scholarly journals A randomized clinical trial on the effects of remote intercessory prayer in the adverse outcomes of pregnancies

2013 ◽  
Vol 18 (8) ◽  
pp. 2379-2384 ◽  
Author(s):  
Maria Inês da Rosa ◽  
Fabio Rosa Silva ◽  
Bruno Rosa Silva ◽  
Luciana Carvalho Costa ◽  
Angela Mendes Bergamo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Randomized Clinical Trial ◽  
Care Service ◽  
Health Care Service ◽  
Adverse Outcomes ◽  
Public Health Care ◽  
Intercessory Prayer ◽  
Control Group ◽  
Double Blind

The scope of this article was to investigate whether intercessory prayer (IP) influences the adverse outcomes of pregnancies. A double-blind, randomized clinical trial was conducted with 564 pregnant women attending a prenatal public health care service. The women were randomly assigned to an IP group or to a control group (n = 289 per group). They were simultaneously and randomly assigned to practice prayer off-site or not. The following parameters were evaluated: Apgar scores, type of delivery and birth weight. The mean age of the women was 25.1 years of age (± 7.4), and the average gestational age was 23.4 weeks (± 8.1). The average number of years of schooling for the women was 8.1 years (± 3.1). The women in the IP and control groups presented a similar number of adverse medical events with non-significant p. No significant differences were detected in the frequency of adverse outcomes in pregnant women who practiced IP and those in the control group.

A double-blind, randomized clinical trial to assess the augmentation with nimodipine of antidepressant therapy in the treatment of “vascular depression”

2005 ◽  
Vol 17 (3) ◽  
pp. 487-498 ◽  
Author(s):  
F. E. Taragano ◽  
P. Bagnatti ◽  
R. F. Allegri
Keyword(s):  
Clinical Trial ◽  
Cerebrovascular Disease ◽  
Randomized Clinical Trial ◽  
Antidepressant Therapy ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Number Needed To Treat ◽  
Double Blind ◽  
Vascular Depression ◽  
Full Remission

Background: Cerebrovascular disease may cause “vascular depression” (VaD). Calcium-channel blockers are presumed treatments for cerebrovascular disease and might be expected to improve depression and prevent recurrence.Objective: To examine the efficacy and tolerability of the use of nimodipine as an augmentation of fluoxetine in the treatment of VaD.Design: A double-blind, randomized clinical trial in which 101 patients with VaD (Alexopoulos criteria) were treated with fluoxetine at standard doses. Patients were randomized to placebo (n=51) or nimodipine (n=50). Treatment outcomes were assessed using the Hamilton Depression Rating Scale (HDRS) regularly up to 8 months after treatment initiation.Results: Depression was reduced in 63% of patients, but those whose treatment was enhanced with nimodipine had greater improvements overall by repeated measures analysis of covariance (ANCOVA) (F(1.80)=9.76, p=0.001). In addition, a greater proportion of patients treated with fluoxetine–nimodipine (54% vs. 27%) exhibited full remission (χ2(d.f. 1)=7.3, p=0.006), with the number needed to treat (NNT) equal to 4 (95% CI 2–12). Of those experiencing full remission in the first 61 days, fewer patients on fluoxetine–nimodipine (3.7%) developed recurrence of major depression as compared to those on fluoxetine alone (35.7%) (χ2(d.f. 1)=7.56, p=0.006), NNT 3 (95% CI 2–9). Side-effects were noted in 33.3% of patients in the control group and 48% of the experimental group (χ2(d.f. 1)=2.25, p=0.133).Conclusions: In treating VaD, augmentation of fluoxetine with nimodipine led to better treatment results and lower rates of recurrence. These findings support the argument that augmentation of antidepressant therapy might be helpful in the treatment of cerebrovascular disease, which is involved in the pathogenesis of this type of depression.

scholarly journals Educational workshops about bonding with the fetus during pregnancy: a clinical trial

