Antithrombin Therapy for Severe Preeclampsia

2000 ◽  
Vol 84 (10) ◽  
pp. 583-590 ◽  
Author(s):  
Masahiro Maki ◽  
Toshihiko Terao ◽  
Tsuyomu Ikenoue ◽  
Kazuo Satoh ◽  
Masao Nakabayashi ◽  
...  
Keyword(s):  
Weight Gain ◽  
Perinatal Outcome ◽  
Controlled Trial ◽  
Severe Preeclampsia ◽  
Fetal Weight ◽  
Low Birth Weight Infants ◽  
Double Blind ◽  
Biophysical Profile ◽  
The Difference ◽  
Estimated Fetal Weight

SummaryA double-blind, randomized, placebo-controlled trial was conducted to evaluate whether treatment with Antithrombin (AT) concentrates improved the clinical and perinatal outcome in patients with severe preeclampsia. Severe preeclamptic patients (24 to 35 weeks of gestation, Gestosis Index (GI) > 6 points) were randomized into two groups: 66 received AT and 67 received placebo. There were no statistical differences in the clinical profiles of the two groups. Study drugs were given intravenously once daily for 7 consecutive days. Maternal symptoms were evaluated from the difference of GI between before and after treatment, and fetal findings were evaluated from the changes of the biophysical profile score and the estimated fetal weight gain. Improvement was significantly greater in the AT group for both the GI (p = 0.020) and the estimated fetal weight gain (p = 0.029). The improvement of coagulation parameters was also evaluated. The D-dimer levels increased significantly in the placebo group (p = 0.026), but did not change in the AT group. Gestation was significantly prolonged (p = 0.007), and the number of low-birth weight infants was significantly smaller (p = 0.011) in the AT group. No adverse events related to AT were observed. It is revealed that AT concentrate therapy for preeclampsia is effective and safe, leading to an improved perinatal outcome.

scholarly journals Asenapine for the treatment of adults with an acute exacerbation of schizophrenia: results from a randomized, double-blind, fixed-dose, placebo-controlled trial with olanzapine as an active control

CNS Spectrums ◽  
2016 ◽  
Vol 22 (4) ◽  
pp. 333-341 ◽  
Author(s):  
Ronald Landbloom ◽  
Mary Mackle ◽  
Xiao Wu ◽  
Linda Kelly ◽  
Linda Snow-Adami ◽  
...  
Keyword(s):  
Weight Gain ◽  
Acute Exacerbation ◽  
Controlled Trial ◽  
Primary Objective ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Text Revision ◽  
Syndrome Scale ◽  
The Difference

ObjectiveEvaluate the efficacy and safety of asenapine 2.5 mg twice daily (bid; n=97) or 5 mg bid (n=113) versus placebo (n=101) in adults with acute exacerbation of schizophrenia.MethodsAdults with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) schizophrenia diagnosis were randomized to asenapine 2.5 mg bid, 5 mg bid, placebo, or olanzapine 15 mg once daily. The primary objective was to test superiority of asenapine versus placebo as measured by the change from baseline to day 42 in the Positive and Negative Syndrome Scale (PANSS) total score. The key safety objective was to evaluate weight change in asenapine versus olanzapine at day 42.ResultsThe primary efficacy endpoint was met; the difference in least squares mean change from baseline to day 42 in PANSS total score between asenapine 5 mg bid and placebo was −5.5 points (unadjusted 95% CI: −10.1, −1.0; multiplicity adjusted P=0.0356). Neither asenapine 2.5 mg bid nor olanzapine 15mg were superior to placebo.Both asenapine groups demonstrated significantly less weight gain than olanzapine at day 42. Significantly higher incidences of oral hypoesthesia and dysgeusia (combined) for asenapine 2.5 mg bid (5.2% vs 0.0%; P=0.0217) and 5 mg bid (7.1% vs 0.0%; P=0.0033) were observed versus placebo. There were no significant differences between asenapine and placebo for insomnia, extrapyramidal symptoms, akathisia, dizziness, or combination of somnolence/sedation/hypersomnia.ConclusionThis study supports previous efficacy and safety findings of asenapine; asenapine 5 mg bid is the lowest effective dose in adults with schizophrenia. Asenapine was associated with significantly less weight gain than olanzapine at day 42.

