Effect of skin-to-skin contact on the placental separation time, mother’s oxytocin and pain levels: randomized controlled trial

2019 ◽  
Vol 44 (5) ◽  
pp. 706-713
Author(s):  
Zekiye Turan ◽  
Ayten Şentürk Erenel
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Routine Care ◽  
Control Group ◽  
Separation Time ◽  
Randomized Controlled ◽  
Skin Contact ◽  
Significant Difference ◽  
Skin To Skin

Abstract Objective This study determined the effect of skin-to-skin contact (SSC) between mother and infant during the third stage of labor on postpartum levels of oxytocin and pain and placental separation time. Methods This randomized controlled trial was composed of 64 parturients: 32 in the intervention group and 32 in the control group. SSC interventions between infants and their mothers occurred for 30 min after birth, whereas infants in the control group were provided routine care. Data were gathered using an introductory information form, Visual Analog Scale, determination of placental separation degree form, and time and records of oxytocin analyses. Results There was no significant difference regarding placental separation time and 1st and 30th min oxytocin levels of mothers (p>0.05), whereas postpartum 5th, 15th and 30th min pain levels of women in the intervention group were significantly lower than women in the control group (p<0.05). Conclusion SSC is a valuable practice for both mother and infant, which especially reduces a mother’s pain. The study should be reiterated by excluding other variables that are likely to affect oxytocin levels.

scholarly journals Effects of Father-Neonate Skin-to-Skin Contact on Attachment: A Randomized Controlled Trial

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Er-Mei Chen ◽  
Meei-Ling Gau ◽  
Chieh-Yu Liu ◽  
Tzu-Ying Lee
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Demographic Data ◽  
Intervention Group ◽  
Active Role ◽  
Control Group ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Skin Contact ◽  
Skin To Skin

This study examines how skin-to-skin contact between father and newborn affects the attachment relationship. A randomized controlled trial was conducted at a regional teaching hospital and a maternity clinic in northern Taiwan. The study recruited 83 first-time fathers aged 20 years or older. By block randomization, participants were allocated to an experimental (n=41) or a control (n=42) group. With the exception of skin-to-skin contact (SSC), participants from each group received the same standard care. Both groups also received anEarly Childcare for Fathersnursing pamphlet. During the first three days postpartum, the intervention group members were provided a daily SSC intervention with their respective infants. Each intervention session lasted at least 15 minutes in length. The outcome measure was the Father-Child Attachment Scale (FCAS). After adjusting for demographic data, the changes to the mean FCAS were found to be significantly higher in the intervention group than in the control group. We recommend that nurses and midwives use instructional leaflets and demonstrations during postpartum hospitalization, encouraging new fathers to take an active role in caring for their newborn in order to enhance father-neonate interactions and establish parental confidence. This trial is registered with clinical trial registration numberNCT02886767.

Kangaroo Care and Breastfeeding of Mother–Preterm Infant Dyads 0–18 Months: A Randomized, Controlled Trial

2008 ◽  
Vol 27 (3) ◽  
pp. 151-159 ◽  
Author(s):  
Sara Hake-Brooks ◽  
Gene Cranston Anderson
Keyword(s):  
Randomized Controlled Trial ◽  
Breast Milk ◽  
Preterm Infant ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Kangaroo Care ◽  
Randomized Controlled ◽  
Skin Contact ◽  
Skin To Skin

Purpose: To determine the effects of kangaroo care (KC) (skin-to-skin contact) on breastfeeding status in mother–preterm infant dyads from postpartum through 18 months.Design: Randomized, controlled trial. The control group received standard nursery care; in the intervention group, unlimited KC was encouraged.Sample: A subsample of 66 mothers and their preterm infants (32–36 completed weeks gestation, 1,300–3,000 g, 5 minute Apgar ≥6) who intended to breastfeed.Main Outcome Variables: Breastfeeding status at hospital discharge and at 1.5, 3, 6, 12, and 18 months as measured by the Index of Breastfeeding Status.Results: KC dyads, compared to control dyads, breastfed significantly longer (5.08 months vs 2.05 months), p = .003. KC dyads also breastfed more exclusively at each measurement, p = .047. More KC dyads than control dyads breastfed at full exclusivity (100 percent breast milk, index of breastfeeding status levels 1 or 2) at discharge and at 1.5, 3, and 6 months. Mean KC contact per day was 4.47 hours.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals The Effect of Writing Therapy on Anxiety in Pregnant Women: A Randomized Controlled Trial

2020 ◽  
Vol 14 (2) ◽  
Author(s):  
Maryam Montazeri ◽  
Khalil Esmaeilpour ◽  
Sakineh Mohammad-Alizadeh-Charandabi ◽  
Sevda Golizadeh ◽  
Mojgan Mirghafourvand
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Block Design ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Writing Therapy ◽  
Randomized Block Design ◽  
Significant Difference

Background: As one of the most enjoyable life experiences, pregnancy may be accompanied by many physiological and psychological changes that make women susceptible to developing mental disorders such as anxiety. Non-pharmacological methods such as writing therapy are among the ways to deal with anxiety. Objectives: The present study aimed to determine the effect of writing therapy on anxiety in women during pregnancy. Methods: This randomized controlled trial was conducted on 70 pregnant women with a gestational age between 28 - 31 weeks. The participants were assigned to an intervention group and a control group using a randomized block design. The intervention group received three in-person writing therapy-based counseling sessions and two telephone calls between the sessions, while the control group received routine pregnancy care. The Beck anxiety inventory was completed before and six weeks after the intervention. Independent t-test and ANCOVA were used for data analysis. Results: There was no significant difference between the two groups in terms of socio-demographic variables and baseline anxiety scores. Based on ANCOVA with baseline score adjustment, the mean score of anxiety was significantly lower in the intervention group than in the control group after the intervention (adjusted mean difference = -6.8; 95%CI = -4.5 to -9.1; P < 0.001). Conclusions: According to the results, writing therapy can reduce anxiety in pregnant women; however, further studies are needed before a definitive conclusion.

scholarly journals EVALUASI INTERVENSI MEDIA BOOKLET TERHADAP TINGKAT PENGETAHUAN DAN KEPATUHAN PASIEN DIABETES MELITUS TIPE 2 DI PUSKESMAS BANJARBARU SELATAN

2019 ◽  
Vol 6 (1) ◽  
Author(s):  
Valentina Meta Srikartika ◽  
M. Rasyid Akbar ◽  
Herningtyas Nautika Lingga
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
P Value ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Level Of Knowledge ◽  
Diabetes Melitus

ABSTRAKKeberhasilan pengobatan diabetes melitus tidak hanya dipengaruhi oleh kualitas pelayanan kesehatan, keterampilan petugasnya, sikap, dan pola hidup pasien, tetapi dipengaruhi juga oleh kepatuhan pasien terhadap pengobatannya. Tingkat kepatuhan minum obat pasien diabetes mellitus di Indonesia mayoritas masih berada dibawah 50%. Tujuan dari penelitian ini adalah mengukur pengaruh edukasi melalui media booklet terhadap pengetahuan dan kepatuhan pasien diabetes melitus tipe 2. Jenis penelitian yang digunakan adalah Randomized Controlled Trial (RCT). Populasi yang didapat dari penelitian ini sebanyak 40 orang dengan kelompok kontrol 20 orang dan kelompok intervensi 20 orang. Kelompok kontrol merupakan kelompok yang tidak mendapatkan booklet, sedangkan kelompok intervensi adalah kelompok yang mendapatkan booklet sebagi media edukasi. Pengetahuan dan kepatuhan responden diukur melalui kuesioner yang diberikan sebelum (pretest) dan 2 minggu kemudian (posttest). Rata-rata skor pengetahuan dan kepatuhan pre-test dibandingkan dengan skor post-test dengan menggunakan uji Wilcoxon. Berdasarkan hasil analisis, terjadi perbedaan tingkat pengetahuan dan kepatuhan yang signifikan (p value < 0,001) antara sebelum dan sesudah pemberian booklet pada kelompok intervensi dan tidak ada perbedaan yang signifikan pada tingkat pengetahuan (p value = 0,83) dan kepatuhan (p value = 0,317) pada kelompok kontrol. Oleh karena itu, dapat disimpulkan bahwa media booklet dapat meningkatkan tingkat pengetahuan dan kepatuhan pada pasien diabetes melitus.Kata-kata kunci: Diabetes melitus, pengetahuan, kepatuhan, bookletABSTRACTThe success of a treatment of diabetes mellitus is not only influenced by the quality of health services, the skills of its officers, attitudes, and lifestyle of patients, but it is also influenced by patient adherence to treatment. The level of medication compliance among diabetes patients in Indonesia were still below 50%. The purpose of this study was to measure the effect of education through booklet media on the knowledge and compliance of patients with type 2 diabetes mellitus. The type of research used was Randomized Controlled Trial (RCT). The population obtained from this study were 40 people with a control group of 20 people and an intervention group of 20 people. The control group was the group that did not get the booklet, while the intervention group was the group that received the booklet as an educational medium. Knowledge and compliance of respondents was measured through questionnaires given before (pretest) and 2 weeks later (posttest). The average score of knowledge and adherence between pretest and posttest will be compared using Wilcoxon analysis. Based on the results of data analysis with the Wilcoxon test, there was a significant difference in the level of knowledge and compliance (p value < 0.001) between before and after booklet administration in the intervention group and no significant difference in knowledge level (p value = 0.83) and compliance (p value = 0.317) in the control group. It can be concluded that the booklet media can increase the level of knowledge and compliance in diabetes mellitus patients.Keywords: Diabetes mellitus, knowledge, compliance, booklet

scholarly journals Effectiveness of WeChat for Improving Exclusive Breastfeeding in Huzhu County China: Randomized Controlled Trial

