title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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WALK behaviors | napping | Physical activity and sedentary time were measured objectively with actigraphy. Participants wore tri-axial accelerometer (Actigraph GT3X, Actigraph, Pensacola, FL) on the hip using an elastic belt or clip. Data collected at 80 Hz were downloaded (Actilife software, v6.13.3, Actigraph, Pensacola, FL, USA). Activity cou... | PMC10496245 | |
SLEEP behaviors | Sleep was measured objectively with actigraphy and subjectively with self-report. Objective sleep measures were collected using an accelerometer (Actiwatch Spectrum Plus; Philips-Respironics, Murrysville, PA) worn on the non-dominant wrist for one week. Data were collected and exported at 30-s epochs, where at least tw... | PMC10496245 | ||
Data analysis | depressive, OSF, sleep behaviors | We were interested in whether the EWS intervention improved key eat, walk, and sleep behaviors. In pre-planned analyses approved by the funder, we compared changes in key eat, walk, and sleep behaviors between the 2 groups that received EWS and the group that did not, across timepoints. Independent variables were exper... | PMC10496245 | |
Discussion | obesity, sleep disturbance, mood disorders, trauma, post-traumatic symptoms, diet-related non-communicable diseases, post-traumatic stress symptoms, traumatic, perspiration, depressive, post-traumatic stress disorder, PTSD, malnutrition, depression, posttraumatic stress, diabetes | OBESITY, UNDERNUTRITION, INSULIN RESISTANCE, MALNUTRITION, HEAT, DIABETES | The main findings from this study are that individuals who received the EWS lifestyle intervention successfully increased their brown rice consumption and their moderate-to-vigorous activity. And whereas we previously reported that the intervention improved self-reported sleep quality, here we found that it did not imp... | PMC10496245 |
Limitations and conclusions | depressive | SECONDARY, INSULIN RESISTANCE | Because the randomized trial was powered to detect group changes in our primary outcomes—HbA1c, insulin resistance, and depressive symptoms—these secondary analyses may be limited by low statistical power. For the secondary outcomes reported here, the sample size had acceptable power (80%) to detect approximately a med... | PMC10496245 |
Acknowledgements | Not applicable. | PMC10496245 | ||
Authors’ contributions | Julie Wagner provided overall scientific direction and wrote the initial draft of the manuscript. Angela Bermúdez-Millán, Thomas Buckley, and Orfeu M. Buxton directed data collection, interpreted results and edited the manuscript. Richard Feinn analyzed the data and prepared the tables and results section. Lindsay Mast... | PMC10496245 | ||
Funding | Digestive, Diabetes | KIDNEY DISEASES, DIABETES | National Institute of Diabetes and Digestive and Kidney Diseases, DK103663 to Julie Wagner. The funder had no role in the design of the study, collection, analysis, and interpretation of data, nor in writing the manuscript. | PMC10496245 |
Availability of data and materials | OSF | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Analyses were conducted in SPSS v28 and syntax code is stored on the OSF link | PMC10496245 | |
Declarations | PMC10496245 | |||
Ethics approval and consent to participate | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent was obtained from all individua... | PMC10496245 | ||
Consent for publication | All authors consent to publication of this manuscript. | PMC10496245 | ||
Competing interests | None. Outside of the current work, Orfeu M. Buxton discloses that he received subcontract grants to Penn State from Proactive Life LLC (formerly Mobile Sleep Technologies) doing business as SleepScape (NSF/STTR #1622766, NIH/NIA SBIR R43-AG056250, R44-AG056250), received honoraria/travel support for lectures from Bosto... | PMC10496245 | ||
References | PMC10496245 | |||
Abstract | Co-last. | PMC10322142 | ||
Background | mTNBC, breast cancer | BREAST CANCER | This trial evaluated the safety and efficacy of ipatasertib in combination with carboplatin, carboplatin/paclitaxel, or capecitabine/atezolizumab in patients with metastatic triple–negative breast cancer (mTNBC). | PMC10322142 |