scholarly journals A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer’s dementia

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Shifu Xiao ◽  
Piu Chan ◽  
Tao Wang ◽  
Zhen Hong ◽  
Shuzhen Wang ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Controlled Trial ◽  
Drug Effects ◽  
Disease Assessment ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
The Difference

Abstract Background New therapies are urgently needed for Alzheimer’s disease (AD). Sodium oligomannate (GV-971) is a marine-derived oligosaccharide with a novel proposed mechanism of action. The first phase 3 clinical trial of GV-971 has been completed in China. Methods We conducted a phase 3, double-blind, placebo-controlled trial in participants with mild-to-moderate AD to assess GV-971 efficacy and safety. Participants were randomized to placebo or GV-971 (900 mg) for 36 weeks. The primary outcome was the drug-placebo difference in change from baseline on the 12-item cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog12). Secondary endpoints were drug-placebo differences on the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, and Neuropsychiatric Inventory (NPI). Safety and tolerability were monitored. Results A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. Conclusions GV-971 demonstrated significant efficacy in improving cognition with sustained improvement across all observation periods of a 36-week trial. GV-971 was safe and well-tolerated. Trial registration ClinicalTrials.gov, NCT02293915. Registered on November 19, 2014

scholarly journals A double-blind randomized controlled trial of topical Curcuma xanthorrhiza Roxb. on mild psoriasis: clinical manifestations, histopathological features, and K6 expressions

2018 ◽  
Vol 27 (3) ◽  
pp. 178-84 ◽  
Author(s):  
Githa Rahmayunita ◽  
Tjut N.A. Jacoeb ◽  
Endi Novianto ◽  
Wresti Indriatmi ◽  
Rahadi Rihatmadja ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinical Manifestations ◽  
Effective Treatment Option ◽  
Psoriasis Area Severity Index ◽  
Double Blind ◽  
Old Patients ◽  
Mean Values ◽  
Significant Difference ◽  
Curcuma Xanthorrhiza ◽  
The Difference

Background: Curcuma xanthorrhiza Roxb. exerts its anti-inflammatory effects by reducing the concentration of IL-6, IL-8, and phosphorylase kinase, which has role in keratinocyte proliferation. Our study aimed to evaluate the efficacy of C. xanthorrhiza in psoriasis.Methods: From 18 to 59 year-old patients with mild psoriasis, 2 similar lesions were selected. The severity assessment was based on the psoriasis area severity index (PASI), Trozak score, and K6 expression. Using a double-blinded randomized method, lesion was treated with 1% C. xanthorrhiza ointment vs placebo for 4 weeks. The results were analyzed by the chi-square test using STATATM V.12 software (Stata Corp.).Results: The study was conducted in 2010 to 2012 with 17 subjects participated. The median of PASI score were reduced significantly in both lesions, either treated with 1% C. xanthorrhiza ointment vs placebo; however when compared between the group, it was not significant (p=0.520). The Trozak score were reduced in lesions treated with 1% C. xanthorrhiza ointment; but it was not significant (p = 0.306). In lesions treated with placebo, the Trozak score was increased significantly. The difference of Trozak score between lesions treated with C. xanthorrhiza and placebo was significant (p=0.024). There was no significant difference of K6 expression in lesions treated with 1% C. xanthorrhiza ointments or placebo as well as on the difference of mean values of K6 expression between the group (p=0.827).Conclusion: Based on the results, 1% C. xanthorrhiza ointment is effective treatment option for mild psoriasis, but longer follow-up period is suggested to confirm this results. C. xanthorrhiza ointment is safe for topical administration as there were no side effects reported in this study.

scholarly journals Metformin for Prevention of Weight Gain and Insulin Resistance with Olanzapine: A Double-Blind Placebo-Controlled Trial

