scholarly journals Convalescent Plasma for COVID-19: A multicenter, randomized clinical trial

2020 ◽  
Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Randomized Clinical Trial ◽  
Strong Dependence ◽  
Standard Of Care ◽  
Ordinal Scale ◽  
Control Group ◽  
Standard Of Care Treatment ◽  
And Control ◽  
To Receive

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).

Effect of prenatal recommendations of Traditional Persian Medicine on obstetric outcomes: a randomized clinical trial

2018 ◽  
Vol 15 (3) ◽  
Author(s):  
Mansoor Keshavarz ◽  
Maryam Kashanian ◽  
Soodabeh Bioos ◽  
Yasaman Vazani
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Active Phase ◽  
Obstetric Outcomes ◽  
Control Group ◽  
Control Groups ◽  
Persian Medicine ◽  
Traditional Persian Medicine ◽  
And Control

Abstract Background Traditional Persian Medicine (TPM) is an ancient medical system that provides suggestions to improve the health of mothers and children during pregnancy and labor. Persian physicians believed that these instructions made labor easier, safer, and less painful. Methods The present randomized clinical trial was conducted among women at 33–38 weeks of pregnancy in Tehran, Iran. TPM instructions consisted of diet, bathing, and application of oil from the 38th week of pregnancy to the onset of labor. The primary outcome was the duration of the active phase of labor. Results The mean duration of the active phase was 331.60 ± 151.48 min for the intervention group and 344.40 ± 271.46 min for the control groups, but it was not statistically significant. The active phase was significantly shorter in women who had better compliance (p=0.03). The need for oxytocin augmentation was 53.3% in the control group and 38.5% in the intervention group (p=0.17). The rate of perineal infection was 13% in the control group and 0% in the intervention group (p=0.11). Conclusions The active phase was not different in the intervention and control groups, but it was shorter in compliant women. It is possible that prolonged use of these recommendations in combination with a sitz baths and a larger sample size could result in more significant outcomes.

scholarly journals Tepid sponging plus dipyrone versus dipyrone alone for reducing body temperature in febrile children

2008 ◽  
Vol 126 (2) ◽  
pp. 107-111 ◽  
Author(s):  
João Guilherme Bezerra Alves ◽  
Natália Dornelas Câmara Marques de Almeida ◽  
Camila Dornelas Câmara Marques de Almeida
Keyword(s):  
Clinical Trial ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Control Group ◽  
Emergency Ward ◽  
Axillary Temperature ◽  
Secondary Outcomes ◽  
To Receive

CONTEXT AND OBJECTIVE: The role of tepid sponging to promote fever control in children is controversial. We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone. The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever. DESIGN AND SETTING: A randomized clinical trial was undertaken at Instituto Materno-Infantil Professor Fernando Figueira, Recife, Pernambuco. METHODS: Children from six months to five years old with axillary temperature greater than 38 ºC in the emergency ward between January and July 2006 were eligible. One hundred and twenty children were randomly assigned to receive oral dipyrone (20 mg/kg) or oral dipyrone and tepid sponging for 15 minutes. The primary outcome was mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes were crying and irritability. RESULTS: 106 children finished the study. After the first 15 minutes, the fall in axillary temperature was significantly greater in the sponged group than in the control group (p < 0.001). From 30 to 120 minutes, better fever control was observed in the control group. Crying and irritability were observed respectively in 52% and 36% of the sponged children and in none and only two of the controls. CONCLUSIONS: Tepid sponging plus dipyrone cooled faster during the first 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.

