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NCT ID: NCT03528941 Not yet recruiting - Clinical trials for Chronic Lymphoid Leukemia

The Incidence of Hepatitis B Reactivations in Patients Affected by Chronic Lymphocytic Leukemia With Ibrutinib

Start date: June 30, 2018
Study type: Observational

This observational retrospective study will enroll at least 158 patients affected by Chronic Lymphoid Leukemia (CLL) with previous HBV exposure (HBsAg negative, anti-HBc positive with or without anti-HBs) treated, with Ibrutinib single agent according to the IWCLL criteria 2008. Patients will be divided into two cohorts, one encompassing patients who received lamivudine and the second one including patients who received no prophylaxis. Each patient will be observed for one year from the first administration of Ibrutinib.

NCT ID: NCT03528785 Recruiting - Clinical trials for Pancreatic Adenocarcinoma

A Study of Nal-IRI With 5-FU, Levofolinic Acid and Oxaliplatin in Patients With Resectable Pancreatic Cancer

Start date: January 1, 2018
Phase: Phase 2
Study type: Interventional

Rational:Pancreatic cancer is a systemic disease at the time of diagnosis, even among patients with apparent localized disease. Surgical resection is the only potentially curative therapy for pancreatic cancer, but in patients who undergo surgery and postoperative therapy, metastatic relapse remains common and no more than 20% of patients achieve 5-year survival. Because of this aggressive biologic behavior, an increasing interest is growing about preoperative treatments in resectable pancreatic cancer. The combination chemotherapeutic regimen with irinotecan + 5-fluorouracil (5-FU)/leucovorin (LV) + oxaliplatin (FOLFIRINOX) is an effective choice for first line treatment in patients affected by advanced pancreatic cancer, and in this setting it achieved a Disease Control Rate of 70.2 % (10). In this regard, FOLFIRINOX is currently explored as preoperative regimen in a number of clinical trials in resectable pancreatic cancer. A critical challenge in this field remains the introduction in these combination treatments of the most novel and effective agents such as nalIRI, in order to obtain a more profound tumor shrinkage, to increase the rate of R0 resections, to allow an early treatment of occult micrometastatic disease, and eventually, to improve survival in patients with resectable pancreatic cancer. This study proposal is designed to address this challenge. Preliminary results, collected during the Part 1 Dose Escalation of a current clinical trial performed in mPDAC, show that dose of nal-IRI: 60 mg/m2, Oxaliplatin: 60 mg/m2, 5-FU/LV: 2400/400 mg/m2 is safe.

NCT ID: NCT03528551 Enrolling by invitation - Clinical trials for Congenital Bleeding Disorder

A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A

Start date: April 30, 2018
Phase: Phase 3
Study type: Interventional

This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.

NCT ID: NCT03526614 Active, not recruiting - Clinical trials for DUAL ANTIPLATELET THERAPY

REpetitive Assessement of SCOREs in Patients on Dual Antiplatelet Therapy

Start date: May 1, 2018
Study type: Observational [Patient Registry]

Patients treated with percutaneous coronary intervention (PCI) require dual antiplatelet therapy (DAPT). Preliminary assessment of the PRECISE-DAPT score is mandatory in order to assess the risk of bleeding while on DAPT. The score takes into consideration age, creatinine clearance, haemoglobin, white-blood-cell count and previous spontaneous bleeding. One should consider, however, that some of the variables included in the PRECISE-DAPT score might change with time. As a consequence, the PRECISE-DAPT score should not be considered a static score as it might vary after the initial computation. It remains unknown, however, if the delta PRECISE-SCORE, reflecting the change in score between baseline and follow-up, might predict more reliably the long-term bleeding risk of PCI patients.

NCT ID: NCT03525665 Recruiting - Follicular Lymphoma Clinical Trials

Study on the Role of FDG-PET in Patients With FL at Time of Relapse/Progression

Start date: May 2016
Study type: Observational

The study is designed as a retrospective analysis of patients with relapsed/refractory FL identified by the hematological centers of Italy.

