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Double-Crush Syndrome

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181. Omega-3 Fatty Acid Supplementation Improves Endothelial Function in Primary Antiphospholipid Syndrome: A Small-Scale Randomized Double-Blind Placebo-Controlled Trial (PubMed)

Omega-3 Fatty Acid Supplementation Improves Endothelial Function in Primary Antiphospholipid Syndrome: A Small-Scale Randomized Double-Blind Placebo-Controlled Trial Endothelial cells are thought to play a central role in the pathogenesis of antiphospholipid syndrome (APS). Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation has been shown to improve endothelial function in a number of diseases; thus, it could be of high clinical relevance in APS. The aim of this study was to evaluate

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2018 Frontiers in immunology Controlled trial quality: predicted high

182. A double blind randomised control trial investigating the efficacy of platelet rich plasma versus placebo for the treatment of greater trochanteric pain syndrome (the HIPPO trial): a protocol for a randomised clinical trial (PubMed)

A double blind randomised control trial investigating the efficacy of platelet rich plasma versus placebo for the treatment of greater trochanteric pain syndrome (the HIPPO trial): a protocol for a randomised clinical trial Greater trochanteric pain syndrome (GTPS) is a painful condition characterised by pain around the greater trochanter usually affecting middle-aged women. The majority of patients will improve with conservative management such as physiotherapy and non-steroidal anti (...) fasciopathy and patellar tendinopathy. Corticosteroids are the established second-line treatment, but do not always work long term. PRP may be a suitable alternative to corticosteroid in GTPS with longer-term effects; however, there are very limited reports. The Hip Injections PRP Vs Placebo (HIPPO) trial aims to assess the ability of PRP to improve symptoms and function in patients with GTPS.HIPPO is a single-centre, double-blind randomized placebo-controlled study in patients with a radiologically

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2018 Trials Controlled trial quality: predicted high

183. A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study of the Effects of Tongxinluo Capsules in Acute Coronary Syndrome Patients with High On-Treatment Platelet Reactivity (PubMed)

A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Study of the Effects of Tongxinluo Capsules in Acute Coronary Syndrome Patients with High On-Treatment Platelet Reactivity High platelet reactivity (HPR) during clopidogrel treatment predicts postpercutaneous coronary intervention (PCI) ischemic events strongly and independently. Tongxinluo capsules (TCs) are a traditional Chinese medicine formulation used as antiplatelet treatment. However, its efficacy against HPR is not known (...) . The aim of the present study was to evaluate the effects of TCs in acute coronary syndrome (ACS) patients with HPR.This multicenter, randomized, double-blind, placebo-controlled study prospectively analyzed 136 ACS patients with HPR who underwent PCI. The patients were enrolled from November 2013 to May 2014 and randomized to receive placebo or TCs in addition to standard dual antiplatelet therapy (DAPT) with aspirin and clopidogrel. The primary end points were the prevalence of HPR at 30 days

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2018 Chinese medical journal Controlled trial quality: predicted high

184. The possible Preventive Role of Pregabalin in Post-mastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial. (PubMed)

The possible Preventive Role of Pregabalin in Post-mastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial. Chronic postmastectomy pain syndrome (PMPS) has a considerable negative impact on the quality of life of breast cancer patients.The objective of this study was to assess the possible preventive role of perioperative pregabalin in PMPS.This randomized controlled study included 200 patients with breast cancer scheduled for elective breast cancer surgery. They were randomly

2018 Journal of pain and symptom management Controlled trial quality: predicted high

185. Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial. (PubMed)

Safety and efficacy of eculizumab in Guillain-Barré syndrome: a multicentre, double-blind, randomised phase 2 trial. Despite the introduction of plasmapheresis and immunoglobulin therapy, many patients with Guillain-Barré syndrome still have an incomplete recovery. Evidence from pathogenesis studies suggests the involvement of complement-mediated peripheral nerve damage. We aimed to investigate the safety and efficacy of eculizumab, a humanised monoclonal antibody against the complement protein (...) C5, in patients with severe Guillain-Barré syndrome.This study was a 24 week, multicentre, double-blind, placebo-controlled, randomised phase 2 trial done at 13 hospitals in Japan. Eligible patients with Guillain-Barré syndrome were aged 18 years or older and could not walk independently (Guillain-Barré syndrome functional grade 3-5). Patients were randomly assigned (2:1) to receive 4 weeks of intravenous immunoglobulin plus either eculizumab (900 mg) or placebo; randomisation was done via