2021 ◽  
Vol 42 ◽  
Author(s):  
Priscila Costa ◽  
Paula Rosenberg de Andrade ◽  
Bruna Arends Roschel Tomaz ◽  
Samara Macedo Cordeiro ◽  
Danielle Castro Jansen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Child Development ◽  
Usual Care ◽  
Pregnant Women ◽  
Randomized Clinical Trial ◽  
Gestational Age ◽  
Health Clinic ◽  
Control Group ◽  
Before And After ◽  
Experimental Group

ABSTRACT Objective: To verify if participation in educational workshops about bonding with the fetus influences the adoption of practices of interaction with the baby by pregnant women. Method: Randomized clinical trial conducted in a health clinic. The experimental group participated in educational workshops designed for the pregnant couple and the control group received usual care. The practices of interaction with the fetus were evaluated before and after the intervention. Results: 19 pregnant women participated in the study. There was a positive correlation between higher gestational age and the interaction with the fetus (p = 0.016), and between younger mothers and the practice of touching or poking the baby (p = 0.019). There was an increase in the interaction with the fetus in the control and experimental groups (p= 0.024). Conclusion: Educational workshops are strategies for sharing knowledge about fetuses' sensory skills and to foster bonding and child development since pregnancy.

scholarly journals Fluoxetine for Anterior Ischemic Optic Neuropathy (AION); a Double Blind Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Hossein Abbasi ◽  
Shahnaz Rimaz ◽  
Zahra Pourmousa ◽  
Leila Janani ◽  
Mostafa Soltan Sanjari
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Optic Neuropathy ◽  
Study Groups ◽  
Anterior Ischemic Optic Neuropathy ◽  
Control Group ◽  
Ischemic Optic Neuropathy ◽  
Double Blind ◽  
Clinical Prognosis ◽  
Before And After

Abstract Background: Fluoxetine enhances the levels of brain-derived neurotrophic factor (BDNF); considering its known improving effects on neurogenesis and plasticity, it seems to improve the Anterior Ischemic Optic Neuropathy (AION). This study aimed to evaluate the effect of Fluoxetine on clinical prognosis of patients with AION.Methods: In this double-blind placebo-controlled randomized clinical trial, subjects with AION who were referred to Rasool Akram Hospital were divided into two study groups; the fluoxetine group that received 20 mg Fluoxetine daily(n=50) and the control group (n=50) that received placebo for a period of six months. Patients underwent clinical and paraclinical evaluations before and after the trial. This study was a registered trial with IRCT code IRCT20181109041596N1.Results: One hundred patients were enrolled from August 2019 to December 2020 and assessed in this study. Subjects in Fluoxetine group showed significant improvement in visual acuity in comparison to the placebo group with less score in LogMAR scale (P: 0.008 and 0.002, respectively), improvement in MD parameters of perimetry (P: 0.003 and 0.002, respectively), and decrease in VEP latencies (P (in 1st minute): <0.001 and <0.001, P (in 15st minute): 0.038 and 0.011, respectively). There were no differences in color vision, Rnfl in all dimensions, PSD parameter of perimetry or VEP amplitudes following the trial of Fluoxetine therapy (Ps> 0.05).Conclusion: Fluoxetine showed promising therapeutic value for patients with AION besides its safety as an additive treatment option to corticosteroids.

Treatment of acute respiratory viral infections: results of a multicenter, double-blind, placebo-controlled, randomized clinical trial

2020 ◽  
Vol 18 (3) ◽  
pp. 178-189
Author(s):  
V.V. Rafalsky ◽  
◽  
R.F. Khamitov ◽  
T.I. Martynenko ◽  
M.V. Chernogorova ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Viral Infections ◽  
Wilcoxon Test ◽  
Controlled Study ◽  
Control Group ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Respiratory Viral Infections

