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Project information and funding
This trial was executed under the model project of Social Impact Bond—one of the styles of Pay for Success policy constructed by the City of Yokohama—with a business contract between the City of Yokohama, Kids Public, Inc., the University of Tokyo, and other stakeholders. Kids Public, Inc. collected personal informatio...
PMC10294407
Discussion
depression, depressive symptoms
Compared to the participants assigned to the usual care group, those assigned to the mHealth group—where they could use mHealth consultation services according to their needs free of charge—had a lower risk of elevated postpartum depressive symptoms three months after delivery. Women assigned to the mHealth group tende...
PMC10294407
Conclusions
This was the first randomized controlled trial to investigate the effectiveness of mHealth consultation services in preventing PPD during the COVID-19 pandemic. Our study showed the considerable potential of mHealth interventions and possible mechanisms to prevent PPD and ensure equity in services in real-world setting...
PMC10294407
Acknowledgements
Hashimoto
HASHIMOTO, RECRUITMENT
Mitsuru Nakao, Co-Governance and Creation Division, Policy Bureau, the City of Yokohama; Naoya Hashimoto, Kids Public, Inc.; and Daisuke Shigemi, Kids Public, Inc., discussed how to implement this study in a real-world setting with our study team. Yuji Watanabe, the City of Yokohama; Kenta Tamura, the City of Yokohama;...
PMC10294407
Authors’ contributions
YA and NK had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
PMC10294407
Funding
This trial was funded by the City of Yokohama. The service provider, Kids Public, Inc. offered the mobile health consultation service funded by the City of Yokohama. This work was supported by the Japan Society for the Promotion of Science (No. 26670306, 18H04071). Before the study was constructed, the University of To...
PMC10294407
Availability of data and materials
The data are available from the corresponding author on reasonable request.
PMC10294407
Declarations
PMC10294407
Ethics approval and consent to participate
The study was conducted in accordance with the principles of the Declaration of Helsinki and relevant local/international guidelines. The study protocol was approved by the ethical review board of the University of Tokyo (no. 2019347NI). All participants provided informed consent to participate in this study by submitt...
PMC10294407
Consent for publication
Not applicable.
PMC10294407
Competing interests
DN2 reports personal fees from Startia, Inc.; en-power, Inc.; MD.net; and AIG General Insurance Company, Ltd. outside the submitted work.
PMC10294407
References
PMC10294407
Methods
anemia, birth anomalies
ADVERSE EVENTS, PRETERM LABOR, PRETERM RUPTURE OF MEMBRANES, ANEMIA
A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga...
PMC10166496
Results
deaths, congenital anomalies
ADVERSE EVENTS
Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.0...
PMC10166496
Conclusion
congenital anomalies, anemia
ANEMIA DURING PREGNANCY, ANEMIA
Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes.
PMC10166496
Data Availability
All relevant data are within the paper and its
PMC10166496
Introduction
anemia, constipation, Anemia, IDA, nausea, vomiting
IRON DEFICIENCY ANEMIA, ANEMIA, IRON DEFICIENCY, ANEMIA
Anemia in women is a major public health burden worldwide, particularly in low- and middle-income countries [Iron deficiency anemia (IDA) is often treated with oral iron supplements even in pregnancy. However, due to gastrointestinal side effects such as nausea, vomiting, and constipation, compliance is often poor and ...
PMC10166496
Methods
PMC10166496
Study setting
The study was carried out at the antenatal (obstetrics) clinics of Nnamdi Azikiwe University Teaching Hospital (NAUTH), Nnewi, Enugu State University of Science and Technology Teaching hospital, Parklane, Enugu and Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, all are tertiary hospitals in South-east ...
PMC10166496
Study design
This was an open-label randomized clinical trial.
PMC10166496
Study population
anemia
RECRUITMENT, ANEMIA
The participants comprised obstetrics participants with clinical and laboratory diagnosis of anemia and gave written informed consent before recruitment. The participants were recruited at the antenatal clinics or referred for treatment of their anemia from other hospitals. Participants were recruited before to commenc...
