title
stringlengths
1
1.19k
keywords
stringlengths
0
668
concept
stringlengths
0
909
paragraph
stringlengths
0
61.8k
PMID
stringlengths
10
11
Group VS
The video stylet (TRS K2, UE Medical Equipment Co., Ltd., Zhejiang, China, Fig. 
PMC10512610
Group FV
The flexible videoscope (TIC, UE Medical Equipment Co., Ltd., Zhejiang, China, Fig. After successful tracheal intubation, the patient was connected to the anesthesia machine for mechanical ventilation, the tidal volume was adjusted to 10 ml/kg, and the respiratory rate 12 breaths/min to maintain PETCO
PMC10512610
Patient evaluation
The success rate of the first intubation was recorded as the primary observation. The level of glottic exposure (Wilson-Cormack-Lehane grading, W–C-L) [
PMC10512610
Statistical analyses
To calculate the sample size, we performed a preliminary experiment with 20 patients in each group (60 patients in total), and the first-pass intubation success rate in each group was 75% in Group VL, 95% in Group VS, and 90% in Group FV. With The data were analyzed using SPSS 26.0 statistical software. Continuous vari...
PMC10512610
Discussion
’s mouth, glottis, epiglottis
In this randomized parallel-group study, we showed that all three devices were ultimately effective for intubation, higher first-pass intubation success rates were obtained with the video stylet and the flexible videoscope. Endotracheal intubation with the video stylet resulted in shorter intubation time when compared ...
PMC10512610
Conclusion
hypoxia
HYPOXIA
When managing the airway of patients with difficult airways, all three devices can be used to achieve high intubation success rates, but the video stylet and flexible videoscope provide a better view of the vocal cords and are superior to the video laryngoscope in terms of the first-pass intubation success rate. The us...
PMC10512610
Acknowledgements
We acknowledge the assistance of American Journal Experts (AJE) for English language editing.
PMC10512610
Authors’ contributions
TZ and RHL designed the study and drafted the manuscript. PZ completed the anesthesia management. KYZ enrolled patients. All authors read and approved the final manuscript.
PMC10512610
Funding
This research was funded by the Research Fund Project at the Hospital Level of Luan Hospital, Anhui Medical University (2021kykt05).
PMC10512610
Availability of data and materials
The datasets used and/or analyzed during the current study were available from the corresponding author on reasonable request.
PMC10512610
Declarations
PMC10512610
Ethics approval and consent to participate
The present study was approved by the Ethics Committee of the Affiliated Luan Hospital, Anhui Medical University (NO. 2021LL005), and written informed consent forms were signed by all the participants or their relatives before enrollment. As part of our study, we adhere to established international standards, including...
PMC10512610
Competing interests
The authors declare that they have no competing interests.
PMC10512610
References
PMC10512610
Purpose
METASTATIC BREAST CANCER
PUFFIN (NCT02896855), a Chinese bridging study in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer, assessed consistency of efficacy and safety of pertuzumab plus trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel, with CLEOPATRA (NCT00567190).
PMC9883304
Methods
Eligible patients,
PMC9883304
Results
Updated median PFS: 16.5 months (pertuzumab arm) and 12.5 months (placebo arm), with a hazard ratio (HR) of 0.60 [95% confidence interval (CI) 0.45, 0.81;
PMC9883304
Keywords
PMC9883304
Mathematics Subject Classification
PMC9883304
Introduction
diarrhea
ADVERSE EVENTS, METASTATIC BREAST CANCER, MUCOSAL INFLAMMATION, FEBRILE NEUTROPENIA
Pertuzumab and trastuzumab (PERJETAPertuzumab plus trastuzumab and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer was shown to improve progression-free and overall survival (PFS and OS) significantly compared with placebo plus trastuzumab and docetaxel in CLE...
PMC9883304
Methods
HER2-positive
ONCOLOGY, DISEASE, METASTATIC BREAST CANCER, METASTATIC DISEASE
PUFFIN was a phase III, randomized, double-blind, placebo-controlled study conducted across 15 centers in China. The protocol was approved by the institutional review board at each participating site. Informed consent was provided from all participants. The study design, eligibility criteria, procedures, assessments, a...
