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1.
researchsquare; 2024.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-4185718.v1

ABSTRACT

This study compared the humoral immune characteristics of children, elderly people, pregnant women, and adults infected with BA.5 and XBB strains in Guangzhou, China. It was found that binding and neutralizing antibodies the titers against distinct SARS-CoV-2 strains were low in the acute-phase sera of BA.5 infected patients, while the corresponding titers were significantly increased in the convalescent phase, the antibody titers against the Wuhan strain were the highest. Regardless of whether they were vaccinated, BA.5 infection did not induce high neutralizing antibodies against XBB. During the recovery phase, the titers of antiviral antibodies in the vaccinated population are more robust than those in the unvaccinated population. For BA.5 infections, the specific binding and neutralizing antibody titers in the children group were lower compared to other population groups. In the convalescence period of the disease, the titers of neutralizing antibodies against Wuhan, BA.5 and XBB strains induced by BA.5 infections are significantly correlated in pairs. XBB can induce a broader and balanced antiviral humoral immune response than BA.5 as a first-time infected strain. This finding can provide a reference for the judgment of the future epidemic law of SARS-CoV-2, and provide a scientific basis for developing novel COVID-19 vaccines, especially for discovering customized vaccines and immune strategies for different populations.

2.
researchsquare; 2024.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-4170144.v1

ABSTRACT

Background: The Coronavirus Disease 2019 (COVID-19) pandemic has significantly impacted the management and prevalence of gestational diabetes mellitus (GDM) among pregnant women worldwide. This study aimed to investigate the effects of the pandemic on GDM prevalence and oral glucose tolerance test (OGTT) characteristics in Hongshan District, Wuhan, China. Methods: We retrospectively analyzed data from 91,932 pregnant women screened for GDM before (January 1, 2018, to December 31, 2019) and after (January 1, 2020, to December 31, 2021) the onset of the COVID-19 pandemic. The study focused on changes in GDM prevalence, OGTT positive rates and glucose value distribution, and the diagnostic performance of OGTT. Results: The prevalence of GDM increased significantly from 14.5% (95% CI, 14.2-14.8%) pre-pandemic to 21.9% (95% CI, 21.5-22.4%) post-pandemic. A notable rise in OGTT positive rates was observed across all time points, with the most significant increase at the 0-hour mark. Regression analysis indicated a significant risk increase for GDM during the pandemic, even after adjusting for age. Diagnostic accuracy of the 0-hour OGTT improved in the pandemic era, with the area under the curve (AUC) rising from 0.78 to 0.79 and sensitivity from 0.56 to 0.58. Median OGTT values at all time points significantly increased post-pandemic, even after adjusting for age, indicating a shift in glucose metabolism among the study population. Conclusion: The COVID-19 pandemic has led to a significant increase in the prevalence of GDM among pregnant women in Hongshan District, Wuhan. This is evidenced by the elevated rates of positive OGTT and altered median glucose values, indicating a shift in glucose metabolism. These findings underscore the profound impact of the pandemic on maternal and neonatal health. They emphasize the imperative for continuous monitoring and the development of updated, localized diagnostic criteria for OGTT to enhance the identification and treatment of GDM during and after global health crises.

3.
preprints.org; 2024.
Preprint in English | PREPRINT-PREPRINTS.ORG | ID: ppzbmed-10.20944.preprints202403.1341.v1

ABSTRACT

Introduction: The emergency of the SARS-CoV-2 virus spread and its subsequent global pan-demic have raised significant concerns regarding its impact on pregnancy outcomes. This review aims to summarize the emerging data on the risk of preterm delivery in pregnant women infected with SARS-CoV-2. Materials and Methods: A systematic search was conducted from March 2020 to December 2023 using PubMed, following PRISMA guidelines. Studies correlating maternal COVID-19 infection with preterm birth were included. Results: Thirteen studies were analyzed, indicating a higher incidence of preterm birth in SARS-CoV-2 positive pregnant women compared to controls. The average incidence rate of pre-term birth in infected patients was 18.5%, with a median of 12.75%, while non infected women showed an average incidence of preterm birth of 10% with a median of 8.2%. Discussion: Studies suggest an association between SARS-CoV-2 infection during pregnancy and increased risk of preterm birth and cesarean section. Severity of symptoms and underlying comorbidities further elevate this risk. Notably, infections during the third trimester pose the highest risk of preterm birth. Conclusion: Preventing SARS-CoV-2 infection during pregnancy is crucial to mitigate adverse obstetric outcomes. Close monitoring and tailored interventions for infected pregnant women, particularly those in later trimesters and with comorbidities, are imperative to reduce the risk of preterm birth and improve maternal-fetal outcomes.

4.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.03.18.24304517

ABSTRACT

Coronavirus disease 2019 (COVID-19), when contracted by pregnant women, can lead to severe respiratory illness, rapid disease progression, and higher rates of intensive care unit admission. COVID-19 infection during pregnancy is associated with an increased risk of preterm delivery, cesarean section, fetal dysfunction, preeclampsia, and perinatal death. Additionally, vertical transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from pregnant women to their fetuses has been observed. While severe infections in neonates and infants are rare, newborns can experience serious consequences from COVID-19, despite their suboptimal humoral immune system protection. The amino acids in the structural proteins of SARS-CoV-2 are subjected to constant mutation. Since around January 2023, COVID-19, caused by infection with omicron-type SARS-CoV-2 variants, has been prevalent globally. Omicron-type SARS-CoV-2 variants can evade the immune response triggered by traditional mRNA-based COVID-19 vaccines, such as BNT162b2. Therefore, vaccination with a vaccine (BNT162b2 XBB.1.5) that can provide protection against omicron-type SARS-CoV-2 variants is recommended. Therefore, we examined the titers of anti-spike glycoprotein of SARS-CoV-2 IgG and IgA in the blood and umbilical cord blood obtained from pregnant women vaccinated with BNT162b2 XBB.1.5. The results showed that anti-spike glycoprotein of SARS-CoV-2 IgG and IgA titers were highest in the blood and cord blood obtained from pregnant women vaccinated with BNT162b2 XBB.1.5 at late gestational age (28-34 weeks). No serious side effects or adverse events caused by vaccination of pregnant women with BNT162b2 XBB.1.5 were observed in either pregnant women or newborns. In the future, to validate our findings, large cohort clinical studies involving numerous pregnant women must be conducted.

5.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.02.27.24303454

ABSTRACT

Introduction:   Pregnant women are considered a high-risk group for COVID-19, and a priority for vaccination. Routine antenatal (ANC) care provides an opportunity to track trends and factors associated with vaccine uptake. We sought to evaluate COVID-19 vaccine uptake among pregnant women attending ANC in Zambia.   Methods  We conducted a repeated cross-sectional study in 39 public health facilities in four districts in Zambia from September 2021 to September 2022. Pregnant women who were aged 15-49 years were enrolled during their first ANC visit. Every month, ~20 women per facility were interviewed during individual HIV testing and counseling. We estimated vaccine uptake as the proportion of eligible participants who self-reported having received the COVID-19 vaccine.   Results   A total of 9,203 pregnant women were screened, of which 9,111 (99%) were eligible and had vaccination status. Of the 9,111 included in the analysis, 1,818 (20%) had received the COVID-19 vaccine during the study period, with a trend of increasing coverage with time (0.5% in September 2020, 27% in September 2022). Conversely, 3,789 (42%) reported not being offered a COVID-19 vaccine. We found that older age, education, employment status, and prior COVID-19 infection were significantly associated with vaccine uptake.     Conclusion  COVID-19 vaccine uptake among pregnant women was lower than estimates from the general population (27% across the four districts in September 2022), pointing to missed opportunities to protect this high-risk group. ANC visits were a viable point for conducting COVID-19 surveillance. Incorporating the vaccine as part of the routine ANC package might increase coverage in this group.

6.
ChiCTR; 2024-02-23; TrialID: ChiCTR2400081132
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400081132

ABSTRACT

Condition:

Long Covid

Intervention:

healthy group:Maintain daily habits;Rehabilitation group:Maintain daily habits;fatigue patients with Long Covid:Maintain daily habits;

Primary outcome:

Peak cardiorespiratory oxygen uptake;Proteomic features;Metabolomics profile;

Criteria:

Inclusion criteria: 1. Inclusion criteria for healthy populations
(1) No history of novel coronavirus infection and SARS infection or morbidity
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
2. Inclusion criteria for persons recovering from novel coronavirus infection
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses and no sequelae such as fatigue or malaise 12 weeks after the diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time
3. Long Covid with Fatigue Patient Inclusion Criteria
(1) Positive polymerase chain reaction (PCR) test or antigen results for novel coronaviruses with sequelae such as fatigue and malaise 12 weeks after diagnosis of COVID-19
(2) 18 years = age = 80 years
(3) Those who can perform exercise cardiopulmonary testing
(4) Able to read and understand the contents of the informed consent form, sign the informed consent form and voluntarily participate
(5) Axillary temperature <37.3?
(6) No history of allergy to vaccine exposure
(7) Non-pregnant or lactating women
(8) No history of immune system diseases, other serious diseases or mental illnesses
(9) Ability to comply with vaccination and blood sample collection procedures, obey the management of the study center, and return to the study center for follow-up visits on time

Exclusion criteria: Subjects with the following conditions should be excluded:
(1) Pulmonary embolism;
(2) Absolute and relative contraindications to cardiopulmonary exercise testing or exercise training;
(3) Obvious arrhythmia or ischemia during low-intensity exercise and severe pulmonary hypertension;
(4) Severe pulmonary diseases (e.g., chronic obstructive pulmonary disease, severe COVID-19-related symptoms, severe asthma);
(5) Recent cardiovascular events (cardiac decompensation, angioplasty or cardiac surgery less than 4 weeks, valvular heart disease requiring surgical correction, pericarditis, fatigue caused by various arrhythmias);
(6) Renal failure requiring dialysis;
(7) Patients with New York Heart Association (NYHA) class ? or recurrent malignant arrhythmia;
(8) Drug-induced muscle atrophy, such as steroids or neuromuscular blocking drugs;
(9) Metabolic diseases ( such as hyperglycemia, malnutrition), and weakness caused by electrolyte disturbances;
(10) Myalgic encephalomyelitis/chronic fatigue syndrome;
(11) Allergic to known components of study drugs;
(12) Refusal to sign informed consent;
(13)Those who participated in other clinical trials or used Chinese medicine (proprietary Chinese medicine) in the last three months.

7.
ChiCTR; 2024-02-23; TrialID: ChiCTR2400081131
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400081131

ABSTRACT

Condition:

long-covid syndrome

Intervention:

treatment group:Chinese Herbal Medicine and Snap-Needle Therapy;control group:Western medicine for symptomatic treatment;

Primary outcome:

Chinese Medicine Score;

Criteria:

Inclusion criteria: ?Patients who meet the above diagnostic criteria of traditional Chinese medicine and western medicine;
? Age 18-65 years old, gender is not limited;
? Patients more than 1 week after negative nucleic acid or antigen test;
? Patients with symptoms of impaired cardiopulmonary function, such as cough, fatigue, palpitation, etc., which last for no more than half a year after turning negative from nucleic acid or antigen test;
? Patient's TCM evidence points, according to the symptoms in the recovery period, the primary symptoms are evaluated according to 0, 1, 2, 3 points, and the secondary symptoms are evaluated according to the presence or absence of the symptoms, using 1 or 0 points, and the sum of the scores is recorded as the TCM evidence points, and the higher the score, the more serious the condition is.
? Patients volunteered to be tested and signed an informed consent form.

Exclusion criteria: ?Patients with severe interstitial lung disease, bronchiectasis, and other underlying lung diseases;
? Patients with underlying diseases such as congenital respiratory malformations and congenital heart disease;
? Patients with severe cardiac, hepatic, renal dysfunction and abnormal coagulation function;
?Patients with diseases that affect cognitive function, such as alcoholism, drug addiction or psychotropic substance abuse;
? People with history of needle fainting and skin infection at the site of needling;
? Patients who are allergic to Chinese medicinal preparations;
? Pregnant or lactating women;
? Those who are participating in other clinical trials or those who have participated in other clinical trials for less than 3 months. Those who meet any of the above criteria should be excluded.

8.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.02.18.24302492

ABSTRACT

Background There were many unknowns for pregnant women during the COVID-19 pandemic. Most of these could have been silent however lethal and anemic conditions could escalate the worsening of pregnancy outcomes. Existing evidence indicate that, array of factors is associated with the ability of compromising maternal anemia, some directly and others indirectly. Objective This review aimed at ascertaining the pooled effect of several anemia interventions. Specifically, the aim of this study was to establish if pregnancy status is associated with COVID-19 severity characterized by a cytokine storm. Methods We searched the Google Scholar, PubMed, Scopus, Web of Science, and Embase databases to studies suitable for inclusion in this meta-analysis. Studies examining women of reproductive age on any maternal anemia intervention were included. The risk of bias was assessed using the Cochrane risk of bias tool. Review Manager 5.4.1 was used to calculate rate ratios (RRs) with 95% CIs, which were depicted using forest plots. Quantitative variables were summarized in total numbers and percentages. The effect on prevention, control, management and or treatment of anemia was calculated and compared between the intervention and the comparator arms. Heterogeneity was evaluated with the Cochran Q statistic and Higgins test. Results A total of 11 articles including data for 6,129 were included. With sensitivity analysis, the interventions had a utility of 39% on maternal anemia prevention and management (random effects model RR 0.61, 95% CI 0.43, 0.87; P = 0.006) (X-squared 6=286.98, P<.00001; I-squared=97%). All the interventions against maternal anemia showed an effect of 17% (fixed-effect model RR 0.83, 95% CI 0.79-0.88; P<.00001) (X-squared 7;24=2.93, P=0.57;I-squared = 0%). Education to pregnant women showed a 28% effect (RR 0.72 95% CI 0.58, 0.89), medicinal administration 19% (RR 0.81 95% CI 0.73, 0.90), iron supplementation 17% (RR 0.83 95% CI 0.75, 0.92) and I.V Ferric Carboxy-maltose 15% (RR 0.85 95% CI 0.74, 0.97) (I-squared = 0%). Interventions in African region had a higher (16%) and significant effect compared to other regions (fixed-effects model RR 0.84, 95% CI 0.79-0.89; P<.001) (X-squared 7;25=176.53, P<.00001;I-squared = 7%). Multiple center studies had a significant predictive effect (16%) compared to single center studies (fixed-effects model RR 0.84, 95% CI 0.79-0.89; P<.00001)(967;25=176.53, P<.00001; I-squared=97%) .The year 2020 recorded the highest effect of maternal anemia interventions at 28% (random-effects model RR 0.72, 95% CI 0.67-0.78; P<.00001) (967;23=167.34, P<.00001; I-squared =98%) Conclusion In the advent of COVID-19, maternal anemia interventions were compromised demonstrated by a low effectiveness trend from the year 2020 to the year 2022. During this period, even the most effective and recommended interventions against maternal anemia were somehow affected.

