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Double-Crush Syndrome

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81. Effects of Chromium and Carnitine Co-supplementation on Body Weight and Metabolic Profiles in Overweight and Obese Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed)

Effects of Chromium and Carnitine Co-supplementation on Body Weight and Metabolic Profiles in Overweight and Obese Women with Polycystic Ovary Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial. The primary aim of our study was to determine the influence of taking chromium plus carnitine on insulin resistance, with a secondary objective of evaluating the influences on lipid profiles and weight loss in overweight subjects with polycystic ovary syndrome (PCOS). In a 12-week randomized (...) , double-blind, placebo-controlled clinical trial, 54 overweight women were randomly assigned to receive either supplements (200 μg/day chromium picolinate plus 1000 mg/day carnitine) or placebo (27/each group). Chromium and carnitine co-supplementation decreased weight (- 3.6 ± 1.8 vs. - 1.0 ± 0.7 kg, P < 0.001), BMI (- 1.3 ± 0.7 vs. - 0.3 ± 0.3 kg/m2, P < 0.001), fasting plasma glucose (FPG) (- 5.1 ± 6.0 vs. - 1.1 ± 4.9 mg/dL, P = 0.01), insulin (- 2.0 ± 1.4 vs. - 0.2 ± 1.2 μIU/mL, P < 0.001

2019 Biological trace element research Controlled trial quality: predicted high

82. Effects of Carnitine Administration on Carotid Intima-media Thickness and Inflammatory Factors in Patients with Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial. (PubMed)

Effects of Carnitine Administration on Carotid Intima-media Thickness and Inflammatory Factors in Patients with Polycystic Ovary Syndrome: A Randomized, Double-blind, Placebo-controlled Trial. This study was performed to evaluate the effects of carnitine administration on carotid intima-media thickness (CIMT) and inflammatory markers in women with polycystic ovary syndrome (PCOS).This randomized, double-blind, placebo-controlled trial was conducted among 60 women diagnosed with PCOS according

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2019 International journal of preventive medicine Controlled trial quality: predicted high

83. Sacral nerve modulation for irritable bowel syndrome: A randomized, double-blinded, placebo-controlled crossover study. (PubMed)

Sacral nerve modulation for irritable bowel syndrome: A randomized, double-blinded, placebo-controlled crossover study. Irritable bowel syndrome (IBS) is among the most common gastrointestinal disorders, and a substantial proportion of patients have an insufficient response to treatment. In a single-blinded study, sacral nerve modulation (SNM) significantly reduced symptoms of IBS. The aim of the present double-blinded, randomized, placebo-controlled study was to evaluate the effect of SNM

2019 Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society Controlled trial quality: uncertain

84. Efficacy of a nutraceutical combination on lipid metabolism in patients with metabolic syndrome: a multicenter, double blind, randomized, placebo controlled trial. (PubMed)

Efficacy of a nutraceutical combination on lipid metabolism in patients with metabolic syndrome: a multicenter, double blind, randomized, placebo controlled trial. Nutraceuticals represent a new therapeutic frontier in the treatment of metabolic syndrom (MetS) and related cardiovascular risk factors. The aim of this study was to evaluate the potential beneficial effects of Armolipid Plus (AP) (berberine 500 mg, red yest rice, monacolin K 3 mg and policosanol 10 mg) on insulin resistance, lipid (...) profile, particularly on small and dense LDL cholesterol (sdLDL-C), representing the most atherogenic components, as well as its effects on high sensitivity C-reactive protein, a notable marker of cardiovascular risk, blood pressure and cardiac remodeling in subjects affected by MetS, with left ventricular hypertrophy.The study was a prospective, multi-center, randomized, double blind, placebo-controlled trial. One hundred and fifty eight patients, aged between 28 and 76 years old, were enrolled

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2019 Lipids in health and disease Controlled trial quality: uncertain

85. The Effect of Vitamin D Supplement Consumption on Premenstrual Syndrome in Vitamin D-Deficient Young Girls: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. (PubMed)

