Parallel Randomized Clinical Trial Research Articles

The Effect of Oral Gabapentin and Pregabalin as a Prodrug in Pain Control after Orthopedic Surgery on the Upper Limb: A Double-Blind Parallel Randomized Clinical Trial Study.

To compare the effects of oral gabapentin (GBP) and pregabalin (PGB) in pain control after orthopedic surgery on the upper limb. In this double-blind randomized clinical trial study, 80 patients who were the candidates for elective orthopedic surgery on one of the parts of the upper limb were divided into two groups using balance-block randomization. For the first group, a 150 mg capsule of PGB (one hour before the surgery) and for the second group, a 300 mg capsule of GBP (two hours before the surgery) were prescribed. Patients were subjected to standard monitoring at the beginning and during surgery. The pain scores were evaluated at before surgery, in PACU (postanesthesia care unit), and 6 and 12 hours after the surgery by VAS (visual analog scale). In this study, 37 subjects were allocated to each group. The participation rate was 92.5%. The mean with 95% confidence interval (CI) of pain scores over 4 times in the PGB group was 4.03 (3.25-4.79), 3.76 (3.02-4.49), 3.65 (3.06-4.23), and 3.41 (2.88-3.93) and in the GBP group was 4.08 (3.33-4.83), 2.78 (2.11-4.45), 2.3 (2.05-2.54), and 2 (1.51-2.50), respectively. The within-group comparisons showed a significant decrease in the pain score over time (P < 0.001). Also, the between-group comparison showed significant differences between the two groups in terms of pain score (P < 0.001). In the end, results showed that there is a significant interaction between time and intervention for pain score (P=0.042). Although two medicines led to a reduction in the pain score, but the rate reduction in the PGB group was significantly more than that in the GBP group. This trial is registered with IRCT20211013052759N1.

Promoting Healthy Adolescent Romantic Relationships: Results of a Multisite, Two-group Parallel Randomized Clinical Trial

PurposeTo examine the impact of About Us, an innovative healthy relationships intervention that promotes positive adolescent romantic relationships and the use of effective contraceptives, on improving behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution at 3- and 9-month follow-up, compared to services as usual. MethodsThis was a multi-site, two-group, parallel, randomized-controlled trial with an intervention/comparison allocation ratio of 3:2 conducted at seven high schools in California between February 2018 and May 2021. ResultsOverall, our study did not find statistically significant evidence of improved behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution among participants (14–18 years old) randomized to the intervention group (n = 316) compared to services as usual (n = 217) during follow-up (group x time; p > .05). Exploratory within group analyses showed that, compared to baseline, at the 3-month follow-up, the prevalence of reporting having had sex increased in the control group relative to intervention group (+19% vs. +9%, p < .01). Our sub-group analyses showed that changes in condom use intentions scores differed across school sites (group x time x school; p < .01); mixed (positive and negative) trends were observed for intervention effect, and schools with positive intervention effect trends tended to have greater program participation. DiscussionAbout Us did not show statistically significant positive impacts on primary or secondary outcomes as anticipated. Our exploratory findings show evidence of some promising trends of intervention effects at the school-level, suggesting a need for better tailored intervention components and/or delivery to address the unique environmental contexts of participants. Overall, the context of study implementation was negatively affected by the COVID-19 pandemic and challenges related to using a non-classroom delivery intervention approach. Combined, these factors may have contributed to the study null findings. Moreover, it is difficult to know (or determine) the intervention's impact under more ideal conditions (i.e., no COVID pandemic).

Caring Letters Sent by a Clinician or Peer to At-Risk Veterans

Caring letters is an evidence-based suicide prevention intervention in acute care settings, but its outcomes among individuals who contact a national crisis line have not previously been evaluated. To examine the outcomes of the Veterans Crisis Line (VCL) caring letters intervention and determine whether there are differences in outcomes by signatory. This parallel randomized clinical trial compared signatories of caring letters and used an observational design to compare no receipt of caring letters with any caring letters receipt. Participants included veterans who contacted the VCL. Enrollment occurred between June 11, 2020, and June 10, 2021, with 1 year of follow-up. Analyses were completed between July 2022 and August 2023. Veterans were randomized to receive 9 caring letters for 1 year from either a clinician or peer veteran signatory. The primary outcome measure was suicide attempt incidence in the 12 months following the index VCL contact. Incidence of Veterans Health Administration (VHA) inpatient, outpatient, and emergency health care use were secondary outcomes. All-cause mortality was an exploratory outcome. Wilcoxon rank-sum tests and χ2 tests were used to assess the differences in outcomes among the treatment and comparison groups. A total of 102 709 veterans (86 942 males [84.65%]; 15 737 females [15.32%]; mean [SD] age, 53.82 [17.35] years) contacted the VCL and were randomized. No association was found among signatory and suicide attempts, secondary outcomes, or all-cause mortality. In the analysis of any receipt of caring letters, there was no evidence of an association between caring letters receipt and suicide attempt incidence. Caring letters receipt was associated with increased VHA health care use (any outpatient: hazard ratio [HR], 1.10; 95% CI, 1.08-1.13; outpatient mental health: HR, 1.19; 95% CI, 1.17-1.22; any inpatient: HR, 1.13; 95% CI, 1.08-1.18; inpatient mental health: HR, 1.14; 95% CI, 1.07-1.21). Caring letters receipt was not associated with all-cause mortality. Among VHA patients who contacted the VCL, caring letters were not associated with suicide attempts, but were associated with a higher probability of health care use. No differences in outcomes were identified by signatory. isrctn.org Identifier: ISRCTN27551361.

