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NCT ID: NCT06275581 Terminated - Tooth Wear Clinical Trials

Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population

Start date: June 14, 2017
Phase: N/A
Study type: Interventional

STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment. STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTS Primary Endpoint: 1. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.) Secondary Endpoints: 1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria) 2. Evaluation of restoration wear based on comparison of digital impressions Safety Endpoint: 1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers - regarding overall survival - regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M) - regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients. Treatment: After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration. Evaluation periods: All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria) - at baseline at day of restoration placement or up to 1 month after restoration placement - after 6 months (± 1 months) - after 1 year (± 1 months) - after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation. In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline.

NCT ID: NCT06192966 Terminated - Clinical trials for Urinary Tract Infections

Effect of Probiotics on Recurrent Urinary Tract Infections

CYSCARE
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Randomized clinical trial to evaluate the effect of a probiotic mixture of Lactobacillus plantarum on recurrent urinary tract infections in women. Secondary outcomes comprise variation in vaginal/perianal microbiota, product tolerability, safety and consumer's satisfaction with the product.

NCT ID: NCT05993143 Terminated - COVID-19 Clinical Trials

Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50

Start date: January 18, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age. Secondary objectives include assessing the efficacy of an early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age and evaluating the safety and tolerability of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.

NCT ID: NCT05992792 Terminated - Health Behavior Clinical Trials

Evaluation of the International Diffusion of the European Code Against Cancer Through Mobile Telephony

CECC-OMS
Start date: January 1, 2018
Phase: N/A
Study type: Interventional

We conducted an implementation research pilot study to assess the adoption, fidelity, appropriateness and acceptability on an intervention to effectively disseminate cancer prevention messages to the public throught a mHealth implementation strategy

NCT ID: NCT05866926 Terminated - Clinical trials for Amyotrophic Lateral Sclerosis

Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis

ADOREXT
Start date: March 6, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis

NCT ID: NCT05856266 Terminated - Hemophilia A Clinical Trials

An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa

JOIN-us
Start date: August 24, 2023
Phase: Phase 4
Study type: Interventional

The goal of this low-interventional study is to describe the overall joint health in patients with haemophilia A or haemophilia B prophylactically treated with rFVIIIFc or rFIXFc. The main question it aims to answer is the: • Evaluation of the overall joint status as detected by ultrasound in haemophilia A and B patients treated with rFVIIIFc or rFIXFc prophylaxis over the 18-month study period. Participants will come to 6-monthly visits during the 18-month long study period and will perform an ultrasound with the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol at each visit. At baseline and end of study visits, the patients will be assessed with the clinical scoring system Haemophilia Joint Health Score (HJHS) and complete patient questionnaires. Retrospective data from patient medical records will also be collected for at least 6 months before enrolment in the study.

NCT ID: NCT05788497 Terminated - Clinical trials for Haemorrhoids Without Complication

Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

This is a Multicentre, double-blind, randomised clinical trial to evaluate and compare the efficacy and safety of Hemorrane Plus (Hemorrane® + benzocaine) with Hemorrane® and with placebo in patients with uncomplicated haemorrhoids.

NCT ID: NCT05715125 Terminated - Psoriatic Arthritis Clinical Trials

VTX958 Versus Placebo for the Treatment of Active Psoriatic Arthritis (Tranquility-PsA)

Start date: January 31, 2023
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.

NCT ID: NCT05643573 Terminated - Atrial Fibrillation Clinical Trials

A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke

OCEANIC-AF
Start date: December 5, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people with atrial fibrillation and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: - how long asundexian works well and - how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: - stroke and/or - systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases. During the study, the study team will: - take blood samples - do physical examinations - examine heart health using an electrocardiogram (ECG) - check vital signs such as blood pressure and heart rate - do pregnancy tests - ask the participants questions about their quality of life - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05641324 Terminated - Multiple Myeloma Clinical Trials

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

Start date: February 10, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of ANV419 monotherapy followed by ANV419 in combination with lenalidomide plus low-dose dexamethasone or ANV419 in combination with daratumumab.