scholarly journals Role of artificial tears with and without hyaluronic acid in controlling ocular discomfort following PRK: a randomized clinical trial

2021 ◽  
Vol 14 (8) ◽  
pp. 1225-1230
Author(s):  
Mehrdad Mohammadpour ◽  
◽  
Delaram Shakoor ◽  
Keyword(s):  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Randomized Clinical Trial ◽  
Visual Analogue Score ◽  
Control Group ◽  
Artificial Tears ◽  
Blurred Vision ◽  
Corneal Erosion ◽  
Ocular Discomfort ◽  
Haze Formation

AIM: To compare outcomes of applying preservative free artificial tears (PFAT) with and without hyaluronic acid (HA) in early postoperative course following photorefractive keratectomy (PRK). METHODS: In this triple-blinded randomized clinical trial, PRK procedure was performed on both eyes of 230 patients. Following PRK, patients were divided into three groups: the HA+ group, 44 patients PFAT containing HA; the HA- group, 71 patients PFAT without HA were administered 5 times per day (every 4h); the third group, 115 patients received no PFAT before lens removal. On the 1st and 4th postoperative day, Visual Analogue Score (VAS) was utilized to evaluate patient’s level of pain. Participants were asked to complete a questionnaire about the severity of eye discomfort ranked from 0 to 10 (0=no complaint; 10=most severe complaint experienced). RESULTS: In eyes receiving PFAT with or without HA (Drop group), mean scores for epiphora, foreign body sensation, and blurred vision on the 1st postoperative day were statistically lower (P<0.05). Filamentous keratitis (FK) was detected in 11 (4.7%) eyes, and recurrent corneal erosion (RCE) was observed in 5 (2.1%) eyes. In the control group, FK was noted in 16 (6.9%) eyes while 13 (5.6%) eyes had RCE and 5 (2.1%) eyes had corneal haze. The rate of complications was statistically lower in Drop group (P=0.009). However, the aforementioned scores were not statically different between HA+ and HA- group one and two (P=0.29). CONCLUSION: Following PRK, applying PFAT with and without HA yields faster visual recovery, decreases postoperative ocular discomfort and haze formation; however there is no additive effect for HA.

scholarly journals Effects of a positive thinking program on hope and sleep quality in Iranian patients with thalassemia: a randomized clinical trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Somayeh Makaremnia ◽  
Marieh Dehghan Manshadi ◽  
Zahra Khademian
Keyword(s):  
Clinical Trial ◽  
Sleep Quality ◽  
Training Program ◽  
Randomized Clinical Trial ◽  
Thalassemia Major ◽  
Trial Registration ◽  
Control Group ◽  
Positive Thinking ◽  
Experimental Group

Abstract Background Thalassemia have a negative impact on the patients' psychological health and sleep quality. This study aimed to determine the effects of a positive thinking training program on hope and sleep quality of patients with thalassemia major. Methods This randomized clinical trial was conducted on 78 patients with thalassemia major including 36 males (46.2%) and 42 females (53.8%) with a mean age of 25.56 ± 29.6 in Iran. Subjects were randomly assigned into experimental and control groups. Experimental group received 16 h training based on positive thinking materials published by Martin Seligman. Control group received only usual programs. Data were collected at baseline, as well as immediately and one month after the intervention, using Snyder’s Hope Scale and the Pittsburgh Sleep Quality Index. Data analysis was performed using SPSS Software 18.0; statistical tests included the independent T-test, the Chi-square, Mann Whitney, and Friedman test. Significance level was set at 0.05 in this study. Results The experimental group had a significantly higher mean hope score compared to the control group immediately (45.38 ± 7.82 vs. 35.32 ± 5.54, P < 0.001) and one month following intervention (44.67 ± 3.47 vs. 35 ± .54, P < 0.001). Moreover, the mean sleep quality scores of the experimental group was significantly greater than that for control group immediately (5.35 ± 2.02 vs. 7 ± 2.4, P = 0.004) and one month after the intervention (4.23 ± 2.2 vs.7.02 ± 3.03, P < 0.001). Conclusion Since our training program on positive thinking improved hope and quality of sleep in patients with thalassemia major, we recommend the use of such courses as an important step toward promotion of hope and sleep quality among these patients. Trial registration The name of the registry: Iranian Registry of Clinical Trials. Trial Registration Number: IRCT2017010431774N1. URL of the trial registry record: https://en.irct.ir/trial/24923. Registration Date: 07/03/2017.

