scholarly journals Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention

10.2196/15610 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e15610 ◽  
Author(s):  
Michael S Businelle ◽  
Scott T Walters ◽  
Eun-Young Mun ◽  
Thomas R Kirchner ◽  
Emily T Hébert ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Data Collection ◽  
Phase I ◽  
Phase Ii ◽  
Phase Iii ◽  
Just In Time ◽  
Pilot Test ◽  
Success Rates ◽  
Adaptive Intervention ◽  
Ecological Momentary

Background Adults who are homeless are more likely to have alcohol use disorders (AUDs) compared with domiciled adults. Although AUD treatments are commonly available, many factors (eg, transportation limitations and inability to schedule appointments) contribute to low treatment completion rates and low success rates of these interventions among adults experiencing homelessness. Most adults who are homeless own mobile phones; however, no interventions have been developed that use mobile devices to deliver and support AUD interventions for this population. Mobile phone–based AUD interventions may reduce barriers that have limited the use and utility of traditional interventions. Objective The aim of this study is to (1) identify variables (eg, affect, stress, geolocation, and cravings) that predict drinking among homeless adults (phase I), (2) develop a mobile intervention that utilizes an algorithm to identify moments of risk for drinking and deliver treatment messages that are tailored to the individual’s current needs in real time (phase II), and (3) pilot test the intervention app (phase III). Methods In phase I, adults experiencing homelessness with an AUD (N=80) will complete baseline, equipment, 2-week, and 4-week follow-up visits in person. Participants will be prompted to complete five daily ecological momentary assessments on a study-provided smartphone for 28 days. The smartphone app will collect GPS coordinates every 5 min for the entire 28-day study period. Participants will wear a transdermal alcohol sensor that will objectively measure alcohol use. In phase II, we will use phase I data to develop an algorithm that identifies moments of heightened risk for drinking and develop treatment messages that address risk factors for drinking. Phase III will pilot test the intervention in 40 adults experiencing homelessness with AUD. Results This project was funded in June 2018. IRB approval was obtained in October 2018, and data collection for phase I began in February 2019. Phase III data collection is expected to conclude in 2020. To date, 80 participants have consented to the study, and data analysis for phase I will begin in early 2020. Conclusions This research will highlight intervention targets and develop a novel intervention for understudied and underserved adults experiencing homelessness with AUD. International Registered Report Identifier (IRRID) DERR1-10.2196/15610

scholarly journals Reducing Drinking Among People Experiencing Homelessness: Protocol for the Development and Testing of a Just-in-Time Adaptive Intervention (Preprint)

2019 ◽  
Author(s):  
Michael S Businelle ◽  
Scott T Walters ◽  
Eun-Young Mun ◽  
Thomas R Kirchner ◽  
Emily T Hébert ◽  
...  
Keyword(s):  
Alcohol Use ◽  
Data Collection ◽  
Phase I ◽  
Phase Ii ◽  
Phase Iii ◽  
Just In Time ◽  
Pilot Test ◽  
Success Rates ◽  
Adaptive Intervention ◽  
Ecological Momentary

BACKGROUND Adults who are homeless are more likely to have alcohol use disorders (AUDs) compared with domiciled adults. Although AUD treatments are commonly available, many factors (eg, transportation limitations and inability to schedule appointments) contribute to low treatment completion rates and low success rates of these interventions among adults experiencing homelessness. Most adults who are homeless own mobile phones; however, no interventions have been developed that use mobile devices to deliver and support AUD interventions for this population. Mobile phone–based AUD interventions may reduce barriers that have limited the use and utility of traditional interventions. OBJECTIVE The aim of this study is to (1) identify variables (eg, affect, stress, geolocation, and cravings) that predict drinking among homeless adults (phase I), (2) develop a mobile intervention that utilizes an algorithm to identify moments of risk for drinking and deliver treatment messages that are tailored to the individual’s current needs in real time (phase II), and (3) pilot test the intervention app (phase III). METHODS In phase I, adults experiencing homelessness with an AUD (N=80) will complete baseline, equipment, 2-week, and 4-week follow-up visits in person. Participants will be prompted to complete five daily ecological momentary assessments on a study-provided smartphone for 28 days. The smartphone app will collect GPS coordinates every 5 min for the entire 28-day study period. Participants will wear a transdermal alcohol sensor that will objectively measure alcohol use. In phase II, we will use phase I data to develop an algorithm that identifies moments of heightened risk for drinking and develop treatment messages that address risk factors for drinking. Phase III will pilot test the intervention in 40 adults experiencing homelessness with AUD. RESULTS This project was funded in June 2018. IRB approval was obtained in October 2018, and data collection for phase I began in February 2019. Phase III data collection is expected to conclude in 2020. To date, 80 participants have consented to the study, and data analysis for phase I will begin in early 2020. CONCLUSIONS This research will highlight intervention targets and develop a novel intervention for understudied and underserved adults experiencing homelessness with AUD. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15610

scholarly journals Pengembangan media pembelajaran matematika sigeru buku pop-up berbasis etnomatematika materi kubus dan balok

2020 ◽  
Vol 6 (1) ◽  
pp. 31
Author(s):  
Fatimah Dwie Hartanti ◽  
Sri Hariyani ◽  
Trija Fayeldi
Keyword(s):  
Data Collection ◽  
Research And Development ◽  
Phase I ◽  
Phase Ii ◽  
Random Sampling ◽  
Visual Display ◽  
Simple Random Sampling ◽  
Phase Iii ◽  
Practical Test ◽  
Is Research

<p><em>The </em><em>learning media pop-up book with based etnomathematic</em><em> use</em><em> method of reasearch is research and development with the model is 4D. The purpose of research is to occurred aspect validity and practicality. The reaseach helpful in learning media is to be held a student’s interest </em><em>and to </em><em>use visual display in cube and beam lesson. A data collection using questionarry. Sample taking technique using simple random sampling with the number of samples based on the Slovin formula were at a fault 5%. Phase I test are a process of media validation and learning validation. Phase II test are a process practical test I was conducted by teacher and 8 students. Phase III test are a process practical test II was conducted by 30 students. The value of media and learning percentage is 92,3% and 86,636%  in highly valid category. 90,909% and highly practice category by phase I test. And then, the value by 30 students is 85,83% in highly practice category. The based on the result is a learning media pop-up book based etnomathematic can be using a learning media in the school.</em><em></em></p>

scholarly journals A Qualitative Look at Faculty Perspectives on Ergonomics in Dental Education

2021 ◽  
Vol 2 (2) ◽  
pp. 36-49
Author(s):  
Cynthia Senior ◽  
Angela Burrell
Keyword(s):  
Data Collection ◽  
Phase I ◽  
Phase Ii ◽  
Dental Students ◽  
Phase Iii ◽  
Clinical Environment ◽  
Clinical Practices ◽  
School Of Dentistry ◽  
Ergonomic Evaluation ◽  
Three Phases

Due to the high-risk nature of musculoskeletal disorder development in dentistry, ergonomic education and evaluation are needed in predoctoral programs.  The purpose of this pilot study is to investigate perceptions of ergonomics within the School of Dentistry (SOD), current ergonomic clinical practices among third- and fourth-year dental students, and dental students' level of knowledge of ergonomics.  The study was conducted utilizing an explanatory sequential mixed methods design to collect both quantitative and qualitative data.  While the data collection occurred in three phases, this article will primarily focus on Phase III.  The three phases of data collection were: Phase I consisted of a questionnaire distributed to all dental students; Phase II consisted of clinical observations of third- and fourth-year dental students' ergonomic postures during patient care, and Phase III consisted of SOD faculty focus groups to determine perceptions of ergonomic education with the predoctoral curriculum.  Data revealed three overarching themes: (1) Didactic to clinical disconnect, (2) Elective impacts, and (3) A ready commitment.  Phase I yielded a response rate of 84% (n=135).  Phase I responses noted that 81.5% (n=110) of the dental students reported experiencing musculoskeletal pain.  Ninety-three dental students reported receiving one or two lectures on ergonomics; however, 60% (n=27) failed to implement proper ergonomic postures while caring for patients in the clinical environment during Phase II.  Phase III, revealed faculty support of ergonomic evaluation and correction among dental students.  The results indicated a need to establish and implement an ergonomic evaluation and corrective program within the SOD

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.

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