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Ethics Approval | NCAIDS/China | Ethics approval was obtained from the review board of the National Center for HIV/STD Control and Prevention, China CDC (NCAIDS/China CDC, Ethical Approval Number X170623469). Digitally informed consent was retrieved from all participants upon enrollment in the study. All data collected from participants were anonymous | PMC10504623 | |
Discussion | HIV testing frequency, sexual behaviors, MSM | This study found the delivery of HIV risk assessment tools and feedback by a phone-based GSN app improved the number of HIV tests over 1 year among MSM app users in Beijing, China. UAI did not significantly improve compared with controls; however, all UAI declined from baseline to 6 months. Overall, this study suggests... | PMC10504623 | |
Conclusion | AIDS, MSM, SRS, ZW | INFECTIOUS DISEASES, AIDS, VIRAL HEPATITIS | This study found GSN app–based interventions that integrate HIV risk assessment with tailored feedback significantly increased HIV testing among MSM in Beijing, China. Integrating these into popular MSM apps would likely increase screening awareness of one’s HIV risk and should be widely considered by stakeholders and ... | PMC10504623 |
Abbreviations | DISEASE | Center for Disease Control and PreventionConsolidated Standards of Reporting Trialsgeosocial networkingincident rate ratiomen who have sex with menpre-exposure prophylaxisrandomized controlled trialunprotected anal intercourseJoint United Nations Program on HIV/AIDS | PMC10504623 | |
Data Availability | The data sets generated and analyzed during this study are not publicly available as participants’ consent only included data sharing within the project research team. | PMC10504623 | ||
Abstract | PMC10580345 | |||
Objective | cardiovascular and cerebrovascular diseases, moyamoya disease, MMD | MOYAMOYA DISEASE, PATHOGENESIS | The role of methionine (Met) cycle in the pathogenesis and progression of cardiovascular and cerebrovascular diseases has been established, but its association with moyamoya disease (MMD) has rarely been studied. This study aimed to analyze the levels of Met cycle‐related metabolites and constructed a risk model to exp... | PMC10580345 |
Methods | REGRESSION | In this prospective study, a total of 302 adult MMD patients and 88 age‐matched healthy individuals were consecutively recruited. The serum levels of Met cycle‐related metabolites were quantified by liquid chromatography‐mass spectrometry (LC–MS). Participants were randomly divided into training set and testing set at ... | PMC10580345 | |
Results | The levels of methionine sulfoxide and homocysteine were significantly increased, while the levels of betaine and choline were significantly decreased in MMD and its subtypes compared to healthy controls ( | PMC10580345 | ||
Conclusion | This study has constructed and validated a risk model based on Met cycle‐related metabolites, which was independently associated with the risk of MMD and its subtypes. The findings provided a new perspective on the risk evaluation and prevention of MMD.We constructed a risk score model based on Met cycle‐related metabo... | PMC10580345 | ||
INTRODUCTION | cerebrovascular disorder, Moyamoya disease, stenosis, MMD | CEREBROVASCULAR DISORDER, MOYAMOYA DISEASE, STENOSIS | Moyamoya disease (MMD) was a rare cerebrovascular disorder characterized by progressive stenosis or occlusion of the internal carotid arteries, leading to the formation of abnormal collateral vessels at the base of the brain.Metabolomics provided a comprehensive understanding of the metabolic state of organisms.Therefo... | PMC10580345 |
METHODS | PMC10580345 | |||
Participants and study design | RECRUITMENT | In this prospective study, we consecutively recruited patients diagnosed with MMD using digital subtraction angiography (DSA) according to the 2012 Japanese diagnostic criteria from September 2020 to December 2021 at Beijing Tiantan Hospital.Key metabolites involved in methionine cycle.Flowchart of participant recruitm... | PMC10580345 | |
Data collection | peripheral venous blood | We collected the baseline patient characteristics, including age, gender, past medical history, heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), body mass index (BMI), RNF213 variants, and laboratory tests. Fasting peripheral venous blood samples were obtained with vacuum biochemical tubes on ... | PMC10580345 | |
