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NCT ID: NCT05072249 Recruiting - Opioid Overdose Clinical Trials

European Cohort Study of the Effectiveness of Take Home Naloxone

NalPORS
Start date: June 8, 2021
Phase:
Study type: Observational

This study aims to assess the effectiveness of take-home naloxone (THN) to reverse opioid overdose when administered by lay persons in a real world setting. This multicentre, prospective, observational cohort study will be conducted across Europe using a mixed method approach. Recruiting 6000 individuals to whom a supply of THN has been provided, for n=600 to witness an opioid overdose. The co-primary outcomes are to determine the rate of administration of naloxone and frequency of deaths in the 24 hours subsequent to the administration of naloxone. This will be captured through structured interviews with those who report witnessing an opioid overdose in the 6 month study period, approximately n=600, to elicit further information on the overdose and any naloxone administered. Naloxone training materials and education provided will be examined through questions in the structured interview. In-depth qualitative interviews will also be conducted with 60 participants who have witnessed an overdose, in order to better understand the use, safety and effectiveness of different naloxone products (particularly Nyxoid). As part of the qualitative analysis, interview transcripts will be assessed by an expert clinician panel for accuracy of diagnosis, actions taken and aftercare. Routine data from national health registers will be used to gather mortality data. This study will report on the use of different formulations of naloxone. In addition, this study serves as a Post Authorisation Efficacy Study (PAES) for the intranasal (IN) naloxone, Nyxoid developed by MundiPharma and focuses on drug safety and training.

NCT ID: NCT05071664 Active, not recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

AFFINITY
Start date: October 25, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

NCT ID: NCT05071300 Recruiting - Clinical trials for Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Start date: January 4, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of extended dosing with Eplontersen in participants with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN).

NCT ID: NCT05070884 Recruiting - Breast Cancer Clinical Trials

Clinical Validation of Radiomics Artificial Intelligence: Application to Breast Cancer Treatment Planning

RADIOVAL
Start date: June 1, 2023
Phase:
Study type: Observational

RadioVal will develop and implement interoperable solutions for clinical deployment of the radiomics tools, including information, training, and communication packages for clinicians and patients, as well as standard operating procedures for the integration of radiomics in clinical oncology. With this study, we will clinically validate these solutions, by looking at their reliability for precise breast cancer diagnosis, treatment recommendation and prognosis estimate, treatment response, evaluation of residual disease and outcome prediction.

NCT ID: NCT05070585 Active, not recruiting - Clinical trials for Metabolic Disturbance

Isothiocyanates and Metabolic Health

IMH
Start date: October 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Many sprouts, for example broccoli sprouts, contain substances that have shown to have protective effects, both against oxidative stress and against carcinogenic substances. In this study we will investigate the activation of the body's antioxidant defense system and effect on blood lactate and glucose after 1 week of isothiocyanate rich sprout supplementation. The subjects will perform maximal and submaximal work test, blood sampling, muscle biopsies and blood pressure monitoring post supplementation. We hypothesize that 1 week of supplementation of isothiocyanate rich sprouts alters blood lactate and glucose metabolism and activates the body's antioxidant defense system.

NCT ID: NCT05070546 Completed - Clinical trials for Respiratory Syncytial Virus Infection Prevention

A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection

Start date: September 29, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.

NCT ID: NCT05069545 Enrolling by invitation - Clinical trials for Diabetes Mellitus, Type 1

A Research Study Looking at How the Use of NovoPen® 6 for Treatment With Tresiba® & Fiasp® Affects the Blood Sugar Level in Patients With Type 1 Diabetes as Part of Local Clinical Practice

CONNECT 1
Start date: October 12, 2021
Phase:
Study type: Observational

The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® & Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels. Participants will use Tresiba® & Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor. NovoPen® 6 is a smart pen, which collects and stores the date and time of injections and number of units of insulin participants have taken. NovoPen® 6 can transfer participants insulin dosing information to the mobile application, which participants use to see their continuous blood sugar level. This will allow participants to see their insulin doses along with continuous blood sugar level in the mobile application. Participants will keep using their own continuous blood sugar monitoring device and the mobile application to see these data during the study. The study will last for about 9-11 months. Participants will be asked to complete 2 questionnaires in this study. One questionnaire is about overall satisfaction of using a digital health solution and other is about quality of life. Participants will complete these questionnaires during their normally scheduled visit with the study doctor, on 2 separate occasions

NCT ID: NCT05069493 Completed - Quality of Life Clinical Trials

Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing

Start date: September 15, 2021
Phase:
Study type: Observational

10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.

NCT ID: NCT05068388 Active, not recruiting - Breast Density Clinical Trials

Effect of Oral (Z)-Endoxifen in Premenopausal Women With Measurable Breast Density

Start date: December 21, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blinded, placebo-controlled dose-response efficacy study of oral (Z)-endoxifen in premenopausal women with measurable breast density. There will be 5 in-clinic visits (Screening, Day 1, Months 1, 3 and 6) and 3 self-report visits (Months 2, 4 and 5). Standard of care mammograms will be used for the screening mammogram as well as the 24-month follow up visit.

NCT ID: NCT05067712 Active, not recruiting - Clinical trials for Embedded and Impacted Teeth

The Effect of Surgical Technique on PDC

PDC
Start date: November 25, 2017
Phase: N/A
Study type: Interventional

Permanent maxillary canines are the second teeth that most commonly assume ectopic positions after the third molars. They are diagnosed as impacted and have an incidence of 1 % to 3% In their ectopic path of eruption, they can cause damage (resorption) of the adjacent roots, a severe complication that may lead to the loss of anterior teeth. When cone-beam computed tomography (CT) scanning is used for diagnose, root resorption is detected in two-thirds of the lateral incisors adjacent to impacted maxillary canines before treatment. The treatment of this condition comprises two stages: a surgical intervention to uncover the canine crown followed by orthodontic treatment to move the canine into correct position. The surgical intervention commonly involves two different techniques: the open and the closed technique. The open technique procedure involves removing the bone and mucosa covering the crown of the canine. The exposed crown is left uncovered and a pack is placed over the area to avoid overgrowth of tissue. When enough spontaneous eruption of the canine has occurred, an orthodontic attachment is bonded to the crown and the tooth is moved above the mucosa with orthodontic appliances into the correct position. The closed technique procedure involves bonding an orthodontic attachment to the crown with a chain after exposing the canine during the surgery. The palatal flap is sutured back covering the exposed crown and the chain is left through the palatal mucosa free in the oral cavity. Shortly after, the canine is forced to erupt through the palatal mucosa and moved into the correct position with orthodontic appliances. The purpose of this prospective randomized clinical trial is to compare outcome variables between the Open and Closed surgical exposure techniques regarding the success of treatment, patient's perceptions of pain and discomfort experienced and analgesic consumption, treatment time, and complications. The null hypothesis is that similar outcomes occur when the surgical exposure of palatally impacted canines is performed by using the open or the closed surgical technique.