Effect of Low-Pressure Drainage Suction on Pharyngocutaneous Fistula After Total Laryngectomy

2020 ◽  
Vol 130 (1) ◽  
pp. 32-37
Author(s):  
Mojtaba Maleki Delarestaghi ◽  
Aslan Ahmadi ◽  
Fatemeh Dehghani Firouzabadi ◽  
Maryam Roomiani ◽  
Mohammad Dehghani Firouzabadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Total Laryngectomy ◽  
Recovery Time ◽  
Low Pressure ◽  
Control Group ◽  
Pharyngocutaneous Fistula ◽  
Significant Difference ◽  
Drain Group ◽  
And Control

Objective: Pharyngocutaneous fistula (PCF) is one of the most severe multifactorial complications following laryngectomy. The current study aimed at determining the effect of a low-pressure vacuum drain on the incidence of PCF after total laryngectomy. Methods: The current randomized clinical trial was conducted on 35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran. The subjects were divided into the vacuum drain (n = 15) and control (without vacuum drain) (n = 20) groups. The incidence of PCF and the recovery time were recorded. Results: The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P < .05). There was no significant difference between the groups in time to recovery from PCF. Conclusion: The low-pressure vacuum drain method is effective in reducing the incidence of PCF after total laryngectomy.

Oral Metronidazole and Cefixime as Prophylaxis on Wound Complications of Uncomplicated Appendicitis Following Appendectomy: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Khosro Ayazi ◽  
Arash Mohammadi Tofigh ◽  
Shohra Qaderi ◽  
Farzad Esmaeili Tarki ◽  
Majid Samsami ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Single Dose ◽  
Randomized Clinical Trial ◽  
Open Appendectomy ◽  
Perforated Appendicitis ◽  
Prophylactic Antibiotics ◽  
Wound Complications ◽  
Control Group ◽  
Case Group ◽  
And Control

Abstract Backgrounds Without proper use of prophylactic antibiotics, the chance of infection at the site of surgery after appendectomy is around 10 to 30%. Although, in the case of nonperforated appendicitis, the therapeutic use of antibiotic prophylaxis is still contentious. Cephalosporins and Metronidazole has been shown to be effective against anaerobe micro-organisms, and its bioavailability after oral and parenteral administration is comparable. The aim of this research is to compare the incidence of infection-related complications following open appendectomy for nonperforated appendicitis in patients who were given prophylactic antibiotics (Metronidazole and Cephalosporins) either intravenously or orally. Materials & Methods In this randomized clinical trial, the open appendectomy was performed on 200 non-perforated appendicitis cases; 87 females and 113 males, with a mean age of 26 years. Of all the enrolled, 100 cases were given single-dose metronidazole and Cefixime orally (study group), and 100 cases were given single-dose intravenous metronidazole and Ceftriaxone (control group). Results The wound infection incidence did not vary substantially between the two groups. (5% and 7% in the control and case group, respectively, P = 0.552). In addition, the length of hospitalization was also similar between both groups (2.4 and 2.6 days in the in the case and control group, respectively, P = 168). Conclusion All in all, it has been concluded that a single-dose metronidazole and Cefixime taken orally before surgery could bestow impactful prophylactic effects for nonperforated appendicitis cases. Therefore, it could be used instead of the parenteral antibiotics (Intravenous Metronidazole and Ceftriaxone).

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 Effect of Foot Reflexology on Postoperative Pain in Patients Undergoing Tibia Plating Surgery: A Randomized Clinical Trial

2020 ◽  
Vol 10 (3) ◽  
pp. 258-269
Author(s):  
Fatemeh Imani ◽  
◽  
Ebrahim Nasiri ◽  
Houshang Akbari ◽  
Mohammad Reza Safdari ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Randomized Clinical Trial ◽  
Repeated Measures ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Chi Square ◽  
Chi Square Test ◽  
And Control

