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NCT ID: NCT05166369 Completed - Clinical trials for Acute Respiratory Tract Infections

Optimisation of Antibiotic Prescription in Acute Noncomplicated Respiratory Tract Infections in Children (OptimAP Study)

OptimAP
Start date: January 3, 2022
Phase: N/A
Study type: Interventional

Background: High-volume antibiotic prescribing in primary care is a major driver of antibiotic resistance. Education of physicians and patients can lower prescribing levels, but it frequently relies on highly trained staff. We will assess whether remotely delivered complex interventions including internet-based training for health care provider, and an educational intervention for parents could improve prescribing practices for respiratory tract infections (RTI) in Spain. Methods: We will develop and evaluate the feasibility of two interventions in a 16-months randomized controlled factorial trial. Primary care (PC) centres will be allocated to one of the following four groups: 1. Intervention targeting healthcare providers (paediatricians, nurses and pharmacists): i) Internet based training about communication skills and optimal antibiotic prescribing (including delayed prescribing); ii) bimonthly antibiotic prescription feedback. 2. Intervention targeting parents: PC centres allocated to this group will display posters and flyers presenting a mobile app that will include information about respiratory tract infections and optimal use of antibiotics. The app can be used before, during and after the consultation, providing condition specific and patient tailored information. 3. Intervention targeting both providers and parents 4. No intervention. During the trial duration we will conduct a process evaluation and a cost-effectiveness analysis. Our primary outcome will be change in the total antibiotic prescription rate. Our secondary outcomes will include: respiratory complications (e.g. pneumonia), antibiotic related adverse effects, repeated consultations, and antibiotic consumption in relation with antibiotic prescribing (delayed antibiotic prescribing). Assuming an average cluster size of 200 RTI consultations per centre, we will need to recruit 222 PC centres.

NCT ID: NCT05164133 Completed - COVID-19 Clinical Trials

A Study Evaluating Tocilizumab in Pediatric Patients Hospitalized With COVID-19

Start date: June 10, 2022
Phase: Phase 1
Study type: Interventional

This is a single-arm, open-label study to assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab (TCZ) for the treatment of pediatric patients from birth to less than 18 years old hospitalized with COVID-19 and who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.

NCT ID: NCT05164068 Completed - Anxiety ; Dental Clinical Trials

Effect of an Informative Anxiety and Stress in Patients Requiring an Oral Biopsy

Anxiety
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

In clinical practice, patients scheduled for biopsy often suffer substantial stress before, during or after the procedure. In particular, most patients feel uncomfortable both with the procedure itself and with the idea of the results of the biopsy. Providing adequate information is crucial, though there is no agreement as to which is the best way to present such information. Although verbal information provided by the professional is the most common scenario, the use of written information in the form of explanatory leaflets, as well as audio recordings or videos, has also been proposed The present study was carried out at the Dental School of Universidad de San Carlos (Guatemala) to evaluate the hypothesis that an audiovisual intervention providing information on oral biopsy is able to reduce patient anxiety and stress.

NCT ID: NCT05162924 Completed - Clinical trials for Chronic Low-back Pain

Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain

Start date: December 17, 2021
Phase: N/A
Study type: Interventional

This is a mechanistic randomized controlled trial on the effects of chiropractic spinal manipulative therapy on patients with chronic low back pain. It is designed as a mechanistic trial, in which the main objective is to identify which variables related to central sensitization can help predict the response to spinal manipulation, and the evolution of which of these variables can help explain clinical changes in chronic low back pain patients receiving spinal manipulative therapy.

NCT ID: NCT05162040 Completed - Hemiparesis Clinical Trials

PedaleoVR: Credibility, Usability and Intrinsic Motivation Study

Start date: October 1, 2021
Phase:
Study type: Observational

The objective of this research is to combine the use of inertial systems with virtual reality in pedalling exercises in a pilot study with subjects with ataxia or hemiparesis. In particular, it is intended to evaluate the validity of the system as a physical training tool for pedalling exercises aimed at providing motivational visual stimuli and biofeedback based on pedalling cadence to improve the exercise experience and promote adherence to the subject's treatment. Primary objectives: - To study the estimation of pedalling cadence performed by the system/platform in subjects with hemiparesis or ataxia.. - To study the usability, credibility and intrinsic motivation characteristics of the platform

NCT ID: NCT05161338 Completed - Infertility, Female Clinical Trials

Impact of Vaginal Microbiome on Vaginal Absorption of Exogenous Progesterone: a Pilot Study.

