Clinical Trials Logo

Filter by:
NCT ID: NCT04819724 Completed - Rotator Cuff Tear Clinical Trials

Load-induced Changes in Glenohumeral Translation in Patients With Rotator Cuff Tear

LiTrans
Start date: May 4, 2021
Phase: N/A
Study type: Interventional

The study is to investigate the dose-response relationship between load-induced muscle activation (liMA) and load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and asymptomatic control subjects. Furthermore the study is to investigate the in vivo dose-response relationship between additional weight and glenohumeral translation, to understand the biological variation in liTr, the influence of disease pathology on the liTr, the potential compensation by muscle activation and muscle size, and the influence of liTr on patient outcomes.

NCT ID: NCT04819438 Completed - Bioequivalence Clinical Trials

Riluzole Orodispersible Film Replicate Bioavailability

Start date: January 15, 2021
Phase: Phase 1
Study type: Interventional

The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their bioequivalence. The subjects will receive single oral doses of 50 mg of riluzole, as test orodispersible film and reference film-coated tablets under fasting conditions, in each of 4 subsequent periods separated by wash-out intervals of at least 7 days between consecutive administrations, according to a 2-treatment, 4-period, replicate cross-over design.

NCT ID: NCT04819360 Recruiting - Multiple Sclerosis Clinical Trials

Botulinum Toxin A vs Anticholinergic Treatment of Neurogenic Overactive Bladder in Patients With Multiple Sclerosis

SEPTOX
Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

Botulinum toxin type A injections into the detrusor at a dose of 200 units (U) of BOTOX® are a recognized second-line treatment for the treatment of adult neurogenic lower urinary tract disorders. Anticholinergics are established as the usual first-line treatment for neurogenic detrusor hyperactivity, but are oft not sufficiently effective and have significant side effects. In patients with multiple sclerosis (MS) suffering from overactive bladder, the 200 U dose of BOTOX® is very effective but induces a risk of urinary retention in 30% of patients requiring the temporary use of self-catheterization1. At 100 U, a recent study shows the efficacy and very good tolerance of botulinum toxin A in terms of probing risk in MS patients with overactive bladder and failure of anticholinergics. Furthermore, the efficacy of anticholinergics in MS has been little studied and is also disputed. The investigators plan to test the therapeutic alternative as the first line of treatment in two groups of randomized MS patients from a homogeneous population suffering from overactive bladder: - a group testing the effectiveness of low doses of botulinum toxin type A (100 U, BOTOX®), - the other group receiving the standard anticholinergic treatment (solifenacin succinate, Vesicare®). During this pilot study, the efficacy and side effects profile of each treatment will be analyzed in order to determine the amplitudes of effect and the safety profiles in this population and in order to establish the statistical hypotheses for a subsequent randomized multicenter study. The aim of this study will be to establish the benefit of botulinum toxin at a dose of 100 U as a first-line treatment instead of anticholinergics

NCT ID: NCT04819074 Recruiting - Aneurysm, Brain Clinical Trials

Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms

PRAEMIUM
Start date: May 20, 2021
Phase:
Study type: Observational

Accurate preoperative identification of patients at high risk for adverse outcomes would be clinically advantageous, as it would allow enhanced resource preparation, better surgical decision-making, enhanced patient education and informed consent, and potentially even modification of certain modifiable risk factors. The aim of the Prediction of adverse events after microsurgery for intracranial unruptured aneurysms (PRAEMIUM) study is therefore to develop and externally validate a clinically applicable, robust ML-based prediction tool based on multicenter data from a range of international centers.

NCT ID: NCT04818502 Active, not recruiting - Clinical trials for Mitral Valve Regurgitation

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

RESOLVE-MR
Start date: May 4, 2021
Phase:
Study type: Observational

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

NCT ID: NCT04818476 Recruiting - Barrett Esophagus Clinical Trials

Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus

Start date: February 10, 2020
Phase:
Study type: Observational

The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.

NCT ID: NCT04818294 Completed - Chronic Pain Clinical Trials

Clinical Trial to Monitor the Efficacy of the Elosan Treatment by Applying Electrostatic

Start date: March 16, 2021
Phase:
Study type: Observational

The Treatment Cabin 'Elosan cabin' is a closed, electrically insulated cabin for the short-term application of a high electrostatic voltage to the body of patients with chronic pain. Patients assigned will have 8 sessions in the treatment cabin, with an interval of 6 days between sessions. The existing therapies and painkillers will be continued at the discretion of the doctor.

NCT ID: NCT04817618 Recruiting - C3G Clinical Trials

Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

APPEAR-C3G
Start date: July 28, 2021
Phase: Phase 3
Study type: Interventional

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

NCT ID: NCT04817592 Not yet recruiting - Myopia Clinical Trials

Characterization of the Corneal Biomechanics of Patients Treated by Corneal Lenticule Extraction for Advanced Refractive Correction (CLEAR) to Correct Myopia

CLEAR Biomech
Start date: December 1, 2021
Phase:
Study type: Observational

This study aims to perform biomechanical tests on extracted CLEAR lenticles that are routinely discarded after surgery. The investigators also aim to perform Brillouin microscopy to get an in-vivo assessment of the patient's cornea preoperatively and to correlate this data with the postoperative characterization of the extracted corneal lenticule. The characterization will be done with established biomechanical and morphologic tests.

NCT ID: NCT04817189 Active, not recruiting - Clinical trials for Chemotherapy-induced Nausea and Vomiting

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk)

CINV
Start date: February 1, 2021
Phase: Phase 4
Study type: Interventional

MyRisk: Efficacy and safety evaluation of oral Akynzeo® in patients receiving MEC at high risk of developing CINV based on a prediction tool. A multinational and multicenter study. Antiemetic guidelines recommendations are based on the emetogenic potential of the chemotherapy. Chemotherapy (CT) agents are divided in Highly, Moderately, Low and Minimally Emetogenic potential. In addition to type of chemotherapy, several patient-related risk factors can increase the risk of CINV (chemotherapy-induced nausea and vomiting). Currently, there is limited consensus surrounding the most relevant patient risk factors that may predict the risk of CINV. Based on a recent study by Dranitsaris et al. (Dranitsaris et al. Ann Oncol. 2017 Jun 1; 28(6):1260-1267.), eight (8) predictive factors have been identified and an algorithm has been developed to incorporate these factors into the optimal selection of prophylactic antiemetics: 1. nausea and/or vomiting in the prior cycle of chemotherapy 2. use of non-prescribed antiemetics at home in the prior cycle of chemotherapy 3. platinum or anthracycline-based chemotherapy 4. age < 60 years 5. expectations for (anticipating) nausea and/or vomiting 6. <7 h of sleep the night before chemotherapy 7. history of morning sickness during previous pregnancy 8. cycle of chemotherapy (A negative association between risk and number of cycles was identified where the hazard for CINV was highest in cycles 1 and 2, with a gradual decline and plateau from cycle 3 onward). The clinical application of this prediction tool has the potential to be an important resource for clinicians and may help to enhance patient care by optimizing the use of the antiemetics in a proactive manner.