Methods | DISEASE, METASTATIC DISEASE | Eligibility criteria were mTNBC, RECIST 1.1 measurable disease, no prior use of platinum for metastatic disease (Arms A and B), and no prior exposure to immune checkpoint inhibitor (Arm C). Primary endpoints were safety and RP2D. Secondary endpoints were progression–free survival (PFS), response rate, and overall survi... | PMC10322142 | |
Results | RP2D for Arm A ( | PMC10322142 | ||
Conclusions | TNBCs | Continuous dosing of ipatasertib with chemotherapy was safe and well-tolerated. Further study is warranted in understanding the role of AKT inhibition in treatment of TNBCs. | PMC10322142 | |
Trial registration | TNBC | TRIPLE-NEGATIVE BREAST CANCER | NCT03853707.More effective therapeutic strategies targeting underlying genomic drivers, as well as novel combinations, are urgently needed for treatment of triple-negative breast cancer (TNBC). This article evaluates the safety and efficacy of ipatasertib in combination with carboplatin, carboplatin/paclitaxel, or cape... | PMC10322142 |
Implications for Practice | tumors, TNBCs | TUMORS | Ipatasertib is a selective pan-AKT inhibitor and displays synergy with chemotherapy preclinically. This study was designed to determine the dose, safety, and preliminary efficacy of ipatasertib plus carboplatin, carboplatin/paclitaxel, or capecitabine/atezolizumab in mTNBC. The combination was safe and well-tolerated a... | PMC10322142 |
Introduction | TNBC, tumor, mTNBC, Cancer | TUMOR, DISEASE, TRIPLE-NEGATIVE BREAST CANCER, TRIPLE NEGATIVE BREAST CANCER, CANCER | Metastatic triple-negative breast cancer (mTNBC), defined as lack of estrogen receptor (ER), progression receptor (PR), and human epidermal growth factor receptor 2 (HER2) overexpression, remains a disease of unmet need. This is largely attributed to tumor heterogeneity and chemotherapy resistance.The Cancer Genome Atl... | PMC10322142 |
Materials and Methods | Cancer | MAY, CANCER | This open-label single institutional Phase I/Ib trial was conducted between May 2019 and June 2022 with institutional review board (IRB 18496) approval at the City of Hope National Cancer Center. The trial was conducted in accordance with the World Medical Association Declaration of Helsinki, International Conference o... | PMC10322142 |
Eligibility Criteria | toxicities, TNBC | BRAIN METASTASIS, DISEASE, METASTASIS, METASTATIC DISEASE | Main eligibility criteria were: ≥18 years; histologically confirmed TNBC defined by ER or PR ≤ 10% by IHC and HER2 negative per ASCO/CAP guidelines; ECOG performance status 0-1; life expectancy ≥3 months; RECIST 1.1 measurable disease for Arm C only (patients on Arms A and B could have non–measurable disease), availabl... | PMC10322142 |
Study Endpoints and Assessments | toxicities, tumor | ADVERSE EVENTS, DISEASE PROGRESSION, TUMOR | The primary objective of the study was to evaluate safety and determine the recommended Phase II dose (RP2D) of ipatasertib plus carboplatin and paclitaxel (Arm A), carboplatin (Arm B), or capecitabine and atezolizumab (Arm C). Secondary endpoints were RR, PFS, and OS. Responses were assessed by RECIST 1.1, and safety ... | PMC10322142 |
Statistical Design for Arms A and B | toxicity, intra-dose | DISEASE, SECONDARY | The combination of paclitaxel and ipatasertib was determined to be safe and well tolerated in previous Phase Ib (PAM 4983g)Treatment Arms are shown in Treatment Arms showing patients included in the study (To confirm the RP2D obtained from the dose escalation, and for an initial assessment of response, correlatives, an... | PMC10322142 |
Tumor Immune Biomarker | tumor, Tumor, Breast Cancer | BREAST CANCER, TUMOR, TUMOR, INFILTRATING, STROMAL TUMOR | Tumor biopsies were formalin-fixed paraffin-embedded (FFPE). Percentage of stromal tumor infiltrating lymphocytes (TILs) in tumor was evaluated using H&E diagnostic sections per International Immuno-Oncology Biomarker Working Group on Breast Cancer Guidelines. | PMC10322142 |
Results | PMC10322142 | |||
Patients | TNBC | MAY | A total of 28 patients with metastatic TNBC were enrolled between May 2019 and April 2021: 10, 12, and 6, respectively, to Arms A, B, and C (Baseline patient characteristics (
| PMC10322142 |
Toxicities | DLTs, stomach pain, diarrhea, rash, pain | ADVERSE EVENT | For Arm A, 3 patients developed DLT (1 grade 3 diarrhea, 1 grade 3 stomach pain, and 1 persistent grade 2 diarrhea) leading to dose delay (less than 75% planned ipatasertib dosing) (DLTs within the first cycle (representing 5 unique patients).
