scholarly journals Once-daily etravirine/raltegravir (400/800 mg q24h) dual therapy maintains viral suppression over 48 weeks in HIV-infected patients switching from a twice-daily etravirine/raltegravir (200/400 mg q12h) regimen

2020 ◽  
Author(s):  
Romain Palich ◽  
Clotilde Allavena ◽  
Gilles Peytavin ◽  
Cathia Soulie ◽  
Roland Tubiana ◽  
...  
Keyword(s):  
Success Rate ◽  
Primary Outcome ◽  
Viral Suppression ◽  
Dual Therapy ◽  
Open Label ◽  
Once Daily ◽  
Drug Concentrations ◽  
Highly Effective ◽  
Lost To Follow Up

Abstract Background Etravirine/raltegravir dual therapy has been shown to be highly effective as a twice-daily (q12h) regimen in suppressed HIV-infected patients enrolled in the ANRS-163 study. Objectives As a once-daily (q24h) regimen is easier for daily life, we aimed to evaluate the capacity of etravirine/raltegravir (400/800 mg) q24h to maintain viral suppression in patients on etravirine/raltegravir q12h. Methods Patients on a suppressive etravirine/raltegravir q12h regimen for at least 96 weeks were switched to etravirine/raltegravir q24h in this prospective, multicentre, open-label, single-arm study. Primary outcome was the rate of virological failure (VF: confirmed pVL >50 copies/mL, single pVL >400 copies/mL or single pVL >50 copies/mL with ART change) at Week 48 (W48). Secondary outcomes included treatment strategy success rate (no VF and no treatment discontinuation), regimen tolerability, plasma drug concentrations and resistance profile in the case of VF. Results A total of 111 patients were enrolled, with a median (IQR) age of 57 years (52–62), CD4 count of 710 cells/mm3 (501–919) and viral suppression for 7.9 years (5.9–10.7). Two patients experienced viral rebound at W24 and W48, leading to a VF rate of 2.0% (95% CI 0.5–7.8) at W48, associated with INSTI resistance in one case. Both had past NNRTI mutations. Ten patients discontinued treatment for adverse events (n = 2), investigator or patient decisions (n = 3), lost to follow-up (n = 3), death (n = 1) or pregnancy (n = 1). Overall, the strategy success rate was 89% (95% CI 81.5–93.6) at W48. In a subgroup of 64 patients, median (IQR) plasma C24h concentrations were 401 ng/mL (280–603) for etravirine and 62 ng/mL (31–140) for raltegravir. Conclusions Switching patients virally suppressed on etravirine/raltegravir q12h to the same regimen but given q24h was highly effective in maintaining virological suppression in HIV-infected patients.

Status and Determinants of Treatment Outcomes Among New Tuberculosis Patients in South Korea: A Retrospective Cohort Study

2021 ◽  
pp. 101053952110005
Author(s):  
Hyunjin Son ◽  
Jeongha Mok ◽  
Miyoung Lee ◽  
Wonseo Park ◽  
Seungjin Kim ◽  
...  
Keyword(s):  
Cohort Study ◽  
South Korea ◽  
Success Rate ◽  
Treatment Outcomes ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Health Care Facilities ◽  
Tuberculosis Patients ◽  
Lost To Follow Up

This is a retrospective cohort study using notification data in South Korea. We evaluated the nationwide status, regional differences, and the determinants of treatment outcomes among tuberculosis patients. Treatment success rate improved from 77.0% in 2012 to 86.0% in 2015. The lost to follow-up rate was higher among older people, males, and foreign nationals. Health care facilities designated for the Public-Private Mix (PPM) project showed higher success rate and lower rate of lost to follow-up. Moreover, municipalities with low regional deprivation index had higher PPM project coverage. Since there is a large regional difference in the coverage of the PPM project, an additional community-based support program should be implemented, especially for tuberculosis patients residing in region with low PPM project coverage.

scholarly journals An Evaluation of Survival of Space Maintainers: A Six-year Follow-up Study

2005 ◽  
Vol 6 (1) ◽  
pp. 74-84 ◽  
Author(s):  
Ozlem Tulunoglu ◽  
Tezer Ulusu ◽  
Yasemin Genç
Keyword(s):  
Survival Time ◽  
Success Rate ◽  
Median Survival ◽  
Median Survival Time ◽  
Age Groups ◽  
Age Group ◽  
Follow Up Study ◽  
Different Types ◽  
Lost To Follow Up

Abstract The aim of this study was to evaluate the median survival time of fixed and removable space maintainers related to age groups, gender, and their distribution in upper and lower dental arches. The adherence of patients to a periodic recall program and the success rate of different types of space maintainers related to different arches were also evaluated. This study included 663 patients aged between 4-15 years old that were treated between the years of 1997 and 2002. The patients were categorized into four main groups: lost to follow-up, failed, successful, and censored at the end of study. Three hundred forty-five space maintainers were considered lost to follow-up, 83 were considered failed, 206 successful, and 20 censored-at-end. The overall median survival time of the appliances was 6.51 months. Median survival time was 7.25 months in the 4-6 age group, 6.35 months in the 7-12 age group, and 7.0 months in the 13+ age groups. Median survival time was 5.76 months in girls and 7.11 months in boys. Median survival time of space maintainers was 7.17 months for maxilla and 6.69 months in the mandible. Median survival time was 5.25 months for space maintainers fabricated in both arches. Citation Tulunoglu Ö, Ulusu T, Genç Y. An Evaluation of Survival of Space Maintainers: A Six-year Follow-up Study J Contemp Dent Pract 2005 February;(6)1:074-084.

scholarly journals An open label trial of anakinra to prevent respiratory failure in COVID-19

eLife ◽  
2021 ◽  
Vol 10 ◽  
Author(s):  
Evdoxia Kyriazopoulou ◽  
Periklis Panagopoulos ◽  
Symeon Metallidis ◽  
George N Dalekos ◽  
Garyphallia Poulakou ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Primary Outcome ◽  
Standard Of Care ◽  
Hazard Ratio ◽  
Open Label ◽  
Once Daily ◽  
Non Invasive ◽  
Non Invasive Ventilation ◽  
Open Label Trial ◽  
Anakinra Treatment

Background It was studied if early suPAR-guided anakinra treatment can prevent severe respiratory failure (SRF) of COVID-19.Methods 130 patients with suPAR ≥6 ng/ml were assigned to subcutaneous anakinra 100mg once daily for 10 days. Primary outcome was SRF incidence by day 14 defined as any respiratory ratio below 150 mmHg necessitating mechanical or non-invasive ventilation. Main secondary outcomes were 30-day mortality and inflammatory mediators; 28-day WHO-CPS was explored. Propensity-matched standard-of care comparators were studied.Results 22.3% with anakinra treatment and 59.2% comparators (hazard ratio, 0.30; 95%CI, 0.20-0.46) progressed into SRF; 30-day mortality was 11.5% and 22.3% respectively (hazard ratio 0.49; 95% CI 0.25-0.97). Anakinra was associated with decrease in circulating interleukin (IL)-6, sCD163 and sIL2-R; IL-10/IL-6 ratio on day 7 was inversely associated with SOFA score; patients were allocated to less severe WHO-CPS strata.Conclusions Early suPAR-guided anakinra decreased SRF and restored the pro-/anti-inflammatory balance.Trial Registration: ClinicalTrials.gov, NCT04357366

scholarly journals A Randomized Trial Comparing Seven-Day Ranitidine Bismuth Citrate and Clarithromycin Dual Therapy to Seven-Day Omeprazole, Clarithromycin and Amoxicillin Triple Therapy for the Eradication ofHelicobacter pylori

2003 ◽  
Vol 17 (9) ◽  
pp. 533-538 ◽  
Author(s):  
Sander Veldhuyzen van Zanten ◽  
Naoki Chiba ◽  
Alan Barkun ◽  
Carlo Fallone ◽  
Alain Farley ◽  
...  
Keyword(s):  
Dual Therapy ◽  
Success Rates ◽  
Open Label ◽  
Treatment Allocation ◽  
Ulcer Disease ◽  
Intention To Treat ◽  
Bismuth Citrate ◽  
The Difference ◽  
H Pylori

OBJECTIVE: To assessHelicobacter pylorieradication after one week dual ranitidine bismuth citrate-clarithromycin (RBC-C) or triple omeprazole, clarithromycin and amoxicillin (OCA) therapy.METHODS: In this multicentre Canadian trial,H pylori-positive patients with functional dyspepsia or inactive peptic ulcer disease were randomized to open-label treatment with RBC-C (ranitidine bismuth citrate 400 mg plus clarithromycin 500 mg) or OCA (omezaprole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg), given twice a day for seven days. Treatment allocation was randomly assigned.H pyloriinfection was confirmed by positive13C-urea breath test (13C-UBT).H pyloristatus was reassessed by UBT at least four and 12 weeks after treatment (negative: δ13CO2below 3.5 per mil). Intention-to-treat (ITT) eradication rates were determined for all patients with confirmedH pyloriinfection. Per protocol (PP) rate was determined for all patients treated with at least two evaluable follow-up visits.RESULTS: Three hundred five patients were included in the ITT and 222 in the PP analysis. The ITT eradication rates were 66% for RBC-C and 78% for OCA. The PP success rates were 84% for RBC-C and 96% for OCA. The difference for both ITT 12% (95% CI 2 to 22) and PP 12% (95% CI 4 to 19) were statistically significant, P=0.030 and P=0.007, respectively. Treatment was generally well tolerated.CONCLUSION: The eradication rate for the seven-day dual RBC-C regimen was lower than that for OCA.

Impact of PSMA PET/CT on SRT planning: Preliminary results from the randomized phase III trial NCT03582774.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 30-30
Author(s):  
Jeremie Calais ◽  
Wesley R Armstrong ◽  
Amar Upadhyaya Kishan ◽  
Kiara M Booker ◽  
David Elashoff ◽  
...  
Keyword(s):  
Success Rate ◽  
Phase Iii ◽  
Open Label ◽  
Phase 3 ◽  
Preliminary Results ◽  
Volume Delineation ◽  
Psma Pet ◽  
Pet Ct ◽  
The Impact

30 Background: The purpose of this trial is to evaluate the success rate of salvage radiation therapy (SRT) for recurrence of prostate cancer (PCa) after radical prostatectomy with and without planning based on prostate specific membrane antigen (PSMA) positron emission tomography (PET). Methods: This is a multicenter, prospective, randomized, controlled, open-label, Phase 3 clinical imaging trial powered for clinical outcome at 5 years. UCLA is the leading central site in which PSMA PET, clinical follow-up and data management are being done. UCSF was a participating site in which PSMA PET imaging can be done. SRT can be performed anywhere, patients are followed remotely by the UCLA investigators. Patients scheduled for SRT for recurrence after primary prostatectomy and with PSA ≥ 0.1ng/ml at time of enrollment were eligible. Patients were randomized to proceed with standard SRT allowing for any conventional imaging aside from PSMA PET/CT (control arm) or undergo a 68Ga-PSMA-11 PET/CT scan prior to SRT planning (investigational arm). The primary endpoint is the success rate of SRT at 5 years in patients who undergo SRT. We report here the preliminary results of a secondary endpoint: the impact of PSMA PET on SRT planning by comparing the pre-randomization RT plans prospectively obtained on surveys before randomization to the actually delivered RT plans obtained after follow-up. Results: Enrollment of the trial was complete. 193 patients were enrolled from 09.06.2018 to 08.17.2020. 7/90 patients (9%) in the control arm dropped-out the study because they underwent a PSMA PET at another institution, while 1/103 (1%) patients of the intervention arm dropped-out due to COVID-19 related complications. After a median follow-up of 13.3 months (last follow-up date 09/01/2020), delivered RT plans were obtained in 60/83 (72%) and 70/102 (69%) of patients of the control and the PSMA arms, respectively. Median PSA at enrollment was 0.32 ng/ml (IQR 0.17-1.35) and 0.22 ng/ml (IQR 0.14-0.50) in the control and PSMA arms, respectively. There was a change between the intended pre-randomization RT plan and the actually delivered RT plan in 17/60 (28%) and 40/70 (57%) of the patients in the control and PSMA arms, respectively (p = 0.002). SRT was aborted in favor of systemic therapy and/or metastasis directed RT for extra-pelvic M1 disease in 2/60 (3%) and 12/70 (17%) of the control and PSMA arms, respectively (p = 0.17). Dose prescription and/or target volume delineation was changed in 2/60 (3%) and 1/70 (26%) in the control and PSMA arms, respectively (p = 0.001). Conclusions: In this prospective randomized phase 3 study, PSMA PET had an impact on the SRT plan in more than half of the patients. Long-term follow-up will show if the impact of PSMA PET on SRT planning translates into improved outcome or not. Clinical trial information: NCT03582774.

scholarly journals Consecutive Case Series of Healed Single-Molar Sites Immediately Restored with Wide-Diameter Implants: A 1-Year Evaluation

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Hadi Antoun ◽  
Pierre Cherfane ◽  
Bouchra Sojod
Keyword(s):  
Success Rate ◽  
Case Series ◽  
Marginal Bone Loss ◽  
Wide Diameter ◽  
Bone Level ◽  
One Year ◽  
Lost To Follow Up ◽  
Single Crowns

Introduction. To evaluate outcomes of wide-diameter (6 mm) implants immediately provisionalized with cement-retained single crowns in posterior molar sites.Materials and Methods. Forty-eight consecutive patients received a total of 53 moderately rough-surface, 6 mm diameter implants in healed sites. All implants were immediately provisionalized with a cement-retained provisional crown. Final prosthesis with cement-retained porcelain fused to metal crowns was delivered 3–6 months later. Patients were followed up for 1 year. Outcome measures were implant failures and success rate, complications, marginal bone levels, bone level changes, papilla index, bleeding on probing, and inflammation.Results. One patient was lost to follow-up. At one year, the implant survival and success rate were 98.1%. The mean marginal bone loss after 1 year was −0.17±1.84 mm. Ideal papilla score was recorded at 83.8% of the sites. More than 95.6% of the sites showed no bleeding or inflammation. No procedure-related or device-related adverse events were reported.Conclusion. Wide-diameter (6 mm) implants can safely and successfully replace single posterior molars. Longer follow-up studies are necessary to evaluate the long-term success of these implants.

scholarly journals Medication Event Monitoring System for Infectious Tuberculosis Treatment in Morocco: A Retrospective Cohort Study

2019 ◽  
Vol 16 (3) ◽  
pp. 412 ◽  
Author(s):  
Seup Park ◽  
Ilham Sentissi ◽  
Seung Gil ◽  
Won-Seok Park ◽  
ByungKwon Oh ◽  
...  
Keyword(s):  
Success Rate ◽  
Monitoring System ◽  
Treatment Success ◽  
Treatment Success Rate ◽  
Control Group ◽  
Event Monitoring ◽  
Tb Treatment ◽  
The Mean ◽  
Lost To Follow Up

Non-adherence to tuberculosis (TB) treatment is a barrier to effective TB control. We investigated the effectiveness of a Medication Event Monitoring System (MEMS) as a tailored adherence-promoting intervention in Morocco. We compared patients who received a MEMS (n = 206) with patients who received standard TB care (n = 141) among new active TB patients with sputum smear-positive. The mean total medication days were 141.87 ± 29.5 in the control group and 140.85 ± 17.9 in the MEMS group (p = 0.7147), and the mean age and sex were not different between the two groups (p > 0.05). The treatment success rate was significantly higher in the MEMS group than in the control group (odds ratio (OR): 4.33, 95% confidence interval (CI): 2.13–8.81, p < 0.001), and the lost to follow-up rate was significantly lower in the MEMS group than in the control group (OR: 0.03, 95% CI: 0.05–0.24, p < 0.001) after adjusting for sex, age, and health centers. The mean drug adherence rate in the first month was significantly higher in the MEMS group than in the control group (p = 0.023). MEMS increased TB treatment success rate and decreased the lost to follow-up rate overall for infectious TB patients in a Moroccan rural area.

Follow-up results of myositis patients treated with H. P. Acthar gel

Rheumatology ◽  
2020 ◽  
Vol 59 (10) ◽  
pp. 2976-2981 ◽  
Author(s):  
Didem Saygin ◽  
Chester V Oddis ◽  
Galina Marder ◽  
Siamak Moghadam-Kia ◽  
Preeya Nandkumar ◽  
...  
Keyword(s):  
Standard Dose ◽  
Manual Muscle Testing ◽  
Open Label ◽  
Muscle Testing ◽  
Core Set ◽  
Minimal Improvement ◽  
Definition Of ◽  
Post Trial ◽  
Lost To Follow Up

Abstract Objectives Idiopathic inflammatory myopathies (IIM) are a group of autoimmune diseases characterized by proximal muscle weakness. H. P. Acthar gel [repository corticotropin injection (RCI)] is a formulation of adrenocorticotropic hormone and has been approved by Food and Drug Administration for use in IIM; however, literature is limited. In this study, we report longitudinal follow-up of myositis patients treated with RCI. Methods Patients with refractory IIM who were enrolled in the prospective, open-label RCI trial were included in this study. The post-trial follow-up period was 6 months with assessments every 2 months, which included myositis core set measures including extra-muscular global, muscle and patient global disease activities, HAQ, and manual muscle testing. Results Two patients were lost to follow-up after finalization of the trial, and the remaining eight patients were enrolled in the follow-up study. One patient remained on RCI after the trial. In the follow-up period, four of eight patients had flare at on average 4.1 months after the RCI trial. Among the patients who flared, three required an increase in prednisone. One patient was restarted on RCI at 5.5 months, but had minimal improvement after 3 months. Four patients who remained stable continued to satisfy criteria for the definition of improvement through the 6-month follow-up. However, none showed any further improvement in the primary or secondary efficacy outcomes after the initial RCI trial. Conclusion To our knowledge, this is the first study reporting the follow-up results of patients treated with standard dose and duration of Acthar. We believe that our study will provide the basis for the development of future randomized RCI trials in IIM.

scholarly journals Completion rate and impact on physician–patient relationship of video consultations in medical oncology: a randomised controlled open-label trial

ESMO Open ◽  
2020 ◽  
Vol 5 (6) ◽  
pp. e000912
Author(s):  
Thomas Walle ◽  
Erkin Erdal ◽  
Leon Mühlsteffen ◽  
Hans Martin Singh ◽  
Editha Gnutzmann ◽  
...  
Keyword(s):  
Mobile Phone ◽  
Success Rate ◽  
Outpatient Clinics ◽  
Controlled Clinical Trial ◽  
Patient Relationship ◽  
Physician Patient Relationship ◽  
Open Label ◽  
Randomised Controlled ◽  
Physician Patient

BackgroundMobile phone video call applications generally did not undergo testing in randomised controlled clinical trials prior to their implementation in patient care regarding the rate of successful patient visits and impact on the physician–patient relationship.MethodsThe National Center for Tumour Diseases (NCT) MOBILE trial was a monocentric open-label randomised controlled clinical trial of patients with solid tumours undergoing systemic cancer therapy with need of a follow-up visit with their consulting physician at outpatient clinics. 66 patients were 1:1 randomised to receive either a standard in-person follow-up visit at outpatient clinics or a video call via a mobile phone application. The primary outcome was feasibility defined as the proportion of patients successfully completing the first follow-up visit. Secondary outcomes included success rate of further video calls, time spent by patient and physician, patient satisfaction and quality of physician–patient relationship.FindingsSuccess rate of the first follow-up visit in the intention-to-treat cohort was 87.9% (29 of 33) for in-person visits and 78.8% (26 of 33) for video calls (relative risk: RR 0.90, 95% CI 0.70 to 1.13, p=0.51). The most common reasons for failure were software incompatibility in the video call and no-show in the in-person visit arm. The success rate for further video visits was 91.7% (11 of 12). Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean −170.8 min, 95% CI −246 min to −95.5 min), p<0.0001; Δmean −€14.37, 95% CI −€23.9 to −€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI −5.4 min to 6.4 min, p=0.86). Physician–patient relationship quality mean scores assessed by a validated standardised questionnaire were higher in the video call arm (1.13-fold, p=0.02).InterpretationFollow-up visits with the tested mobile phone video call application were feasible but software compatibility should be critically evaluated.Trial registration numberDRKS00015788.

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