10.2196/23273 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e23273
Author(s):  
Qiong Wu ◽  
Yiwen Huang ◽  
Zijun Liao ◽  
Michelle Helena van Velthoven ◽  
Wei Wang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pregnant Women ◽  
Exclusive Breastfeeding ◽  
Controlled Trial ◽  
Intervention Group ◽  
Mobile Technologies ◽  
Control Group ◽  
Randomized Controlled ◽  
Breastfeeding Rate ◽  
Significant Difference

Background The benefits of breastfeeding for both infants and mothers have been well recognized. However, the exclusive breastfeeding rate in China is low and decreasing. Mobile technologies have rapidly developed; communication apps such as WeChat (one of the largest social networking platforms in China) are widely used and have the potential to conveniently improve health behaviors. Objective This study aimed to assess the effectiveness of using WeChat to improve breastfeeding practices. Methods This 2-arm randomized controlled trial was conducted among pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China. Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet. A total of 344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group. Women in the intervention group received breastfeeding knowledge and promotion information weekly through a WeChat official account from their third month of pregnancy to 6 months postpartum. The primary outcome of exclusive and predominant breastfeeding rate was measured 0-1 month, 2-3 months, and 4-5 months postpartum. Results At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001). Similarly, mothers in the intervention group were more likely to provide predominantly breast milk (OR 2.77, 95% CI 1.55-4.96; P<.001) and less likely to give dairy products to their children (OR 0.40, 95% CI 0.21-0.75; P=.005). There was no statistically significant difference for exclusive breastfeeding rate 2-3 months (P=.09) and 4-5 months postpartum (P=.27), though more children in the intervention group were exclusively breastfed than those in the control group 2-3 months postpartum (intervention: 111/152, 73.0%; control: 96/152, 63.2%) and 4-5 months postpartum(intervention: 50/108, 46.3%; control: 46/109, 42.2%). Conclusions This study is the first effort to promote exclusive breastfeeding through WeChat in China, which proved to be an effective method of promoting exclusive breastfeeding in early life. WeChat health education can be used in addition to local breastfeeding promotion programs. Trial Registration Chinese Clinical Trial Registry ChiCTR1800017364; http://www.chictr.org.cn/showproj.aspx?proj=29325 International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7676-2

No evidence of effectiveness of mirror therapy early after stroke: an assessor-blinded randomized controlled trial

2019 ◽  
Vol 33 (5) ◽  
pp. 885-893 ◽  
Author(s):  
Paola Antoniotti ◽  
Laura Veronelli ◽  
Antonio Caronni ◽  
Alessia Monti ◽  
Evdoxia Aristidou ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Upper Limb ◽  
Controlled Trial ◽  
Intervention Group ◽  
Functional Independence ◽  
Control Group ◽  
Mirror Therapy ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Flexion Extension

Objective: The aim of this study was to investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients. Design: Assessor-blinded randomized controlled trial. Setting: Inpatient rehabilitation clinic. Subjects: A total of 40 patients with upper-limb impairment due to a first-ever ischaemic or haemorrhagic stroke, within four weeks from the cerebrovascular accident. Intervention: The intervention group received mirror therapy, while the control group received sham therapy. During mirror therapy, patients’ sound hand was reflected by a mirror. During sham therapy, an opaque surface replaced the mirror-reflecting surface. Both the mirror therapy and sham therapy groups practised their sound hand with exercises, ranging from the simple elbow flexion–extension to complex tasks (e.g. reaching and grasping). Mirror therapy and sham therapy were added to conventional rehabilitation. Main measures: Primary outcome includes Fugl–Meyer upper extremity scale. Secondary outcomes include action research arm test (ARAT) and functional independence measure (FIM) scale. Outcomes were measured at the beginning (T0) and end (T1) of the treatment. Results: At baseline, both groups (sham therapy vs. mirror therapy; mean (SD)) were comparable for Fugl–Meyer (30.9 (23.9) vs. 28.5 (21.8)), ARAT (25.1 (25.5) vs. 23.5 (24)) and FIM (71.0 (20.6) vs. 72.9 (17.8)) scores. At the end of the treatment, both groups significantly improved in the Fugl–Meyer (40.6 (21.3) vs. 38.3 (23.4)), ARAT (31.9 (23.0) vs. 30 (24.1)) and FIM (100.3 (21.9) vs. 99.4 (22.6)) scores. However, at T1, no significant difference was observed between the sham therapy and mirror therapy groups, neither for the Fugl–Meyer, nor for ARAT and FIM scores. Conclusion: Compared with sham therapy, mirror therapy did not add additional benefit to upper-limb recovery early after stroke.