PMC10166496
Inclusion criteria
Anemia, anemia
ANEMIA, ANEMIA IN PREGNANCY, ANEMIA
Inclusion criteria included obstetrics adult participants with confirmed clinical and laboratory diagnosis of anemia (hematocrit of <31.5%) and with normal liver and renal function markers or profiles. Anemia was confirmed by prospective expert hematology review. In this study, significant anemia in pregnancy is define...
PMC10166496
Exclusion criteria
nausea and vomiting, anemia, cancers, chronic medical disorders
CANCERS, ANEMIA
Pregnant women in the first trimester of pregnancy (because of nausea and vomiting during this period), chronic medical disorders including HIV/AIDS, cancers, etc. and women on chronic medications that cause anemia were excluded.
PMC10166496
Randomization and allocation sequence
Following consent, patients at the selected hospitals were screened for eligibility. The participants, eligible for the study, were randomized into two groups (blocks of 4, 1:1 ratio) using block randomization using a randomization table created by a computer software program by a person not involved in the study and a...
PMC10166496
Blinding of participants, personnel and outcome assessors
Only the outcome assessors were blinded. The study was open-label, with both participants and investigators aware of treatment assignment.
PMC10166496
Study procedure/Drug administration
anemia
ANEMIA
Participants with a clinical and laboratory diagnosis of anemia presenting in Outpatient Clinic or antenatal clinic of the study hospitals for symptoms or signs of anemia were screened consecutively. All participants underwent routine medical examination that included pulse rate, body weight, blood pressure determinati...
PMC10166496
Intervention therapy
Standard doses of 50 mls (200mg/50mls) of Mojeaga were administered three times daily in conjunction with conventional iron therapy (standard-of-care) two times a day (breakfast and dinner) for 2 weeks.
PMC10166496
Control therapy
Standard/conventional doses of iron therapy (standard-of-care) were administered two times a day (breakfast and dinner) for 2 weeks. The standard-of-care consist of standard doses of one capsule of Astyfer (a supplement with Ferrous fumarate 150mg, Glycine 10mg, L-Histidine hydrochloride H
PMC10166496
Follow-up
anemia, nausea, vomiting, bowel disturbances
SIDE EFFECT, ADVERSE EVENTS, ANEMIA, ADVERSE EFFECTS, EVENTS, COMPLICATIONS
All participants were followed up in outpatient settings. During each follow-up weekly visit, participants were contacted on phone on weekly basis to assess the level of compliance with the trial drugs. Participants were informed about the usual side effect of hematinic preparations and were told to report nausea, vomi...
PMC10166496
Outcome measures
PMC10166496
Primary
The primary endpoint included changes in the hematocrit level and mean or median hematocrit level at two weeks after initial therapy.
PMC10166496
Secondary
diarrhea, birth anomaly, pain, dizziness, nausea,, colitis
ADVERSE EVENTS, PRETERM PREMATURE RUPTURE OF MEMBRANES, ADVERSE EFFECTS, SECONDARY, PRETERM LABOR, COLITIS
The secondary endpoints included the proportion of patients with persisting anemic symptoms (epigastric pain, weakness, dizziness) at two weeks after initial therapy, incidence of any maternal adverse events (such as diarrhea, nausea, vomiting, colitis and drop-out from adverse effects) following commencement of therap...
PMC10166496
Sample size determination
Since this is a pilot study, we assumed a mean hematocrit level of 29.1% in the control group, mean hematocrit level of 31.5% in the intervention group after the intervention [
PMC10166496
Sampling approach
All individuals during the period from February 27, 2020 to February 20, 2022, after satisfying the inclusion and the exclusion criteria were randomly allocated.
PMC10166496
Drug active dose validation/standardization
The cover of the Mojeaga remedy bottle has a measuring cap which is of 25 mls capacity for uniform administration and validation. Each 500mls of Mojeaga remedy contains 2069.57 mg of active Mojeaga remedy [
PMC10166496
Statistical analysis
Data was analyzed using SPSS version 23, IBM Company, USA. The data were expressed as the number (percentage), mean (standard deviation [SD]) or median (±interquartile range), and 95% confidence interval [95% CI] as appropriate. Categorical variables were compared using the Chi-squared test and Fisher’s exact test, as ...
PMC10166496
Ethical consideration
The study adhered to CONSORT guidelines [
PMC10166496
Certification of analysis
To ensure a high quality standardized formulations, the raw material was authenticated and the product was laboratory tested and certified by Prof JU Iyasele of Chemistry Department, University of Benin, Nigeria in accordance with Institute of Public analyst of Nigeria Decree no 100 of 1992.
PMC10166496
Results
PMC10166496
Baseline characteristics
Between February 27, 2020, and February 20, 2022, two hundred and sixty seven participants were assessed for eligibility, 72 participants were excluded for different reasons (58 did not meet the inclusion criteria: HIV/AIDS (25); first trimester pregnancy (17) and declined to participate (16)), while 95 eligible partic...
PMC10166496
Flowchart of the participants.
Of the 95 participants, 85 were pregnant: Mojeaga group (n = 42) and standard-of-care group (n = 43), while 10 were puerperal women (Mojeaga group (n = 6) and standard-of-care group (n = 4). So far, all 95 participants completed the treatment and were included in analysis.As shown in
PMC10166496
Distribution of sociodemographic variables across research groups.
Abbreviations: BMI = Body mass index; SSCE = Senior school certificate examination; OND = Ordinary National diploma; HND = Higher national diploma; BSC = Bachelor of science; SD = Standard deviationAdditionally, the baseline pre-therapy hematocrit level, pre-therapy serum electrolyte, urea and creatinine level and live...
PMC10166496
Comparison of pre-treatment serum variables between research groups.
Abbreviations: Na (NR) = Sodium (Normal range: 135–145); K = Potassium (NR 3.5–5.5); Cl = Chloride (NR 96–106); Bicarbonate (NR 21–31); Urea (NR 1.7–9.1); Creatinine (NR 53–106); AST = Aspartase transaminase (NR 1–40); ALP = Alkaline phosphatase (NR 60–170); ALT = Alanine transaminase (NR 1–40); Hematocrit (NR 30–54); ...
PMC10166496
Primary endpoints
PMC10166496
Median rise in hematocrit values
The median rise in hematocrit values at two weeks follow-up was significantly higher in Mojeaga group (10.00±7.00% vs 6.00±4.00%; p<0.001). Similarly, the median hematocrit values at two weeks follow-up were significantly higher in Mojeaga group (31.00±2.00% vs 27.700±3.00%; p<0.001). This is shown in
PMC10166496
Comparison of hematocrit parameters (primary outcome) among research groups after treatment.
Abbreviations: IR = interquartile range
PMC10166496
Comparison of symptom resolution between research groups pre and post-therapy.
PMC10166496
Proportion of participants with persisting anemic symptoms (epigastric pain, weakness, dizziness) at two weeks after initial therapy
Persistent anemic symptoms were reported in 4.2% of the Mojeaga group and 8.5% of the control group (p = 0.329). There were no cases of treatment failure.
PMC10166496
Comparison of incidence of fetal adverse events among research groups.
PROM, Premature rupture
Abbreviations: PROM = Premature rupture of fetal membranes;Not available* = Those that was recruited at puerperal period.
PMC10166496
Frequency of adverse effects in research groups during treatment.
PMC10166496
Comparison of serum electrolyte and function tests of all research participants at post-therapy.
Abbreviations: Na (NR) = Sodium (Normal range: 135–145); K = Potassium (NR 3.5–5.5); Cl = Chloride (NR 96–106); Bicarbonate (NR 21–31); Urea (NR 1.7–9.1); Creatinine (NR 53–106); AST = Aspartase transaminase (NR 1–40); ALP = Alkaline phosphatase (NR 60–170); ALT = Alanine transaminase (NR 1–40); Hematocrit (NR 30–54); ...
PMC10166496
Median levels of liver function parameters (AST, ALT and ALP) at two weeks after initial therapy
As shown in
PMC10166496
Discussion
toxicity, congenital anomalies, hepatic and renal functions, anemia
ANEMIA IN PREGNANCY, STILL, ADVERSE EVENTS, RECRUITMENT, ANEMIA, WORMS, PRETERM LABOR, DISEASES
This trial which is the first positive randomized trial involving Mojeaga therapy in women with anemia shows that Mojeaga therapy improves anemia compared with the use of standard of care alone. Until now, treatment recommendations for moderate and severe anemia in pregnancy and gynecological patients were based on the...
PMC10166496
Conclusion
congenital anomalies, anemia
ADVERSE EVENTS, ANEMIA DURING PREGNANCY, ANEMIA
In conclusion, based on the findings of our study, Mojeaga should be considered a new adjuvants to standard-of-care option for pregnant and puerperal women with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, low birthweight, p...
PMC10166496
Supporting information
PMC10166496
CONSORT 2010 checklist of information to include when reporting a randomised trial*.
(DOC)Click here for additional data file.(DOCX)Click here for additional data file.(XLSX)Click here for additional data file.The study was coordinated by the Effective Care Research Unit at Nnamdi Azikiwe University University, Awka, Nigeria. The authors appreciate the help of the staff of Nnamdi Azikiwe University Uni...
PMC10166496
Background and purpose
cardioembolic stroke, cardioembolic ischemic stroke
The efficacy and safety of tirofiban in endovascular therapy for cardioembolic ischemic stroke patients remain controversial. This study aimed to evaluate the role of intravenous tirofiban before endovascular therapy in cardioembolic stroke.
PMC10621173
Methods
sICH, stroke, cardioembolism, Vessel Occlusion Stroke, disability
INTRACRANIAL HEMORRHAGE, STROKE
This post hoc analysis utilized data from the RESCUE BT (Endovascular Treatment With versus Without Tirofiban for Patients with Large Vessel Occlusion Stroke) trial, which was an investigator-initiated, randomized, double-blind, placebo-controlled trial. Participants were randomized to receive either tirofiban or a pla...
PMC10621173
Results
cardioembolic stroke
A total of 406 cardioembolic stroke patients were included in this study, with 212 assigned to the tirofiban group and 194 assigned to the placebo group. Tirofiban treatment did not correlate with a favorable shift towards a lower 90-day mRS score (adjusted common odds ratio [OR], 0.91; 95% CI 0.64–1.3;
PMC10621173
Conclusions
sICH, disability, cardioembolic stroke
Tirofiban treatment was not associated with a lower level of disability and increased the incidence of sICH after endovascular therapy in cardioembolic stroke patients.
PMC10621173
Keywords
PMC10621173
Introduction
Ischemic stroke, cardioembolic stroke
SECONDARY, ISCHEMIC STROKE
Ischemic stroke remains a significant global health burden, contributing to substantial morbidity and mortality rates [Tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, has gained attention as a potential adjunctive therapy in the context of EVT for cardioembolic stroke [In this secondary analysis of the RESCUE BT...
PMC10621173
Methods
PMC10621173
Study design and participants
stroke, vessel occlusion, acute ischemic stroke, cardio-embolism
STROKE
The RESCUE BT trial was a prospective, investigator-initiated, double-blind, randomized, placebo-controlled trial aimed at assessing the safety and efficacy of intravenous tirofiban versus placebo prior to EVT in acute ischemic stroke with large vessel occlusion from 55 hospitals in China between October 2018 and Octob...
PMC10621173
Etiological identification of Cardiac embolism
cardioembolic stroke
ACUTE STROKE
In this study, we implemented a meticulous and comprehensive approach for the etiological identification of cardioembolic stroke. Data were collected from various sources, including case report forms and source documents, encompassing comprehensive medical history, clinical features, laboratory tests, 24-h electrocardi...
PMC10621173
Treatments
stroke, angioplasty
STROKE, DEEP VEIN THROMBOSIS
Eligible subjects were randomly assigned to the tirofiban group or the control group. The tirofiban group received intravenous bolus and continuous infusion of tirofiban, while the control group received saline placebo. Tirofiban was administered as a 10 μg/kg bolus, followed by a maintenance infusion of 0.15 μg/kg/min...