9.
ClinicalTrials.gov; 19/02/2024; TrialID: NCT06278324
Clinical Trial Register | ICTRP | ID: ictrp-NCT06278324

ABSTRACT

Condition:

Acute Respiratory Tract Infection;Flu, Human;COVID-19;Common Cold

Intervention:

Device: Nasal Spray HSV Treatment

Primary outcome:

Performance of nasal spray in eliminating viruses

Criteria:


Inclusion Criteria:

- With early symptoms of respiratory infection (onset less than 48 hours before
inclusion) of mild to moderate intensity (TSS = 2 and < 9).

- Having a mobile phone allowing using the patient reported outcome App. (NursTrial®).

- Patient able to understand and comply with protocol requirements and instructions,
including answering a questionnaire on a mobile phone, as required by protocol.

- Signed informed consent.

- Affiliated to a French Health insurance scheme.

Exclusion Criteria:

- Concomitant disease or infection that could interfere with participation in the study:
acute ear, nose, and throat and respiratory tract disease other than the common cold,
flu or COVID (e.g., tonsillitis, otitis, bronchitis) and chronic sinusitis or allergic
rhinitis, or other reasons for nasal obstruction and other past or present conditions
and treatments that could influence symptom scores.

- Severe nasal septum deviation or other conditions that could cause nasal obstruction
such as the presence of nasal polyps.

- Known or suspected intolerance or hypersensitivity, including history of allergies, to
any component investigational device material, any history of drug hypersensitivity.

- Concomitant treatment that might impair the trial results (i.e., decongestants, local
anesthetics, topical corticosteroids, saline solution) during the seven days prior to
inclusion.

- Smokers.

- Have a condition or is taking a medication that the Investigator and/or designee
believes could jeopardize the safety of the subject, would interfere with the
evaluation, or confound the interpretation of the study results.

- Non-compliant or may not respect the constraints imposed by the protocol.

- Enrolled in another clinical trial or being in a period of exclusion from a previous
clinical trial;

- Woman of childbearing age (except menopausal, hysterectomised, sterilized) not using
effective contraception (oral contraceptives, intra-uterine device, contraceptive
implant, or condoms).

- Person belonging to a population referred to in articles 64 (incapacitated subjects),
65 (minors), 66 (pregnant or breastfeeding women), 67 (persons performing mandatory
military service, persons deprived of liberty, persons who, due to a judicial
decision) and 68 (patients in emergency) of the Medical Device Regulation.


10.
researchsquare; 2024.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-3970345.v1

ABSTRACT

Purpose The study aimed to investigate the potential influence of COVID-19 infection on embryo implantation and early development in women undergoing frozen embryo transfer(FET), with a specific focus on infections occurring at different periods around FET.Methods A retrospective analysis was performed on women who had undergone FET during a period marked by a significant surge in COVID-19 infection in Shanghai. All enrolled women experienced their first documented COVID-19 infection around the time of FET, ensuring that infections did not occur prior to oocyte retrieval. Participants were categorized into six groups based on the timing of infection: uninfected, ≥ 60 days, < 60 days before FET, 0–14 days, 15–28 days, and 28–70 days after FET. Clinical outcomes were compared across these groups.Results The infection rate among the total of 709 cases was 78.28%. Infected individuals exhibited either asymptomatic or mild symptoms. The ongoing pregnancy rates for the first four groups were 40.7%, 44.4%, 40.5%, and 34.2% (P = 0.709) respectively, biochemical pregnancy rates (59.1% vs. 61.1% vs. 67.6% vs. 55.7%, P = 0.471) and clinical pregnancy rates (49.6% vs. 55.6% vs. 55.4% vs. 48.1%, P = 0.749), all showed no significant differences. Early spontaneous abortion rates across all six groups were 18.3%, 20.0%, 25.0%, 28.9%, 5.4%, and 19.0% respectively, with no significant differences (P = 0.113). Multivariable logistic analysis revealed no significant correlation between the infection and ongoing pregnancy.Conclusion Asymptomatic or mild COVID-19 infections occurring around FET do not appear to have a significant adverse impact on early pregnancy outcomes.

11.
ClinicalTrials.gov; 18/02/2024; TrialID: NCT06272253
Clinical Trial Register | ICTRP | ID: ictrp-NCT06272253

ABSTRACT

Condition:

COVID-19 Pandemic;COVID-19 Vaccines

Intervention:

Biological: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 µg

Primary outcome:

Humoral Immune Response (Neutralizing antibody)

Criteria:


Inclusion Criteria:

1. Healthy males and females, adolescents age 12-17 years old. Healthy status will be
determined by the investigator based on medical history, clinical laboratory results,
vital sign measurements, and physical examination at screening.

2. Subjects already received 2 (two) doses of Coronavac (Sinovac) vaccines at least 3
months prior to this study.

3. Subjects and the parents or guardian have been informed properly regarding the study
and signed the informed consent form

4. Subject and the parents or guardian will commit to comply with the instructions of the
investigator and the schedule of the trial

5. Participants agree not to donate bone marrow, blood, and blood products from the first
study vaccine administration until 3 months after receiving the vaccine.