2018 Lancet Neurology Controlled trial quality: predicted high

186. Treatment of Danhong Injection Combined with Naoxintong Capsule in Acute Coronary Syndrome Patients Undergoing PCI Operation: Study for a Randomized Controlled and Double-Blind Trial. (PubMed)

Treatment of Danhong Injection Combined with Naoxintong Capsule in Acute Coronary Syndrome Patients Undergoing PCI Operation: Study for a Randomized Controlled and Double-Blind Trial. This double-blind and randomized placebo-controlled trial evaluated the safety and efficacy of Danhong injection combined with Naoxintong capsule in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI).ACS patients scheduled to undergo PCI (n = 130) were equally and randomly

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2018 Evidence-based Complementary and Alternative Medicine (eCAM) Controlled trial quality: uncertain

187. Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study (PubMed)

Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study The modification of microbial ecology in human gut by supplementing probiotics may be an alternative strategy to ameliorate or prevent depression.The current study was conducted to assess the safety and efficacy of the probiotic strain Bacillus coagulans MTCC 5856 for major depressive disorder (MDD) in IBS (...) patients.Patients (n = 40) diagnosed for MDD with IBS were randomized (1:1) to receive placebo or B. coagulans MTCC 5856 at a daily dose of 2 × 109 cfu (2 billion spores) and were maintained to the end of double-blind treatment (90 days). Changes from baseline in clinical symptoms of MDD and IBS were evaluated through questionnaires.Significant change (p = 0.01) in favour of the B. coagulans MTCC 5856 was observed for the primary efficacy measure Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg

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2018 Food & nutrition research Controlled trial quality: uncertain

188. A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia (PubMed)

A Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial of Qi-Zhi-Wei-Tong Granules on Postprandial Distress Syndrome-Predominant Functional Dyspepsia Functional dyspepsia (FD) is a common upper gastrointestinal disorder worldwide, but the current treatments for FD are still unsatisfactory. The aims of this study were to investigate the efficacy and safety of Qi-Zhi-Wei-Tong granules in patients with postprandial distress syndrome (PDS)-predominant FD.The study was conducted (...) as a randomized, double-blinded, multicenter, placebo-controlled design in 197 patients with PDS. All participants received placebo treatment for 1 week. Patients whose total symptom score decreased by <50% after the placebo treatment were recruited into the 4-week treatment period, in which they were randomly assigned to be treated with either Qi-Zhi-Wei-Tong granules or placebo. The patients were then followed for 2 weeks without any treatment. Dyspeptic symptoms were scored at weeks 2 and 4 during

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2018 Chinese medical journal Controlled trial quality: predicted high

189. Efficacy and Safety of a Mixed Extract of Trigonella foenum-graecum Seed and Lespedeza cuneata in the Treatment of Testosterone Deficiency Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (PubMed)

Efficacy and Safety of a Mixed Extract of Trigonella foenum-graecum Seed and Lespedeza cuneata in the Treatment of Testosterone Deficiency Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial The aim of this study was to investigate the efficacy and safety of a mixed extract of Trigonella foenum-graecum seed and Lespedeza cuneata (TFGL) for the treatment of testosterone deficiency syndrome (TDS).Patients were instructed to take a placebo or 200 mg TFGL capsule twice per day

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2018 The world journal of men's health Controlled trial quality: predicted high

190. Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial. (PubMed)

Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes (LILACS): protocol and study rationale for a randomised, double-blind, placebo-controlled, phase I/II clinical trial. Inflammation and dysregulated immune responses play a crucial role in atherosclerosis, underlying ischaemic heart disease (IHD) and acute coronary syndromes (ACSs). Immune responses are also major determinants of the postischaemic injury in myocardial infarction. Regulatory T (...) cells (CD4+CD25+FOXP3+; Treg) induce immune tolerance and preserve immune homeostasis. Recent in vivo studies suggested that low-dose interleukin-2 (IL-2) can increase Treg cell numbers. Aldesleukin is a human recombinant form of IL-2 that has been used therapeutically in several autoimmune diseases. However, its safety and efficacy is unknown in the setting of coronary artery disease.Low-dose interleukin-2 in patients with stable ischaemic heart disease and acute coronary syndromes is a single

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2018 BMJ open Controlled trial quality: predicted high

