bluuebunny/crossref_metadata_2025 huggingface dataset:
Heparin-free after 3000 IU heparin loaded in veno-venous ECMO supported acute respiratory failure patients with hemorrhage risk: a novel anti-coagulation strategy
Authors: Zhao Yang-Chao , Zhao Xi , Fu Guo-Wei , Huang Ming-Jun , Li Xing-Xing , Sun Qian-Qian , Kan Ya-Bai , Li Jun , Wang Shi-Lei , Ma Wen-Tao , Xu Qin-Fu , Liu Qi-Long , Li Hong-Bin
Published: June 2022

Background

The anti-coagulation protocol of patients with hemorrhage risk primary disease who need extracorporeal membrane oxygenation (ECMO) supported is controversial. This study evaluated the feasibility of a new anti-coagulation strategy, that is heparin-free after 3000 IU heparin loaded in veno-venous ECMO (VV ECMO) supported acute respiratory failure patients with hemorrhage risk.

Methods

A retrospective study was performed in a series of hemorrhage risk patients supported with VV ECMO at the First Affiliated Hospital of Zhengzhou University, between June 2012 to Sept 2020. A total of 70 patients received a low heparin bolus of 3000 units for cannulation but without subsequent, ongoing heparin administration. Patients were divided into survival (n = 25) and non-survival group (n = 45). Data of coagulation, hemolysis and membrane lung function were calculated and analyzed. The complications of patients were recorded. Finally, the binary Logistic regression was conducted.

Results

The longest heparin-free time was 216 h, and the mean heparin-free time was 102 h. Compared with survivors, the non-survivors were showed higher baseline SOFA score and lower platelet counts in 0.5 h, 24 h, 48 h and 96 h after ECMO applied. However, there was no significant differences between survivors and non-survivors in ACT, APTT, INR, D-dimer, fibrinogen, LDH, blood flow rate, Δp and Ppost-MLO2 (all p < 0.05) of all different time point. Moreover, only the baseline SOFA score was significantly associated with mortality (p < 0.001, OR(95%CI): 2.754 (1.486–5.103)) while the baseline levels of ACT, APTT, INR, platelet, D-dimer, fibrinogen and LDH have no association with mortality. The percentage of thrombosis complications was 54.3% (38/70) including 3 oxygenator changed but there was no significant difference of complications in survival and non-survival groups (p > 0.05).

Conclusions

The anticoagulation protocol that no heparin after a 3000 units heparin bolus in VV ECMO supported acute respiratory failure patients with hemorrhage risk is feasible.
Patient experiences and preferences for antiretroviral therapy service provision: implications for differentiated service delivery in Northwest Ethiopia
Authors: Belay Yihalem Abebe , Yitayal Mezgebu , Atnafu Asmamaw , Taye Fitalew Agimass
Published: June 2022

Background

Understanding the experiences, needs, preferences, and behaviors of people living with HIV (PLHIV) are critical to tailor HIV treatment. However, there is limited empirical evidence in Ethiopia on the views of PLHIV regarding their experiences with current antiretroviral therapy (ART) services and preferred models of HIV treatment. Hence, this study aimed to explore the patients’ experiences of taking medications and preferences for ART service provision in Northwest Ethiopia.

Methods

A phenomenological study design was employed. In this study, stable and 18 years old and above PLHIVs, who had been using ART service at four public hospitals and two health centers in East Gojjam, West Gojjam and Awi zones, and Bahir Dar city administration of Amhara National Regional State, Northwest Ethiopia, were purposively selected. Fifteen in-depth interviews were conducted from July 2021 to September 2021 to collect data. ATLAS.ti version 9 software was used for coding translated transcripts. A thematic analysis approach was employed.

Findings

Participants in this study had reported positive and negative experiences in receiving ART services and also varied preferences toward ART service features. The study identified five themes on experiences for ART service and 15 attributes of ART service characteristics. The identified themes were stigma, time, availability of drugs and providers, costs for clinic visits, and provider-patient interaction. The fifteen attributes were buddy system, ART refill (individualized or group), ART packaging and labeling, drug formulation and administration, ART room labeling, distance, location of service, preferences on involvement in treatment decision-making, the person providing ART refills, provider’s attitude, spatial arrangement of ART room, time of health facility operation, time spent at clinics, and total cost of the visit.

Conclusions

The results raise awareness for the positive and negative experiences of patients informing us about barriers and supporting factors in ART service provision. They open up the potential for HIV treatment service improvement. The preferences of PLHIVs toward ART service delivery features were heterogeneous. Policy and program efforts should tailor ART services that suit patients’ needs and priorities in Ethiopia. Future research should further assess the reasons for patients’ distrust of the community ART delivery models.
TWIICE One powered exoskeleton: effect of design improvements on usability in daily life as measured by the performance in the CYBATHLON race
Authors: Vouga Tristan , Fasola Jemina , Baud Romain , Manzoori Ali Reza , Pache Julien , Bouri Mohamed
Published: June 2022

Background

Spinal cord injury leading to paraplegia affects the mobility and physiological well-being of one in a thousand people. Powered exoskeletons can temporarily restore the ability to walk. Their relevance in daily life is still limited because of low performance beyond ground that is even. CYBATHLON is an international competition promoting improvements in assistive technology. In this article, we present the latest design and results of testing of TWIICE One version 2018, one of the competing devices in the 2020 race.

Methods

A person with a motor-complete spinal cord injury at thoracic level T10 participated as race pilot. Training ahead of the race took place over one week at a rate of 2 h per day. The time to perform each of the seven tasks of the competition was recorded together with the number of repetitions. Performance is compared over the training period and against the 2016 race results.

Results

Progression was observed in all tasks and accounted for by both user training and technology improvements. Final competition rank was second out of seven participating teams, with a record time of 4′40". This represents an average improvement of 40% with respect to comparable obstacles of the 2016 race, explaining the two ranks of improvement since then.

Conclusion

These results help understand which features had a positive impact on the real-life performance of the device. Understanding how design affects performance is key information to create devices that really improve the life of people living with paraplegia.
Brain white matter correlates of learning ankle tracking using a wearable device: importance of the superior longitudinal fasciculus II
Authors: Shiao Chishan , Tang Pei-Fang , Wei Yu-Chen , Tseng Wen-Yih Isaac , Lin Ta-Te
Published: June 2022

Background

Wearable devices have been found effective in training ankle control in patients with neurological diseases. However, the neural mechanisms associated with using wearable devices for ankle training remain largely unexplored. This study aimed to investigate the ankle tracking performance and brain white matter changes associated with ankle tracking learning using a wearable-device system and the behavior–brain structure relationships in middle-aged and older adults.

Methods

Twenty-six middle-aged and older adults (48–75 years) participated in this study. Participants underwent 5-day ankle tracking learning with their non-dominant foot using a custom-built ankle tracking system equipped with a wearable sensor and a sensor-computer interface for real-time visual feedback and data acquisition. Repeated and random sequences of target tracking trajectories were both used for learning and testing. Ankle tracking performance, calculated as the root-mean-squared-error (RMSE) between the target and actual ankle trajectories, and brain diffusion spectrum MR images were acquired at baseline and retention tests. The general fractional anisotropy (GFA) values of eight brain white matter tracts of interest were calculated to indicate their integrity. Two-way (Sex × Time) mixed repeated measures ANOVA procedures were used to investigate Sex and Time effects on RMSE and GFA. Correlations between changes in RMSE and those in GFA were analyzed, controlling for age and sex.

Results

After learning, both male and female participants reduced the RMSE of tracking repeated and random sequences (both p < 0.001). Among the eight fiber tracts, the right superior longitudinal fasciculus II (R SLF II) was the only one which showed both increased GFA (p = 0.039) after learning and predictive power of reductions in RMSE for random sequence tracking with its changes in GFA [β = 0.514, R2 change = 0.259, p = 0.008].

Conclusions

Our findings implied that interactive tracking movement learning using wearable sensors may place high demands on the attention, sensory feedback integration, and sensorimotor transformation functions of the brain. Therefore, the SLF II, which is known to perform these brain functions, showed corresponding neural plasticity after such learning, and its plasticity also predicted the behavioral gains. The SLF II appears to be a very important anatomical neural correlate involved in such learning paradigms.
Depression and anxiety in different hypertension phenotypes: a cross-sectional study
Authors: Nemcsik-Bencze Zsófia , Kőrösi Beáta , Gyöngyösi Helga , Batta Dóra , László Andrea , Torzsa Péter , Kovács Illés , Rihmer Zoltán , Gonda Xénia , Nemcsik János
Published: June 2022

Background

Hypertension is a major risk factor of cardiovascular mortality. Mood disorders represent a growing public health problem worldwide. A complex relationship is present between mood disorders and cardiovascular diseases. However, less data is available about the level of depression and anxiety in different hypertension phenotypes. The aim of our study was to evaluate psychometric parameters in healthy controls (Cont), in patients with white-coat hypertension (WhHT), with chronic, non-resistant hypertension (non-ResHT), and with chronic, treatment-resistant hypertension (ResHT).

Methods

In a cross-sectional study setup 363 patients were included with the following distribution: 82 Cont, 44 WhHT, 200 non-ResHT and 37 ResHT. The patients completed the Beck Depression Inventory (BDI) and the Hamilton Anxiety Scale (HAM-A).

Results

BDI points were higher in WhHT (7 (3–11)) and ResHT (6 (3–11.5)) compared with Cont (3 (1–6), p < 0.05). Similarly, HAM-A points were higher in WhHT (8 (5–15)) and ResHT (10.5 (5.25–18.75)) compared with Cont (4 (1–7), p < 0.05) and also compared with non-ResHT (5 (2–10), p < 0.05). ResHT was independently associated with HAM-A scale equal or above 3 points (Beta = 3.804, 95%CI 1.204–12.015). WhHT was independently associated with HAM-A scale equal or above 2 points (Beta = 7.701, 95%CI 1.165–18.973) and BDI scale equal or above 5 points (Beta = 2.888, 95%CI 1.170–7.126).

Conclusions

Our results suggest psychopathological similarities between white-coat hypertension and resistant hypertension. As recently it was demonstrated that white-coat hypertension is not a benign condition, our findings can have relevance for future interventional purposes to improve the outcome of these patients.
Lung ultrasound response to awake prone positioning predicts the need for intubation in patients with COVID-19 induced acute hypoxemic respiratory failure: an observational study
Authors: Ibarra-Estrada Miguel , Gamero-Rodríguez María J. , García-de-Acilu Marina , Roca Oriol , Sandoval-Plascencia Laura , Aguirre-Avalos Guadalupe , García-Salcido Roxana , Aguirre-Díaz Sara A. , Vines David L. , Mirza Sara , Kaur Ramandeep , Weiss Tyler , Guerin Claude , Li Jie
Published: June 2022

Background

Awake prone positioning (APP) reduces the intubation rate in COVID-19 patients treated by high-flow nasal cannula (HFNC). However, the lung aeration response to APP has not been addressed. We aimed to explore the lung aeration response to APP by lung ultrasound (LUS).

Methods

This two-center, prospective, observational study enrolled patients with COVID-19-induced acute hypoxemic respiratory failure treated by HFNC and APP. LUS score was recorded 5–10 min before, 1 h after APP, and 5–10 min after supine in the first APP session within the first three days. The primary outcome was LUS score changes in the first three days. Secondary outcomes included changes in SpO2/FiO2 ratio, respiratory rate and ROX index (SpO2/FiO2/respiratory rate) related to APP, and the rate of treatment success (patients who avoided intubation).

Results

Seventy-one patients were enrolled. LUS score decreased from 20 (interquartile range [IQR] 19–24) to 19 (18–21) (p < 0.001) after the first APP session, and to 19 (18–21) (p < 0.001) after three days. Compared to patients with treatment failure (n = 20, 28%), LUS score reduction after the first three days in patients with treatment success (n = 51) was greater (− 2.6 [95% confidence intervals − 3.1 to − 2.0] vs 0 [− 1.2 to 1.2], p = 0.001). A decrease in dorsal LUS score > 1 after the first APP session was associated with decreased risk for intubation (Relative risk 0.25 [0.09–0.69]). APP daily duration was correlated with LUS score reduction in patients with treatment success, especially in dorsal lung zones (r =  − 0.76; p < 0.001).

Conclusions

In patients with acute hypoxemic respiratory failure due to COVID-19 and treated by HFNC, APP reduced LUS score. The reduction in dorsal LUS scores after APP was associated with treatment success. The longer duration on APP was correlated with greater lung aeration.

Trial registration This study was prospectively registered on clinicaltrials.gov on April 22, 2021. Identification number NCT04855162.
Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial
Authors: Kazachenko Ekaterina , Garmanova Tatiana , Derinov Alexander , Markaryan Daniil , Lee Hanjoo , Magbulova Sabrina , Tsarkov Petr
Published: June 2022

Background

Hemorrhoidectomy is associated with intense postoperative pain that requires multimodal analgesia. It includes nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics to reach adequate pain control. There are data in literature preemptive analgesia could decrease postoperative pain after hemorrhoidectomy. The aim of this study is to assess the efficacy of preemptive analgesia with ketoprofen 100 mg 2 h before procedure per os with spinal anesthesia to decrease postoperative pain according to visual analog scale and to reduce the opioids and other analgesics consumption.

Methods

Patients of our clinic who meet the following inclusion criteria are included: hemorrhoids grade III–IV and the planned Milligan-Morgan hemorrhoidectomy. After signing the consent all participants are randomly divided into 2 groups: the first one gets a tablet with 100 mg ketoprofen, the second one gets a tablet containing starch per os 2 h before surgery (72 participants per arm). Patients of both arms receive spinal anesthesia and undergo open hemorrhoidectomy. Following the procedure the primary and secondary outcomes are evaluated: opioid administration intake, the pain at rest and during defecation, duration, and frequency of other analgesics intake, readmission rate, overall quality of life, time from the procedure to returning to work, and the complications rate.

Discussion

Multimodality pain management has been shown to improve pain control and decrease opioid intake in patients after hemorrhoidectomy in several studies. Gabapentin can be considered as an alternative approach to pain control as NSAIDs have limitative adverse effects. Systemic admission of ketorolac with local anesthetics also showed significant efficacy in patients undergoing anorectal surgery. We hope to prove the efficacy of multimodal analgesia including preemptive one for patients undergoing excisional hemorrhoidectomy that will help to hold postoperative pain levels no more than 3–4 points on VAS with minimal consumption of opioid analgesics.

Trial registration

ClinicalTrial.govNCT04361695. Registered on April 24, 2020, version 1.0.
Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial
Authors: Rojo Pablo , Moraleda Cinta , Tagarro Alfredo , Domínguez-Rodríguez Sara , Castillo Lola Madrid , Tato Luis Manuel Prieto , López Aranzazu Sancho , Manukyan Lilit , Marcy Olivier , Leroy Valeriane , Nardone Alessandra , Burger David , Bassat Quique , Bates Matthew , Moh Raoul , Iroh Tam Pui-Ying , Mvalo Tisungane , Magallhaes Justina , Buck W. Chris , Sacarlal Jahit , Musiime Victor , Chabala Chishala , Mujuru Hilda Angela
Published: June 2022

Background

Pneumonia is the primary cause of death among HIV-infected children in Africa, with mortality rates as high as 35–40% in infants hospitalized with severe pneumonia. Bacterial pathogens and Pneumocystis jirovecii are well known causes of pneumonia-related death, but other important causes such as cytomegalovirus (CMV) and tuberculosis (TB) remain under-recognized and undertreated.

The immune response elicited by CMV may be associated with the risk of developing TB and TB disease progression, and CMV may accelerate disease caused both by HIV and TB. Minimally invasive autopsies confirm that CMV and TB are unrecognized causes of death in children with HIV. CMV and TB may also co-infect the same child.

The aim of this study is to compare the impact on 15-day and 1-year mortality of empirical treatment against TB and CMV plus standard of care (SoC) versus SoC in HIV-infected infants with severe pneumonia.

Methods

This is a Phase II-III, open-label randomized factorial (2 × 2) clinical trial, conducted in six African countries. The trial has four arms. Infants from 28 to 365 days of age HIV-infected and hospitalized with severe pneumonia will be randomized (1:1:1:1) to (i) SoC, (ii) valganciclovir, (iii) TB-T, and (iv) TB-T plus valganciclovir. The primary endpoint of the study is all-cause mortality, focusing on the short-term (up to 15 days) and long-term (up to 1 year) mortality. Secondary endpoints include repeat hospitalization, duration of oxygen therapy during initial admission, severe and notable adverse events, adverse reactions, CMV and TB prevalence at enrolment, TB incidence, CMV viral load reduction, and evaluation of diagnostic tests such as GeneXpert Ultra on fecal and nasopharyngeal aspirate samples and urine TB-LAM.

Discussion

Given the challenges in diagnosing CMV and TB in children and results from previous autopsy studies that show high rates of poly-infection in HIV-infected infants with respiratory disease, this study aims to evaluate a new approach including empirical treatment of CMV and TB for this patient population. The potential downsides of empirical treatment of these conditions include toxicity and medication interactions, which will be evaluated with pharmacokinetics sub-studies.

Trial registration

ClinicalTrials.gov, NCT03915366, Universal Trial Number U111-1231-4736, Pan African Clinical Trial Registry PACTR201994797961340.
Getting it wrong most of the time? Comparing trialists’ choice of primary outcome with what patients and health professionals want
Authors: Treweek Shaun , Miyakoda Viviane , Burke Dylan , Shiely Frances
Published: June 2022

Background

Randomised trials support improved decision-making through the data they collect. One important piece of data is the primary outcome — so called because it is what the investigators decide is the most important. Secondary outcomes provide additional information to support decision-making. We were interested in knowing how important patients and healthcare professionals consider the outcomes (especially the primary outcome) measured in a selection of published trials.

Methods

The work had three stages: (1) We identified a body of late-stage trials in two clinical areas, breast cancer management and nephrology. (2) We identified the primary and secondary outcomes for these trials. (3) We randomly ordered these outcomes and presented them to patients and healthcare professionals (with experience of the clinical area), and we asked them to rank the importance of the outcomes. They were not told which outcomes trial authors considered primary and secondary.

Results

In our sample of 44 trials with 46 primary outcomes, 29 patients, one patient representative and 12 healthcare professionals together ranked the primary outcome as the most important outcome 13/46 times or 28%. Breast cancer patients and healthcare professionals considered the primary outcome to be the most important outcome for 8/21 primary outcomes chosen by trialists. For nephrology, the equivalent figure was 5/25. The primary outcome appeared in a respondent’s top 5 ranked outcomes 151/178 (85%) times for breast cancer and 225/259 (87%) times for nephrology even if the primary was not considered the most important outcome.

Conclusions

The primary outcome in a trial is the most important piece of data collected. It is used to determine how many participants are required, and it is the main piece of information used to judge whether the intervention is effective or not. In our study, patients and healthcare professionals agreed with the choice of the primary outcome made by trial teams doing late-stage trials in breast cancer management and nephrology 28% of the time.
A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial)
Authors: Naef Rahel , Filipovic Miodrag , Jeitziner Marie-Madlen , von Felten Stefanie , Safford Judith , Riguzzi Marco , Rufer Michael
Published: June 2022

Background

Family members of critically ill patients face considerable uncertainty and distress during their close others’ intensive care unit (ICU) stay. About 20–60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.

Methods

To test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, we will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. It will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 h or longer. Families in the intervention arm will receive a family support intervention in addition to usual care. The intervention consists of specialist nurse support that is mapped to the patient pathway with follow-up care and includes psycho-educational and relationship-focused family interventions, and structured, interprofessional communication, and shared decision-making with families. Families in the control arm will receive usual care. The primary study endpoint is quality of family care, operationalized as family members’ satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members’ mental health (well-being, psychological distress) measured at admission, discharge, and after 3, 6, and 12 months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.

Discussion

This trial will examine the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and could be scaled up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.

Trial registration

ClinicalTrials.gov NCT05280691. Prospectively registered on 20 February 2022.
Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units
Authors: Iflaifel Mais , Partlett Christopher , Bell Jennifer , Cook Andrew , Gamble Carrol , Julious Steven , Juszczak Edmund , Linsell Louise , Montgomery Alan , Sprange Kirsty
Published: June 2022

Background

Blinding is an established approach in clinical trials which aims to minimise the risk of performance and detection bias. There is little empirical evidence to guide UK clinical trials units (CTUs) about the practice of blinding statisticians. Guidelines recommend that statisticians remain blinded to allocation prior to the final analysis. As these guidelines are not based on empirical evidence, this study undertook a qualitative investigation relating to when and how statisticians should be blinded in clinical trials.

Methods

Data were collected through online focus groups with various stakeholders who work in the delivery and oversight of clinical trials. Recordings of the focus groups were transcribed verbatim and thematic analysis was used to analyse the transcripts.

Results

Thirty-seven participants from 19 CTUs participated in one of six focus groups. Four main themes were identified, namely statistical models of work, factors affecting the decision to blind statisticians, benefits of blinding/not blinding statisticians and practicalities. Factors influencing the decision to blind the statistician included available resources, study design and types of intervention and outcomes and analysis.

Although blinding of the statistician is perceived as a desirable mitigation against bias, there was uncertainty about the extent to which an unblinded statistician might impart bias. Instead, in most cases, the insight that the statistician offers was deemed more important to delivery of a trial than the risk of bias they may introduce if unblinded.

Blinding of statisticians was only considered achievable with the appropriate resource and staffing, which were not always available. In many cases, a standard approach to blinding was therefore considered unrealistic and impractical; hence the need for a proportionate risk assessment approach identifying possible mitigations.

Conclusions

There was wide variation in practice between UK CTUs regarding the blinding of trial statisticians. A risk assessment approach would enable CTUs to identify risks associated with unblinded statisticians conducting the final analysis and alternative mitigation strategies. The findings of this study will be used to design guidance and a tool to support this risk assessment process.
Tumor lysis syndrome following ifosfamide monotherapy in metastatic osteosarcoma: a case report and review of the literature
Authors: Luminais Steven N. , Chen Xiao T. , Roman Darwin , Ma Brian , Christ Alexander B. , Hu James S.
Published: June 2022

Background

Tumor lysis syndrome is an oncologic emergency that involves multiple metabolic abnormalities and clinical symptoms such as acute renal failure, cardiac arrhythmias, seizures, and multiorgan failure, and may be fatal if not promptly recognized. Tumor lysis syndrome occurs most often in patients with hematologic malignancies, and relatively few cases have been described in patients with sarcoma.

Case presentation

A 64-year-old male of Asian heritage presented to his primary care physician with a right lower-extremity mass and was ultimately diagnosed with widely metastatic osteosarcoma. He was treated with one cycle of cisplatin and doxorubicin that was complicated by hypervolemia and hypoxic respiratory failure. Given concerns for volume overload, therapy was changed to single-agent, dose-reduced ifosfamide. After receiving one dose of ifosfamide 1 g/m2 (1.8 g total) intravenously over 1 hour, the patient developed renal failure, hyperuricemia, hyperkalemia, hyperphosphatemia, and lactic acidosis. The patient ultimately died from severe electrolyte abnormalities associated with tumor lysis syndrome.

Conclusion

This is the first instance of tumor lysis syndrome described in a patient with osteosarcoma undergoing ifosfamide monotherapy. Clinicians must be vigilant in identifying tumor lysis syndrome regardless of the malignancy type or chemotherapy regimen in order to prevent potentially fatal complications.
Consideration of sex and gender differences in addiction medication response
Authors: McKee Sherry A. , McRae-Clark Aimee L.
Published: June 2022

Substance use continues to contribute to significant morbidity and mortality in the United States, for both women and men, more so than any other preventable health condition. To reduce the public health burden attributable to substances, the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism have identified that medication development for substance use disorder is a high priority research area. Furthermore, both Institutes have stated that research on sex and gender differences in substance use medication development is a critical area. The purpose of the current narrative review is to highlight how sex and gender have been considered (or not) in medication trials for substance use disorders to clarify and summarize what is known regarding sex and gender differences in efficacy and to provide direction to the field to advance medication development that is consistent with current NIH ‘sex as a biological variable’ (SABV) policy. To that end, we reviewed major classes of abused substances (nicotine, alcohol, cocaine, cannabis, opioids) demonstrating that, sex and gender have not been well-considered in addiction medication development research. However, when adequate data on sex and gender differences have been evaluated (i.e., in tobacco cessation), clinically significant differences in response have been identified between women and men. Across the other drugs of abuse reviewed, data also suggest sex and gender may be predictive of outcome for some agents, although the relatively low representation of women in clinical research samples limits making definitive conclusions. We recommend the incorporation of sex and gender into clinical care guidelines and improved access to publicly available sex-stratified data from medication development investigations.
Anatomy and the type concept in biology show that ontologies must be adapted to the diagnostic needs of research
Authors: Vogt Lars , Mikó István , Bartolomaeus Thomas
Published: June 2022

Background

In times of exponential data growth in the life sciences, machine-supported approaches are becoming increasingly important and with them the need for FAIR (Findable, Accessible, Interoperable, Reusable) and eScience-compliant data and metadata standards. Ontologies, with their queryable knowledge resources, play an essential role in providing these standards. Unfortunately, biomedical ontologies only provide ontological definitions that answerWhat is it?questions, but no method-dependent empirical recognition criteria that answerHow does it look?questions. Consequently, biomedical ontologies contain knowledge of the underlying ontological nature of structural kinds, but often lack sufficient diagnostic knowledge to unambiguously determine the reference of a term.

