Protocol for a single-blind randomized clinical trial to test the efficacy of bilateral transcranial magnetic stimulation on upper extremity motor function in patients recovering from stroke
This study is currently in progress.Graphical Abstract (Source: Trials)
Source: Trials - September 22, 2023 Category: Research Source Type: clinical trials

The anesthetic efficacy of ultrasound-guided lumbar plexus combined with quadratus lumborum block with Shamrock approach in total hip arthroplasty: study protocol for a randomized controlled trial
AbstractIntroductionThe lumbar plexus originates from multiple segments of the spinal cord. Both single-level lumbar plexus block (LPB) and transmuscular quadratus lumborum block (TQLB) are commonly used to provide analgesia for the patients undergoing total hip arthroplasty (THA). However, neither of them can completely cover the lumbar plexus. Multiple-level LPB is also not recommended since this expert technique involves more potential risks. To achieve a better anesthetic effect and avoid risks, we propose to combine ultrasound-guided LPB with TQLB with Shamrock approach. We aim to assess the anesthetic efficacy of thi...
Source: Trials - September 18, 2023 Category: Research Source Type: clinical trials

Prospective randomized study on the efficacy of three-dimensional reconstructions of bronchovascular structures on preoperative chest CT scan in patients who are candidates for pulmonary segmentectomy surgery: the PATCHES (Prospective rAndomized sTudy efficaCy of tHree-dimensional rEconstructions Segmentecomy) study protocol
AbstractIntroductionPulmonary segmentectomy, when combined with hilar and mediastinal lymphadenectomy, is currently considered the gold standard treatment for early-stage lung tumors (NSCLC) smaller than 2 cm in diameter. The preoperative planning for segmentectomies usually includes a contrast-enhanced CT with 2D reconstructions (axial, coronary, and sagittal). Recent technological advances allow 3D (volume rendering) reconstructions of preoperative CT scans, intended to improve the surgeon ’s understanding of the segmental anatomy.The study aims to investigate the added value of 3D reconstruction in enhancing the surge...
Source: Trials - September 16, 2023 Category: Research Source Type: clinical trials

A double-blind, randomised, placebo-controlled parallel study to investigate the effect of sex and dietary nitrate on COVID-19 vaccine-induced vascular dysfunction in healthy men and women: protocol of the DiNOVasc-COVID-19 study
This study aims to evaluate whether sex or dietary influences endothelial function and inflammatory responses in healthy volunteers after receiving the COVID-19 vaccine.Trial NCT04889274.  Registered on 5 May 2023. The study was approved by the South Central – Oxford C Research Ethics Committee (21/SC/0154). (Source: Trials)
Source: Trials - September 16, 2023 Category: Research Source Type: clinical trials

Q-HAM: a multicenter upfront randomized phase II trial of quizartinib and high-dose Ara-C plus mitoxantrone in relapsed/refractory AML with FLT3-ITD
ConclusionCurrently, there is no commonly accepted standard for salvage chemotherapy treatment. The objective of the salvage therapy is to reduce leukemic burden, achieve the best possible remission, and perform a hemopoietic stem-cell transplantation. Thus, in patients withFLT3-ITD mutation, the comparison of quizartinib with intensive salvage therapy versus chemotherapy alone appears as a logical consequence in terms of efficacy and safety.Ethics and disseminationEthical approval and approvals from the local and federal competent authorities were granted. Trial results will be reported via peer-reviewed journals and pres...
Source: Trials - September 15, 2023 Category: Research Source Type: clinical trials

A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention “mStress-IHD” trial
AbstractBackgroundStress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiv...
Source: Trials - September 15, 2023 Category: Research Source Type: clinical trials

The effect of smartphone-based monitoring and treatment including clinical feedback versus smartphone-based monitoring without clinical feedback in bipolar disorder: the SmartBipolar trial —a study protocol for a randomized controlled parallel-group trial
AbstractIntroductionA substantial proportion of patients with bipolar disorder experience daily subsyndromal mood swings, and the term “mood instability” reflecting the variability in mood seems associated with poor prognostic factors, including impaired functioning, and increased risk of hospitalization and relapse.During the last decade, we have developed and tested a smartphone-based system for monitoring bipolar disorder. The present SmartBipolar randomized controlled trial (RCT) aims to investigate whether (1) daily smartphone-based outpatient monitoring and treatmentincluding clinical feedback versus (2) daily sm...
Source: Trials - September 12, 2023 Category: Research Source Type: clinical trials

