scholarly journals A feasibility study of activity tracking devices in pregnancy

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Michelle A. Kominiarek ◽  
Lauren C. Balmert ◽  
Hallie Tolo ◽  
William Grobman ◽  
Melissa Simon
Keyword(s):  
Energy Expenditure ◽  
Gestational Age ◽  
Phase 1 ◽  
Median Number ◽  
Phase 2 ◽  
Activity Tracking ◽  
Technical Problems ◽  
Calculated Energy ◽  
Median Proportion ◽  
Tracking Device

Abstract Background We aimed to evaluate the feasibility of using an activity-tracking device (ATD) during pregnancy and compare self-reported to ATD-calculated energy expenditure in a 2-phase study. Methods (Phase 1) Twenty-five pregnant women were asked about exercise, computer use, smartphone ownership, and ATD attitudes. Descriptive statistics were reported. (Phase 2) Women ≥18 years, smartphone owners, < 16-weeks gestation, and without exercise restrictions were approached to participate in 2016–2017. Women received instructions to wear and sync the ATD daily. We assessed protocol adherence and satisfaction via surveys at 36-weeks and used mixed models to assess the relationship between gestational age and ATD data. Energy expenditure from the Pregnancy Physical Activity Questionnaire (PPAQ) was compared to ATD-calculated energy expenditure. Results (Phase 1) Walking was the most common exercise; 8% did not perform any activity during pregnancy. All women had internet access and owned a smartphone. Women stated they would wear the ATD all the time during a pregnancy (88%), with the intent to improve their health (80%). (Phase 2) The characteristics of the 48 women were: pre-pregnancy BMI 28, 62% non-Hispanic black, 62% multiparas. Of the 18 women who completed the 36-week survey, only 56% wore the ATD daily, 33% had a lost or broken ATD, and 17% had technical problems; however, 94% enjoyed wearing it, 94% would recommend it to a pregnant friend, and 78% thought it helped them reach activity goals. According to ATD data, the median number of active days was 41 (IQR 20–73) and the median proportion of active days out of potential days was 22% (IQR 11–40). As gestational age increased, mean log steps decreased, active minutes decreased, and sedentary hours increased in unadjusted and adjusted models (P < 0.05 all comparisons). There were no differences in mean energy expenditure (MET-h/week) estimated by PPAQ or ATD data at 28 weeks gestation [212 (22–992 range) vs. 234 (200–281 range), P = 0.66] and at 36 weeks [233 (86–907 range) vs. 218 (151–273 range), P = 0.68]). Conclusions Women reported high motivation to wear an ATD and high satisfaction with actually using an ATD during pregnancy; however adherence to the study protocol was lower than expected and ATD technical problems were frequent.

scholarly journals CTNI-18. FINAL RESULTS OF A PHASE 2 STUDY OF EFFICACY, SAFETY AND INTRATUMORAL PHARMACOKINETICS (PK) OF SELINEXOR MONOTHERAPY IN RECURRENT GLIOBLASTOMA (rGBM)

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii46-ii46
Author(s):  
Andrew Lassman ◽  
Patrick Wen ◽  
Martin van den Bent ◽  
Scott Plotkin ◽  
Annemiek Walenkamp ◽  
...  
Keyword(s):  
Nuclear Export ◽  
Phase 1 ◽  
Progression Free Survival ◽  
Median Number ◽  
Recurrent Glioblastoma ◽  
Phase 2 ◽  
Nuclear Retention ◽  
Phase 2 Trial ◽  
Human Gbm

