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Multicenter Clinical Trial - Europe PMC

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Last Updated: 25 July 2022

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Evaluation of the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children: study protocol for a prospective, multicenter, randomized, open-label, parallel-group, pragmatic clinical trial.

Background Inadequate postoperative pain management raises the risk of adverse events after the surgery and active perioperative pain prevention have both short-term and long-term benefits. Methods This is a pragmatic, randomized controlled trial that will investigate the effect of S-ketamine hydrochloride injection in children with postoperative acute pain in a pragmatic clinical setting. During the entire perioperative period, the participants will be randomized 2:1 to either receive S-ketamine hydrochloride injection or traditional therapy without S-ketamine. Commentary This trial will be the first pragmatic clinical trial to prospectively determine the effects of perioperative S-ketamine hydrochloride injection for postoperative acute pain in children, which is of utmost importance to continuing education of clinical anesthesia and analgesia services for children.

Source link: https://europepmc.org/article/MED/35870990


Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial.

Methods Between May 2015 and August 2020, 488 patients who underwent Coroflex ISAR stent implantation were enrolled in the study and randomly assigned to the 3-month or 6-month DAPT group and randomly assigned to the 3-month or 6-month DAPT group. Conclusion Compared to 6 months of DAPT, three months of DAPT did not raise the risk of primary endpoint implantation, however, it should be noted that the trial has limited power to see differences due to low event rate and low recruitment rate.

Source link: https://europepmc.org/article/MED/35863061


Comparative efficacy and safety of two insulin aspart formulations (Rapilin and NovoRapid) when combined with metformin, for patients with diabetes mellitus: a multicenter, randomized, open-label, controlled clinical trial.

Objectives of this phase 3 confirmatory diabetes mellitus treatment study compared Rapilin and NovoRapid insulin asparts in combination with metformin. Methods This 24-week, open-label, experimentally controlled, noninferiority phase 3 research carried out across China's centers in the hopes of enrolling patients with type 2 diabetes mellitus and blood sugar glucose levels that could not be adequately controlled by oral antidiabetic drugs. After 24 weeks, the primary aim was to show noninferiority in HbA1c change from baseline and compare safety profiles of Rapilin versus NovoRapid. The Rapilin and NovoRapid groups were randomized to 590 patients with type 2 diabetes mellitus. Conclusions Rapilin demonstrated non-inferior glucose control, as well as matching safety and immunogenicity to NovoRapid in patients with type 2 diabetes mellitus who also received metformin over 24 weeks.

Source link: https://europepmc.org/article/MED/35833285


Intensive Olfactory Training in Post-COVID-19 Patients: A Multicenter Randomized Clinical Trial.

Previous studies have found olfactory training as a vital treatment for postinfectious OD; however, little is known about its benefits and optimizations after SARS-CoV-2 infection. After COVID-19, this study was conducted to see if olfactory training results can be improved using more fragrances over a shorter period of time in patients with persistent OD following COVID-19. In addition, we discovered the presence of other variables related to OD and treatment response in this population. Methods This multicenter randomized clinical trial recruited 80 patients with persistent OD and prior COVID-19 infection for less than three months. Study Findings Significant olfactory improvement was measured objectively and using the UPSIT in both groups; however, no significant differences were found between the two groups were found. Conclusion These results indicate that training intensification by increasing the number of essences for 4 weeks does not demonstrate superiority over the classical method.

Source link: https://europepmc.org/article/MED/35866202


Cost-Effectiveness of Care Coordination for Children With Chronic Noncomplex Medical Conditions: Results From a Multicenter Randomized Clinical Trial.

Objects: Objectives: For children with persistent noncomplex medical disorders, it's possible to determine the cost-effectiveness of care coordination in comparison to standard care. Methods: As part of a multicenter random controlled trial, 81 children aged between 2 and 15 years old and noncomplex chronic illness were randomly assigned to either care coordination or standard care. Children in the intervention program received an additional $ 17 in additional health system costs and increased an additional 0. 031 QALYs over 12 months, resulting in an incremental cost-effectiveness ratio of $ 548 per QAly. Given a willingness to pay $50 000 per QALY, there was a 73% likelihood that care coordination was cost-effective from a health system perspective. Conclusions Care coordination is expected to be a cost-effective measure for children with persistent noncomplex medical problems in the Australian healthcare sector.

Source link: https://europepmc.org/article/MED/35871140


High-Flow Versus VenturiMask Oxygen Therapy to Prevent Re-Intubation in Hypoxemic Patients After Extubation: A Multicenter, Randomized Clinical Trial.