This multicenter, double-blind, placebo-controlled clinical trial was conducted to obtain additional data on the efficacy and safety of Anaferon for the treatment of acute respiratory viral infections (ARVI) during seasonal increase in their incidence (RCT of the Ministry of Health of Russia No 356 dated 24.07.2018; ClinicalTrials.gov Identifier: NCT03707912). Patients and methods. Between October 2018 and March 2019, a total of 204 patients aged 18 to 70 years with ARVI symptoms were included in this study within the first 24 hours of symptom onset. Patients were randomized into 2 groups: 104 individuals received oral Anaferon (should be kept in the mouth until completely dissolved and without food) according to the following scheme: 1 tablet every 30 minutes during the first 2 hours; then 3 more doses at regular intervals during the first day; then 1 tablet 3 times a day on days 2–5; 100 individuals received placebo according to the same scheme. The primary endpoint was time to resolution of symptoms of clinically diagnosed and/or PCR (polymerase chain reaction) – confirmed ARVI. Addithional endpoints included: time to resolution of symptoms of ARVI confirmed by PCR; proportion of patients with resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI and separately PCR-confirmed ARVI; severity of clinically diagnosed and/or PCR-confirmed ARVI (assessed by ‘area under the curve’ for the total severity index); the number of antipyretic doses taken according to indications on days 1–3 of treatment (checked in the patient's diary); proportion of patients who required antibiotic treatment on days 4–7 of follow-up. To assess safety, we analyzed the incidence and type of adverse events (AEs), their severity, association with drug use, and treatment outcome. The following statistical methods were used: Fisher's exact test, Cochran–Mantel–Haenszel test, Wilcoxon test, and repeated measures ANOVA, PROC MIXED. Results. A total of 203 patients were included in the intention-to-treat (ITT) and per protocol (РР) analysis: 103 [95] individuals in the Anaferon arm and 100 [93] individuals in the Placebo arm. Patients receiving Anaferon had significantly shorter time to resolution of all ARVI symptoms than patients receiving placebo: 4.1 ± 1.6 days vs 4.5 ± 1.5 days (p = 0.032). The disease was on average 1 day shorter in patients from the experimental group compared to controls: 3.6 ± 1.5 days vs 4.6 ± 1.5 days (p = 0.007). The proportion of patients who had resolution of symptoms of clinically diagnosed and/or PCR-confirmed ARVI was significantly higher in the Anaferon arm compared to Placebo arm (p = 0.0012). Among patients with PCR-verified ARVI, treatment with Anaferon resulted in twice as frequent recovery as in the control group on day 4 (53.7% vs 26.3%) and day 7 (70.7% vs 36.8%). In the Anaferon arm, we observed shorter disease duration and higher proportion of patients recovered compared to the Placebo arm; however, patients in both groups had a similar need for antipyretic drugs on days 1–3 of treatment, as well as for antibiotic therapy. The incidence of AEs in the Anaferon and Placebo groups did not vary significantly. No AEs with a reliable association with Anaferon were registered. Conclusion. Our findings suggest high efficacy and safety of Anaferon in patients with ARVI. The best results were obtained in patients with PCR-verified diagnosis, which can be attributed to the involvement of the interferon system in the action of the drug. The results of this RCT confirm the data obtained in previous studies and long-term clinical experience of using Anaferon. Key words: acute respiratory viral infections, ARVI, treatment, effective therapy, placebo-controlled study, Anaferon, randomized clinical trial, comprehensive therapy, efficacy, safety

scholarly journals The Efficacy of Mindfulness-Based Alzheimer’s Stimulation (Mbas) in the Progression of Cognitive Impairment: A Double-Blind, Randomized Clinical Trial

2014 ◽  
Vol 4 (2) ◽  
pp. 101-112
Author(s):  
Domingo Jesús Quintana Hernández ◽  
María del Pino Quintana Montesdeoca
Keyword(s):  
Clinical Trial ◽  
Cognitive Impairment ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Cognitive Stimulation ◽  
Mindfulness Practice ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
And Control