scholarly journals Intraoperative protective ventilation in patients undergoing major neurosurgical interventions: a randomized clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcome ◽  
Adverse Events ◽  
Respiratory Rate ◽  
Randomized Clinical Trial ◽  
Protective Ventilation ◽  
Adult Patients ◽  
Control Group ◽  
Neurosurgical Procedures ◽  
Neurosurgical Patients

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

scholarly journals A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Christine Elizabeth Jones ◽  
Anna Calvert ◽  
Jo Southern ◽  
Mary Matheson ◽  
Nick Andrews ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Pertussis Toxin ◽  
Geometric Mean ◽  
Control Group ◽  
Primary Immunization ◽  
Link Type ◽  
In Pregnancy ◽  
Pertussis Antigens ◽  
Phase Iv

Abstract Background Pertussis vaccines containing three or five pertussis antigens are recommended in pregnancy in many countries, but no studies have compared the effect on infants’ antigen-specific immunoglobulin G (IgG) concentrations. The aim of this study was to compare anti-pertussis IgG responses following primary immunization in infants of mothers vaccinated with TdaP5-IPV (low dose diphtheria toxoid, tetanus toxoid, acellular pertussis [five antigens] and inactivated polio) or TdaP3-IPV in pregnancy (three pertussis antigens). Methods This multi-centre phase IV randomized clinical trial was conducted in a tertiary referral centre and primary care sites in England. Women were randomized to receive TdaP5-IPV (n = 77) or TdaP3-IPV (n = 77) at 28–32 gestational weeks. A non-randomized control group of 44 women who had not received a pertussis-containing vaccine in pregnancy and their 47 infants were enrolled post-partum. Results Following infant primary immunization, there was no difference in the geometric mean concentrations (GMCs) of anti-pertussis toxin, filamentous haemagglutinin or pertactin IgG between infants born to women vaccinated with TdaP5-IPV (n = 67) or TdaP3-IPV (n = 63). However, the GMC of anti-pertussis toxin IgG was lower in infants born to TdaP5-IPV- and TdaP3-IPV-vaccinated mothers compared to infants born to unvaccinated mothers (n = 45) (geometric mean ratio 0.71 [0.56–0.90] and 0.78 [0.61–0.98], respectively); by 13 months of age, this difference was no longer observed. Conclusion Blunting of anti-pertussis toxin IgG response following primary immunization occurs in infants born to women vaccinated with TdaP5-IPV and TdaP3-IPV, with no difference between maternal vaccines. The blunting effect had resolved by 13 months of age. These results may be helpful for countries considering which pertussis-containing vaccine to recommend for use in pregnancy. Trial registration ClinicalTrials.gov, NCT02145624, registered 23 May 2014

Heart Rate Variability And Respiratory Muscle Strength In Patients With Type Ii Diabetes Practicing Pilates: A Randomized Clinical Trial

2021 ◽  
Vol 17 ◽  
Author(s):  
Samara Sousa Vasconcelos Gouveia ◽  
Guilherme Pertinni de Morais Gouveia ◽  
Leydnaya Maria Souza ◽  
Bruno Cunha da Costa ◽  
Gustavo Henrique Melo Sousa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Muscle Strength ◽  
Normal Distribution ◽  
Randomized Clinical Trial ◽  
Respiratory Muscle ◽  
Control Group ◽  
Respiratory Muscle Strength

