Safety and Efficacy of 25 mg/kg and 35 mg/kg vs 10 mg/kg Rifampicin in Pulmonary TB: A Phase IIb Randomized Controlled Trial
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PROVIDER: S-EPMC10914527 | biostudies-literature | 2024 Feb
REPOSITORIES: biostudies-literature
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| S-TOXR1267 | biostudies-other
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| S-TOXR1264 | biostudies-other
Project description:Genome-wide measurements of chromatin accessibility in prostate cancer cells to study the tumorigenic programs.
2024-10-23 | GSE265757 | GEO
Project description:BackgroundCompliant ectoparasiticide product use is a comprehensive way to control ticks and reduce the risk of tick-borne pathogen transmission to dogs. Because the systemically acting isoxazoline ectoparasiticides require tick attachment for drug delivery, fast speed of kill is essential to minimize tick-borne pathogen transmission risk.MethodsDogs of satisfactory tick-carrying capacity were randomly allocated to treatment groups and administered, per label instructions, Bravecto® Chews (minimum 25 mg/kg fluralaner), Simparica TRIO® (minimum 1.2 mg/kg sarolaner, 24 µg/kg moxidectin, 5 mg/kg pyrantel), or no treatment. Dogs were infested with approximately 50 unfed adult (35 female, 15 male) Ixodes scapularis on Day -2, 21 and 28. Live tick counts were performed at 4, 8, 12 and 24 h post-treatment (Day 0) and post-infestation on Day 21 and 28. Tick control efficacy was determined by comparing live tick means for each product-treated group to the untreated control group and each other at all time points using a linear mixed model. The percent of dogs free of live ticks was analyzed using the Fisher's exact test for treatment group comparison.ResultsThe untreated control group maintained adequate tick infestations throughout the study. Using geometric means, an existing I. scapularis infestation was controlled by 99.7% and 93.0% 12 h post-treatment and by 100% and 99.5% 24 h post-treatment, for Bravecto® and Simparica TRIO®-treated dogs, respectively. Ixodes scapularis infestations were controlled more quickly for Bravecto®- compared to Simparica TRIO®-treated dogs on Day 21 at 8 h (efficacy 74.0% vs. 0.0%, p = 0.003) and 12 h (efficacy 99.2% vs. 39.4%, p < 0.001) post-infestation and Day 28 at 8 h (efficacy 92.2% vs. 0.0%, p < 0.001) and 12 h (efficacy 99.6% vs. 27.7%, p < 0.001) post-infestation. On Day 28 post-treatment, the efficacy of Bravecto® and Simparica TRIO® to control a new I. scapularis infestation was 100% and 96.6%, respectively, by 24 h post-infestation. Of product-treated dogs, 100% of Bravecto®-treated dogs were free of live ticks by 24 h post-treatment or post-infestation. No treatment-related adverse reactions occurred during the study.ConclusionsIxodes scapularis infestations are controlled more quickly 21 and 28 days post-treatment for dogs administered a single dose of Bravecto® compared to dogs administered a single dose of Simparica TRIO®.
| S-EPMC10683217 | biostudies-literature
Project description:Mixed MCBA PBFM dosing of wild-type C57BL/6Crl mice. 80 mg/kg total bile acid dose (10 mg/kg individual MCBA). MCBAs included in the dosing included AlaCA, AspCA, GluCA, LeuCA, PheCA, SerCA, ThrCA, and TyrCA.
2023-10-21 | MSV000093171 | MassIVE
Project description:BackgroundNeoadjuvant immunotherapy utilizing novel combinations has the potential to transform the standard of care for locally/regionally advanced melanoma. We hypothesized that neoadjuvant ipilimumab in combination with high dose IFNα2b (HDI) is safe and associated with durable pathologic complete responses (pCR).MethodsPatients with locally/regionally advanced melanoma were randomized to ipilimumab 3 or 10 mg/kg × 4 doses bracketing definitive surgery, then every 12 weeks × 4. HDI was given concurrently. We evaluated the safety and efficacy of the combination with ipilimumab 3 or 10 mg/kg. The impact on T-cell fraction and clonality were investigated in tumor and blood.ResultsThirty patients (age 37-76), 15 each at 3 and 10 mg/kg, 18 male and 12 female were treated. Considering immune related adverse events (irAEs) of interest, more grade 3/4 irAEs were seen with ipilimumab 10 mg/kg versus 3 mg/kg (p = 0.042). Among 28 evaluable patients, 11 relapsed, of whom 5 died. Median follow-up for 17 patients who have not relapsed was 32 months. The radiologic preoperative response rate was 36% (95% CI, 21-54); 4 patients at ipilimumab 3 mg/kg and 6 at 10 mg/kg and 2 (at 10 mg/kg) later relapsed. The pCR was 32% (95% CI, 18-51); 5 patients at ipilimumab 3 mg/kg and 4 at 10 mg/kg and one (at 3 mg/kg) had a late relapse. In patients with pCR, T-cell fraction was significantly higher when measured in primary melanoma tumors (p = 0.033). Higher tumor T-cell clonality in primary tumor and more so following neoadjuvant therapy was significantly associated with improved relapse free survival.ConclusionsNeoadjuvant ipilimumab-HDI was relatively safe and exhibited promising tumor response rates with an associated measurable impact on T-cell fraction and clonality. Most pCRs were durable supporting the value of pCR as a primary endpoint in neoadjuvant immunotherapy trials.Trial registrationClinicalTrials.gov, NCT01608594 . Registered 31 May 2012.
