bluuebunny/crossref_metadata_2025_split huggingface dataset:
The effects of a low carbohydrate diet combined with partial meal replacement on obese individuals
Authors: Zhong Yulian , Chen Ximin , Huang Chao , Chen Yuexiao , Zhao Fengyi , Hao Runhua , Wang Niannian , Liao Wang , Xia Hui , Yang Ligang , Wang Shaokang , Sun Guiju 
Published: March 2023

Abstract
Objective
We explored the dietary effects of replacing normal dietary staple foods with supplementary nutritional protein powder, dietary fiber, and fish oil on several metabolic parameters. We examined weight loss, glucose and lipid metabolism, and intestinal flora in obese individuals when compared with individuals on a reduced staple food low carbohydrate diet.

Methods
From inclusion and exclusion criteria, 99 participants (28 kg/m2 ≤ body mass index (BMI) ≤ 35 kg/m2) were recruited and randomly assigned to control and intervention 1 and 2 groups. Physical examinations and biochemical indices were performed/gathered before the intervention and at 4 and 13 weeks post intervention. After 13 weeks, feces was collected and 16s rDNA sequenced.

Results
After 13 weeks, when compared with controls, body weight, BMI, waist circumference, hip circumference, systolic blood pressure, and diastolic blood pressure values in intervention group 1 were significantly reduced. In intervention group 2, body weight, BMI, waist circumference, and hip circumference were significantly reduced. Triglyceride (TG) levels in both intervention groups were significantly reduced. Fasting blood glucose, glycosylated hemoglobin, glycosylated albumin, total cholesterol, and apolipoprotein B levels in intervention group 1 were decreased, while high density lipoprotein cholesterol (HDL-c) decreased slightly. Glycosylated albumin, TG, and total cholesterol levels in intervention group 2 decreased, while HDL-c decreased slightly, High sensitive C-reactive protein, MPO, Ox-LDL, LEP, TGF-β1, IL-6, GPLD1, pro NT, GPC-4, and LPS levels in both intervention groups were lower when compared with controls. Adiponectin (ADPN) levels in intervention groups were higher when compared with controls. Tumor necrosis factor-α (TNF-α) levels in intervention group 1 were lower when compared with controls. There is no obvious difference in α diversity and β diversity between intestinal flora of 3 groups. Among the first 10 species of Phylum, only the control group and the intervention group 2 had significantly higher Patescibacteria than the intervention group 1. Among the first 10 species of Genus, only the number of Agathobacter in intervention group 2 was significantly higher than that in control group and intervention group 1.

Conclusions
We showed that an LCD, where nutritional protein powder replaced some staple foods and dietary fiber and fish oil were simultaneously supplemented, significantly reduced weight and improved carbohydrate and lipid metabolism in obese individuals when compared with an LCD which reduced staple food intake.
Emergency administration of fibrinogen concentrate for haemorrhage: systematic review and meta-analysis
Authors: Itagaki Yuki , Hayakawa Mineji , Takahashi Yuki , Hirano Satoshi , Yamakawa Kazuma 
Published: March 2023

Abstract
Introduction
The occurrence of massive haemorrhages in various emergency situations increases the need for blood transfusions and increases the risk of mortality. Fibrinogen concentrate (FC) use may increase plasma fibrinogen levels more rapidly than fresh-frozen product or cryoprecipitate use. Previous several systematic reviews and meta-analyses have not effectively demonstrated FC efficacy in significantly improving the risk of mortality and reducing transfusion requirements. In this study, we investigated the use of FC for haemorrhages in emergency situations.

Methods and analysis
In this systematic review and meta-analysis, we included controlled trials, but excluded randomized controlled trials (RCTs) in elective surgeries. The study population consisted of patients with haemorrhages in emergency situations, and the intervention was emergency supplementation of FC. The control group was administered with ordinal transfusion or placebo. The primary and secondary outcomes were in-hospital mortality and the amount of transfusion and thrombotic events, respectively. The electronic databases searched included MEDLINE (PubMed), Web of Science, and the Cochrane Central Register of Controlled Trials.