NCT ID: NCT03525639 Recruiting - Clinical trials for Myocardial Inflammation

CMR Evaluation of Myocardial Inflammation Persistence After Acute Myocarditis: Prognostic Relevance

Start date: December 6, 2016
Phase: N/A
Study type: Interventional

Patients with acute myocarditis (AM) usually experience spontaneous healing, but a considerable percentage of them evolve toward chronic cardiac impairment at long-term. The evolution toward dilated cardiomypathy (DCM) occurs in a subtle manner, frequently after an initial recover that mimics complete healing. Differences in the course of disease may reflect the course of underlying myocardial inflammation related to viral clearance or persistence and to the following autoimmunity response. New cardiac magnetic resonance (CMR) parameters are sensitive to myocardial inflammation. They may have a prognostic role and, in particular, our hypothesis is that a short-term monitoring with CMR (1 month) may identify the subgroup of patients at high risk to progress toward DCM. The trend of CMR parameters during the first month will be compared with the following outcome in 80 patients with AM. Results of this study will help to significantly improve management and outcome of patients with AM.

NCT ID: NCT03525587 Recruiting - Clinical trials for Growth Hormone Deficiency

Development and Validation of a Self-assessment System Based on a Mobile App to Manage Adult Growth Hormone Deficiency

Start date: January 17, 2018
Phase: N/A
Study type: Interventional

Adult Growth Hormone Deficiency (AGHD) is a recognized clinical entity but several barriers concerning patient-clinician communication, inadequate patients' awareness of the disease, low perceived benefit of replacement therapy and poor compliance still remains. The overall goal of the study is to improve AGHD management through a Smartphone app (MAGHD App: Manage Adult Growth Hormone Deficiency) integrated with a software framework able to merge patients daily data on physical activity, quality of life (QoL), and well-being with clinical data collected in institutional databases. The target population consists of 100 patients with a previous diagnosis of AGHD, whether in treatment with growth hormone or not. In a prospective 24 months study, MAGHD App will be developed and connected to MAGHD Framework. This system will allow to integrate: 1) Physical Activity Data collected by wearable devices, 2) Patient Related Outcomes Data, periodically inserted by the patients through MAGHD App in response to questions extrapolated from validated questionnaires, 3) HCP Data registered in clinical databases and including medical history, biochemical and radiological examination. Data will converge in MAGHD Framework where they will be analyzed and used to create reports visible to patients (in MAGHD App) and clinicians (by a monitoring dashboard). The results are expected to positively influence AGHD management by involving patients in care process and giving clinicians a useful tool for clinical practice.

NCT ID: NCT03525301 Recruiting - Brain Metastases Clinical Trials

Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

Start date: November 8, 2017
Phase: N/A
Study type: Interventional

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors

NCT ID: NCT03525171 Completed - Clinical trials for Growth Hormone Deficiency

Evalutation of Insulin Sensitivity Through Hyperinsulinemic Clamp in Children With GH Deficiency

Start date: January 1, 2014
Phase: N/A
Study type: Interventional

Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels. The investigators aimed to evaluate insulin sensitivity through the euglycemic hyperinsulinemic clamp, considered the gold standard technique, in children affected by growth hormone deficiency and to compare the M-value with the most commonly used surrogate indexes of insulin sensitivity.

NCT ID: NCT03524924 Recruiting - Atrial Fibrillation Clinical Trials

Edoxaban and Frailty in Senior Individuals

Start date: January 7, 2018
Study type: Observational [Patient Registry]

Edoxaban, has shown in clinical registration trials a significant reduction of major bleeding compared to warfarin, especially in elderly patients. Efficacy and safety of edoxaban will be assessed in a cohort of very elderly patients (≥80 years of age) with NVAF. A secondary analysis will correlate outcomes with frailty defined according to SHARE-FI (not-frail, pre-frail or frail).