scholarly journals Effects of the Liaison Nurse Management on the Infectious Stroke Complications: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Zohreh Kalani ◽  
Sedigheh Ebrahimi ◽  
Hossein Fallahzadeh
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Tract Infection ◽  
Urinary Tract ◽  
Tract Infection ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Liaison Nurse

Abstract Background Two of the most serious complications after stroke are pneumonia, and urinary tract infection. Liaison nurse, from hospital admission to discharge and then at home helps patients with complicated caring issues stroke. This study investigates the effect of liaison nurse management on the incidence of pneumonia and urinary tract infection in patients with stroke after discharge from the hospital. Methods This randomized controlled trial was conducted on 80 patients in a hospital in Iran. The intervention group was assessed and developed a caring program by the liaison nurse and the control group received routine care. Two weeks and two months after discharge, the patients were evaluated for the incidence of pneumonia and urinary tract infection. Collected data were analyzed using the Chi-square test. P < 0.05 was considered statistically significant. Results The two groups were homogenous in terms of mean age; gender frequently distribution, and having urinary catheter. The incidence of pneumonia in intervention and control groups (11.6% vs. 19.2%, P = 0.35) had no statistically significant differences, but there was a significant difference in the incidence of urinary tract infection (0% vs. 24.6%, P < 0.001). Conclusions With liaison nurse performance, there was a significant difference in the incidence of urinary tract infection, in two months after discharge from hospital, but the incidence of pneumonia had no statistically significant differences in two groups. Nurse's evaluation each patient individually according to needs, developing and monitoring the home-based care program, beyond overall education to these patients, could reduce some of complications of a stroke. Trial registration: This study is retrospectively registered by Iranian Registry of Clinical Trials with decree code: IRCT20170605034330N3 on April 4, 2018.

scholarly journals Comparing The Effects of Self-Selected Music Versus Predetermined Music On Patient Anxiety Prior To Gynaecological Surgery: The MUANX Randomized Controlled Trial

2021 ◽  
Author(s):  
Danielle Reynaud ◽  
Nicolas Bouscaren ◽  
Victorine Lenclume ◽  
Malik Boukerrou
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Well Being ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Gynaecological Surgery ◽  
Patient Anxiety ◽  
Randomized Controlled ◽  
Significant Difference

Abstract Background: Anxiety is frequently observed in the preoperative setting. The negative impact of preoperative anxiety is well known. In the context of gynaecological surgery, anxiety is exacerbated by the fact that the intervention can have catastrophic repercussions on a woman’s body image, sexuality, and psycho-affective well-being. Music listening is increasingly used as an alternative therapy for minimizing preoperative anxiety. Personal preferences, familiarity and popularity may be key elements for an optimal relaxation response to music. This study aimed to determine whether listening to self-selected music decreases preoperative anxiety in women scheduled to undergo gynaecologic surgery compared with predetermined music from an application (MUSIC CARE®).Methods: The MUANX study was a single-blind, monocentric, parallel, superiority, randomized controlled trial. A total of 174 women were included and randomized in two groups between August 2017 and September 2018. Patients in the intervention group listened to the personal music playlist that they had created before being hospitalized. Patients in the control group listened to the predetermined playlist on the MUSIC CARE® application. All patients received standard nursing care and listened to 20 minutes of music one hour before surgery. Anxiety scores were assessed before and after the music session using Spielberger’s State-Trait Anxiety Inventory (STAI).Results: The mean age of the 171 evaluated patients was 41.5 years (SD=10.0 years). Before the music session, the STAI state anxiety score was similar in the control group (M=38.8, SD=11.9) and the intervention group (M=39.0, SD=13.1). After the music session, this score had significantly decreased in both the control group (M= -7.2, SD=9.0) and the intervention group (M=-5.5, SD=6.6), with no significant difference in score reduction between groups. Physiological parameters were unchanged after the music session. No significant differences in postoperative measurements (pain intensity, hospitalization duration) were observed between the two groups.Conclusion: Self-selected music is as effective as predetermined music for reducing patient anxiety before gynaecological surgery. As it has no side effects and is easily applicable in gynaecological surgical services, this non-drug intervention may be proposed by healthcare professionals in the management of preoperative anxiety.Trial registration The MUANX trial is registered at the US National Institutes of Health (ClinicalTrials.gov) #NCT03226834. Registered on 24 July 2017. https://clinicaltrials.gov/ct2/show/NCT03226834?term=muanx&draw=2&rank=1

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