Abstract BACKGROUND Selinexor is an FDA-approved first-in-class, oral selective nuclear export inhibitor which forces nuclear retention of many tumor suppressor proteins. METHODS We conducted a phase 2 trial of selinexor monotherapy for adults with recurrent GBM including a surgical arm to explore intratumoral PK and 3 medical arms to optimize dosing. Prior treatment with radiotherapy and temozolomide was required; prior bevacizumab was exclusionary. The primary endpoint was 6-month progression-free survival (6mPFS) rate. RESULTS Selinexor administered ~2 hours pre-operatively yieleded average intratumoral concentration (136 nM, n=6) comparable to the in vitro IC50 (130 nM) from 7 primary human GBM cell lines. Among all 68 patients accrued to 3 medical arms (~85 mg BIW, n=24; 60 mg BIW, n=14; 80 mg QW, n=30), median age was 56 years (21–78). Median number of prior lines of therapies was 2 (1–7). At 80 mg QW, 28% patients were progression-free at the end of cycle 6; the 6mPFS was 17%; disese control rate by RANO was 37% (1 CR, 2 PRs, 7 SD) among 27 evaluable patients; responses were durable (median 11.1 months), and treatment lasted for 442, 547 and 1282 days in 3 responders, as of data lock, with one responder remaining on treatment off study; median overall survival was 10.2 months with 95% CI (7.0, 15.4). The ~85 mg BIW-schedule was abandoned due to poor tolerability. The related adverse events (all grades) in patients on ~85 mg BIW/60 mg BIW/80 mg QW were nausea (41.7%/64.3%/66.7%), fatigue (70.8%/71.4%/50.0%), neutropenia (29.2%/14.3%/33.3%), decreased appetite (45.8%/71.4%/26.7%), thrombocytopenia (66.7%/28.6%/23.3%) and weight loss (16.7%,/42.9%/6.7%). CONCLUSION Selinexor monotherapy demonstrated encouraging intratumoral penetration and efficacy, with durable disease control in rGBM. Monotherapy dose at 80 mg QW is recommended for further development in rGBM. A phase 1/2 study of combination therapy for newly diagnosed or rGBM has been initiated (NCT04421378).

Effect of olutasidenib (FT-2102) on complete remissions in patients with relapsed/refractory (R/R) mIDH1 acute myeloid leukemia (AML): Results from a planned interim analysis of a phase 2 clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 7006-7006
Author(s):  
Stéphane De Botton ◽  
Karen W. L. Yee ◽  
Christian Recher ◽  
Andrew Wei ◽  
Pau Montesinos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Median Duration ◽  
Interim Analysis ◽  
Phase 1 ◽  
Median Number ◽  
Clinical Activity ◽  
Phase 2 ◽  
Duration Of Treatment ◽  
Transfusion Independence

7006 Background: Olutasidenib, a potent, selective, oral, small molecule inhibitor of mutant IDH1 (m IDH1), has exhibited favorable tolerability and clinical activity in high-risk AML patients (pts) in a phase 1 trial (Watts, Blood 2019). Here, we present interim analysis results of a phase 2 trial (NCT02719574) in R/R m IDH1 AML pts receiving olutasidenib monotherapy 150 mg twice daily. Methods: The efficacy evaluable (EE) set comprised m IDH1R132X pts whose first dose was ≥180 days before the data cut-off (18-JUN-20). The primary endpoint was CR+CRh (complete remission [CR] or CR with partial hematologic recovery [CRh] according to modified IWG 2003 criteria) rate. CRh was defined as bone marrow blasts <5%, absolute neutrophil count >0.5×109/L, and platelet count >50×109/L. Overall response rate (ORR) comprised CR+CRh+CR with incomplete recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR). Duration of treatment (DOT), duration of response (DOR), and overall survival (OS) were estimated using Kaplan-Meier methodology. Results: This clinical trial met its pre-specified early enrollment-stopping criteria for efficacy. A total of 153 pts with R/R AML received olutasidenib; median DOT, 5.5 mo (95% CI: 4.4, 8.7). 43 pts (28%) remain on treatment and 110 (72%) discontinued, most commonly due to: disease progression, 31%; AEs, 14%; death, 10%; and transplant, 8%. For the EE set (123 pts), the median age was 71 y (range: 32‒87) with a median number of prior therapies of 2 (1‒7). The CR+CRh rate was 33% including 30% of pts in CR (Table). Median duration of CR+CRh was not reached (NR) and 13.8 mo in a sensitivity analysis when HSCT or relapse was deemed end of response. ORR was 46% and median duration of ORR was 11.7 mo. Of responders who were transfusion-dependent at baseline, 56-day platelet transfusion independence (TI) and RBC TI were gained by 100% and 83%, respectively, of pts who achieved CR+CRh, and by 56% and 50% who did not. Median OS was 10.5 mo (EE set). In CR+CRh responders, median OS was NR and the estimated 18-mo OS was 87%. TEAEs in ≥25% of pts were nausea, 38%; constipation, 25%; leukocytosis, 25%. Grade 3/4 all-causality TEAEs in >10% of pts were febrile neutropenia, 20%; anemia, 19%; thrombocytopenia, 16%; neutropenia, 13%. Investigator-assessed IDH1 differentiation syndrome (any grade) was observed in 21 pts (14%); most cases resolved with treatment management; one case was fatal; 19 pts had concomitant leukocytosis. Conclusions: Olutasidenib was well tolerated and induced durable CR in a subset of high-risk R/R m IDH1 AML pts. TI was achieved in all response groups. Clinical benefit, per DOR and OS, extended beyond CR+CRh responders. Clinical trial information: NCT02719574. [Table: see text]

Bfr (bendamustine, fludarabine, rituximab) Nonmyeloablative Allogeneic Conditioning: A Novel Regimen Inducing Immunosuppression Without Myelosuppression

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 541-541 ◽  
Author(s):  
Issa F. Khouri ◽  
Wei Wei ◽  
Rosamar Valverde ◽  
Martin Korbling ◽  
Francesco Turturro ◽  
...  
Keyword(s):  
T Cell ◽  
Phase 1 ◽  
Large Cell ◽  
Allogeneic Transplantation ◽  
Median Number ◽  
Outpatient Setting ◽  
Unrelated Donor ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Donor Cells

Abstract Background We previously reported the use of BFR, with phase 1 escalating daily doses of 70, 90, 110, or 130 mg/m2 of bendamustine daily x 3 days prior to transplantation without dose-limiting toxicity (Khouri et al. ASH 2011, Abstract # 894). In this study, we report results of an expanded phase 2 trial. Methods Bendamustine 130 mg/m2 IV daily on days -5 to - 3 prior to transplantation , together with 30 mg/m2 IV of fludarabine given on the same days. Rituximab was given at a dose of 375 mg/m2 IV on day –13 and 1000 mg/m2 on days -6, +1, and +8, as previously described. Rituximab was omitted in patients with T-cell diseases. Tacrolimus and mini-methotrexate were used for GVHD prophylaxis. In addition, thymoglobulin 1 mg/kg IV was given on days -2, and -1 in patients receiving an unrelated donor transplant. Results The analysis included all 56 patients who received BFR (48 from the expanded phase 2 trial, and 8 from the phase 1 part). Histologies included: mantle cell (n=16), CLL (n=15) (3 with 17p- and 2 Richter’s), follicular (n=13), Diffuse large cell (n=9), peripheral T-cell lymphoma (n=3). Median age was 56 (range, 59-70) years. Median prior treatments was 3 (range, 1-7); 7 (12%) had failed a prior autotransplant. At study entry,27 (48%) patients were in CR/CRu, 23 (41%) in PR, and 6 (11%) had refractory disease. Thirty (54%) received their transplants from HLA-compatible siblings and 26 (46%) from unrelated donors. Median number of CD34-positive cells infused was 5.58 x 106/kg. Neutrophil counts recovered to > 0.5 x 109/L a median of 6 days after transplantation (range, 0-16 days). The median number of days on G-CSF was 1.5 days (range, 0-8 days). Thirteen patients (23%) did not require G-CSF as they never experienced an ANC < 0.5 x 109/L. Forty-nine patients (87.5%) did not require platelet transfusions. Platelet counts recovered to > 20 x 109/L in the remaining 7 patients after a median of 11 days (range, 10-19 days). All patients engrafted donor cells. By day 30, median donor myeloid and T-cells were 85% and 97%, respectively. Both increased to 100% by day 90. Recovery of donor cells was similar in both sibling and unrelated donor transplantation. Acute grade 2-4 GvHD and chronic extensive GvHD were observed in 7 (12.5%) and 8 (14%) of patients respectively. Treatment-related mortality at 1-year was 9%. Six patients died: 2 of progression, 2 of infection and 2 of GVHD complications. With a median follow-up time of 12 months (range, 2-37 months), the OS and PFS rates were 89% and 80%, respectively. Conclusions Our results show that the BFR regimen with bendamustine at a dose level of 130 mg/m2 daily x 3 days, constitutes a well-tolerated nonmyeloablative allogeneic conditioning for lymphoid malignancies. It allows engraftment of both sibling and unrelated donor cells with minimal myelosuppression. This regimen can be used as a platform for allogeneic transplantation in the outpatient setting. Disclosures: Khouri: Cephalon: Research Funding. Off Label Use: Bendamustine in transplantation.