Objective: One of the major problems of patients after orthopedic surgeries is acute pain. The present study aims to evaluate the effect of foot reflexology massage on postoperative pain in patients undergoing plating surgery for tibia fracture. Methods: This study is a randomized clinical trial conducted on 96 patients who were candidates for tibia plating surgery referred to Imam Ali Hospital in Bojnourd, Iran, randomly divided into intervention and control groups. Foot reflexology massage in the intervention group was performed on patients’ healthy feet for 10 minutes, one hour before surgery. In the control group, the foot sole was touched for one minute without any pressure. Pain intensity was measured using the standard Visual Analog Scale before and immediately after the intervention and 2, 4, 6, 12 and 24 hours after surgery. Data were analyzed using chi-square test, t-test, repeated measures ANOVA, Mann-Whitney U and Friedman tests. Results: The baseline pain scores in the intervention and control groups were reported 8.1±0.9 and 8.4±0.9, respectively. After the intervention, the pain score in these groups was reduced to 6.9±1.1 and 8.1±1.0, respectively (P<0.001). At other times, up to 24 hours after surgery, the pain reduction was higher in the intervention group (P<0.05). Conclusion: Foot reflexology massage reduces postoperative pain of patients undergoing tibia plating surgery. Therefore, this method can be used to reduce pain and anxiety in orthopedic surgery patients.

scholarly journals Effect of lavender aromatherapy on well-being among hemodialysis patients: A randomized clinical trial

2018 ◽  
Author(s):  
Masoumeh Bagheri Nesami ◽  
Seyed Afshin Shorofi ◽  
Attieh Nikkhah ◽  
Hossein Roohi Moghaddam ◽  
Ali Mahdavi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Well Being ◽  
Underlying Disease ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Significant Difference ◽  
The Mean ◽  
And Control ◽  
Experimental Group

  In spite of the improvement of dialysis techniques, hemodialysis patients still experience debilitation. Impaired functioning, well-being, and quality of life are among the factors that are of a great concern in these patients. The current study aimed to examine the effects of lavender essential oil on well-being among hemodialysis patients. This randomized clinical trial was conducted on 30 hemodialysis patients. For each patient in the experimental group, five cotton balls were prepared using two drops of lavender essence diluted with sweet almond oil. Lavender was used at five concentrations of 10%, 20%, 30%, 40%, and 50%, administered through pinning the soaked cotton ball on the patients' collar on the first, second, third, fourth, and fifth weeks of the intervention, respectively. The patients were asked to breathe normally for 20 min. On the other hand, the control group received only routine nursing care. The perceived sense of well-being was measured in both groups at the end of each week using a visual analog scale. The mean ages of patients were obtained as 58.9 ± 14.31 and 53.03 ± 15.84 years for the experimental and control groups, respectively. Hypertension was reported to be the most common underlying disease in both groups. The results showed a significant difference in the mean level of well-being in the experimental group in the fourth and fifth weeks of the intervention, compared to that before the intervention. Inhalation aromatherapy with 40% and 50% lavender essence had a positive effect on the perceived sense of well-being in hemodialysis patients. However, lower concentrations of 10%, 20%, and 30% did not exert a comparable effect.

scholarly journals The Effects of Manual Lung Hyperinflation on Pulmonary Function after Weaning from Mechanical Ventilation among Patients with Abdominal Surgeries: Randomized Clinical Trial

2021 ◽  
Vol 10 (4) ◽  
pp. 216-222
Author(s):  
Mahboube Yazdani ◽  
Javad Malekzadeh ◽  
Alireza Sedaghat ◽  
Seyed Reza Mazlom ◽  
Aliyeh Pasandideh khajebeyk
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Abdominal Surgery ◽  
Pulmonary Function ◽  
Randomized Clinical Trial ◽  
Arterial Oxygen ◽  
Control Group ◽  
Artificial Airway ◽  
Rapid Shallow Breathing Index ◽  
Significant Difference