Construction of Met cycle‐related risk model | REGRESSION | The levels of Met cycle‐related metabolites in the training set were incorporated into LASSO regression to construct the risk model. The lambda that minimized the deviations has been selected. Based on the levels of Met cycle‐related metabolites, a risk score was calculated for each participant using the following form... | PMC10580345 | |
Statistical analysis | The SPSS software (version 26.0) and R project (version 3.6.3) were used for the statistical analyses in this study. Continuous variables were analyzed for normality of the distribution using the Kolmogorov–Smirnov test. Normally distributed continuous variables were compared by | PMC10580345 | ||
RESULTS | PMC10580345 | |||
Study participants and baseline information | SAH, diabetes | HYPERLIPIDEMIA, MOYAMOYA DISEASE, HYPERTENSION, DIABETES | A total of 390 individuals were eventually enrolled in this study, consisting of 88 HCs and 302 MMD patients. Baseline characteristics between the two groups were compared, revealing that MMD patients had a higher prevalence of hypertension, diabetes, hyperlipidemia, smoking, and drinking, as well as higher levels of S... | PMC10580345 |
Construction of Met cycle‐related risk model | REGRESSION | All participants were randomly divided into training and testing sets, with equal numbers of 44 healthy individuals and 151 MMD patients in each set. The data of Met cycle‐related metabolites in training set was used to construct the risk score system by LASSO regression (Figure Construction of Met cycle‐related risk m... | PMC10580345 | |
Role of the risk score in | REGRESSION, EVENTS | In the training set, logistic regression analyses showed a significant positive association between the Met cycle‐related risk score and the risk of MMD in Crude model (OR = 5.904, 95%CI = 3.153–11.057, Association between Met cycle‐related risk score and risk of MMD and its subtypes in the training set.
ROC curves of ... | PMC10580345 | |
DISCUSSION | hemorrhage, high disability, hemorrhagic MMD | DISEASE, HEMORRHAGE, REGRESSION, OXIDATIVE STRESS, PATHOGENESIS | In this prospective study, we first compared the difference in clinical characteristics between MMD patients and HCs. We further explored the differences in ischemic and hemorrhagic MMD groups. It showed that the levels of four Met cycle‐related metabolites were significantly different in the MMD group and its subtypes... | PMC10580345 |
CONCLUSION | PATHOGENESIS | In summary, our study has constructed and validated a risk model based on Met cycle‐related metabolites. We found that the Met cycle‐related risk score was independently associated with the risk of MMD and its subtypes. Our study provided a new perspective on the role of metabolism dysregulation in the pathogenesis of ... | PMC10580345 | |
AUTHOR CONTRIBUTIONS | Junsheng Li illustrated all the results and drafted the manuscript. Peicong Ge and Chaofan Zeng performed all the statistical analyses. Qiheng He, Chenglong Liu, Chuming Tao, and Yuanren Zhai collected the data. Wei Liu, Qian Zhang, Rong Wang, and Yan Zhang revised the manuscript. Dong Zhang and Jizong Zhao conceived a... | PMC10580345 | ||
FUNDING INFORMATION | This study was supported by the National Natural Science Foundation of China (81701137), the National Key Research and Development Program of China (2021YFC2500502), Beijing Municipal Organization Department Talents Project (2015000021469G219), and Beijing Municipal Administration of Hospitals' Mission Plan (SML2015050... | PMC10580345 | ||
CONFLICT OF INTEREST STATEMENT | The authors declared that no conflicts of interest existed. | PMC10580345 | ||
CONSENT TO PARTICIPATE | Written informed consent was obtained from all participants included in this study. | PMC10580345 | ||
ACKNOWLEDGMENTS | We acknowledged all the participants involved in this study. | PMC10580345 | ||
DATA AVAILABILITY STATEMENT | All raw data supporting the findings in this study were available from the corresponding authors with reasonable requests. | PMC10580345 | ||
REFERENCES | PMC10580345 | |||
Objectives | MINST, periodontitis | PERIODONTITIS | To determine if minimally invasive non-surgical therapy (MINST) outperforms classical non-surgical periodontal therapy for stage III periodontitis with primarily suprabony (horizontal) type defects. | PMC10071470 |
Materials and methods | MINST, tooth | REGRESSION | In a split-mouth randomised controlled trial, 20 patients’ dental quadrants were randomly assigned to MINST or classical non-surgical treatment. The primary outcome variable was the number of sites with probing pocket depth ≥ 5 mm and BOP. Treatment method, tooth type, smoking status, and gender were evaluated using a ... | PMC10071470 |
Results | MINST, PD | After 6 months, the percentage of sites with PD ≥ 5 mm and BOP that healed (MINST = 75.5%; control group = 74.1%; | PMC10071470 | |
Conclusions | periodontitis | PERIODONTITIS | MINST reduces gingival recession associated with molar teeth, although it performs similarly to traditional non-surgical therapy in treating stage III periodontitis with predominately horizontal-type defects. | PMC10071470 |
Clinical relevance | MINST, periodontitis, predominantly suprabony defects | PERIODONTITIS | MINST performs similarly to non-surgical periodontal therapy in stage III periodontitis with predominantly suprabony defects. | PMC10071470 |
Trial registration | Clinicaltrials.gov (NCT04036513) on June 29, 2019. | PMC10071470 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00784-023-04994-4. | PMC10071470 | ||
Keywords | Open access publishing supported by the Slovenian Research Agency and Central Technical Library in Ljubljana. | PMC10071470 | ||
Introduction | periodontitis, MINST, PD, intrabony defects, calculus | PERIODONTITIS, PLAQUE | The initial periodontal treatment aims to minimise supra/subgingival plaque, calculus deposits, and bacterial load through behavioural adjustments and risk factor management, supported by non-surgical debridement techniques. As the second stage therapeutic measure, surgical intervention or extractions are recommended f... | PMC10071470 |
Materials and methods | A 6-month, single-centre, split-mouth, randomised controlled clinical trial was conducted. The National Medical Ethical Committee of the Republic of Slovenia granted ethical approval (No. 0120–595/2018/4). The clinical protocol was also submitted to Clinicaltrials.gov (No. NCT04036513). Before taking part, all subjects... | PMC10071470 | ||
Study population | endo-perio, periodontitis, cancer | PERIODONTITIS, CANCER, DIABETES MELLITUS, PERIODONTAL DISEASE, DISEASES | All included patients were referred by their general dentists to the Department of Oral Medicine and Periodontology, University Dental Clinic of Ljubljana, Slovenia, for periodontal assessment and treatment. Between March 2019 and November 2021, 20 male or female participants were explicitly selected as participants in... | PMC10071470 |
Clinical and radiographic examination | PD, bleeding | BLEEDING, PLAQUE | At baseline and follow-ups, an experienced, masked, calibrated examiner (R. G.) performed a comprehensive periodontal examination of all patients using a manual Williams probe (POW6, Hu-Friedy, Chicago, Illinois, USA). At 6 sites of each tooth, the following periodontal parameters were measured: absence/presence of pla... | PMC10071470 |
Clinical intervention | PD, pain | After a baseline examination, each of the 20 patients received two 90-min sessions of cause-related periodontal non-surgical treatment from the same therapist (A. C. K.) within 7 days, beginning with motivation and instruction on proper oral hygiene. Both dental arches’ left and right sides were randomly assigned to on... | PMC10071470 | |
Statistical analysis | PD | Since further clinical attachment loss is expected at sites with PD ≥ 5 mm and persistent BOP after non-surgical periodontal treatment, surgical intervention is usually indicated [ | PMC10071470 | |
Patient-reported outcomes | pain | Conventional therapy and the MINST procedure required comparable average chair-side times (62 ± 11 and 64 ± 14 min for conventional and MINST, respectively). After treatment, none of the patients complained of pain or required pain medication. In addition, 17/40 quadrants of the test group and 19/40 quadrants of the co... | PMC10071470 | |
Conclusion | MINST, PD, periodontitis | REGRESSION, PERIODONTITIS, BONE LOSS | MINST and standard non-surgical periodontal debridement resulted in significant but comparable decreases in the number of sites with PD ≥ 5 mm + BOP and other clinical parameters. Furthermore, in a multilevel, multivariate logistic regression model, male gender and molar teeth were related to a higher number of residua... | PMC10071470 |
Acknowledgements | We thank Mrs. Vanja Erčulj, PhD (RHO sigma, Ljubljana) for the statistical analysis. | PMC10071470 | ||
Author contribution | A.C.K.: methodology, investigation, data curation, formal analysis, and writing—original draft; R.G.: conceptualisation, methodology, investigation, formal analysis, writing—review and editing, and funding acquisition. Both authors approved the final version of the manuscript. | PMC10071470 | ||
Funding | The study was supported by the Ministry of Science and Technology of the Republic of Slovenia, grant number P3-0293. | PMC10071470 | ||
Data Availability | The data that support the findings are avaliable on reasonable request from corresponding author. | PMC10071470 | ||
Declarations | PMC10071470 | |||
Competing interests | The authors declare no competing interests. | PMC10071470 | ||
Ethical approval | All procedures involving human participants followed the ethical standards of the 1964 Helsinki declaration and the Code of Medical Ethics of the Medical Association of Slovenia. The study protocol was reviewed by the National Medical Ethics Committee (No. 0120–595/2018/4) of the Republic of Slovenia. It was also regis... | PMC10071470 | ||
Informed consent
| Informed consent was obtained from all individual participants included in the study. | PMC10071470 | ||
Conflict of interest | The authors declare no competing interests. | PMC10071470 | ||
References | PMC10071470 | |||
Background | OA, swelling, inflammation, osteoarthritis, pain | CHRONIC PAIN, INFLAMMATION, OSTEOARTHRITIS, INFLAMMATORY DISEASE | Specialized pro-resolving mediators (SPMs), including 18-HEPE, 17-HDHA, and 14-HDHA are recognized as potentially therapeutic in inflammatory diseases because SPMs regulate the inflammation process, which leads to, for example; swelling and the sensation of pain. In osteoarthritis (OA), chronic pain is described as the... | PMC10308764 |
Methods | Pain, pain | This randomized, multicenter, double-blind, and placebo-controlled parallel-group pilot study was performed in Spain and conducted on adults 18–68 years old diagnosed with symptomatic knee OA. Patients were enrolled in the study for up to 24 weeks, which included a 12-week intervention period and a follow-up visit on w... | PMC10308764 | |
Results | pain | ADVERSE EVENTS, MAY | Patients were enrolled in the study from May 2018 to September 2021. VAS pain score was evaluated in the per protocol population (n = 51 patients), in which we observed a statistically significant reduction after 8 weeks (p = 0.039) and 12 weeks (p = 0.031) of treatment in patients consuming SPMs (n = 23 subjects) vs. ... | PMC10308764 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12967-023-04283-4. | PMC10308764 | ||
Keywords | PMC10308764 | |||
Background | functional disability, Osteoarthritis, OA, arthritis, pain, peripheral sensitization | INFILTRATION, OSTEOARTHRITIS, DISEASE, ARTHRITIS, INFILTRATION | Osteoarthritis (OA) is the most common form of arthritis and a significant cause of pain, functional disability, and socioeconomic cost worldwide. OA is a disease that involves inflammatory, mechanical, and metabolic factors. All these lead to pathological changes across different weight-bearing joint tissues, severely... | PMC10308764 |
Methods | PMC10308764 | |||
Study design | The GAUDI study was a randomized, multicenter, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish centers in compliance with the World Medical Association Declaration of Helsinki, all its amendments, and national regulations. The Independent Ethic Committee of Hospital Universitario La ... | PMC10308764 | ||
Patient population | Eligible patients for the study were adults between 18 and 68 years old that were diagnosed with symptomatic knee OA (according to the American College of Rheumatology [ACR]) and primary knee OA with both confirmed scores of 2–3 on the Kellgren and Lawrence radiological scale [ | PMC10308764 | ||
Study endpoints | pain | OSTEOARTHRITIS | The primary endpoint was the change in pain measured as VAS score before supplementation and VAS score on week 12 of supplementation. Secondary endpoints included the comparison in pain change, stiffness, and joint function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between ... | PMC10308764 |
Statistical considerations | Three patient populations were considered in analyses: (i) The per protocol (PP) population, including all randomized patients who received at least one treatment dose and had all primary endpoint measurements and no major protocol deviations; (ii) the intention-to-treat (ITT) population, including all randomized patie... | PMC10308764 | ||
Results | PMC10308764 | |||
Functional changes in OA patients treated with SPMs | Osteoarthritis, OA | OSTEOARTHRITIS | The WOMAC score mean did not significantly differ between patients in the SPMs and the placebo groups at any recorded time (at t = 0: SPMs group: 33.6 ± 19.04, placebo group: 29.6 ± 12.97, p-value = 0.377; at week 4: SPMs group: 24.9 ± 13.71, placebo group: 22.0 ± 10.62, p-value = 0.391; at week 8: SPMs group: 23.1 ± 1... | PMC10308764 |
Quality of life | OA | Overall, patients in the SPMs group showed improvements in all five dimensions of the EUROQoL-5 compared to the placebo group, including significant changes in the usual activities dimension (52.17% vs. 14.29%; p-value = 0.004) (Table Quality of life in OA patients (N = 51)Percentage change in each patient has been use... | PMC10308764 | |
Safety and tolerability | lameness | Only two AEs were reported in one patient from the SPMs group (lameness and locked knee), which were mild and not related to the study treatment. These did not require any action from the research team and were resolved. None of the patients withdrew from the study. | PMC10308764 | |
Discussion | OA, Pain, inflammation, osteoarthritis, arthritis, pain | DEGENERATION, ADVERSE EVENTS, INFLAMMATION, OSTEOARTHRITIS, ARTHRITIS, CHRONIC PAIN, DISEASES | The results of this randomized, double-blind, placebo-controlled study imply that oral supplementation with SPMs reduces pain and improves QoL in patients with symptomatic knee OA. While a placebo effect is observed in clinical variables, this is not as significant as the effect of SPMs consumption. Following a dose re... | PMC10308764 |
Conclusions | OA, pain | This randomized, double-blind, placebo-controlled study evaluates for the first time the effect of continuous oral SPMs consumption on an adult population of symptomatic knee OA patients. SPMs supplementation reduced pain and improved the quality of life of OA patients. Our results do not support a long-lasting residua... | PMC10308764 | |
Acknowledgements | Alberto García Mariscal (Evidenze Group Europe SL) provided medical writing support to the authors of this paper. Dr. Jaume Padrós and Ana Regatero from the medical services of FC Barcelona helped in the design of the study. | PMC10308764 | ||
Author contributions | JV conceived and designed the study and oversaw the overall direction and planning of the study; JV and NM executed and led the completion of the project; JV and NM wrote the original draft with support and revisions from GR, IM, JMV, FA, JAR; JV and NM supervised the findings of this work; GR, IM, JMV, FA and JAR revi... | PMC10308764 | ||
Funding | Solutex GC SL funded this work. | PMC10308764 | ||
Availability of data and materials | The datasets analyzed during the current study are available from the corresponding author upon reasonable request. | PMC10308764 | ||
Declarations | PMC10308764 | |||
Ethics approval and consent to participate | The GAUDI study was conducted in compliance with the World Medical Association Declaration of Helsinki, all its amendments, and national regulations. The Independent Ethic Committee of Hospital Universitario La Paz (Madrid, Spain) approved this study. All patients gave their written informed consent. | PMC10308764 | ||
Consent for publication | Not applicable. | PMC10308764 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10308764 | ||
References | PMC10308764 | |||
Background | Delpazolid, toxicity, DECODE | DRUG-RESISTANT TUBERCULOSIS | Linezolid is an effective, but toxic anti-tuberculosis drug that is currently recommended for the treatment of drug-resistant tuberculosis. Improved oxazolidinones should have a better safety profile, while preserving efficacy. Delpazolid is a novel oxazolidinone developed by LegoChem Biosciences Inc. that has been eva... | PMC10243693 |
Methods | toxicities, myelosuppression, neuropathy | PULMONARY TUBERCULOSIS, NEUROPATHY | Seventy-five participants with drug-sensitive, pulmonary tuberculosis will receive bedaquiline, delamanid and moxifloxacin, and will be randomized to delpazolid dosages of 0 mg, 400 mg, 800 mg, 1200 mg once daily, or 800 mg twice daily, for 16 weeks. The primary efficacy endpoint will be the rate of decline of bacteria... | PMC10243693 |
Discussion | toxicities, DECODE | DECODE is an innovative dose-finding trial, designed to support exposure-response modelling for safe and effective dose selection. The trial design allows assessment of occurrence of late toxicities as observed with linezolid, which is necessary in clinical evaluation of novel oxazolidinones. The primary efficacy endpo... | PMC10243693 | |
Trial registration | RECRUITMENT | DECODE was registered in ClinicalTrials.gov before recruitment start on 22 October 2021 (NCT04550832). | PMC10243693 | |
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10243693 | ||
Introduction | PMC10243693 | |||