Medication Histories in Critically Ill Patients Completed by Pharmacy Personnel

2019 ◽  
Vol 53 (6) ◽  
pp. 596-602
Author(s):  
Bridgette L. Kram ◽  
Morgan A. Trammel ◽  
Shawn J. Kram ◽  
Sandy E. Wheeley ◽  
Ben G. Mancheril ◽  
...  
Keyword(s):  
Critically Ill ◽  
Medical Center ◽  
Phase 1 ◽  
Academic Medical Center ◽  
Median Number ◽  
Phase 2 ◽  
Medication History ◽  
Medication Discrepancies ◽  
Critically Ill Adults ◽  
Ill Adults

Background: Although critically ill adults often have extended hospital lengths of stay and are at high risk of having medication-related adverse events, the value of medication histories in these patients remains underreported. Objective: To assess the feasibility of performing medication histories in critically ill adults and to establish the frequency of and characterize identified discrepancies. Methods: This prospective study included patients admitted to 4 intensive care units (ICUs) in a large academic medical center and was conducted in 2 phases. In phase 1, medication histories were conducted over a 5-week period by clinical pharmacists to assess feasibility. In phase 2, medication histories were conducted over a 3-week period by a pharmacy technician. Medication discrepancies, defined as any difference between the documented and pharmacy personnel–identified home medication list, were aggregated in both phases and adjudicated for severity. Results: In phase 1, 127 medication histories were completed (42.3% of admitted patients). Impaired cognition was the most common barrier encountered; however, 76% of patients were able to have a history completed if an attempt was made. In phase 2, a medication history was completed for 176 patients (58.9% of admitted patients). In aggregate, 1155 discrepancies were identified, with 78.2% of patients having a discrepancy. The median number of discrepancies per patient was 3 (interquartile range = 1-5); 11 life-threatening, 101 serious, and 326 significant discrepancies were identified. Conclusion and Relevance: A pharmacy personnel–based medication history program in the ICU is feasible and assists in the discovery of medication discrepancies with the potential for patient harm.

A phase I study of the oral administration of irinotecan in combination with the potent P-glycoprotein (P-gp) inhibitor HM30181A.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 3032-3032
Author(s):  
Antonio Jimeno ◽  
Mateusz Opyrchal ◽  
Jennifer Robinson Diamond ◽  
Christos Fountzilas ◽  
Bradley Corr ◽  
...  
Keyword(s):  
Oral Administration ◽  
Dose Level ◽  
Phase 1 ◽  
Median Number ◽  
Phase 2 ◽  
Dose Escalation Study ◽  
Best Response ◽  
Grade 3 ◽  
Number Of Cycles ◽  
Pharmacologically Active