Introduction: After abdominal surgery, the patients who are separated from mechanical ventilation and provided with oxygen therapy via a T-piece are at risk for respiratory complications. Therefore, they need additional respiratory support. This study aimed to evaluate the effects of manual hyperinflation (MHI) on pulmonary function after weaning. Methods: This randomized clinical trial included 40 patients who had undergone abdominal surgery and were receiving oxygen via a T-piece. Patients were selected from the intensive care units (ICU) of two hospitals in Mashhad, Iran. The subjects were randomly allocated to intervention (MHI) and control groups. Patients in the MHI group were provided with three 20-minute MHI rounds using the Mapleson C, while the control group received routine cares. Tidal volume (Vt), Rapid Shallow Breathing Index (RSBI), and the ratio of arterial oxygen partial pressure to fractional inspired oxygen (P/F ratio) were measured before the intervention, as well as 5 and 20 minutes after the intervention. Atelectasis prevalence was assessed before and 24 hours after the intervention. Data were analysed by SPSS software version 13. Results: At baseline, there were no significant differences between the groups regarding Vt, RSBI, P/F ratio, and atelectasis rate. No significant difference was also found between the groups regarding atelectasis rate 24 hours after the intervention. However, at both posttests, Vt, RSBI, and P/F ratio in the MHI group were significantly better than the control group. Conclusion: In patients with artificial airway and spontaneous breathing, MHI improves pulmonary function.

scholarly journals Surfactant Administration in Preterm Neonates Using Laryngeal Mask Airway: A Randomized Clinical Trial

2019 ◽  
Author(s):  
Elaheh Amini ◽  
Mahdi Sheikh ◽  
Mamak Shariat ◽  
Hosein Dalili ◽  
Negin Azadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Laryngeal Mask Airway ◽  
Endotracheal Tube ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Laryngeal Mask ◽  
Control Group ◽  
Premature Neonates ◽  
Surfactant Administration ◽  
To Receive

Abstract- In this study, we aimed to compare the efficacy of laryngeal mask airway (LMA) versus endotracheal tube in the early rescue surfactant administration in premature neonates with respiratory distress syndrome (RDS). This randomized, clinical trial evaluated 60 premature neonates with RDS. Numbered envelopes randomly assigned 30 neonates to the intervention group to receive 2.5 ml/kg/dose surfactant (Curosurf) via LMA and 30 to the control group to receive 2.5 ml/kg/dose surfactant via an endotracheal tube using the INSURE technique, exclusively during the first two hours of life. There were no differences in the requirement for mechanical ventilation (23.3% vs. 20%, P=0.75), requirement for second dose surfactant (13.3% vs. 6.7%, P=0.67), bronchopulmonary dysplasia (13.3% vs. 6.7%, P=0.67), pneumothorax (6.7% vs. 0%, P=0.49), and intraventricular hemorrhage (10% vs. 10%, P=1) between neonates who received surfactant via LMA versus those who received surfactant via endotracheal tube. LMA seems to be an effective and less invasive alternative to endotracheal intubation for surfactant delivery in premature neonates with RDS.

scholarly journals Effect of Abdominal Massage with and without Salvia officinalis on Nausea and Vomiting in Patients with Cancer Undergoing Chemotherapy: A Randomized Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Farshid Rafiee Sarbijan Nasab ◽  
Parvin Mangolian Shahrbabaki ◽  
Mahlagha Dehghan ◽  
Haleh Tajadini ◽  
Hamideh Baniasadi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Considerable Effect ◽  
Salvia Officinalis ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Patients With Cancer ◽  
Abdominal Massage ◽  
The Mean ◽  
And Control

Objective. The aim of this study was to determine the effect of abdominal massage with and without Salvia officinalis on nausea and vomiting in patients with cancer undergoing chemotherapy. Methods. In this randomized clinical trial, 60 patients undergoing chemotherapy were placed in one of two intervention groups or in a control group. Abdominal massage with and without Salvia officinalis was performed for 15 minutes twice a day for 3 consecutive days by the patient’s companion. The rate of nausea and vomiting was measured with a Visual Analog Scale. Results. Findings showed that immediately after the intervention, the mean score of nausea in abdominal massage with Salvia officinalis group was lower than that of the control group. The mean score of nausea was not different between abdominal massage and control groups. One week after the intervention, the mean score of nausea was not different among the three groups. In addition, the frequency of vomiting was not different among the three groups. Conclusion. Abdominal massage with/without Salvia officinalis as a complementary medicine has not considerable effect on reducing nausea and vomiting in patient with cancer undergoing chemotherapy. More studies are needed to achieve better and more accurate results.

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