The Effect of Vitamin D Supplement Consumption on Premenstrual Syndrome in Vitamin D-Deficient Young Girls: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Premenstrual syndrome (PMS) alludes to a cyclic advent of somatic and psychiatric symptoms that affect some women of reproductive age. Some studies demonstrated that vitamin D was associated with premenstrual symptoms.The aim of this study was to evaluate the effect of vitamin D supplementation in the treatment of PMS (...) in vitamin D-deficient young girls.In this randomized double-blind placebo-controlled trial, 130 vitamin D-deficient girls aged 18-30 years, with PMS, were randomly divided into 2 groups and received a 2,000 IU vitamin D tablet (n = 64) or a placebo (n = 66) every other day for 12 weeks. At the beginning and at the end of week 12, serum 25(OH)-D, premenstrual symptoms, anthropometric indices, dietary intake, physical activity level, and sun exposure were evaluated. Statistical analysis was performed

2019 Complementary medicine research Controlled trial quality: predicted high

86. Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. (PubMed)

Effect of intranasal oxytocin on alcohol withdrawal syndrome: A randomized placebo-controlled double-blind clinical trial. In a pilot study, intranasal oxytocin was demonstrated to reduce the benzodiazepine dose needed to relieve withdrawal symptoms during alcohol detoxification. The aim of the present study was to compare the effect of oxytocin and placebo during a three-day period of alcohol detoxification at an addiction treatment center in Norway.Randomized, double-blind, placebo-controlled

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2019 Drug and alcohol dependence Controlled trial quality: predicted high

87. Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial. (PubMed)

Efficacy of laser acupuncture for carpal tunnel syndrome: A study protocol for a prospective double-blind randomized controlled trial. Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy that causes hand discomfort and work disability. Since no satisfactory conventional treatments for mild to moderate CTS exist, we apply complementary alternative medicine (CAM) to this problem. Laser acupuncture (LA), a new, non-invasive therapy which uses low-level-laser therapy (LLLT (...) ) in acupuncture could help to manage CTS. However, only one small randomized, double-blind and crossover trial had been conducted, which is not enough to provide an evidence-based assessment of the effects of LA on CTS.The aim of this study protocol is to investigate the efficacy of LA therapy on patients with mild to moderate CTS through sonography of the median nerve and offer clear parameters of LLLT.This study protocol is a prospective double-blind randomized controlled trial. Forty subjects aged 20 to 80

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2019 Medicine Controlled trial quality: predicted high

88. Efficacy and safety of Xinnaoning capsule in treating chronic stable angina (qi stagnation and blood stasis syndrome): Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. (PubMed)

Efficacy and safety of Xinnaoning capsule in treating chronic stable angina (qi stagnation and blood stasis syndrome): Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Chronic stable angina (CSA) is a cardiovascular disease with high prevalence. At present, drug treatment is still the main measure of stable angina pectoris. Traditional Chinese medicine has a long history in the treatment of CSA. Qi stagnation and Blood stasis syndrome is a common syndrome (...) of CSA. Xinnaoning (XNN) capsule is considered as an effective adjuvant treatment for CSA with the efficacy of promoting qi and blood circulation but lack of high-quality clinical evidence. The purpose of this study is to evaluate the efficacy and safety of XNN capsule compared with placebo by clinical trial.This multicenter, randomized, double-blind, placebo-controlled trial will be conducted with a total of 240 participants diagnosed with chronic stable angina (qi stagnation and blood stasis

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2019 Medicine Controlled trial quality: predicted high

89. Prevention of relapses with levamisole as adjuvant therapy in children with a first episode of idiopathic nephrotic syndrome: study protocol for a double blind, randomised placebo-controlled trial (the LEARNS study). (PubMed)