Purpose: This study aimed to analyze the effect of a Pilates protocol on respiratory muscle strength and heart rate variability (HRV) in patients with type 2 diabetes. Method: A randomized clinical trial (RBR-2gc2qj) was conducted with a type 2 diabetic target population. Patients practiced the Pilates protocol for 8 weeks, with two visits per week. The variables tested were maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), and HRV (time and frequency domains). All variables were tested for normal distribution. Using SPSS 21.0, analysis of variance was performed for variables with normal distribution, and the Wilcoxon and Friedman tests were used for variables that did not show a normal distribution, with a 5% significance level. Results: Forty-four participants were included in the study (intervention group: 22; control group: 22; mean age: 61.23 ± 8.49 years), most of whom were female (77.3%), married or in a consensual union (59.1%), had complete literacy (31.8%), and had an average body mass index of 26.96 ± 4.35 kg/m2. There were no significant differences in MIP and MEP before and after the protocol between the intervention and control groups. Regarding HRV, there were significant differences in autonomic modulation, especially between the moments before and during exercise and between the moments during and after exercise; however, it was not possible to determine which system (sympathetic or parasympathetic) is most involved in these changes. Conclusion: The exercise protocol based on the Pilates method did not alter respiratory muscle strength but promoted changes in HRV, especially between the moments before and during exercise and during and after exercise.

Melatonin reduces the mortality of severely-infected COVID-19 patients

2021 ◽  
Vol 4 (4) ◽  
pp. 613-616
Author(s):  
Dun-Xian Tan ◽  
Russel J Reiter
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Mortality Rate ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Mortality Reduction ◽  
Single Center ◽  
Open Label ◽  
Melatonin Treatment ◽  
The World

SARS-CoV-2 has ravaged the population of the world for two years. Scientists have not yet identified an effective therapy to reduce the mortality of severe COVID-19 patients. In a single-center, open-label, randomized clinical trial, it was observed that melatonin treatment lowered the mortality rate by 93% in severely-infected COVID-19 patients compared with the control group (see below). This is seemingly the first report to show such a huge mortality reduction in severe COVID-19 infected individuals with a simple treatment. If this observation is confirmed by more rigorous clinical trials, melatonin could become an important weapon to combat this pandemic.

scholarly journals Stress of nursing students in clinical simulation: a randomized clinical trial

2018 ◽  
Vol 71 (3) ◽  
pp. 967-974 ◽  
Author(s):  
Radamés Boostel ◽  
Jorge Vinícius Cestari Felix ◽  
Carina Bortolato-Major ◽  
Edivane Pedrolo ◽  
Stela Adami Vayego ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Nursing Students ◽  
Randomized Clinical Trial ◽  
Interpersonal Relationships ◽  
Control Group ◽  
High Fidelity ◽  
Clinical Simulation ◽  
Skill Laboratory ◽  
Before And After ◽  
Experimental Group

ABSTRACT Objective: To evaluate and compare the perception of stressors by nursing students before and after a high-fidelity clinical simulation or conventional laboratory practice class. Method: This is a randomized clinical trial conducted with 52 nursing students. Both groups had theoretical classes about cardiothoracic physical examination, followed by practice class in skill laboratory. In addition, the experimental group took part in a high-fidelity simulation scenario. Stressors were evaluated before and after class, with the application of KEZKAK questionnaire. Results: The experimental group was significantly more worried about six factors related to lack of competence and to interpersonal relationships (p < 0.05), while the control group was significantly more worried about being in contact with suffering (p = 0.0315). Conclusion: The simulation affects students’ perception of stressors and promotes their self-evaluation and critical thinking regarding the responsibility that comes with their learning.

scholarly journals Effectiveness of Acromioclavicular Joint Mobilization and Physical Therapy vs Physical Therapy Alone in Patients with Frozen Shoulder: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Mohammad Rahbar ◽  
Sepideh Ranjbar Kiyakalayeh ◽  
Bina Eftekharsadat ◽  
Behzad Izadseresht ◽  
Neda Dolatkhah
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Randomized Clinical Trial ◽  
Shoulder Pain ◽  
Acromioclavicular Joint ◽  
Frozen Shoulder ◽  
Secondary Outcome ◽  
Control Group ◽  
Joint Mobilization ◽  
Active Abduction