We conducted a randomized, controlled study in order to investigate the feasibility, security as well as the effects of the practice of mindfulness upon the evolution of AD. The efficacy of a Mindfulness-based Cognitive Stimulation program for Alzheimer’s patients was tested in this double-blind, randomized clinical trial, using repeated measures of CAMDEX (CAMCOG y MMSE) every six months during two years. A total of 168 patients, presenting a Probable Alzheimer Disease according to NINCDS-ADRDA criteria and treated with donepezil, were randomly assigned to the four following non-pharmacological treatments: standard cognitive stimulation, progressive muscular relaxation, mindfulness-based Alzheimer stimulation and control group, which received no intervention. Each experimental group worked in 90-minute sessions, three times per week during two years (a total of 96 weeks). Results indicated that the Mindfulness-based Alzheimer Stimulation group did not show as much a significant decline of cognitive function as the other groups did. Therefore, it seems that mindfulness practice, as implemented in this program, can have a preventive role against the progression of cognitive impairment in AD. These results support the use of mindfulness as a non-pharmacological treatment.

scholarly journals Comparing Efficacy of Cerclage and Adjunctive Therapy (Cerclage & Pessary) in Prevention of Preterm Birth in Pregnant Women with Cervical Insufficiency: A Randomized Clinical Trial.

2020 ◽  
Author(s):  
Mitra Arjmandifar ◽  
Maryam Moshfeghi ◽  
Maryam Mohammadi ◽  
Mahya Eftekhari
Keyword(s):  
Clinical Trial ◽  
Survival Analysis ◽  
Preterm Birth ◽  
Pregnant Women ◽  
Randomized Clinical Trial ◽  
Gestational Age ◽  
Adjunctive Therapy ◽  
Intervention Group ◽  
Control Group ◽  
Cervical Insufficiency

Abstract Background: Cervical insufficiency is the responsible factor for 15-25% of pregnancy loss in the second trimester. Midwifery specialists sometimes prefer to use adjunctive therapy in combination with cerclage surgery for management of cervical insufficiency. The aim of this study was to evaluate the effectiveness of adjunctive pessary therapy after cerclage in improving perinatal and neonatal outcome and increasing satisfaction in women with cervical insufficiency.Methods: This concurrent randomized clinical trial was conducted at the infertility department of Royan Institute, Tehran, Iran from May 2018 to May 2020. In this trial, 170 singleton pregnant women, diagnosed with cervical insufficiency, of gestational age 14 to 26 weeks, were enrolled. Patients were randomized 1:1 to receive either cervical cerclage or pessary after cerclage. The primary outcomes were gestational age at the time of delivery and the percentage of preterm labor (<37 weeks). The secondary outcomes were the method of delivery, neonatal outcomes, maternal adverse events and maternal satisfaction of interventions.Results: Preterm birth before 37 weeks of gestation occurred in 16 women (19.3%) in the pessary group and 17 women (21%) in the control group (between-group difference, 1.11%; 95%CI 0.518−2.388%). In the survival analysis to 37 WK of gestation, the incidence of preterm birth was not significantly different between the two groups (Relative Risk (RR), 1; 95%CI, 0.161-6.202). Based on survival analysis, the incidence of vaginal bleeding and pelvic pain significantly differed between the two groups (RR, 2.68; 95%CI (1.31-5.46)) and (RR, 1.73; 95%CI (1.04-2.87), respectively. The mean score of satisfaction in the intervention group (5.73) was significantly higher than the control group (5.25), (between-group difference, 0.47; 95%CI (0.10-0.84).Conclusions: The placement of an adjunctive pessary for pregnant women with singleton pregnancy and a cervical insufficiency, did not result in a lower rate of preterm delivery before 37 weeks of gestation compared to cerclage alone. However, the complications of pregnancy after the intervention until delivery, were less in these women, while the level of satisfaction was higher. Trial registration: Iranian Registry of Clinical Trials (IRCT20180302038914N1), May 5,2018.

scholarly journals Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: initial results of a double-blind, placebo-controlled randomized clinical trial

2021 ◽  
Author(s):  
Berta Grau-Pujol ◽  
Daniel Camprubí ◽  
Helena Marti-Soler ◽  
Marc Fernández-Pardos ◽  
Clara Carreras-Abad ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Healthcare Workers ◽  
Similar Proportion ◽  
Control Group ◽  
Treatment Schedule ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Epidemic Period ◽  
Exposure Prophylaxis