Rationale In comparison to VenturiMask after extubation, high-flow nasal oxygen provides physiological benefits. In comparison to VenturiMask, it is found that high-flow oxygen helps with endotracheal re-intubation in hypoxemic patients after extubation. Methods In this multicentre controlled trial, 494 patients with PaO2:FiO2 ratiou2264300 mmHg after extubation were randomly selected to receive high-flow or VenturiMask oxygen, with the possibility of applying rescue noninvasive ventilation before re-intubation. 32 patients in the high-flow group and 27 patients in the VenturiMask group required re-intubation at 72 hours despite intubation criteria approval requiring intubation. Modified hazard ratio 0. 49 [95%CI 0. 32-0. 83], p=0. 007], p=0. 007. After extubation, the re-intubation rate did not differ between patients treated with VenturiMask or high-flow oxygen after extubation.

Source link: https://europepmc.org/article/MED/35849787


Clinical utility of purgative bowel preparation prior to capsule endoscopy: A multicenter, blinded, randomized controlled trial.

Patients with acute intestinal bleeding were randomized to 3 arms: A CF and simethicone 200 mg in 150 ml water immediately before CE; B same as A + 1L PEG + sodium ascorbate 3 hours before. P=0. 94 indicates that there was no significant difference in the diagnosis of P2 lesions in arms A, B and C 48. 7%, 48. 0%, and 49. 9% respectively, p=0. 94. Overall SBVQ and distal SBVQ were similar across the three arms, p=0. 94 and p=0. 68 respectively. Patients who had improved tolerability in arm A mean score 1. 5 compared to arms B and C mean scores 3. 5 and 2. 6 respectively, p 0. 001. Conclusion Use of purgative bowel preparations prior to CE does not improve diagnostic accuracy or small bowel visualization, and is associated with lower patient tolerance and lower patient tolerance.

Source link: https://europepmc.org/article/MED/35843287


Reconstructive surgical therapy of peri-implantitis: a multicenter randomized controlled clinical trial.

Aims: Objective: To determine the potential use of a bone substitute material in reconstructive surgical therapy of peri-implanttitis. Methods In this multicenter randomized clinical trial, 138 patients with peri-implanttitis were surgically transplanted by coin toss to either a control or a test group. When compared to the control group, Buccal REC was less prominent in the test group. One case of allergic reaction to the antibiotic therapy was documented. Conclusions : Peri-implanttitis surgical therapy effectively enhanced the clinical and radiographic status at 12 months. Although the use of a bone substitute material did not result in decreases of PPD and BOP, buccal REC was less pronounced in the test group.

Source link: https://europepmc.org/article/MED/35804491


A randomized, parallel control and multicenter clinical trial of evidence-based traditional Chinese medicine massage treatment VS External Diclofenac Diethylamine Emulgel for the treatment of knee osteoarthritis.

Background Both massage and topically administered NSAIDs are safe and effective knee osteoarthritis treatments, but different massage sects in China contributed to evaluation difficulties in treating KOA. knee osteoarthritis therapy in China was designed to standardize the massage techniques and procedures. We assembled multi-disciplinary experts in China to obtain an evidence-based traditional Chinese medicine massage therapy for knee osteoarthritis. Comparing to External Diclofenac Diethylamine Emulgel, the aim of this report is to give clinicians a complementary and alternative therapy for patients as well as a measure the effectiveness and safety of evidence-based traditional Chinese medicine massage therapy of KOA. Methods and design A randomized controlled trial in which 300 people diagnosed with KOA will be recruited and randomly assigned to either the experimental group or the control group in a ratio of 2:1.

Source link: https://europepmc.org/article/MED/35804406


Topical sirolimus solution for lingual microcystic lymphatic malformations in children and adults (TOPGUN): study protocol for a multicenter, randomized, assessor-blinded, controlled, stepped-wedge clinical trial.

Topical applications of sirolimus on the buccal mucosae have been reported in other oral diseases with good tolerance and no references to tiny amounts of sirolimus in the blood. After 4, 8, 20, 20 and 24 weeks of treatment compared to normal care, we want to measure the effectiveness and safety of a 1 mg/mL sirolimus cream applied once a day on LMLM of any stage in children and adults. The primary result will be the assessment of global significance of the LMLM on monthly standardized photographs by three independent blinded experts using the physical global assessment from 0 to 5 scale. Discussion Given the current treatment options for LMLMs, topical sirolimus may be able to become the firstline therapy in treating LMLMs if its efficacy and safety were to be established.

Source link: https://europepmc.org/article/MED/35804404

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions