scholarly journals Hemispheric Brain Dominance and Mathematics Performance of Western Visayas College of Science and Technology Students – Phase III

2015 ◽  
Vol 2 ◽  
pp. 154-162
Author(s):  
Doly Joy C. Celindro ◽  
Belinda M. Go
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Mathematics Performance ◽  
Math Performance ◽  
Phase Iii ◽  
Hemispheric Dominance ◽  
Brain Dominance ◽  
Left Brain ◽  
The Right ◽  
Post Hoc

This study was anchored in the Split-Brain or Lateralization Theory of Roger Wolcott Sperry which states that the brain is divided into two hemispheres, the left hemisphere, and the right hemisphere. This was conducted to determine the significance of the difference in the mathematics(math) performance of the participants when they were grouped according to their hemispheric dominance (HD) and program. There were 172 first-year participants of Western Visayas College of Science and Technology, Iloilo City in phase I (SY 2011-2012). This was reduced to 120 participants in phase II (SY 2012-2013) and to 88 participants in phase III (SY 2013-2014). The participants’ HD was determined by the use of a researcher-made 46-item Hemispheric Brain Dominance Test while their mathematics performance was based on their average final grades in their Math classes. The statistical tools used were the mean, standard deviation, Mann-Whitney, Kruskal-Wallis, and Post hoc tests. The test in the hypothesis was set at .05 alpha level. Results showed that as an entire group, the left brain was the dominant brain hemisphere among the participants in phases I, II and III. In phase I and II, the participants had “fair” mathematics performance while phase III had “good” mathematics performance. When the participants were grouped according to their hemispheric dominance in phase I, the participants who were right-brain dominant had “conditional” mathematics performance while in phase II and III, they had “fair” mathematics performance. Those which were left-brain dominant in phase I had “fair” mathematics performance while in phase II and III, they had “good” mathematics performance. In phases, I, II and III of the study, significant differences existed in the level of mathematics performance when the participants were grouped according to their hemispheric brain dominance. The left brain dominant participants performed better in their mathematics performance than the right brain dominant participants. In phases, I, II and III, significant differences existed in the level of mathematics performance when the participants were grouped according to their program. The Post hoc (Scheffe) test results showed that BS Math significantly differs in their math performance from BSECE and BSMEAE participants. Furthermore, BSECE significantly differs in their math performance from BSEd and BSMEAE participants. Also, BSMEAE significantly differs from BSEE and BSEd participants in their math performance. There is no significant difference in the hemispheric brain dominance of the participants when they were grouped according to the phase of the study. This implies that the hemispheric brain dominance of the participants did not change for the last three years. It is highly recommended to administrators and guidance counselors to assess the brain dominance of the incoming freshmen and give priority to left-brained students for Math-laden courses. More researches should be conducted in different subjects, programs, and backgrounds to add support to this study.

scholarly journals Hemispheric Brain Dominance and Mathematics Performance of Western Visayas College of Science and Technology Students – Phase IV

2015 ◽  
Vol 2 ◽  
pp. 111-119 ◽  
Author(s):  
Belinda M. Go ◽  
Doly Joy C. Celindro
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Mathematics Performance ◽  
Phase Iii ◽  
Brain Dominance ◽  
Brain Hemisphere ◽  
Bachelor Of Science ◽  
Left Brain ◽  
Right Brain ◽  
Phase Iv