PMC10621173
Variables and imaging assessment
ischemic injury, Thrombolysis, Stroke, Cerebral Ischemia
CEREBRAL ISCHEMIA, STROKE
During the enrollment process, demographic variables, vascular risk factors, baseline NIHSS score, treatment information, and workflow measures were recorded. To ensure consistency and reliability in the evaluation process, all imaging data were reviewed by the imaging core laboratory of the RESCUE BT. The determinatio...
PMC10621173
Outcomes
The primary outcome of this study was to assess the proportion of patients achieving functional independence after 90 days, defined as a modified Rankin Scale (mRS) score of 0–2 [
PMC10621173
Statistical analysis
Patient characteristics and clinical outcomes in the two groups were reported using descriptive statistics, including number (percentage) or median and interquartile range. Categorical variables were analyzed using the χ [
PMC10621173
Results
PMC10621173
Discussion
bleeding, sICH, cardioembolic, cardioembolic stroke, platelet aggregation
BLEEDING
This paper reports on a post hoc analysis of the RESCUE BT randomized trial, which aimed to investigate the efficacy of tirofiban for patients presenting with cardioembolic LVO within 24 h of onset. The results demonstrated that the administration of intravenous tirofiban prior to EVT didn’t improve the rate of functio...
PMC10621173
Conclusion
bleeding, sICH, cardio-embolism, cardioembolic stroke
SECONDARY, BLEEDING
The secondary analysis conducted in the RESCUE BT trial, with a specific focus on the cardio-embolism subgroup, has provided concerning insights into the concomitant administration of tirofiban and EVT. Our analysis has revealed a significant association between tirofiban usage and an increased risk of sICH among patie...
PMC10621173
Acknowledgements
We are grateful to all patients and investigators in the RESCUE BT trial.
PMC10621173
Author contributions
BR and ZY: the conception and design of the study. WZ, ZQ, XY and FL: acquisition of data. LG, YY, RM and ZL: analysis and interpretation of data. YL, JZ and HZ drafting the article or revising it critically for important intellectual content. ZY, TL, JF and GT: final approval of the version to be submitted.
PMC10621173
Funding
This study was supported by the Sichuan Provincial Central Leading Local Science and Technology Development Special Project. No.2021ZYD0106.
PMC10621173
Availability of data and materials
All data relevant to the study are included in the article or supplement. Further inquiries on data availability can be directed to the corresponding authors.
PMC10621173
Declarations
PMC10621173
Ethics approval and consent to participate
The research was conducted ethically in accordance with the World Medical Association Declaration of Helsinki. The study protocol received approval from the ethics committee of Xinqiao Hospital, Army Medical University, as well as the relevant ethics committees at all participating centers.
PMC10621173
Competing interests
All authors declare that they have no competing interests in the study.
PMC10621173
References
PMC10621173
Background
MH, opioid use disorder
Considering different factors, such as high withdrawal rates in methadone maintenance treatment (MMT) programs alongside mental health (MH) problems appearing in patients with opioid use disorder and the lack of prior research on the effect of zinc supplementation in this respect, the present study aimed to investigate...
PMC9817328
Methods
opioid use disorder, Depression, Anxiety
RELAPSE
For this purpose, a randomized controlled trial with a clinical basis was fulfilled on a total of 68 patients with opioid use disorder receiving MMT, allocated to two groups, viz. intervention, and control (each one consisting of 34 individuals). Then, the participants in the intervention group were given zinc suppleme...
PMC9817328
Findings
Compared to the control group, the likelihood of drug use (
PMC9817328
Conclusion
MH, opioid use disorder
Accordingly, it was concluded that zinc supplementation could reduce the PoR and improve MH problems in patients with opioid use disorder experiencing MMT. However, further research is recommended to fill the gaps.
PMC9817328
Trial registration
The research protocol has also been listed on the Iranian Registry of Clinical Trials (IRCT) with code no. IRCT2020050904736N1.
