scholarly journals Efficacy and safety of chloroquine or hydroxychloroquine in moderate type of COVID-19: a prospective open-label randomized controlled study

2020 ◽  
Author(s):  
Lan Chen ◽  
Zhen-Yu Zhang ◽  
Jian-Guo Fu ◽  
Zhi-Peng Feng ◽  
Su-Zhen Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Oral Treatment ◽  
Drug Repurposing ◽  
Control Treatment ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Duration Of Hospitalization ◽  
Novel Coronavirus ◽  
And Control

ABSTRACTThe outbreak of novel coronavirus disease 2019 (COVID-19) has become a pandemic. Drug repurposing may represent a rapid way to fill the urgent need for effective treatment. We evaluated the clinical utility of chloroquine and hydroxychloroquine in treating COVID-19.Forty-eight patients with moderate COVID-19 were randomized to oral treatment with chloroquine (1000 mg QD on Day 1, then 500 mg QD for 9 days; n=18), hydroxychloroquine (200 mg BID for 10 days; n=18), or control treatment (n=12).Adverse events were mild, except for one case of Grade 2 ALT elevation. Adverse events were more commonly observed in the chloroquine group (44.44%) and the hydroxychloroquine group (50.00%) than in the control group (16.67%). The chloroquine group achieved shorter time to clinical recovery (TTCR) than the control group (P=0.019). There was a trend toward reduced TTCR in the hydroxychloroquine group (P=0.049). The time to reach viral RNA negativity was significantly faster in the chloroquine group and the hydroxychloroquine group than in the control group (P=0.006 and P=0.010, respectively). The median numbers of days to reach RNA negativity in the chloroquine, hydroxychloroquine, and control groups was 2.5 (IQR: 2.0-3.8) days, 2.0 (IQR: 2.0-3.5) days, and 7.0 (IQR: 3.0-10.0) days, respectively. The chloroquine and hydroxychloroquine groups also showed trends toward improvement in the duration of hospitalization and findings on lung computerized tomography (CT). This study provides evidence that (hydroxy)chloroquine may be used effectively in treating moderate COVID-19 and supports larger trials.

scholarly journals Renoprotective effects of canagliflozin, a sodium glucose cotransporter 2 inhibitor, in type 2 diabetes patients with chronic kidney disease: A randomized open-label prospective trial

2018 ◽  
Vol 15 (5) ◽  
pp. 469-472 ◽  
Author(s):  
Hiroyuki Takashima ◽  
Yoshinori Yoshida ◽  
Chinami Nagura ◽  
Tetsuya Furukawa ◽  
Ritsukou Tei ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Adverse Events ◽  
Prospective Trial ◽  
Control Group ◽  
Open Label ◽  
And Control ◽  
Diabetes Patients

Background: To evaluate the renoprotective effects of canagliflozin, we assessed the albuminuria-lowering effect in Japanese type 2 diabetes patients with chronic kidney disease (CKD). Methods: In this prospective, open-label, parallel-group study, type 2 diabetes patients with CKD were randomized to receive either oral canagliflozin (100 mg/day) or usual care (control group) for 52 weeks. Endpoints included changes in urinary albumin-to-creatinine ratio (UACR), other urinary biomarkers, laboratory parameters, and adverse events. Results: Both groups included 20 patients in the analysis. Mean changes in UACR was −83 (−266 to −31) mg/gCr and 27 (−11 to 131) mg/gCr, in the canagliflozin and control groups, respectively ( p = 0.004). Urinary liver-type free acid binding protein, N-acetyl-β-d-glucosaminidase, and β2-microglobulin levels were also significantly decreased in the canagliflozin group, but not in the control group. Mean change in estimated glomerular filtration rate at the end of the study was 0.7 and −3.4 mL/min/1.73 m2 in the canagliflozin and control group, respectively ( p = 0.024). Canagliflozin treatment led to improvement of glycaemic control and reduction in body weight, blood pressure, and liver transaminase. There were no adverse events associated with canagliflozin. Conclusion: Canagliflozin was associated with slower progression of kidney disease and reduction in albuminuria and tubulointerstitial markers in diabetes patients with CKD.

