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Double-Crush Syndrome

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121. The effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of patients with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. (PubMed)

The effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of patients with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial. This study was conducted to evaluate the effects of fish oil omega-3 fatty acid supplementation on mental health parameters and metabolic status of women with polycystic ovary syndrome (PCOS).This randomized double-blind, placebo-controlled trial was conducted on 60 women with PCOS, aged 18

2018 Journal of psychosomatic obstetrics and gynaecology Controlled trial quality: predicted high

122. The Effect of Curcumin on Serum Copper and Zinc and Zn/Cu Ratio in Individuals with Metabolic Syndrome: A Double-Blind Clinical Trial. (PubMed)

The Effect of Curcumin on Serum Copper and Zinc and Zn/Cu Ratio in Individuals with Metabolic Syndrome: A Double-Blind Clinical Trial. Metabolic syndrome is a complex disorder with high socioeconomic costs and a high global prevalence. The serum concentrations of some trace elements are higher in people with metabolic syndrome compared to normal individuals. Curcumin is derived from turmeric and has antioxidant and anti-inflammatory properties. Curcumin may therefore have a potential role (...) in the management of cardiovascular risk. The aim of this study was to investigate the effects of curcumin on serum copper (Cu), zinc (Zn), and Zn/Cu ratio levels in patients with metabolic syndrome. A double-blind clinical trial was designed in which 120 individuals with metabolic syndrome were randomly assigned to one of three groups: curcumin 1gr/day, phospholipidated curcumin 1gr/day, or a placebo, each taken for 6 weeks. Serum copper and zinc were measured before and after intervention. At baseline

2018 Journal of dietary supplements Controlled trial quality: uncertain

123. Effects of selenium supplementation on expression of SEPP1 in mRNA and protein levels in subjects with and without metabolic syndrome suffering from coronary artery disease: Selenegene study a double-blind randomized controlled trial. (PubMed)

Effects of selenium supplementation on expression of SEPP1 in mRNA and protein levels in subjects with and without metabolic syndrome suffering from coronary artery disease: Selenegene study a double-blind randomized controlled trial. Selenoprotein P (SePP) is involved in the protection against diseases. The present study is the first investigation of the effect of selenium supplementation on plasma selenium and expression of SEPP1 in mRNA and protein levels based on metabolic syndrome (MetS

2018 Journal of cellular biochemistry Controlled trial quality: predicted high

124. Lofexidine versus diazepam for the treatment of opioid withdrawal syndrome: A double-blind randomized clinical trial in Singapore. (PubMed)

Lofexidine versus diazepam for the treatment of opioid withdrawal syndrome: A double-blind randomized clinical trial in Singapore. Many individuals leave costly inpatient detoxification programs prematurely because of the severity of withdrawal symptoms experienced. In the absence of opioid-assisted detoxification in Singapore, diazepam is used to manage withdrawal. However since diazepam is addictive, there is a need to explore the effectiveness of alternative medications.The study aimed (...) to examine the safety and efficacy of lofexidine, a non-opiate, non-addictive, alpha 2-adrenergic agonist in assisting opioid detoxification in Singapore, using a randomized, double-blind, investigator-initiated placebo-controlled trial comparing lofexidine against diazepam. Opioid dependent patients (n = 111) were randomized to receive a 10-day course of lofexidine (n = 56) or diazepam (n = 55). The primary endpoint was the Objective Opioid Withdrawal Scale (OOWS) score on days 3 and 4 and secondary

2018 Journal of substance abuse treatment Controlled trial quality: predicted high

125. Efficacy of ultramicronized palmitoylethanolamide in burning mouth syndrome-affected patients: a preliminary randomized double-blind controlled trial. (PubMed)

Efficacy of ultramicronized palmitoylethanolamide in burning mouth syndrome-affected patients: a preliminary randomized double-blind controlled trial. This preliminary randomized double-blind controlled trial was performed to test the efficacy of ultramicronized palmitoylethanolamide treatment in the burning mouth syndrome.Patients with referred burning mouth intensity greater than 4, according to the Numeric Rating Scale, were included in the study according to established inclusion (...) as a viable therapy in the management of burning mouth syndrome.The use of an effective compound to manage the burning mouth syndrome, devoid of adverse effects for the patient and that does not interfere with other pharmacological therapies, could find wide employability from clinicians.