Adverse events at RP2D per CTCAE 5.0 (
As previously mentioned, of the 10... | PMC10322142 |
Response and Survival | PD | DISEASE | The best responses for patients in Arm A (carboplatin/paclitaxel plus ipatasertib) included 2 (20%) PR (for the RP2D it was 2/7, 29%), 4 (40%) SD, and 4 (40%) PD. Arm B (carboplatin plus ipatasertib) best response included 1 (8%) CR, 2 (17%) PR, 6 (50%) SD, and 3 (25%) PD. Arm C (capecitabine, atezolizumab, and plus ip... | PMC10322142 |
Immune Correlatives | PD-L1 testing for Arm C patients showed 4 patients who were PD-L1 positive by SP142 and 2 patients who were PD-L1 negative ( | PMC10322142 | ||
Androgen Receptor | A total of 10 patients were AR positive (defined by IHC AR ≥2+ and ≥30%, | PMC10322142 | ||
Tumor Genomics | NextGen exome sequencing was performed with commercial testing ( | PMC10322142 | ||
Discussion | TNBC, tumors, mTNBC | TUMORS | The results of the current trial provide evidence that combining ipatasertib with continuous daily dosing with weekly carboplatin or carboplatin/paclitaxel is safe and has modest clinical activity in patients with mTNBC. In addition, ipatasertib (21 days on and 7 days off) combined with capecitabine and atezolizumab is... | PMC10322142 |
Conclusions | TNBC | Results from this study showed that continuous dosing of ipatasertib in combination with carboplatin-based therapy or capecitabine/atezolizumab is safe; however, moderate efficacy was seen in TNBC patients with PI3K/AKT/PTEN alterations. Encouraging efficacy was seen in luminal androgen receptor TNBC. Future studies wi... | PMC10322142 | |
Supplementary Material | Click here for additional data file. | PMC10322142 | ||
Acknowledgments | Cancer | CANCER | We thank Genentech for providing funding and the study drug, ipatasertib, for NCT03853707, and the patients and their families for participating. The COH Biostatistics Core was supported by the National Cancer Institute of the National Institutes of Health (P30CA033572). | PMC10322142 |
Funding | Cancer | CANCER | Genentech provided funding and the study drug, ipatasertib. The COH Biostatistics Core was supported by the National Cancer Institute of the National Institutes of Health (P30CA033572). | PMC10322142 |
Ethics Approval | The study was approved by City of Hope Internal Review Board (IRB). Procedures were performed in accordance with the ethical standards of the City of Hope, the National Research Committee, and the 1964 Declaration of Helsinki and International Conference on Harmonization Guidelines for Good Clinical Practice and later ... | PMC10322142 | ||
Conflict of Interest | Yuan Yuan has contracted research sponsored by Merck, Eisai, Novartis, Puma, Genentech, Celgene, and Pfizer; is a consultant for Pfizer and Gilead; and is on the Speakers Bureau for Merck, Genentech, AstraZeneca, Daiichi Sankyo, and Immunomedics. The other authors indicated no financial relationships. | PMC10322142 | ||
Author Contributions | Conception/design: Y.Y. Provision of study material or patients: Y.Y., J.W., N.P., L.V., L.T., D.P. Collection and/or assembly of data: S.E.Y., Y.C., C.R., M.M., A.T., N.M., D.S., M.B., P.H.F. Data analysis and interpretation: Y.C., C.R., P.H.F. Manuscript writing: Y.Y., S.E.Y. Final approval of manuscript: All authors... | PMC10322142 | ||
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10322142 | ||
References | PMC10322142 | |||
Introduction | hypertriglyceridemia, ALL | CARDIOVASCULAR DISEASE, ACUTE LYMPHOBLASTIC LEUKEMIA, DEL, SECONDARY, HYPERTRIGLYCERIDEMIA | Edited by: Jessie Zurita-Cruz, Hospital Infantil de México Federico Gómez, MexicoReviewed by: Juan Carlos Núñez-Enríquez, Instituto Mexicano del Seguro Social, Mexico; Ornella Guardamagna, University of Turin, Italy; Miguel Villasis-Keever, Mexican Social Security Institute (IMSS), MexicoThis article was submitted to P... | PMC10140550 |