Results
Nine RCTs in the qualitative synthesis with a total of 701 patients were included. Results showed a slight increase in in-hospital mortality with FC treatment (RR 1.24, 95% CI 0.64–2.39, p = 0.52) with very low certainty of the evidence. There was no reduction in the use of red blood cells (RBC) transfusion in the first 24 h after admission with FC treatment (mean difference [MD] 0.0 Unit in the FC group, 95% CI − 0.99–0.98, p = 0.99) with very low certainty of the evidence. However, the use of fresh-frozen plasma (FFP) transfusion significantly increased in the first 24 h after admission with FC treatment (MD 2.61 Unit higher in the FC group, 95% CI 0.07–5.16, p = 0.04). The occurrence of thrombotic events did not significantly differ with FC treatment.

Conclusions
The present study indicates that the use of FC may result in a slight increase in in-hospital mortality. While FC did not appear to reduce the use of RBC transfusion, it likely increased the use of FFP transfusion and may result in a large increase in platelet concentrate transfusion. However, the results should be interpreted cautiously due to the unbalanced severity in the patient population, high heterogeneity, and risk of bias.
Effect of Remote Peer-Counsellor- delivered Behavioral Activation and Peer-support for Antenatal Depression on Gestational Age at Delivery: a single-blind, randomized control trial
Authors: Chaput Kathleen H. , Freeman Makayla , McMorris Carly , Metcalfe Amy , Cameron Emily E. , Jung James , Tough Suzanne , Hicks Laurel M. , Dimidjian Sona , Tomfohr-Madsen Lianne M. 
Published: March 2023

Abstract
Background
Antenatal depression (AD) is the most common complication of pregnancy in developed countries and increases the risk of preterm birth (PTB). Many pregnant individuals with AD do not obtain treatment due in part to risks associated with antidepressant medications, the expense and wait times for psychological services, and perceived stigma. Accessible and timely treatment of antenatal depression is crucial to minimize foetal impacts and associated long-term child health outcomes. Previous studies show that behavioural activation and peer support are promising avenues of treatment for perinatal depression. Additionally, remote and paraprofessional counselling interventions show promise as more accessible, sustainable, and cost-effective treatment avenues than traditional psychological services. The primary aim of this trial is to test the effectiveness of a remote, behavioural activation and peer support intervention, administered by trained peer para-professionals, for increasing gestational age at delivery among those with antenatal depression. The secondary aims are to evaluate the effectiveness for treating AD prior to delivery, with persistence into the postpartum; improving anxiety symptoms; and improving parenting self-efficacy compared to controls.

Methods
A two-arm, single-blinded, parallel groups randomized controlled trial (RCT) with repeated measures will be conducted. Participants scoring >10 on the Edinburgh Postnatal Depression Scale will be recruited from the larger P3 cohort and invited to enroll. Assessments will be conducted prior to 27 weeks’ gestation at trial intake (T1), post-intervention, prior to delivery (T2), 5–6 months postpartum (T3), and 11–12 months postpartum (T4) and will include self-report questionnaires and linked medical records.

Discussion
Our remote, peer paraprofessional-delivered behavioural activation plus peer support intervention has the potential to successfully reduce symptoms of AD, which may in turn decrease the risk of PTB and subsequent health impacts. The current trial builds on previous findings and uses a patient-oriented approach to address priorities for patient care and to provide a cost-effective, accessible, and evidence-based treatment to pregnant individuals with AD.

Trial registration
International Standard Randomised Controlled Trial Number (ISRCTN) registry (ISRCTN51098220) ISRCTN51098220. Registered on April 7, 2022.
Randomized controlled trial protocol of health coaching for veterans with complex chronic pain
Authors: Crosky Sarah , McFarlin Mikhaela , Sullivan Nicole , Winograd Darren , Litke David , Masheb Robin M. , Lu Shou-En , Costanzo Michelle , Anastasides Nicole , Gonzalez Christina , Doshi Jaineel , Graff Fiona , Khatib Linda , Thien Scott , McAndrew Lisa M. 
Published: March 2023

Abstract

Background
Pain predominant multisymptom illness (pain-CMI) refers to symptom-based conditions where pain is a primary symptom. There is initial evidence that health coaching may be efficacious in treating pain-CMI because it can be tailored to the veteran’s goals and emphasizes long-term behavior change, which may indirectly impact the maintaining factors of pain-CMI (e.g., catastrophizing, poor pain control, and limited activity). This paper describes the study protocol and rationale of a randomized controlled trial that will compare the efficacy of remote-delivered health coaching in reducing disability and pain impairment for veterans with pain-CMI to remote-delivered supportive psychotherapy.

Methods
This randomized controlled trial will consist of two treatment arms: remote-delivered health coaching and remote-delivered supportive psychotherapy, the active control. Each treatment condition will consist of twelve, weekly one-on-one meetings with a study provider. In addition to the baseline assessment, participants will also complete 6-week (mid-treatment), 12-week (post-treatment), and 24-week (follow-up) assessments that consist of questionnaires that can be completed remotely. The primary aims for this study are to determine whether health coaching reduces disability and pain impairment as compared to supportive psychotherapy. We will also examine whether health coaching reduces physical symptoms, catastrophizing, limiting activity, and increasing pain control as compared to supportive psychotherapy.

Discussion
This study will contribute to the existing literature on pain-CMI and report the effectiveness of a novel, remote-delivered behavioral intervention.
Long-term aerobic and combined exercises enhance the satiety response and modulate the energy intake in patients with type 2 diabetes mellitus (T2DM): A randomized controlled trial
Authors: Vidanage Dinithi , Wasalathanthri Sudharshani , Hettiarachchi Priyadarshika 
Published: March 2023

Abstract
Background
Energy homeostasis plays a vital role in achieving glycemic control in people with type 2 diabetes mellitus (T2DM). Exercise is known to increase energy expenditure. However, its role in energy intake has not been explored in people with T2DM. Thus, this study aimed at determining the impact of long-term aerobic and combined exercises in modulating hunger, satiety and energy intake in T2DM.

Methods
A randomized controlled trial, with 108 people with T2DM, aged 35–60 years were assigned into an aerobic, combined (aerobic and resistance) and a control group. Primary outcomes were subjective levels of hunger and satiety measured by a 100 mm visual analogue scale in relation to a standard breakfast meal (453 kcal) and energy and macronutrient intake determined by a 3-day diet diary at 0, 3 and 6 months.

Results
Aerobic and combined groups exhibited reduced hunger and increased satiety at 3 and 6 months (p < 0.05). The combined group demonstrated a profound increase in satiety at 3 and 6 months compared to aerobics (3 months; p = 0.008, 6 months; p = 0.002) and controls (3 months; p = 0.006, 6 months, p = 0.014). Mean daily energy intake was reduced only at 6 months in the aerobic group (p = 0.012), whereas it was reduced in the combined group at 3 and at 6 months compared to controls (3 months: p = 0.026, 6 months: p = 0.022).

Conclusions
Long-term aerobic and combined exercises produced a reduction in hunger, energy intake and increase satiety in people with T2DM. Despite energy expenditure, exercise seems to play a significant role in reducing energy intake as well. Combined exercises show more advantages over aerobic exercise since combined exercises have a greater impact on satiety and energy intake in people with T2DM.
Trial registration number: SLCTR/2015/029, https://slctr.lk/trials/slctr-2015-029.
Granulosa tumor: two spontaneous pregnancies after combined medico-surgical treatment: case report and review of the literature
Authors: Kaakoua Mohamed , Chidiac Jean , Notf Andrianandrasana , Chen Ruiqian , Mahe Isabelle , Djennaoui Sadji 
Published: March 2023

Abstract
Background
Granulosa tumor is a rare tumor that arises from the mesenchyme and the sexual cord of the ovary. The prognosis is generally excellent, and treatment is mainly based on surgery, followed by chemotherapy depending on the extension of the disease. However, “the obstetrical prognosis” is compromised.

Case presentation
We report the case of a 32-year-old Caucasian patient who was diagnosed during a primary infertility assessment with an ultrasound image of a 39 mm organic left ovarian cyst confirmed on pelvic magnetic resonance imaging with infiltration of the uterosacral space. Tumor markers, including cancer antigen 125, alpha fetoprotein, and β-human chorionic gonadotropin, were normal. Histological study of biopsies of the ovarian lesion taken during exploratory laparoscopy confirmed the diagnosis of adult granulosa tumor. After a normal extension assessment including a thoracoabdominopelvic computed tomography scan and a positron emission tomography scan, the patient underwent complete conservative surgery and the disease was classified as stage Ic. Three cycles of adjuvant chemotherapy according to the “BEP” protocol combining bleomycin, etoposide, and cisplatin were performed after oocyte cryopreservation. After a 5-year follow-up period, the patient had no sign of tumor progression and had two spontaneous pregnancies, the first occurring 3 months after the end of chemotherapy and the second 14 months later.

Conclusion
Granulosa cell tumor remains a rare tumor whose management considerably compromises fertility and reduces the chances of having a spontaneous pregnancy. The particularity of our observation is that the diagnosis of the granulosa tumor was made following a primary infertility assessment and that the patient had two spontaneous pregnancies 3 months after the end of a medico-surgical treatment known to be very gonadotoxic.
Dentinogenic ghost cell tumor treated with a combination of marsupialization and radical resection: a case report and review of the literature
Authors: Toyodome Soichiro , Wakasa Tomoko , Hirose Katsutoshi , Iwamoto Noriko , Suzuki Seiya , Nemoto Naoto , Toyosawa Satoru , Nagata Tetsuji 
Published: March 2023

Abstract
Background
Dentinogenic ghost cell tumor is a rare benign tumor that accounts for less than 3% of all cases and consists of the stellate reticulum, which is made up of enamel epithelioid and basaloid cells. Although DGCT is a benign tumor, the local infiltration of the odontogenic epithelium or recurrences have been reported, and its detailed pathology and treatments remain unclear.

Case presentation
This report describes the case of a 60-year-old Japanese male diagnosed with a maxillary dentinogenic ghost cell tumor. Images showed well-circumscribed, multilocular cystic lesions with a calcified substance in the interior. Marsupialization was performed along with biopsy to prevent the expansion of the lesion, and a partial maxillectomy was performed 2 years after the initial examination. Histopathological findings showed ameloblastomatous proliferation containing clusters of ghost cells and dentinoid materials, resulting in the diagnosis of dentinogenic ghost cell tumor. This article also reviews recently reported cases of dentinogenic ghost cell tumor.

Conclusion
It is important to perform marsupialization, proper resection, and postoperative follow-up because of possible recurrence.
Intraoperative MRI-derived volumetric ablation margins and initial correlation with local outcome after MRI-guided cryoablation of renal tumors
Authors: de Jager Nienke S. , van Oostenbrugge Tim J. , Pätz Torben , Jenniskens Sjoerd F. M. , Fütterer Jurgen J. , Langenhuijsen Johan F. , Overduin Christiaan G. 
Published: March 2023

Abstract
Purpose
To assess volumetric ablation margins derived from intraoperative pre- and post-ablation MRI after magnetic resonance imaging (MRI)-guided percutaneous cryoablation of renal tumors and explore its correlation with local treatment success.

Methods
Retrospective analysis was performed on 30 patients (mean age 69y) who underwent percutaneous MRI-guided cryoablation between May 2014 and May 2020 for 32 renal tumors (size: 1.6–5.1 cm). Tumor and ice-ball volumes were segmented on intraprocedural pre- and post-ablation MR images using Software Assistant for Interventional Radiology (SAFIR) software. After MRI-MRI co-registration, the software automatically quantified the minimal treatment margin (MTM),defined as the smallest 3D distance between the tumor and ice-ball surface. Local tumor progression (LTP) after cryoablation was assessed on follow-up imaging.

Results
Median follow-up was 16 months (range: 1–58). Local control after cryoablation was achieved in 26 cases (81%) while LTP occurred in 6 (19%). The intended MTM of ≥5 mm was achieved in 3/32 (9%) cases. Median MTM was significantly smaller for cases with (− 7 mm; IQR:-10 to − 5) vs. without LTP (3 mm; IQR:2 to 4) (P < .001). All cases of LTP had a negative MTM. All negative treatment margins occurred in tumors > 3 cm.