Results

We argue that this is because ontology terms are usually textually defined and conceived as essentialistic classes, while recognition criteria often require perception-based definitions because perception-based contents more efficiently document and communicate spatial and temporal information—a picture is worth a thousand words. Therefore, diagnostic knowledge often must be conceived as cluster classes or fuzzy sets. Using several examples from anatomy, we point out the importance of diagnostic knowledge in anatomical research and discuss the role of cluster classes and fuzzy sets as concepts of grouping needed in anatomy ontologies in addition to essentialistic classes. In this context, we evaluate the role of the biological type concept and discuss its function as a general container concept for groupings not covered by the essentialistic class concept.

Conclusions

We conclude that many recognition criteria can be conceptualized as text-based cluster classes that use terms that are in turn based on perception-based fuzzy set concepts. Finally, we point out that only if biomedical ontologies model also relevant diagnostic knowledge in addition to ontological knowledge, they will fully realize their potential and contribute even more substantially to the establishment of FAIR and eScience-compliant data and metadata standards in the life sciences.
Fuelwood use and carbon emission reduction of improved biomass cookstoves: evidence from kitchen performance tests in Tigray, Ethiopia
Authors: Manaye Ashenafi , Amaha Selemawit , Gufi Yirga , Tesfamariam Berihu , Worku Adefires , Abrha Haftu
Published: June 2022

Background

In Ethiopia, biomass contributes to about 92% of the household fuel consumption. As a result, deforestation rate has alarmingly increased associated with greenhouse gas (GHG) emissions and land degradation. The concerned government agencies have been widely making concerted efforts to reverse the situation by of promotion of improved cookstoves (ICS). However, the performance of these technologies in terms of saving fuelwood and their contribution to CO2 emission reduction in a real kitchen was not studied systematically. Thus, this research was initiated to address the knowledge gap.

Methods

The study was conducted in Tigray region in northern Ethiopia. The study households were selected following cross-sectional and longitudinal study designs. A kitchen performance test (KPT) was carried out based on 3 days of repeated fuelwood use measurements to compare the wood-saving performance of ICS in comparison with the traditional cookstove (TCS). The emission reduction potential of both ICS and TCS was calculated based on the Clean Development Mechanism and United Nation’s Framework of Convention on Climate Change and presented in CO2 equivalent (CO2e).

Results

The result suggests significant differences in total and per capita wood consumption (p < 0.05) between improved and TCS. The use of Mirt and Tikikil compared to the traditional stove has reduced the household wood consumption by 35% and 18%, respectively. Furthermore, ICS stoves also reduced CO2e emission per stove per year by 0.65 and 0.27 tons, respectively.

Conclusion

The study deals with the significant contribution that the shift from TCS to the ICS brought in terms of reducing the amount of fuelwood used at household level and the carbon emission per capita. It addresses the crucial roles of such technologies in reducing forest degradation and the associated ecosystem loss. Therefore, policy aimed at reducing greenhouse gas emissions in developing countries at household level should at least start via promotions of ICS.
The application of full-size three-dimensional individual printed model combined with three-dimensional digital demonstration can facilitate patient’s preoperative comprehension to robotic-assisted laparoscopic partial nephrectomy
Authors: Yuan Xiaobin , Liu Xiaolei , Jing Qiang , Liu Fan , Zhang Xuhui
Published: June 2022

Background

In this study, it was aimed to evaluate the feasibility and effectiveness of full-size three-dimensional individual printed model (3D-IPM) based on computerized tomography (CT) reconstruction combined with 3D individual digital models (3D-IDMs) for improving the patient’s and their families’ comprehension levels of robotic-assisted laparoscopic partial nephrectomy (RALPN) preoperatively.

Methods

Between January 2020 and January 2021, 37 patients underwent RALPN in our institution. 3D individual digital models (3D-IDMs) were reconstructed based on the data of computerized tomography (CT) scanning and full-size 3D-IPMs were fabricated correspondingly. For each patient and his/her closest accompanying immediate family member (CAIFM) (spouse or son/daughter), two semi-structured conversations were held by using CT films (1st conversation) and 3D-IPM combined with 3D-IDM demonstration (2nd one) respectively. The preoperative levels of comprehension were evaluated quantitatively by using a self-made preoperative comprehending score (PCS) in the patients and CAIFMs.

