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NCT ID: NCT04666597 Completed - Clinical trials for Dental Caries in Children

Pandemic-adapted Caries Care Multicentre Single-group Interventional Study

Start date: November 15, 2020
Phase:
Study type: Observational

The current understanding of dental caries has not been completely transferred into the clinical practice to control caries lesion progression (severity / activity) and the individual risk of caries. This situation led to the development of the CariesCare International CCI Caries Management System (2018), derived from ICCMS™- International Caries Classification and Management System (2012) and the ICDAS - International Caries Detection and Assessment System (2002) in a consensus among more than 45 cariologists, epidemiologists, public health professionals, researchers and cliniciansfrom all over the world. The consensus aimed to guide dentists and dental teams in clinical practice, facilitating the control of the caries process and the maintenance of oral health in their patients. The general lack of implementation of an updated management of dental caries is evident in Colombia, in the survey of 1094 clinicians, teachers and students, failures were reported to adopt related behaviours, motivation barriers (remuneration), opportunity (in terms of relevance, physical/infrastructure resources, time) and training. As an additional barrier, the Colombian Chapter of the Alliance for a Cavity-Free Future (ACFF), evidences the absence of a facilitating Oral Health Record (OHR), this situation lead to stablish a new Alliance between the Ministry of Health and Social Protection (MSPS) and the AFLC to develop an inter-institutional consensus at the national level, of a clinical history for diagnosis and management of lesions and caries risk. Finally, 55 institutions participated in this consensus, and we have just finished a pilot test of the forms to submit a proposal for national standardization from the MSPS. The aim of this multicentre case series is to assess after 3, 6 and 12 months in children oral health outcomes, caregivers' satisfaction and in dentists' process outcomes, after the implementation of the CCI system adapted for the COVID-19 era -non-aerosol generating procedures. Oral health outcomes will be evaluated in terms of: - Effectiveness of CCI to control bacterial plaque, caries progression and caries risk, and to achieve behavioural change in oral health in children. - Acceptance of CCI caries management adapted for COVID-19 through Treatment Evaluation Interventory in dentists, and in children/parents through satisfaction questionnaire. - Costs of CCI adapted for caries management, in economic terms, number and appointment time.

NCT ID: NCT04664426 Completed - Polyneuropathies Clinical Trials

Sensory Neuropathy Scores Validated by Quantitative Sensory Testing and Nerve Conduction Studies for Kidney Transplant Recipients

SENS
Start date: December 20, 2021
Phase:
Study type: Observational

Sensory polyneuropathy is one of the most prevalent neurological disorders and a common finding in kidney transplant recipients (KTR). However, prevalence, course and underlying aetiology in this specific patient group remain unexplored. To diagnose sensory polyneuropathy in KTR in clinical practice, a relatively easy and inexpensive method is needed. The Erasmus Polyneuropathy Symptom Score (E-PSS) and the adapted modified Toronto Clinical Neuropathy Score (amTCNS) are such scores. These scores would enable internal medicine physicians to diagnose polyneuropathy in a reliable way without the need of additional examinations. However, a validation of the E-PSS and amTCNS with the golden standard of diagnosing sensory polyneuropathy, which are quantitative sensory testing (QST) and nerve conduction studies (NCS), is needed. The objective of this observational cross-sectional study is to validate the E-PSS and amTCNS with QST and NCS and to determine reference values of the amTCNS. 200 KTR will be included to take part in one study visit which encompasses neurological examination according to the protocol of the amTCNS, QST and NCS. Prior to the study visit, participants will be asked to answer the E-PSS questionnaire in the home setting. The main study endpoint is to validate the E-PSS and the amTCNS result with QST and NCS. To reach this endpoint different study parameters will be included which are the result of the E-PSS and amTCNS, results of the QST (thermal threshold testing), and results of the NCS (amplitude, velocity and distal latency of measurements at the sural sensory nerve, ulnar sensory nerve, peroneal motor nerve, tibial motor nerve and ulnar motor nerve, soleus H reflex).

NCT ID: NCT04662411 Completed - Metabolic Disease Clinical Trials

Butyrate/Hexanoate in Metabolic Health

Start date: January 13, 2021
Phase: N/A
Study type: Interventional

In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that increases circulating SCFA concentrations and improves postprandial substrate metabolism, which could be further used for a long-term study.