Conclusions
Determination of volumetric ablation margins from intraoperative MRI was feasible and may be useful in predicting local outcome after MRI-guided renal cryoablation. In our preliminary data, an intraoperative MRI-derived minimal margin extending at least 1 mm beyond the MRI-visible tumor led to local control and this was more difficult to achieve in tumors > 3 cm. Ultimately, online margin analysis may be a valuable tool to intraoperatively assess therapy success, but larger prospective studies are needed to establish a reliable threshold for clinical use.
Co-production of a feasibility trial of pacing interventions for Long COVID
Authors: Turner Grace M. , McMullan Christel , Aiyegbusi Olalekan Lee , Hughes Sarah E. , Walker Anita , Jeyes Felicity , Adler Yvonne , Chong Amy , Buckland Lewis , Stanton David , Davies Elin Haf , Haroon Shamil , Calvert Melanie 
Published: March 2023

Abstract
Background
The high incidence of COVID-19 globally has led to a large prevalence of Long COVID but there is a lack of evidence-based treatments. There is a need to evaluate existing treatments for symptoms associated with Long COVID. However, there is first a need to evaluate the feasibility of undertaking randomised controlled trials of interventions for the condition. We aimed to co-produce a feasibility study of non-pharmacological interventions to support people with Long COVID.

Methods
A consensus workshop on research prioritisation was conducted with patients and other stakeholders. This was followed by the co-production of the feasibility trial with a group of patient partners, which included the design of the study, the selection of interventions, and the production of dissemination strategies.

Results
The consensus workshop was attended by 23 stakeholders, including six patients. The consensus from the workshop was to develop a clinical trial platform that focused on testing different pacing interventions and resources. For the co-production of the feasibility trial, patient partners selected three pacing resources to evaluate (video, mobile application, and book) and co-designed feasibility study processes, study materials and undertook usability testing of the digital trial platform.

Conclusion
In conclusion, this paper reports the principles and process used to co-produce a feasibility study of pacing interventions for Long COVID. Co-production was effective and influenced important aspects of the study.
Topical cannabidiol is well tolerated in individuals with a history of elite physical performance and chronic lower extremity pain
Authors: Hall Nicole , James Bradie , Bhuiyan Mohammad Alfrad Nobel , Crane Erin , Falgout Carlie , Murnane Kevin Sean 
Published: March 2023

Abstract
Introduction
Cannabidiol (CBD) is a potential therapeutic for pain management. Yet, there exists a dearth of studies of its tolerability and efficacy, especially in special populations. Former elite athletes are a special population both susceptible to chronic pain and also highly trained and attuned to assess medication tolerability concerns. The purpose of the present open-label pilot study was to assess the tolerability of CBD in this population.

Materials and methods
Retrospective analysis was conducted in deidentified data from 20 individuals who were all previously professional athletes in US/American football, track and field, or basketball, with careers ranging from 4 to 10 years. Participants received topical CBD (10 mg twice daily by controlled dispenser) for chronic pain resulting from acute lower extremity injuries. Assessments of tolerability and secondary analyses of pain, pain-related disability, and activities of daily living were collected by self-report over the 6-week study period. Data were analyzed by descriptive statistics, pairwise t-test, and linear regression.

Results
Seventy percent of participants completed the study. Of the individuals who completed the study, 50% reported minor adverse effects, none of which required medical attention, and 50% did not report any adverse effects. The mostly commonly reported effects were skin dryness (43% of study completers) and skin rash (21% of study completers), which rapidly resolved. There was a significant improvement in self-reported pain levels (intake mean 3.5 ± 0.29; exit mean 1.7 ± 0.23; P < 0.001) and pain-related disability, including family and home responsibilities, life support activities, occupational activities, recreational activities, self-care, sexual function, and social activities (all P < 0.001).

Discussion
To the best of our knowledge, this is the first study to assess CBD treatment in elite athletes, who are disproportionally susceptible to disabling injuries. Topical administration of CBD was tolerated well by this population and resulted in only minor adverse effects. As elite athletes are trained and attuned to assess their own bodies due to their professional lives, this population is likely to detect tolerability concerns. However, this study was limited to a convenience sample and self-reported data. These pilot findings warrant further study of topical CBD in randomized and controlled studies of elite athletes.