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Filter by:This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA vs. INSURE in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the total time of device positioning. The secondary outcomes will be the success of the first and the participant's satisfaction.
Cardiac rehabilitation after an acute coronary syndrome is recognised in the latest guidelines and recommendations published by the major scientific societies as a class I indication. Despite this evidence, the number of patients entering such programmes in Europe is still around 30%. The present study aims to validate a new comprehensive Telerehabilitation System to provide support for cardiac rehabilitation, to optimize it and to test its usefulness in terms of improving adherence to physical exercise and cardiovascular risk parameters.
Distal radial access (DRA) has recently introduced and previous studies have demonstrated that it is feasible option, showing several advantages including less bleeding and access-site complications over proximal radial access (PRA). Previous study reported the feasibility of DRA as an alternative option for primary percutaneous coronary intervention (PCI) in STEMI patients without major complication. However, comparison study of each vascular access for primary PCI have not been conducted until now. Here, The investigators aim to compare the DRA, PRA and femoral access (FA), in terms of feasibility and safety, in patients with STEMI. This is a retrospective study with patients who underwent primary PCI for STEMI between March 2020 to May 2021. The primary outcome of this study is the access-site complication including major bleeding requiring transfusion or surgery, hematoma and arterial occlusion.
As off-the-counter foot orthoses are readily available and have an economic advantage, they are increasingly being used by healthcare professionals to treat mechanical foot pains in place of custom foot orthosis. However, there is a lack of available evidence to determine if a plain off-the-counter foot orthosis that aims to contours to the foot or a specifically optimized off-the-counter foot orthosis utilizing the type of orthotic design proposed by Abbasian and Pomeroy is more effective in the management of mechanical foot pains in the Subtle Cavus foot type. This study proposal seeks to fill the gap in this area. Primary Aim: To investigate the effectiveness of specifically optimized off-the-counter foot orthosis designed for the Subtle Cavus foot type in improving patient reported outcomes in patients with mechanical foot pains when compared to plain off-the-counter foot orthosis. Primary Null Hypothesis: There is no difference in pain and functional scores reported by patients between specifically optimized off-the-counter foot orthosis and plain off-the-counter foot orthosis in patients with mechanical foot pains at four, eight and twelve weeks of intervention. In our study, the Subtle Cavus foot refers to the flexible idiopathic forefoot-driven Pes Cavus that can be clinically recognised with a positive "Peek a Boo" sign, inverted hindfoot position in weight bearing stance and Positive Coleman Block Test as reported by Manoli and Graham in 2005. Also, for our study, mechanical foot pains are limited to clinically diagnosed Plantar Fasciitis, Achilles Tendinopathy, Peroneal Strain or Metatarsalgia: Plantar Fasciitis is clinically diagnosed using the following history and physical examination findings: - Plantar medial heel pain /or pain along the plantar fascia: most noticeable with initial steps after a period of inactivity but also worse following prolonged weight bearing - Heel pain /or pain along the plantar fascia precipitated by a recent increase in weightbearing activity - Pain with palpation of the proximal insertion of the plantar fascia /or along the band of plantar fascia structure Achilles Tendinopathy is clinically diagnosed using the following history and physical examination findings: Midportion Achilles Tendinopathy: - Self-reported localized pain and perceived stiffness in the Achilles tendon following a period of inactivity (eg, sleep, prolonged sitting) lessen with an acute bout of activity and may increase after the activity. - Symptoms are frequently accompanied by Achilles tendon tenderness. - Pain located 2 to 6 cm proximal to the Achilles tendon insertion that began gradually and pain with palpation of the midportion of the tendon to diagnose midportion Achilles tendinopathy Insertional Achilles Tendinopathy: - Self-reported pain that is aggravated by activity and stiffness that is associated with prolonged periods of rest. - Pain and tenderness with palpation within the distal 2 cm of the Achilles tendon. - Redness and swelling over area of Achilles Tendon insertion over posterior heel Peroneal Strain is clinically diagnosed using the following history and physical examination findings: - Pain and swelling posterior to the lateral malleolus - Pain with active eversion and dorsiflexion against resistance - May have a history of chronic lateral ankle pain and instability - Pain and tenderness with palpation along the course of the peroneal tendons Metatarsalgia is clinically diagnosed using the following history and physical examination findings: - Self-reported pain during the propulsive phase of gait. The pain is localized underneath the prominent metatarsal heads - The plantar soft tissue can be swollen and inflamed. - Presence of hyperkeratosis over tender areas may be present - Pain and tenderness with palpation of plantar metatarsophalangeal joints Secondary Aim: To investigate the effectiveness of specifically optimized off-the-counter foot orthosis designed for the Subtle Cavus foot type in improving patient reported outcomes in patients with mechanical foot pains pre- and post-intervention. Secondary Null Hypothesis: There is no difference in pain and functional scores reported by patients after introduction of specifically optimized off-the counter foot orthosis pre- and post-intervention at initial to four, initial to eight and initial to twelve weeks of intervention.
Analysis of the efficacy, maintenance of efficacy, long-term safety, and investigation of the potential for dependence and abuse and the effect of abrupt drug withdrawal of VER-01 in the treatment of patients with chronic non-specific low back pain when drug treatment is indicated and previous optimised treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.
Pseudophakic cystoid macular edema (PCME), or Irvine-Gass syndrome, is retinal thickening of the macula, which usually develops within 3 months after surgery, with a peak incidence between 4 and 6 weeks. Despite recent improvements in surgical techniques, PCME remains one of the most common causes of visual decline following an uneventful cataract surgery. Symptoms of PCME usually are blurred vision, metamorphopsia, loss of contrast sensitivity, and central scotomas. PCME usually responds well to medical therapy or may resolve spontaneously but carries a risk of permanent vision loss or loss of contrast sensitivity. There is wide discrepancy in opinions about the most effective antiinflammatory drops for the prevention of PCME. Patients with diabetes mellitus (DM) have attracted special interest because of higher incidence of cataract and increased risk for developing CME after cataract surgery. The optimum antiinflammatory prophylaxis for PCME in patients with nonproliferative diabetic retinopathy (NPDR) remains unknown. Purpose of this study is to determine the efficacy of topical bromfenac and topical dexamethasone on intraocular concentration of interleukin-6 (IL6) and the incidence of pseudophakic cystoid macular edema (PCME) after cataract surgery in patients with nonproliferative diabetic retinopathy (NPDR).
More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management. A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain. A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients. Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes. The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care. Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.
Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all around the world, however optimal graft source for ACLR still remains controversial. Although Quadriceps tendon (QT) is the least used and least studied autograft, it could be an appropriate and good alternative for ACLR. If investigaters use the same surgical technique, and exert the same rehabilitation methods they may have better results than hamstring tendon (HT) autografts.
Targeting the PD-L1 pathway with atezolizumab has demonstrated objective responses across a broad range of malignancies including head and neck squamous cell carcinoma (SCCHN). MO39839 is a window of opportunity study investigating the feasibility, safety and postoperative complication rates of preoperative short time immunotherapy with atezolizumab in patients with local SCCHN. In the scope of MO39839 a comprehensive translational research program will be conducted to assess the potential effect of atezolizumab on dynamics in tumor immunity, and to identify and validate potential predictive and prognostic biomarkers.