6. Participants and the parents or guardian must be willing to provide verifiable
identification, has means to be contacted and to contact the investigator during the
study.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial

2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever
(axillary temperature 37.5oC or more) concurrent or within 7 days prior to study
vaccination. This includes respiratory or constitutional symptms consistent with
SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)

3. Known history of allergy to any component of the vaccines

4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular
injection

5. Any autoimmune or immunodeficiency disease/condition

6. Subjects who have received in the previous 4 weeks a treatment likely to alter the
immune response (intravenous immunoglobulin, blood derived products, long term
corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for
immunosuppressive treatment within 6 months after last vaccination. The use of topical
or nasal steroid will be permitted. Inhaled glucocorticoids are prohibited.

7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart
failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes
requiring use of medicine. The final decision regarding this condition will be decided
by the attending field clinicians or investigator.

8. Any abnormality or chronic disease which according to the investigator might interfere
with the assessment of the trial objectives

9. Subjects already immunized with any other vaccines within 4 weeks prior and expect to
receive other vaccines within 60 days following the first dose

10. Individuals who have a previously ascertained Covid-19 in the period of 1 month (for
mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the
first recruit of this study, or in a close contact in the last 14 days with confirmed
case of Covid-19.

11. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to the vaccination.
Testing may be repeated during the screening period if exposure to positive confirmed
case of SARS-CoV-2 is suspected, at the discretion of investigator.

12. History of alcohol or substance abuse

13. HIV patients.

14. Malignancy patients within 3 years prior to study vaccination.

15. Any neurological disease or history of significant neurological disorder such as
meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc

16. Vital sign abnormalities and clinical laboratory abnormalities as decided by the
investigators. Vital sign measurements and clinical laboratory testing may be repeated
before the final decision.

17. Women who are pregnant or who plan to become pregnant during the study.

18. Participant has major psychiatric problem or illness

19. Participant cannot communicate reliably with the investigator

20. Participant has contraindication to intramuscular injection and blood draws, such as
bleeding disorders or phobia.

21. Participant had major surgery within 12 weeks before vaccination which will not be
fully recovered, or has major surgery planned during the time participant is expected
to participate in the study or within 6 months after the vaccination.

22. Any condition that in the opinion of the investigators would pose a health risk to the
subject if enrolled or could interfere with the evaluation of the vaccine or
interpretation of the study results

23. Study team members.

24. Subject planning to move from the study area before the end of study period.


12.
ChiCTR; 2024-02-18; TrialID: ChiCTR2400080912
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400080912

ABSTRACT

Condition:

type 2 diabetes

Intervention:

the control group:Traditional Chinese Medicine Treatment;

Primary outcome:

fasting blood glucose;2-hour postprandial blood glucose;glycated hemoglobin;standard deviation of blood glucose;mean amplitude of glycemic excursions;maximum blood glucose fluctuation amplitude;average absolute difference of daytime blood glucose;coefficient of variation;time in range of blood glucose;time above range of blood glucose;time below range of blood glucose;

Criteria:

Inclusion criteria: ? According to the T2DM criteria defined in the Guideline for the Prevention and Treatment of Type 2 diabetes mellitus in China (2020 edition);
? According to the syndrome of Damp-heat trapping the spleen in the Guidelines for Integrated Diagnosis and Treatment of Type 2 Diabetes Mellitus (2020 Edition) and the Guidelines for Clinical Diagnosis and Treatment of Diabetes Mellitus in Traditional Chinese Medicine (2020 Edition);
? The course of the disease is = 12 months;
? The age of patients were between 18 and 65, regardless of gender;
? Overweight and obese, BMI = 24kg/m2, defined by Chinese criteria29; ?no COVID-19 infections in the last 6 months, 48 hours negative for novel coronavirus-N gene test and negative for novel coronavirus-ORF1ab gene test.

Exclusion criteria: ? Failure to meet the new diagnosis of T2DM;
? Women who are pregnant or breastfeeding;
? Those with severe heart, lung, brain, liver and kidney diseases;
? Combination of any diabetic comorbidities and complications of diabetes mellitus;
? Allergy or intolerance to therapeutic drugs;
? Severe mental disorders, hysteria and inability to communicate properly;
? Other diseases that may have an effect on glucose metabolism;
? Experience of a critical illness or other stressful situation within the last month;
? Participation in other studies within the last 3 months;
? COVID-19 infection in the last 6 months, or 48 hours positive for novel coronavirus-N gene and positive for novel coronavirus-ORF1ab gene.

13.
ChiCTR; 2024-02-18; TrialID: ChiCTR2400080931
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2400080931

ABSTRACT

Condition:

COVID-19

Intervention:

intervention group:receiving pharmacologic treatment and press needles intervention;control group:only receiving pharmacologic treatment;

Primary outcome:

clinical symptom score;

Criteria:

Inclusion criteria: 1) Age from 14 to 90 years old, regardless of gender;
2) patients with COVID-19, mild or common type;

Exclusion criteria: 1) Known or suspected allergic history or serious adverse reactions to metal and tape in intradermal needle, or allergic constitution.
2) Complicated with serious heart and lung diseases, kidney disease, diabetes, advanced tumors, hematological and hematopoietic system diseases, or serious or progressive diseases of other systems.
3) patients with comorbid neurological or mental disorders who were unable to cooperate or unwilling to cooperate.
4) pregnant and lactating women.
5) Other conditions that the investigator considers inappropriate to participate in the trial.
6) those who are participating in other COVID-19 intervention clinical trials.

