Predictors Of The Post-Thrombotic Syndrome In a Large Cohort Of Patients With Proximal DVT: Secondary Analysis Of The Sox Trial

Background The post-thrombotic syndrome (PTS) is a frequent complication of deep venous thrombosis (DVT). Identifying predictors of PTS is important to counsel DVT patients on their expected prognosis and to identify patients who may benefit from closer monitoring or preventive strategies. Objective In a secondary analysis of the SOX Trial, we aimed to identify predictors of developing PTS during 2 years follow-up after a first episode of proximal DVT. Methods The study cohort consisted of participants in the SOX Trial, a multicenter (24 centres in Canada and U.S.) randomized placebo controlled trial of active elastic compression stockings vs. placebo stockings worn for 2 years after a first, symptomatic proximal DVT. PTS, the primary study endpoint, was diagnosed at or after the 6 month visit based on patient-reported pain and swelling of ≥ 1 month duration that were typical in character, i.e. worse at end of day or after prolonged sitting/standing and improved after rest/leg elevation (Ginsberg criteria). Cumulative incidences of PTS were compared in subgroups defined by sex, age category, body mass index (BMI) category, anatomic extent of index DVT, type of DVT (cancer-associated, secondary risk factor-associated, unprovoked) and 1-month Villalta score category (score 0-4: none; 5-9, mild; 10-14, moderate; >14, severe), using Cox regression. Losses to follow-up, withdrawals and deaths were censored as of last date of follow-up. Results are presented as cumulative incidence by 750 days follow-up and hazard ratios (HR) with 95% confidence intervals (CI). Results Among the 803 participants in the SOX Trial, 60% were male, mean age was 55.1 years, and 87% were out-patients. In analyses adjusted for intervention group (i.e. allocation to active vs. placebo stockings), iliac vein DVT (HR 2.26 [95% CI 1.12, 4.53]; reference category: popliteal DVT) and Villalta score category at 1 month after DVT (score 5-9, HR 2.74 [95% CI 1.62, 4.64]; score 10-14, HR 5.81[95% CI 2.99, 11.29]; score >14, HR 7.59 [95% CI 3.31, 17.44]; reference category: score <5) were significant predictors of PTS. In analyses adjusted for intervention group and all predictor variables of interest, Villalta score category at 1 month was a highly statistically significant, independent predictor of PTS (see Table). Age, sex, BMI and type of DVT did not predict development of PTS. Conclusions In a large prospective cohort of patients with proximal DVT who were participants in the SOX Trial, Villalta score category (which reflects severity of venous symptoms and signs) at 1 month after DVT was strongly predictive of development of PTS during 2 years follow-up. This confirms a similar finding that we first observed in the VETO cohort study (Kahn SR et. al., Annals Intern Med 2008). More extensive DVT was also associated with PTS. Patients with these risk factors may benefit from closer monitoring after proximal DVT, and in the case of iliac vein DVT, from more aggressive strategies to treat acute DVT. Disclosures: No relevant conflicts of interest to declare.

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83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

Age and Ageing ◽

10.1093/ageing/afab030.44 ◽

2021 ◽

Vol 50 (Supplement_1) ◽

pp. i12-i42

Author(s):

C Yang ◽

Z Hui ◽

S Zhu ◽

X Wang ◽

G Tang ◽

...

Keyword(s):

Medication Adherence ◽

Pilot Study ◽

Older People ◽

Intervention Group ◽

Self Management ◽

Control Group ◽

Medication Knowledge ◽

Management Intervention ◽

Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P < 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

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Robot-assisted training after proximal humeral fracture: A randomised controlled multicentre intervention trial

Clinical Rehabilitation ◽

10.1177/0269215520961654 ◽

2020 ◽

pp. 026921552096165

Author(s):

Inga Kröger ◽

Corinna Nerz ◽

Lars Schwickert ◽

Sabine Schölch ◽

Janina Anna Müßig ◽

...

Keyword(s):

Prospective Trial ◽

Intervention Group ◽

Humeral Fracture ◽

Patient Reported Outcome ◽

Control Group ◽

Robot Assisted ◽

Patient Reported ◽

Usual Therapy ◽

Randomised Controlled

Objective: To examine whether robotic-assisted training as a supplement to usual therapy is safe, acceptable and improves function and patient reported outcome after proximal humeral fractures (PHF). Design: Multicentre, assessor-blinded, randomised controlled prospective trial. Setting: Three different rehabilitation hospitals in Germany. Subjects: In total 928 PHF patients between 35 and 70 years were screened. Forty-eight participants were included in the study (intervention group n = 23; control group n = 25). Intervention: The control group received usual occupational and physiotherapy over three weeks, and the intervention group received additional 12 robot-assisted training sessions at the ARMEO®-Spring. Main measures: Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH), the Wolf Motor Function Test-Orthopaedic, active range of motion and grip strength were determined before and after intervention period. The DASH was additionally obtained postal 6 and 13 months following surgery. Results: The mean age of participants was 55 ± 10 years and was similar in both groups ( p > 0.05). The change in DASH as the primary endpoint in the intervention group after intervention was −15 (CI = 8–22), at follow-up six month −7 (CI = −2 to 16) at follow up 13 month −9 (CI = 1–16); in control group −14 (CI = 11–18), at follow-up six month −13 (CI = 7–19) at follow up 13 month −6 (CI = −3 to 14). No difference in the change was found between groups ( p > 0.05). None of the follow-up time points demonstrated an additional benefit of the robotic therapy. Conclusion: The additional robot-assisted therapy was safe, acceptable but showed no improvement in functional shoulder outcome compared to usual therapy only.

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Long-Term Follow-Up of a Randomized Phase III Multicenter Study Comparing a Standard Versus an Intensified Conditioning Regimen for High-Dose Chemotherapy in Patients with Multiple Myeloma.

Blood ◽

10.1182/blood.v104.11.945.945 ◽

2004 ◽

Vol 104 (11) ◽

pp. 945-945

Author(s):

Roland Fenk ◽

Peter Schneider ◽

Martin Kropff ◽

Ali-Nuri Huenerlituerkoglu ◽

Ulrich Steidl ◽

...

Keyword(s):

Multiple Myeloma ◽

Stem Cell ◽

Conditioning Regimen ◽

High Dose Chemotherapy ◽

Phase Iii ◽

Study Endpoint ◽

Primary Study ◽

High Dose ◽

Significant Difference

Abstract High-dose chemotherapy (HDT) improves the outcome of patients with multiple myeloma (MM) in comparison to conventional chemotherapy. Dose-escalating strategies including tandem HDT are currently evaluated to further improve remission rates and survival of patients. Therefore we conducted a randomized multicenter trial to compare an intensified conditioning regimen with the current standard high-dose melphalan. The primary study endpoint was response rate, with overall survival (OS), event-free survival (EFS) and toxicity analysed as secondary endpoints. Between 1997 and 1999 a total of 56 patients with stage II and III disease, who were matched for age (median 56 years), number of previous therapies (median time from diagnosis to transplant 7 months) and different risk factors (beta2-microglobulin, LDH, CRP, cytogentic abnormalities, chemoresistant disease, IgA-subtype, renal impairment), were randomized. All patients received 2 courses of oral idarubicine/dexamethasone and 2 courses of intravenous cyclophosphamide/adriamycine in combination with G-CSF followed by peripheral stem cell collection. Thirty patients were treated with melphalan 200mg/m2 (HD-M) whereas 26 patients received idarubicine 42mg/m2, melphalan 200mg/m2 and cyclophosphamide 120mg/kg (HD-IMC) followed by autologous blood stem cell transplantation. Acute toxicity was higher with HD-IMC, including 5 (20%) treatment-related deaths due to infections versus none (0%) in the HD-M group. This lead to early termination of the study. Severity of mucositis (grade III-IV 19 vs. 8 pts., p=0.001), CRP (20 vs. 7 mg/dl, p<0.001), days of fever (11 vs. 3, p<0.001), days with iv-antibiotics (13 vs. 4, p<0.001), number of erythrocyte-transfusions (6 vs. 2, p<0.001), number of platelet-transfusions (16 vs. 4, p<0.001) and days to granulocyte engraftment (18 vs. 11, p=0.007) were significantly higher after HD-IMC. After a follow-up of 5 years analysis restricted to patients surviving the first 30 days after HDT showed a trend to higher response rates (CR+vgPR: 47% (95%CI 24–72%) vs. 35% (95%CI 18–56%), PR 37% (95%CI 17–63%) vs. 48% (95%CI 29–68%) and time-to-progression (median 31 vs. 15 months, p=0.1) in the HD-IMC treatment arm in comparison to HD-M, but there was no significant difference in EFS and OS (median 22 vs. 30, p= 0.31 and 66 vs. 66 months, p=0.8, respectively). Univariate analysis demonstrated that LDH levels > 200 U/L (p=0.04) and chemoresistant disease (p=0.05) were a bad prognostic factor for EFS. Beta2-Microglobulin levels > 5mg/dl (p=0.01), abnormal conventional cytogenetics (p=0.02) and LDH levels > 200 U/L (p=0.03) were predictive for an inferior OS. In conclusion intensified conditioning for HDT had an intolerable high treatment-related mortality and did not improve EFS and OS in patients with multiple myeloma.

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Definition of the Responder to Hydroxyurea Therapy: Revisited.

Blood ◽

10.1182/blood.v114.22.1513.1513 ◽

2009 ◽

Vol 114 (22) ◽

pp. 1513-1513 ◽

Cited By ~ 1

Author(s):

Samir K. Ballas ◽

William F. McCarthy ◽

Robert L Bauserman ◽

Faramarz Valafar ◽

Myron Waclawiw ◽

...

Keyword(s):

Placebo Group ◽

Sickle Cell ◽

Sickle Cell Anemia ◽

Adult Patients ◽

Study Endpoint ◽

Primary Study ◽

Analgesic Use ◽

Daily Pain ◽

At Home

Abstract Abstract 1513 Poster Board I-536 Introduction Treatment of sickle cell anemia with hydroxyurea (HU) is associated with significant decreases in the frequency of painful crises, acute chest syndrome, morbidity, and mortality. Some patients, however, show no improvement even with prolonged HU therapy. Identifying treatment responders is important for predicting clinical improvements and for assessing the risk/benefit ratio of HU treatment for individual patients. The salutary effects of HU are thought to be the result of increasing the fetal hemoglobin (Hb F) level. NHLBI guidelines for sickle cell treatment define levels of 15%-20% Hb F as therapeutic endpoints. Research and reviews based on pediatric and adult patients have variously argued that levels from about 10% to 20% are beneficial. Patients and Methods Patients in this study were from the Multicenter Study of Hydroxyurea (MSH) in Sickle Cell Anemia, a randomized double-blind placebo controlled trial of HU. The N=299 adult patients were recruited from 21 sites across the U.S. and Canada, and were evenly distributed between males and females. Following randomization to placebo or HU, patients had biweekly follow-up visits until the trial was terminated early due to a significant reduction in painful crises (the primary study endpoint) in the HU arm. Levels of Hb F in MSH patients were assessed at baseline and again approximately 18-21 months after treatment began, with the level at each time being the average of two measurements. In the previously reported MSH study, patients were divided into quartiles of Hb F change as a measure of response to HU treatment. In this approach the bottom two quartiles showed either no or minimal positive change in Hb F levels, and fully overlapped with placebo group in the extent of change. We redefined HU patients as ‘responders’ or ‘nonresponders’ based on a 15% Hb F threshold; those with baseline HbF below 15% and follow-up above 15% were labeled ‘responders,’ while all others were labeled ‘nonresponders.’ The 15% level was chosen due to its frequent identification in previous publications as a level at which meaningful benefits could be expected. For both coding schemes, we compared the following outcomes between subgroups: rate of painful crises, proportion of days at home with pain and with opioid use, and average daily pain. Results Using the 15% rule, responders had significantly better outcomes than nonresponders on all outcome measures: rate of painful crises (p=.011), proportion of at-home days with pain (p=.025), proportion of days with analgesic use (p=.002), and average daily pain (p<.0001). Nonresponders, in turn, did not differ from the placebo group on any of these outcomes. Using the quartiles approach, the highest quartile had significantly fewer painful crises (p<.05) than the bottom two and placebo, but did not differ from the second highest; for the proportion of days with pain, the highest group did not differ from 2 of the other 3 quartiles or from the placebo group. Only for proportion of days with analgesic use and average daily pain did the highest quartile significantly differ from all other quartiles and from placebo patients. Finally, applying the 15% rule to the pl‘cebo group resulted in no placebo patients being mislabeled as treatment responders, suggesting that increases above the 15% cutoff for post-treatment Hb F levels is outside normal variability in sickle cell patients not in HU treatment. Conclusions The 15% Hb F rule successfully identified a ‘responder’ group that significantly differed from other HU patients and from placebo patients on all outcomes, including painful crises. Despite overlap with responders under the 15% rule, patients in the highest quartile for Hb F change did not consistently differ from all other quartiles or placebo on the primary outcome (painful crises) and on proportion of days with pain. Our data suggest that using the 15% Hb F threshold identifies a subset of patients with the best clinical outcomes. Disclosures No relevant conflicts of interest to declare.

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Randomized phase III trial comparing vincristine, actinomycin, cyclophosphamide (VAC) with VAC/V topotecan/cyclophosphamide (TC) for intermediate risk rhabdomyosarcoma (IRRMS). D9803, COG study

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.9509 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 9509-9509 ◽

Cited By ~ 4

Author(s):

C. A. Arndt ◽

D. S. Hawkins ◽

J. A. Stoner ◽

M. D. Wharam ◽

D. A. Rodeberg ◽

...

Keyword(s):

Local Therapy ◽

Phase Iii ◽

Study Endpoint ◽

Primary Study ◽

Significant Activity ◽

Undifferentiated Sarcoma ◽

Primary Study Endpoint ◽

Alpha Level ◽

Adequate Organ Function

9509 Background: IRRMS was defined as nonmetastatic alveolar (A) RMS or undifferentiated sarcoma (UDS); stage (stg) 2 and 3, group (gr) III embryonal (E) RMS; stg 4 ERMS <10y. IRRMS had a 5 yr failure free survival (FFS) of 64% on IRS IV. Since T alone and with C has significant activity in RMS, we tested whether alternating VAC/VTC improved FFS for IRRMS compared with VAC alone. Methods: Patients (pts) < 50 y with IRRMS with adequate organ function were randomized to 39 wks of VAC (V=1.5 mg/m2, A=0.045 mg/kg, C=2.2 g/m2 q 3 wk) vs VAC alternating with VTC (T=0.75 mg/m2/d ×5, C=250 mg/m2/d ×5 q 3 wk), with additional wkly V; doses adjusted for age <3y; local therapy was after wk 12. Pts with parameningeal RMS/meningeal extension (PME) were nonrandomly treated with VAC and immediate XRT. Primary study endpoint was FFS. The study was designed with 80% power (5% 2-sided alpha level) to detect an increase in 5 yr FFS from 64% to 75%, a relative risk (RR) of 0.64, with VAC/VTC, requiring 518 randomized pts. Results reflect the 3rd of 4 planned analyses (75% information); O'Brien Fleming adjusted alpha level is 0.0166; and Cox PH model was used. Results: 620 eligible pts were entered from 9/99 to 8/05: 266 randomized to VAC, 253 to VAC/VTC, 101 PME patients were nonrandomly treated with VAC. Treatment strata were ERMS stg 2/3, gr III 37%; ERMS grp IV <10 y 6%; ARMS/UDS stg 1 or gr I 16%; ARMS/UDS other 25%; PME 16%. 3% of pts were <1 y, 69% 1–9 y, 28% ≥10 y; 13% of pts were stg 1; 26% stg 2; 54% stg 3; 7% stg 4. 77% pts had gr III tumors. Primary tumor sites were PM in 35% pts, extremity 15%, bladder/prostate 16%, retroperitoneal/perineal 15%, other 19%. Median follow up is 2.4 yrs. FFS at 2 yrs is 77% with VAC and 72% with VAC/VTC. Observed data are inconsistent with hypothesized improvement under VAC/VTC (RR=1.20, 98.34% CI: 0.78–1.85, p=0.3). Similar patients on IRS IV had 2 yr FFS of 77%. 2 yr survival (OS) with VAC: 91%; VAC/VTC: 87% (RR=0.94, CI: 0.55–1.59, p=0.8). There were 12 2nd malignancies and 10 deaths as first events. 4 of 10 deaths were from hepatopathy, which decreased in incidence following dose changes for A and C. Conclusions: In IRRMS, VAC/VTC does not significantly improve FFS nor OS versus VAC, and outcome is similar to IRS IV. No significant financial relationships to disclose.

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Rotational and aspiration atherectomy for infrainguinal in-stent restenosis

VASA ◽

10.1024/0301-1526/a000256 ◽

2013 ◽

Vol 42 (2) ◽

pp. 127-133 ◽

Cited By ~ 19

Author(s):

Ulrich Beschorner ◽

Hans Krankenberg ◽

Dierk Scheinert ◽

Horst Sievert ◽

Thilo Tübler ◽

...

Keyword(s):

Ankle Brachial Index ◽

Primary Patency ◽

Study Endpoint ◽

Primary Study ◽

Lesion Length ◽

Secondary Patency ◽

Peripheral Vascular ◽

Stent Restenosis ◽

In Stent Restenosis

Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. Patients and methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.

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Capecitabine plus oxaliplatin (XELOX) versus bolus 5-fluorouracil/leucovorin (5-FU/LV) as adjuvant therapy for stage III colon cancer: Survival follow-up of study NO16968 (XELOXA).

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.388 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 388-388 ◽

Cited By ~ 6

Author(s):

Hans-Joachim Schmoll ◽

Josep Tabernero ◽

Jean Alfred Maroun ◽

Filippo G. De Braud ◽

Timothy Jay Price ◽

...

Keyword(s):

Colon Cancer ◽

Adjuvant Therapy ◽

Disease Free Survival ◽

Stage Iii ◽

Study Endpoint ◽

Primary Study ◽

Stage Iii Colon Cancer ◽

Systemic Treatments ◽

Resected Stage

388 Background: The MOSAIC trial demonstrated that adding oxaliplatin to 5-FU/LV (FOLFOX4) improved 3-year disease-free survival (DFS) compared to infusional and bolus 5-FU/LV as adjuvant therapy in patients (pts) with stage II/III colon cancer [André et al. NEJM 2004]. A significant survival advantage for FOLFOX4 versus 5-FU/LV was not evident until after median duration of follow-up had exceeded 6 years [André et al. JCO 2009]. Study NO16968 demonstrated that XELOX was superior to bolus 5-FU/LV as adjuvant therapy in pts with stage III colon cancer in terms of DFS at 57 months median follow-up (HR 0.80; 95% CI 0.69–0.93; p=0.0045) [Haller et al. JCO 2011]. The difference between treatment groups in overall survival (OS) was not significant at 59 months median follow-up (HR=0.87; p=0.1486). Data from the planned final analysis of NO16968 are presented. Methods: Pts with resected stage III colon cancer were randomized to receive XELOX (8 cycles, 24w) or bolus 5-FU/LV (Mayo Clinic, 6 cycles; 24w or Roswell Park, 4 cycles; 32w). The primary study endpoint was DFS. Secondary endpoints included OS. Results: The ITT population included 1886 pts (XELOX, n=944; 5-FU/LV, n=942). After a median follow-up of 74 months, the HR (XELOX vs 5-FU/LV) for DFS was 0.80 (95% CI 0.69–0.93; p=0.0038). Seven-year DFS rates were 63% for XELOX and 56% for 5-FU/LV. After a median follow-up of 83 months, the HR for OS was 0.83 (95% CI 0.70–0.99; p=0.0367). Absolute 7-year OS rates were 73% with XELOX and 67% with 5-FU/LV. After adjusting for stratification and prognostic variables, HRs remained essentially unchanged for both DFS (0.79; 95% CI 0.68–0.91; p=0.0016) and OS (0.84; 95% CI 0.71–1.00; p=0.0477). Locoregional / systemic treatments after recurrence were given in 230 (24%) XELOX pts and 308 (33%) 5-FU/LV pts. Conclusions: The combination of oxaliplatin and capecitabine improves OS significantly compared with 5-FU/LV in the adjuvant treatment of stage III colon cancer after a median follow-up of 83 months; these data are comparable to those achieved with FOLFOX4 in the MOSAIC trial. XELOX is an effective adjuvant therapy option for pts with resected stage III colon cancer.

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A placebo controlled, randomized, double-blinded trial of olanzapine for the treatment of chronic nausea and/or vomiting, unrelated to chemotherapy/radiation.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.31_suppl.118 ◽

2019 ◽

Vol 37 (31_suppl) ◽

pp. 118-118 ◽

Cited By ~ 1

Author(s):

Rudolph M. Navari

Keyword(s):

Advanced Cancer ◽

Study Endpoint ◽

Primary Study ◽

Double Blind ◽

Wilcoxon Rank Sum Test ◽

Patient Reported ◽

Nausea And Emesis ◽

Chronic Nausea ◽

Cancer Experience ◽

Double Blinded

118 Background: Patients with advanced cancer experience substantial nausea/vomiting. Methods: Eligible patients had advanced cancer without receiving chemotherapy/radiation for the prior 14 days and chronic nausea (>3, 0-10, VAS) that had been present for >1 week and/or vomiting >5 times during the prior week. Patients were randomized, in a double blind manner, to receive olanzapine (5 mg) or a placebo, orally, days 1-7. Prior to starting treatment (Day 1) and daily for 7 days (Days 2-8), patients recorded the intensity of their appetite, nausea, fatigue, sedation, and pain using a numerical VAS, and the number of emetic episodes/24 hours. The primary study endpoint was the change in VAS nausea scores from baseline to the last treatment day. Nausea change scores were compared between arms using a Wilcoxon rank sum test. Results: Thirty patients were enrolled in the study. No patient reported any apparent adverse event or excess sedation. Data are shown in the table. Conclusions: Olanzapine 5 mg/day significantly decreased nausea and emesis in this patient population. [Table: see text]

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Role ofFAM19A4/miR124-2methylation analysis in predicting regression or non-regression of CIN2/3 lesions: a protocol of an observational longitudinal cohort study

BMJ Open ◽

10.1136/bmjopen-2019-029017 ◽

2019 ◽

Vol 9 (7) ◽

pp. e029017 ◽

Cited By ~ 4

Author(s):

Wieke W Kremer ◽

Johannes Berkhof ◽

Maaike CG Bleeker ◽

Daniëlle AM Heideman ◽

Nienke E van Trommel ◽

...

Keyword(s):

Methylation Status ◽

Intraepithelial Neoplasia ◽

Surgical Excision ◽

Study Endpoint ◽

Primary Study ◽

Hpv Test ◽

Registration Number ◽

Receive Treatment ◽

Secondary Study

IntroductionThe clinical course of high-grade cervical intraepithelial neoplasia (CIN2/3) is characterised by a high spontaneous regression rate. Histological assessment is unable to differentiate between CIN2/3 lesions likely to regress and those likely to persist or progress. Most CIN2/3 lesions are treated by surgical excision, leading to overtreatment of a substantial proportion. In this prospective study, we evaluate the value of DNA methylation of host cell genes, which has shown to be particularly sensitive for the detection of advanced CIN2/3 and cervical cancer, in the prediction of regression or non-regression of CIN2/3 lesions.Methods and analysisThis is a multicentre observational longitudinal study with 24-month follow-up. Women referred for colposcopy with an abnormal cervical scrape, who have been diagnosed with CIN2/3 and a small cervical lesion (≤50% of cervix) will be asked to participate. Participants will be monitored by 6-monthly cytological and colposcopic examination. In case of clinical progression, participants will receive treatment and exit the study protocol. At baseline and during follow-up, self-sampled cervicovaginal brushes and cervical scrapes will be collected for high-risk human papillomavirus (HPV) testing andFAM19A4/miR124-2methylation analysis. A colposcopy-directed biopsy will be taken from all participants at the last follow-up visit. The primary study endpoint is regression or non-regression at the end of the study based on the histological diagnosis. Regression is defined as CIN1 or less. Non-regression is defined as CIN2 or worse. The secondary study endpoint is defined as HPV clearance (double-negative HPV test at two consecutive time-points). The association between methylation status and regression probability will be evaluated by means of χ2testing.Ethics and disseminationEthics approval was obtained in all participating clinics. Results of the main study will be submitted for publication in a peer-reviewed journal.Trial registration numberNTR6069; Pre-results

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Contralateral deep vein thrombosis after stenting across the iliocaval confluence in chronic venous disease – A systematic review

Phlebology The Journal of Venous Disease ◽

10.1177/0268355519889873 ◽

2019 ◽

Vol 35 (4) ◽

pp. 221-230 ◽

Cited By ~ 1

Author(s):

Luis Duarte-Gamas ◽

João P Rocha-Neves ◽

António Pereira-Neves ◽

Marina Dias-Neto ◽

Niels Baekgaard

Keyword(s):

Systematic Review ◽

Deep Vein Thrombosis ◽

Iliac Vein ◽

Venous Disease ◽

Antithrombotic Treatment ◽

Vein Thrombosis ◽

Anticoagulation Treatment ◽

Post Thrombotic Syndrome ◽

Deep Vein

Objective Stenting of the iliac veins is increasingly considered in the presence of symptomatic obstructive chronic lesions in the iliac vein segment. However, it is often necessary to extend the stented zone into the inferior vena cava, increasing the risk of contralateral iliac vein thrombosis. This study aims to review the current literature concerning the incidence of contralateral deep vein thrombosis after stenting across the iliocaval confluence. Methods A systematic review from potentially relevant published articles reporting contralateral deep vein thrombosis after iliac venous stenting between January 2007 and February 2019 was performed. Results A total of 764 references were retrieved initially. Twelve studies reporting events of contralateral deep vein thrombosis were selected for review, with a total of 1864 patients. Contralateral deep vein thrombosis incidence varied between 0% and 15.6%. The post-interventional and follow-up anticoagulation regimens were heterogeneous between studies. The decision to maintain patients on anticoagulation and the duration of treatment was based on the presence of comorbidities, hypercoagulable states, post-thrombotic syndrome and history of recurrent deep vein thrombosis. Patients with non-thrombotic iliac vein lesions were either anticoagulated for three or six months after stenting or received no anticoagulation. Patients with post-thrombotic syndrome were anticoagulated for longer periods. Most studies (eight studies) used an oral vitamin K antagonist agent. The data on compliance with anticoagulation treatment is scarce and few references present data on whether contralateral deep vein thrombosis occurred during anticoagulation treatment. The use of antiplatelet agents in addition to the anticoagulant treatment in the follow-up period was also variable. Conclusion The incidence of contralateral deep vein thrombosis due to iliac vein jailing is not negligible and reported being as high as 15.6%. Large-scale studies on the ideal antithrombotic treatment and its impact are necessary. It is possible that patients with stent crossing the iliocaval confluence might benefit from long-term antithrombotic treatment.

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