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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Previous protocol | A description of the assay can be found in a previously published article [ | PMC9927051 | ||
Cohort details of the earlier clinical trial | lung cancer, Lung cancer | LUNG CANCER, -11, LUNG CANCER | Subjects were enrolled between 2014-06-02 and 2017-11-16 in three medical centers. In all cases, the study received approval of Institutional Review Boards (IRB) in accordance with the Declaration of Helsinki, and subjects read and signed a dedicated consent form. Inclusion and exclusion criteria were applied as descri... | PMC9927051 |
Cohort details of the later clinical trial | lung cancer, Lung cancer | LUNG CANCER, LUNG CANCER | Subjects were enrolled between 2019-03-24 and 2021-03-09 in three medical centers. In all cases, the study received IRB approval in accordance with Declaration of Helsinki, and subjects read and signed a dedicated consent form. The same inclusion and exclusion criteria were applied as described in our previous publishe... | PMC9927051 |
Data analysis | cancer stage, cancer, malignancy, lung cancer, Machine Learning | CANCER, LUNG CANCER, REGRESSION, SEPARATION, PATHOLOGY | Each subject was assigned a datasheet containing raw fluorescent readings of the plate wells as a function of time. The fluorescent readings were transformed into values which correlate with the acidity of the sample. We modeled the biological progression of the immunological response and extracted a set of informative... | PMC9927051 |
Results | PMC9927051 | |||
Analytical sensitivity and specificity of the metabolic activity lung cancer test (MA-LC) | The Metabolic Activity test measures the change in acid concentration over time in reaction to exposure to a stimulant. We use 8-Hydroxypyrene-1,3,6-trisulfonic acid (HPTS)—a highly water-soluble, membrane-impermeant pH indicator (pH 6.6 to 8.0) that is added to each plate’s well. HPTS exhibits a pH-dependent adsorptio... | PMC9927051 | ||
Data analysis | lung cancer, cancer, malignancy, cancer stage | REGRESSION, CANCER, PATHOLOGY, LUNG CANCER | Each subject was assigned a datasheet containing raw fluorescent readings of the plate wells as a function of time. The fluorescent readings were transformed into values which correlate with the acidity of the sample. We modeled the biological progression of the immunological response and extracted a set of informative... | PMC9927051 |
Discussion | tumor, allergy, lung cancer, early-stage lung cancer, TAA | VIRUS, TUMOR, DISEASE, ALLERGY, SENSITIVITY, LUNG CANCER, DISEASES | We describe an improved immunometabolism blood test that measures the function of the immune cells in response to LC antigenic stimuli based on enhancement of the glycolysis metabolic pathway of immune cells. Glycolysis enhancement is a marker for the rapid activation of most immune cells [This research article compare... | PMC9927051 |
Conclusions | lung cancer, lung cancer stage, lung cancer stage II | LUNG CANCER | Data analysis of a clinical trial applying the improved protocol of the ImmunoBiopsy™ test shows test specificity and sensitivity of 94.0% and 97.3%, respectively in detecting lung cancer stage I, and test specificity and sensitivity of 94.0% and 100%, respectively in detecting lung cancer stage II. The sensitivity and... | PMC9927051 |
Acknowledgements | THORACIC | The authors are indebted to Dr. Ori Haberfeld, Dr. Yaron Saiet, Dr. Eran Gilad from Department of General Thoracic Surgery, Rambam Health Care Campus, Israel and to Dr. Yana Kogan, Dr. Einat Fireman Klain, Dr. Sonia Shneer and Dr. Raya Cohen from Pulmonary Division, Faculty of Medicine, Lady Davis Carmel Medical Center... | PMC9927051 | |
Author contributions | ONCOLOGY, THORACIC | SS—Conceptualization, project administration, investigation, writing—original draft, review and editing. FP—Biochemistry expert, methodology. HD—Software, formal analysis, data curation, writing—original draft. ES—Resources, investigation, validation. ED—Formal analysis, funding acquisition, visualization. ST—Software,... | PMC9927051 | |
Funding | This work was supported by Savicell Diagnostics Ltd. | PMC9927051 | ||
Availability of data and materials | Available from the corresponding author on reasonable request. | PMC9927051 | ||
Declarations | PMC9927051 | |||