PMC9817328
Keywords
PMC9817328
Background
anxiety, MH, Behavioral impairments, aggression, opioid use disorder, depression, irritability, affective dysregulation
DISORDER, ZINC DEFICIENCY, DYSFUNCTION, DISORDERS
As one of the first-line treatments for opioid use disorder, methadone maintenance treatment (MMT) seems to be a long-acting or permanent therapy that replaces opioids with other safe alternatives to control physical and mental problems facing patients with opioid use disorder [The evidence further suggests that many p...
PMC9817328
Aim
MH, opioid use disorder
Considering the high withdrawal rate in methadone maintenance treatment (MMT) programs alongside mental health (MH) problems appearing in patients with opioid use disorder and the lack of prior research on the effect of zinc supplementation on PoR and MH status in patients with opioid use disorder undergoing MMT, the p...
PMC9817328
Methodology
PMC9817328
Research design
opioid use disorder
This study was a randomized, single-blind, parallel, two-arm clinical trial on patients with opioid use disorder receiving MMT in an addiction treatment clinic in an urban area of ​​Iran from April 2021, lasting three months. The research protocol was also listed on the Iranian Registry of Clinical Trials (IRCT) with c...
PMC9817328
Participants
schizophrenia, opioid use disorder, bipolar disorder, psychosis
The statistical population included adult patients with opioid use disorder undergoing MMT. The inclusion criteria in this study were the willingness to participate, age over 18, literacy, drug use confirmed by positive urine tests, taking methadone as supervised by a physician for at least three months, and no chronic...
PMC9817328
Data collection
Depression, Anxiety
RELAPSE
The study data were collected using the Demographic Survey Form (DSF), the Relapse Prediction Scale (RPS), and the Depression, Anxiety, and Stress Scale 21 (DASS-21) before, one month after, and three months after the intervention (i.e., the completion of the intervention program).
PMC9817328
DSF
The DSF consisted of items focused on the participants’ age, gender, marital status, living conditions (single or with family), smoking status (cigarettes or hookahs), education level, and occupation.
PMC9817328
RPS
The 45-item RPS was administered to assess the PoR. Each item included a situation in which the respondent could rate the likelihood of drug use and drug craving [
PMC9817328
DASS-21
MH
The DASS-21 was implemented to measure the MH status of the study participants. Lovibond and Lovibond [
PMC9817328
Intervention program
The participants allocated to the intervention group were visited by a physician every two weeks, and then received a two-week supplement of zinc combined with methadone as planned. The daily dosage of the zinc supplement was about 12 mg. The supplement used in this study was Suzin Zinc Sulfate, made by Alhawi Pharmace...
PMC9817328
Data analysis
MH
The SPSS Statistics software package (ver. 23) was used for the data analysis. To this end, the data from the intervention and control groups were summarized descriptively, using frequency and percentage for the categorical variables and mean and standard deviation (SD) for the continuous ones. The Kolmogorov–Smirnov t...
PMC9817328
Discussion
gastrointestinal tract function, anxiety, abdominal pain, MH, vomiting, constipation, opioid use disorder, malnutrition, depression, anorexia
INFLAMMATION, MALNUTRITION, ZINC DEFICIENCY, OXIDATIVE STRESS, GASTROESOPHAGEAL REFLUX DISEASE, ANOREXIA, COMPLICATIONS
This study aimed to investigate the effect of zinc supplementation on the PoR and MH in patients with opioid use disorder undergoing MMT, wherein the results indicated that zinc supplementation could reduce the PoR and improve the MH status in such individuals. As no studies had so far assessed the effect of zinc suppl...
PMC9817328
Limitations
MH, opioid use disorder
BLIND
To interpret the findings, there are some limitations in the present study that should be considered. First, this clinical trial was conducted in only one addiction treatment clinic located in an urban area of ​​Iran, which could reduce the generalizations to all patients with opioid use disorder undergoing MMT. Second...
PMC9817328
Implications for clinical practice
MH, opioid use disorder
This study has some implications for clinical practice. In view of that, the findings highlight the effect of zinc supplementation on reducing the PoR and improving MH in patients with opioid use disorder experiencing MMT. Therefore, healthcare providers can introduce zinc supplements into the treatment plans for such ...
PMC9817328