NCT ID: NCT04661397 Completed - Healthy Clinical Trials

A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents

Start date: January 5, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the single-dose pharmacokinetics (PK) and pivotal bioequivalence of 3 compounds Darunavir (DRV), emtricitabine (FTC), and tenofovir alafenamide (TAF) in the presence of cobicistat (COBI) when administered as an fixed dose combination (FDC) (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide [D/C/F/TAF]) compared to the co-administration as the separate commercial formulations (DRV and F/TAF and COBI), under fed conditions, in healthy adult participants.

NCT ID: NCT04660162 Completed - Microcirculation Clinical Trials

Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging

LACOM
Start date: December 10, 2018
Phase: N/A
Study type: Interventional

The microcirculation plays a fundamental role in metabolic reactions and has been shown as an essential determinant in many clinical scenarios such as shock states, chronic and cardio-metabolic diseases. Microcirculation can be assessed directly using laser-based techniques and intravital microscopes. When combined with provocation tests, microvascular monitorization can be used to assess microvascular function. Laser-based techniques are consist of two different methods named laser doppler imaging (LDI), laser speckle contrast imaging (LSCI). LSCI is a technique based on speckle contrast analysis that provides an index of blood flux. No need for skin contact, continuous and real-time assessment of the microcirculation led the LSCI to be broadly used in clinical practice. LDI is also a non-invasive diagnostic method used to measure the blood flux of tissue. The technique is based on measuring the doppler shift induced by moving red blood cells to the illuminating coherent light. Iontophoresis is one of the most commonly used provocation tests to study the endothelium in terms of endothelium-dependent and endothelium-independent vasodilation. Simultaneously with LDI and LSCI are used to follow and assess the skin blood flux during iontophoresis. Therefore, it provides a state to make a comparison between two different laser-based techniques in terms of flux characteristics. The accurate assessment of burn depth is a critical step in the management of the burn-injured patient. Currently, LDI is the most widely used non-invasive measurement tool for assessing burn wounds and the only technique approved by the U.S. Food and Drug Administration. However, the LDI device is rather costly, cumbersome, and has a poor spatial resolution. LSCI measures perfusion in a similar way, but it provides high-quality images with a much higher spatial resolution. In addition, LSCI is much quicker, maneuverable, and able to assess larger skin areas. In order to use the LSCI technique in the clinical practice of burn-injured patients, as a first step, the linearity of LDI and LSCI should be shown. In this study, we aimed to compare LSCI and LDI with iontophoresis and stepwise occlusion technique. So, we will test the linearity of devices over a large range of blood flux values.

NCT ID: NCT04656418 Completed - Clinical trials for Hereditary Angioedema

CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.

NCT ID: NCT04656392 Completed - Esophageal Cancer Clinical Trials

Early Detection of Barrett's Esophagus in Participants With Reflux Symptoms in Primary Care

ELECTRONIC
Start date: April 20, 2021
Phase: N/A
Study type: Interventional

In the Netherlands, the incidence of esophageal adenocarcinoma (EAC) is increasing. In addition, EAC has a dismal prognosis. Therefore, screening for Barrett's Esophagus (BE) has stimulated interest. Although BE is a known precursor of EAC, a minority of patients with EAC are known with a previous diagnosis of BE. A non-invasive screening tool, such as breath testing, could select patients at risk for BE, after which unsedated transnasal endoscopy (uTNE) can confirm or exclude the diagnosis. The objective is to determine the accuracy and acceptability of a non-invasive screening strategy i.e. breath testing followed by uTNE for BE and EAC.

NCT ID: NCT04652102 Completed - Covid19 Clinical Trials

A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

Start date: December 11, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.

NCT ID: NCT04651153 Completed - Parkinson's Disease Clinical Trials

A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)

Start date: December 14, 2020
Phase: Phase 1
Study type: Interventional

The primary purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB7853 in healthy male study participants and to evaluate the safety and tolerability of multiple ascending doses of UCB7853 administered in study participants with Parkinson's Disease (PD)

NCT ID: NCT04650802 Completed - Stroke Clinical Trials

Improving Propulsion of the Paretic Leg In Chronic Stroke

I-PICS
Start date: March 4, 2019
Phase: N/A
Study type: Interventional

Stroke survivors may have a latent, propulsive capacity of the paretic leg, that can be elicited during short, intensive gait training interventions. The aim of this study was therefor to investigate the effect of a five-week gait training on paretic propulsion, propulsion symmetry, gait capacity, and daily-life mobility and physical activity in chronic stroke survivors.