The effect of letrozole versus artificial hormonal endometrial preparation on pregnancy outcome after frozen-thawed embryos transfer cycles: a randomized clinical trial

Abstract Background Considering that clinical trial studies are limited in polycystic ovary syndrome (PCOS) patients, and there is no consensus on an optimum endometrial preparation protocol for frozen embryo transfer (FET), the present study was designed as a randomized clinical trial to compare the reproductive outcomes following stimulated cycles with letrozole plus human menopausal gonadotropin (HMG) for endometrial preparation compared with routine AC-FET. Methods This randomized controlled trial was carried out on infertile PCOS patients who underwent IVF/ICSI and FET cycles in Arash Women’s Hospital affiliated to Tehran University of Medical Sciences between September 2018 and January 2020. PCOS diagnosis was based on the Rotterdam criteria. Eligible patients were randomly allocated into two groups: stimulated cycle with letrozole plus (HMG) (intervention group) and routine artificial hormonal endometrial preparation (control group). Results One hundred seventy-seven infertile patients were recruited for participation in the study. Of these, 57 women were excluded due to non-eligibility for entering the study, and a total of 120 patients were randomly assigned to two study groups. After follow up, the cycle outcomes of 57 patients in the intervention group and 59 patients in the control group were compared. The data analysis showed that the two groups did not have significant differences in fundamental and demographic characteristics. After the intervention, there were no significant differences in implantation rate, chemical, ectopic, and clinical pregnancy rates between groups. Moreover, the rates of miscarriage and ongoing pregnancy were similar between groups (P > 0.05). Conclusions We found similar pregnancy outcomes with two endometrial preparation methods. Noting that each treatment centre should select the most beneficial and cost-effective method with the least adverse effects for patients, letrozole preparations for FET could be incorporated into possible options; however, establishing this approach as first-line treatment is premature in light of current evidence, and future randomized clinical trials with larger sample sizes are required for widespread application. Trial registration The study was also registered in the Iranian Registry of Clinical Trials on March 20th, 2020. (IRCT20090526001952N12 at www.irct.ir, registered retrospectively).

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

Journal of Telemedicine and Telecare ◽

10.1177/1357633x211009640 ◽

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)

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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 ◽

10.1186/s12916-021-02005-5 ◽

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

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

Melatonin Research ◽

10.32794/mr112500115 ◽

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.

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

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2017-0085 ◽

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.

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The Effect of Support Surfaces on the Incidence of Pressure Injuries in Critically Ill Patients: A Randomized Clinical Trial

Critical Care Research and Practice ◽

10.1155/2018/3712067 ◽

2018 ◽

Vol 2018 ◽

pp. 1-6 ◽

Cited By ~ 1

Author(s):

Wesley Henrique Bueno de Camargo ◽

Rita de Cassia Pereira ◽

Marcos T. Tanita ◽

Lidiane Heko ◽

Isadora C Grion ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Critically Ill ◽

Critically Ill Patients ◽

Intervention Group ◽

Control Group ◽

Support Surface ◽

Intention To Treat ◽

Support Surfaces ◽

Effect Of Support

Purpose. To analyze whether a viscoelastic mattress support surface can reduce the incidence of stage 2 pressure injuries compared to a standard hospital mattress with pyramidal overlay in critically ill patients. Method. A randomized clinical trial with intention-to-treat analysis was carried out recruiting patients with Braden scale ≤14 on intensive care unit admission from April 2016 to April 2017. Patients were allocated into two groups: intervention group (viscoelastic mattress) and control group (standard mattress with pyramidal overlay). The level of significance adopted was 5%. Results. A total of 62 patients were included in the study. There was a predominance of males (53%) and the mean age was 67.9 (SD 18.8) years. There were no differences in clinical or severity characteristics between the patients in the control group and the intervention group. Pressure injuries occurred in 35 patients, with a median time of 7 days (ITQ 4–10) from admission. The frequency of pressure injuries was higher in the control group (80.6%) compared to the intervention group (32.2%; p<0.001). Conclusions. Viscoelastic support surfaces reduced the incidence of pressure injuries in moderate or higher risk critically ill patients when compared to pyramidal support surfaces.

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Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial

BMC Cancer ◽

10.1186/s12885-020-07558-x ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

María Nieves Muñoz-Alcaraz ◽

Luis Ángel Pérula-de-Torres ◽

Jesús Serrano-Merino ◽

Antonio José Jiménez-Vílchez ◽

María Victoria Olmo-Carmona ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Randomized Clinical Trial ◽

Group Intervention ◽

Skin Care ◽

Stage I ◽

Current Evidence ◽

Link Type ◽

Proprioceptive Neuromuscular Facilitation ◽

Arm Lymphedema

Abstract Background Breast cancer (BC) is a major public health issue. More than one out of five women treated for breast cancer will develop lymphedema in an upper extremity. Current evidence advocates transdisciplinary oncological rehabilitation. Therefore, research in this area is necessary since limited consensus having been reached with regard to the basic essential components of this rehabilitation. Consensus has, however, been reached on the use of decongestive lymphedema therapy (DLT), but due to a lack of tests, the necessary dosages are unknown and its level is moderately strong. This study attempts to verify both the efficacy of activity-oriented proprioceptive antiedema therapy (TAPA), as compared to conventional treatments such as DLT or Complex Physical Therapy (CPT), as well as its efficiency in terms of cost-effectiveness, for patients affected by breast cancer-related arm lymphedema. Methods Controlled, randomized clinical trial with dual stratification, two parallel arms, longitudinal and single blind. 64 women with breast cancer-related arm lymphedema will take part in the study. The experimental group intervention will be the same for stage I and II, and will consist of neuro-dynamic exercises oriented to the activity, proprioceptive neuromuscular facilitation activities and proprioceptive anti-edema bandaging. The control group intervention, depending on the stage, will consist of preventive measures, skin care and exercise-prescribed training in the lymphedema workshop as well as compression garments (Stage I) or conservative Complex Decongestive Therapy treatment (skin care, multi-layer bandaging, manual lymphatic drainage and massage therapy) (Stage II). Results Sociodemographic and clinical variables will be collected for the measurement of edema volume and ADL performance. Statistical analysis will be performed on intent to treat. Discussion It has been recommended that patient training be added to DLT, as well as a re-designing of patient lifestyles and the promotion of health-related aspects. In addition, clinical trials should be undertaken to assess neural mobilization techniques and proprioceptive neuromuscular facilitation should be included in the therapy. Cohesive bandaging will also be performed as an early form of pressotherapy. The proposed study combines all of these aspects in order to increased comfort and promote the participation of individuals with lymphedema in everyday situations. Limitations The authors have proposed the assessment of the experimental treatment for stages I and II. One possible limitation is the lack of awareness of whether or not this treatment would be effective for other stages as well as the concern for proper hand cleansing during use of bandages, given the current COVID-19 pandemic situation. Trial registration This trial was registered in ClinicalTrials.gov (NCT03762044). Date of registration: 23 November 2018. Prospectively Registered.

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Effect of Mindfulness Sessions on Chronic Fatigue Syndrome and Job Satisfaction of Nurses: A Randomized Clinical Trial

10.21203/rs.3.rs-567623/v1 ◽

2021 ◽

Author(s):

Nasrin Bonakdari ◽

Nadereh Mohammadi ◽

Mohammad Reza Taghvizadeh Yazdi ◽

Reza Norouzadeh ◽

Mohammad Abbasinia ◽

...

Keyword(s):

Job Satisfaction ◽

Clinical Trial ◽

Chronic Fatigue Syndrome ◽

Randomized Clinical Trial ◽

Intervention Group ◽

Clinical Trial Design ◽

Well Being ◽

Chronic Fatigue ◽

Control Group ◽

Fatigue Syndrome

Abstract Background: Nursing is considered a stressful profession, so nurses are at higher risk of physical and mental illness. Mindfulness is an important concept for nursing with practical implications for nurse well-being, development, and quality nursing care sustainability.Objectives: This study identified mindfulness sessions' effect on nurses' chronic fatigue syndrome(CFS) and job satisfaction )JS.(Methods: A randomized clinical trial design was conducted on 80 nurses to intervention and control groups. The intervention in the intervention group was eight mindfulness sessions training, and the control group had no intervention. Nurses' CFS and JS were assessed using the Minnesota Satisfaction Questionnaire and The Multidimensional Fatigue Inventory.Results: After implementing a mindfulness-based stress reduction program, the intervention group nurses reported lower CFS and higher JS than the control group(p<0.005). Conclusion: The findings of this study indicate the effectiveness of mindfulness programs on improving nurses' chronic fatigue and JS. Since CFS and job dissatisfaction are two disturbing elements for nurses' optimal performance in professional and personal life, this study can recommend the implementation of mindfulness exercises as a routine, operational and uncomplicated program in nurses.

