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NCT ID: NCT04362072 Active, not recruiting - Carcinoma Clinical Trials

Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer

Start date: September 29, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment. Participants will take part in this study for up to approximately 4 years, depending on when the study is completed and how their cancer responds to the study treatment. They will take lorlatinib orally (by mouth) once daily. Participants will visit the study site about every six weeks to meet with the study team. During these visits, the study team will monitor the safety and effects of lorlatinib.

NCT ID: NCT04361994 Recruiting - Takotsubo Syndrome Clinical Trials

The GErman Italian Spanish Takotsubo (GEIST) Registry

GEIST
Start date: April 2015
Phase:
Study type: Observational [Patient Registry]

GEIST is a multicenter, international observational registry of patients with Takotsubo syndrome. Data regarding the clinical profile (demographic characteristics, clinical presentation, laboratory measures, electrocardiography /echocardiography / coronary angiography parameters, treatment and medication), in-hospital course and complications and short-/long-term outcome are collected prospectively and retrospectively to increase the understanding of the disease.

NCT ID: NCT04361916 Terminated - COVID-19 Clinical Trials

Home Care for Patients With COVID-19: Active Monitoring in Two Italian Health Units (Casale Monferrato and Torino)

Mon-Covid
Start date: April 21, 2020
Phase: N/A
Study type: Interventional

Starting an early home management and monitoring of patients with suspected or confirmed COVID-19 to ensure a rapid and adequate transfer to hospital care. Assess the feasibility of home monitoring in a pilot study to possibly extend it to a larger scale.

NCT ID: NCT04361721 Recruiting - Chronic Migraine Clinical Trials

Neurophysiological, Biomolecular and Psychological Aspects of Erenumab Treatment in Chronic Migraine

Start date: January 15, 2020
Phase:
Study type: Observational

Monoclonal antibodies (mABs) targeting calcitonin gene-related peptide (CGRP) proved effective in the preventive treatment of episodic and chronic migraine as well as in difficult-to-treat patients such as those who had previously failed multiple prevention treatments or those with associated medication overuse (MO). A characteristic dysfunction in Chronic Migraine (CM) is sensitization, occurring peripherally in the trigeminovascular system but then spreading to the central nervous system, where it manifests with an increased neuronal excitability in multiple areas. Several neurophysiological studies in CM patients have demonstrated the occurrence of central sensitization in the brain as well as at the spinal level. MicroRNAs (miRNAs) are involved in the generation and maintenance of chronic pain. Current evidence suggests that specific miRNAs may also play a role in migraine, thus representing possible biomarkers of the disease. A previous study reported an upregulation of miR-34a-5p and miR-382-5p, implicated in the regulation of GABAergic signaling and IL-10 gene expression respectively, during migraine attacks. The aim of this open label, hypothesis generating study is the evaluation of the impact of erenumab treatment on neurophysiological, biomolecular and psychological aspects in a representative cohort of CM patients who had previously failed at least 2 preventive treatments.

NCT ID: NCT04360694 Recruiting - Clinical trials for End Stage Renal Disease on Dialysis

RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed. Methods/Design: The Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is "REAL LIFE", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness. Discussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.

NCT ID: NCT04360226 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Assessing the Utility of Peak Inspiratory Flow as a Predictor for COPD Exacerbations

Start date: December 14, 2020
Phase:
Study type: Observational

This is an international, mulitcentre, observational, prospective study into Peak Inspiratory Flow in COPD patients that aims to: A) Determine the prevalence of suboptimal Peak Inspiratory Flow (PIF) and inadequate inhaler choice and assess the baseline characteristics of these groups. B) Assess the clinical role of PIF and inhaler choice in predicting COPD exacerbations and symptom burden. C) Assess the variability and correlation of PIF with other lung function measurements and CAT score in stable COPD. It is a 12 month study comprising one baseline assessment and 2 follow-up visits at 6 and 12 months.

NCT ID: NCT04360148 Active, not recruiting - Overweight Clinical Trials

Th Effect of Ketogenic Metabolic Nutritional Pattern on High-frequency Episodic Migraine (EMIKETO)

EMIKETO
Start date: February 6, 2020
Phase: N/A
Study type: Interventional

The study aims to investigate the impact of 2 nutritional patterns on high-frequency episodic migraine. Subjects enrolled will be randomized in two arms: a) very-low-calorie-ketogenic-diet (VLCKD), b) hypocaloric balanced non ketogenic-diet (HBD).

NCT ID: NCT04359732 Recruiting - Esophageal Cancer Clinical Trials

Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI

Escape
Start date: May 8, 2020
Phase: N/A
Study type: Interventional

Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).

NCT ID: NCT04359394 Recruiting - Clinical trials for Pustular Psoriasis (PP)

International Rare And Severe Psoriasis Expert Network

IRASPEN
Start date: September 22, 2021
Phase:
Study type: Observational [Patient Registry]

This registry is a prospective observational study in order to describe primarily the natural course of PP subtypes and to gain detailed information about their phenotype.

NCT ID: NCT04359212 Completed - COVID-19 Disease Clinical Trials

Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19

VTE-COVID
Start date: May 1, 2020
Phase:
Study type: Observational

The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.