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NCT ID: NCT05647551 Completed - Facial Lines Clinical Trials

A Study to Evaluate Satisfaction in Adult Participants With the Aesthetics of the Periorbital Area After JUVÉDERM® Fillers and BOTOX®/VISTABEL® Injections

Start date: January 5, 2023
Phase: Phase 4
Study type: Interventional

Different studies have shown the negative effects of aging around the area of the eyes. Signs of aging may contribute to erroneously projected emotions (e.g., anger, tiredness, or sadness) that do not reflect the individual's true feelings affecting interpersonal relationships. Minimally invasive aesthetic treatments with botulinum toxin and hyaluronic acid (HA) fillers are used to treat wrinkles and volume deficiencies associated with the appearance of most of the signs of aging. This Phase 4 post-marketing study is an open-label study in which all subjects will receive active study treatment. The purpose of this study is to evaluate the subject's satisfaction after the treatment of JUVÉDERM® fillers and BOTOX®/VISTABEL® on the upper and/or mid face, which includes areas around the eyes, under the eyes, eyebrows, the temple, and the cheek. This study will enroll approximately 80 healthy male and female subjects ages 40 to 65 across 10 sites in Australia, Belgium, and United Kingdom. Each subject will be in the study for approximately 90 days. The initial treatment of the JUVÉDERM fillers (Juvéderm VOLBELLA with lidocaine, Juvéderm VOLIFT with lidocaine, and/ or Juvéderm VOLUMA with lidocaine) will be given on Visit 2, and if needed, a touch-up treatment will be given. On Visit 4, the Juvéderm VOLBELLA with lidocaine filler, may be given, followed by a touch-up treatment, if needed. On Visit 6, subjects will receive study drug BOTOX/VISTABEL. All subjects will return for the study exit visit on Day 90. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.

NCT ID: NCT05646966 Completed - Trunk Stability Clinical Trials

Trunkstability: a Predisposition for Armfunction

Start date: December 2016
Phase: N/A
Study type: Interventional

Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated.

NCT ID: NCT05643586 Completed - Clinical trials for Coronary Artery Disease

Effects of Ticagrelor Versus Prasugrel on Coronary Microcirculation in Patients Undergoing Elective Percutaneous Coronary Intervention: Results of the PROtecting MICROcirculation During Coronary Angioplasty (PROMICRO)-3 Randomised Study

PROMICRO-3
Start date: December 1, 2017
Phase: Phase 4
Study type: Interventional

Besides being at least as effective as prasugrel in inhibiting platelet aggregation, ticagrelor has been shown to have additional properties potentially affecting coronary microcirculation. We sought to compare the effects of ticagrelor and prasugrel on absolute coronary blood flow (Q) and microvascular resistance (R) in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI). The PROMICRO-3 study shows that in patients with stable CAD undergoing PCI pre-treatment with a loading dose of ticagrelor compared with prasugrel improves post-procedural coronary flow and microvascular function and seems to reduce the related myocardial injury.

NCT ID: NCT05643391 Completed - Clinical trials for Hepatocellular Carcinoma

Safety and Feasibility of Radioembolization Using Ho-166 in Patients With Unresectable Hepatocellular Carcinoma

RETOUCH
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

Background: Hepatocellular carcinoma (HCC) accounts for 90% of primary liver cancers and represents a growing health problem worldwide. Most patients present locally advanced disease and are candidates for palliative transarterial locoregional treatment. Transarterial radioembolization (TARE) using 90Y has been used for more than a decade for patients with advanced disease. The use of 166Ho could offer a more personalized approach in terms of imaging and dosimetry. Aim: to evaluate the feasibility and safety of TARE using 166Ho in a selected population of HCC patients and assess the biological peripheral response to this therapy. Materials and methods: In this open-label, prospective, non-randomized, singlecenter pilot study, 20 patients with unresectable hepatocellular carcinoma will undergo TARE using 166Ho. The primary outcome is the feasibility of 166Ho radioembolization as well as the assessment of safety and toxicity profiles (CTAE V5.0). Secondary outcomes include the evaluation of efficacy of 166Ho radioembolization in unresectable hepatocellular carcinoma, according to mRECIST and metabolic criteria, as well as the impact on the tumor marker alpha-fetoprotein (AFP), assessment of biodistribution/dosimetry using a "scout dose" and time to progression (TTP). A substudy will assess the hepatic function using 99mTc-IDA hepato-biliary scintigraphy (HBS) and the comparison between "pre-scout" HBS and HBS just after "scout dose". Finally, blood samples will be collected at different time points in order to explore the biological peripheral response to these therapies. Perspectives: The newly developed 166Ho-microspheres have distinctive advantages over the existing 90Ymicrospheres with improved dosimetry that represents a prerequisite for optimal safety and efficacy.

