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Double-Crush Syndrome

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61. A phase 1, randomized double-blind, placebo controlled trial to evaluate safety and efficacy of epigallocatechin-3-gallate and cognitive training in adults with Fragile X syndrome. (PubMed)

A phase 1, randomized double-blind, placebo controlled trial to evaluate safety and efficacy of epigallocatechin-3-gallate and cognitive training in adults with Fragile X syndrome. Despite the wide spectrum of experimental compounds tested in clinical trials, there is still no proven pharmacological treatment available for Fragile-X syndrome (FXS), since several targeted clinical trials with high expectations of success have failed to demonstrate significant improvements. Here we tested (...) epigallocatechin-3-gallate (EGCG) as a treatment option for ameliorating core cognitive and behavioral features in FXS.We conducted preclinical studies in Fmr1 knockout mice (Fmr1-/y) using novel object-recognition memory paradigm upon acute EGCG (10 mg/kg) administration. Furthermore we conducted a double-blind placebo-controlled phase I clinical trial (TESXF; NCT01855971). Twenty-seven subjects with FXS (18-55 years) were administered of EGCG (5-7 mg/kg/day) combined with cognitive training (CT) during 3

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

62. Double-blind, randomized, placebo-controlled study of trofinetide in pediatric Rett syndrome. (PubMed)

Double-blind, randomized, placebo-controlled study of trofinetide in pediatric Rett syndrome. To determine safety, tolerability, and pharmacokinetics of trofinetide and evaluate its efficacy in female children/adolescents with Rett syndrome (RTT), a debilitating neurodevelopmental condition for which no pharmacotherapies directed at core features are available.This was a phase 2, multicenter, double-blind, placebo-controlled, parallel-group study, in which safety/tolerability, pharmacokinetics (...) , and concomitant medications. Clinician- and caregiver-based efficacy measurements assessed clinically relevant, phenotypic dimensions of impairment of RTT.All dose levels were well tolerated and generally safe. Trofinetide at 200 mg/kg bid showed statistically significant and clinically relevant improvements relative to placebo on the Rett Syndrome Behaviour Questionnaire, RTT-Clinician Domain Specific Concerns-Visual Analog Scale, and Clinical Global Impression Scale-Improvement. Exploratory analyses

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2019 Neurology Controlled trial quality: predicted high

63. Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial. (PubMed)

Effects of synbiotic supplementation on metabolic parameters and apelin in women with polycystic ovary syndrome: a randomised double-blind placebo-controlled trial. Polycystic ovary syndrome (PCOS) is one of the most common causes of infertility in women of reproductive age. Insulin resistance is a main pathophysiologic feature in these patients. According to some studies, the intake of probiotic bacteria may improve glucose homoeostasis. The aim of this study was to investigate the effect (...) of synbiotics on metabolic parameters and apelin in PCOS patients. This randomised double-blind placebo-controlled trial was conducted on eighty-eight PCOS women aged 19-37 years old. The participants were randomly assigned to two groups receiving (1) synbiotic supplement (n 44), and (2) placebo (n 44) for 12 weeks. Fasting blood samples were taken at baseline and after 12 weeks. The two groups showed no difference in fasting blood sugar (adjusted mean difference: 0·60; 95 % CI -3·80, 5·00, P=0·727), plasma

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2019 The British journal of nutrition Controlled trial quality: predicted high

64. Effect of low-dose aspirin on the development of ovarian hyperstimulation syndrome and outcomes of assisted reproductive techniques in the women with PCOS, a randomized double-blinded clinical trial. (PubMed)

Effect of low-dose aspirin on the development of ovarian hyperstimulation syndrome and outcomes of assisted reproductive techniques in the women with PCOS, a randomized double-blinded clinical trial. Ovarian hyperstimulation syndrome (OHSS) is a major complication of assisted reproductive technologies (ART). Polycystic ovary syndrome (PCOS) is a risk factor for OHSS. The aim of this randomized clinical trial (RCT) was to study the effect of low-dose aspirin (LDA) on the development of OHSS (...) and ART outcomes in PCOS during ART.This double-blinded placebo controlled RCT was performed on 232 PCOS infertile women in their first ART cycles during 2010-2016. LDA and placebo capsules were prepared, packed and specified by code numbers in similar shapes. One package was given to every woman and asked to take one capsule/day since the 21st day of her cycle prior to the gonadotropin stimulation. Gonadotropin releasing hormone agonist long protocol and triggering by human chorionic gonadotropin