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The impact of social network-based nursing care training on oncology nurses’ occupational stress and self-efficacy: Non-randomized clinical trial

Nursing Practice Today ◽

10.18502/npt.v8i1.4494 ◽

2020 ◽

Author(s):

Mehri Bozorgnejad ◽

Tahereh Najafi Ghezeljeh ◽

Hamid Haghani ◽

Amin Iri

Keyword(s):

Clinical Trial ◽

Social Network ◽

Randomized Clinical Trial ◽

Occupational Stress ◽

Nursing Care ◽

Self Efficacy ◽

Intervention Group ◽

Oncology Nurses ◽

Control Group ◽

Care Training

Background & Aim: Inadequate clinical knowledge is one of the leading causes of stress and low occupational self-efficacy among nurses. Nursing training can enhance self-efficacy and reduce stress. Therefore, this study aimed to determine the effect of social network-based nursing care training, using mobile phones, occupational stress, and self-efficacy among oncology nurses. Methods & Materials: This non-randomized clinical trial study was conducted on 78 nurses working in oncology wards of two selected educational hospitals in Tehran in 2018. The nurses entered the study through available sampling. They were randomly assigned to two groups of control and intervention. Nursing care training in chemotherapy was provided to the nurses in the intervention group through a mobile phone social network for four weeks. On the other hand, the nurses in the control group were provided with the routine training pamphlets and brochures in the oncology ward. The nurses’ stress level was examined using an expanded nursing stress scale and their occupational stress was measured using a job self-efficacy questionnaire once before the intervention and then one month after the intervention. The data analysis was then performed according to independent t-test, paired t-test, and chi-square using SPSS software version 16. Results: The two groups were homogeneous in terms of age, gender, work experience, and education. There was no significant difference in terms of occupational stress and self-efficacy between the two groups before the intervention (P<0.05). The changes in the occupational stress score were statistically significant (P<0.05) among the nurses in the intervention group. Moreover, the changes in the occupational self-efficacy score were statistically significant among nurses in the intervention group compared to the control group (P<0.05). Conclusion: Educational intervention through social networking can lead to a reduction of occupational stress and an increase in self-efficacy among oncology nurses. Reducing stress and increasing nurses’ occupational self-efficacy will improve their performance at the bedside. This is an easy, inexpensive, and effective training method that can be used by health managers and educators to enhance employee’s performance.

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The Effect of Simultaneous Sand-Ice Bag Application on Hemorrhage and Hematoma after Percutaneous Coronary Intervention: A Randomized Clinical Trial

Journal of Caring Sciences ◽

10.34172/jcs.2020.029 ◽

2020 ◽

Vol 9 (4) ◽

pp. 188-194

Author(s):

Maryam Valikhani ◽

Seyyed Mousa Mahdizadeh ◽

Ali Eshraghi ◽

Seyyed Reza Mazloum ◽

Javad Dehghani

Keyword(s):

Clinical Trial ◽

Percutaneous Coronary Intervention ◽

Randomized Clinical Trial ◽

Hospital Costs ◽

Intervention Group ◽

Coronary Intervention ◽

Control Group ◽

Selective Treatment ◽

Percutaneous Coronary ◽

Coronary Syndromes

Introduction: Angioplasty is widely used as a selective treatment for acute coronary syndromes. The complications of this procedure often lead to an increase in the length of the patients’ stay and hospital costs. Therefore, this study aimed to determine the effect of using sand and ice bags on hematoma and hemorrhage after percutaneous coronary intervention (PCI). Methods: In this randomized clinical trial, study was completed with participation of 60 patients with femoral angioplasty candidate, referring to Imam Reza hospital in Mashhad, were randomly divided into control and intervention groups. In the control group, a sand bag was placed on the location for up to 4 hours. In the intervention group, the ice bag and the sand bag were used simultaneously for 15 minutes, and then for 45 minutes, with the pressure of the sand bag only. This cycle was repeated four times. Hemorrhage (volume and weight) and hematoma (area and lump) were checked four times. The data were analyzed using SPSS software version 22. Results: The rate of hemorrhage after intervention was significantly reduced in the intervention group compared to the control group. Although the incidence of hematoma in the intervention group decreased from control to 20% to 6.7%, but the statistical test was not significant. Conclusion: According to the results of the present study, the simultaneous sand-ice bag application can reduce post-PCI’ hemorrhage (and hematoma rate, though insignificantly) through compression and vasoconstriction.

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Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

Anesthesiology and Pain Medicine ◽

10.5812/aapm.117140 ◽

2021 ◽

Vol 11 (4) ◽

Author(s):

Farhad Soltani ◽

Farahzad Janatmakan ◽

Sara Jorairahmadi ◽

Fatemeh Javaherforooshzadeh ◽

Pooyan Alizadeh ◽

...

Keyword(s):

Clinical Trial ◽

Traumatic Brain Injury ◽

Brain Injury ◽

Randomized Clinical Trial ◽

Rating Scale ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Disability Rating Scale ◽

Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

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