This is the last phase of a four-year study which aimed to determine the significance of the difference in the mathematics (math) performance of the participants when grouped according to their hemispheric dominance (HD). The study was anchored in the Split-Brain or Lateralization Theory of Roger Wolcott Sperry which states that the brain is divided into two hemispheres, the left, and the right hemisphere. The participants were eighty-eight (88) fourth-year college students from the courses of Bachelor of Science in Mathematics (BSM), Bachelor of Science in Education major in Mathematics (BSEd), Bachelor of Science in Electrical Engineering (BSEE), Bachelor of Science in Electronics and Communication Engineering (BSECE), and Bachelor of Science in Mechanical Engineering major in Automotive Engineering (BSMEAE) at Western Visayas College of Science and Technology SY 2014-2015. The participants’ HD was determined by the use of a researcher-made 46-item Hemispheric Brain Dominance Test while their mathematics performance was based on their Math classes average final grades. The statistical tools used were the mean, standard deviation, Mann-Whitney, Kruskal-Wallis, and Post hoc tests. The hypothesis was set at the 0.05 alpha level. As an entire group, the left brain was the dominant brain hemisphere among the participants from phase I to phase IV. When the participants were grouped according to program in phase I, the BSM, BSEd, and BSMEAE was left-brain dominant while the BSEE participants were right-brain dominant. The BSECE had an equal number of left-brained and right-brained participants. In phase II, the dominant brain hemisphere was the left brain. Only the BSEE participants were right-brain dominant. In phase III, the dominant brain hemisphere was the left brain, except for the BSMEAE where there was an equal number of left-brained and right-brained participants. In phase IV, all participants from the different programs were left-brained. Only the BSEE participants were right-brain dominant. As an entire group, phase I and II participants had “fair” mathematics performance; phase III had “good” mathematics performance, and phase IV had “very good” mathematics performance. When the participants who were right-brained were grouped according to mathematics performance, phase I had “conditional” mathematics performance; phase II and III had “fair” mathematics performance; and phase IV had “good” mathematics performance. Those who were left-brain dominant had “fair” mathematics performance in phase I, “good” mathematics performance in phase II and III, and “very good” mathematics performance in phase IV. In all phases of the study, significant differences existed in the level of mathematics performance when the participants were grouped according to their hemispheric brain dominance. The “left-brained” performed better in mathematics than the “right-brained”. There was a significant decrease in the enrolment of participants who were right-brain dominant because they shifted to other courses or they transferred to other schools. In phases, I, II and III, significant differences existed in the level of mathematics performance when the participants were grouped according to their program. There is no significant difference in the hemispheric brain dominance of the participants when grouped according to the phase of the study. This implies that the slight changes in the hemispheric brain dominance of the participants were not significant in the last four years.

scholarly journals IMPACT OF HEMISPHERIC DOMINANCE ON BEHAVIOURAL LATERALITY STYLE

2020 ◽  
pp. 31-39
Keyword(s):  
Cerebral Hemispheres ◽  
Hemispheric Dominance ◽  
Strongly Correlated ◽  
Brain Dominance ◽  
Close Link ◽  
Left Brain ◽  
Behavioural Characteristics ◽  
Processing Modes ◽  
The Right ◽  
The Brain

The cerebral hemispheres play crucial role in forming the mental state of human being. “Hemisity”, is an aspect of the brain that considers two distinguished modes of information flow into the brain their differential processing modes within the two hemispheres. These two modes of information processing become the foundation for the development of differences in the functions of the two cerebral hemispheres. Each hemisphere has certain areas assigned with certain functions. The dominance of a particular processing mode in the brain of an individual gives rise to specific behavioural and personality characteristics. An individual may be excellent in performing certain tasks and may exhibit characteristics which would define his individuality, his identity and the dominant talent. These characteristics may be strongly correlated with the hemispheric dominance. Thus, it is considered that there may be a close link between hemisity and behavioural characteristics of an individual. This research aims at understanding the correlation between Hemisity and behavioural characteristics of a group of volunteers. The samples selected for this research were 150 males and 150 females of age group, 18-25 years. To measure characteristics exhibited by an individual Binary Preference Questionnaire (Morton, 2003) will be used and a questionnaire is developed and validated by an expert neuropsychologist to measure the brain dominance and characteristics exhibited by the right or left-brain oriented individuals. The results showed that less than half of the total number of samples reflected hemispheric dominance and exhibited respective hemisphere characteristics. However, more than half of the samples reflected hemispheric dominance but exhibited characteristics of nondominant hemisphere. The hypothesis that there exists a relation between Hemisity and behavioural characteristics exhibited by the right and left-brain oriented individuals is not completely supported by the data obtained. Thus, the result stands inconsistent with the data obtained and the earlier researches.