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2019 Taiwanese journal of obstetrics & gynecology Controlled trial quality: predicted high

65. A Pilot Randomised Double-Blind Study of the Tolerability and efficacy of repetitive Transcranial Magnetic Stimulation on Persistent Post-Concussion Syndrome. (PubMed)

A Pilot Randomised Double-Blind Study of the Tolerability and efficacy of repetitive Transcranial Magnetic Stimulation on Persistent Post-Concussion Syndrome. This study investigates the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on persistent post-concussion syndrome (PCS). The study design was a randomized (coin toss), placebo controlled, and double-blind study. Thirty-seven participants with PCS were assessed for eligibility; 22 were randomised and 18 completed the study

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2019 Scientific reports Controlled trial quality: predicted high

66. Effects of Vitamin D Supplementation in Patients with Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. (PubMed)

Effects of Vitamin D Supplementation in Patients with Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. There are some evidence that Vitamin D supplementation may be beneficial for patients with irritable bowel syndrome (IBS). The aim of this study was to evaluate the effects of Vitamin D supplementation on symptoms and quality of life (QOL) in patients with IBS.In a randomized, double-blind, placebo-controlled clinical trial, 116 patients with IBS were

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

67. Corrigendum to "Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial" [Complement Ther Med 44 (June) (2019) 261-268]. (PubMed)

Corrigendum to "Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial" [Complement Ther Med 44 (June) (2019) 261-268]. 31331578 2019 07 23 1873-6963 45 2019 08 Complementary therapies in medicine Complement Ther Med Corrigendum to "Short-term effects of massage with olive oil on the severity of uremic restless legs syndrome: A double-blind placebo-controlled trial" [Complement Ther Med 44 (June) (2019) 261-268

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2019 Complementary Therapies In Medicine Controlled trial quality: predicted high

68. Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial. (PubMed)

Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic symptoms and is challenging to manage. Hou Gu Mi Xi (HGMX) is a dietary TCM (...) formula for SQD. This study aims to evaluate the efficacy and safety of HGMX in patients with SQD who have undergone radical gastrectomy for gastric cancer.This study is a multicenter, randomized, double-blind, placebo-controlled trial. One hundred thirty patients with SQD who have undergone radical gastrectomy for gastric cancer will be assigned to receive either HGMX or placebo for 2 years. The main outcome will be changes in SQD symptoms assessed by the Spleen Qi Deficiency Symptoms Grading

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2019 Trials Controlled trial quality: predicted high

69. Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. (PubMed)

Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome. Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil.We performed a double-blind trial of 190 patients with IBS

2019 Gastroenterology Controlled trial quality: predicted high

70. Retraction notice to: "Calcium versus oral contraceptive pills containing drospirenone for the treatment of mild to moderate premenstrual syndrome: A double blind randomized placebo controlled trial" [Eur J Obstet Gynecol Reprod Biol (2016) 100-104]. (PubMed)

Retraction notice to: "Calcium versus oral contraceptive pills containing drospirenone for the treatment of mild to moderate premenstrual syndrome: A double blind randomized placebo controlled trial" [Eur J Obstet Gynecol Reprod Biol (2016) 100-104]. 31455589 2019 08 29 1872-7654 240 2019 09 European journal of obstetrics, gynecology, and reproductive biology Eur. J. Obstet. Gynecol. Reprod. Biol. Retraction notice to: "Calcium versus oral contraceptive pills containing drospirenone (...) for the treatment of mild to moderate premenstrual syndrome: A double blind randomized placebo controlled trial" [Eur J Obstet Gynecol Reprod Biol (2016) 100-104]. 387 S0301-2115(19)30279-9 10.1016/j.ejogrb.2019.05.044 Shehata Nesreen A A NAA Department of Obstetrics and Gynecology, Faculty of Medicine, Beni-Suef University, Egypt. eng Journal Article Retraction of Publication Ireland Eur J Obstet Gynecol Reprod Biol 0375672 0301-2115 IM Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:100-104 26808666 2019 05 29