2006 ◽  
Vol 51 (3) ◽  
pp. 192-196 ◽  
Author(s):  
Trino Baptista ◽  
Jessan Martínez ◽  
Anny Lacruz ◽  
Nairy Rangel ◽  
Serge Beaulieu ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Weight Gain ◽  
Controlled Trial ◽  
Double Blind ◽  
Double Blind Placebo

scholarly journals CoMET: a protocol for a randomised controlled trial of co-commencement of METformin as an adjunctive treatment to attenuate weight gain and metabolic syndrome in patients with schizophrenia newly commenced on clozapine

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e021000 ◽  
Author(s):  
Dan Siskind ◽  
Nadia Friend ◽  
Anthony Russell ◽  
John J McGrath ◽  
Carmen Lim ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Body Weight ◽  
Weight Gain ◽  
Controlled Trial ◽  
Adjunctive Treatment ◽  
Double Blind ◽  
Human Research Ethics ◽  
Increased Risk ◽  
Point Body ◽  
Randomised Controlled

IntroductionClozapine, while effective in treatment refractory schizophrenia, is associated with significant weight gain, heart disease and increased risk of type 2 diabetes mellitus (T2DM). Although there is evidence for weight loss with metformin for people with obesity who are already taking clozapine, there have been no published trials that have investigated the effect of metformin in attenuating weight gain at the time of clozapine initiation.Methods and analysisA 24-week double-blind placebo-controlled trial of concomitant prescription of metformin at clozapine commencement. Eighty-six people being commenced on clozapine will be randomised to placebo or metformin (variable dose, up to 2 g/day). The primary outcome is comparative end point body weight, between the placebo and metformin groups. Secondary outcomes are comparative rates of conversion to T2DM, alteration of metabolic syndrome parameters, proportion gaining >5% body weight and changes in diet and appetite. We will additionally examine biomarkers associated with change in weight among trial participants.Ethics and disseminationEthics approval was granted by the Metro South Human Research Ethics Committee HREC/17/QPAH/538-SSA/17/QPAH/565. We plan to submit a manuscript of the results to a peer-reviewed journal, and present results at conferences, consumer forums and hospital grand rounds.Trial registration numberACTRN12617001547336; Pre-results.

Intertwin estimated fetal weight or crown rump length discordance and adverse perinatal outcome

2016 ◽  
Vol 44 (8) ◽  
Author(s):  
Apostolos Kaponis ◽  
Nikolaos Thanatsis ◽  
Vassilis Papadopoulos ◽  
George Decavalas
Keyword(s):  
Perinatal Outcome ◽  
Adverse Outcomes ◽  
Fetal Weight ◽  
Crown Rump Length ◽  
Adverse Perinatal Outcome ◽  
Structural Abnormalities ◽  
Gestational Age At Delivery ◽  
Review Study ◽  
Estimated Fetal Weight ◽  
Threshold Range

AbstractAim:In the current review study, we present recent data regarding the importance of intertwin estimated fetal weight (EFW) and crown rump length (CRL) discordance for the prediction of adverse perinatal outcome both in monochorionic and in dichorionic diamniotic gestations.Results:Twins with significant weight disparity are associated with higher rates of perinatal morbidity and mortality, regardless of gestational age at delivery. However, there is no agreement regarding as to the cut off value above which the perinatal outcome is unfavorably affected and the threshold range from 10 to 30%. On the other hand, CRL discrepancy has proved to be a weak predictor of adverse outcomes, such as fetal or neonatal death in fetuses without chromosomal and structural abnormalities. In clinical practice, decisions about obstetric surveillance of discordant twin gestations, frequency of fetal sonographic monitoring and time of delivery are usually based on amniotic fluid volume and Doppler assessments on a weekly basis.Conclusion:Significant EFW discordance leads to adverse perinatal outcome, although the cut-off value has not yet been estimated. CRL discrepancy is not correlated well with adverse perinatal outcome. However, increased monitoring of women with EFW and CRL discrepancy is suggested.