2018 Clinical oral investigations Controlled trial quality: uncertain

126. Double-Blind Placebo-Controlled Study of Rifaximin and Lactulose Hydrogen Breath Test in Gulf War Veterans with Irritable Bowel Syndrome. (PubMed)

Double-Blind Placebo-Controlled Study of Rifaximin and Lactulose Hydrogen Breath Test in Gulf War Veterans with Irritable Bowel Syndrome. Irritable bowel syndrome (IBS) occurs in up to 33% of Gulf War (GW) Veterans. Alterations in gut microflora including small intestinal bacterial overgrowth (SIBO) during deployment may play a role in development of IBS. Rifaximin is a minimally absorbed antibiotic speculated to improve IBS symptoms, in part, by restoring normal gut microflora. The aim (...) of this study was to compare rifaximin to placebo on IBS symptoms and quality of life (QOL) in GW Veterans with IBS without constipation.A double-blind, placebo-controlled study was performed. One hundred and twenty-two GW Veterans with IBS (Rome III) from our database and referral to gastroenterology and internal medicine clinics were screened. After a 2-week run-in period, 50 patients were randomized (1:1) to receive either rifaximin 550 gm or placebo twice daily for 2 weeks in a double-blind study

2018 Digestive diseases and sciences Controlled trial quality: uncertain

127. Predictors of clinical response in a double-blind placebo controlled crossover trial of gabapentin enacarbil for restless legs syndrome. (PubMed)

Predictors of clinical response in a double-blind placebo controlled crossover trial of gabapentin enacarbil for restless legs syndrome. Restless Legs Syndrome (RLS) is a sensory-motor disorder which produces sleep disturbance. Using data from a large clinical trial of gabapentin enacarbil (GEn) we sought to assess the ability of baseline, and changes from baseline, in clinical trial endpoints to predict treatment response.Data were derived from a randomized, double-blind, placebo-controlled

2018 Sleep medicine Controlled trial quality: predicted high

128. Oral Magnesium Supplementation and Metabolic Syndrome: A Randomized Double-Blind Placebo-Controlled Clinical Trial. (PubMed)

Oral Magnesium Supplementation and Metabolic Syndrome: A Randomized Double-Blind Placebo-Controlled Clinical Trial. The objective of the study was to evaluate the efficacy of oral magnesium supplementation in the improvement of metabolic syndrome (MetS) and its components. This is a randomized double-blind, placebo-controlled clinical trial that enrolled 198 individuals with MetS and hypomagnesemia who were randomly allocated to receive either 30 mL of magnesium chloride 5% solution, equivalent

2018 Advances in chronic kidney disease Controlled trial quality: predicted high

129. The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren's syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial. (PubMed)

The efficacy and safety of total glucosides of peony in the treatment of primary Sjögren's syndrome: a multi-center, randomized, double-blinded, placebo-controlled clinical trial. To evaluate the efficacy and safety of total glucosides of peony (TGP) in adults with primary Sjögren's syndrome (pSS). A multi-center, randomized, double-blinded, placebo-controlled study was conducted between March 2012 and July 2014 at ten Chinese hospitals. In total, 320 pSS patients-classified according (...) to the 2002 American-European Consensus Group Criteria-were randomized (2:1 ratio) to receive TGP(600 mg, tid) in the TGP group or placebo for 24 weeks in the placebo group. Study personnel, investigators, and patients were blinded to the treatment grouping. The primary endpoint was the improvement of EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) at week 24. The secondary endpoints were dry eyes/mouth/skin/nose/throat/vagina visual analogue scale (VAS), pain and discomfort VAS, fatigue VAS

2018 Clinical rheumatology Controlled trial quality: predicted high

130. Glucocorticoid injections for greater trochanteric pain syndrome: a randomised double-blind placebo-controlled (GLUTEAL) trial. (PubMed)

Glucocorticoid injections for greater trochanteric pain syndrome: a randomised double-blind placebo-controlled (GLUTEAL) trial. Small observational studies suggest that local glucocorticoid (GC) injection may be effective in the management of the greater trochanteric pain syndrome (GTPS). The objective was to perform the first randomised double-blind placebo-controlled trial to investigate the efficacy of local GC injection in the management of GTPS. The trial was conducted between November

2018 Clinical rheumatology Controlled trial quality: predicted high

131. Second IVIg course in Guillain-Barré syndrome patients with poor prognosis (SID-GBS trial): Protocol for a double-blind randomized, placebo-controlled clinical trial. (PubMed)