| S-EPMC6199801 | biostudies-literature
Project description:BackgroundBranch pulmonary artery (PA) Stenting is an established strategy for PA stenosis in older children and adults. Its use in infants is less well established. We describe our experience of branch PA Stenting in infants <10 kg.MethodRetrospective chart review of infants <10 kg who underwent PA Stenting at The Children's Hospital, Westmead between 2010 and 2020. Pre and post-procedural angiograms were reviewed to determine PA size. Technical procedural success was defined as >50% increase in PA diameter. Procedural complications and need for PA re-intervention were ascertained.ResultsForty-one children (age 7.6 months, IQR 2.4-9.8 months, weight 5.9 ± 2.2 kg) had 43 primary Stent implantations (10/43 intraoperative versus 33/43 transcatheter; left pulmonary artery [LPA] 25/43, right pulmonary artery [RPA] 8/43 and bilateral 10/43). Diagnoses were tetralogy of Fallot (27%), hypoplastic left heart syndrome (24%), truncus arteriosus (12%), transposition of the great arteries (7%), other single ventricle (10%) and other biventricular (20%). 40/41 (98%) had undergone a cardiac intervention in the preceding 31 days, [IQR 1-181], with 17/41 having prior branch PA intervention. 14/41 patients had urgent Stenting. There were 2 minor and 1 major complications with no procedural mortality. LPA (LPApre 2.3 ± 1.0 × 2.2 ± 1.2 mm versus LPApost 5.2 ± 1.3 × 5.0 ± 1.7 mm, p < 0.01) and RPA (RPApre 2.5 ± 0.8 × 1.9 ± 0.8 mm versus RPApost 4.9 ± 1.0 × 4.1 ± 1.0 mm, p < 0.01) calibre increased post Stenting. 20/41 required branch PA reintervention (time to reintervention 13.6 months [IQR 8.2-29.3].ConclusionsBranch PA Stenting is effective and safe in infants <10 kg with expected high rates of reintervention. Urgent PA Stenting provides relief of early post-operative haemodynamic compromise.
| S-EPMC11657479 | biostudies-literature
Project description:To determine the long-term ARN22089 treatment on tumor growth
2022-02-23 | GSE197068 | GEO
Project description:For the treatment of hypertension, fixed-dose combinations (FDCs) of antihypertensive drugs can provide complementary benefits from improved compliance and cost-effectiveness compared with loose combinations of corresponding drugs. A new FDC of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg is undergoing clinical development. A randomized, open-label, single-dose, 3-period, 3-sequence, partially replicated crossover phase 1 study was conducted to compare the pharmacokinetics (PKs) between the FDC of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg and a loose combination of a dual-combination FDC (fimasartan/amlodipine 60/10 mg) and hydrochlorothiazide 25 mg. Sixty healthy subjects were randomized, and 55 subjects completed the study. Serial blood samples were collected, and plasma concentrations of fimasartan, amlodipine and hydrochlorothiazide were measured to analyze PK parameters. The PK profiles of the FDC were similar to those of the loose combinations. The geometric mean ratios (GMRs) and 90% confidence intervals (CIs) of the FDC to loose combinations for the maximum plasma concentration (Cmax) and area under the curve until the last measurable time point (AUClast) were within the conventional bioequivalent range of 0.80 to 1.25. The GMRs and 90% CIs of fimasartan, amlodipine and hydrochlorothiazide were 1.0163 (0.8681-1.1898), 0.9595 (0.9256-0.9946), and 1.1294 (1.0791-1.1821) for Cmax and 1.0167 (0.9347-1.1059), 0.9575 (0.9317-0.9841), and 1.0561 (1.0170-1.0967) for AUClast, respectively. Both the FDC and loose combinations were well tolerated. In conclusion, the FDC of fimasartan/amlodipine/hydrochlorothiazide 60/10/25 mg showed similar PK profiles to those of the corresponding loose combination, and both treatments were well tolerated.
| S-EPMC8020363 | biostudies-literature
Project description:Data from 10 mg/kg MCBA dosing via peanut butter feeding method.
2023-10-20 | MSV000093170 | MassIVE