Ethics approval and consent to participate | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committees and with the 1964 Helsinki declaration and its later amendments (subjects read and signed a dedicated consent form). Ethics committee approval numbers of the Institutio... | PMC9927051 | ||
Consent for publication | Not applicable. | PMC9927051 | ||
Competing interests | Shafrira Shai, Hagai Drori, Eyal J. Scheinman, Eyal Davidovits, Giora Davidovits, Shoval Tirman, are employed by Savicell Diagnostics and own stock and/or options in Savicell Diagnostics’ parent company. Fernando Patolsky and Yochai Adir are consultants and own stock and/or options in Savicell Diagnostics’ parent compa... | PMC9927051 | ||
References | PMC9927051 | |||
Methods | cancers, cancer testis antigen-specific immune | CANCERS | Forty-nine patients with CCR4-negative solid cancers were enrolled in the phase Ia and Ib trials on KW-0761. An integral analysis of safety, clinical responses, prognosis, blood laboratory data, and cancer testis antigen-specific immune responses was performed. | PMC10511099 |
Results | lung cancer | ADVERSE EVENTS, DISEASE, LUNG CANCER | Grade 3–4 treatment-related adverse events were reported in 21 (42.9%) out of 49 patients, all of which were manageable. A partial response and stable disease were observed in 1 and 9 patients, respectively. A durable clinical response was noted in 2 esophageal and 2 lung cancer patients. eTreg depletion in peripheral ... | PMC10511099 |
Conclusions | A durable clinical response was noted in some patients, and high lymphocyte levels before treatment initiation may be a biomarker for the efficacy of KW-0761. The synergistic effect of KW-0761 for depleting Tregs and other immunotherapies is expected in the future. | PMC10511099 | ||
Data Availability | All relevant data are within the paper and its | PMC10511099 | ||
Introduction | Sezary Syndrome, various cancer, Cancer | MYCOSIS FUNGOIDES, SEZARY SYNDROME, CYTOTOXICITY, ADULT T-CELL LEUKEMIA-LYMPHOMA, CANCER | Cancer immunotherapy is now more frequently used in clinical practice and immune checkpoint inhibitors (ICIs) have improved the prognosis of patients with various cancer types; however, their efficacy is still insufficient [KW-0761 (mogamulizumab) is a humanized anti-C-C chemokine receptor type 4 (CCR4) IgG1 monoclonal... | PMC10511099 |
Materials and methods | PMC10511099 | |||
Patients | cancer | CANCER | Patients were eligible if they had CCR4-negative advanced or recurrent solid cancer with target lesions. CCR4 expression was examined by immunohistochemistry (IHC) using an anti-CCR4 mAb (KM2160; Kyowa Kirin) and confirmed by a review committee with a central evaluation. The inclusion criteria were the same as those in... | PMC10511099 |
Study design | DISEASE PROGRESSION | The present study was designed as multi-institutional, open-label, investigator-initiated phase Ia and Ib clinical trials on KW-0761 (mogamulizumab). The investigational drug KW-0761 was provided by Kyowa Kirin. Patients received 8 intravenous infusions of KW-0761 weekly followed by monthly infusions until disease prog... | PMC10511099 | |
CONSORT diagram for trial. | Phase Ia (a) and Phase Ib (b) studies. | PMC10511099 | ||
Toxicity evaluation | Tumor, Toxicity, Cancer | ADVERSE EVENT, TUMOR, CANCER | Toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The independent data monitoring committee chaired by Professor Ryuzo Ueda, Department of Tumor Immunology, Aichi Medical University School of Medicine evaluated the safety data for each dose level. | PMC10511099 |
Clinical response evaluation | Responses were evaluated 12 weeks after the first KW-0761 treatment or at the point of study discontinuation based on computed tomography (CT) scans according to RECIST (ver. 1.1) and immune-related RECIST [ | PMC10511099 | ||
Blood laboratory data | BLOOD | Peripheral blood sampling was performed at baseline and at every timepoint of KW-0761 infusions. Blood laboratory tests consisted of a blood count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), phosphate, albumin, γ-glutamyltransferase (GGT), ... | PMC10511099 | |
Treg depletion effects on PBMCs | Treg depletion was assessed as previously described [ | PMC10511099 | ||
IHC | tumor | TUMOR | Archived or newly obtained tumor samples from patients were screened for the expression of CCR4, NY-ESO-1, and XAGE1 (GAGED2a) by IHC as previously described [ | PMC10511099 |