Second IVIg course in Guillain-Barré syndrome patients with poor prognosis (SID-GBS trial): Protocol for a double-blind randomized, placebo-controlled clinical trial. One course of intravenous immunoglobulins (IVIg) of 2 g/kg is standard treatment in Guillain-Barré syndrome (GBS) patients unable to walk independently. Despite treatment some patients recover poorly, in part related to rapid consumption of IVIg, indicating that they may benefit from a second course of IVIg. The aim of the study (...) on the modified Erasmus GBS outcome score (mEGOS) at 1 week after start of the first IVIg course are eligible for randomization in this double-blind, placebo-controlled (IVIg or albumin) clinical trial. This study will determine if a second course of IVIg administered in the acute phase of the disease is safe, feasible, and effective in patients with GBS and a poor prognosis. This Dutch trial is registered prospectively as NTR 2224 in the Netherlands National Trial Register (NTR) which is the Primary Registry

2018 Journal of the peripheral nervous system : JPNS Controlled trial quality: predicted high

132. Randomized, double-blind, placebo-controlled study vs data in the daily practice using linaclotide in patients with irritable bowel syndrome with constipation. (Full text)

Randomized, double-blind, placebo-controlled study vs data in the daily practice using linaclotide in patients with irritable bowel syndrome with constipation. 29700962 2018 04 27 1365-2982 30 5 2018 May Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society Neurogastroenterol. Motil. Randomized, double-blind, placebo-controlled study vs data in the daily practice using linaclotide in patients with irritable bowel syndrome with constipation

2018 Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society Controlled trial quality: predicted high

133. The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial. (PubMed)

The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial. Data on the effects of synbiotic supplementation on glycemic control, lipid profiles, and atherogenic index of plasma (AIP) of women with polycystic ovary syndrome (PCOS) are limited. The purpose of this study was to assess the effects of synbiotic supplementation on glycemic control and lipid profiles in women with PCOS. A prospective, randomized (...) , double-blind, placebo-controlled trial was done at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017. Sixty women with PCOS were randomized to intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 109 CFU/g each) plus 800 mg inulin (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples

2018 Probiotics and antimicrobial proteins Controlled trial quality: predicted high

134. 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. (Full text)

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

2018 Clinical nutrition ESPEN Controlled trial quality: predicted high

135. Impact of Metformin on IVF Outcomes in Overweight and Obese Women With Polycystic Ovary Syndrome: A Randomized Double-Blind Controlled Trial. (PubMed)

Impact of Metformin on IVF Outcomes in Overweight and Obese Women With Polycystic Ovary Syndrome: A Randomized Double-Blind Controlled Trial. To evaluate the impact of metformin on in vitro fertilization (IVF) outcomes in overweight and obese women with polycystic ovary syndrome (PCOS).This was a randomized double-blind placebo-controlled study ( ClinicalTrials.gov : NCT 02910817) carried out in a University IVF Center. The study included 102 overweight and obese women (body mass index [BMI (...) pregnancy rate (13.4% vs 3.9%, P = .08), or miscarriage rate (23.5% vs 35.7%, P = .46). No cases of ovarian hyperstimulation syndrome (OHSS) were observed in both groups.Short-term administration of metformin to overweight or obese women with PCOS undergoing IVF decreased number of the retrieved oocytes but did not improve the LBR. Synopsis Metformin use could decrease the number of retrieved oocytes in overweight and obese women with polycystic ovary syndrome undergoing IVF.

2018 Reproductive sciences (Thousand Oaks, Calif.) Controlled trial quality: predicted high

136. Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study. (Full text)

Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study. Clinical testing to determine a suitable dose of linaclotide for Japanese patients with irritable bowel syndrome with constipation (IBS-C) was needed.This was a randomized, double-blind, placebo-controlled, dose-finding trial. Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49

2018 Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society Controlled trial quality: predicted high

137. TCF7L2-rs7903146 polymorphism modulates the effect of artichoke leaf extract supplementation on insulin resistance in metabolic syndrome: a randomized, double-blind, placebo-controlled trial. (PubMed)

