Lesparre Médoc, France

Examining Psycho-Socioeconomic Linkages in TB Care: The UPLIFT Trial

Background - Previous Studies on Social Protection for TB in Vietnam This study has been designed based on the results of previous formative research on the preferences, acceptability, and feasibility of TB-specific social protection interventions in the Vietnamese context. This body of research found that people with TB and healthcare providers prefer cash transfers and enrollment in Vietnam's social health insurance scheme, especially when targeted to those with the greatest financial need and severe illness. A pilot study was conducted that provided cash transfers and social health insurance to economically vulnerable people starting TB treatment. The intervention was found broadly acceptable, but stakeholders felt that cash-transfers should be subject to limited forms of conditionality. Findings from this pilot indicated that future socioeconomic interventions in Vietnam should consider both conditional and unconditional cash transfers to be feasible. Following this pilot, a non-randomized social assistance intervention was conducted under programmatic conditions. Among the group receiving financial support, it was found that a combination of transport vouchers, cash transfers and health insurance enrollment, combined with existing government and social network support could reduce catastrophic costs by 37.8%. Finally, a one-year consultative process was conducted in 2023 to co-prioritize challenges and solutions with Vietnam's TB Program. This process found that an intervention supplementing the existing social safety net with TB-specific support was the priority. Methods - Sample Size Two sample sizes were calculated to determine the effectiveness of the intervention. The larger sample will be used to recruit individuals undergoing TB treatment to measure changes in TB treatment success, while a subset of these same individuals will be recruited to assess catastrophic cost incurrence in the household, which will utilize a modified, longitudinal WHO TB Patient Cost Survey tool. A total of 1,324 participants (662 per study arm) will be recruited for the treatment success sample, while 450 (225 per study arm) will be recruited for the household costing sample.

Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles

CAPA-IVM (In Vitro Maturation) technology is an assisted reproductive method offering significant benefits in terms of safety and treatment costs, particularly for high-risk patients. These include individuals with ovarian hyperstimulation syndrome (OHSS), venous thrombosis, ovarian torsion, or polycystic ovary syndrome (PCOS) - who typically present with a high number of antral follicles (constituting nearly 15% of all patients). Although the live birth rate following the first transfer in the CAPA-IVM group is 35.2%, which is not statistically different from the conventional IVF group at 43.2% (risk difference: -8.1%; 95% confidence interval: -16.6% to 0.5%), the number of good-quality embryos per cycle and the cumulative clinical pregnancy rate remain lower than in conventional IVF. Therefore, improving the CAPA-IVM culture process to achieve the optimal number and quality of oocytes is essential. Concurrently, adding growth factors commonly found in follicular fluid to the culture medium represents a remarkable advancement in improving oocyte quality in CAPA-IVM. Some somatic compartments, such as expansion, metabolism, and apoptosis, are regulated by soluble growth factors, known as oocyte secretion factors (OSFs). Two OSFs, Growth differentiation factor 9 (GDF9) and Bone morphogenetic protein 15 (BMP15), have been identified as critical for follicular development and fertility in various species such as mice, sheep, and humans. During IVM culture, both the immature and mature forms of these factors as well as their homo- and heterodimer structures have been tested. Notably, the heterodimer structure has shown the most positive effects on cumulus-oocyte complexes (COCs) during IVM culture. Although both growth factors exist in homodimeric forms, recent studies have found that the GDF9 and BMP15 heterodimer can also form a more potent growth factor called cumulin. BMP15 activates latent GDF9 in cumulin, leading to strong signaling in granulosa cells via type I receptors (ALK4/5) and SMAD2/3 transcription factors. Biomedically engineered cumulin has been proposed to noticeably improve embryo outcomes in mouse and porcine models. Recently, a modified version of wild-type GDF9, called super GDF9, has been demonstrated to be >1000 times more potent than GDF9 and 4 times more activity than cumulin in SMAD2/3-responsive transcriptional assays in granulosa cells. Previous research has illustrated that adding super GDF9 to CAPA-IVM media in mice induces gene expression in the ovulatory cascade during CAPA-IVM maturation that closely resembles in vivo maturation. Super GDF9 effectively promotes cumulus cell expansion and enhances oocyte developmental competence in vitro. Hence, super GDF9 can potentially replace cumulin, which faces challenges in production and purification. This study investigates the impact of supplementing super GDF9 during CAPA-IVM culture, aiming to improve outcomes of cumulus-oocyte complexes (COCs) from small follicles and ultimately enhance treatment success. This study will recruit 300 COCs (an estimated 10 needed patients). 100 COCs will be allocated to the research arm (sGDF-9), while 200 COCs will be allocated to the control arm. - Screening for eligibility - This study will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam. - Women who are potentially eligible will be provided information about the study at the time of IVM treatment indication. - Screening for eligibility will be performed on the day of the first visit when the IVM treatment is indicated. - Patients will be provided information about the study and informed consent documents. The investigators will obtain signed informed consent forms from all women before enrollment. - Eligible women will be scheduled to undergo oocyte pick-up procedures within 1-7 days from informed consent. - Oocytes retrieval The oocyte pick-up procedure will be conducted according to the center's standard practices for CAPA-IVM cycles. Cumulus-oocyte complexes (COCs) from small follicles after OPU will be divided into 2 groups: - Group 1 (sGDF-9): donated COCs will be cultured in the CAPA and IVM steps, adding 50ng/ml Super-GDF9 during both steps in CAPA-IVM - Group 2 (Control): The subject's remaining COCs will be cultured in the CAPA and IVM steps without adding Super-GDF9 during CAPA-IVM. Groups 1 and 2: Collecting after the capacitation step: spent media and blank wells. Collecting after the maturation step: spent media, cumulus cell, and blank wells. - CAPA and Maturation culture: CAPA and Maturation culture will be performed routinely following current laboratory protocols. ICSI will be used to fertilize mature oocytes.

A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure

The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.

A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Effectiveness of Anti-Inflammatory Drugs for Preventing Pain Versus Treating Pain During Medical Abortion From 13 to 22 Weeks at Hung Vuong Hospital

Effects of Electronic Acupuncture Combined With Dry Cupping Therapy in Treating Back Pain Due to Lumbar Spondylosis

The goal of this clinical trial is to learn if Electroacupuncture combined with Dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. I The main questions it aims to answer are: - Does Electroacupuncture combined with Dry cupping therapy reduces pain on Visual Analog Scale (VAS) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern? - Dose Electroacupuncture combined with Dry cupping therapy improving the daily activities on Oswestry Disability index (ODI) of patients suffered from back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern? - What medical problems do participants have when taking Electroacupuncture combined with Dry cupping therapy ? Researchers will compare dry cupping to a sham dry cupping (a sham cupping device was developed by establishing a small hole to reduce the negative pressure after suction such that inner pressure could not be maintained in the cup) to see if dry cupping therapy works to treat back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern. Patients with back pain due to lumbar spondylosis in the qi stagnation and blood stasis pattern will be registered for this study. They will be treated with a combination of Electroacupuncture combined with Dry cupping therapy. The intervention period is two weeks. Electronic acupuncture will be performed once a day for 2 weeks. Dry cupping therapy will be performed every 4 days for 2 weeks. Data on the Visual Analog Scale (VAS), Oswestry Disability index (ODI), and side effects of Electroacupuncture and Dry cuppingwill be recorded before the study and weekly for 2 weeks.

Cerclage with Progesterone Versus Progesterone Only in Singleton Pregnancies

This open-label, multi-center, randomized controlled trial aims to compare the effectiveness of cervical cerclage with vaginal progesterone (the combined therapy group) to vaginal progesterone only (the progesterone-only group) for the prevention of preterm birth in women with a singleton pregnancy and a cervical length ≤ 25mm. After written informed consent, women will be randomly assigned in a 1:1 ratio to receive a cervical cerclage with vaginal progesterone or vaginal progesterone only. Randomization will be carried out by entering participant details into HOPE Epi® (a web portal of HOPE Research Center, My Duc Hospital). Treatment allocation will be assigned according to a computer-generated randomization list stored in the online system, with a permuted random block size of 2, 4, or 6. Blinding will not be possible due to the nature of interventions. However, neonatologists assessing the neonates will be unaware of treatment allocation. Apart from randomization, participants will be monitored and treated according to local protocol. All women at 16 0/7 to 24 0/7 weeks' gestation with a singleton pregnancy will undergo cervical length measurement and digital examination at screening routinely. Women with a cervical length ≤25 mm will be eligible for the study. Eligible women will further undergo a speculum examination to assess the feasibility of treatment with either cervical cerclage or vaginal progesterone and to exclude premature rupture of the membranes, acute vaginitis, and cervicitis. Only women in whom the clinician assesses both treatments as feasible will be randomized. Women allocated to a combined therapy group will receive the intervention according to local protocol within a week after randomization. Briefly, cervical cerclage (McDonald technique) will be performed in the operation theatre. From the same day of undergoing cerclage, participants will be receiving 200 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 200mg, Actavis, United Kingdom), once daily at bedtime. Participants will be asked to record their drug application in a participant diary sheet. Women allocated to the progesterone-only group will be receiving 200 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 200mg, Actavis, United Kingdom), once daily at bedtime. Participants will be asked to record their drug application in a participant diary sheet. In both groups, interventions will be stopped at 37 0/7 weeks of gestation or at delivery. Primary analysis will be performed on an intention-to-treat basis. The primary outcome, the time from randomization to delivery, will be summarised as median and IQR and compared between the two arms using the Mann-Whitney test. A mean ratio with a 95% confidence interval will be calculated to assess the effect of the treatment. Kaplan-Meier and Cox proportional hazard analysis will be performed in which the gestational week at delivery will be the time scale, continued pregnancy will be the event, and results will be compared with a log-rank test. Hazard ratio (HR) values will be estimated using a Cox proportional hazards model, with a formal test of the proportional hazard assumption. The secondary outcome will be analysed by reporting continuous variables as mean and standard deviation for normally distributed variables or median and interquartile range (Q1; Q3) for non-normally distributed variables. Categorical variables will be presented as the number of events and proportions. Student T-test or Mann-Whitney U test will be used for continuous outcomes to compare the differences between groups. For categorical outcomes, the Chi-squared or Fisher exact test will be used. In the case of dichotomous endpoints, the relative risk (RR) and 95% confidence interval (CI) values will be calculated using the Wald or Adjusted Wald methods for a small proportion. Per-protocol analysis will also be conducted if needed. A prespecified subgroup analysis will be performed by quartiles of cervical length, which tested for interaction between cervical length and the treatment effect on the primary outcome, the major secondary outcome and PTB <28, <34, <37 weeks. The p-values <0.05 will be considered to indicate statistical significance. Statistical analyses will be performed using the R statistical software. Details of the analysis will be described in a separate statistical analysis plan developed during the study and finalized before the data lock. Cost data will be collected and will be reported on a separated paper. Interim analysis will be done after completion of data recruitment of the first 162 participants, by an independent Data Safety Monitoring Committee. The Data Safety Monitoring Committee will be asked to assess the primary endpoint for effectiveness. Also, the Data Safety Monitoring Committee will be provided insight into the serious adverse events (SAEs) that have occurred. The interim analysis will be conducted using a two-sided significant test with the Haybittle-Peto spending function and a type I error rate of 5 percent with p <0.001 (Z alpha = 3.29) being a reason to stop the trial. The continuation of the study will depend on the advice of Data Safety Monitoring Committee.

Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke

Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men

Sexual violence is prevalent in adolescence and heightens the risk of harmful long-term health effects. Sexual violence includes any sexual act committed against a person without freely given consent. All genders may experience sexual violence, but sexual violence more often burdens women than men globally, and men most often perpetrate such violence. Adolescence is a period of vulnerability to sexual violence, with about one in five college women in the US experiencing a campus sexual assault and 91% of victims being women. Less is known about rates of sexual violence on college campuses. Still, estimates from large, multi-country surveys confirm that young men's reported sexually violent behavior and young women's reported sexual violence victimization are high, including in Asia/Pacific. In Vietnam, from 2010 to 2019, women's reports of lifetime sexual violence by a partner increased (10% to 13%), especially in women 18-24 years (5% to 14%). Such trends may reflect changing exposure and more openness to discuss sex and sexual violence. Also, nearly one in ten women (9%) report non-partner sexual violence since age 15, mostly perpetrated by non-family male acquaintances, co-workers, or strangers. Young women who are victims of sexual violence are at heightened risk of acute and chronic mental and physical health conditions. The researchers will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Proctor et al. frameworks and a mixed-methods, comparative interrupted time series (CITS) design to compare implementation; implementation drivers and outcomes; implementation effectiveness; and cost-effectiveness of lower-intensity vs higher-intensity (LIS; HIS) implementation strategies to deliver GlobalConsent.

The Incidence And Risk Factors Of Recurrent Febrile Seizures And Epilepsy Following Febrile Seizures

This was a single-center, longitudinal cohort study. Vietnamese children were prospectively identified for their first febrile seizures (FS) through the General Pediatric Department and Neurology Department of Children's Hospital 2 in Ho Chi Minh City between March and December 2023. This hospital is one of the largest tertiary pediatric hospitals in southern Vietnam with 1,400 beds, and receives about 90,000 admissions every year, with 800-1,000 cases of initial FS. After recruitment, the participants have been monitored for an average of two years to determine whether they experience recurring FS or develop epilepsy. Sample size and sampling: The sample size was calculated using a specific formula to estimate the incidence of FS recurrence in the cohort study. With the desired confidence level of 95%, an estimated error of 0.1, and an expected incidence of 31.8% based on a similar study conducted by Berg, the minimum sample size required was determined to be 385 participants. The sample size was also estimated based on the number of events per predictor in regression models, with at least 10 events per predictor recommended by Peduzzi et al. For the recurrent FS outcome, we have 12 potential predictor variables including age of onset, male gender, prematurity, low birth weight, neurodevelopmental abnormality, family history of FS or epilepsy, temperature, duration of fever at the time of the seizure, and characteristic of the first FS such as semiology, duration and number of seizures during the illness yielding approximately 120 cases to achieve the required sample size for estimating recurrence of FS. Besides that, we also have 16 potential predictor variables for the subsequent epilepsy outcome, including the above factors adding to the number of FS, and characteristics of all FS (first and recurrences). As such, we aimed to obtain at least 160 children. Finally, the overall sample size required at least 385 patients. Convenience sampling was applied to recruit the participants. In detail, every weekday, the list of inpatient reports of the General Pediatric Department and Neurology Department on the electronic medical record database of Children's Hospital 2 was used to identify all children who had been diagnosed with FS and admitted to these departments. The investigator met with these children's parents or caregivers and asked a series of screening questions to confirm that they had not previously experienced febrile or unprovoked seizures. If the child had such a history, they were excluded from the study. The patients were then followed up until they recovered and were discharged from the hospital. At this point, the investigator made the final diagnosis of the first FS and assessed whether any exclusion criteria applied. If the patients were eligible for the study, the investigator obtained informed consent from their parents and proceeded to gather study data. Data collection The standardized questionnaire solicited child-related data including the age of onset, gender, perinatal history (i.e. age of gestation, birth weight, asphyxia, hospitalization at the neonatal intensive care unit), medical history (previous neurological diseases), family history of FS and epilepsy (including first relative and any relative); seizure-related data including semiology, duration, and number of seizures during the illness; and illness-related data including temperature, duration of fever at the time of the seizure, and the cause of fever. The interviewer obtained a comprehensive description of the seizure from either the parent or, if unavailable, from an eyewitness. Descriptions were compiled from both medical records and interviews, and additional clarification was sought, if necessary, by contacting the parent or witness again. Particular note was taken of the presence of asymmetrical features involving a unilateral arm, leg, or face (or some combination) or an eye deviation to one side, even if the fit later became bilateral tonic-clonic. Those seizures were classified as focal-onset seizures according to the ILAE classification in 2017. The presence of Todd's paresis (paralysis of one limb or one side of the body or a gaze palsy in the immediate postictal period) was considered indicative of a focal seizure. The study used medical records to gather information on seizures, associated symptoms, diagnosis, and temperature. At the time of the first FS, a detailed neurologic examination and Denver II developmental screening test were conducted by a pediatrician. Test Denver II is a scale to assess the psychomotor development of children under 6 years old, which is validated and used in clinical practice in Vietnam. Test Denver II is a fairly comprehensive assessment of child development and focuses on 4 areas: personal-social, fine motor-adaptive, language, and gross motor. The interpretation of the test results indicates an obvious developmental delay if there are delayed items in at least two areas, with each area having a minimum of two items. A child is considered to have a suspected developmental delay if there are delayed items in one area with at least two items. If there are no signs of suspected or delayed development as described above, the child is considered normal. Developmental Quotient (DQ) is a calculation that reflects the rate of development in any given area and represents the percentage of normal development present at the time of testing. Developmental Quotient (DQ)= (Developmental age (DA))/(Chronological age (CA)) x 100% Lumbar puncture was performed only in cases that were indicative of meningitis or encephalitis, whereas neuroimaging (computerized tomography [CT] or magnetic resonance imaging [MRI]) was performed on children with focal seizures, febrile status epilepticus, or abnormal neurologic examination. Children who experience their first FS in our setting usually do not undergo an electroencephalography (EEG). Following the initial interview, parents were contacted every three months to determine whether their child had experienced any further seizures and the circumstances under which they occurred. If a febrile seizure recurs or an afebrile seizure occurs, parents can report it immediately and directly to the investigator. Descriptions of the recurrent seizures were obtained in the same manner as for the initial FS. Whenever possible, we also obtained documentation of the recurrence from the medical record. Our goal was to follow children for an average of two years from the initial FS. We considered a seizure unprovoked if there were no acute precipitating circumstances to which the seizure could reasonably be attributed. According to the ILAE practical clinical definition from 2014, epilepsy is characterized by having two unprovoked seizures that are more than 24 hours apart. Children were censored from further analysis if they experienced an unprovoked seizure or were lost to follow-up. Ethical considerations The study protocol was approved by the Ethical Committee of Children's Hospital 2 (124/ GCN-BVNĐ2). and written consent was obtained from all participants. Informed consent was obtained from all study participants and their parents/caregivers.