Trials
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Randomized Controlled Trial Multicenter Study
Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial.
Chronic heart failure (CHF), the final stage of various cardiovascular diseases, is a major public health problem resulting in significant hospitalization rates, mortality, and huge health care costs despite advances in the treatment and management of heart failure and heart failure-related risk factors. Qishen granules (QSG), a Chinese herbal formula, is widely used by traditional Chinese medicine (TCM) practitioners to treat CHF. Several animal experimental studies have showed that QSG can significantly relieve the heart failure symptoms in CHF rat models. However, there is as yet no standard clinical trial to confirm this. Thus, the investigators are conducting this study to evaluate the efficacy and safety of QSG in a large, and varied population. ⋯ On a background of standard treatment, QSG may further reduce the levels of NT-proBNP. This trial will provide high-quality evidence on the efficacy and safety of QSG in treating CHF, thus providing reference for clinical application of QSG.
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Randomized Controlled Trial Multicenter Study Comparative Study
PANSAID-PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial.
Effective postoperative pain management is essential for the rehabilitation of the surgical patient. The PANSAID trial evaluates the analgesic effects and safety of the combination of paracetamol and ibuprofen. This paper describes in detail the statistical analysis plan for the primary publication to prevent outcome reporting bias and data-driven analysis results. ⋯ PANSAID will provide a large trial with low risk of bias regarding benefits and harms of the combination of paracetamol and ibuprofen used in a perioperative setting.
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Randomized Controlled Trial
Mechanical wrist traction as a non-invasive treatment for carpal tunnel syndrome: a randomized controlled trial.
Carpal tunnel syndrome (CTS) is a common, compressive nerve-entrapment disorder with symptoms of numbness, paresthesia, and pain. Carpal tunnel release surgery is the only known long-term effective treatment. However, surgery is invasive and up to 30% of patients report recurrence or persistence of symptoms or suffer from post-surgical complications. A promising non-surgical treatment for CTS is mechanical wrist traction. The purpose of this study was to evaluate clinical outcomes following mechanical traction in patients with CTS compared to care as usual. ⋯ Mechanical traction is associated with fewer surgical interventions compared to care as usual in CTS patients. Reductions in patient-reported symptoms at 6 months' follow-up was similar in both groups. The long-term effects of mechanical traction require further evaluation.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial.
Contrast-induced acute kidney injury (CI-AKI) is one of the most common causes of iatrogenic kidney injury and, therefore, its prevention is an important issue. However, whether the administration of 0.9% saline is the optimal prophylaxis method remains uncertain due to its supra-physiologic chloride component. In particular, recent studies suggest that chloride-restricted solutions showed superiority over 0.9% saline in several clinical settings. ⋯ To our knowledge, this study will be the first study assessing the preventive value of a balanced salt solution over 0.9% saline for CI-AKI. If the trial shows that the balanced salt solution is as effective for CI-AKI prophylaxis as 0.9% saline, the use of the balanced salt solution could be promoted due to the reduced possibility of consequent metabolic acidosis compared to 0.9% saline.
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Randomized Controlled Trial Comparative Study
Central venous Access device SeCurement And Dressing Effectiveness for peripherally inserted central catheters in adult acute hospital patients (CASCADE): a pilot randomised controlled trial.
Peripherally inserted central catheters (PICCs) are commonly used for delivering intravenous therapy. PICC failure is unacceptably high (up to 40%) due to mechanical, infectious and thrombotic complications. Poor securement potentiates all complication types. This randomised controlled trial (RCT) aimed to examine the feasibility of a large RCT of four dressing and securement methods to prevent PICC failure. ⋯ A large RCT of CSD + CHG and TA + SPU (but not PAL + CHG + Tape) versus standard care is feasible.