Methods | ALL | Thirty-four children (placebo group: 20 patients; ω3-LCPUFAs group: 14 patients) aged 6.7 ± 2.7 years who were newly diagnosed with ALL were evaluated. Children were randomized to receive either ω3-LCPUFAs or placebo capsules (sunflower oil). ω3-LCPUFAs were administered in the form of 500-mg soft capsules. The ω3-LCPU... | PMC10140550 | |
Results | hypertriglyceridemia | HYPERTRIGLYCERIDEMIA | We found significantly lower levels of TGs (p=0.043), VLDL-C (p=0.039), IL-6 (p=0.025), and AIP (p=0.042) in the ω3-LCPUFAs group than in the placebo group at three months. In contrast, the total cholesterol concentration was higher at 3 months in the ω3-LCPUFAs group than in the placebo group (155 mg/dl vs. 129 mg/dl,... | PMC10140550 |
Conclusion | cardiometabolic, ALL | These findings support the use of ω3-LCPUFAs to reduce some adverse cardiometabolic and inflammatory risk factors in children with ALL. | PMC10140550 | |
Clinical trial registration | PMC10140550 | |||
Introduction | TNF-α, cardiovascular disease, malignancy, cancer, inflammation, leukemia, ALL | CARDIOVASCULAR DISEASE, CHILDHOOD CANCER, CANCER, INFLAMMATION, LEUKEMIA, ACUTE LYMPHOBLASTIC LEUKEMIA, SECONDARY, INFLAMMATORY RESPONSE | Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy, accounting for almost one-third of all childhood cancers worldwide, with an incidence of 20-35 per million children under 15 years (Different authors have found associations between android fat (abdominal fat located around the trunk of the bod... | PMC10140550 |
Materials and methods | PMC10140550 | |||
Study design | leukemia | LEUKEMIA, REMISSION, DEL | This analysis is part of a randomized clinical trial designed to evaluate the effect of supplementation with ω3-LCPUFAs on body composition in children with leukemia at the end of the remission phase and three months after supplementation, registered in the ClinicalTrials.gov database (clinicaltriasl.gov #: NCT01051154... | PMC10140550 |
Patients | death, allergies, neutropenic colon, ALL | SECONDARY, COMPLICATIONS, ALLERGIES | We included 72 children with ALL at the Pediatric Hospital of the National Medical Center XXI Century IMSS, National Medical Center, and at the “Gaudencio González Garza” General Hospital, of the “La Raza” National Medical Center. Eligibility criteria were children newly diagnosed with ALL (established according to bon... | PMC10140550 |
Recruitment and allocation | Patients who met all the inclusion criteria and volunteered to participate were randomized in a 1:1 ratio. Selected children were randomly assigned to the placebo group (control) or to the ω3-LCPUFA group (intervention) by a computer-generated list of random numbers using software for parallel groups (Random Allocation... | PMC10140550 | ||
Intervention | EPS | Children received either capsules of ω3-LCPUFAs or placebo capsules. ω3-LCPUFAs were administered in the form of 500 mg soft capsules of natural TGs, made from gelatin, formulated without artificial colors or flavors, molecularly distilled, and of pharmaceutical grade (Nordic Naturals, Inc., Watsonville CA, USA). The o... | PMC10140550 | |
Compliance | When the patient was discharged, compliance was monitored by the leftover pill count at their next appointment. In addition, the concentration of polyunsaturated fatty acids in erythrocyte membranes was determined before and during intervention with ω3-LCPUFAs. All side effects that the children presented during the in... | PMC10140550 | ||
Procedures | PMC10140550 | |||
Anthropometry and adiposity | obesity, overweight | OBESITY, DISEASE | Participants arrived at the medical center between 8:00 and 9:00 am after an overnight fast. Body weight was measured with an electronic scale (TANITA BWB-700, Tanita Corporation, Tokyo, Japan) with the subjects wearing lightweight clothing. Height was measured to the nearest 0.1 cm with a wall-mounted stadiometer (SEC... | PMC10140550 |
