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NCT ID: NCT04540497 Active, not recruiting - Clinical trials for IgG4 Related Disease

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

Start date: October 26, 2020
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

NCT ID: NCT04540029 Completed - Prenatal Stress Clinical Trials

Measuring Outcomes of Maternal COVID-19-related Prenatal Exposure

MOM-COPE
Start date: May 6, 2020
Phase:
Study type: Observational

The rapidly spreading coronavirus Covid-19 pandemic is a major concern worldwide and Italy is at the forefront of this emergency. At the present moment, the effects on the offspring of Covid-19 disease in pregnant women and/or the indirect effect of COVID-19-related prenatal maternal stress are poorly understood. Epigenetic mechanisms - and especially DNA methylation - are involved in the embedding of prenatal exposures to large-scale disasters into the epigenome and phenotypic outcomes of the offspring. Specific target genes include SLC6A4, NR3C1, OXTR, BDNF, and FKBP5. The central hypothesis of this project is that the exposure to the COVID-19-related prenatal maternal stress may affect infants' outcomes from birth to 12 months partially through increased methylation of target genes involved in stress regulation. The main goal is to investigate the association between Covid-19 disease in pregnancy or COVID-19-related PMS in women pregnant during the first 9 months of the year 2020 and the emotional, social, and cognitive developmental outcomes in their infants from birth to 12 months. Additionally, the role of target genes methylation in mediating this association will be investigated. Mothers and their infants will be enrolled from the delivery units of eleven neonatal facilities located in Northern Italy's COVID-19 contagion hotspot. One group will be enrolled from April to October 2020 (COVID-Exposure Pregnancy, CEP), a second group will be enrolled from April to October 2021 (Non-Exposure Pregnancy, NEP). Moreover, the CEP group will include mothers positive or exposed to COVID-19-related MPS during different trimesters of pregnancy, allowing within-group comparisons on developmentally sensitive time windows. Within 48 hours from baby delivery, saliva samples will be obtained from CEP and NEP newborns, immediately stored at -20°C and analyzed for epigenetic analyses using Next-Generation Sequencing. At 3 and 6 months, mothers will be asked to fill-in validated and reliable questionnaires on the emotional and social-behavioral development of their infants. At 12 months, infants' stress regulation and maternal sensitivity will be evaluated through video recording of mother-infant interactions. This study will provide unprecedented relevant insights on the biochemical mechanisms underlying the impact of Covid-19 disease and the related PMS on human offspring's developmental outcomes.

NCT ID: NCT04538768 Not yet recruiting - Clinical trials for Incisional LLQ Hernia

Prevention of Lateral Incisional Hernia After Stomal Closure Using P4HB Retro-muscular Mesh

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

The aim of the study is to determine whether the use of the P4HB retro muscular mesh can prevent the lateral incisional hernia after stomal closure.

NCT ID: NCT04538742 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

DB-07
Start date: December 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

NCT ID: NCT04538664 Active, not recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

PAPILLON
Start date: October 13, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

NCT ID: NCT04538404 Completed - Surgery Clinical Trials

Mortality Score in Elderly Patients With Colon Cancer

MECC
Start date: January 1, 2011
Phase:
Study type: Observational

CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.

NCT ID: NCT04537923 Completed - Type 2 Diabetes Clinical Trials

A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

SURPASS-6
Start date: October 19, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

NCT ID: NCT04536129 Completed - Glaucoma Clinical Trials

Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma.

NCT ID: NCT04536064 Enrolling by invitation - Clinical trials for Description of an Effective Surgical Strategy to Treat Cancer Related Lymphedema, a High Incidence Pathology

COMBINATION OF LYMPHATICO-VENULAR ANASTOMOSIS AND LIPOSUCTION IN TREATING LYMPHEDEMA

Start date: February 22, 2021
Phase:
Study type: Observational

- cooperation of an International team with many years of experience in surgical management of lymphedema - description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology - the combination of LVA and liposuction guarantees long lasting results

NCT ID: NCT04535609 Completed - Clinical trials for Primary Mitochondrial Myopathy

An Efficacy and Safety Study of 24 Week Treatment With Mavodelpar (REN001) in Primary Mitochondrial Myopathy Patients

STRIDE
Start date: May 21, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel group, multi-centre, study designed to investigate the efficacy and safety of REN001 administered once daily over a 24-week period to patients with PMM.