Outcome and Prognostic Factors for Partial and Full Pulpotomy in the Management of Spontaneous Symptomatic Pulpitis in Carious Mature Permanent Teeth: A Randomized Clinical Trial

IntroductionThe aim of this study was to compare the outcome and prognostic factors for partial and full pulpotomy in the management of mature teeth with spontaneous symptomatic pulpitis. MethodsThe study was a parallel double-blind randomized clinical trial; 200 carious mature permanent teeth with spontaneous symptomatic pulpitis were randomized using a block randomization technique to either partial pulpotomy (n = 99) or full pulpotomy (n = 101). Intraoperative assessment of the pulp under magnification was performed, hemostasis was achieved with a 2.5% sodium hypochlorite moist pellet, and NeoPUTTY (Avalon Biomed, Bradenton, FL) was the pulpotomy material. Preoperative pain levels were recorded and re-evaluated after 1 week. Clinical and radiographic evaluation was performed after 6 and 12 months. Data were analyzed using the chi-square test, the Wilcoxon rank test, and regression analysis. ResultsAt 1 week, immediate failure occurred in 4 cases in partial pulpotomy, and 196 of 200 subjects reported pain relief and were satisfied with the treatment with no significant difference. At 6 months, 6 teeth failed in the partial pulpotomy group and 1 tooth in the full pulpotomy group, with a higher success rate for full pulpotomy (98.96 vs 89.69, P = .003). At 12 months, the recall rate was 98% (96/200). Full pulpotomy was more successful than partial pulpotomy (98.98% [98/99] vs 84.53% [82/97], P < .001). Multivariate analysis revealed that the odds of success for full pulpotomy were 13.6 times higher than partial pulpotomy. Increased age and higher time to hemostasis were significantly associated with decreased odds of success. ConclusionsFull pulpotomy has a higher success rate than partial pulpotomy in the management of spontaneous symptomatic pulpitis. Hemostasis within 4 minutes in partial pulpotomy can be set as the cutoff point beyond which further tissue removal is indicated.

The effectiveness of a web-based information-knowledge-attitude-practice continuous intervention on the psychological status, medical compliance, and quality of life of patients after coronary artery bypass grafting surgery: a parallel randomized clinical trial

BackgroundCoronary artery disease (CAD) patients who have undergone coronary artery bypass grafting (CABG) often experience a severe psychological burden for a long period of time, which can adversely affect their post-operative prognosis. Therefore, this study aimed to evaluate the effect of a web-based Information-Knowledge-Attitude-Practice (WIKAP) continuous intervention on the psychological status, medical compliance, and quality of life (QoL) in patients with CAD after CABG surgery.MethodsA parallel randomized clinical trial enrolled 174 CAD patients who underwent CABG at our hospital between January 2018 and December 2019. The participants were randomly divided into the Control and WIKAP group and received intervention for 12 months. The scores for anxiety, depression, medical compliance, and QoL were assessed on the first day (M0), 3rd month (M3), 6th month (M6), 9th month (M9) and 12th month (M12) after discharge. Furthermore, the occurrence of major adverse cardiac and cerebrovascular events (MACCE) was analyzed using the Kaplan-Meier curve and Cox proportional regression models for an additional 24-month follow-up period without any intervention.ResultsAfter the 12-month intervention, the scores of anxiety and depression were significantly reduced in the WIKAP group at M9 and M12 compared to those in the Control group (all P < 0.05). Additionally, the scores of medical compliance in the WIKAP group were remarkably elevated at M6, M9, and M12 compared with those scores in the Control group (all P < 0.05). Furthermore, the QoL scores were lower in the WIKAP group at M6, M9, and M12 compared to the Control group (all P < 0.05). However, the MACCE-free survival showed no significant difference between the two groups (P > 0.05). Cox proportional regression analysis also showed that the nursing intervention (Control vs. WKIAP) was not associated with the incidence of MACCE.ConclusionWIKAP nursing intervention effectively improved the psychological health, medical compliance, and QoL in CAD patients who underwent CABG operation, but it did not prolong MACCE-free survival.Trail registrationThe study is registered in isrctn.org: ISRCTN13653455.

Annatto-Enriched Egg Improves the Perception of Satiety in Healthy Adults-Randomized Clinical Trial: EGGANT Study.

