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Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.

Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent information about the adverse events associated with interventions.

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An atypical and bilateral presentation of Charcot foot disease.

Charcot neuropathic osteoarthropathy (CNO) is one of the most devastating complications of neuropathy in patients with diabetes. Establishing diagnosis of CNO is difficult, due to the lack of clear clinical and radiological diagnostic criteria. Diagnosis is even more difficult when there is atypical and bilateral clinical presentation. Since CNO may lead to foot deformity, lower-extremity amputation and significant decrements in quality of life, it must be detected and treated without delay. Treatment focuses mainly on interruption of the inflammatory process and relief from pain using feet offloading devices. In more severe cases, surgical intervention may be needed. Additionally, the use of custom-made insoles and custom-made orthopaedic shoes is mandatory.

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Correlation between multifidus fatty atrophy and lumbar disc degeneration in low back pain.

Chronic low back pain (LBP) is common and associated with lumbar disc herniation. The purpose of this study was to investigate if the grade of lumbar disc degeneration correlates with the degree of lumbar multifidus muscle (LMM) fatty atrophy.

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Safety and Efficacy of Mitapivat in Pyruvate Kinase Deficiency.

Pyruvate kinase deficiency is caused by mutations in and leads to congenital hemolytic anemia. Mitapivat is an oral, small-molecule allosteric activator of pyruvate kinase in red cells.

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Trial of SAGE-217 in Patients with Major Depressive Disorder.

Altered neurotransmission of γ-aminobutyric acid (GABA) has been implicated in the pathogenesis of depression. Whether SAGE-217, an oral, positive allosteric modulator of GABA type A receptors, is effective and safe for the treatment of major depressive disorder is unknown.

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Peripheral Nociception Is Associated with Voluntary Activation Deficits and Quadriceps Weakness Following Total Knee Arthroplasty.

Quadriceps weakness is a hallmark of total knee arthroplasty and is driven by reduced voluntary muscle activation following the surgical procedure. The mechanisms underlying postoperative activation deficits are not well established, although nociception has been implicated via both spinal reflex and supraspinal pathways. The purpose of this study was to assess the role of nociception in postoperative recovery of strength and activation.

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Tranexamic acid may benefit patients undergoing total hip/knee arthroplasty because of haemophilia.

The lower limb joints, including hip and knee, are the most commonly involved joints in haemophilic arthropathy. With a higher risk of transfusion, total hip and knee arthroplasty (THA and TKA) are still the first choice after failure of conservative treatment. In the present study, we aimed to analyze clinical outcomes and complications rate after total joint arthroplasty of the lower limbs using tranexamic acid (TXA) or not.

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Neuromodulatory effects of pudendal nerve stimulation on bladder hypersensitivity are present in opioid-pretreated rats.

Bilateral electrical pudendal nerve stimulation (bPNS) reduces bladder hypersensitivity in rat models and anecdotally reduces pain in humans with pelvic pain of urologic origin. Concomitant opioids are known to alter responses to neuromodulation in some systems. So prior to the development of a clinical trial for purposes of regulatory approval, the preclinical interaction between opioids and stimulation effectiveness was examined.

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Prevalence of self-reported knee symptoms and management strategies among elderly individuals from Frederiksberg municipality: protocol for a prospective and pragmatic Danish cohort study.

The Global Burden of Disease 2010 study ranked osteoarthritis (OA) as a leading cause of years lived with disability. With an ageing population, increasing body weight and sedentary lifestyle, a substantial increase especially in knee OA (KOA) is expected. Management strategies for KOA include non-pharmacological, pharmacological and surgical interventions. Meanwhile, over-the-counter pain medications have been discredited as they are associated with several risks with long-term usage. By consequence, the use of exercise and all sorts of complementary and alternative medicine (CAM) for joint pain has increased. The available self-management strategies are plenty, but there is no overview of their use at a population level and whether they are used along with doctors' prescriptions or replace these. The aim of this study is to estimate the population incidence of developing knee symptoms and analyse the association between (and impact of) the use of self-reported preventive measures and knee symptoms.

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Left renal vein entrapment syndrome: nutcracker syndrome!

Nutcracker syndrome (NCS) is a rare vascular compression disorder that involves compression of the left renal vein most commonly between the aorta and the superior mesenteric artery (SMA), although variations exist. It is associated with the formation of the left renal vein from the aortic collar during the 6th-8th week of gestation and abnormal angulation of the SMA from the aorta. Collateralisation of venous circulation including mainly the left gonadal vein and the communicating lumbar vein are the most significant effects. It has a female predilection occurring in the third to fourth decade and it tends to be diagnosed earlier in men. Affected individuals may present with a myriad of symptoms such as haematuria, left flank pain and proteinuria. As patients often present with these non-specific symptoms to primary care, knowledge of NCS is essential. The diagnosis can be rendered with Doppler ultrasonography, retrograde venography, CT angiography, intravascular ultrasound and magnetic resonance angiography. The authors describe the case of a 39-year-old woman with a low body mass index (BMI) presenting with generalised abdominal and flank pain as well as chronic microcytic anaemia. Physical examination findings were suggestive of biliary or renal colic. Laboratory investigations confirmed her anaemia (haemoglobin 88 g/L, mean corpuscular volume (MCV) 72 fL), but were otherwise unremarkable. Urinalysis showed proteinuria and haematuria. However, ultrasonography was unremarkable with a normal gallbladder and no evidence of calculi. Her CT scan showed marked compression of the left renal vein between the aorta and the SMA (nutcracker phenomenon), with upstream left renal, left gonadal and left lumbar vein dilatation. She was managed conservatively. This paper provides an overview of the aetiology, embryology, clinical manifestations, imaging modalities and management of NCS.

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