A randomized phase III/IV study to determine benefit and safety of cytarabine liposome injection for treatment of neoplastic meningitis

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1528-1528 ◽  
Author(s):  
W. R. Shapiro ◽  
M. Schmid ◽  
M. Glantz ◽  
J. J. Miller
Keyword(s):  
Cox Regression ◽  
Neoplastic Meningitis ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Controlled Study ◽  
Control Group ◽  
Patient Benefit ◽  
Open Label ◽  
Cox Regression Analysis ◽  
And Control

1528 Background: Cytarabine liposome injection (CLI) maintains cytotoxic concentrations in the cerebral spinal fluid (CSF) for >14 days with a single 50 mg dose. This study compared patient benefit and safety of intrathecal CLI with methotrexate (MTX) or nonliposomal cytarabine (Cyt) against solid tumor neoplastic meningitis (STNM) and lymphomatous neoplastic meningitis (LNM), respectively. Methods: This multicenter, randomized, open-label, active-controlled study was powered to detect a 50% hazard ratio for progression-free survival (PFS; i.e., days from randomization to neurological progression or death) in STNM patients. STNM patients (n=103) were randomized to CLI or MTX and LNM patients (n=25) to CLI or Cyt. Patients had either histologically documented STNM or LNM confirmed by ventricular or lumbar CSF cytology or symptomatic meningeal tumor verified by magnetic resonance imaging or computed tomography. CLI treatment consisted of 6 Induction Cycles (2 weeks per cycle) and 4 Maintenance Cycles (4 weeks per cycle). Results: By per-protocol Cox regression analysis, CLI (STNM and LNM combined) was noninferior to MTX and Cyt combined (Control Group). The median PFS was 35 days and 43 days (p=0.7321), respectively; the hazard ratio (95% CI) was 0.98 (0.65, 1.46). CLI was also noninferior to MTX in the STNM group, where the hazard ratio was 0.94 (0.58; 1.53). In the LNM group, superiority of CLI over Cyt was demonstrated a hazard ratio of 0.12 (0.02, 0.77). Median PFS was 34 and 50 days, respectively. More LNM patients had complete response (clearance of tumor cells from CSF) with CLI (33.3%) than with Cyt (16.7%; p=0.3640). All patients experienced AEs; 48% and 60% of the patients in CLI and Control Group, respectively, experienced drug-related AEs. The incidence of serious AEs was 86% and 77%, respectively. Conclusions: These results demonstrate at least comparable patient benefit between CLI and control treatments for STNM and improved benefit for CLI in LNM patients. Intrathecal CLI provides patients with the added convenience of bimonthly treatment. [Table: see text]

Advances in the use of electrospun nanofibrous polymeric matrix for dermal healing at the donor site after the split-thickness skin graft excision: a prospective, randomized, controlled, open-label, multicenter study

2021 ◽  
Author(s):  
Josef Haik ◽  
Yehuda Ullman ◽  
Eyal Gur ◽  
Dean Ad-El ◽  
Dana Egozi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Skin Graft ◽  
Wound Care ◽  
Donor Site ◽  
Control Group ◽  
Split Thickness Skin Graft ◽  
Open Label ◽  
Thickness Skin ◽  
And Control