This study evaluated the effects of egg and annatto-enriched egg consumption on satiety markers and CVD risk factors in healthy adults from Colombia. A parallel randomized clinical trial was conducted, where one hundred and five (n = 105) men and women, divided into three groups, consumed daily for 8 weeks: (a) two eggs (egg group), or (b) two eggs with annatto (egg + annatto group), or (c) two egg whites (placebo group). The three groups were similar in gender distribution. No significant changes were found over time (before vs. after) in any of the groups nor between the groups in anthropometric variables, physical activity, eating profile, and ghrelin as an objective marker of satiety. In the egg + annatto group, subjective satiety increased (effect size 0.431; p < 0.05) after consumption. In healthy adults, the intake of two eggs, or two eggs with annatto daily for 8 weeks, did not result in significant changes in ghrelin; but eggs with annatto tend to increase the perception of satiety.

Common Study Designs of Nutrition Clinical Trials: Review of the Basic Elements and the Pros and Cons

Introduction: Nutrition Clinical Trials (NCTs) are pivotal in establishing causal links between nutritional interventions and chronic diseases. This review comprehensively examines prevalent clinical trial designs, emphasizing their strengths and limitations. The goal is to provide insights into the selection and optimization of these designs for dietary intervention studies.&#x0D; Methods: Various study designs in NCTs are explored, including quasi-experimental designs, double-blind randomized placebo-controlled trials for nutrient/functional foods supplementation, community-based lifestyle interventions, pragmatic nutrition interventions, and field trial projects. The characteristics, advantages, and challenges of each design are discussed. Real examples are presented to illustrate how these designs can be tailored and optimized for dietary intervention studies.&#x0D; Results: Parallel randomized clinical trials are acknowledged as the gold standard, despite requiring substantial sample sizes and having inherent limitations. Cross-over NCTs emerge as valuable for assessing temporary treatment effects while mitigating potential confounders and interpatient variability. However, they may not be suitable for acute diseases and progressive disorders, and attrition rates can be higher. Multi-arm randomized designs offer increased study power with a lower sample size but necessitate more intricate design, analysis, and result reporting.&#x0D; Conclusion: In conclusion, each study design in NCTs comes with its set of strengths and limitations. The selection of an appropriate design should consider determinants and common considerations to provide robust evidence for establishing cause-and-effect associations or assessing the safety and efficacy of food products in nutrition research. This comprehensive understanding aids researchers in making informed choices when planning and conducting nutrition clinical trials.

Mesenchymal Stem Cells for Prophylaxis of Chronic Graft-vs-Host Disease After Haploidentical Hematopoietic Stem Cell Transplant

ImportanceChronic graft-vs-host disease (GVHD) limits the long-term benefit of haploidentical hematopoietic stem cell transplant (HSCT). This clinical trial evaluated repeated infusions of umbilical cord mesenchymal stem cells (MSCs) during the early stage (45 days and 100 days) after haplo-HSCT to prevent chronic GVHD.ObjectiveTo determine whether repeated infusions of MSCs during the early stage after haplo-HSCT decreases the incidence of severe chronic GVHD.Design, Setting, and ParticipantsThis open-label, multicenter, parallel randomized clinical trial was conducted from April 2016 to January 2022. Eligibility criteria included a diagnosis of acute leukemia and having a haploidentical, suitable related donor for HSCT. The median (range) follow-up time was 39.0 (1.5-67.0) months.InterventionsThe enrolled patients with a haploidentical relative for HSCT received the modified busulfan/cyclophosphamide + antithymocyte globulin modified regimen and standard GVHD prophylaxis. Patients were randomly chosen to receive MSCs (the MSC group) (1 × 106 cells/kg, every 2 weeks, starting from 45 days after transplant, 4 times total) or regular prophylaxis (control group).Main Outcome and MeasureThe cumulative incidence of severe chronic GVHD.ResultsOf 158 patients, 58 (36.7%) were female individuals; the median (range) age for the MSC and control groups was 28 (18-60) years and 28 (18-56) years, respectively. A total of 158 patients were screened, and 148 patients were randomly assigned to the MSC group (n = 74) or control group (n = 74) 1 day before MSCs infusion. The estimated 2-year cumulative incidence of severe chronic GVHD was 5.4% (95% CI, 1.8%-14.0%) in the MSC group and 17.4% (95% CI, 10.1%-28.5%) in the control group (hazard ratio [HR], 0.29; 95% CI, 0.10-0.88; P = .03). There was no difference between the MSC and control groups in the cumulative incidence of leukemia relapse (HR, 1.17; 95% CI, 0.55-2.47; P = .68). The cumulative incidence of stage II to IV acute GVHD in the MSC group was significantly lower than that in the control group (HR, 0.25; 95% CI, 0.09-0.67; P = .01). The MSC group had better GVHD-free and relapse-free survival rates than the control group (HR, 0.62; 95% CI, 0.39-0.98; P = .04).Conclusions and RelevanceThe results of this randomized clinical trial show that early repeated infusions of MSCs decreased the incidence and severity of chronic GVHD, and the incidence and severity of acute GVHD manifested as a better GVHD-free and relapse-free survival rate for patients after haplo-HSCT.Trial RegistrationChinese Clinical Trial Registry: ChiCTR-IIR-16007806