Prevention of relapses with levamisole as adjuvant therapy in children with a first episode of idiopathic nephrotic syndrome: study protocol for a double blind, randomised placebo-controlled trial (the LEARNS study). Idiopathic nephrotic syndrome (INS) is characterised by a high relapse rate up to 80% after initial response to standard therapy with corticosteroids. Steroid toxicity is common and causes a great burden of disease that negatively influences the health-related quality of life (...) protocol for the LEARNS study (LEvamisole as Adjuvant therapy to Reduce relapses of Nephrotic Syndrome).An international, double-blind, placebo-controlled randomised trial will be conducted in 20 participating hospitals in the Netherlands and Belgium. Participants (n=92) with a first episode of INS, aged 2-16 years, who achieve remission after 4 weeks of oral prednisolone will be randomly assigned (1:1) to receive either levamisole 2.5 mg/kg alternate day or placebo added to prednisolone (18-week

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2019 BMJ open Controlled trial quality: predicted high

90. A single-centre, placebo-controlled, double-blind randomised cross-over study of nebulised iloprost in patients with Eisenmenger syndrome: A pilot study. (PubMed)

A single-centre, placebo-controlled, double-blind randomised cross-over study of nebulised iloprost in patients with Eisenmenger syndrome: A pilot study. Pulmonary arterial hypertension (PAH), is a rare and progressive disease with a high morbidity and mortality. Prostanoid pulmonary vasodilators are the most effective treatment for idiopathic and connective tissue associated PAH. Nonetheless, data examining their safety and efficacy in patients with Eisenmenger syndrome the most severe form (...) of PAH, that is, related to cyanotic congenital heart disease (CHD-PAH) remains limited.To evaluate safety and the clinical efficacy of nebulised iloprost in patients with Eisenmenger syndrome who are on maximum background oral PAH therapy.This pilot study was a randomised, double-blind, placebo-controlled, cross-over study. Patients were randomised to receive nebulised placebo or iloprost for 12 weeks and were then crossed over, with a 7-14-day washout. The primary endpoint was a change in 6-minute

2019 International journal of cardiology Controlled trial quality: uncertain

91. A borderline form of empty follicle syndrome treated with a double-trigger of gonadotropin-releasing hormone agonist and human chorionic gonadotropin: A case report. (PubMed)

A borderline form of empty follicle syndrome treated with a double-trigger of gonadotropin-releasing hormone agonist and human chorionic gonadotropin: A case report. The borderline form of empty follicle syndrome (EFS) is a phenomenon where only a few mature or immature oocytes are retrieved despite adequate response to controlled ovarian hyperstimulation (COH). It is a rare phenomenon with an unclear underlying mechanism, and there is currently no effective treatment.The patient received 3 (...) assisted reproductive technology cycles, and although her follicular development and estrogen levels were normal during COH, the outcome with respect to the oocytes obtained was unsatisfactory.Borderline form of EFS.In the context of undergoing GnRH-antagonist protocol, we implemented a double-trigger with human chorionic gonadotropin (hCG) after 6 hours of gonadotropin-releasing hormone agonist (GnRH-a) administration.Eleven oocytes were obtained (M I × 3, M II × 8), which underwent in vitro

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2019 Medicine

92. Kuntai capsules improve glucolipid metabolism in patients with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial. (PubMed)

Kuntai capsules improve glucolipid metabolism in patients with polycystic ovary syndrome: A randomized, double-blind, placebo-controlled trial. The aim of this study was to observe the effect and safety of Heyan Kuntai Capsule (HYKT) on glucose and lipid metabolism in patients with polycystic ovary syndrome (PCOS).Hundred patients with PCOS were randomly divided into HYKT group (n = 50) and placebo groups (n = 50) in which the individuals were treated with HYKT and its placebo continuously

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2019 Medicine

93. A nutraceutical combination reduces left ventricular mass in subjects with metabolic syndrome e and left ventricular hypertrophy: A multicenter, randomized, double-blind, placebo-controlled trial. (PubMed)

