insight and help further understand these mechanisms. To investigate gut microbiota change will be associated with the sintoms of knee and / or hip OA in italian patients.

NCT ID: NCT03978858 Not yet recruiting - Clinical trials for Leukemia, Myeloid, Acute

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Start date: June 28, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.