The effects of intermittent fasting diet in comparison with low-calorie diet on lipid profile, glycemic status, and liver fibrosis in patients with non-alcoholic fatty liver (NAFLD): a study protocol for a randomized controlled clinical trial

IntroductionNon-alcoholic fatty liver disease (NAFLD) is a common liver disease characterized by an increase in fat in liver cells. The outbreak of NAFLD is estimated to be 32.4% worldwide, with higher rates in Asia and Iran. Nutritional factors such as excessive calorie intake, high fructose intake, copper deficiency, and increased iron intake play an important role in NAFLD. Since there is no specific treatment for NAFLD, intermittent fasting (IF) diet has been suggested as an alternative treatment for obesity and related complications. Previous studies showed the potential positive effects of IF on metabolic health and the reduction of oxidative stress in NAFLD. This randomized controlled trial (RCT) will be aimed to examine the effect of the IF diet in comparison with a low-calorie diet (LCD) on lipid profile, glycemic status, and liver fibrosis in patients with NAFLD.Methods and analysisThis is a parallel randomized clinical trial conducted on 52 overweight and obese patients with NAFLD. Participants will be randomly assigned to receive either 16:8 IF (fasting from 8 P.M. to 12 P.M. the next day) or a low-calorie (55% carbohydrate- 30% fat, 15% protein) diet for 12 weeks. Anthropometric measurements, liver assessments, and metabolic evaluations will be assessed before and after the intervention. Primary outcomes include liver steatosis and fibrosis, while secondary outcomes include liver function enzymes, insulin resistance, lipid profile, and anthropometric measurements.DiscussionSince obesity and insulin resistance are the most important risk factors of NAFLD, and there is no treatment for it, it seems that lifestyle changes such as low caloric diet like IF and exercise can improve lipid metabolism and liver enzymes.Trial registrationIranian registry of clinical trials (IRCT20170202032367N5).

Combined treatment with Minocycline and methylprednisolone in acute traumatic spinal cord Injury: A pilot study

ObjectiveThis randomized clinical trial (RCT) aimed to compare the neurologic outcomes of spinal cord injury (SCI) patients treated with Minocycline plus methylprednisolone (MCMP) versus MP (Methylprednisolone) alone. MethodsThis double-blind, single-center parallel RCT study was conducted in a community-based setting from 2022 to 2023 on consecutive patients with acute SCI within 12 h of injury. The intervention group (MPMC) received a bolus infusion of MP 30 mg/kg in 15 min intravenously, followed by a 5.4 mg/kg infusion of MP for 24–48 h and 50 mg Minocycline orally every 12 h for one week. The control group received the same amount of MP alone. Neurologic exam according to the Frankel Grading System compared two groups. ResultsA total of 54 patients completed the 6-month follow-up with a mean age of 42.5 and 41.5 in the MP (n = 27) and MPMC (n = 27) groups, respectively. The Baseline Frankel score was similar between the two groups (P = 0.92).During the follow-up period, 7.4 % and 22.2 % of the MP and MPMC groups improved to the Frankel score of D and E in the three months but insignificant between the groups (OR: 1.34, 95 % CI: 0.997–1.813, P = 0.052). At the 6-month follow-up, 33.3 % and 48.1 % of patients in MP and MPMC groups improved to Frankel scores D and E, respectively, which was significant in the mixed-effect analysis (OR: 1.45, 95 % CI: 1.074–1.952, P = 0.015). ConclusionCombination therapy with Minocycline and MP might be more effective in improving neurological recovery and reducing inflammation and tissue damage in SCI patients in the short term.

The effect of orally consumed Lactuca sativa syrup on human milk volume and weight gain in the preterm infant: a randomized controlled clinical trial