A nutraceutical combination reduces left ventricular mass in subjects with metabolic syndrome e and left ventricular hypertrophy: A multicenter, randomized, double-blind, placebo-controlled trial. Increased left ventricular mass (LVM) is often present in metabolic syndrome (MS), also in the setting of well-controlled blood pressure (BP). Aim of the present study was to evaluate the efficacy of a nutraceutical combination of berberine, red yeast rice extract and policosanol (Armolipid Plus™, AP (...) ) in reducing LVM in patients with MS and left ventricular hypertrophy (LVH).In this multicenter, randomized, double-blind, placebo-controlled trial, 158 patients with MS (IDF criteria) and LVH (LVM > 48 g/m2.7 in men and > 44 g/m2.7 in women), were randomized 1:1 to receive AP or placebo for 24 weeks. Reduction of LVM, regression of LVH, and changes in lipids were analysed.One-hundred-and-forty-five patients (AP n = 74, placebo n = 71) completed the study. A significant percentage reduction in LVM

2019 Clinical nutrition (Edinburgh, Scotland) Controlled trial quality: predicted high

94. Comparing the effects of auricular seed acupressure and foot reflexology on neonatal abstinence syndrome: A modified double blind clinical trial. (PubMed)

Comparing the effects of auricular seed acupressure and foot reflexology on neonatal abstinence syndrome: A modified double blind clinical trial. The neonates of addicted women are at risk for neonatal abstinence syndrome. This study aimed to compare the effects of auricular seed acupressure and foot reflexology on neonatal abstinence syndrome among the neonates of addicted women.Thirty one neonates of addicted women were purposively recruited and randomly allocated through coin flipping (...) to receive either foot reflexology then seed acupressure or seed acupressure then foot reflexology. Interventions were performed in two successive days with a 12-h washout interval. Foot reflexology was applied for 15 min to the first horizontal zone of the sole while seed acupressure was applied for 24 h through attaching acupuncture-specific ear seeds to the posterior surface of the auricle on the SJ 17 acupoint. The symptoms of abstinence syndrome were assessed using Finnegan Neonatal Abstinence

2019 Complementary Therapies in Clinical Practice Controlled trial quality: uncertain

95. Study protocol: multicenter double-blind, randomized, placebo-controlled trial of rituximab for the treatment of childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial). (PubMed)

Study protocol: multicenter double-blind, randomized, placebo-controlled trial of rituximab for the treatment of childhood-onset early-stage uncomplicated frequently relapsing or steroid-dependent nephrotic syndrome (JSKDC10 trial). Eighty percent of children with idiopathic nephrotic syndrome respond well to steroid therapy, but up to 50% of patients with steroid-sensitive nephrotic syndrome exhibit frequently relapsing (FRNS) or steroid-dependent nephrotic syndrome (SDNS). Several studies (...) identified the chimeric anti-CD20 monoclonal antibody rituximab as an effective treatment for patients with complicated FRNS/SDNS. Recent studies suggested that rituximab could also be a first-line treatment for early-stage uncomplicated FRNS/SDNS, although further studies are required to confirm its efficacy and safety.We are conducting a multicenter, double-blind, randomized placebo controlled trial to investigate the efficacy and safety of rituximab for the treatment of childhood-onset early-stage

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2019 BMC Nephrology Controlled trial quality: predicted high

96. Acetyl-L-Carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome: A Double-Blind, Randomized, Controlled Trial. (PubMed)

Acetyl-L-Carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome: A Double-Blind, Randomized, Controlled Trial. Carpal tunnel syndrome is very common. Although surgery is effective in mild and moderate cases, recovery is often incomplete in severe cases. Therefore, adjuvant therapy to improve nerve regeneration in those patients is much needed. Acetyl-L-carnitine has been shown to be effective in other neuropathies. The goal of this study is to test the hypothesis that acetyl-L (...) -carnitine can promote nerve regeneration and improve function in patients with severe carpal tunnel syndrome.In this proof-of-principle, double-blind, randomized, placebo-controlled trial, adults with severe carpal tunnel syndrome were randomized to receive 3000 mg/day of acetyl-L-carnitine orally or placebo following carpal tunnel release surgery for 2 months. Outcomes were assessed at baseline and at 3, 6, and 12 months postoperatively. Symptom severity and functional outcomes were assessed using