191. Insights About the Neuroplasticity State on the Effect of Intramuscular Electrical Stimulation in Pain and Disability Associated With Chronic Myofascial Pain Syndrome (MPS): A Double-Blind, Randomized, Sham-Controlled Trial (PubMed)

Insights About the Neuroplasticity State on the Effect of Intramuscular Electrical Stimulation in Pain and Disability Associated With Chronic Myofascial Pain Syndrome (MPS): A Double-Blind, Randomized, Sham-Controlled Trial Background: There is limited evidence concerning the effect of intramuscular electrical stimulation (EIMS) on the neural mechanisms of pain and disability associated with chronic Myofascial Pain Syndrome (MPS). Objectives: To provide new insights into the EIMS long-term

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2018 Frontiers in human neuroscience Controlled trial quality: predicted high

192. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. (PubMed)

Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Perineural injection with 5% dextrose (D5W) is a novel strategy in the treatment of carpal tunnel syndrome (CTS). In contrast, perineural injection with corticosteroid has been used for decades for treating CTS, but possible neurotoxicity has been a major concern. No studies investigating the comparative effects have been published so far. The authors performed (...) a prospective, randomized, double-blinded, head-to-head comparative trial to compare these two approaches for patients having mild-to-moderate CTS.Fifty-four participants with mild-to-moderate CTS were randomly divided into dextrose and steroid groups. The patients were administered 1 session of perineural injection with 5ml D5W (dextrose group) or 3ml triamcinolone acetonide mixed with 2ml normal saline (steroid group), under ultrasound guidance. A visual analog scale was assigned to assess the primary

2018 Annals of Neurology Controlled trial quality: predicted high

193. Pilocarpine and Artificial Saliva for the Treatment of Xerostomia and Xerophthalmia of Sjögren's Syndrome: A double blind control trial. (PubMed)

Pilocarpine and Artificial Saliva for the Treatment of Xerostomia and Xerophthalmia of Sjögren's Syndrome: A double blind control trial. Sjögren syndrome (SS) is associated with xerostomia and xerophthalmia. Pilocarpine has been shown to stimulate the secretion of saliva.To investigate and compare the efficacy of pilocarpine and artificial saliva as symptomatic treatments for xerostomia and xerophthalmia in patients with SS.A double-blind randomized controlled study was performed. A total of 72

2018 British Journal of Dermatology Controlled trial quality: predicted high

194. Prevention of Low Cardiac Output Syndrome After Pediatric Cardiac Surgery: A Double-Blind Randomized Clinical Pilot Study Comparing Dobutamine and Milrinone. (PubMed)

Prevention of Low Cardiac Output Syndrome After Pediatric Cardiac Surgery: A Double-Blind Randomized Clinical Pilot Study Comparing Dobutamine and Milrinone. Dobutamine and milrinone are commonly used after open-heart surgery to prevent or treat low cardiac output syndrome. We sought to compare efficacy and safety of these drugs in pediatric patients.Prospective, single-center, double-blinded, randomized clinical pilot study.Tertiary-care university children's hospital postoperative pediatric (...) . Central venous oxygen saturation, serum lactate levels, urine output, time to chest tube removal, length of mechanical ventilation, ICU, and hospital stay were similar in both groups. Both drugs were well tolerated, no serious adverse events occurred.Dobutamine and milrinone are safe, well tolerated, and equally effective in prevention of low cardiac output syndrome after pediatric cardiac surgery. The hemodynamic response of the two drugs is comparable. In uncomplicated cases, a trend toward the more

2018 Pediatric Critical Care Medicine Controlled trial quality: uncertain

195. A double blind, placebo-controlled, randomized clinical trial that breast milk derived-Lactobacillus gasseri BNR17 mitigated diarrhea-dominant irritable bowel syndrome (PubMed)

A double blind, placebo-controlled, randomized clinical trial that breast milk derived-Lactobacillus gasseri BNR17 mitigated diarrhea-dominant irritable bowel syndrome The exact pathogenesis of diarrhea-dominant irritable bowel syndrome (IBS) is not known, but the abnormal microbiota of the gastrointestinal tract is considered to be one of the important contributing factors as in other gastrointestinal diseases such as inflammatory bowel disease, antibiotic-associated diarrhea, and colorectal

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2018 Journal of clinical biochemistry and nutrition Controlled trial quality: uncertain

196. Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, placebo-controlled pilot trial (PubMed)

Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, placebo-controlled pilot trial This study aims to explore the safety, efficacy, and feasibility of Danggwijagyaksan (DJS) for alleviating climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern.This is a randomized, double-blind, placebo-controlled pilot clinical trial. A total of 34 women (...) with climacteric syndrome who have signed informed consent forms will be registered in this study. Placebo or DJS will be randomly assigned to the participants in an equal proportion. The participants will visit the clinical trial center every 2 weeks and receive placebo or DJS granules. The treatment period is 4 weeks and the administration frequency is three times daily. Data will be collected from the participants at baseline, at week 5, and at week 9 after random allocation. The primary outcome measure

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2018 Trials Controlled trial quality: predicted high

197. One Pass Thalamic and Subthalamic Stimulation for Patients with Tremor-Dominant Idiopathic Parkinson Syndrome (OPINION): Protocol for a Randomized, Active-Controlled, Double-Blinded Pilot Trial (PubMed)

One Pass Thalamic and Subthalamic Stimulation for Patients with Tremor-Dominant Idiopathic Parkinson Syndrome (OPINION): Protocol for a Randomized, Active-Controlled, Double-Blinded Pilot Trial Besides fluctuations, therapy refractory tremor is one of the main indications of deep brain stimulation (DBS) in patients with idiopathic Parkinson syndrome (IPS). Although thalamic DBS (ventral intermediate nucleus [Vim] of thalamus) has been shown to reduce tremor in 85-95% of patients, bradykinesia (...) for both target regions.This study investigates a one path thalamic (Vim/DRT) and subthalamic implantation of DBS electrodes and a possibly combined stimulation strategy for both target regions.This is a randomized, active-controlled, double-blinded (patient- and observer-blinded), monocentric trial with three treatments, three periods and six treatment sequences allocated according to a Williams design. Eighteen patients will undergo one-path thalamic (Vim/DRT) and STN implantation of DBS electrodes

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2018 JMIR Research Protocols Controlled trial quality: uncertain

198. Single- vs double-unit cord blood transplantation for children and young adults with acute leukemia or myelodysplastic syndrome (PubMed)

Single- vs double-unit cord blood transplantation for children and young adults with acute leukemia or myelodysplastic syndrome Transplantation of 2 unrelated cord blood (UCB) units instead of 1 has been proposed to increase the cell dose. We report a prospective randomized study, designed to compare single- vs double-UCB transplantation in children and young adults with acute leukemia in remission or myelodysplasia. Eligible patients had at least two 4-6 HLA-identical UCBs with >3 × 10(7 (...) transplanted. Double-UCB transplantation did not decrease transplantation strategy failure (23.4% ± 4.9% vs 14.9% ± 4.2%). Two-year posttransplant survival, disease-free survival, and TRM were 68.8% ± 6.0%, 67.6% ± 6.0%, and 5.9% ± 2.9% after single-unit transplantation compared with 74.8% ± 5.5%, 68.1% ± 6.0%, and 11.6% ± 3.9% after double-unit transplantation. The final relapse risk did not significantly differ, but relapses were delayed after double-unit transplantation. Overall incidences of graft

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2016 EvidenceUpdates Controlled trial quality: uncertain

199. A lecithin phosphatidylserine and phosphatidic acid complex (PAS) reduces symptoms of the premenstrual syndrome (PMS): Results of a randomized, placebo-controlled, double-blind clinical trial. (PubMed)

A lecithin phosphatidylserine and phosphatidic acid complex (PAS) reduces symptoms of the premenstrual syndrome (PMS): Results of a randomized, placebo-controlled, double-blind clinical trial. Many women experience emotional and physical symptoms around the time of ovulation and more so before menstruation interfering with their daily normal life also known as premenstrual syndrome (PMS). Recent observational data suggest that supplementation with Lipogen's phosphatidylserine (PS

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2018 Clinical nutrition ESPEN Controlled trial quality: predicted high

200. Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. (PubMed)

Faecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomised, placebo-controlled, parallel-group, single-centre trial. Irritable bowel syndrome (IBS) is a common condition characterised by abdominal pain, bloating, and poor quality of life. IBS might be caused by a gut dysbiosis. We aimed to compare faecal microbiota transplantation (FMT) with placebo in patients with IBS.In this double-blind, randomised, placebo-controlled

2018 The lancet. Gastroenterology & hepatology Controlled trial quality: predicted high

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