Abstract Background: Pre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period.Methods: We conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400mg of hydroxychloroquine daily the first four consecutive days and subsequently, 400mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets. Results: 52.8% (142/269) of participants were in the hydroxychloroquine arm and 47.2% (127/269) in the placebo arm. Both groups showed similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AEs were reported. Almost all AEs (96.4%, 106/110) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (27.4% (39/142) vs 15.7% (20/127), p=0.041). Given the national epidemic incidence decay, only one participant in each group was COVID-19 diagnosed. Consequently, our study design deemed underpowered to evaluate any benefit regarding PrEP efficacy.Conclusions: First month follow-up analysis displayed that PrEP with hydroxychloroquine at low doses is safe.Trial registration: This trial was registered at clinicaltrials.gov (NCT04331834) on April 2nd 2020. https://clinicaltrials.gov/ct2/show/NCT04331834?term=NCT04331834&draw=2&rank=1

scholarly journals Educational intervention with serial album about pregnant women positioning for spinal anesthesia: randomized clinical trial

2020 ◽  
Vol 73 (suppl 4) ◽  
Author(s):  
Sarah de Lima Pinto ◽  
Larissa Alves Sampaio ◽  
Nelson Miguel Galindo Neto ◽  
Paulo César de Almeida ◽  
Mirna Fontenele de Oliveira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pregnant Women ◽  
Spinal Anesthesia ◽  
Randomized Clinical Trial ◽  
Educational Intervention ◽  
Intervention Group ◽  
Maternity Hospital ◽  
Control Group ◽  
Chi Square ◽  
Exact Test

ABSTRACT Objective: To evaluate effectiveness of using educational intervention serial album to positioning pregnant women for spinal anesthesia. Method: Randomized clinical trial with 90 women casually assigned to control (CG) and intervention group (IG), in a maternity hospital located in Northeast region of Brazil. The primary endpoint was “achieve correct positioning to perform spinal anesthesia”; and secondary, “how number of spinal cord puncture attempts”. Effectiveness was verified using the chi-square test, Fisher’s exact test and likelihood ratio. Results: The positioning was correct in 37 women in each group. There was an association between women in control group remaining still, relaxing shoulders and flexing the spine; and women in intervention group should remain still and relax the shoulders; furthermore there was a statistical association achieved by correct positioning and the number of attempts to access the lumbar puncture. Conclusion: Educational intervention with serial album was effective and contributed to immobility and positioning of pregnant women. Brazilian Registry of Clinical Trials (RBR-3Z7SRD).

scholarly journals Effect of probiotic supplement (kidilact) on prevention of acute diarrhea in children: a double-blind randomized clinical trial

2017 ◽  
Vol 5 (7) ◽  
pp. 2861
Author(s):  
Mehran Hesaraki
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Vital Signs ◽  
Control Group ◽  
Early Recovery ◽  
Double Blind ◽  
Viral Diarrhea

Background: Acute viral diarrhea is one of the most common diseases in children, which is associated with high risk of mortality. The present study aimed to determine the effect of Kidilact on the treatment of children with acute diarrhea.Methods: This double-blind randomized clinical trial was conducted on 84 children aged 6-60 months with diarrhea, hospitalized in pediatric ward of Amir al-Mu'minin hospital of Zabol, Iran. The patients who met the inclusion criteria were included and assigned to the control and treatment groups (42 patients in each group). Data collection instruments included clinical examination of participants in terms of gender, medication, diet, stool test, weight, average heart rate, average respiratory rate, average body temperature, and average frequency of defecation Data was analyzed with descriptive and analytical tests (chi-square, Fisher's exact test, t-test, etc.) in SPSS-21.Results: Body temperature, heart rate, and frequency of defecation significantly reduced in the intervention group after three days (p<0.05). In addition, weight gain presented an improving trend in the intervention group, but not significantly different from the control group (p<0.05).Conclusions: Findings indicated that the use of Kidilact may be helpful in the treatment of acute viral diarrhea in children and play a key role in early recovery, reduction of disease severity, and improvement of vital signs in these patients.

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