NCT ID: NCT05639387 Completed - Epilepsy Clinical Trials

TMS as a Tool for the Evaluation of Neuromodulatory Effects of Transcutaneous Vagus Nerve Stimulation

Start date: February 6, 2019
Phase: N/A
Study type: Interventional

Transcutaneous vagus nerve stimulation (tVNS) has been investigated as a potential treatment for epilepsy with inconsistent results. The combination of transcranial magnetic stimulation with electromyography (TMS-EMG) and electroencephalography (TMS-EEG) allows to investigate the neuromodulatory effect of interventions such as tVNS by evaluating changes in motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs). The goal of this study is to objectively evaluate the effect of tVNS on cortical excitability with TMS-EMG and TMS-EEG. These findings are expected to provide insight in the mechanism of action and help identify more optimal stimulation paradigms. In this prospective single-blind cross-over study, 15 healthy subjects will undergo active and sham tVNS during 60 minutes, using a maximum tolerated stimulation current. Single and paired pulse TMS will be delivered over the right-sided motor hotspot to evaluate MEPs and TEPs before and after the intervention.

NCT ID: NCT05638685 Completed - COVID-19 Clinical Trials

The Bodily Complaints Barometer: The Impact of the Corona Measures and of Contracting a COVID-19 Infection on the Body.

COVID-MSK
Start date: December 22, 2021
Phase:
Study type: Observational

Since December 2019, a new corona virus (SARS-CoV-2) causing COVID-19 disease, has expeditiously spread over the entire globe. Almost a half billion people caught the disease, and in those who survived, it soon became clear that residual complaints are not rare phenomena. Early focus lay on diminished lung capacity and cardiovascular-related problems. As time passed however, it became more apparent that those are not the only residual symptoms survivors may experience. Furthermore, nearly every country in the world took some sort of lockdown measures in order to try contain the spreading of the virus. These measures had great impact on all inhabitants, infected with the virus or not. This questionnaire-based study therefore aims to investigate (a) the effects of a COVID-19 infection on fatigue and/or musculoskeletal complaints, new or already existing, but also (b) the effects of lockdown measures on fatigue and/or musculoskeletal complaints, new or already existing, in people living, working or studying in Belgium during the pandemic.

NCT ID: NCT05633368 Completed - Covid-19 Clinical Trials

Impact of Covid-19 Pandemic on Patients Receiving Continuation or Maintenance Electroconvulsive Therapy

COVID-M-ECT
Start date: March 31, 2020
Phase:
Study type: Observational

Electroconvulsive therapy is a safe and effective therapeutic strategy in patients with treatment resistant depression. As relapse after successful ECT is significant even with adequate pharmacological strategies, continuation (up to 6 months after completion of index-ECT) or maintenance ECT (more than 6 months after index-ECT) is often necessary to maintain remission. During the current Covid-19 pandemic hospitals redirected resources and closed or significantly diminished ECT services. In this study we aim to assess the impact of discontinuing maintenance electroconvulsive therapy in patients diagnosed with unipolar depressive disorder.

NCT ID: NCT05626738 Completed - Colonoscopy Clinical Trials

Endorail in Long Lasting Colonoscopy

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Patients with long lasting colonoscopy are characterized by higher risk of incompletion. Endorail is an accessory for colonoscopy aimed at facilitating progression of the endoscope in the large intestine. Endorail works as a magnetic anchor that is able to guide the colonoscope and to straighten colon curves and loops. The aim of this study is to test the safety and efficacy of Endorail in ensuring that incompletion rate in long-lasting colonoscopies is lower than the 10% threshold. Outpatients of either sex aged between 22-75 years undergoing elective diagnostic or surveillance colonoscopy with caecal intubation time greater than 10 minutes will take part in the study. The primary efficacy endpoint is the percentage minor or equal to 10% of incomplete long-lasting colonoscopies. The primary safety endpoints are the absence of device-related serious adverse events and the evaluation of the equality or reduction of the adverse events rates compared to diagnostic colonoscopies without Endorail.

NCT ID: NCT05623631 Completed - Thoracic Injury Clinical Trials

Delphi Study to Identify Crucial Steps and Errors in the Placement of Chest Tubes

Start date: March 30, 2021
Phase: N/A
Study type: Interventional

The goal of this Delphi study is to identify the crucial steps and the errors in Chest Tube Insertion (CTI). These steps and errors will be used for the development of a new assessment tool based on international consensus.

NCT ID: NCT05618808 Completed - Clinical trials for Venous Thromboembolism

A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants

Start date: May 24, 2023
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin The secondary objectives of the study are: - To evaluate the bleeding risk (ie, major and clinically relevant non-major [CRNM] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin - To assess overall safety and tolerability of REGN9933 in participants undergoing TKA - To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin - To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin - To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration - To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways - To assess immunogenicity following a single dose of REGN9933 over time - To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA