Ursodeoxycholic acid in neonatal sepsis-associated cholestasis

Background Sepsis-associated cholestasis (SAC) is an intrahepatic cholestasis caused by inflammatory cytokines. Patients with this condition have poor prognoses. Antibiotics are the mainstay of therapy, however, other adjuvant therapies, such as ursodeoxycholic acid (UDCA), have not been well established.Objective To assess the effect ofUDCA for treatment ofneonatal sepsis-associated cholestasis.Methods We performed a randomized, double-blind, controlled trial in 3 7 neonates who were diagnosed with sepsis-associated cholestasis in the Neonatal Care Unit of Cipto Mangunkusumo Hospital. Subjects were divided into two groups, with 19 neonates randomly allocated to the intervention group (received UDCA at 30 tngikg/day divided into 3 doses for 7 days) and 18 neonates to the control group (received placebo) . After 7 days of treatment, we evaluated the subjects' liver function parameters and performed asurvival analysis.Results Liver function parameter improvements at day 7 were not significantly different between the UDCA group and the control group, including for mean decrease of total bilirubin (TB) levels [2.2 (SD 2.9) mg/dL vs 1.7 (SD 4.6) mg/dL; P=0.080), mean decrease of direct bilirubin (DB) levels [1.1 (SD 2.3) mg/dL vs 0.6 (SD 3.6) mg/dL; P=0.080), median indirect bilirubin (lB) levels [0.4 (range 0.1- 5.6) mg/dL vs 0.9 (range 0.1-4.1) mg/dL; P=0.358) , mean decrease of alanine aminotransferase (ALT) levels [0.5 (-80.0 -21.0) U/L vs -2.0 (ranged -167 .0 - 85.0) U/L; P= 0.730), median aspartate aminotransferase (AST) levels [ 43 .0 (range 14.0-297 .0) U/L vs 150.0 (range 24.0-840.0) U/L; P=0.081), and median gamma-glutamyl transpeptidase (GGf) levels [125.0 (48.0-481.0) U/L vs 235.0 (56.0-456.0) U/L; P=0.108)). Five neonates in control group died compared to two in the UDCA group (P=0.232). In addition, UDCA did not significantly lengthen the survival time (hazard ratio/HR 3.62; 95%CI 0.69 to 18.77) .Conclusion Ursodeoxycholic acid tends to improve total bilirubin, direct bilirubin, and AST levels in sepsis associated cholestasis .

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Therapeutic Effects of Ursodeoxycholic Acid in Neonatal Indirect Hyperbilirubinemia; a Randomized Double-Blind Clinical Trial

Archives of Anesthesia and Critical Care ◽

10.18502/aacc.v5i3.1211 ◽

2019 ◽

Author(s):

Iraj Shahramian ◽

Kaveh Tabrizian ◽

Pouya Ostadrahimi ◽

Mahdi Afshari ◽

Mahdieh Soleymanifar ◽

...

Keyword(s):

Clinical Trial ◽

Ursodeoxycholic Acid ◽

Total Bilirubin ◽

Intervention Group ◽

Total Bilirubin Level ◽

Direct Bilirubin ◽

Therapeutic Effects ◽

Double Blind ◽

Double Blind Clinical Trial ◽

Double Blinded

Background: Ursodeoxycholic acid (UDCA) is a safe drug used in the treatment of cholestatic liver disorders in children. The aim of this study was to investigate the synergistic effect of UDCA in combination with phototherapy in treating indirect neonatal hyperbilirubinemia. Methods: Present double-blinded, randomized clinical trial was conducted among neonates with jaundice who were under treatment with phototherapy in the neonatal ward affiliated with the Zabol University of Medical Sciences in 2017. The patients (200 neonates) were randomly divided into intervention (phototherapy+ UDCA) and control (phototherapy alone) groups. The intervention group received 15 mg/kg UDCA daily. Results: Total bilirubin levels at birth, 24, 48, and 72 hours after therapy were 16.89± 2.49, 14.28± 2.05, 11.62± 2.46, and 10.26± 1.92 mg/dl in controls and 15.79± 2.18, 12.77± 1.86, 10.08± 1.66, and 8.94± 1.38 mg/dl in intervention group respectively (P< 0.001). The ratio of neonates with total bilirubin< 10 mg/dl were 28% and 55% after 48 hours, and 64% and 90% after 72 hours of therapy initiation in phototherapy alone and phototherapy+ UDCA groups respectively (P< 0.001). The mean reduction of direct bilirubin was not significantly different between the groups. Conclusion: UDCA was effective in accelerating reduction of total bilirubin level in neonates with unconjugated hyperbilirubinemia under phototherapy but had no effect on direct bilirubin levels.

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Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

European Respiratory Journal ◽

10.1183/13993003.00752-2021 ◽

2021 ◽

pp. 2100752

Author(s):

Pradeesh Sivapalan ◽

Charlotte Suppli Ulrik ◽

Therese Sophie Lapperre ◽

Rasmus Dahlin Bojesen ◽

Josefin Eklöf ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Safety Outcome ◽

Hospitalised Patients ◽

Double Blinded ◽

Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

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Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽

10.3390/md17030157 ◽

2019 ◽

Vol 17 (3) ◽

pp. 157 ◽

Cited By ~ 6

Author(s):

Young Tak ◽

Yun Kim ◽

Jeong Lee ◽

Yu-Hyun Yi ◽

Young Cho ◽

...

Keyword(s):

Body Fat ◽

Animal Studies ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Collagen Peptides ◽

Collagen Peptide ◽

Skin Collagen ◽

Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

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Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

10.21203/rs.3.rs-18733/v2 ◽

2020 ◽

Author(s):

Hadi Bazyar ◽

Ahmad Zare Javid ◽

Hossein Bavi Behbahani ◽

Fardin Moradi ◽

Bahman Moradi Poode ◽

...

Keyword(s):

Diabetes Mellitus ◽

Disease Risk ◽

Controlled Trial ◽

Cardiovascular Disease Risk ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Anthropometric Indices ◽

Double Blind ◽

Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

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Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

10.21203/rs.3.rs-36678/v1 ◽

2020 ◽

Author(s):

Ricard Carrillo Muñoz ◽

Jose Luis Ballve Moreno ◽

Ivan Villar Balboa ◽

Yolanda Rando Matos ◽

Oriol Cunillera Puertolas ◽

...

Keyword(s):

Primary Care ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Perceived Disability ◽

Randomised Controlled ◽

The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

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Positive Effect of Vitamin D and Magnesium Supplementation on Mental health Status of Attention-Deficit Hyperactive Children; A Randomized Double blind Controlled Clinical Trial

10.21203/rs.3.rs-52324/v1 ◽

2020 ◽

Author(s):

Mostafa Hemamy ◽

Naseh Pahlavani ◽

Gholamreza Askari ◽

Mahsa Malekahmadi

Keyword(s):

Mental Health ◽

Vitamin D ◽

Attention Deficit ◽

Controlled Trial ◽

Neurodevelopmental Disorder ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Magnesium Supplementation ◽

Double Blind

Abstract Background: Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in ADHD. The aim of this study is to determine the effect of Vitamin D and magnesium supplementation on mental health in children with ADHD.Method: This double‑blind, randomized controlled trial was performed on 66 ADHD children. participants were randomly allocated to receive both Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8 weeks. Strengths and difficulties questionnaire were used to evaluate children’s mental health at baseline and at the end of the study.Results: After 8 weeks of intervention, the serum levels of 25‑hydroxy‑Vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also a significant decrease in changes of emotional problems (p=0.001), conduct problems (p=0.002), peer problems (p=0.001), prosocial score (p=0.007), total difficulties (p=0.001), externalizing score (p=0.001), and internalizing score (p=0.001) was seen in intervention group at the end of study.Conclusion: Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation during 8-week could improve the behavioral function and mental health in ADHD. Although further well-designed studies with a larger sample size are needed.the IRCT registration: IRCT2016030326886N1.

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The Modified Hospital Elder Life Program (HELP) in geriatric hospitalized patients in internal wards: A double-blind randomized control trial

BMC Geriatrics ◽

10.1186/s12877-021-02520-3 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

A. Kojaie-Bidgoli ◽

F. Sharifi ◽

F. Maghsoud ◽

M. Alizadeh-Khoei ◽

F. Jafari ◽

...