PROGEBIOMA
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Is already demonstrated that around 30% of patients undergoing an artificial cycle with vaginal progesterone do not reach a minimum threshold value of serum progesterone levels on the day of embryo transfer. Women with serum progesterone levels below this threshold have 20% lower ongoing pregnancy and live birth rates, decreasing their chances of success. However, the cause of this high heterogeneity in exogenous vaginal progesterone absorption among our patients remains unknown. It has been suggested that vaginal microbiome, and vaginal pH (due to its impact in microbiota growth), may explain the differences in vaginal progesterone absorption. The aim of the present pilot study is to assess if certain vaginal conditions, such as its microbiome status or its pH level, might affect vaginal progesterone absorption (measured by serum progesterone levels) and, in turn, the chances of success. In order to evaluate it, a prospective cohort unicentric study will be conducted in IVI RMA Valencia (Spain). Infertile patients undergoing an embryo transfer in the context of an artificial cycle when using vaginal progesterone will be recruited. Serum progesterone and estradiol levels, microbiome genetic analysis in vaginal samples and vaginal pH will be measured both on the embryo transfer-scheduling day and on the embryo transfer day.

NCT ID: NCT05160766 Completed - COVID-19 Clinical Trials

Assessing Immune Response of Different COVID-19 Vaccines in Older Adults

EU-COVAT-1
Start date: November 8, 2021
Phase: Phase 2
Study type: Interventional

This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV- 2 wild-type and variants in the elderly, a usually neglected population. Additional vaccines and extended follow-up visits can be added through amendments of this sub-protocol. As stated in the EU-COVAT master protocol, this trial, i.e., the EU-COVAT-1_AGED study, implements a specific safety monitoring strategy (see below). Cohorts and arms can be withdrawn or added as deemed necessary according to the criteria specified in this protocol

NCT ID: NCT05159908 Completed - Focal Onset Seizure Clinical Trials

A Study to Investigate How Effective, Safe and Tolerable the Drug NBI-921352 is When Used With Anti-seizure Medications in Adults With Focal Onset Seizures

Start date: November 8, 2021
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures

NCT ID: NCT05158686 Completed - Clinical trials for Chronic Total Occlusion

Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty

IMPROVED-RECTO
Start date: October 1, 2018
Phase:
Study type: Observational

Observational retrospective registry to compare effectiveness of paclitaxel-coated vs. non coated balloon angioplasty proximal to a Chronic Total Occlussion (CTO) after failed revascularization. Primary objective is to determine success rate after repeated percutaneous coronary intervention of a CTO 3 to 6 months after paclitaxel-coated balloon angioplasty proximal to the persistent lesion.

NCT ID: NCT05158075 Completed - Obesity Clinical Trials

Program for the Comprehensive Neurocognitive Treatment of Excess Weight

TRAINEP
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

The present study aims to determine the effectiveness of a comprehensive neurocognitive program for the treatment of excess weight. The program will include sessions to improve multiple cognitive processes implicated in weight gain and obesity. These cognitive processes include approach-avoidance bias, inhibition control, implementation intentions and episodic future thinking. Participants will be randomly allocated to one of three groups: 1) the experimental group will receive active neurocognitive sessions, 2) an active control group that will receive sham sessions and 3) a usual treatment control group. All three groups will receive a motivational interviewing session, along with personalized diet and physical exercise recommendations. We hypothesized that the neurocognitive program will decrease body mass index in people with overweight and obesity. In addition, the neurocognitive program will improve other anthropometric measures (waist circumference, waist-to-hip and waist-to-height ratios), lifestyle behaviors (eating behavior and physical activity), as well as cognitive processes (approach-avoidance bias, food inhibition, food liking and delay of gratification). Finally, the program will show its efficiency in the economic balance of cost-effectiveness and cost-utility.