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NCT ID: NCT05119868 Recruiting - Obesity Clinical Trials

Effects of the Mediterranean Diet During Pregnancy on the Onset of Allergies in the Offspring

PREMEDI
Start date: November 2, 2021
Phase: N/A
Study type: Interventional

Allergy prevalence is increasing steadily with some describing as the "epidemic of the twenty-first century". Maternal diet during pregnancy has been linked to offspring allergy risk, so it represents a potential target for allergy prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models which exerts regulatory effects on immune system, due to the synergistic and interactive combinations of nutrients. We aim to study the effects of MD in pregnancy on the onset of allergic diseases at 2 years of age in the offspring.

NCT ID: NCT05119816 Completed - Kidney Diseases Clinical Trials

Music Therapy Intervention During Kidney Biopsy.

MTI-KB
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

Kidney biopsy (KB) is an invasive procedure that is very useful in diagnosing kidney disease in both the native kidney and the transplanted kidney. Patients undergo KB can feel anxiety and pain. Pain is considered one of the worst experiences for patients and anxiety affects the sympathetic nervous system, the endocrine system and the immune system. The aim of this preliminary study was to evaluate the influence of MTI as a complementary/nonpharmacological intervention on heart rate variability, anxiety and pain and promote more compliant behaviours during KB.

NCT ID: NCT05119673 Completed - Emergencies Clinical Trials

POCUS for Difficult Peripheral Access in the Emergency Department - a RCT

Start date: October 22, 2021
Phase: N/A
Study type: Interventional

Peripheral intravenous line insertion is the most commonly performed invasive procedure in the emergency department (ED). The research hypothesis is that a biplane sonographic approach (i.e., an out-of-plane and in-plane view) might be superior to a mono-plane approach (i.e., an out-of-plane or in-plane view) obtaining a peripheral vascular access among difficult patients admitted to the ED

NCT ID: NCT05119309 Completed - Clinical trials for Monoclonal Gammopathy of Renal Significance

MGRS: Clinical-histological Features of a Multicenter Case Series

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

The term "Monoclonal Gammopathies of Renal Significance" (MGRS) describes a group of diseases characterized by the presence of an immunoglobulin or monoclonal immunoglobulin fraction that has the ability to cause renal damage. It is important to diagnose MGRS correctly and early as renal survival depends on the renal function present at the time of diagnosis and it is necessary to establish a specific treatment that aims to stop the progression of the damage. organ and restoration of renal function. To date, there are no targeted therapeutic strategies that can prevent the formation of deposits or that can eliminate the deposits already present in the kidney, which constitute the etiopathogenetic factor of these pathologies. Therefore, the only valid therapeutic option is to act against the clone of B lymphocytes underlying the nephrological pathology, although it is not a clone with such requirements to be able to define it as a tumor. Therefore, given the absence of a well-defined policy in the therapy of MGRS and the doubts present on the validity of a therapeutic approach aimed at the suppression of a plasma cell clone, the investigators decided to carry out an observational retrospective study with the aim of describing, in a large series of MGRS treated with oncohematological therapy, the renal and overall outcome of patients and identify any presenting prognostic characteristics that can help improve the diagnosis of these disorders and the long-term survival of patients.

NCT ID: NCT05118789 Recruiting - Clinical trials for Metastatic Solid Tumor

A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Start date: January 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.

NCT ID: NCT05117242 Recruiting - Clinical trials for Non Small Cell Lung Cancer Metastatic

Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

Start date: October 27, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to investigate the safety and efficacy of acasunlimab (also known as GEN1046) as monotherapy and in combination with pembrolizumab in patients with non-small cell lung cancer who have progressed during or after treatment of previous standard of care

NCT ID: NCT05116774 Terminated - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

BCX9930 for Treatment of PNH in Subjects With Inadequate Response to C5 Inhibitor Therapy

REDEEM-1
Start date: December 6, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of BCX9930 monotherapy for the treatment of PNH compared to continued C5 inhibitor therapy in adult PNH patients with residual anemia despite treatment with a C5 inhibitor.

NCT ID: NCT05116748 Completed - COVID-19 Clinical Trials

COVID19 Vaccine in SOT Adult Recipients

COVID19_VaxSOT
Start date: October 1, 2021
Phase:
Study type: Observational

Background: ISHLT and AASLD guidelines recommend SARS-CoV2 vaccination in all individuals undergoing lung and liver transplantation, but there are currently scarce data on the safety and efficacy of these vaccines in this population. In Italy, immunocompromised patients have received the indication to be administered mRNA vaccines only. Primary outcome: safety and reactogenicity Secondary outcomes: immunogenicity and prevention of COVID19 Visits and timepoints: - T0: before first dose administration: visit and venous sampling to assess baseline COVID19 serum status - Telephone calls to assess safety and reactogenicity 1 and 2 days after each dose of vaccination - T21 or 28 (based on vaccine; mRNA BNT162b2 and mRNA-1273, respectively): visit, venous sampling to assess immunogenicity - Follow up visits after 60, 120, 180 and 365 from T0: visit and venous sampling to assess immunogenicity

NCT ID: NCT05116553 Completed - Self Efficacy Clinical Trials

Motivational Evaluation and Intervention With Co-Adapt Application for Healthy Ageing

Start date: November 11, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to identify effective methodologies to help people to improve their awareness of change, motivation, self-confidence and self-efficacy, compliance in behavioral change and psychological well-being.

NCT ID: NCT05116501 Recruiting - Clinical trials for Low Von Willebrand Factor

Genetic Background of Patients With Low Von Willebrand Factor Levels

LOVMIC
Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Von Willebrand disease (VWD) is caused by either quantitative or qualitative von Willebrand (VWF) defects and is the commonest inherited bleeding disorder with an estimated prevalence of about 1% in the general population. According to several guidelines, patients with a mild quantitative reduction in VWF (30-50 IU/dL) should be labeled as "low VWF". Quantitatively VWF defects account for almost 75% of all cases with VWD and among them, low VWF seems to be the most common form. Studies on patients with VWD reported only around 50% VWF mutations in low VWF cases indicating that some possible genes outside of the VWF gene may be responsible for the low VWF levels. To date, using genome-wide association study (GWAS) more than 19 non-VWF loci (such as ABO blood group system, Stabilin 2, Scavenger Receptor Class A Member 5, C-Type Lectin Domain Family 4 Member M, etc.) were identified to be associated with VWF levels. The identified genes are related to different mechanisms of the VWF life-cycle such as synthesis, secretion, glycosylation, or clearance. Despite the importance of the genetic background of low VWF levels for understanding its etiology, this issue is not well investigated yet. Thus the Low VWF Milan Cohort (LOVMIC) Study is designed to address some unanswered questions in patients with low VWF.