Abstract Dressings used to manage donor site wounds have up to 40% of patients experiencing complications that may cause suboptimal scarring. We evaluated the efficacy and safety of a portable electrospun nanofibrous matrix that provides contactless management of donor site wounds compared with standard dressing techniques. This study included adult patients who underwent an excised split-thickness skin graft with a donor site wound area of 10-200 cm 2. Patients were allocated into two groups; i.e., the nanofiber group managed with a nanofibrous polymer-based matrix, and the control group managed using the standard of care such as Jelonet® or Biatain® Ibu dressing. Primary outcomes were postoperative dermal healing efficacy assessed by Draize scores. The time to complete re-epithelialization was also recorded. Secondary outcomes included postoperative adverse events, pain, and infections during the first 21-days and extended 12-month follow-up. The itching and scarring were recorded during the extended follow-up (months 1,3,6,9,12) using Numerical-Analogue-Score and Vancouver scores, respectively. The nanofiber and control groups included 21 and 20 patients, respectively. The Draize dermal irritation scores were significantly lower in the nanofiber vs. control group (Z=-2.509; P=0.028) on the first postoperative day but became similar afterward (Z≥-1.62; P≥0.198). In addition, the average time to re-epithelialization was similar in the nanofiber (17.9±4.4 days) and control group (18.3±4.5 days) (Z=-0.299; P=0.764), so were postoperative adverse events, pain, and infection incidence, itching and scarring. The safety and efficacy of electrospun nanofibrous matrix are similar to standard wound care allowing its use as an alternative donor site dressing following the split-thickness skin graft excision.

scholarly journals Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e028197 ◽  
Author(s):  
Oliver Hendricks ◽  
Tonny Elmose Andersen ◽  
Afshin Ashouri Christiansen ◽  
Jette Primdahl ◽  
Ellen Margrethe Hauge ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Ankylosing Spondylitis ◽  
Pain Treatment ◽  
Oral Treatment ◽  
Controlled Study ◽  
Control Group ◽  
Efficacy And Safety ◽  
Medical Cannabis ◽  
Open Label ◽  
Pain Mechanisms

IntroductionRheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity.Methods and analysisA double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan.Ethics and disseminationThe Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

scholarly journals The effect of short-term use of finasteride versus cyproterone acetate on perioperative blood loss with monopolar transurethral resection of prostate

2021 ◽  
Vol 27 (1) ◽  
Author(s):  
Shabieb A. Abdelbaki ◽  
Adel Al-Falah ◽  
Mohamed Alhefnawy ◽  
Ahmed Abozeid ◽  
Abdallah Fathi
Keyword(s):  
Blood Loss ◽  
Transurethral Resection ◽  
Cyproterone Acetate ◽  
Histopathological Examination ◽  
Microvascular Density ◽  
Controlled Study ◽  
Control Group ◽  
Transurethral Resection Of Prostate ◽  
Perioperative Bleeding ◽  
And Control

Abstract Background Perioperative bleeding is the most common complication related to transurethral resection of prostate; the aim of the study was to compare the effect of pre-operative use of finasteride versus cyproterone acetate (CPA) on blood loss with monopolar TURP. Methods This prospective randomized controlled study was conducted on (60) patients with BPH underwent monopolar TURP between July 2019 and July 2020. Patients were distributed into three equal groups; CPA group: 20 patients received cyproterone acetate 50 mg tab BID for two weeks before TURP, finasteride group: 20 patients received single daily dose of finasteride 5 mg for two weeks before TURP, control group: 20 patients received no treatment before TURP, all patients underwent monopolar TURP, and then histopathological examination of the resected tissues was done with assessment of the microvascular density of the prostate. Results Our study showed that there was significant decrease in intraoperative blood loss and operative time in CPA and finasteride groups in comparison with control group (p = 0.0012) (p < 0.0001), respectively, significant decrease in post-operative Hb and HCT value in finasteride and control groups in comparison with CPA group (p < 0.01), significant increase in specimen weight in CPA group compared to other groups (p < 0.01), and there was also significant decrease in microvascular density in CPA group in comparison with other groups (p < 0.01). Conclusion Cyproterone acetate is more effective than finasteride in decreasing perioperative bleeding with TURP by decreasing microvascular density of the prostate.

scholarly journals Open-Label Evaluation of Eteplirsen in Patients with Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping: PROMOVI Trial