14.
researchsquare; 2024.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-3967898.v1

ABSTRACT

Background The WHO, reported world widespread coronavirus disease (COVID-19) as an international public health emergency. Pregnancy is associated with immunological changes that may make women susceptible to COVID-19. The present study was conducted to clarify the impacts of the pandemic on intra uterine growth restriction (IUGR) and other complications of pregnancy.Material & methods In a historical cohort study, COVID-19-positive cases who were hospitalized and a subgroup of Intensive Care Unit (ICU)-admitted (severe) cases were compared with those who had no history of COVID-19 infection, regarding IUGR and other complications of pregnancy.Results Among 1010 pregnant women enrolled in the study, 43 (4.3%) had a history of hospitalization due to COVID-19 (including 28 ICU-admitted severe cases) through pregnancy and the other 967 cases who had no history of infection were compared. In the comparison of COVID-19 with non-COVID-19 groups, IUGR, and preterm laborwere more frequent in the COVID-19 group(16.3% versus 6.9%) and (51.2% versus 19.9%), respectively. Also, the cesarean section rate was higher (75% versus 55.3%) and the low APGAR score was more frequent (16.3% versus 3.3–3.7%)Conclusion Complications of COVID-19 infection in pregnancy such as IUGR, preterm labor, higher rate of cesarean section,and low APGAR score might make pregnant women more vulnerable to the COVID-19 pandemic and probable future versions of viral pandemics.

15.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.02.15.24302882

ABSTRACT

Pregnant women with coronavirus infection are at a higher risk for severe diseases. In the present study, we evaluated and compared clinical characteristics and outcomes in pregnancy of normal females and females with SARS-CoV-2 infection. Our study was a cross-sectional study. The pregnant females were examined, their blood samples were taken for Covid Panel (D-Dimer, Ferritin, IL-6, CRP, PCT (Procalcitonin)); and oral-nasal swabs were taken for SARS-CoV-2 infection. Both SARS-CoV-2 positive and negative (control) females were followed up every trimester for any complication related to pregnancy. We found that females suffering from SARS-CoV-2 infection had reduced gestation periods, and had higher percentage of caesarean and pre-term delivery than SARS-CoV-2 negative females. Based on our findings, it appears that there exist close associations between SARS-CoV-2 infection in pregnant females and increased risk of reduced gestation periods, and spontaneous caesarean and pre-term delivery. However, more studies are still needed to validate present findings.

16.
medrxiv; 2024.
Preprint in English | medRxiv | ID: ppzbmed-10.1101.2024.02.14.24302750

ABSTRACT

Background: Over five billion people globally rely on a plant- and animal-based pharmacopoeia for their healthcare needs. The inhalation, topical application, subcutaneous injection, or ingestion of animal products - such as faeces, fur, milk, blood, brain tissue, or meat - likely facilitates the spill over of zoonotic pathogens. Certain practices use species known to be involved in the transmission of pathogens of public health relevance, such as reservoir species for filoviruses, poxviruses, and coronaviruses. These practices and the public health risk they entail have not been previously reviewed and analysed for the African continent. Methods We first conducted a systematic review of literature using web-scraping algorithms targeted at peer-reviewed (PubMed) and peer-reviewed or grey literature (Google Scholar) databases, followed by manual search of reference lists published before July 30th, 2023. We used terms encompassing zoo*, animal*, health*, practice*, tradition* followed by a list of all 54 African countries in combination with Boolean operators. We then created a categorical score reflecting the risk of zoonotic pathogen spill over for each recorded zootherapeutic practice, and compared this risk between geographic regions and between demographic groups. Findings A total of 53 studies were included, reporting the use of over 2,000 zootherapeutic practices. Half of the included studies were published after 2020. Nigerian, Ethiopian, Tanzanian and South African practices were comparatively well documented. The mean total risk score was significantly lower in western (p < 0.0001), central (p < 0.003), and southern (p < 0.0001) Africa, compared to eastern Africa, while there was no significant difference between eastern and northern Africa. Further, we found that physically sick children are overall at increased risk for pathogen spill over (p = 0.001) compared to physically sick adults, and that pregnant or lactating women are exposed to animal tissues of significantly greater infectious potential (p = 0.032). Interpretation The WHO recently hosted its first global summit on Traditional, Complementary and Integrative Medicine (TCIM), highlighting its importance to fulfil SDG 3: Health and Wellbeing. Where other forms of healthcare are unavailable or inefficient, zootherapeutic practices can provide valuable solutions to acute, chronic, physical, and psychological issues. However, significant risks of zoonotic disease transmission exist. This article aims to guide research on sustainable alternatives to mainstream medical treatments that balance cultural significance and public health.