scholarly journals The Evaluation of the Body Weight Lowering Effects of Herbal Extract THI on Exercising Healthy Overweight Humans: A Randomized Double-Blind, Placebo-Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Soo Hyun Cho ◽  
Yoosik Yoon ◽  
Young Yang
Keyword(s):  
Body Weight ◽  
Controlled Trial ◽  
Safety Evaluation ◽  
Hdl Cholesterol ◽  
Treated Group ◽  
The Body ◽  
Herbal Extract ◽  
Double Blind ◽  
The Difference ◽  
Group 2

We investigated the effects of herbal extracts, a mixture of Scutellariae Radix and Platycodi Radix containing the active ingredients Baicalin and Saponin (target herbal ingredient (THI)), on lowering body weight. The present study was a prospective, randomized, double-blind, and placebo-controlled trial carried out at the outpatient department of a hospital over a period of 2 months. Group 1 patients (n=30) received THI, and group 2 patients (n=23) received placebo three times a day before meals. Weight, waist circumference, BMI, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and glucose were measured at baseline and again at the 2nd month. For safety evaluation, various hematological and biochemical parameters were assessed. Values of mean change of weight in the THI-treated group were−1.16±1.41 kg and in the placebo-treated group were−0.24±1.70 kg, respectively. The difference in mean change of weight in the THI-treated group compared with that in the placebo-treated group was statistically significant (P<0.05). The incidence of subjective and objective adverse drug reactions was insignificant (P>0.05). THI was statistically significant in its effectiveness on the weight loss.

Effect of prebiotic (fructooligosaccharide) on uremic toxins of chronic kidney disease patients: a randomized controlled trial

2018 ◽  
Vol 34 (11) ◽  
pp. 1876-1884 ◽  
Author(s):  
Christiane Ishikawa Ramos ◽  
Rachel Gatti Armani ◽  
Maria Eugenia Fernandes Canziani ◽  
Maria Aparecida Dalboni ◽  
Carla Juliana Ribeiro Dolenga ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Uremic Toxins ◽  
Trophic Factors ◽  
Secondary Outcome ◽  
Model Assessment ◽  
Double Blind ◽  
The Difference

Abstract Background Microbial-derived uremic toxins, p-cresyl sulfate (PCS), indoxyl sulfate (IS) and indole 3-acetic acid (IAA), have been associated with the burden of chronic kidney disease (CKD). Prebiotics have emerged as an alternative to modulate the gut environment and to attenuate toxin production. This trial aims to investigate the effect of a prebiotic fructooligosaccharide (FOS) on uremic toxins of non-dialysis-dependent CKD (NDD-CKD) patients. Methods A double-blind, placebo-controlled, randomized trial was conducted for 3 months. In all, 50 nondiabetic NDD-CKD patients [estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2], aged 18–80 years, were allocated to prebiotic (FOS, 12 g/day) or placebo (maltodextrin, 12 g/day) groups. Primary outcomes were changes in serum (total and free) and urinary (total) PCS. Secondary outcomes included changes in IS, IAA, serum markers of intestinal permeability (zonulin), gut-trophic factors (epidermal growth factor and glucagon-like peptide-2), eGFR, inflammation (high sensitive c-reactive protein and interleukin-6), homeostatic model assessment-insulin resistance, lipid profile and gastrointestinal symptoms. Results From 50 participants (54% men, 57.3 ± 14.6 years and eGFR 21.4 ± 7.6 mL/min/1.73 m2), 46 completed the follow-up. No changes in dietary intake or gastrointestinal symptoms were observed. There was a trend in the difference of serum total ΔPCS (treatment effect adjusted for baseline levels: −12.4 mg/L; 95% confidence interval (−5.6 to 0.9 mg/L; P = 0.07) and serum-free Δ%PCS [intervention −8.6 (−41.5 to 13.9%) versus placebo 3.5 (−28.8 to 85.5%); P = 0.07] between the groups. The trend in the difference of serum total ΔPCS was independent of eGFR and dietary protein:fiber ratio intake. No difference was found in urinary PCS. Aside from the decreased high-density lipoprotein cholesterol in the intervention, no differences were observed in the change of IS, IAA or other secondary outcome between the groups. Conclusions Our result suggests the potential of FOS in reducing serum total and free PCS in nondiabetic NDD-CKD patients.

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