2021 ◽  
pp. 1-13
Author(s):  
Craig M. McDonald ◽  
Perry B. Shieh ◽  
Hoda Z. Abdel-Hamid ◽  
Anne M. Connolly ◽  
Emma Ciafaloni ◽  
...  
Keyword(s):  
Duchenne Muscular Dystrophy ◽  
Muscular Dystrophy ◽  
Natural History ◽  
Adverse Events ◽  
Exon Skipping ◽  
Control Group ◽  
Phase 2 ◽  
Open Label ◽  
M Phase ◽  
Positive Treatment

Background Eteplirsen received accelerated FDA approval for treatment of Duchenne muscular dystrophy (DMD) with mutations amenable to exon 51 skipping, based on demonstrated dystrophin production. Objective To report results from PROMOVI, a phase 3, multicenter, open-label study evaluating efficacy and safety of eteplirsen in a larger cohort. Methods Ambulatory patients aged 7–16 years, with confirmed mutations amenable to exon 51 skipping, received eteplirsen 30 mg/kg/week intravenously for 96 weeks. An untreated cohort with DMD not amenable to exon 51 skipping was also enrolled. Results 78/79 eteplirsen-treated patients completed 96 weeks of treatment. 15/30 untreated patients completed the study; this cohort was considered an inappropriate control group because of genotype-driven differences in clinical trajectory. At Week 96, eteplirsen-treated patients showed increased exon skipping (18.7-fold) and dystrophin protein (7-fold) versus baseline. Post-hoc comparisons with patients from eteplirsen phase 2 studies (4658-201/202) and mutation-matched external natural history controls confirmed previous results, suggesting clinically notable attenuation of decline on the 6-minute walk test over 96 weeks (PROMOVI: –68.9 m; phase 2 studies: –67.3 m; external controls: –133.8 m) and significant attenuation of percent predicted forced vital capacity annual decline (PROMOVI: –3.3%, phase 2 studies: –2.2%, external controls: –6.0%; p <  0.001). Adverse events were generally mild to moderate and unrelated to eteplirsen. Most frequent treatment-related adverse events were headache and vomiting; none led to treatment discontinuation. Conclusions This large, multicenter study contributes to the growing body of evidence for eteplirsen, confirming a positive treatment effect, favorable safety profile, and slowing of disease progression versus natural history.

scholarly journals Remdesivir Treatment for COVID 19 in Pregnant Patients with Moderate to Severe Symptoms: Serial Case Report

2021 ◽  
Vol 13 (2) ◽  
pp. 437-443
Author(s):  
Yudianto Budi Saroyo ◽  
Amanda Rumondang ◽  
Irene Sinta Febriana ◽  
Achmad Kemal Harzif ◽  
Rima Irwinda
Keyword(s):  
Adverse Effects ◽  
Adverse Events ◽  
Pregnant Women ◽  
Clinical Symptoms ◽  
Recovery Period ◽  
Rapid Improvement ◽  
Major Health Problem ◽  
Hospitalization Period ◽  
Duration Of Hospitalization ◽  
Novel Coronavirus

Introduction: Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) infection that causes novel Coronavirus Disease 2019 (COVID-19) has become a major health problem worldwide and been declared a pandemic since March 2020 by WHO. One special population that poses a challenge is pregnant women with COVID-19. There have not been many studies related to COVID-19 in pregnancy. In this study, we present five serial cases of Remdesivir treatment for COVID-19 in pregnant women with moderate to severe symptoms. Case Illustration: We briefly describe five serial cases being treated with Remdesivir therapy during hospitalization. Four cases were delivered by cesarean section, and one was delivered vaginally in gestation week 37. All cases showed a shortened duration of hospitalization, rapid improvement in clinical symptoms, and no adverse events were observed in mothers, fetuses, and neonates. Discussion: Remdesivir, an inhibitor RNA Polymerase, has been used in COVID-19 treatment and is known to shorten recovery time in nonpregnant women. Some studies have shown no adverse effects on Remdesivir for pregnant women. Based on randomized control trial (RCT) during the Ebola epidemic, Remdesivir was safe to use for pregnant women. All cases showed reduced hospitalization time and better clinical outcomes without maternal, fetal, or neonatal adverse events. Conclusion: Remdesivir protocol for pregnant women with moderate to severe symptoms of COVID-19 has resulted in better clinical improvement with a shorter recovery period and no adverse effects during the hospitalization period. Further studies and RCT are warranted to evaluate the biosafety and effects of Remdesivir in pregnant women.