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2019 European journal of obstetrics, gynecology, and reproductive biology Controlled trial quality: predicted high

71. Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. (PubMed)

Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. Patients with severe cubital tunnel syndrome often have poor functional recovery with conventional surgical treatment. Postsurgical electrical stimulation (PES) has been shown to enhance axonal regeneration in animal and human studies.To determine if PES following surgery for severe cubital tunnel syndrome would result in better outcomes (...) compared to surgery alone.Patients with severe cubital tunnel syndrome in this randomized, double-blind, placebo-controlled trial were randomized in a 1:2 ratio to the control or stimulation groups. Control patients received cubital tunnel surgery and sham stimulation, whereas patients in the stimulation group received 1-h of 20 Hz PES following surgery. Patients were assessed by a blinded evaluator annually for 3 yr. The primary outcome was motor unit number estimation (MUNE) and secondary outcomes

2019 Neurosurgery Controlled trial quality: predicted high

72. A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome. (PubMed)

A Placebo-Controlled Double-Blind Randomized Trial with Individualized Homeopathic Treatment Using a Symptom Cluster Approach in Women with Premenstrual Syndrome.  In a double-blind placebo-controlled randomized trial with parallel groups, the efficacy of individually prescribed homeopathic medicines was evaluated in women with premenstrual syndrome (PMS). In an outpatient department of a university clinic in Jerusalem, Israel (1996-1999), women with PMS, aged 18 to 50 years, entered a 2-month

2019 Homeopathy : the journal of the Faculty of Homeopathy Controlled trial quality: predicted high

73. Low-level laser therapy in patients with Burning Mouth Syndrome: A double-blind, randomized, controlled clinical trial. (PubMed)

Low-level laser therapy in patients with Burning Mouth Syndrome: A double-blind, randomized, controlled clinical trial. Evaluate the effect of LLLT in the treatment of burning mouth syndrome (BMS).Twenty-one BMS patients were randomly assigned to two groups: 12 in the laser group (LG) and 9 in the control group (CG). Patients in the LG underwent 2-week sessions of LLLT for 4 weeks. The spot tip area of this tool is 0.088cm2, semi-conductor GaAlAs, with a wavelength of 808nm ±5nm (infrared), 200 (...) , pain and the treatment (p=0.0538).LLLT may be an alternative treatment for the relief of oral burning in patients with BMS. Key words:Burning mouth syndrome, oral pain, laser dentistry, laser therapy, low intensity laser therapy.

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2019 Journal of clinical and experimental dentistry Controlled trial quality: uncertain

74. Effect of Zinc Supplementation on Physical and Psychological Symptoms, Biomarkers of Inflammation, Oxidative Stress, and Brain-Derived Neurotrophic Factor in Young Women with Premenstrual Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial. (PubMed)

Effect of Zinc Supplementation on Physical and Psychological Symptoms, Biomarkers of Inflammation, Oxidative Stress, and Brain-Derived Neurotrophic Factor in Young Women with Premenstrual Syndrome: a Randomized, Double-Blind, Placebo-Controlled Trial. Zinc is known to have multiple beneficial effects including anti-inflammatory and antioxidant and anti-depressant actions. Data on the effects of zinc supplementation on biomarkers of inflammation, oxidative stress, and antidepressant-like effect (...) among young women with premenstrual syndrome (PMS) are scarce. This study was a randomized, double-blind, placebo-controlled trial. Sixty women (18-30 years) with premenstrual syndrome diagnosed according to 30-item questionnaire were randomly assigned to receive either 30-mg zinc gluconate (group 1; n = 30) and/or placebo (group 2; n = 30) for 12 weeks. Premenstrual syndrome symptoms, total antioxidant capacity, high sensitivity reactive protein, and brain-derived neurotrophic factor were measured

2019 Biological trace element research Controlled trial quality: predicted high

75. The impact of pulsed electromagnetic field therapy on blood pressure and circulating nitric oxide levels: a double blind, randomized study in subjects with metabolic syndrome. (PubMed)