2019 Plastic and reconstructive surgery Controlled trial quality: predicted high

97. Effect of oral citrulline supplementation on whole body protein metabolism in adult patients with short bowel syndrome: A pilot, randomized, double-blind, cross-over study. (PubMed)

Effect of oral citrulline supplementation on whole body protein metabolism in adult patients with short bowel syndrome: A pilot, randomized, double-blind, cross-over study. As citrulline is produced by small intestine, plasma citrulline concentration is decreased and may become essential in patients with short bowel syndrome (SBS). In a rat model of SBS, citrulline supplementation enhanced muscle protein synthesis. The aim of the study was to determine whether citrulline impacts whole body (...) protein metabolism in patients with SBS.Nine adults with non-malignant SBS (residual small bowel 90 ± 48 cm; mean ± SD) who were in near-normal nutritional status without any artificial nutrition, were recruited long after surgery. They received 7-day oral supplementation with citrulline (0.18 g/kg/day), or an iso-nitrogenous placebo in a randomized, double-blind, cross-over design with a 13-day wash-out between regimens, and an intravenous 5-h infusion of L-[1-13C]-leucine in the postabsorptive state

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2019 Clinical nutrition (Edinburgh, Scotland) Controlled trial quality: predicted high

98. Extended-release gabapentin for failed back surgery syndrome: results from a randomized double-blind cross-over study. (PubMed)

Extended-release gabapentin for failed back surgery syndrome: results from a randomized double-blind cross-over study. Persistent pain after lumbar surgery (failed back surgery syndrome [FBSS]) remains a leading indication for chronic analgesia. However, no analgesics have proven efficacious for this condition. Although trials have evaluated gabapentinoids for chronic low back pain, none of these trials focused solely on FBSS. This randomized, double-blind cross-over trial evaluated (...) outcome measure, including the primary (least square mean difference in NRS: -0.01 confidence interval: [-0.22 to 0.20]). Given the escalating rate of complex lumbar surgery, future research to develop novel therapies for this prevalent syndrome is needed.

2019 Pain Controlled trial quality: predicted high

99. Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial. (PubMed)

Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial. Although the efficacy of olive oil massage has been established for different disorders, no studies have yet focused on the effect of olive oil massage on restless legs syndrome (RLS). In this study, we aimed to evaluate the short-term effects of massage with olive oil in reducing the severity of uremic RLS.This double-blind placebo-controlled trial (...) and one week after the final massage therapy session by using the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale.In terms of different categories of RLS severity, a significant decline was observed only in the olive oil group from the pre- to post-intervention stages (P =  0.003). After the intervention, the decline in the total RLS severity was more significant in the olive oil group (P <  0.001), compared to the placebo group (P =  0.019). Moreover, a significant difference

2019 Complementary Therapies In Medicine Controlled trial quality: uncertain

100. <i>Citrus aurantium</i> Aroma for Anxiety in Patients with Acute Coronary Syndrome: A Double-Blind Placebo-Controlled Trial. (PubMed)

Citrus aurantium Aroma for Anxiety in Patients with Acute Coronary Syndrome: A Double-Blind Placebo-Controlled Trial. Objective: This study evaluated the antianxiety effect of Citrus aurantium aroma (neroli oil) inhalation on patients with acute coronary syndrome (ACS). Design: A double-blind, placebo-controlled randomized trial. Setting/Location: This study was conducted in the Coronary Care Unit of Torfeh Hospital in Tehran, Iran, from September 2017 to February 2018. Subjects: A total

2019 Journal of Alternative and Complementary Medicine Controlled trial quality: predicted high

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