Keyword(s):

Nursing Students ◽

Controlled Trial ◽

Intervention Group ◽

Confusion Assessment Method ◽

Aged Care ◽

Assessment Method ◽

Hospitalized Patients ◽

Control Group ◽

Double Blind ◽

Hospital Elder Life Program

Abstract Background Hospital Elder Life Program (HELP) provides protocols based on factors for reducing delirium. Due to the lack of geriatric wards and aged care teams in Iran, it seems that some of the original HELP interventions need to be modified through a trial study. Hence, this study was conducted to determine whether the Iranian modified HELP could reduce delirium in geriatric hospitalized patients. Methods This double-blind randomized controlled trial was designed and conducted in a hospital at Kashan University of Medical Sciences in Iran. A total of 195 hospitalized patients aged ≥70 years, were 84 in the Intervention Group (IG) and 111 in the Control Group (CG). After assessing delirium risk factors, participants in the IG group received interventions based on the cognitive, vision/hearing, sleep, mobility, feeding, and hydration protocols by nursing students and the CG group received routine care. Delirium incidence was assessed by the Confusion Assessment Method. Delirium incidence, cognitive and functional abilities, frailty, fall, and length of stay were outcomes. Results The mean age of the patients was 78.53(Standard Deviation = 5.87) years. Delirium incidence was higher in the CG comparing to IG (14.71% vs 3.66%).Significant reduction observed in risk incidence of delirium because of interventions [Odds Ratio:0.124, Confidence Interval: 0.03–0.48]. Conclusion The modified HELP effectively reduced delirium rates in geriatric hospitalized patients. Trial registration This study was registered at the Iranian Registry of Clinical Trials IRCT20180910040995N1.

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The effect of triclosan-coated sutures on the rate of surgical site infection after hip and knee arthroplasty: a double-blind randomized controlled trial of 2546 patients

The Bone & Joint Journal ◽

10.1302/0301-620x.100b3.bjj-2017-0247.r1 ◽

2018 ◽

Vol 100-B (3) ◽

pp. 296-302 ◽

Cited By ~ 22

Author(s):

A. P. Sprowson† ◽

C. Jensen ◽

N. Parsons ◽

P. Partington ◽

K. Emmerson ◽

...

Keyword(s):

Surgical Site Infection ◽

Knee Arthroplasty ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Site Infection ◽

Double Blind ◽

Suture Group ◽

Double Blinded ◽

Complication Of Surgery

AimsSurgical site infection (SSI) is a common complication of surgery with an incidence of about 1% in the United Kingdom. Sutures can lead to the development of a SSI, as micro-organisms can colonize the suture as it is implanted. Triclosan-coated sutures, being antimicrobical, were developed to reduce the rate of SSI. Our aim was to assess whether triclosan-coated sutures cause a reduction in SSIs following arthroplasty of the hip and knee.Patients and MethodsThis two-arm, parallel, double-blinded study involved 2546 patients undergoing elective total hip (THA) and total knee arthroplasty (TKA) at three hospitals. A total of 1323 were quasi-randomized to a standard suture group, and 1223 being quasi-randomized to the triclosan-coated suture group. The primary endpoint was the rate of SSI at 30 days postoperatively.ResultsThe baseline characteristics of age, gender and comorbidities were well matched in the two groups. The rates of superficial SSI were 0.8% in the control group and 0.7% in the intervention group (p = 0.651), and when deep and superficial SSIs were combined the rates were 2.5% and 1.8 (p = 0.266). The length of stay in hospital and the rates of medical complications did not differ significantly between the groups (p = 1.000).ConclusionThis trial provided no evidence that the use of triclosan-coated sutures at THA and TKA leads to a reduction in the rate of SSI. Cite this article: Bone Joint J 2018;100-B:296–302.