Human milk feeding can support premature infants to thrive. Yet those with premature infants can be challenged in human milk production. Considering this, and the use of potentially harmful human milk enhancers, the present study was conducted with the aim of determining the effect of orally consumed Lactuca sativa (L. sativa) syrup (lettuce extract) on human milk volume and subsequent weight gain in the preterm infant. Extracts from lettuce and other plants such as silymarin are already evidenced to be safe for use during lactation and have other therapeutic effects in humans. Yet this is the first study of its kind. This parallel randomized clinical trial included lactating participants with their preterm infants who were born at < 32 weeks' gestation and admitted to an intensive care unit. Convenience sampling was used to recruit participants. Eligible participants were allocated to groups randomly: intervention (n = 47), placebo (n = 46), and control (n = 47). The intervention group received one tablespoon of Lactuca sativa (L. sativa) syrup, and the placebo group received one tablespoon of placebo syrup 3 times a day for 1 week. Those in the control group did not receive any herbal or chemical milk-enhancing compounds. Routine care was provided to all three groups. Participants recorded their milk volume for 7 days in a daily information recorder form. Infant weight was measured prior to the intervention, and on the third, fifth and seventh days of the intervention period. There was a statistically significant difference observed in the adjusted mean volume of milk on the fourth and fifth days between the intervention, placebo, and control groups (P < 0.05). The adjusted mean milk volume of those in the intervention group on the first day was significantly higher than those in the control group and those in the placebo group. On the second day, the adjusted mean milk volume of those in the intervention group was higher than in those from the control group; and on the fourth day it was higher than in those from both the control and placebo groups; on the fifth day it was higher than in those in the placebo group; on the sixth day it was higher than in those in the control group and on the seventh day it was higher than in those in the control group (P < 0.05). There was no statistically significant difference in terms of the mean changes (with or without adjustment) in the weight of preterm infants between any of the groups. Lactuca sativa (L. sativa) syrup increases the volume of human milk production and no specific side effects have been reported in its use. Therefore, Lactuca sativa syrup can be recommended for use as one of the compounds that increase human milk volume.

The Effect of Cognitive Behavioral Group Therapy on the Improvement of Postmenopausal Women’s Body Image: A Randomized Clinical Trial

Background: The physiological changes in postmenopausal women, especially age-related physical changes, may lead to negative experiences in body image among these women. Objectives: This study aimed to determine the effectiveness of cognitive behavioral group therapy on the negative body image of postmenopausal women. Methods: This parallel randomized clinical trial study was conducted on 22 eligible postmenopausal women attending a health care center in Ahvaz, Iran, in 2018. They were randomly selected and assigned to intervention and control groups (n = 11 per group). The intervention group attended eight 90-minute sessions of cognitive behavioral therapy (CBT) based on the Cash 8-step model. All participants completed the body image concern inventory (BICI) and Multidimensional Body-Self Relations Questionnaire (MBSRQ) before, immediately after, and 1 month after the intervention. The chi-square test, independent t-test, and repeated measures test were used to investigate the trend of changes in BICI and MBSRQ and their domains over time in both groups. P values less than 0.05 were considered statistically significant for all tests. Results: Before the intervention, there were no statistically significant differences in demographic characteristics (such as age, age of menopause, and body mass index (BMI)) between the 2 groups; also, there were no statistically significant differences in the mean scores of MBSRQ and BICI between the 2 groups (P &lt; 0.05). After the intervention, a significant increase was observed in the mean scores of MBSRQ and its 3 out of 6 domains (appearance evaluation (AE), appearance orientation (AO), and body areas satisfaction (BAS); P &lt; 0.05), while a significant decrease was observed in the mean scores of BICI in the intervention group compared with the control group (P &lt; 0.05). Conclusions: Cognitive behavioral group therapy based on the Cash 8-step model in postmenopausal women can promote satisfaction with their body image.

Effect of Solution-focused Counseling on Depression and Quality of Life in Women under Mastectomy: A Randomized Clinical Trial

Objective: This study was conducted with the objective of determining whether solution-focused counseling reduces depression and increases the quality of life in breast cancer women. Methods: This study was a parallel randomized clinical trial on mastectomy women. A total of 100 volunteer participants completed the Beck's Depression Inventory (BDI) depression inventory and the WHO Quality of Life-Brief (WHOQOL- BREF) questionnaire. Fifty-six participants who scored less than the cut-off point in two questionnaires were randomly placed in two intervention and control groups. The participants in the intervention group received the solution-focused counseling method for six sessions (once a week). The control group received routine care. Then both groups filled out the questionnaires again. The results were analyzed by SPSS 22 using independent t-test, chi-square, Fisher’s exact, and ANOVA repeated measurement tests. Results: The results indicated that the post-intervention depression score in the intervention group decreased after adjusting the variables compared to the control group (p-value=0.001). Moreover, it was revealed that solution-focused counseling increased the post-intervention quality of life after adjusting variables compared to the control group (p=0.001). Conclusion: The results of the present study showed that solution-focused counseling improved mood and quality of life. Therefore, it is necessary for midwives/nurses to provide counseling approaches for depression patients to help them pass the treatment process of cancer and have better psychological and physical health by improving their quality of life.

Impact of autofluorescence for detection of parathyroid glands during thyroidectomy on postoperative parathyroid hormone levels: parallel multicentre randomized clinical trial.