17.
ClinicalTrials.gov; 13/02/2024; TrialID: NCT06259656
Clinical Trial Register | ICTRP | ID: ictrp-NCT06259656

ABSTRACT

Condition:

Covid-19

Intervention:

Diagnostic Test: COVID-19 Spike Protein IgG Quantitative Antibody (CMIA)

Primary outcome:

COVID-19 Spike Protein IgG Quantitative Antibody (CMIA) Level

Criteria:


Inclusion Criteria:

- Thai term pregnant women

- 18-45 year old

- At least 1 covid vaccination received

- admission at Vachira Phuket Hospital Labor Room

Exclusion Criteria:

- Do not want to participate

- Unstable or Emergency condition


18.
ClinicalTrials.gov; 12/02/2024; TrialID: NCT06268015
Clinical Trial Register | ICTRP | ID: ictrp-NCT06268015

ABSTRACT

Condition:

Colorectal Cancer

Intervention:

Drug: Botensilimab;Drug: Balstilimab;Drug: Oxaliplatin;Drug: Leucovorin;Drug: Fluorouracil;Drug: Bevacizumab;Drug: Panitumumab

Primary outcome:

Disease control rate based on iRECIST at second restaging scan;Proportion of subjects with a best overall response of complete response or partial response according to iRECIST

Criteria:


Inclusion Criteria:

1. Male or female participants who are at least 18 years of age on the day of signing
informed consent.

2. Histologically confirmed metastatic and/or unresectable colorectal cancer without
liver metastasis or known or suspected bone or brain metastases.

a. Up to 3 patients with peritoneal carcinomatosis will be included. Other than those
three, subjects must only have lung, lymph node, and locoregional sites of disease
(primary tumor or serosal implant without carcinomatosis).

3. Microsatellite stable disease.

4. Subject must be willing to provide fresh biopsy of tumor lesion. Those who do not have
a tumor lesion that is safe and amenable to biopsy may still be enrolled.

5. ECOG performance status of 0 or 1.

6. No prior systemic therapy for colon cancer.

a. Subjects who received systemic therapy in the neoadjuvant or adjuvant setting may
be eligible with approval from the principal investigator.

7. Measurable disease per RECIST v1.1.

8. Female participants must not be pregnant or breastfeeding and meet at least one of the
following conditions:

1. Not a woman of childbearing potential (WOCBP).

2. A WOCBP must agree to use a reliable method of contraception during the treatment
period and for at least 180 days after the last dose of study treatment.

9. Male participants must practice effective contraceptive methods during the treatment
period, unless documentation of infertility exists.

10. Expected to survive >3 months per investigator assessment.

11. The participant (or legally acceptable representative if applicable) provides written
informed consent for the trial.

12. Adequate organ function as defined below. Specimens must have been collected within 7
days prior to the start of study treatment:

- Absolute neutrophil count (ANC) =1500/µL

- Platelets =100,000/µL

- Hemoglobin =9.0 g/dL or =5.6 mmol/L (without packed red blood cell transfusion
within the last 2 weeks)

- Creatinine OR measured or calculated creatinine clearance (GFR can be used in
place of CrCl) =1.5 x ULN OR =45 mL/min for participant with creatinine levels
>1.5 x institutional ULN (Creatinine clearance should be calculated per
institutional standard.)

- Total bilirubin =1.5 x ULN OR direct bilirubin =ULN for participants with total
bilirubin levels > 1.5 x ULN

- AST (SGOT) and ALT (SGPT) =2.5 x ULN

- International normalized ratio (INR) OR prothrombin time (PT) =1.5 x ULN unless
participant is receiving anticoagulant therapy as long as PT or aPTT is within
therapeutic range of intended use of anticoagulants

- Activated partial thromboplastin time (aPTT) =1.5 x ULN unless participant is
receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range
of intended use of anticoagulants

Exclusion Criteria:

1. Prior therapy with an immune checkpoint inhibitor.

2. A WOCBP who is pregnant or breastfeeding or has a positive pregnancy test within 72
hours prior to receiving study treatment.

3. Not willing to use an effective method of birth control as defined in the protocol.

4. Known liver, bone, or CNS metastases and/or carcinomatous meningitis.

5. Diagnosis of other carcinomas within the last 2 years, except cured non-melanoma skin
cancer, treated thyroid cancer, curatively treated in-situ cervical cancer, or
localized prostate cancer treated curatively with no evidence of biochemical or
imaging recurrence.

6. Documented history of clinically significant autoimmune disease or syndrome that
requires systemic steroids or immunosuppressive agents. Subjects with vitiligo, type 1
diabetes mellitus, psoriasis not requiring systemic treatment, well-controlled
hypothyroidism, or conditions not expected to recur in the absence of an external
trigger are permitted to enroll.

7. Any history of chronic or autoimmune pancreatitis.

8. Known history of or any evidence of active, non-infectious pneumonitis.

9. Current use of medications specified by the protocol as prohibited for administration
in combination with study drug.

1. Patients with a condition requiring systemic treatment with either
corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive
medications within 14 days prior to the start of study drug are not eligible.

2. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily
prednisone equivalents are permitted in the absence of active autoimmune disease.

3. Corticosteroids administered as pre-medication for IV contrast allergy are also
allowed.

10. Received a live vaccine within 30 days prior to the start of study drug.

1. Seasonal influenza vaccines for injection are generally killed virus vaccines and
are allowed. However, intranasal influenza vaccines (e.g. Flu-Mist) are
live-attenuated vaccines, and are not allowed within 28 days of study treatment.

2. COVID-19 vaccines will be allowed. However, COVID-19 vaccines are not allowed
within 7 days of starting study drug treatment.

11. Recent or current active infectious disease requiring systemic antivirals,
antibiotics, or antifungals, or treatment within 2 weeks prior to the start of study
drug.

12. Concurrent severe and/or uncontrolled medical conditions, which may compromise
participation in the study, including impaired heart function or clinically
significant heart disease.

13. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to the start of study drug (56 days for hepatectomy, open thoracotomy, major
neurosurgery) or anticipation of need for major surgical procedure during the course
of the study.

14. Serious, non-healing wound, ulcer, or bone fracture.

15. Patients with a history of organ or allogenic hematopoietic stem cell transplantation.

16. Partial or complete bowel obstruction within the last 3 months, signs/ symptoms of
bowel obstruction, or known radiologic evidence of impeding obstruction.

17. Refractory ascites defined as requiring 2 or more therapeutic paracenteses within the
last 4 weeks or =4 times within the last 90 days or =1 time within the last 2 weeks
prior to study entry or requiring diuretics within 2 weeks of study entry.

18. Positive tuberculosis test at screening.

19.
ClinicalTrials.gov; 11/02/2024; TrialID: NCT06255600
Clinical Trial Register | ICTRP | ID: ictrp-NCT06255600

ABSTRACT

Condition:

Cardiovascular Diseases;Long Covid19

Intervention:

Other: High Definition-transcranial Direct Current Stimulation;Dietary Supplement: Chlorella Pyrenoidosa

Primary outcome:

Increasead B12 by blood analysis biochemical

Criteria:


Inclusion Criteria:

- Patients with cardiovascular diagnosis or risk;

- Adults and elderly people (18 to 80 years old);

- Able to respond to commands and grant consent to participate in the research through
the informed consent form;

- Who have post-COVID symptoms.

Exclusion Criteria:

- Patients with a clinical history of neuromuscular or cognitive instability, pregnancy
and contraindications for receiving neurostimulation (such as cardiac pacemakers and
metallic brain implants);

- Patients with contraindications to the use of Chlorella (gastritis, esophagitis,
peptic ulcers),

- Pregnant patients, patients with stroke and tumors


20.
ClinicalTrials.gov; 09/02/2024; TrialID: NCT06265012
Clinical Trial Register | ICTRP | ID: ictrp-NCT06265012

ABSTRACT

Condition:

Marburg Virus Disease

Intervention:

Biological: PHV01;Biological: Placebo

Primary outcome:

Solicited Adverse Events (AEs);Unsolicited AEs;Other AEs;Immunogenicity, Antibodies (Ab);Immunogenicity, Neutralizing antibodies (NEUT)

Criteria:


Inclusion Criteria:

- Healthy, adult, male or non-pregnant, non-lactating females, age 18-60 years

- Given written informed consent

- No clinically significant health problems

- Negative test for SARS-CoV-2

- Agree to avoid conception through Day 29

- Agree to minimize blood and body fluid exposures to others after vaccination through
Day 29

- Agree to avoid exposure to immunocompromised persons after vaccination through Day 29

Exclusion Criteria:

- Prior infection with Marburg virus, related filovirus, or Ebola virus

- Prior infection with vesicular stomatitis virus (VSV)

- Received any VSV-vectored vaccine

- BMI of = 35

- Household contact who is immunodeficient, or on immunosuppressive medication

- Hepatitis B, hepatitis C, HIV-1, HIV-2, history of long COVID, diabetes, atopic
dermatitis (eczema), chronic inflammatory disease, autoimmune or autoinflammatory
disorder, malignancy, chronic or active neurologic disorder

- History of severe reactions to any vaccine or history of severe allergies

- Receipt of investigational product up to 30 days prior to randomization

- Receipt of licensed or authorized non-live vaccines within 14 days of planned study
immunization (30 days for live vaccines).

- Known allergy to components of PHV01

- Injection sites obscured by tattoos or physical condition

- Significant psychiatric or medical condition or laboratory abnormality on screening

- History of Guillain Barre Syndrome or any chronic or acute neurological disorder

- Alcohol or illicit drug abuse within past 5 years

- Pregnant or lactating female

- Administration of blood or IgG within 60 days preceding study

- Administration of systemic chronic immunosuppressants (defined as more than 14 days)
or other immune modifying drugs within 6 months of study entry

- History of blood donation within 60 days of study

- Unwilling to undergo diagnostic evaluation of rash (skin biopsy, if indicated) or
joint symptoms (arthrocentesis if indicated by joint effusion), in both cases if
acceptable to subject

- Elective surgery planned during the study period


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