Abstract Background: Frozen shoulder (FS) is a prevalent musculoskeletal condition characterized by an often prolonged pain, disability and limited active and passive range of motion (ROM), however its management remains challenging yet. The objective of this trial was to compare the efficacy of acromioclavicular joint mobilization and physical therapy versus physical therapy in treatment of FS.Methods: In this single-blind randomized clinical trial, patients with diagnosis of FS were randomly allocated into mobilization + physical therapy (n=28) as experiment group, and physical therapy (n=28) as control group in two outpatient clinics of Tabriz University of Medical Sciences, Iran. The primary outcomes were self-reported shoulder pain-related disability measured by the Shoulder Pain and Disability Index (SPADI) questionnaire and goniometric assessment of shoulder ROM. The secondary outcome was the Visual Analogue Scale (VAS). Measures were performed at the baseline, immediately and one month after beginning the treatments.Results: Totally 51 patients with 25.73 ± 6.88 years old of age completed the study and their data were analyzed. VAS, SPADI, pain and disability improved more significantly in experiment group compared to control group immediately [-4.63 (-5.58- -3.67) vs. -2.22 (-2.96- -1.47), p<0.001; -23.08 (-28.63- -17.53) vs. -13.04 (-17.93- -8.16), p=0.008; -26.00 (-31.71- -20.29) vs. -16.35 (-23.39- -9.31), p=0.034 and -21.25 (-29.11- -13.39) vs. -10.98 (-17.53- -4.43), p=0.042, respectively] and one month after beginning of treatment [-5.58 (-6.45- -4.72) vs. -3.61 (-4.60- -2.62), p<0.001; -33.43 (-40.85- -26.01) vs. -20.03 (-26.00- -14.07), p=0.001; --42.83 (-49.09- -36.57) vs. -25.57 (-33.92- -17.21), p<0.001 and -27.55 (-36.19- -15.94) vs. -16.58 (-24.48- -8.67), p=0.041, respectively]. Active abduction ROM was also improved more significantly immediately after treatment in experiment group compared to control group [25.83 (11.45- 40.13) vs. 10.17 (1.02- 19.15), p=0.025], however there were no significant differences between two groups concerning other measured ROMs immediately and one month after treatment (all p>0.05). Conclusions: Acromioclavicular mobilization along with conventional physical therapy was more efficient in decreasing pain and disability and improving active abduction ROM compared to physical therapy in patients with FS. These findings would suggest a new therapeutic method for shoulder disorders with pain and disability.Trial registrationwww.irct.ir, IRCT20100605004104N7, registered 06.01.2019 (https://www.irct.ir/trial/35900)

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).

scholarly journals Intravesical Instillation of Sodium Hyaluronate (Cystistat®) for the Treatment of Patients with Radiation Cystitis-Randomized Clinical Trial

2020 ◽  
Vol 13 (11) ◽  
Author(s):  
Farzad Allameh ◽  
Abbas Basiri ◽  
Saleh Ghiasy ◽  
Atefeh Javadi ◽  
Seyyed Ali Hojjati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Sodium Hyaluronate ◽  
Intravesical Instillation ◽  
Control Group ◽  
Radiation Cystitis ◽  
Vas Score ◽  
The Mean

Background: Radiotherapy (RT) is a choice to manage pelvic organ malignancies that can affect bladder; therefore, it causes radiation cystitis with some bothering urinary symptoms and decreasing the patient’s quality of life. Intravesical hyaluronic acid (HA) is an agent with promising results in some studies for cystitis, and Cystistat is a derivative of hyaluronic acid. Objectives: This clinical trial aimed at evaluating the effects of intravesical instillation of Cystistat on symptoms of radiation cystitis and quality of life (QOL). Methods: A total of 58 patients with radiation cystitis were randomized in 2 groups (case: 30, control: 28). One group received intravesical Cystistat, the other received normal saline weekly for up to 4 weeks and then monthly for up to 2 months. Hematuria, Visual Analog scale (VAS) and QOL based on King’s Health questionnaire were compared before and 3, 6 and 9 months after intravesical instillation. Results: The mean age of the patients was 63.93 ± 10.89 years old. The mean of each sub-category of QOL and total score of QOL, as well as, VAS score were significantly improved in comparison to the control group at each time of follow-ups (P < 0.05). Hematuria was significantly different in the 3rd, 6th and 9th month of follow-ups (P < 0.05). Conclusions: Findings showed that patients with radiation cystitis could significantly benefit from intravesical instillation of HA, their hematuria would be successfully resolved rather than control group in addition to lowering the VAS score, so their QOL would be improved.

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