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NCT ID: NCT04074291 Completed - Quality of Life Clinical Trials

Cross Cultural Validation of the Italian Version of the Bt-DUX

Start date: August 20, 2019
Phase:
Study type: Observational

The purpose of the presented study is to translate the English Bt-DUX (Bt-DUX-Eng) questionnaire into the Italian language and then examine the validity of the Italian version of the Bt-DUX (Bt-DUX-It).

NCT ID: NCT04073654 Recruiting - Bone Resorption Clinical Trials

SA Versus SOI Surfaces for Single Implant-supported Crown

Start date: September 26, 2019
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.

NCT ID: NCT04073420 Recruiting - Clinical trials for Valve Disease, Heart

Medtronic Cardiac Surgery PMCF Registry

Start date: December 2, 2019
Phase:
Study type: Observational [Patient Registry]

This registry is being conducted to support ongoing post-market surveillance activities.

NCT ID: NCT04073264 Completed - Clinical trials for Cesarean Scar Defect

Isthmocele After Two Different Sutures in Cesarean Section

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Cesarean delivery (CD) rates are rising globally. about 30% of women delivered by CD in 2015 only in the USA. This increasing CD rate has stimulated an interest in the potential short- and long-term morbidity of CD scars. In more than 50% of women with history of CD, a uterine scar defect, also called a "isthmocele," defined as a disruption of the myometrium in the CD uterine scar, can be observed when examined by gel instillation sonohysterography 6-12 months after the CD. Uterine scar defects detected on ultrasound have been associated with prolonged menstrual bleeding and postmenstrual spotting, as well as with an increased risk of several obstetrical complications in subsequent pregnancies, including uterine dehiscence and/or rupture, scar pregnancy and placenta previa and accreta. Another screening method associated with uterine scar rupture in women with prior CD is ultrasonographic measurement of the thickness of the lower uterine segment, as pioneered by Rozenberg et al. in 1996. A meta-analysis by Kok et al. supports the use of the residual myometrial thickness (RMT) for predicting uterine rupture during vaginal birth after cesarean. Uterine scar defects have been associated with lower RMT. A growing body of evidence suggests that the surgical technique for uterine closure influences uterine scar healing and the RMT, but there is still no consensus about optimal uterine closure and type of suture. It is imperative to have evidence-based guidelines for each surgical step before recommending one technique over another. The aim of our trial is to evaluate the incidence of cesarean scar defect according to type of suture at the time of cesarean

NCT ID: NCT04073251 Completed - Cough Clinical Trials

Efficacy, Safety and Palatability of the Syrup "KalobaTuss® Children" for the Treatment of Cough in Children

KALOCOUGH
Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice. In the majority of cases, it is self-limiting, but its persistence could become exasperating and it could reduce quality of life and social activities. Even if inappropriate prescription of antitussive pharmacological treatment in children has been reduced, pediatrics prescribing attitudes do not still always are reflecting accurate treatment of cough. Furthermore, pediatric approach is always compromised by parental exaggerate perception of symptoms and usual consequent requirement of pharmacological prescription of antibiotics, that they consider the appropriate and effective therapeutic option for cough. The World Health Organization identifies honey as a potential demulcent treatment for cough. On the light of the above considerations and since available pediatric treatments for acute cough are limited by lack of demonstrated efficacy, a pediatric cough syrup product containing Acacia honey as well as specific fractions of resins, polysaccharides, saponins, flavonoids and sugars derived from Malva sylvestris extract, Inula helenium, Plantago major extract, Helichrysum stoechas (KalobaTuss) was developed to be clinically tested on persisting cough of children. Investigators evaluated through a randomized, double blind controlled clinical study the effects of KalobaTuss on persistent cough in children aging 3-6 years. The effects of Kalobatuss were compared with effects of placebo on nocturnal and daytime persistent cough for eight days. Objective of the study was to evaluate the clinical efficacy of KalobaTuss by using as primary endpoint the assessment of changes in day- and night-time cough score.

NCT ID: NCT04072887 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

Start date: September 12, 2019
Phase: Phase 2
Study type: Interventional

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

NCT ID: NCT04072575 Completed - Schizophrenia Clinical Trials

A Study of Paliperidone Palmitate 6-Month Formulation

Start date: September 19, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.

NCT ID: NCT04072198 Recruiting - Colorectal Cancer Clinical Trials

Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients

NIVACOR
Start date: September 26, 2019
Phase: Phase 2
Study type: Interventional

This is a multicentric single arm, open label trial. In this study patients candidated to a first line of chemotherapy for metastatic colorectal cancer will be treated with 8 cycles of folfoxiri plus bevacizumab plus nivolumab followed by a maintenance with bevacizumab plus nivolumab. Patients who do not progress during chemotherapy phase will receive bevacizumab plus nivolumab as maintenance therapy. Patients will be treated until disease progression, unacceptable toxicity or patient/physician decision.

NCT ID: NCT04072068 Completed - Cancer Clinical Trials

Study on Impact of Edoxaban Treatment in Cancer Patients With Venous Thromboembolism During Antineoplastic Therapy

EDOI
Start date: June 27, 2019
Phase: Phase 4
Study type: Interventional

This is a multicentric, phase IV study. In this study patients that are receiving an antineoplastic treatment and that have been diagnosed with venous thromboembolism will receive edoxaban as per clinical practice. Edoxaban will be administered according to summary of product characteristics. Patients will receive 6 to 12 months of treatment with edoxaban administered orally. The thromboembolic event will be monitored as per local clinical practice. In this study patients will be evaluated at baseline, at the beginning of therapy with edoxaban, after 1 month (+/- 7 days), after 3, 6 and 12 months (+/- 3 weeks). During these visits, patients will be provided of a diary in which they should report drug intake and interruptions and quality of life questionnaires.

NCT ID: NCT04071847 Recruiting - Parkinson Disease Clinical Trials

Abbott DBS Post-Market Study of Outcomes for Indications Over Time

ADROIT
Start date: November 26, 2019
Phase:
Study type: Observational

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.