3032 Background: Irinotecan is a prodrug of the potent topoisomerase inhibitor SN-38. In animals, oral administration of irinotecan with the selective minimally absorbed P-gp inhibitor HM30181A increased the bioavailability of irinotecan. Oral administration of irinotecan may also increase the conversion to SN-38. Objectives: To determine the MTD and DLT of orally administered irinotecan in combination with HM30181A 15 mg on day 1 of a 21-day cycle. Additional objectives include determining the recommended phase 2 dose and the PK of irinotecan and SN-38. Methods: This was a phase 1 dose escalation study enrolling cohorts of 3-6 patients with advanced malignancies. Patients had Hb ≥9 gm/dL, ANC ≥ 1.5x109/L, platelets ≥ 100x109/L, adequate hepatic and renal function, ECOG 0-1 and were not homozygous for UGT1A1*28. Patients were administered HM30181A 15 mg and oral irinotecan 20, 40, 80, 120, 160, 200, 240, 280 and 320mg/m2. Results: Thirty male and female patients, mean age 60.9 (range 33-78) were enrolled into this ongoing study. The most common cancers were ovarian (6), colorectal (4), breast (4), endometrial (3), and pancreatic (3). The median number of cycles administered was 3 (range 1-9). Treatment-related Grade 3-4 AEs were experienced by 12 (40%) subjects. The most common were nausea 7 (23%), vomiting 6 (20%) and abdominal pain 3 (10%). Treatment-related SAEs were experienced by 6 (20%) patients (nausea or vomiting in 4 subjects). DLTs occurred in 2 patients at the 320 mg/m2 dose level (neutropenia and C. Difficile diarrhea) and additional patients are being enrolled at the 280mg/m2 dose level to define the MTD. Acute cholinergic diarrhea has not been observed. The best response was stable disease in 9/21 evaluable patients. PK at the three highest dose levels is summarized below. Conclusions: Oral administration of HM30181A in combination with irinotecan tablets results in pharmacologically active concentrations of SN-38. Confirmation of the MTD when dosed on a 21-day cycle is ongoing. Phase 2 studies are being planned. Clinical trial information: NTC02250157. [Table: see text]

Acceptability and effects of a seated active workstation during sedentary work

2014 ◽  
Vol 7 (1) ◽  
pp. 2-15 ◽  
Author(s):  
Lucas J. Carr ◽  
Hotaka Maeda ◽  
Brandon Luther ◽  
Patrick Rider ◽  
Sharon J. Tucker ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cognitive Function ◽  
Energy Expenditure ◽  
Work Performance ◽  
Muscle Activation ◽  
Phase 1 ◽  
Phase 2 ◽  
Content Type ◽  
Work Tasks

Purpose – The purpose of this paper is to test the user acceptability (Phase 1) and effects (Phase 2) of completing sedentary work while using a seated active workstation. Design/methodology/approach – In Phase 1, 45 sedentary employees completed an acceptability questionnaire immediately after performing sedentary work tasks (typing, mousing) while using the seated active workstation for 30 minutes. In Phase 2, the paper tested the differential effects of completing sedentary work tasks at two different workstations (sedentary workstation vs seated active workstation) on physiological (energy expenditure, muscle activity, heart rate, blood pressure), cognitive (learning, memory, attention) and work performance (typing and mousing ability) outcomes among 18 sedentary employees. Findings – In Phase 1, 96 percent of participants reported they would use the seated active workstation “daily” if provided access in their office. In Phase 2, working while using the seated active workstation increased energy expenditure (p<0.001; d=3.49), heart rate (p<0.001; d=1.26), systolic blood pressure (p=0.02; d=0.79), and muscle activation of the biceps femoris (p<0.001; d=1.36) and vastus lateralis (p<0.001; d=1.88) over the sedentary workstation. No between-group differences were observed for any measures of cognitive function. Mouse point and click time was slower while using the seated active workstation (p=0.02). Research limitations/implications – These findings suggest this seated active workstation to be acceptable by users and effective for offsetting occupational sedentary time without compromising cognitive function and/or work performance. Originality/value – The present study is the first to test the potential of this seated active workstation in any capacity.

Combination of Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Richter’s Syndrome and Fludarabine-Refractory Chronic Lymphocytic Leukemia.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 2825-2825 ◽  
Author(s):  
Apostolia-Maria Tsimberidou ◽  
William G. Wierda ◽  
Susan O’Brien ◽  
William W. Plunkett ◽  
Thomas J. Kipps ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Excision Repair ◽  
Phase 1 ◽  
Leukemia Cell ◽  
Median Number ◽  
Lymphocytic Leukemia ◽  
Platinum Compound ◽  
Phase 2 ◽  
Cross Links ◽  
Richter’S Syndrome

Abstract Background: Richter’s syndrome (RS) and fludarabine-refractory chronic lymphocytic leukemia (CLL) are associated with poor prognosis. Oxaliplatin is a platinum compound that covalently binds DNA, inducing DNA intra- and inter-strand cross-links. Fludarabine and cytarabine act synergistically to inhibit excision repair of DNA cross-links. We conducted a phase 1–2 trial of oxaliplatin, fludarabine, cytarabine, and rituximab (OFAR) in patients with RS or fludarabine-refractory CLL. The objectives of this trial were to identify a safe, tolerated dose and any dose-limiting toxicities (DLT) of oxaliplatin, to assess pharmacodynamic endpoints (phase 1); and to assess the complete (CR) and partial remission (PR) rates for the OFAR regimen (phase 2). Methods: The OFAR regimen consisted of increasing doses of oxaliplatin (17.5, 20, or 25 mg/m2/d), D1–4 (phase 1); fludarabine 30 mg/m2, D2–3; cytarabine 1 g/m2, D2–3; rituximab 375 mg/m2, D3; and pegfilgrastim 6 mg, D6, every 4 weeks for a maximum of 6 courses. Prophylaxis for PCP pneumonia and DNA virus were given. DLT was defined as any non-hematologic, treatment-related toxicity > grade (G) 3. Results: From November 2004 to August 2006, 46 patients were enrolled, including 19 patients in phase 1. The tolerated oxaliplatin dose identified was 25 mg/m2. No DLT was observed. Pharmacodynamic analyses demonstrated enhanced leukemia cell killing by oxaliplatin in the presence of fludarabine and cytarabine. Thirty-seven patients are currently evaluable (14 RS, 23 fludarabine-refractory CLL). The median age of patients with RS was 69 yrs (range, 41–78) and of fludarabine-refractory CLL was 57 yrs (range, 34–77); the median number of prior therapies was 3 (range, 0–10), and 4 (range, 1–11), respectively. Among patients with fludarabine-refractory CLL, 16 (70%) had Rai stage 3–4. G3–4 septic episodes occurred in 2, pneumonia in 4, and CMV infection occurred in 2 patients. The median number of OFAR cycles was 2 (range, 1–6). RBC and platelet transfusions were required in 56% and 61% of cycles, respectively. Responses are shown in Table [insert]. Nine patients (1 RS) received allogeneic stem cell transplantation. Responses included 6 of 16 patients with 17p deletion, 1 of 5 evaluable patients with 11q deletion, 3 of 3 patients with trisomy 12, 1 of 4 patients with 13q deletion, and 2 of 7 others. With a median follow-up of 7 months, 6 of 14 with RS and 11 of 23 patients with fludarabine-refractory CLL have failed. The median failure-free survival has not been reached for RS and is 4 months for fludarabine-refractory CLL. Conclusions: The OFAR regimen is highly active in RS and has activity in fludarabine-refractory patients with CLL. No DLT for oxaliplatin at 25 mg/m2 was noted. Hematologic toxicities did occur, but no prolonged myelosuppression was observed. The trial continues to accrue patients, with a target accrual of 40 patients on phase 2. Oxaliplatin dose (mg/m2/d) 17.5 20 25 All doses RS Evaluable 2 5 5 12 CR 0 2 1 3 PR 0 2 2 4 Overall (%) 0 4 (80) 3 (60) 7 (58) Fludarabine-refractory CLL Evaluable 1 3 19 23 CR, nodular 0 0 1 1 PR 0 0 5 5 Overall (%) 0 0 6 (32) 6 (26) Total (%) 0 4 (50) 9 (38) 13 (37)

Pediatric phase 1 study of pemetrexed: A report from the Children’s Oncology Group

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 9019-9019 ◽  
Author(s):  
H. S. Nicholson ◽  
S. M. Blaney ◽  
A. M. Ingle ◽  
M. Krailo ◽  
L. C. Stork ◽  
...  
Keyword(s):  
Folic Acid ◽  
Solid Tumors ◽  
De Novo ◽  
Phase 1 ◽  
Median Number ◽  
Hematological Toxicity ◽  
Phase 2 ◽  
Purine Nucleotides ◽  
Rectal Hemorrhage ◽  
Dose Levels

9019 Background: Pemetrexed is a new multi-targeted antifol that inhibits enzymes involved in the de novo biosynthesis of thymidine and purine nucleotides. Methods: A phase 1 dose escalation and pharmacokinetic study (PK) was performed in children with refractory solid tumors to define the dose limiting toxicities (DLTs) and a recommended phase 2 dose. Pemetrexed was administered as a 10 min iv infusion every 21 days. All patients received folic acid (400 mcg/day po), vitamin B12 (500–1000 mcg every 3rd course IM) and dexamethasone (0.1 mg/kg/dose bid × 3 days each course) . Cohorts of 3 to 6 children were enrolled at dose levels of 400, 520, 670, 870, 1,130, 1,470, 1,910 and 2,480 mg/m2. DLT was defined as any Gr. 3 or 4 non-hematological toxicity (except nausea/vomiting, alopecia, or AST/ALT elevation that returns to Gr. 1), Gr. 4 neutropenia or Gr. 4 thrombocytopenia ≥ 7 days. Results: 33 subjects (31 fully evaluable for toxicity), median age of 12 yrs (range, 1–21), with diagnoses including osteosarcoma (12), Ewing’s sarcoma (3), hepatoblastoma (2), renal cell carcinoma (2), brainstem glioma (3), glioma (3), and other (n=8) were enrolled. DLT occurred in 1/6 patients at 1,470 mg/m2 (Gr. 3 AST and ALT), and in 2/4 at 2,480 mg/m2 (Gr. 3 ANC and Gr. 3 rash in both). Other DLTs at 2,480 mg/m2 that occurred in 1 patient included Gr. 3 diarrhea and rectal hemorrhage, and Gr. 4 thrombocytopenia, lipase, GGT, hypophosphatemia, hypokalemia and hyponatremia. At 1,910 mg/m2, 0/6 patients had DLT. The median number of courses administered was 1 (range 1 to 17). No CRs or PRs have been observed. Results of PK and other correlative studies will be presented. Conclusions: The recommended phase 2 dose of pemetrexed for children and adolescents with recurrent solid tumors is 1,910 mg/m2 administered q21 days with dexamethasone, folic acid and B12 supplementation. A phase II COG study is planned. No significant financial relationships to disclose.

Experience with the implementation of a web-based teledermatology system in a nursing home in Singapore

2008 ◽  
Vol 14 (8) ◽  
pp. 404-409 ◽  
Author(s):  
Lavanya Janardhanan ◽  
Yung H Leow ◽  
Martin TW Chio ◽  
Yongmin Kim ◽  
Cheong B Soh
Keyword(s):  
Nursing Home ◽  
Online Survey ◽  
Phase 1 ◽  
Information Management System ◽  
Personal Health Information ◽  
Phase 2 ◽  
Specialist Care ◽  
Web Based ◽  
Technical Problems ◽  
Face To Face

We introduced a web-based teledermatology system, the distributed personal health information management system (DPHIMS), into a nursing home in Singapore. The introduction was conducted in two phases. Five staff nurses in Phase 1 and nine nurse aides in Phase 2 performed the data entry and uploaded digital images of the resident's skin condition. By the end of Phase 2, there were 50 residents registered with DPHIMS. The average age of the participants was 82 years and 84% were women. There were 31 first-time referral requests registered in the system during Phase 2. The average time taken to complete a referral request was 86 minutes. The average time taken by the dermatologist to prepare and submit a diagnosis/treatment report was 11 minutes. An online survey form was given to the nurses and the dermatologists to gauge their level of satisfaction and their experience of using DPHIMS. All the nurses said they would readily recommend DPHIMS to other nurses. Overall, the dermatologists felt that DPHIMS was helpful in obtaining specialist care for the residents. However, some skin conditions required a face-to-face consultation. Thus a mixture of face-to-face consultations and consultations via teledermatology may be necessary to provide complete diagnosis and treatment to patients. Our experience suggests that understanding and addressing the organizational concerns is as important as solving the technical problems.

scholarly journals Sleep Duration during Pregnancy using an Activity Tracking Device

2020 ◽  
Vol 10 (03) ◽  
pp. e309-e314
Author(s):  
Michelle A. Kominiarek ◽  
Chen Yeh ◽  
Lauren C. Balmert ◽  
Francesca Facco ◽  
William Grobman ◽  
...  
Keyword(s):  
Sleep Duration ◽  
Gestational Age ◽  
Mixed Models ◽  
Neonatal Outcomes ◽  
Activity Tracking ◽  
Gestational Age At Delivery ◽  
Maternal And Neonatal Outcomes ◽  
The Mean ◽  
Diabetes Gestational ◽  
Tracking Device

Abstract Objective The aim of this study was to describe sleep duration across gestation in women who wore an activity-tracking device (ATD) during pregnancy, and to study the association between sleep duration and adverse maternal and neonatal outcomes Study Design Women ≥ 18 years old who owned a smartphone were approached to participate in 2016 to 2017. Participants received instructions to wear and sync an ATD daily. Steps, sedentary hours, and sleep duration were wirelessly transmitted via cellular technology. We measured sleep duration for the main episode of sleep and excluded sleep times < 120 minutes. Mixed models were used to assess the trajectory of mean weekly hours of sleep by gestational age. Secondary analyses evaluated differences in pregnancy outcomes between insufficient (< 7/24 hours) and sufficient sleep (≥ 7/24 hours) groups, based on mean hours of sleep within the first 7 days of ATD use. Results The majority of 94 participants self-reported minority racial–ethnic status (33% non-Hispanic black and 51% Hispanic), had government insurance (83%), were nulliparous (61%), and had pre-pregnancy overweight or obesity (56%). The mean (standard deviation) duration of sleep was 7.2 ± 2.4 hours per 24 hours. In mixed models analyses, gestational age was statistically significantly associated with mean hours of sleep (β = −0.02; 95% confidence interval: −0.04 to −0.01; p < 0.001). Women who had < 7 hours of sleep had greater median daily steps compared with those who had ≥ 7 hours of sleep (median: 7,122; interquartile range [IQR]: 5,167–8,338 vs. median: 5,005; IQR: 4,115–7,059; p < 0.01), but there were no significant differences in other outcomes (sedentary time, gestational weight gain, pregnancy associated hypertension, gestational diabetes, gestational age at delivery, cesarean delivery, or mean birthweight), p  > 0.05 for all comparisons. Conclusion The mean sleep duration was 7.2 ± 2.4 hours among the 94 women in this cohort and decreased with advancing gestational age. Further research is required to evaluate sleep measurements with ATD in pregnant women and how sleep duration and quality is related to maternal and neonatal outcomes.

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