PMC9883304
Procedures
visceral disease
Randomization was 1:1, using visceral disease and hormone receptor status to stratify patients to pertuzumab (840 mg loading dose, followed by 420 mg every 3 weeks), trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks), and docetaxel (75 mg/mAfter the primary analysis, patients could cross over from the place...
PMC9883304
Statistical methods
PFS and OS were estimated using the Kaplan–Meier approach. HR and 95% CIs were estimated by a Cox proportional hazard model using the stratification factors. To compare the two arms, a two-sided stratified log-rank test was used. Statistical testing was considered exploratory. Safety analyses were descriptive.
PMC9883304
Results
PMC9883304
Study population
From 13 September 2016 to 28 September 2017, 243 eligible patients were randomized: 122 and 121 to the pertuzumab and placebo arms, respectively [Disposition of patients
PMC9883304
Progression-free survival
Updated median investigator-assessed PFS was 16.5 months (95% CI 12.7, 20.2) in the pertuzumab arm and 12.5 months (95% CI 10.4, 14.6) in the placebo arm (Fig. Investigator-assessed PFS in
PMC9883304
Overall survival
Median OS was not reached in either arm. The stratified HR was 0.68 (95% CI 0.45, 1.03; OS in
PMC9883304
Treatment exposure
Prior to crossover, the median number of pertuzumab or placebo cycles administered to patients was 22.0 (range 1–4) and 17.0 (range 1–68), over the respective median duration of 66.1 weeks (range 3–225) and 52.3 weeks (range 3–207). The median number of trastuzumab cycles in the pertuzumab and placebo arms was 22.0 (ra...
PMC9883304
Discussion
Leukopenia, pneumonia, neutropenia, diarrhea, leukopenia, febrile neutropenia, anemia, hypertension
LEUKOPENIA, PNEUMONIA, NEUTROPENIA, LEUKOPENIA, FEBRILE NEUTROPENIA, DISEASE, ANEMIA, HYPERTENSION
PUFFIN previously met its primary objectives, demonstrating consistency of efficacy with CLEOPATRA [Subgroup analyses showed consistency with the overall PFS and OS results. Compared with the primary PFS subgroup analysis, the final analysis showed an overall shift toward the pertuzumab group having improved PFS and OS...
PMC9883304
Conclusions
METASTATIC BREAST CANCER
This final analysis of PUFFIN showed, as with the primary analysis, that overall efficacy was consistent with that of the ITT population in CLEOPATRA. Safety of pertuzumab remained consistent with the known pertuzumab profile. Overall, PUFFIN contributes to the totality of data with pertuzumab in previously untreated H...
PMC9883304
Author contributions
All authors contributed to drafting the work or revising it critically for important intellectual content and read and approved the final the version of the manuscript to be published. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any ...
PMC9883304
Funding
This work was supported by F. Hoffmann-La Roche Ltd, Basel, Switzerland (no grant number applicable). F. Hoffmann-La Roche Ltd was involved in the study design, data interpretation, and the decision to submit for publication in conjunction with the authors.
PMC9883304
Data availability
For eligible studies, qualified researchers may request access to individual patient-level clinical data through a data request platform. At the time of writing, this request platform is Vivli.
PMC9883304
Declarations
PMC9883304
Conflict of interest
WL, HL
BX reports institutional research funding (investigator fees for this study to his institution) from F. Hoffmann-La Roche Ltd; and consultant/advisory roles for Novartis, Roche, and AstraZeneca. WL, QZ, QL, XW, HL, TS, YY, HZhe, and JF all report institutional research funding (investigator fees for this study) from F....
PMC9883304
Ethics approval
ICH
This study was conducted in full conformance with the International Council for Harmonisation (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or with the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to...
PMC9883304
Consent to participate
Written informed consent for participation in the study had to be obtained before performing any study-specific screening tests or evaluations. Informed consent forms for enrolled patients and for patients who were not subsequently enrolled were maintained at the study site.
PMC9883304
Consent for publication
Not applicable.
PMC9883304
References
PMC9883304
Purpose
rUTI
RECURRENT URINARY TRACT INFECTION
To evaluate efficacy and safety of vaccination with StroVac compared to placebo in patients with recurrent urinary tract infections (rUTI).
PMC9870822
Material and methods
UTI, rUTI
BACTERIAL URINARY TRACT INFECTION, RECURRENCES, RECURRENCE, UTI
We performed a prospective, double-blinded, placebo-controlled study in patients with uncomplicated rUTI. Patients received three single intramuscular injections with StroVac every two weeks. Primary endpoint was the number of bacterial urinary tract infections (UTI) over 13.5 months after randomization and adjusted by...
PMC9870822
Results
376 patients were randomized to both groups between January 2012 and March 2015. Mean age was 44.4 years. Patients were mainly female (98.4%). In the StroVac group (
PMC9870822
Conclusion
UTIs, rUTI
StroVac reduced the number of clinically relevant UTIs like in former studies but did not show statistically significant better results than the chosen placebo. Most likely, that was due to a, since confirmed, prophylactic effect of the chosen placebo itself. Therefore, placebo-controlled and double-blinded studies usi...
PMC9870822
Keywords
PMC9870822
Introduction
UTI, rUTI
DISEASE, URINARY TRACT INFECTIONS, UTI
Urinary tract infections (UTI) are a common disease affecting 11% of women worldwide at least once per year [StroVac offers a different approach consisting of 10 strains of inactivated uropathogens: six of Therefore, we conducted a prospective, multicentre, randomized, double-blinded and placebo-controlled study on eff...
PMC9870822
Patients and methods
ICH
This double-blinded, randomized and placebo-controlled phase IV study was conducted from January 2012 to March 2015 in 40 sites in Germany. This study was conducted in compliance with the ICH Guideline E6 (R1) on Good Clinical Practice and registered under EudraCT no. 2010-020882-25. Several ethic committees were invol...
PMC9870822
Study participants
lower urinary tract symptoms, malignancy, diabetes mellitus, rUTI, liver or renal insufficiency, systemic infectious disease, neurogenic bladder dysfunction, bladder or kidney stones, UTIs
DIABETES MELLITUS, CONCOMITANT DISEASE, NEUROGENIC BLADDER DYSFUNCTION, UTI, SYSTEMIC INFECTIOUS DISEASE, COMPLICATIONS
Patients of both sexes aged 18–80 years were included if they had at least five symptomatic uncomplicated bacterial UTIs within 12 months prior to study inclusion. In accordance with current literature, UTI diagnosis required a positive urine culture with ≥ 10Exclusion criteria comprised complicated UTI, lower urinary ...
PMC9870822
Endpoints
bacterial UTIs, UTIs
RECURRENCES, RECURRENCE
The primary endpoint was the number of bacterial UTIs over 13.5 months after randomization adjusted by the respective “baseline” value (ITT-population) when comparing verum and placebo group. Baseline adjustment was done by including the respective baseline value as covariate into the statistical model. Secondary endpo...
PMC9870822
Study medication
The investigational medicinal products consisted of a basic suspension and a dry substance for preparing the suspension for injection. Finished verum suspension for one injection contained at least 10
PMC9870822
Statistical analysis
UTIs
RECURRENCES, RECURRENCE
The sample size calculation was based upon an average of 6.2 UTIs in the year pre-study, a 50% placebo response and an additional 15% StroVac effect in reducing UTIs during the study period. The number of 6.2 UTIs was calculated from data of an earlier study [The efficacy analyses were performed using the intention to ...
PMC9870822
Results
UTIs, rUTI
RECURRENCES, RECURRENCE, UTI
Of the 412 patients screened for eligibility, 376 patients were randomized equally to both groups between January 2012 and March 2015 (i.e. 188 patients per group, see Table Characteristics of patients with rUTI under prophylaxis with StroVac or placeboThe Results are presented as: mean and standard deviation (SD) and ...
PMC9870822
Subgroup analysis
cystitis, UTIs
RECURRENCES, CYSTITIS, UTI
In premenopausal women, no statistically significant difference was seen between the two treatment groups in the frequency of recurrences (In patients older than 70 years, the reduction of frequency of UTI (by 4.4–4.5 UTIs, Using a broader UTI definition (patients with self-documented UTIs without visiting a doctor, wi...
PMC9870822
Patient-reported outcomes/quality of life questionnaires (QoL)
UTI
In the StroVac group, complaints recorded in most QoL questionnaires were reduced by approximately 50% from V1 (baseline) to V9, in parallel to the reduction of UTI frequency. The mean scores of “symptom burden”, "mental consequences", and "effect on daily life" declined from 21.2 to 10.2, from 11.8 to 5.9, and from 9....
PMC9870822
Safety results
pyrexia, influenza-like illness, nasopharyngitis, pain
ADVERSE EVENTS, EVENT, INFLUENZA-LIKE ILLNESS, NASOPHARYNGITIS
Overall, 619 adverse events (AE) occurred within the treatment period, 426 AEs in the StroVac group in 115 patients (62.2%), and 193 AEs in 83 patients in the placebo group (44.1%). By the end of the study, most AEs had resolved (98.7%). Most AEs were mild (54.9%) and moderate (33.4%) in intensity, and 11.6% were class...
PMC9870822
Discussion
StroVac reduced rUTI, urinary tract infections, fever, rUTI, UTIs
RECURRENCE, URINARY TRACT INFECTIONS, PERTUSSIS, FLU-LIKE ILLNESS, UTI, HEAT
Due to the emerging possibilities in non-antibiotic prophylaxis and a growing body of evidence proving their efficacy [Since the aim of the study was to prove the efficacy of StroVac in prophylaxis of rUTI, one has to state, that our study showed no significant advantage of StroVac over the placebo we used. We even saw...
PMC9870822
Author contributions
SP and AHH designed the study, SN wrote the manuscript with input from CP, AHH, WV, WF and AN, AN and SN edited the manuscript.
PMC9870822
Funding
This research was performed under funding of Strathmann GmbH & Co. KG.
PMC9870822
Declarations
PMC9870822
Conflict of interest
FABRY
S Nestler works as an advisor/author for Dermapharm, Strathmann, Abbvie, GlaxoSmithKline. S Peschel and AH Horstmann are employees of Strathmann GmbH & Co. KG. W Vahlensieck works as advisor/author for Apogepha, Bene, Bionorica, Strathmann, Fresenius, Infectopharm, Medice, Perrigo, Repha. W Fabry have no conflicts of i...
PMC9870822
Ethical approval
ICH
This study was conducted in compliance with the ICH Guideline E6 (R1) on Good Clinical Practice and registered under EudraCT no. 2010-020882-25. Several ethic committees were involved, including a leading committee in Berlin and local ethic committees in regions with participating centres. Informed consent was obtained...
PMC9870822
References
PMC9870822
Subject terms
CKD
SECONDARY
We investigated the effect of two dosing regimens of oral iron on iron status and hematological parameters in patients with CKD. In this single center, open label, randomized, active controlled clinical trial, stable adult patients with CKD stage G3–4 with percentage transferrin saturation (%TSAT) ≤ 30% and serum ferri...
PMC9813132
Introduction
Anemia, CKD, chronic kidney disease, CVD
CVD, ANEMIA, CARDIOVASCULAR DISEASE
Anemia is common in chronic kidney disease (CKD) and has been associated with impaired quality of life, cardiovascular disease (CVD) and mortalityIn patients with CKD who are not on dialysis, oral route may be preferred as initial mode of iron supplementation. Oral iron is inexpensive, self-administered, convenient and...
PMC9813132
Methods
PMC9813132
Study design
The study was a single centre, pilot study. It was parallel arm, randomized, open label, active controlled, interventional trial conducted at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India. The trial was approved by the Institute Ethics Committee of PGIMER, Chandigarh and prosp...
PMC9813132
Study population
TSAT ≤, CKD
All adults with a diagnosis of CKD stage G3–4 attending the outpatient clinic at PGIMER were eligible for screening. Subjects between the ages of 18 and 70 years, TSAT ≤ 30%, serum ferritin ≤ 500 mg/L
PMC9813132
Enrolment and randomization
At enrolment, all participants entered 2-week run-in period. This was done to ensure clinically stable status of participants. The visit scheduled after completion of run-in period was referred to as baseline visit. Participants were randomized in 1:1 allocation ratio to either of the two study groups at baseline visit...
PMC9813132
Intervention and follow up
ADVERSE EVENTS
Participants were randomized to oral iron supplementation with ferrous ascorbate in either once daily (100 mg of elemental iron once daily i.e., 100 mg total daily dose, referred to as OD group) or twice daily (100 mg elemental iron twice daily i.e., 200 mg total daily dose, referred to as BD group) dosing for 12 weeks...
PMC9813132
Outcomes
hypochromic red blood cells
SECONDARY
The primary outcome was difference in change in % TSAT over 12 weeks between the two groups. The secondary outcomes were differences in changes in serum ferritin, blood hemoglobin concentrations, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), percenta...
PMC9813132
Measurements
BLOOD
All measurements were done in fasting blood samples. Blood hemoglobin concentrations, MCH, MCV, MCHC, % HYPO-He and RET-He were measured at every visit on Sysmex XN-1000™ Hematology Analyzer (Sysmex Corporation, Kobe, Japan). These measurements were done within 4 h of sample collection. % TSAT concentrations were calcu...
PMC9813132
Statistical considerations
SD
REGRESSION, SECONDARY
Assuming dropout rate of 10%, a sample size of 80 participants (40 in either group) was required to detect absolute difference of 3% in % TSAT [standard deviation (SD) ± 4.5%] between the two groups with 80% power and two sided α of 0.05. All participants with non-missing outcome data were included in the analysis. Des...
PMC9813132
Ethics approval and consent to participate
Study was approved from the Institute Ethics Committee and patients were enrolled in this study after getting the written consent prior to study procedures.
PMC9813132
Change in iron status and hematological parameters in the study population
Serial measurements done at 2, 5 and 12 weeks in both the groups are shown in Supplementary Tables
PMC9813132
Adverse events and others
ADVERSE EVENTS
All participants who completed study were compliant with study medication. Minor adverse events were recorded during the study (Supplementary Table
PMC9813132
Discussion
iron deficiency anemia, CKD, TIBC
IRON DEFICIENCY ANEMIA, IRON DEFICIENCY, SECONDARY
In our study, the changes in %TSAT, serum iron and TIBC did not differ significantly between OD and BD dosing groups over 12 weeks. However, serum ferritin increased significantly in the BD group as compared to the OD group. Either repletion of intracellular stores or sequestration of iron within the cellular stores wi...
PMC9813132
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-022-26589-x.
PMC9813132
Acknowledgements
We are thankful to Junior Laboratory Technicians: Ms Kiran Khere and Mr Nand Lal in the Department of Paediatrics at PGIMER, Chandigarh for their help in carrying out the study.
PMC9813132
Author contributions
P.K.
Conceived and designed the work: S.V., K.V., P.B., S.M.; data acquisition (screening, enrolment, and follow-up of patients): V.S., K.V., R.R., M.R., H.S.K., K.L.G., T.S. and S.K.S.; laboratory measurements: P.B., P.K., K.K. and A.K.Y.; data analysis: K.K., M.K., A.G., K.V., A.K.Y.; manuscript: K.V., V.S., A.K.Y., P.B.,...
PMC9813132
Funding
This study was funded in-part through grant received by VJ from Department of Biotechnology, Ministry of Science and Technology, India (Grant No. BT/PR11105/MED/30/1345/2014). The funding agency had no role in design and conduct of this study.
PMC9813132
Data availability
The datasets analysed during this study are available from the corresponding author on reasonable request.
PMC9813132
Competing interests
VJ has research grants from Baxter, GSK and reports Consultancy and Advisory Board honoraria from Baxter Healthcare, and AstraZeneca, outside the published work. All other authors reported no conflict of interest.
PMC9813132
References
PMC9813132
Introduction
Eating disorders, Bulimia nervosa, psychosomatic disorders, Anorexia nervosa, AN
Eating disorders (EDs) including Anorexia nervosa (AN) and Bulimia nervosa (BN) are severe psychosomatic disorders with lifetime prevalence among females ranging from 2–4% [EDs can be treated in a variety of treatment settings. Different treatment settings offer varying degrees of treatment intensity and treatment stru...