The impact of pulsed electromagnetic field therapy on blood pressure and circulating nitric oxide levels: a double blind, randomized study in subjects with metabolic syndrome. Purpose: Regulation of blood pressure (BP) is important in reducing the risk for cardiovascular disease. There is growing interest in non-pharmacological methods to treat BP including a novel approach using pulsed electromagnetic field therapy (PEMF). PEMF therapy has been proposed to impact physiological function (...) at the cellular and tissue level and one possible mechanism is through an impact on endothelial function and nitric oxide (NO) related pathways. The focus of the present study was to evaluate the effect of PEMF on BP and NO in subjects with mild to moderate metabolic syndrome. Materials and methods: For 12 weeks, 23 subjects underwent PEMF therapy and 21 subjects underwent sham therapy. BP was measured at rest and near the end of submaximal exercise pre- and 12 week post-therapy. Additionally, plasma

2019 Blood pressure Controlled trial quality: uncertain

76. Effects of ginger supplementation on anthropometric, glycemic and metabolic parameters in subjects with metabolic syndrome: A randomized, double-blind, placebo-controlled study. (PubMed)

Effects of ginger supplementation on anthropometric, glycemic and metabolic parameters in subjects with metabolic syndrome: A randomized, double-blind, placebo-controlled study. Metabolic syndrome (MetS) is one of the worldwide most chronic endocrine disorders. The disease can also lead to several other chronic disorders such as type 2 diabetes mellitus, cardiovascular diseases, renal diseases and cancers. This study aimed to evaluate the safety and efficacy of ginger powder on biochemical

2019 Journal of diabetes and metabolic disorders Controlled trial quality: uncertain

77. Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. (PubMed)

Faecal microbiota transplantation for diarrhoea-predominant irritable bowel syndrome: a double-blind, randomised, placebo-controlled trial. Faecal microbiota transplantation (FMT) has shown promise in alleviating the symptoms of irritable bowel syndrome (IBS); however, controlled data on this technique are scarce. The aim of this clinical trial was to assess the efficacy of FMT in alleviating diarrhoea-predominant IBS (IBS-D).We did a double-blind, randomised, placebo-controlled crossover trial

2019 The lancet. Gastroenterology & hepatology Controlled trial quality: predicted high

78. Corrigendum to "A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation". (PubMed)

Corrigendum to "A Randomized, Double-Blind, Placebo-Controlled Trial: The Efficacy of Multispecies Probiotic Supplementation in Alleviating Symptoms of Irritable Bowel Syndrome Associated with Constipation". [This corrects the article DOI: 10.1155/2016/4740907.].

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2019 BioMed research international Controlled trial quality: predicted high

79. Effectiveness of Phonophoresis Treatment in Carpal Tunnel Syndrome: A Randomized Double-blind, Controlled Trial. (PubMed)

Effectiveness of Phonophoresis Treatment in Carpal Tunnel Syndrome: A Randomized Double-blind, Controlled Trial. To determine the effects of phonophoresis of piroxicam (PH-P) and phonophoresis of dexamethasone sodium phosphate (PH-Dex) on mild to moderate carpal tunnel syndrome (CTS), and to compare each of them with the control group of nondrug ultrasound (US) therapy.A randomized, double-blind controlled trial.Department of rehabilitation medicine, university hospital.Patients with clinical

2019 PM & R : the journal of injury, function, and rehabilitation Controlled trial quality: predicted high

80. Erratum to The Possible Preventive Role of Pregabalin in Post-mastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial [Journal of Pain and Symptom Management 57 (2019) 1-9]. (PubMed)

Erratum to The Possible Preventive Role of Pregabalin in Post-mastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial [Journal of Pain and Symptom Management 57 (2019) 1-9]. 31126419 2019 11 20 1873-6513 57 6 2019 Jun Journal of pain and symptom management J Pain Symptom Manage Erratum to The Possible Preventive Role of Pregabalin in Post-mastectomy Pain Syndrome: A Double-Blinded Randomized Controlled Trial [Journal of Pain and Symptom Management 57 (2019) 1-9]. e11 S0885-3924

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2019 Journal of pain and symptom management Controlled trial quality: uncertain

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