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Effects of Intravenous Lidocaine on Alfentanil Consumption During Procedural Sedation for Colonoscopy in Patients With Inflammatory Bowel Disease: a Randomized Controlled Trial

10.21203/rs.3.rs-50910/v1 ◽

2020 ◽

Author(s):

Twan Aalbers ◽

Sandra A.S. van den Heuvel ◽

Ewald M. Bronkhorst ◽

Aura A.J. van Esch ◽

Gert Jan Scheffer ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Primary Objective ◽

Procedural Sedation ◽

Controlled Study ◽

Control Group ◽

Double Blind ◽

Lidocaine Group ◽

Sedation And Analgesia ◽

Inflammatory Bowel

Abstract Background: Procedural sedation and analgesia (PSA) is used during colonoscopy to facilitate the procedure and relieve patient’s discomfort. The foremost risk of PSA is respiratory depression. Lidocaine could be a promising additional analgesic in IBD patients to minimise side effects of PSA.Our primary objective was to investigate whether i.v. lidocaine reduces the amount of alfentanil used during PSA in IBD patients. Additionally, we investigated whether lidocaine reduces cardiorespiratory incidents and the amount of propofol required during the procedure.Methods: A randomised, double-blind, placebo controlled study was performed at the endoscopy unit of the Radboud University Medical Centre from November 2016 to December 2018. Seventy-six patients with IBD, ASA 1 or 2, between 18 and 65 years, scheduled for colonoscopy with PSA were included. Patients received lidocaine 1.5 mg kg-1 followed by a continuous infusion of 2 mg kg-1 h-1 (intervention group, n=38) or 0.9% saline in equivalent volumes (control group, n=38) during colonoscopy.Results: There was a reduction in the use of alfentanil (327µg (95%CI=-31-505, p=0.082)), and propofol (39 mg (95%CI=-5-83, p=0.083)) in the lidocaine group compared with the control group. Ten patients (26%) in the control group and 8 patients in the lidocaine group (21%) experienced a period of hypoxia (p=0.788). In both groups, no periods of hypotension were noted.Conclusion: Our investigation has shown a reduction in the use of propofol and alfentanil in patients undergoing colonoscopy with PSA. The differences were not statistically significant. Lidocaine did not reduces the incidence of cardiorespiratory events.Trial registration:EudraCT, 2016-002210-46, registered 19 may 2016,https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002210-46/resultsISRCTN, ISRCTN47787339, retrospectively registered 6 February 2019, http://www.isrctn.com/ISRCTN47787339

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Osteopathic manipulative treatment to improve exclusive breast feeding at 1 month

Archives of Disease in Childhood - Fetal and Neonatal Edition ◽

10.1136/archdischild-2020-319219 ◽

2021 ◽

pp. fetalneonatal-2020-319219

Author(s):

Marie Danielo Jouhier ◽

Cécile Boscher ◽

Jean-Christophe Roze ◽

Nicolas Cailleau ◽

Frédéric Chaligne ◽

...

Keyword(s):

Breast Feeding ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Osteopathic Manipulative Treatment ◽

Breastfeeding Support ◽

Double Blind ◽

Exclusive Breast Feeding ◽

Breastfeeding Rate ◽

Suboptimal Breastfeeding

ObjectivePrevious studies have assessed breastfeeding-support programmes. Among these, osteopathic manipulative treatment (OMT) is a frequently used approach, although without strong evidence of efficacy.MethodsA double-blind randomised controlled trial was conducted between July 2013 and March 2016. Breastfed term infants were eligible if one of the following criteria was met: suboptimal breastfeeding behaviour, maternal cracked nipples or maternal pain. The infants were randomly assigned to the intervention or the control group. The intervention consisted of two sessions of early OMT, while in the control group, the manipulations were performed on a doll behind a screen. The primary outcome was the exclusive breastfeeding rate at 1 month, which was assessed in an intention-to-treat analysis. Randomisation was computer generated and only accessible to the osteopath practitioner. The parents, research assistants and paediatricians were masked to group assignment.ResultsOne hundred twenty-eight mother–infant dyads were randomised, with 64 assigned to each group. In each group, five infants were lost to follow-up. In the intervention group, 31 of 59 (53%) of infants were still exclusively breast fed at 1 month vs 39 of 59 (66%) in the control group, (OR 0.55, 95% CI 0.26 to 1.17; p=0.12). After adjustment for suboptimal breastfeeding behaviour, caesarean section, use of supplements and breast shields, the adjusted OR was 0.44 (95% CI 0.17 to 1.11; p=0.08). No adverse effects were reported in either group.ConclusionOMT did not improve exclusive breast feeding at 1 month.Trial registration numberNCT01890668.

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