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NCT ID: NCT04542746 Completed - Periodontal Pocket Clinical Trials

Treatment of Periodontal Intraosseous Defects

Start date: July 28, 2017
Phase: N/A
Study type: Interventional

The aim of the present study was to evaluate the impact of surgical flap design on the healing of intrabony defects treated by means periodontal regeneration. Forty patients were enrolled and allocated random in two groups. Patients of test group received a minimally invasive surgical flap , while patients of control group received a conventional access flap. In both group the intrabony were treated by means the same periodontal regeneration procedure (i.e application of enamel matrix derivative). Periodontal parameters were recoded at baseline and after 12-months observation time.

NCT ID: NCT04542499 Completed - Parkinson Disease Clinical Trials

Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor Fluctuations

TEMPO-3
Start date: October 27, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.

NCT ID: NCT04542070 Completed - HIV Infections Clinical Trials

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

SOLAR
Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

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: 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: 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.

NCT ID: NCT04535037 Completed - Diphtheria Clinical Trials

A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers

Start date: February 17, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV's DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12 weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age vaccination schedule.

NCT ID: NCT04529642 Completed - Stroke Clinical Trials

Is the 6-Minute Walking Test Combined With an IMU Useful in Stroke Rehabilitation Assessment?

Start date: February 1, 2019
Phase:
Study type: Observational

This Observational study aims at the evaluation of stroke subjects with an inertial measurement unit (IMU) during the execution of a 6-Minute Walking test, to evaluate the associations between the kinematic parameters retrieved trough an IMU and the classical outcome scales. Moreover compare the stroke subjects with age-matched healthy subjects, and detect the differences of gait kinematic.