Results

All the fabrications of full-size 3D-IPMs and all the operations were technically successful. The total PCS elevated significantly by presenting 3D-IPM combined with 3D-IDM demonstration compared with CT films (42.5 vs 35.5 in patients, P < 0.001; 42.9 vs 35.8 in CAIFMs, P < 0.001). Sub-PCSs in the evaluating aspects of renal anatomy, mass characteristics, the upcoming RALPN procedure, potential complication risks, and prognosis also showed a uniformed climbing pattern with the assistance of 3D-IPM+3D-IDM.

Conclusion

The application of 3D-IPM presentation combined with 3D-IDM demonstration can improve the preoperative comprehension of patient and CAIFM to RALPN with more direct-viewing and verisimilar presentation, and can be used in RALPN patient education for increasing patients’ and their families’ cognitive empowerment.
TLR4 regulates RORγt+ regulatory T-cell responses and susceptibility to colon inflammation through interaction with Akkermansia muciniphila
Authors: Liu Yaojiang , Yang Min , Tang Li , Wang Fengchao , Huang Shengjie , Liu Shuang , Lei Yuanyuan , Wang Sumin , Xie Zhuo , Wang Wei , Zhao Xiaoyan , Tang Bo , Yang Shiming
Published: June 2022

Background

Well-balanced interactions between gut microbiota and the immune system are essential to prevent chronic intestinal inflammation, as observed in inflammatory bowel diseases (IBD). Toll-like receptor 4 (TLR4) functions as a sensor mediating the crosstalk between the intestinal commensal microbiome and host immunity, but the influence of TLR4 on the shaping of intestinal microbiota and immune responses during colon inflammation remains poorly characterized. We investigated whether the different susceptibilities to colitis between wild-type (WT) and TLR4−/− mice were gut microbiota-dependent and aimed to identify the potential immunity modulation mechanism.

Methods

We performed antibiotic depletion of the microbiota, cohousing experiments, and faecal microbiota transplantation (FMT) in WT and TLR4−/− mice to assess the influence of TLR4 on intestinal microbial ecology. 16S rRNA sequencing was performed to dissect microbial discrepancies, and dysbiosis-associated immune perturbation was investigated by flow cytometry. Akkermansia muciniphila (A. muciniphila)-mediated immune modulation was confirmed through the T-cell transfer colitis model and bone marrow chimaera construction.

Results

TLR4−/− mice experienced enhanced susceptibility to DSS-induced colitis. 16S rRNA sequencing showed notable discrepancy in the gut microbiota between WT and TLR4−/− mice. In particular, A. muciniphila contributed most to distinguishing the two groups. The T-cell transfer colitis model and bone marrow transplantation (BMT) consistently demonstrated that A. muciniphila ameliorated colitis by upregulating RORγt+ Treg cell-mediated immune responses. Mucosal biopsies from human manifested parallel outcomes with colon tissue from WT mice, as evidenced by the positive correlation between TLR4 expression and intestinal A. muciniphila colonization during homeostasis.

Conclusions

Our results demonstrate a novel protective role of TLR4 against intestinal inflammation, wherein it can modulate A. muciniphila-associated immune responses. These findings provide a new perspective on host-commensal symbiosis, which may be beneficial for developing potential therapeutic strategies.

Graphical Abstract
Effects of medications on incidence and risk of knee and hip joint replacement in patients with osteoarthritis: a systematic review and meta-analysis
Authors: Cui Beibei , Chen Yuehong , Tian Yunru , Liu Huan , Huang Yupeng , Yin Geng , Xie Qibing
Published: June 2022

Background

This systematic review and meta-analysis aimed to investigate the incidence and risk of knee and hip replacement in patients with osteoarthritis (OA) treated with different medications.

Methods

OVID MEDLINE, OVID EMBASE, Cochrane and Web of Science electronic databases were searched from inception to May 4th, 2022. Clinical trials, including randomized controlled trials, cohort studies and case–control studies, were selected. The meta-analysis effect size was estimated using either incidence with 95% confidence intervals (CIs) or odds ratio (OR)/relative risk (RR) with 95% CIs. The risk of bias and heterogeneity among studies were assessed and analyzed.

Results

Forty studies were included, involving 6,041,254 participants. The incidence of joint replacement in patients with OA varied according to the study design and treatments. The incidence of knee arthroplasty varied from 0 to 70.88%, while the incidence of hip arthroplasty varied from 11.71 to 96.43%. Compared to non-users, bisphosphonate users had a reduced risk of knee replacement (RR = 0.71, 95% CI: 0.66–0.77; adjusted hazard ratio [aHR] = 0.76, 95% CI: 0.70–0.83). Compared to intra-articular corticosteroid users, hyaluronic acid (HA) users had a higher risk of knee arthroplasty (RR = 1.76, 95% CI: 1.38–2.25). No publication bias was observed.