Enzyme-linked Immunosorbent Assay (ELISA) for NY-ESO-1 or XAGE1 antibodies | Serum samples were obtained at baseline, 4 and 8 weeks after the first KW-0761 treatment, and every 4 weeks during the continuous treatment until the point of study discontinuation. Recombinant NY-ESO-1 and the synthetic XAGE1 protein (1 μM) in ELISA Buffer kit (PeproTech, Rocky Hill, NJ) were adsorbed onto a 96-well E... | PMC10511099 | ||
Statistical analysis | Quantitative data without a normal distribution were analyzed using the 2-tailed non-parametric Mann-Whitney U test. The 2-tailed Fisher’s exact probability test was used for bivariate analyses. Cumulative survival was plotted using the Kaplan–Meier method, and differences were compared using the Log-rank test. Statist... | PMC10511099 | ||
Results | PMC10511099 | |||
Patient characteristics | cancer | CANCER | Between October 2013 and April 2016, 49 patients with CCR4-negative advanced solid cancer were assigned to receive the KW-0761 treatment at doses of 0.1 mg/kg (n = 23), 0.5 mg/kg (n = 3), and 1.0 mg/kg (n = 23) in the phase I study ( | PMC10511099 |
Adverse events (AEs) | All grade and grade 3–4 treatment-related AEs occurred in 46 (93.9%) and 21 (42.9%), respectively, out of 49 patients ( | PMC10511099 | ||
Reagent-related adverse events. | ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, Gamma-glutamyltransferase | PMC10511099 | ||
Clinical responses | PD, SD | DISEASE | Clinical responses were 1 partial response (PR), 9 stable disease (SD), and 39 PD ( | PMC10511099 |
Characteristics of clinical responses. | esophageal cancer, tumor, Tumor | TUMOR, METASTASIS, TUMOR, OESOPHAGEAL CANCER, ADVERSE EVENTS, TUMOR GROWTH | (a) A Waterfall plot for the best percentage change from baseline. A positive change in the tumor burden indicates tumor growth, while a negative change reflects a tumor reduction. The tumor type, presence or absence of adverse events, and presence or absence of NY-ESO-1 and XAGE1 antibody responses are annotated for e... | PMC10511099 |
Representative CT imaging in patients with a durable clinical response. | esophageal cancer, Multiple liver metastases, cancer, Esophageal cancer, pleural tumor | METASTASIS, OESOPHAGEAL CANCER, CANCER, PLEURAL METASTASIS, LYMPH NODE METASTASIS, ESOPHAGEAL CANCER, DISEASE PROGRESSION | (a) Esophageal cancer patient B-09. Pleural metastasis (yellow arrow) was observed on CT and FDG-PET at baseline. The pleural tumor was decreased in size by the KW-0761 treatment, which was also confirmed by a reduction in standardized uptake value-max (SUV-max) on FDG-PET. Although pleural metastasis shrank, abdominal... | PMC10511099 |
FoxP3 | eTreg depletion in peripheral blood by KW-0761 was examined at baseline and during the KW-0761 treatment by flow cytometry. The percentage of eTregs in CD4 | PMC10511099 | ||
Blood laboratory data | The lymphocyte count, percent lymphocytes in leukocytes (% lymphocytes), NLR, MLR, and PLR were analyzed by blood laboratory tests at baseline and weekly after the initiation of KW-0761 until 8 infusions. The lymphocyte count and % lymphocytes markedly decreased immediately after the initiation of KW-0761, along with r... | PMC10511099 | ||
Changes in blood laboratory data and correlations for overall survival. | (a) The lymphocyte count (/μl), percent lymphocytes in leukocytes (% lymphocytes), NLR, MLR, and PLR were assessed by blood laboratory tests at baseline and weekly after the first KW-0761 treatment until 8 infusions. Kaplan-Meier curves of OS were analyzed between high and low groups divided by the median values of cal... | PMC10511099 | ||
Cancer-testis (CT) antigen-specific antibody responses | Serum NY-ESO-1 and XAGE1 antibodies at baseline and after the first 8 infusions or at the time of the discontinuation of treatment were analyzed by ELISA in patients with less than 8 infusions ( | PMC10511099 | ||
Discussion | cancer, peripheral T-cell lymphoma | NON-SMALL CELL LUNG CANCER, PERIPHERAL T-CELL LYMPHOMA, HTLV-1-ASSOCIATED MYELOPATHY-TROPICAL SPASTIC PARAPARESIS, CANCER, SOLID TUMORS, ADULT T-CELL LEUKEMIA/LYMPHOMA | We conducted phase Ia and Ib clinical trials on KW-0761 to examine the selective depletion of Tregs in 49 patients with CCR4-negative solid cancer [Strategies targeting Tregs to increase anti-tumor immunity, including antibodies against CTLA-4, OX40, 4-1BB, and ICOS, have attracted attention [Treg reductions by KW-0761... | PMC10511099 |