Analytical methods | Stored serum aliquots were used to determine the lipid profile and cytokines. TGs, total cholesterol, and HDL-C were measured by the enzymatic colorimetric method (SPIN 120 automatic analyzer, Shenzhen, Mindray) with commercially available kits. TGs levels were considered acceptable <75/<90 mg/dL, borderline 75-99/90-1... | PMC10140550 | ||
Fatty acid analyses by gas chromatography | Analyses were performed with a 7820A gas chromatograph (Agilent Technologies, Santa Clara, CA, USA) with a flame ionization detector (FID) as described previously ( | PMC10140550 | ||
Statistical analysis | The data were analyzed using SPSS 21.0 software for Windows (SPSS, Inc. IBM, NY, USA). Data are presented as the mean ± standard deviation (SD) or as the median (minimal, maximal), according to data (determined by the Shapiro-Wilk test), while categorical variables are presented as frequency (percentages) and were anal... | PMC10140550 | ||
Results | leukemia | LEUKEMIA | We summarize the Consolidated Standards of Reporting Trials followed in this study in Flow diagram of the progress through the phases of the clinical trial and present analysis.Demographic, clinical, and baseline markers characteristics of children with leukemia.Data are presented as mean ± Standard Deviation (SD), at ... | PMC10140550 |
Lipids and inflammatory markers | acute lymphoblastic leukemia, Necrosis, Tumor, ALL | TUMOR, ACUTE LYMPHOBLASTIC LEUKEMIA, NECROSIS, ACUTE LYMPHOBLASTIC LEUKEMIA, BLOOD | Blood lipid profiles for each group at baseline and after 3 months of intervention are shown in Blood Lipid profile at baseline and 3 months of intervention in children with acute lymphoblastic leukemia.Data are presented as mean ± Standard Deviation (SD), at median (minimum, maximum) or as number (percentage); TC, Tot... | PMC10140550 |
Discussion | obesity, TNF-α, inflammation, cancer, AIP, ALL, hypertriglyceridemia | OBESITY, DYSLIPIDEMIA, CANCER, EVENT, INFLAMMATION, SECONDARY, HYPERTRIGLYCERIDEMIA, ATHEROGENIC DYSLIPIDEMIA | In this secondary analysis, we confirmed the effect of ω3-LCPUFA supplementation at a rate of 0.100 g/kg/day on the lipid profile, specifically on the TGs and VLDL-C concentrations during the first 3 months of ALL treatment. We observed a significantly lower concentration of TGs and VLDL-C in the ω3-LCPUFA group than i... | PMC10140550 |
Conclusion | dyslipidemia, cancer, cardiometabolic, ALL | CANCER, DYSLIPIDEMIA | These findings support the use of omega-3 fatty acids to reduce some adverse cardiometabolic and inflammatory risk factors in children with ALL. Our findings show that an ω3-LCPUFA intervention is feasible, and the results suggest that ω3-LCPUFA supplementation in these patients could help prevent, delay, and/or mitiga... | PMC10140550 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10140550 | ||
Ethics statement | This study was approved by the Research and Ethics Committee of the Pediatric Hospital at the Mexican Social Security Institute (2009-785-107). We obtained written informed consent from parents and informed assent from children. Written informed consent to participate in this study was provided by the participants’ leg... | PMC10140550 | ||
Author contributions | ZH-P | LB-C, designed the study, analyzed data, obtained funding, and prepared the manuscript; SA-M, EJ-A, JM-T and FM-B, contributed to the analysis and interpretation of data and helped prepare the manuscript; ML-A, JM-A performed the analysis and interpretation of data, and helped prepare the manuscript; SD-P, BG, JD-P, AA... | PMC10140550 | |
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10140550 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10140550 | ||
References | PMC10140550 | |||
ABSTRACT. | malaria, deaths, malaria infection, neutropenia | RECRUITMENT, NEUTROPENIA, MALARIA, ADVERSE EVENTS, ADVERSE EVENT, EVENT, TERATOGENICITY, MALARIA | Financial support: The study was funded, designed, conducted, and analyzed by Medicines for Malaria Venture. Medicines for Malaria Venture is funded by several donors. Unrestricted funding comes from several donors, including the Foreign Commonwealth and Development Office, German Ministry for Education and Research, B... | PMC9833083 |
ACKNOWLEDGMENTS | MALARIA | We thank the patients for their participation. The contributions of the study staff are acknowledged, including Cherinet Abebe, Alemseged Abdissa Lencho, Abebe Genetu Bayih, Gebrehiwot Lemma, Solomon Afework, Zeleke Alemu, Mubarik Taju, Meseret Birhanie Fentahune, Abdulhakim Abamecha Abafogi, Seid Amdala, Kaleab Eskind... | PMC9833083 | |
REFERENCES | PMC9833083 | |||
Methods | arterial stiffness, asthma, tumor necrosis | REACTIVE HYPEREMIA, TUMOR NECROSIS, ASTHMA, ARTERIAL STIFFNESS, DILATION | Twenty-six people with asthma and 25 controls underwent three airway challenges (placebo, mannitol, and methacholine) in random order. Markers of cardiovascular risk, including serum C-reactive protein, interleukin-6, and tumor necrosis factor, endothelial function (flow-mediated dilation), microvascular function (bloo... | PMC10351735 |
Results | Both the mannitol and methacholine challenges resulted in clinically significant reductions in forced expiratory volume in 1 second (FEV | PMC10351735 | ||
Conclusion | pulmonary inflammation, asthma exacerbations | INFLAMMATION, PULMONARY INFLAMMATION, SECONDARY | Neither acutely induced bronchoconstriction nor pulmonary inflammation and bronchoconstriction resulted in meaningful changes in systemic inflammatory or vascular function. These findings question whether the increased cardiovascular risk associated with asthma exacerbations is secondary to acute bronchoconstriction or... | PMC10351735 |
Data Availability | All relevant data are within the paper and its | PMC10351735 | ||
Introduction | chest tightness, asthma-like, inflammation, wheezing, pulmonary inflammation, breathlessness, airway hypersensitivity, Asthma | INFLAMMATION, CHRONIC AIRWAY DISEASE, PULMONARY INFLAMMATION, ASTHMA, EVENTS | Asthma is a chronic airway disease characterized by recurrent episodes of pulmonary inflammation leading to bronchoconstriction and symptoms such as breathlessness, wheezing, and chest tightness [Findings from animal studies suggest that increased levels of systemic inflammation during asthma-like events originate in t... | PMC10351735 |
Methods | This case-control, cross-over randomized controlled clinical trial-study was approved by the University of Alberta Ethics Board (Pro0054047), Health Canada (#9427-G0890-88C), registered on ClinicalTrials.gov ( | PMC10351735 | ||
Research participants | asthma | LUNG, ASTHMA, ASTHMA | Patients with physician-diagnosed asthma between the ages of 18 and 45 years were identified by chart review from the University of Alberta Asthma Clinic and The Lung Health Clinic, Edmonton, Alberta 2015–2021. Asthma was confirmed if the participant tested positive for one of the following: a) more than 12% and 200 ml... | PMC10351735 |
Study design | ARTERIAL STIFFNESS, BLIND, ASTHMA | Following signing informed consent, reporting medical history, and filling out the Asthma Control Questionnaire (ACQ) [The subsequent study consisted of three experimental days where the participant received either: 1) mannitol airway challenge, 2) methacholine airway challenge, or 3) saline airway challenge (i.e. plac... | PMC10351735 | |
Mannitol | The mannitol challenge was performed according to manufacturer guidelines [ | PMC10351735 | ||