PMC10313003
Materials and methods
PMC10313003
Participants and procedure
Data were drawn from a large clinical trial [
PMC10313003
Overview of study.
Sixty-four patients with AN and 66 patients with BN were enrolled in the study. Fifty-nine patients with AN and 57 patients with BN participated. Potentially eligible patients who were voluntarily admitted between July 2014 and April 2017 to cooperating treatment centers were approached by staff members and informed ab...
PMC10313003
Cooperating sites and treatment
psychiatric
The study sites included nine treatment sites in western Germany and northern Switzerland, which provided CBT-based interventions in accordance with the national clinical practice treatment guideline for the treatment of ED [Full-time treatment consisted of 24/7-care in a medical or psychiatric hospital or a privately ...
PMC10313003
Measures
PMC10313003
Diagnostic interview
DISORDERS
A clinician-administered, semi-structured diagnostic interview (DIPS; Diagnostic Interview for Mental Disorders) [
PMC10313003
Self-report questionnaire
Eating Disorder
PATHOLOGY
At pre- and post-measurement, all patients completed an online questionnaire including questions regarding age, education, nationality, relationships status, use of psychopharmaceutics, and number of cigarettes smoked per day. Symptoms of ED pathology were assessed by the global score of the Eating Disorder Examination...
PMC10313003
Body-Mass-Index (BMI)
At pre- and post-measurement, weight and height of study participants were measured using a calibrated electronic scale (Seca 899, Basel, Switzerland) and a stadiometer (Seca 213, Basel, Switzerland). BMI was calculated as weight in kilograms divided by height in meters squared.
PMC10313003
Remission rates
weight gain
REMISSION
Patients were considered fully remitted if they met the following criteria: a) Full remission based on diagnostic interview (i.e., after full criteria for AN/BN were previously met, none of the criteria have been met for a sustained period of time), b) BMI ≥ 18.5 and c) EDE-Q global score ≤ 2.77. Patients were consider...
PMC10313003
Treatment intensity and treatment characteristics
To examine treatment intensity and treatment characteristics, brief online questionnaires were administered to therapists at post-measurement. Items assessed the number of individual and group sessions as well as treatment components and treatment goals discussed with patients (a list of response options was provided)....
PMC10313003
Statistical analyses
Statistical analyses were conducted using SPSS 27 (IBM). To describe the total sample as well as subsamples by diagnosis (AN vs. BN) and setting (full-time treatment vs. ambulatory treatment), means, standard deviations, frequencies, and percentages of measured variables were reported. Statistical comparisons between g...
PMC10313003
Results
PMC10313003
Descriptive characteristics of patients
On average, patients with EDs were 22.8 years (Descriptive characteristics of patients between treatment settings are also displayed in
PMC10313003
Treatment components and treatment goals reported by patients and therapists three months after treatment admission.
Anorexia Nervosa, Bulimia Nervosa
Note: Treatment may continue after the three-months post-measurement (particularly among ambulatory patients).* Only assessed among patients with AN. AN = Anorexia Nervosa. BN = Bulimia Nervosa.
PMC10313003
Descriptive statistics of treatment received within three months after admission (therapist-report).
Anorexia Nervosa, Bulimia Nervosa
Note: Treatment may continue after the three-months (particularly among outpatients). AN = Anorexia Nervosa. BN = Bulimia Nervosa.
PMC10313003
Symptomatic changes (means, standard deviations, Cohen’s
Anxiety, Bulimia Nervosa, Anorexia Nervosa, Depression, Eating Disorder
Note. Amb. = Ambulatory, AN = Anorexia Nervosa, BN = Bulimia Nervosa, BMI = Body-Mass-Index, EDE-Q = Eating Disorder Examination Questionnaire, BDI = Beck Depression Inventory, BAI = Beck Anxiety Inventory, SOMS = Somatic Symptoms Scale. M = mean, SD = standard deviation, n = sample size, d = Cohen’s d. Descriptive sta...
PMC10313003
Correlates of symptomatic improvements
weight gain
Among women with AN, a significant correlation was found only between weight gain and ED severity (
PMC10313003