Techniques for autofluorescence have been introduced to visualize the parathyroid glands during surgery and to reduce hypoparathyroidism after thyroidectomy. This parallel multicentre RCT investigated the use of Fluobeam® LX to visualize the parathyroid glands by autofluorescence during total thyroidectomy compared with no use. There was no restriction on the indication for surgery. Patients were randomized 1 : 1 and were blinded to the group allocation. The hypothesis was that autofluorescence enables identification and protection of the parathyroid glands during thyroidectomy. The primary endpoint was the rate of low parathyroid hormone (PTH) levels the day after surgery. Some 535 patients were randomized, and 486 patients received an intervention according to the study protocol, 246 in the Fluobeam® LX group and 240 in the control group. Some 64 patients (26.0 per cent) in the Fluobeam® LX group and 77 (32.1 per cent) in the control group had low levels of PTH after thyroidectomy (P = 0.141; relative risk (RR) 0.81, 95 per cent c.i. 0.61 to 1.07). Subanalysis of 174 patients undergoing central lymph node clearance showed that 15 of 82 (18 per cent) in the Fluobeam® LX group and 31 of 92 (33 per cent) in the control group had low levels of PTH on postoperative day 1 (P = 0.021; RR 0.54, 0.31 to 0.93). More parathyroid glands were identified during operation in patients who had surgery with Fluobeam® LX, and fewer parathyroid glands in the surgical specimen on definitive histopathology. No specific harm related to the use of Fluobeam® LX was reported. The use of autofluorescence during thyroidectomy did not reduce the rate of low PTH levels on postoperative day 1 in the whole group of patients. It did, however, reduce the rate in a subgroup of patients. Registration number: NCT04509011 (http://www.clinicaltrials.gov).

The effect of midwife-oriented breastfeeding counseling on self-efficacy and performance of adolescent mothers: a clinical trial study

BackgroundBreastfeeding behaviors are strongly influenced by self-efficacy. This research aimed to determine the effect of breastfeeding counseling based on the Ready Set Baby (RSB) education program on self-efficacy and breastfeeding performance in adolescent mothers.MethodsIn 2022, a parallel randomized clinical trial was carried out in Hamadan city's comprehensive health centers, involving 64 pregnant teenagers. The block randomization method was employed to divide the participants into two groups. The data collection instruments were a demographic characteristics questionnaire, a breastfeeding self-efficacy questionnaire, and the Bristol breastfeeding checklist. Three individual counseling sessions during pregnancy were conducted based on the "RSB" program. The ANCOVA was used for comparing groups. The statistical analyst was blinded to the group assignment.ResultsThe study included 64 participants with a mean age of 16.97(1.30) years, data from 60 participants were analyzed. The demographic and clinical characteristics of the two groups were relatively similar (P > 0.05). Following the intervention, self-efficacy and breastfeeding performance scores were measured and adjusted for confounding factors. The mean scores for self-efficacy were 116.03(20.64) and 100.02(20.64) (P < 0.005), with effect size 0.77 [MD = 16.01 (95% CI: 5.34,26.67)], and the mean scores for breastfeeding performance were 6.30(2.07) and 4.12(2.07) (P < 0.002), with effect size 1.05 [MD = 2.18 (95% CI: 1.11,3.24)] in the intervention and control groups, respectively.ConclusionsThe Ready Set Baby education program's breastfeeding counseling for primiparous adolescent pregnant women significantly boosted their self-efficacy and performance in breastfeeding. Given the crucial role of breastfeeding in ensuring the well-being of both mother and child, further research is imperative to identify suitable and impactful interventions that can encourage breastfeeding practices among adolescents.Trial registrationThe trial protocol of this study has been registered in Iranian Registry of Clinical Trials at 08/09/2021. The registration reference is IRCT20200530047596N3.

Comparison of the effect of pressure control and volume control ventilation on endotracheal tube cuff pressure in patients undergoing general anesthesia and mechanical ventilation: a parallel randomized clinical trial

BackgroundEndotracheal intubation and mechanical ventilation are prevalent interventions in the operating room and intensive care unit. Recently, the complications of endotracheal tube cuff pressure have been a topic of interest. Therefore, this study compared the effect of pressure control and volume control ventilation modes on the endotracheal cuff pressure rate in patients undergoing general anesthesia and mechanical ventilation.MethodsIn this triple-blinded randomized clinical trial, 50 patients undergoing open limb surgery and inguinal hernia were allocated to two groups of 25 based on inclusion criteria. After intubation, one group underwent ventilation on the pressure control ventilation mode, and the other underwent ventilation on the volume control ventilation mode. In both groups, using a manometer, the cuff’s pressure was first adjusted in the range of 25–30 cm of water. Then, the cuff pressure was measured at 10, 20, and 30 min intervals. The data were statistically analyzed using independent t-test, and two-way repeated measures ANOVA.ResultsThe present study’s findings showed that cuff pressure has significantly decreased over time in both study groups (F = 117.7, P < 0.001). However, a repeated measures ANOVA with a Greenhouse-Geisser correction showed no interaction between time and groups (F = 0.019, P = 0.98). The two groups had no significant difference in cuff pressure (F = 0.56, P = 0.458).ConclusionSince the cuff pressure has been significantly reduced in both groups over time, continuous monitoring of endotracheal tube cuff pressure in patients undergoing mechanical ventilation is essential. Therefore, it is suggested to keep the cuff pressure within the recommended range to prevent complications resulting from cuff pressure reduction, such as aspiration and ventilation decrease.Trial registrationThe study was registered in the Iranian Registry of Clinical Trial on 23/02/2019 (trial registration number: IRCT20181018041376N1).