TCF7L2-rs7903146 polymorphism modulates the effect of artichoke leaf extract supplementation on insulin resistance in metabolic syndrome: a randomized, double-blind, placebo-controlled trial. Transcription factor 7-like 2 (TCF7L2)-rs7903146 polymorphism is associated with increased risk of type 2 diabetes. The response of insulin and insulin resistance to artichoke leaf extract (ALE) may be affected by TCF7L2-rs7903146 polymorphism.This study examined the effects of ALE supplementation (...) on metabolic parameters of the TCF7L2-rs7903146 polymorphism in patients with metabolic syndrome (MetS).This double-blind clinical trial was conducted on 80 patients with MetS in Sina Clinic, Khoy, Iran. The patients were randomized into ALE or placebo groups to receive either ALE (1800 mg/d as four tablets) or matching placebo for 12 weeks.Anthropometric indices, blood pressure, glucose and lipid profile levels were measured before and after the study. Moreover, patients were genotyped for TCF7L2

2018 Journal of integrative medicine Controlled trial quality: predicted high

138. The evolution of transanal surgery for obstructed defecation syndrome: Mid-term results from a randomized study comparing double TST 36 HV and Contour TRANSTAR staplers. (PubMed)

The evolution of transanal surgery for obstructed defecation syndrome: Mid-term results from a randomized study comparing double TST 36 HV and Contour TRANSTAR staplers. A randomized study was carried out to compare the mid-term outcome of transanal rectal resection with the CCS-30 TRANSTAR and two TST36 staplers in patients with obstructed defecation syndrome. After selection, patients were randomly assigned to 2 groups:104 underwent a TRANSTAR operation and 104 a transanal rectal resection (...) with two TST36 staplers. Patients were followed up with clinical examination, and defecography. Cumulative complication rate was significantly higher in TRANSTAR operation (P = 0.019). All symptoms and defecographic parameters significantly improved (P < 0.001), without differences. Costs were significantly lower with double TST (P = 0.035). Recurrence rates were 6.2% in TRANSTAR group and 11.4% with double TST (P = 0.206). Two circular TST 36 staplers consent to obtain the same clinical and functional

2018 American journal of surgery Controlled trial quality: uncertain

139. Efficacy of Bacillus coagulans Unique IS2 in treatment of irritable bowel syndrome in children: a double blind, randomised placebo controlled study. (PubMed)

Efficacy of Bacillus coagulans Unique IS2 in treatment of irritable bowel syndrome in children: a double blind, randomised placebo controlled study. The efficacy of the probiotic strain, Bacillus coagulans Unique IS2 in the treatment of Irritable Bowel Syndrome (IBS) was evaluated in children. A total of 141 children of either sex in the age group 4-12 years, diagnosed with IBS according to the Rome III criteria, participated in the double-blind randomised controlled trial. Children received (...) either B. coagulans Unique IS2 chewable tablets or placebo once daily for eight weeks followed by a two week follow-up period. Reduction in pain intensity as well as other symptoms associated with Irritable Bowel Syndrome like abdominal discomfort, bloating, distension, sense of incomplete evacuation, straining at stool, urgency of bowel movement, passage of gas and mucus, and bowel habit satisfaction were assessed. B. coagulans Unique IS2 treated group showed a greater reduction in pain scores

2018 Beneficial microbes Controlled trial quality: predicted high

140. Letter to the Editor regarding Kolk et al: "Does acromioplasty result in favorable clinical and radiologic outcomes in the management of chronic subacromial pain syndrome? A double-blinded clinical trial with 9 to 14 years' follow-up". (PubMed)

Letter to the Editor regarding Kolk et al: "Does acromioplasty result in favorable clinical and radiologic outcomes in the management of chronic subacromial pain syndrome? A double-blinded clinical trial with 9 to 14 years' follow-up". 29307673 2018 02 13 1532-6500 27 3 2018 Mar Journal of shoulder and elbow surgery J Shoulder Elbow Surg Letter to the Editor regarding Kolk et al: "Does acromioplasty result in favorable clinical and radiologic outcomes in the management of chronic subacromial (...) pain syndrome? A double-blinded clinical trial with 9 to 14 years' follow-up". e82-e83 S1058-2746(17)30746-2 10.1016/j.jse.2017.11.001 Hustedt Joshua W JW University of Arizona College of Medicine-Phoenix, Phoenix, AZ, USA. Harmsen Samuel M SM University of Arizona College of Medicine-Phoenix, Phoenix, AZ, USA; The Orthopedic Clinic Association, Phoenix, AZ, USA. Electronic address: gwsharmsen@gmail.com. Lederman Evan S ES University of Arizona College of Medicine-Phoenix, Phoenix, AZ, USA

2018 Journal of Shoulder and Elbow Surgery Controlled trial quality: uncertain

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