Background and rationale {6a} | anaemia, TB, death, cheese syndrome, neutropenia, neuropathy, toxicity, toxicities, infections, ZeNix, XDR-TB, hypertensive, peripheral and optic neuropathy | ANAEMIA, NEUTROPENIA, NEUROPATHY, ADVERSE EVENTS, THROMBOCYTOPENIA, INFECTIONS, TUBERCULOSIS (TB), DRUG-DRUG INTERACTION | Tuberculosis (TB) is the thirteenth leading cause of death worldwide and, before the advent of COVID-19, was the leading cause from a single infectious agent, ranking above human immunodeficiency virus (HIV)/AIDS [Linezolid (LZD), an oxazolidinone, approved by the US Food and Drug Administration (FDA) since 2000 for th... | PMC10243693 |
Objectives {7} | toxicity | PULMONARY TUBERCULOSIS, RECURRENCE, RECURRENT DISEASE, SECONDARY, REINFECTION | The primary objective of this study is to generate data for a pharmacokinetic–pharmacodynamic modelling approach, and to establish the exposure–response and exposure–toxicity curve for DZD.The aim is to identify the optimal dose of DZD to be used in subsequent studies that will provide the best efficacy and acceptable ... | PMC10243693 |
Trial design {8} | TB, pulmonary TB | This will be an open-label, phase IIb, randomized, controlled, dose-finding, multi-centre study in participants with newly diagnosed, smear-positive, uncomplicated drug-sensitive pulmonary TB. Adult participants (≥ 18 years of age) will be randomized by centralized allocation at a ratio of 1:1:1:1:1 to one of five trea... | PMC10243693 | |
Methods: participants, interventions and outcomes | PMC10243693 | |||
Study setting {9} | TB | The study will be implemented in South Africa and Tanzania, with enrolment taking place in two dedicated TB trial centres in Johannesburg, South Africa, and in three dedicated TB trial institutes in Mbeya, Dar es Salaam and Moshi, Tanzania. A list of all participating study centres can be obtained at | PMC10243693 | |
Who will take informed consent? {26a} | pulmonary TB | Information about the trial is provided by study doctors/nurses at the trial site, who need to be delegated to perform these tasks. Participants will be invited to be screened for inclusion in the trial if they are suspected to have pulmonary TB or have an established diagnosis by smear microscopy, GeneXpert or chest X... | PMC10243693 | |
Additional consent provisions for collection and use of participant data and biological specimens {26b} | TB | The study aims to collect further data and biological samples to advance the science around TB and TB treatment. Therefore, additional informed consent will be thought to collect retention samples and samples for genetic analysis for possible sub-studies. | PMC10243693 | |
Interventions | PMC10243693 | |||
Explanation for the choice of comparators {6b} | This dose-finding study is small and does not contain a classical comparator arm. 15 participants will receive DLM, BDQ, and MOX without DZD, but this is not powered to show the effect of adding DZD, unless the core regimen or DZD is much more effective or much less effective than anticipated, although this arm does pr... | PMC10243693 | ||
Intervention description {11a} | TB | After assessing the eligibility of the participants at screening, the study will recruit into five different treatment arms. The experimental and control treatment will be administered daily for 16 weeks. Figure Study design and five different treatment arms. DZD, delpazolid; BDM, bedaquiline, delamanid, moxifloxacin; ... | PMC10243693 | |
Criteria for discontinuing or modifying allocated interventions {11b} | TB, diaphoresis, Tremor, fever, fatigue, Hypertonia, rash, pain, eosinophilia, hyperreflexia, agitation, nausea,, tenderness, hypertension | HYPERTENSION, EOSINOPHILIA | Besides withdrawal of consent, requiring medication prohibited by protocol or sponsor decision, several stopping criteria for participants’ safety are in place:• A participant should discontinue study drug if:◦ ALT or AST >8×ULN ◦ ALT or AST >5×ULN for more than 2 weeks ◦ ALT or AST >3×ULN and (total bilirubin (TBL) >2... | PMC10243693 |
Strategies to improve adherence to interventions {11c} | Study treatment intake will be observed by study staff during the study visits in the morning and will be administered at home on the other days. Facility-based directly observed treatment or community-based directly observed treatment (i.e. a friend or relative of the participant will act as a treatment supervisor) wi... | PMC10243693 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | CYP3A4-BDQ, epileptic seizures | EPILEPTIC SEIZURE | BDQ, DLM and MXF are metabolized by different hepatic enzymes (CYP3A4-BDQ and DLM; UDP-glucuronoyltransferase-MXF). A change in activity of these hepatic enzymes can change the drug concentrations in blood and tissue and thereby influence safety and efficacy readouts. Therefore, all drugs that would lead to a substanti... | PMC10243693 |
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