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NCT ID: NCT05051917 Recruiting - Clinical trials for Patients With Acute Coronary Syndrome and Angiographic Evidence if Coronary Aneurysms and/or Ectasia

The Italian Coronary Artery Aneurysm and Ectasia Observational Study In Patients With Acute Coronary Syndrome

ITACA
Start date: September 1, 2021
Phase:
Study type: Observational

The ITACA study is a prospective, observational no profit registry enrolling patients with Acute Coronary Syndrome and angiographic evidence if coronary aneurysms and/or ectasia.

NCT ID: NCT05051735 Not yet recruiting - Cancer Clinical Trials

PARASTOP - Paracetamol With Strong Opioids

PARASTOP
Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

Current guidelines recommend all people with cancer-related pain should be prescribed paracetamol, even those receiving high doses of strong pain killers (opioids) such as morphine. Although this has been shown in studies to be beneficial in other conditions, for instance dental work and after surgery, it has not been shown to further improve pain in people with cancer-related pain. We know that people can find taking tablets burdensome and we hope to determine whether the inconvenience of taking eight extra paracetamol tablets per day can be justified. In this study we plan to show whether or not pain control is changed (non-inferior) when stopping paracetamol compared to continued use of paracetamol in people already taking strong pain killers for cancer-related pain. We will do this by recruiting voluntary participants who are taking a combination of paracetamol and a strong opioid.

NCT ID: NCT05050214 Not yet recruiting - Clinical trials for Membranous Nephropathy

Obinutuzumab in Primary MN

ORION
Start date: December 2021
Phase: Phase 2
Study type: Interventional

Primary membranous nephropathy (MN) is an antibody-mediated autoimmune glomerular disease, that represents one of the most frequent causes of nephrotic syndrome in adults. The first-generation chimeric anti-CD20 monoclonal antibody rituximab is effective in inducing MN remission in the majority of patients, but a significant fraction of them can experience disease relapses that require multiple re-treatments over time. Repeated infusions may result in hypersensitivity reactions, which contraindicate further treatment with rituximab. Independent of previous treatment response, Rituximab-Intolerant patients require a safe and effective therapeutic alternative that could reduce the risk of hypersensitivity reactions. On the other end a substantial proportion of patients do not benefit of rituximab therapy and might benefit of other anti CD20 monoclonal antibodies. A few patients transiently benefit of rituximab but their relapses after rituximab administration are so frequent that they spend most of their live with nephrotic range proteinuria (rituximab-dependent patients). Obinutuzumab is a humanized monoclonal antibody with enhanced B cell-depleting potential. Due to humanization and glycoengineering, this drug may be safe and effective in inducing disease remission even in patients with prior hypersensitivity reactions to rituximab. Moreover, it has been found to be effective in patients with membranous nephropathy who failed to respond to rituximab.

NCT ID: NCT05049798 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

PsABIOnd
Start date: August 25, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).

NCT ID: NCT05049603 Not yet recruiting - Graves' Orbitopathy Clinical Trials

A Randomized Clinical Trial to Evaluate the Effects of Atorvastatin on Graves' Orbitopathy (GO): the STAGO-2 Study

STAGO-2
Start date: January 1, 2022
Phase: Phase 3
Study type: Interventional

Graves' orbitopathy (GO) is the most common extra-thyroidal manifestation of Graves' disease (GD). Based on its clinical signs and symptoms, GO is graded as mild, moderate-to-severe, or severe, and active or inactive, the latter feature being established on a 5/7-scale score named Clinical Activity Score (CAS). The European Group on Graves Orbitopathy (EUGOGO) has recently formulated and published up-to-date guidelines for the management of GO, according to which high dose intravenous (iv) glucocorticoids (GC) (ivGC) is the first line treatment for moderate-to-severe and active GO. A protective effect of atorvastatin on the development of GO in patients with GD has been reported, based on which we recently conducted a phase II, randomized, open label clinical trial and found that atorvastatin improves the response of GO to ivGCs in hypercholesterolemic patients. The effect was unrelated to cholesterol levels, suggesting that it may be the consequence of a direct action of atorvastatin. To investigate this issue further and to introduce atorvastatin in the clinical practice, we designed the present Phase III, double-blinded, multicenter, randomized, adaptive, superiority, no profit, clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy, regardless of cholesterol levels.