Pharmacodynamic and pharmacokinetic properties of the combined preparation of levothyroxine plus sustained- release liothyronine; a randomized controlled clinical trial

BackgroundUnderstanding pharmacokinetics (PK) and pharmacodynamics (PD) of the sustained-release liothyronine (SR-T3) is of paramount importance to design therapeutic regimens that are able to simulate normal thyroid hormone secretion while avoiding excursions in the T3 serum concentration. Here, we designed a parallel randomized clinical trial to characterize the PK and PD of the combined preparations of LT4 + SR-T3 in hypothyroid patients.MethodsRadioiodine-treated hypothyroid patients over 20 years of age, who attained euthyroidism with LT4 monotherapy were recruited from the Endocrine Clinic in Tehran. The patients were allocated to two intervention groups of group A: 9 µg SR-T3 plus 68.5 μg LT4 (ratio 1:7.5) and group B: 12 µg SR-T3 plus 60 µg LT4 (ratio 1:5), and a control group with LT4 monotherapy. For PD study, thyroid hormone profile was evaluated at 8 and 12 weeks intervals after intervention. To assess PK properties of SR-T3, T3-Cmax, T3-Tmax and AUC0 − 24 were calculated at the last visit.ResultsSerum T4 and FT4 concentrations decreased in the intervention groups after 3 months. No significant difference was observed in serum T3 and FT3 concentrations before and after intervention. Serum T3/T4 ratio increased significantly in the intervention groups after intervention, with the highest increase in group B from 8.6 ± 2.03 at baseline to 12.2 ± 1.6. Comparison of trial groups at follow-up showed no differences in serum TSH, T4, T3 and T3/T4 concentrations among different groups. During 24 h, minimal variation in serum T3 concentration was observed in group B with mean ∆T3 of 15.4 ± 10.5 ng/dl. T3-Tmax, T3-Cmax and AUC0 − 24 in the combined sustained-release preparation were 4.38 ± 1.1 h., 101.0 ± 5.7 ng/dl and 2257 ± 110 ng.h/L, respectively which were significantly different from the control group.ConclusionCombined treatment with a single dose of SR-T3 plus LT4 is associated with increased serum T3/T4 ratio and minimal excursions in serum T3 concentration during 24 h; however, it was not significantly different from the control group. To incorporate sustained-release T3 in the management of hypothyroidism, a higher ratio of SR-T3 to LT4 than that of the previously recommended by the international organizations is suggested.IRCT registration numberIRCT20100922004794N13. https://www.irct.ir/search/result?query=IRCT20100922004794N13. Registration date: 08/12/2021.

Growth differentiation factor-15 and circulating biomarkers as predictors of periodontal treatment effects in patients with periodontitis: a randomized-controlled clinical trial

BackgroundDuring the last decades, in patients with periodontitis, periodontal treatment has been shown to reduce the potential release of local and systemic biomarkers linked to an early risk of systemic inflammatory disorders. This study evaluated the efficacy of non-surgical-periodontal treatment (NSPT) on growth differentiation factor 15 (GDF-15) and related circulating biomarkers such as glutathione peroxidase 1 (GPx-1), c-reactive protein (hs-CRP), and surfactant protein D (SP-D) in periodontal patients and explored whether subjects who had high GDF-15 levels at baseline showed increased clinical benefits following NSPT at 6-months follow-up.MethodsFor this two-arm, parallel randomized clinical trial, patients with periodontitis were randomly allocated to receive quadrant scaling and root-planing (Q-SRP, n = 23, median age 51 years old) or full-mouth disinfection (FMD, n = 23, median age 50 years old) treatment. Clinical and periodontal parameters were recorded in all enrolled patients. The primary outcome was to analyse serum concentrations changes of GDF-15 and of GPx-1, hs-CRP, and SP-D at baseline and at 30, 90, and 180-days follow-up after NSPT through enzyme-linked immunosorbent assay (ELISA) and nephelometric assay techniques.ResultsIn comparison with FMD, patients of the Q-SRP group showed a significant improvement in clinical periodontal parameters (p < 0.05) and a reduction in the mean levels of GDF-15 (p = 0.005), hs-CRP (p < 0.001), and SP-D (p = 0.042) and an increase of GPx-1 (p = 0.025) concentrations after 6 months of treatment. At 6 months of treatment, there was a significant association between several periodontal parameters and the mean concentrations of GDF-15, GPx-1, hs-CRP, and SP-D (p < 0.05 for all parameters). Finally, the ANOVA analysis revealed that, at 6 months after treatment, the Q-SRP treatment significantly impacted the reduction of GDF-15 (p = 0.015), SP-D (p = 0.026) and the upregulation of GPx-1 (p = 0.045).ConclusionThe results evidenced that, after 6 months of treatment, both NSPT protocols improved the periodontal parameters and analyzed biomarkers, but Q-SRP was more efficacious than the FMD approach. Moreover, patients who presented high baseline GDF-15 and SP-D levels benefited more from NSPT at 6-month follow-up.Trial registrationNCT05720481.