Conclusions

Bisphosphonate treatment is associated with a reduced risk of knee replacement. More studies are needed to validate our results due to the limited number of eligible studies and high heterogeneity among studies.
An indoor fusion navigation algorithm using HV-derivative dynamic time warping and the chicken particle filter
Authors: Chen Jian , Song Shaojing , Gong Yumei , Zhang Shanxin
Published: June 2022

The use of dead reckoning and fingerprint matching for navigation is a widespread technical method. However, fingerprint mismatching and low fusion accuracy are prevalent issues in indoor navigation systems. This work presents an improved dynamic time warping and a chicken particle filter to handle these two challenges. To generate the Horizontal and Vertical (HV) fingerprint, the pitch and roll are employed instead of the original fingerprint intensity to extract the horizontal and vertical components of the magnetic field fingerprint. Derivative dynamic time warping employs the HV fingerprint in its derivative form, which receives higher-level features because of the consideration of fingerprint shape information. Chicken Swarm Optimization (CSO) is used to enhance particle weights, which minimizes position error to tackle the particle impoverishment problem for a fusion navigation system. The results of the experiments suggest that the enhanced algorithm can improve indoor navigation accuracy significantly.
ICT and agricultural sector performance: empirical evidence from sub-Saharan Africa
Authors: Oyelami Lukman O. , Sofoluwe Nurudeen Afolabi , Ajeigbe Omowumi Monisola
Published: June 2022

ICT infrastructure is considered crucial to performance and overall development of many sectors in sub-Saharan Africa (SSA). Yet, there exists insufficient evidence on the effect of ICT on agriculture real output and export performance in the African continent. This study investigates the effect of ICT infrastructure on agriculture sector performances in SSA using panel autoregressive distributed lag (ARDL) approach. Panel data were collected over the period of twenty-three (23) years (1995–2017) in 39 SSA countries. Two models were specified using agricultural value addition and agriculture products as a percentage of total merchandise export as dependent variables. Key independent variables include mobile-cellular telephone subscription and individual using the internet. The study also introduced important control variables such as livestock production index and crop production index. The results from the estimation provide substantial evidence to show that ICT infrastructure has positive externality on agricultural sector performances in the long run. However, there is no evidence to maintain this position in the short run. The study, therefore, recommends that there should be a cautious approach to increasing investment in ICT infrastructure. Provision of in ICT infrastructure alone may not automatically improve agricultural output. Thus, there is a need for extension services to propagate and educate farmers on the importance of continuous adoption of ICT infrastructure for agricultural practices in SSA.
H-theorems for systems of coupled nonlinear Fokker-Planck equations
Authors: Plastino A. R. , Wedemann R. S. , Nobre F. D.
Published: June 2022

Nonlinear diffusion and Fokker-Planck equations constitute valuable tools in the study of diverse phenomena in complex systems. Processes described by these equations are closely related to thermostatistical formalisms based on generalized entropic functionals. Inspired by these relations, we explore the behavior of systems of coupled, nonlinear Fokker-Planck equations. In particular, we establish an H-theorem for a wide family of this type of systems. This H-theorem is formulated in terms of an appropriate free-energy–like functional. The nonlinear evolution equations discussed here include, as particular instances, those governing the dynamics of interacting multi-species, many-body systems in the overdamped-motion regime.
Comparison of Ondansetron versus Domperidone for treating vomiting in acute gastroenteritis in children at a resource limited setting of South Punjab, Pakistan
Authors: Ahmad Tauseef , Zarafshan Uzma , Sahar Bushra
Published: June 2022

Objectives: To compare the efficacy of Ondansetron versus Domperidone for treating vomiting in acute gastroenteritis (AGE) in children at a resource limited emergency setting of South Punjab, Pakistan.

Methods: This open label randomized controlled trial was conducted at The Pediatric Emergency Department of Tehshil Headquarter Hospital, Liaqatpur, Pakistan, from July 2020 to June 2021. A total of 300 children of both genders aged below 12 years of age having 3 or more non-bilious, non-bloody vomiting episodes within 24 hours and with suggestive signs and symptoms of AGE were enrolled and randomized (150 in each group). Efficacy of both drugs was compared in terms of need of 2nd dose within 15 minutes, cessation of vomiting at 6-hour and 24-hour follow up.

Results: Out of a total of 300 children, 162 (54.0%) were male. Mean age was 4.7±2.3 years. Twenty seven (18.0%) children in Ondansetron group required 2nd dose within 15 minutes while 38 (25.3%) children in Domperidone group required the 2nd dose (p=0.1232). Cessation of vomiting at 6-hour interval was noted among 126 (84.0%) children in Ondansetron group in comparison to 118 (78.7%) in Domperidone group (p=0.2359). It was revealed that 127/142 (89.4%) children in Ondansetron group had cessation of vomiting at 24-hours follow up while this was noted to be among 108/134 (80.6%) children in Domperidone group (p=0.0390).

Conclusion: In comparison to Domperidone, Ondansetron was found to have better efficacy aiming cessation of AGE associated vomiting among children with mild to moderate dehydration.

Clinical Trial Registration: NCT05076461 (www.clinicaltrials.gov).

doi: https://doi.org/10.12669/pjms.38.6.5532

How to cite this:Ahmad T, Zarafshan U, Sahar B. Comparison of Ondansetron versus Domperidone for treating vomiting in acute gastroenteritis in children at a resource limited setting of South Punjab, Pakistan. Pak J Med Sci. 2022;38(6):---------.  doi: https://doi.org/10.12669/pjms.38.6.5532

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