Supporting information | PMC10511099 | |||
Clinical courses of patients. | cancer, PD | CANCER, DISEASE | Kaplan–Meier curves of OS and PFS for 49 CCR4-negative solid cancer patients were analyzed with doses of KW-0761 (a, b) and clinical responses (c, d). PD, progressive disease; SD, stable disease; PR, partial response.(TIF)Click here for additional data file. | PMC10511099 |
Characteristics of clinical responses and survival in esophageal cancer patients. | esophageal cancer, tumor, cancer, Esophageal cancer, non-esophageal cancer | ESOPHAGEAL CANCER, TUMOR, OESOPHAGEAL CANCER, CANCER, ESOPHAGEAL CANCER | (a) A Spaghetti plot for the percentage change in the target lesion tumor burden from baseline over time in esophageal cancer patients (n = 14, left) and non-esophageal cancer patients (n = 35, right). (b-c) Kaplan-Meier curves of OS and PFS for 49 CCR4-negative solid cancer patients were analyzed with or without esoph... | PMC10511099 |
Effects of Treg depletion in peripheral blood. | Longitudinal changes in the percentage of eTregs in CD4(TIF)Click here for additional data file. | PMC10511099 | ||
Longitudinal changes in serological immune responses for NY-ESO-1 and XAGE-1. | Antibody responses in the phase Ib trial were analyzed for NY-ESO-1 (a) and XAGE-1 (b) in patients with positive antibody responses at baseline or during the KW-0761 treatment.(TIF)Click here for additional data file. | PMC10511099 | ||
Clinical courses of patients based on NY-ESO-1 and XAGE1 antibody responses. | tumor | TUMOR | Kaplan-Meier curves of OS and PFS were analyzed based on the presence or absence of tumor NY-ESO-1 or XAGE1 antigen expression (a, b), baseline serum NY-ESO-1 or XAGE1 antibody responses (c, d), and increased NY-ESO-1 or XAGE1 antibody responses after the KW-0761 treatment (e, f).(TIF)Click here for additional data fil... | PMC10511099 |
Patient characteristics and serological immune response. | (DOCX)Click here for additional data file. | PMC10511099 | ||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file. | PMC10511099 | ||
References | PMC10511099 | |||
Summary | Both authors contributed equally.ICON study group members are listed in the | PMC10755111 | ||
Background | CHRONIC CLUSTER HEADACHE | We demonstrated in the randomised controlled ICON study that 48-week treatment of medically intractable chronic cluster headache (MICCH) with occipital nerve stimulation (ONS) is safe and effective. In L-ICON we prospectively evaluate its long-term effectiveness and safety. | PMC10755111 | |
Methods | attack-frequency | ICON participants were enrolled in L-ICON immediately after completing ICON. Therefore, earlier ICON participants could be followed longer than later ones. L-ICON inclusion was stopped after the last ICON participant was enrolled in L-ICON and followed for ≥2 years by completing six-monthly questionnaires on attack fre... | PMC10755111 | |
Findings | ± | EVENTS | Of 103 eligible participants, 88 (85%) gave informed consent and 73 (83%) were followed for ≥2 year, 61 (69%) ≥ 3 year, 33 (38%) ≥ 5 years and 3 (3%) ≥ 8.5 years. Mean (±SD) follow-up was 4.2 ± 2.2 years for a total of 370 person years (84% of potentially 442 years). The pooled geometric mean (95% CI) weekly attack fre... | PMC10755111 |
Interpretation | ONS is a safe, well-tolerated and long-term effective treatment for MICCH. | PMC10755111 | ||
Funding | The | PMC10755111 | ||
Keywords | PMC10755111 | |||
Research in context | PMC10755111 | |||
Evidence before this study | cluster headache, headache | ADVERSE EVENTS, CHRONIC CLUSTER HEADACHE, CLUSTER HEADACHE | We searched PubMed on November 13th, 2023, with the keywords “chronic cluster headache”, “cluster headache”, and “occipital nerve stimulation” (ONS), without restrictions to language or publication year. Of the 171 items, we excluded reviews and publications that did not report attack frequency at least 24 months after... | PMC10755111 |
Added value of this study | ± | ADVERSE EVENTS | This study provides a prospective detailed follow-up (range 2–8.5 years) of the long-term efficacy and safety of ONS in patients with MICCH who had participated in the only randomized, dose-controlled study of the effects of ONS in MICCH to date (ICON trial). Both participants who had improved at the end of the randomi... | PMC10755111 |
Implications of all the available evidence | ONS offers long-term and well-tolerated improvement in MICCH and may also be considered for patients with CCH who respond only sub-optimally to standard medical treatment but do not yet meet the strict criteria of MICCH. Improved ONS devices and stimulation protocols currently under development may confer even better e... | PMC10755111 | ||
Introduction | CHRONIC CLUSTER HEADACHE, CLUSTER HEADACHE | Medically intractable chronic cluster headache (MICCH) is the most extreme and disabling form of cluster headache, in which patients continue to have frequent, often daily, attacks despite a variety of standard prophylactic medication.We showed in the randomized double-blind ICON study that both 100% and 30% electrical... | PMC10755111 | |
Methods | PMC10755111 | |||
Ethics | Written informed consent was obtained from all participants and the study protocol was approved by the ethical committee of the LUMC (METC-LDD; Protocol number P10.016). | PMC10755111 | ||
ICON trial | paresthesia | PARESTHESIA | The parent study (ICON trial) was an investigator-initiated, international, multicentre, randomised, double-blind, phase 3, electrical dose-controlled clinical trial. After 12 weeks of baseline observation, participants were randomised to 24 weeks of occipital nerve stimulation at either 100% or 30% of the individually... | PMC10755111 |
Patients and questionnaires | MOS, COMPLICATIONS | For logistic reasons, only Dutch patients who had completed the full 48-week ICON study were invited for prospective structured follow-up every 6 months for at least two years but if possible longer.ICON study participants were asked to participate and enrolled in the L-ICON follow-up study immediately after completion... | PMC10755111 | |
Statistics | REGRESSION, ADVERSE EVENT, EVENT, ADVERSE EVENTS | Because participants in the LICON follow-up study were each enrolled immediately after completion of the ICON study (i.e. 48 weeks after ONS implantation), while the ICON study was still recruiting new patients until December 3rd 2017, the initial LICON participants (who started the ICON study already in 2013) had a mu... | PMC10755111 | |
Outcomes | ADVERSE EVENTS | The primary outcome was the change in mean weekly attack frequency 2 years after completion of the ICON study (i.e. 3 years after ONS implantation) compared to baseline (i.e. the three months before ONS implantation). Secondary outcomes were (i) Change in mean attack frequency from baseline after 1, 2 and 5 years (ii) ... | PMC10755111 | |
Role of the funding source | The funders had no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. | PMC10755111 | ||
Results | PMC10755111 | |||
Subjective response and satisfaction | Most participants (69/88; 78% [68%–86%]) reported a subjective improvement from baseline at their last follow-up; 9/88 (10% [5%–19%]) reported no change and 4/88 (5%) a worsening. The remaining 6 (7%) could not answer the question since they had a broken stimulator (n = 2) or the stimulator was turned off for varying r... | PMC10755111 | ||
Predictive factors for efficacy at 2 years | DISEASE | Sex, age, number of autonomic symptoms, disease duration, restlessness and attack frequency at baseline are presented in | PMC10755111 | |
Adverse events | ADVERSE EVENTS | From the end of the ICON trial to the last follow-up visit, N = 202 serious adverse events (SAE) occurred in 63/88 (72%) participants ( | PMC10755111 | |
Discussion | headache, attack-frequency, fracture, dislocation | ADVERSE EVENTS, THIGH DISEASE, CLUSTER HEADACHE, STAGGERED, EVENTS | In this study, we prospectively and structurally assessed the long-term effectiveness, safety and tolerability of ONS in 88 patients with MICCH who had initially completed the 48-week randomised, double-blind, electrically dose-controlled ICON trial. Both ICON responders and non-responders were followed for at least tw... | PMC10755111 |
Contributors | Study design (conceptualization and methodology): LAW, JH, WM, FJPMH, EWZ, MDF, ICON study group; Data collection and curation: RBB, LAW, IFC; Data analysis and formal analysis: RBB, EWZ; Writing—original draft: RBB, MDF, RF; Writing—review and editing: RBB, LAW, IFC, JH, WM, FJPMH, EWZ, MDF, RF; Supervision: MDF, RF.R... | PMC10755111 | ||