NCT ID: NCT05048602 Recruiting - Arrhythmia Clinical Trials

Drug-induced Brugada Syndrome Research Database

Start date: September 7, 2021
Phase:
Study type: Observational

All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated.

NCT ID: NCT05047263 Not yet recruiting - Clinical trials for Non-diabetic Chronic Kidney Disease

A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease

FIND-CKD
Start date: September 21, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months. During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments.

NCT ID: NCT05046119 Not yet recruiting - Migraine Clinical Trials

Psychological and Biological Markers of Refractory Migraine

Start date: September 15, 2021
Phase:
Study type: Observational

The term "refractory" migraine describes a particularly aggressive form of the disease in which the patient does not benefit from any of the preventive therapies with the various classes of drugs available, including treatment with monoclonal antibodies directed against Calcitonin Gene Related Peptide (CGRP). Anxiety, depressive symptoms, somatization, and pain hypersensitivity are significantly more prevalent in refractory migraineurs than in non-refractory subjects who benefit from preventive therapies, suggesting that these symptoms may contribute to treatment refractoriness. Recently, in a preliminary study on the efficacy of a CGRP-targeting monoclonal antibody in Chronic Migraine (CM) patients with at least 3 failures to previous preventive treatments, the investigators showed a higher prevalence of psychological disturbances in those who did respond to the monoclonal antibody compared with the responders. These data, although preliminary, point to a more psychologically complicated picture in non-responder patients compared with responders. To date, however, no neurobiological evaluations are available to explain how psychological comorbidities may contribute to treatment refractoriness. Isolated clinical evidence and growing pre-clinical evidence suggests a role for the endocannabinoid system in migraine. Hence, the present study aims to identify psychological and biological factors associated with refractory migraine. The investigators' hypothesis is that patients presenting with psychological disorders may bear an associated dysfunction of the endocannabinoid system, which makes them more resistant to migraine preventive therapies, including monoclonal antibodies directed against CGRP.

NCT ID: NCT05045105 Recruiting - Clinical trials for Intracranial Hypertension

Timing of Invasive Intracranial Pressure Monitoring Between Neurosurgeons and Intensive Care Physicians

TIMING-ICP
Start date: April 27, 2021
Phase:
Study type: Observational

Invasive intracranial pressure monitoring takes on essential importance in patients with traumatic brain injury and in all cerebral pathologies in which intracranial hypertension is the main cause of death. Prolonged Intracranial Hypertension has been related to poor outcome and its occurrence has therefore to be assessed as soon as possible. Invasive intracranial pressure monitoring performed by placing an intracerebral catheter is currently the gold standard technique for continuous ICP invasive monitoring. This maneuver has usually been performed by neurosurgeons, but recently this procedure has more often been carried out by intensivists, at the bedside. Management of intracranial pressure handling and treatment is currently achieved by joint decisions between neurosurgeons and intensive care physicians, but differences in logistic matters and in the executive availability could impact on the dose of intracranial pressure to which patient is exposed. The aim of this study is to compare timing of invasive intracranial pressure monitoring placement performed by intensive care physicians and neurosurgeons and to detect possible differences in the incidence of complications between the two groups.

NCT ID: NCT05044143 Not yet recruiting - Clinical trials for Preterm Labor With Preterm Delivery

Prediction of Preterm Delivery With Serial Cervical Length Measurements After Threatened Preterm Labor

Start date: September 20, 2021
Phase:
Study type: Observational

Prospective cohort study on pregnant women discharged from the hospital after their first episode of threatened preterm labor. Cervical length (CL) will be measured with transvaginal US upon initial presentation (i.e at the time of hospital admission), at the time of hospital discharge, and respectively 2, 4, 8 and 12 weeks later. Pregnant women undelivered after their 1st episode of threatened preterm labor will be invited to participate in the study if their CL upon discharge is < 25 mm. The study will investigate the potential association between cervical shortening over time and time of delivery, to assess if spontaneous preterm delivery can be predicted by CL as women are discharged from the hospital after their 1st episode of threatened preterm labor.