A pre-conception clinical trial to reduce intergenerational obesity and diabetes risks: The NDPP-NextGen trial protocol

BackgroundIntrauterine exposure to maternal overweight/obesity or diabetes transmits risks to offspring, perpetuating a disease cycle across generations. Prenatal interventions to reduce maternal weight or dysglycemia have limited impact, while postpartum interventions can alter the intrauterine environment only if child-bearing continues. Efficacious preconception interventions are needed, especially for underserved populations, and with the potential to be scaled up sustainably. Research is also needed to assess intervention effects at conception, throughout pregnancy, and among offspring. MethodsThis two-arm, parallel randomized clinical trial will include 360 biological females with overweight/obesity and moderate-to-high likelihood of pregnancy within 24 months. Participants will be randomized 1:1 to a yearlong pre-conception lifestyle intervention based on the National Diabetes Prevention Program (NDPP-NextGen) or usual care. Data collection will occur at enrollment (before conception), post-conception (<8 weeks gestation), late pregnancy (28–32 weeks gestation), and delivery (before discharge) for participants who become pregnant within 24 months of enrollment. Main outcomes are post-conception body mass index (<8 weeks gestation; primary outcome), post-conception fasting glucose (<8 weeks gestation; secondary outcome), and neonatal adiposity (<2 days post-birth). Additional clinical, behavioral, perinatal and offspring data will be collected, and biospecimens (blood, urine, stool, cord blood) will be banked for future ancillary studies. ConclusionThis clinical trial will evaluate an intervention model (NDPP-NextGen) with potential to improve maternal health among the >50% of US females with overweight/obesity or diabetes risks in pregnancy. If successful, it can be scaled among >1800 organizations delivering NDPP in the United States to benefit the health of future generations.

Comparison of Masticatory Efficiency and Patient Satisfaction of Injection-Molded Conventional Complete Dentures and Biofunctional Prosthetic System Dentures: A Parallel Randomized Clinical Trial.

Introduction Complete loss of natural teeth severely compromises the masticatory efficiency of geriatric patients and directly affects their general health. Biofunctional prosthetic system (BPS) has been developed as an alternate method of denture fabrication to match the higher expectations of patients. Studies comparing BPS dentures with injection-molded conventional complete dentures (IM-CCD) are lacking. Our study aimed to compare the masticatory efficiency and patient satisfaction of BPS dentures with IM-CCD. Methods This trial was designed as a randomized, prospective, single-center, double-blindedstudy with two parallel arms (BPS group and IM-CCD group) having an equal allocation (1:1). Completely edentulous patients aged 45-80 who visited our outpatient department between January and August 2018 were screened and enrolled according to our inclusion and exclusion criteria. Random sequence generation was done using an online randomization program. Allocation concealment was done using sequentially labeled opaque envelopes. The participants and the outcome assessors were blinded. A single operator performed all the clinical procedures in both groups under the guidance of the instructor. The age and gender of the patients were recorded for demographic data at baseline. Primary outcomes were assessed six weeks after denture insertion. The number of denture adjustments required during the first six weeks after denture delivery was recorded as the secondary outcome. Masticatory efficiency was evaluated by the volumetric single-sieve method. An abbreviated version of the Oral Health Impact Profile questionnaire for edentulous patients (OHIP-EDENT) was used for patient satisfaction scores. The total OHIP-EDENT score was calculated by adding all the responses to the 19 questions (ranging from 0 to 38). Individual domain scores were calculated by adding the response to all the questions in that domain. All the data obtained were tested for normality using the Kolmogorov-Smirnov test. Data were analyzed using either unpaired Student's T-test or Mann-Whitney U test for normal and non-normal data, respectively. The gender characteristics of the sample were compared usingChi-Square test. Results Two patients in the IM-CCD group and one patient in the BPS group were lost to follow-up. Hence only the secondary outcome data were analyzed for these patients. Primary outcome data of patients who were lost to follow-up were excluded from the analysis. No significant differences (p>0.05) were found between the two groups for age and gender characteristics of the samples. Masticatory efficiency for both peanut and carrot was found to be significantly higher (p<0.05) in the BPS group than in the IM-CCD group. No significant differences (p>0.05) in the mean scores were observed between the two groups for total OHIP-EDENT scores or the individual domain scores. No significant differences (p>0.05) were observed between the groups for the number of denture adjustments done. Conclusion Within the limitations of the trial, it can be concluded that the BPS dentures significantly improved the masticatory efficiency for both hard (carrots) and soft (peanuts) foods compared to the IM-CCD. However, there was no difference between the masticatory-related complaints domain scores between the two dentures. No significant differences were found between BPS dentures and IM-CCD with respect to overall patient satisfaction scores or post-insertion denture adjustments.