Data sharing statement | The data sets used and/or analysed during the present study are available from the corresponding author on reasonable request. | PMC10755111 | ||
Declaration of interests | BRAIN | WM reports honoraria from Novartis, Teva, AbbVie, Lundbeck and Lilly, and consultancy and lecture fees from Lilly; RF reports consultancy and lecture fees from Novartis, Lundbeck, AbbVie, Lilly and TEVA, and independent support from the Dutch Brain Foundation, Leiden University Fund and Innovation Fund Dutch Healthcare... | PMC10755111 | |
References | PMC10755111 | |||
Supplementary data | PMC10755111 | |||
Supplementary Figures and Tables | PMC10755111 | |||
Study protocol | PMC10755111 | |||
PubMed table | PMC10755111 | |||
ICON group | PMC10755111 | |||
Acknowledgements | This study was funded by the Supplementary data related to this article can be found at | PMC10755111 | ||
Background | PD, anorexia nervosa, purging disorder, bulimia nervosa | DISORDER, PATHOPHYSIOLOGY, DELAYED GASTRIC EMPTYING | Prior work supports delayed gastric emptying in anorexia nervosa and bulimia nervosa (BN) but not binge-eating disorder, suggesting that neither low body weight nor binge eating fully accounts for slowed gastric motility. Specifying a link between delayed gastric emptying and self-induced vomiting could offer new insig... | PMC10106287 |
Methods | Women ( | PMC10106287 | ||
Results | gastrointestinal distress, Delayed gastric emptying | DELAYED GASTRIC EMPTYING, PURGING | Delayed gastric emptying was associated with purging with no main or moderating effects of binge eating in the placebo condition. Medication eliminated group differences in gastric emptying but did not alter group differences in reported gastrointestinal distress. Exploratory analyses revealed that medication caused in... | PMC10106287 |
Conclusions | Delayed gastric emptying, purging behaviors | DELAYED GASTRIC EMPTYING, PURGING | Delayed gastric emptying demonstrates a specific association with purging behaviors. However, correcting disruptions in gastric emptying may exacerbate disruptions in gut peptide responses specifically linked to the presence of purging after normal amounts of food. | PMC10106287 |
Key words | gastrointestinal diseases, nausea, nonpurging, postprandial gastrointestinal distress, postprandial fullness, non-eating disorder, Delayed gastric emptying, vomiting, PD, increases gastric motility | GASTROINTESTINAL DISEASES, DELAYED GASTRIC EMPTYING, PURGING | Delayed gastric emptying has been observed in numerous gastrointestinal diseases marked by increased postprandial fullness, nausea, and stomach discomfort (Hajishafiee, Bitarafan, & Feinle-Bisset, The current study examined gastric emptying in women with PD and BN who used vomiting as their primary purging method, wome... | PMC10106287 |
Methods | PMC10106287 | |||
Participants | Women (The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. This study was approved by the Human Subjects Committee of the IRB at bo... | PMC10106287 | ||
Procedure | Axis I Disorders, Depression | SCID, MENDELSON | During their first visit, participants completed a medical exam, including pregnancy tests and tests of liver function, the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) (First, Spitzer, Gibbon, & Williams, Descriptive statistics for clinical measures and gastric emptying by groupBDI, Beck Depression... | PMC10106287 |
Gastric emptying assessment | Plasma acetaminophen concentrations were measured using a validated Liquid Chromatography-Mass Spectrometry (LCMS) method (Baliga & Kallury, | PMC10106287 | ||
Gut peptide assessment | Plasma samples for PYY were collected, stored, and assayed following instructions for a commercially available radioimmunoassay (RIA) kit (Millipore, St. Charles, MO, USA; PYYT-66HK), with a sensitivity of 10 pg/ml, and intra-assay and interassay CVs of 5.3% and 7.0%. | PMC10106287 | ||
Data analyses | gastrointestinal distress | Multi-level models captured within-subject levels and changes in acetaminophen concentrations, gastrointestinal distress, and postprandial PYY (Level 1) and whether group (Level 2) differed in these levels or changes, with random effects for intercept and slope (time) (Keel et al., | PMC10106287 |
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