Bewegungstherapie und körperliche Aktivität bei Patienten mit Herzinsuffizienz

Praxis ◽  
2018 ◽  
Vol 107 (17-18) ◽  
pp. 951-958 ◽  
Author(s):  
Matthias Wilhelm
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Körperliche Aktivität ◽  
Phase Iii

Zusammenfassung. Herzinsuffizienz ist ein klinisches Syndrom mit unterschiedlichen Ätiologien und Phänotypen. Die überwachte Bewegungstherapie und individuelle körperliche Aktivität ist bei allen Formen eine Klasse-IA-Empfehlung in aktuellen Leitlinien. Eine Bewegungstherapie kann unmittelbar nach Stabilisierung einer akuten Herzinsuffizienz im Spital begonnen werden (Phase I). Sie kann nach Entlassung in einem stationären oder ambulanten Präventions- und Rehabilitationsprogramm fortgesetzt werden (Phase II). Typische Elemente sind Ausdauer-, Kraft- und Atemtraining. Die Kosten werden von der Krankenversicherung für drei bis sechs Monate übernommen. In erfahrenen Zentren können auch Patienten mit implantierten Defibrillatoren oder linksventrikulären Unterstützungssystemen trainieren. Wichtiges Ziel der Phase II ist neben muskulärer Rekonditionierung auch die Steigerung der Gesundheitskompetenz, um die Langzeit-Adhärenz bezüglich körperlicher Aktivität zu verbessern. In Phase III bieten Herzgruppen Unterstützung.

scholarly journals AB0332 IMMUNOSUPPRESSIVE AND IMMONOMODULATING AGENTS IN RHEUMATOID ARTHRITIS: A SYSTEMATIC REVIEW OF CLINICAL TRIALS AND THEIR CURRENT DEVELOPMENT STAGE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1464.1-1465
Author(s):  
J. Blaess ◽  
J. Walther ◽  
J. E. Gottenberg ◽  
J. Sibilia ◽  
L. Arnaud ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
B Cells ◽  
Phase I ◽  
Phase Ii ◽  
Clinical Development ◽  
Phase Iii ◽  
Jak Inhibitors ◽  
Exclusion Criteria ◽  
Immunomodulating Drugs

Background:Rheumatoid arthritis (RA) is the most frequent chronic inflammatory diseases with an incidence of 0.5% to 1%. Therapeutic arsenal of RA has continuously expanded in recent years with the recent therapeutic progress with the arrival of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biological (bDMARDs) and targeted synthetic (tsDMARDs), JAK inhibitors. However, there are still some unmet needs for patients who do not achieve remission and who continue to worsen despite treatments. Of note, only approximately 40% of patients are ACR70 responders, in most randomized controlled trials. For these patients, finding new therapeutic avenues is challenging.Objectives:The objective of our study was to analyze the whole pipeline of immunosuppressive and immunomodulating drugs evaluated in RA and describe their mechanisms of action and stage of clinical development.Methods:We conducted a systematic review of all drug therapies in clinical development in RA in 17 databases of international clinical trials. Inclusion criterion: study from one of the databases using the keywords “Rheumatoid arthritis” (search date: June 1, 2019). Exclusion criteria: non-drug trials, trials not related to RA or duplicates. We also excluded dietary regimen or supplementations, cellular therapies, NSAIDs, glucorticoids or their derivatives and non-immunosuppressive or non-immunomodulating drugs. For each csDMARD, bDMARD and tsDMARD, we considered the study at the most advanced stage. For bDMARDs, we did not take into account biosimilars.Results:The research identified 4652 trials, of which 242 for 243 molecules met the inclusion and exclusion criteria. The developed molecules belong to csDMARDs (n=21), bDMARDs (n=117), tsDMARDs (n=105).Among the 21 csDMARDs molecules: 8 (38%) has been withdrawn, 4 (19%) are already labelled in RA (hydroxychloroquine, leflunomide, methotrexate and sulfasalazine) and 9 (43%) are in development: 1 (11%) is in phase I/II, 5 (56%) in phase II, 3 (33%) in phase IV.Among the 117 bDMARDs molecules: 69 (59%) has been withdrawn, 9 (8%) are labeled in RA (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab) and 39 (33%) are in development: 9 (23%) in phase I, 3 (8%) in phase I/II, 21 (54%) in phase II, 5 (12%) are in phase III, 1 (3%) in phase IV. bDMARDs currently under development target B cells (n=4), T cells (n=2), T/B cells costimulation (n=2),TNF alpha (n=2), Interleukine 1 or his receptor (n=3), Interleukine 6 or his receptor (n=7), Interleukine 17 (n=4), Interleukine 23 (n=1), GM-CSF (n=1), other cytokines or chemokines (n=5), integrins or adhesion proteins (n=3), interferon receptor (n=1) and various other targets (n=4).Among the 105 tsDMARDs molecules: 64 (61%) has been withdrawn, 6 (6%) JAK inhibitors, have just been or will probably soon be labelled (baricitinib, filgotinib, peficitinib, tofacitinib and upadacitinib), 35 (33%) are in development: 8 (24%) in phase I, 26 (74%) in phase II, 1 (3%) in phase III and. tsDMARDs currently under development target tyrosine kinase (n=12), janus kinase (JAK) (n=3), sphingosine phostate (n=3), PI3K pathway (n=1), phosphodiesterase-4 (n=3) B cells signaling pathways (n=3) and various other targets (n=10).Conclusion:A total of 242 therapeutic trials involving 243 molecules have been or are being evaluated in RA. This development does not always lead to new treatments since 141 (58%) have already been withdrawn. Hopefully, some of the currently evaluated drugs will contribute to improve the therapeutic management of RA patients, requiring a greater personalization of therapeutic strategies, both in the choice of molecules and their place in therapeutic sequences.Disclosure of Interests:Julien Blaess: None declared, Julia Walther: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Jean Sibilia: None declared, Laurent Arnaud: None declared, Renaud FELTEN: None declared

