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NCT ID: NCT04387604 Completed - Clinical trials for Diabetic Macular Edema

Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema

DEVITRA
Start date: August 1, 2017
Phase:
Study type: Observational

PURPOSE: To evaluate the effect of the vitreous in response to intravitreal (IV) injections of ranibizumab 0.5 mg/0.05ml (Lucentis; Genentech, South San Francisco, CA) for the treatment of diabetic macular edema (DME). METHODS: Prospective, observational, multicenter study, conducted at Centro Hospitalar e Universitário do Porto, Portugal. Best-corrected visual acuity and central foveal thickness will be evaluated at baseline and every month until the end of follow-up. OCT biomarkers such as retinal layers thickness will also be analyzed. A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Vitrectomized patients will improve less than non-vitrectomized patients.

NCT ID: NCT04378088 Completed - Colon Polyp Clinical Trials

The Colon Endoscopic Bubble Scale (CEBuS); Validation Study

CEBuS
Start date: October 1, 2019
Phase:
Study type: Observational

Colonoscopy is currently accepted as the gold standard in screening, surveillance and prevention for colorectal cancer (CRC), and therefore, its quality is a major priority. The quality of colonoscopy is greatly dependent on the quality of the bowel preparation, which can be limited by stool, foam, bubbles and other debris. In fact, colonic bubbles are described in 30 to 40% of colonoscopies, possibly undermining the quality of the exam, impairing the endoscopists view, demanding the further use of water or simethicone and eventually increasing fatigue and costs, while diminishing diagnostic accuracy. Although previous attempts, to date no endoscopic scale is validated regarding the presence of bubbles and most widely accepted and already validated scales do not include the presence or absence of bubbles in their definition, leading to the use of different home-made scales in randomized trials and impairing any solid meta-analysis conclusion. As so, the goal of this study is to develop and validate a new colonic bubble score (Colon Endoscopic Bubble Scale - CEBuS).

NCT ID: NCT04370808 Completed - COVID-19 Clinical Trials

VITACOV: Vitamin D Polymorphisms and Severity of COVID-19 Infection

VITACOV
Start date: August 1, 2020
Phase:
Study type: Observational

Vitamin D deficiency has been linked to hypertension, autoimmune, infectious and cardiovascular diseases which are risk factors for COVID-19. Moreover, COVID-19 patients have a very high prevalence of hypovitaminosis D (Turin data). Taken together, we aim to investigate whether genetic variants in vitamin D-related genes contribute to a poor COVID-19 outcome, particularly in hypertension and CV patients, proposing thus a personalized therapeutics based on vitamin D supplementation in order to reduce the severity and deaths.

NCT ID: NCT04367337 Completed - Health Behavior Clinical Trials

Health Behavior Change During COVID-19 Pandemic

Start date: March 25, 2020
Phase:
Study type: Observational

This study aims at investigating handwashing behavior during COVID-19 pandemic. It was hypothesized that social-cognitive and emotional predictors as well as COVID-19 morbidity and mortality rates within the country would be associated with handwashing behavior in the general population of adults in 14 countries.

NCT ID: NCT04366713 Completed - Clinical trials for HER2 Amplified Breast Cancer

A Study to Characterize Colon Pathology in Patients With HER2 Amplified Breast Cancer Treated With Neratinib

Start date: June 30, 2020
Phase: Phase 2
Study type: Interventional

This study will investigate colon pathology in patients with HER2-positive breast cancer treated with neratinib. Colonoscopy will be performed after eligibility has been confirmed, prior to administration of the first dose of neratinib, and after 28 days of neratinib treatment.

NCT ID: NCT04355741 Completed - COVID-19 Clinical Trials

Gut Microbiota, "Spark and Flame" of COVID-19 Disease

Start date: April 20, 2020
Phase:
Study type: Observational

Elderly, hypertension, diabetes and cardiovascular diseases are risk factors for COVID-19 morbility and mortality. However, the real reason for this is not yet understood. It is well documented that gut microbiota has a critical role in health, particularly in the immune system and therefore, we propose that gut microbiota composition could affect vulnerability and disease outcomes of COVID-19.