Outcome of lymph node tuberculosis management with conventional treatment with and without prednisolone

2021 ◽  
pp. 004947552098474
Author(s):  
Arjuman Sharmin ◽  
Ali Hossain ◽  
Nazmul Islam ◽  
Zakir H Sarker ◽  
Sheikh S Hossain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lymph Node ◽  
Complete Resolution ◽  
Conventional Treatment ◽  
Symptomatic Improvement ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Lymph Node Tuberculosis ◽  
And Control

The outcome of lymph node tuberculosis (LNTB) management with conventional anti-tubercular treatment alone is unsatisfactory. We conducted a randomised open-label controlled clinical trial in the Department of Respiratory Medicine in Government Institute of Dhaka, Bangladesh from April 2017 to March 2019. Compared with controls, 54 patients of LNTB received category 1 anti-tubercular treatment with additional prednisolone after randomisation. Complete resolution in 21/54 (75%) and 7 (26.9%), symptomatic improvement in 26 (92.9%) and 22 (84.6%) and complications in 11 (39.28%) and 16 (61.53%) were observed in the treatment and control group, respectively. Thus, we recommend the use of steroids in this setting.

Effect of Aerosol Inhalation of Budesonide Suspension on Clinical Efficacy, Remission Time of Asthma and Disappearance Time of Rales in Children with Mycoplasma Pneumoniae Pneumonia

2021 ◽  
Vol 7 (5) ◽  
pp. 3057-3062
Author(s):  
TingTing Zheng ◽  
XiNi Liu ◽  
Xuechun Chen
Keyword(s):  
Mycoplasma Pneumoniae ◽  
Clinical Efficacy ◽  
Oral Treatment ◽  
Control Group ◽  
Study Group ◽  
Aerosol Inhalation ◽  
Significant Difference ◽  
Disappearance Time ◽  
And Control ◽  
Mycoplasma Pneumoniae Pneumonia

To investigate the effect of aerosol inhalation of budesonide suspension on clinical efficacy, remission time of asthma and disappearance time of rales in children with mycoplasma pneumoniae pneumonia. Methods: 100 cases of mycoplasma pneumoniae pneumonia in our hospital from February 2019 to February 2021 were randomly divided into study group (n = 50) and control group (n = 50). The control group was given azithromycin intravenous drip followed by oral treatment, and the study group was given aerosol inhalation of budesonide suspension on the basis of the control group. Results: Compared with the control group, disappearance time of rales in the study group, remission time of cough, remission time of asthma and time of hospitalization in the study group were relatively short (P<0.05), and the efficacy in the study group was relatively high (P<0.05). There was no significant difference in the incidence of nausea, vomiting, abdominal pain, diarrhea and hoarseness between the two groups (P>0.05). The improvement of FVCS FEV1 and PEF and other indexes was relatively high in the study group by comparing with the control group (P<0.05). Conclusion: Aerosol inhalation of budesonide suspension in children with mycoplasma pneumoniae pneumonia can effectively enhance the therapeutic effect, promote the improvement of lung function, and reduce the disappearance time of rales and remission time of asthma, so it can be popularized.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

2018 ◽  
Vol 2018 ◽  
pp. 1-15
Author(s):  
Ranran Chen ◽  
Dianrong Song ◽  
Wei Zhang ◽  
Guanwei Fan ◽  
Yingqiang Zhao ◽  
...  
Keyword(s):  
Drug Withdrawal ◽  
Endometrial Thickness ◽  
Vaginal Epithelium ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vulvovaginal Atrophy ◽  
Normal Ranges ◽  
And Control

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.

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