scholarly journals Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 136-140 ◽  
Author(s):  
Andrew J. Vickers ◽  
Joyce Kuo ◽  
Barrie R. Cassileth
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Finding ◽  
Phase Iii ◽  
High Dose ◽  
Free Text ◽  
Phase Ii Trials ◽  
Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

Hydrogeological Characterization Based on Long Term Groundwater Pressure Monitoring

2010 ◽  
Author(s):  
Shuji Daimaru ◽  
Ryuji Takeuchi ◽  
Masaki Takeda ◽  
Masayuki Ishibashi
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Large Scale ◽  
Pumping Test ◽  
Phase Iii ◽  
Pressure Monitoring ◽  
Energy Agency ◽  
Hydrogeological Characteristics ◽  
Under Construction

The Mizunami Underground Research Laboratory (MIU) is now under construction by the Japan Atomic Energy Agency in the Tono area of central Japan. The MIU project is being implemented in three overlapping Phases: Surface-based Investigation (Phase I), Construction (Phase II) and Operation (Phase III). The changes of groundwater pressure due to shaft excavation can be considered analogous to a large-scale pumping test. Therefore, there is the possibility that the site scale groundwater field (several km square) can be approximated by the long-term groundwater pressure monitoring data from Phase II. Based on the monitoring observations, hydrogeological characteristics were estimated using the s-log(t/r2) plot based on the Cooper-Jacob straight line method. Results of the s-log(t/r2) plots are as follows. The groundwater flow field around the MIU construction site is separated into domains by an impermeable fault. In other words, the fault is a hydraulic barrier. Hydraulic conductivity calculated from s-log(t/r2) plots are in the order of 1.0E−7(m/s). The above results from the long term monitoring during Phase II are a verification of the hydrogeological characteristics determined in the Phase I investigations.

Phase I Trial of Escalating-Dose Irinotecan Given Weekly With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Cancer

2003 ◽  
Vol 21 (15) ◽  
pp. 2926-2932 ◽  
Author(s):  
David H. Ilson ◽  
Manjit Bains ◽  
David P. Kelsen ◽  
Eileen O’Reilly ◽  
Martin Karpeh ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Phase I ◽  
Induction Chemotherapy ◽  
Phase Ii ◽  
Phase I Trial ◽  
Locally Advanced ◽  
Phase Iii ◽  
Concurrent Radiotherapy ◽  
Minimal Toxicity ◽  
Grade 3

Purpose: To identify the maximum-tolerated dose and dose-limiting toxicity (DLT) of weekly irinotecan combined with cisplatin and radiation in esophageal cancer. Patients and Methods: Nineteen patients with clinical stage II to III esophageal squamous cell or adenocarcinoma were treated on this phase I trial. Induction chemotherapy with weekly cisplatin 30 mg/m2 and irinotecan 65 mg/m2 was administered for four treatments during weeks 1 to 5. Radiotherapy was delivered weeks 8 to 13 in 1.8-Gy daily fractions to a dose of 50.4 Gy. Cisplatin 30 mg/m2 and escalating-dose irinotecan (40, 50, 65, and 80 mg/m2) were administered on days 1, 8, 22, and 29 of radiotherapy. DLT was defined as a 2-week delay in radiotherapy for grade 3 to 4 toxicity. Results: Minimal toxicity was observed during chemoradiotherapy, with no grade 3 or 4 esophagitis, diarrhea, or stomatitis. DLT caused by myelosuppression was seen in two of six patients treated at the 80-mg/m2 dose level, thus irinotecan 65 mg/m2 was defined as the recommended phase II dose. Dysphagia improved or resolved after induction chemotherapy in 13 (81%) of 16 patients who reported dysphagia before therapy. Only one patient (5%) required a feeding tube. Six complete responses (32%) were observed, including four pathologic complete responses in 15 patients selected to undergo surgery (27%). Conclusion: Cisplatin, irinotecan, and concurrent radiotherapy can be administered on a convenient schedule with relatively minimal toxicity and an acceptable rate of complete response in esophageal cancer. Further phase II evaluation of this regimen is ongoing. A phase III comparison to fluorouracil or taxane-containing chemoradiotherapy should be considered.

scholarly journals Etude par resonance magnetique des mouvements moléculaires dans l'acrylonitrile solide

1973 ◽  
Vol 51 (23) ◽  
pp. 3889-3900 ◽  
Author(s):  
Buu Ban ◽  
C. CHACHATY
Keyword(s):  
Phase Transitions ◽  
Phase I ◽  
Phase Ii ◽  
Phase Iii ◽  
Solid Matrix ◽  
Peroxy Radicals ◽  
Γ Irradiation ◽  
Rotational Oscillation ◽  
Résonance Magnétique ◽  
Oxygen Addition

Phase transitions and molecular motions in solid acrylonitrile and its deuterated homologue CH2=CDCN, have been studied between 100 and 191 °K (m.p.) by wide line n.m.r. and by T1 relaxation time measurements. Phase I (164 °K < T < 191 °K) is trapped and becomes metastable by quick cooling of acrylonitrile at 77 °K. It changes into the phase II, stable between 113 °K and 164 °K by a long duration annealing at 155–160 °K. The phase II → phase III transition occurs at 113 °K. It may be assumed that phase III, stable below this temperature, is rigid at T < 105 °K. Phase II may be characterized by a rotational oscillation of molecules around an axis defined by the N atom and the middle of the vinyl double bond. In phase I, acrylonitrile molecules undergo a binary reorientation motion around this axis with an activation energy of 4.2 kcal mol−1. The motion of peroxy radicals, trapped in acrylonitrile has been also studied by e.s.r. These radicals were produced by oxygen addition to free radicals previously formed by γ irradiation of acrylonitrile at 77 °K. The g anisotropy variation with temperature, shows no discontinuities at phase transitions, the activation of reorientation of peroxy radicals being 0.65 kcal mol−1. This result suggests that we are dealing in fact with macroradicals, the internal rotation of which is only observable in a solid matrix.

Offline Well Abandonment SIMOPs: An 81 Well Phase I & II Case Study Enabling ABEX Reduction in South East Asia

2021 ◽  
Author(s):  
Steven A. Canny ◽  
Jane Amarin ◽  
Verapich Pinprayong ◽  
Chumpae Sratongroy ◽  
Pancharat Pitchayang ◽  
...  
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Business Performance ◽  
Net Present Value ◽  
Balance Sheet ◽  
Pressure Control ◽  
Phase Iii ◽  
Well Abandonment ◽  
The Cost