NCT ID: NCT04340726 Completed - Clinical trials for Dental Implant Failed

Periimplant Bone Changes in Different Abutment Heights and Insertion Timing in Posterior Mandibular Areas

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

The aim of this study was to compare the influence of the abutment height and insertion timing on early marginal bone loss (MBL) in posterior mandibular partial implant-supported restorations. Material and methods: The study was planned as a prospective, randomized, controlled parallel group including subjects in need of two implants for the restoration of an edentulous posterior mandibular area. Data were gathered on age, gender, attached gingiva height, bleeding on probing (BoP), smoking habits and previous periodontitis. The patients were allocated into three groups: Group A implants were immediately connected to 2 mm height abutments; Group B implants were immediately connected to 1 mm height abutments; Group C implants were left to heal in a sub-mucosal position and 2 mm abutments were inserted in a second stage surgery. Peri-apical radiographs were taken at the implant surgery (baseline), 4 weeks after surgery (T1), 16 weeks after implant placement at the final restoration delivery (T2) and 1-year after implant placement (T3).

NCT ID: NCT04338321 Completed - Clinical trials for Depressive Disorder, Major

A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selective Serotonin Reuptake Inhibitor/Serotonin-Norepinephrine Reuptake Inhibitor, in Participants With Treatment Resistant Major Depressive Disorder

ESCAPE-TRD
Start date: August 21, 2020
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of flexibly dosed esketamine nasal spray compared with quetiapine extended-release (XR), both in combination with a continuing selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI), in achieving remission in participants who have treatment-resistant major depressive disorder (MDD) with a current moderate to severe depressive episode.

NCT ID: NCT04334603 Completed - Heart Failure Clinical Trials

EXercise InTervention in Heart Failure

EXIT-HF
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

This is a pragmatic, non-inferiority clinical trial, enrolling heart failure patients who will be randomized to a 12-week exercise training program either centre-based or home-based with telemonitoring. The impact of this intervention will be assessed on established surrogate markers in HF such as maximal exercise capacity, plasma biomarkers and quality of life. The cost-effectiveness and overall satisfaction with the treatment will also be studied. In addition to measure the clinical and economic impact of this innovative way of delivering exercise, it is intended to unravel new molecular pathways and assess a pool of biomarkers that provide a wide mechanistic picture underlying the clinical effects of exercise.

NCT ID: NCT04319354 Completed - Cancer of Rectum Clinical Trials

Evaluation of cfDNA as a Marker of Response in Rectal Cancer

Start date: November 18, 2019
Phase: N/A
Study type: Interventional

A pathological complete response (pCR) after surgery occurs in approximately 20% of rectal cancer patients submitted to neoadjuvant chemotherapy, with apparent survival benefit. This group could, potentially, be spared the morbidity of surgery. The diversified response to neoadjuvant chemotherapy (nCRT) amongst tumors suggests a complex relationship between tumor biology and response possibly due to a number of genetic or molecular pathways that might regulate chemoradiosensitivity. Accumulating evidence indicated that circulating cell-free nucleic acids can be a promising biomarker of response, in liquid biopsy, for rectal cancer. The concentration of baseline plasma cell-free DNA (cfDNA) appears significantly higher in responders compared to non-responders. The objective of this study is to investigate the potential role of cfDNA as a marker of pCR (or partial response) to nCRT as well as a marker of outcomes (overall survival and disease-free survival). The investigators are conducting a prospective, observational, cohort, non-randomized study of consecutive patients with locally advanced rectal cancer submitted to nCRT, followed by surgical excision 6-12 weeks later. Patients are assigned to groups according to their pathological response to nCRT. A total of 20 patients with complete pathological response, 50 partial response and 50 non-responders will be selected over a year and followed for another year. Participants will be observed and examined during the entire course of treatment and the follow-up period. Serial analysis of cfDNA through liquid biopsies will be performed in consecutive patients at specific time points (pre-nCRT, post-nCRT and postoperative week 1), incorporating analysis of concentration, dimension of DNA fragments, % of mutation frequency (CIN, APC, p53, MSI, KRAS, BRAF, EGFR, cKIT) and next-generation sequencing of tumour biopsy and surgical specimens. This study will serve as the feasibility of a larger, comparative study.