Concordance of a decision algorithm and multidisciplinary team meetings for patients with liver cancer —a study protocol for a randomized controlled trial
DiscussionThe implementation of ADBoard aims to improve the quality and completeness of the data required for MDM decision-making and to propose therapeutic recommendations that consider current medical evidence and guidelines in a transparent and reproducible manner.Ethics and disseminationThe project was approved by the Ethics Committee of the Charit é – Universitätsmedizin Berlin.Registration detailsThe study was registered on (trial identifying number: NCT05681949; on 12 January 2023. (Source: Trials)
Source: Trials - September 9, 2023 Category: Research Source Type: clinical trials

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine
ConclusionThis randomized trial is designed to assess whether bupivacaine is of any value during EUS-CPN. (Source: Trials)
Source: Trials - September 8, 2023 Category: Research Source Type: clinical trials

PHaLIR: prevent hernia after loop ileostomy reversal —a study protocol for a randomized controlled multicenter study
DiscussionThis double-blinded randomized controlled superiority study will compare retromuscular synthetic mesh during the closure of loop ileostomy to standard care. If this study can show a lower frequency of hernia with the use of prophylactic mesh, it may lead to new surgical guidelines during stoma closure.Trial NCT03720262. Registered on October 25, 2018. (Source: Trials)
Source: Trials - September 8, 2023 Category: Research Source Type: clinical trials

The effect of patient-led goal setting approach combined with pain neuroscience education or manual therapy in patients with chronic low back pain: protocol for a parallel-group randomized controlled trial
DiscussionThis trial will demonstrate which supplementary intervention can better improve the impact of a patient-led goal-setting approach to treat LBP. If successful, the results will potentially have implications for athletic trainers, physiotherapists, and health care practitioners.Trial registrationIRCT Iranian Registry of Clinical Trials IRCT20210927052616N1. Registered on November 03, 2021. (Source: Trials)
Source: Trials - September 8, 2023 Category: Research Source Type: clinical trials

Effectiveness and safety of mesenchymal stem/stromal cell for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-III): a study protocol for a single-centre, double-blinded, randomised, placebo-controlled, phase II study
DiscussionThe trials will investigate the efficacy and safety of ASC injection to the submandibular gland as a potential new treatment for post-radiation xerostomia. We hope the results will pave the way for a clinically relevant treatment to ameliorate patients with xerostomia, a severely hampering condition.Trial registrationThe study is approved by the Danish Data Protection Agency (protocol number P-2020-1164), the National Ethics Committee protocol number: (Protocol number: 1802872), and the Danish Medical Agency (2018-000348-24). The protocol was registered at the database (NCT04776538). (Source: Trials)
Source: Trials - September 1, 2023 Category: Research Source Type: clinical trials

The effects of therapeutic virtual reality experience to promote mental well-being in older people living with physical disabilities in long-term care facilities
This study employs a single-blinded, two-parallel-group (intervention-to-control group ratio  = 1:1), non-inferiority, randomized controlled trial. Eligible participants are aged 60 years or above, LTCF residents, and living with physical disabilities. The study will be conducted in LTCF. In the intervention group, participants will receive a 6-week VR experience program. In the contro l group, participants will receive the usual care provided by the LTCF. The primary outcome is mental well-being, as measured by World Health Organization Five Well-being Index at the time point of baseline (i.e., week 0) and after comp...
Source: Trials - August 26, 2023 Category: Research Source Type: clinical trials

Anesthesia Counseling, Consent, & Professionalism
Conditions:   Communication;   Preoperative;   Ethics Intervention:   Behavioral: Script guided conversation Sponsor:   Johns Hopkins University Active, not recruiting (Source:
Source: - August 25, 2023 Category: Research Source Type: clinical trials