Methacholine | The methacholine challenge was performed using the incremental two-minute tidal breath-protocol [ | PMC10351735 | ||
Placebo | The placebo challenge was performed identical to the methacholine challenge; however, no methacholine was added to the inhaled saline (i.e. participant inhaled saline only). The challenge was terminated following five rounds of saline. | PMC10351735 | ||
Outcome measurements | PMC10351735 | |||
Systemic inflammation | tumor necrosis | TUMOR NECROSIS | Ten ml of blood was collected from a vein in the antecubital fossa using standard venipuncture technique. The samples were allowed to coagulate for a minimum of 30 minutes at room temperature, then centrifuged at 12,000 rpm for 10 minutes. Serum was then collected and aliquoted into samples of 100°L and stored in a -80... | PMC10351735 |
Vascular function | Vascular function (main study outcome), including endothelial function and microvascular function, was evaluated according to guidelines [ | PMC10351735 | ||
Arterial stiffness | Central arterial stiffness | Central arterial stiffness was evaluated between the carotid and femoral arteries using automated applanation tonometry (Complior, Alam Medical, Saint Quentin Fallavier, France) [ | PMC10351735 | |
Divergences from the early protocol | exhaled breath condensate | INFLAMMATION | This study reports data from a large research initiative registered on ClinicalTrails.gov (ID#: NCT02630511) in 2015. The study has since evolved and the following updates to the research procedures were made: a) pulmonary inflammatory markers were to be evaluated in exhaled breath condensate (EBC). Initial testing det... | PMC10351735 |
Statistical analysis | asthma | ASTHMA | Baseline characteristics for controls and asthma were summarized as mean with standard deviation (SD) for continuous variables and proportions for categorical variables. Differences in baseline clinical characteristics, including lung function and results from the cardiopulmonary exercise test, were evaluated using the... | PMC10351735 |
Results | PMC10351735 | |||
Participant characteristics | asthma | ASTHMA | One hundred and nineteen potential participants were initially identified from the general population and through chart review. Of these, 25 control participants and 26 participants with asthma were included in the study ( | PMC10351735 |
Consort diagram of recruitment, selection, testing, and analysis. | PMC10351735 | |||
Clinical characteristics, control vs asthma. | LUNG, ASTHMA | Values are expressed as mean (standard deviation) unless otherwise indicated. Lung function values reported were assessed without inhaled bronchodilators prior to testing.BMI: body mass index; ACQ: asthma control questionnaire; FEV | PMC10351735 | |
Pulmonary responses to bronchial challenges | The overall responses in FEV | PMC10351735 | ||
Unadjusted mean change and 95% Cl in FEV | DILATION, ARTERIAL STIFFNESS | FMD: flow-mediated dilation; VHR: velocity time integral adjusted for heart rate; cPWV: central arterial stiffness. | PMC10351735 | |
Systemic responses following positive bronchial challenges | SECONDARY, INFLAMMATORY RESPONSES | The secondary analysis examined vascular and inflammatory responses among only those with a positive test (i.e., a reduction of ≥10% in FEV | PMC10351735 | |
Unadjusted mean change and 95% Cl in FEV | DILATION, ARTERIAL STIFFNESS | FMD: flow-mediated dilation; VHR: velocity time integral adjusted for heart rate; cPWV: central arterial stiffness. | PMC10351735 | |
Systemic inflammatory responses to positive airway challenges regardless of asthma status. | tumor necrosis | TUMOR NECROSIS | Values are expressed as unadjusted means (SD).CRP: C-reactive protein; TNF: tumor necrosis factor; IL-6: interleukin-6. | PMC10351735 |
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