Abstract In the decommissioning phase of oilfield facility lifecycles, focus pivots from positive net present value to executing the care and preservation, then decommissioning in the safest and most environmentally sensitive manor, and at the lowest total cost of ownership. Asset Retirement Obligation (ARO) is a long-term liability carried on the balance sheet, as a provision for the cost to return a wellsite to pre-exploration condition. The reduction of abandonment and decommissioning expenditure (ABEX) in executing compliant operations is a key business performance factor, and critical in executing higher volumes of wells earlier than planned. In doing so maximizing value to company shareholders, residents, industries and government level stakeholders. In the case study, an offline pre-abandonment and Phase I primary reservoir isolation project is presented, which seeks to maximize net project efficiency via offline wellbore intervention, executing the primary reservoir isolation of the wellbore via rigless techniques. This approach contributed to ABEX reductions by up to 40% per well vs the planned approval for expenditure (AFE) provisions taken for the operations. The project execution structure utilized offline intervention and Phase I primary reservoir isolation of 81 wellbores, across 5 wellhead platforms and 47 days continuous operations. Operations were part of a simultaneous operation (SIMOPS) project, as an offline work front located on the wellhead platform (WHP) weather deck. A second work front for Phase II and Phase III well abandonment operations, is executed concurrently, from the jack-up rig cantilever above the WHP. Live well operations are conducted concurrently by both work fronts, through the Christmas Tree (XT) and pressure control equipment in Phase I, and through the drilling riser and blowout preventor for Phase II and Phase III, to maximize productivity when the rig is on location. The scope of operations included wellhead qualification, wellbore access and preparation, well kill, injectivity testing, various wellbore preparation and cement placement techniques, pressure testing and lubrication of the wellbore. The operator's system engineering, design of operations and planning agility are key to its success. Acute focus was given to the batching of operations and delivery of these in a phased approach to increase productivity and maintain high service delivery through repetition of tasks. The project successfully executed Incident Free Operations (IFO) with 100% productive time and facilitated combined project performance, which delivered wells up to 44% ahead of the planned AFE. To enable this, over 4.19 million feet of slickline was run, conveying 428 bottom hole assemblies (BHAs), preparing the wellbores to isolate 804 primary reservoirs, and 2 intermediate reservoirs.

scholarly journals Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study

2020 ◽  
Vol 13 ◽  
pp. 175628482090287
Author(s):  
Lawrence Hookey ◽  
Gerald Bertiger ◽  
Kenneth Lee Johnson ◽  
Mena Boules ◽  
Masakazu Ando ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Age Groups ◽  
Secondary Analysis ◽  
Oral Solution ◽  
Phase Iii ◽  
Age Group ◽  
Split Dose ◽  
Sodium Picosulfate ◽  
The Right ◽  
Post Hoc

Background: The incidence and mortality of colorectal cancer (CRC) increase with age and, therefore, it is recommended that adults undergo regular CRC screening, ideally by colonoscopy, with some new guidelines recommending screening begin at 45 years. Effective bowel preparation is a critical step to a successful colonoscopy. Of concern is that older adults may have poorer quality of bowel preparation or reduced tolerability for the bowel preparation. Here, we performed a post hoc secondary analysis for the effect of age on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. Methods: A phase III, randomized, assessor-blinded, multicenter, non-inferiority study was conducted comparing split-dose, low-volume SPMC oral solution with split-dose, low-volume sodium picosulfate, magnesium oxide, and citric acid powder for oral solution. A post hoc secondary analysis was performed to assess efficacy, safety, and tolerability of SPMC oral solution by age group (<50 years, 50–64 years, ⩾65 years). The prespecified primary efficacy endpoint (‘responders’) was the proportion of participants with ‘excellent’ or ‘good’ ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. Results: Within age groups, at least 83.9% of participants were responders by the AS, and at least 91.1% of participants were responders by the BBPS in the right colon. On both scales, responder rates were highest in the youngest age group and decreased with increasing age. Greater than 88% of participants in any age group found the preparation ‘easy’ or ‘acceptable’ to ingest, with rates of ‘easy’ being highest in the oldest age group. No new safety signals were seen in any age group. The most commonly reported drug-related, treatment-emergent AEs were, by ascending age group, nausea (7.0%, 3.2%, 0.8%), headache (4.2%, 2.8%, 1.6%) and vomiting (2.8%, 1.2%, 0.8%). Conclusion: Ready-to-drink SPMC oral solution showed good efficacy of overall colon cleansing and tolerability in adults across different age groups, including those ⩾65 years. ClinicalTrials.gov identifier: NCT03017235.

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