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Showing 1 to 19 of 19 for “"interim analysis"”.

  1. Interim analysis of Acute Myeloid Leukaemia treated on the Red Cross Children's Hospital Rx 2071 (adapted from the MRC AML 15 protocol)

    Background: Due to the poor outcomes achieved in acute myeloid leukaemia (AML) treatment, the Red Cross War Memorial Children's Hospital (RCWMCH) Oncology service changed from a BFM-87 based protocol to one based on MRC-AML15 in 2007. Rationale: This study was designed to assess the outcomes and …

    cape-town Repository record for Interim analysis of Acute Myeloid Leukaemia treated on the Red Cross Children's Hospital Rx 2071 (adapted from the MRC AML 15 protocol) (opens in a new tab)

  2. The South African Cardiovascular Magnetic Resonance (SA-CMR) Registry: An Interim Analysis of Clinical Utility, Indications and Baseline Characteristics of Patients Undergoing CMR in a Single Centre in South Africa

    … into CMR in the South African setting. This interim analysis of the first 1,142 patients aims to establish the clinical use and indications for CMR, to assess the quality of CMR images and to the assess the baseline demographic and clinical characteristics of the cohort. Secondary objectives …

    cape-town Repository record for The South African Cardiovascular Magnetic Resonance (SA-CMR) Registry: An Interim Analysis of Clinical Utility, Indications and Baseline Characteristics of Patients Undergoing CMR in a Single Centre in South Africa (opens in a new tab)

  3. Study of Product Line Complexity, Supply Chain Coordination, and Phase III New Drug Development

    … drugs, companies use clinical studies without interim analysis or clinical studies with interim analyses. Through the interim analysis, a firm tests whether the drug passes the hypothesis test of the study. It may file the new drug application, and abandon or continue the study. For a clinical …

    wustl Repository record for Study of Product Line Complexity, Supply Chain Coordination, and Phase III New Drug Development (opens in a new tab)

  4. Peer support to encourage adoption and maintenance of a Mediterranean diet

    … dietary change in adults; (ii) qualitative analysis of barriers to a MD in a Northern European population; (iii) validation of a Mediterranean diet score (MDS) to assess MD adherence in a Northern European population and (iv) development and interim-analysis of a pilot RCT to assess the …

    qu-belfast Repository record for Peer support to encourage adoption and maintenance of a Mediterranean diet (opens in a new tab)

  5. Optimising medicine reconciliation at the healthcare interface

    … of pharmacy led medicines reconciliation. Interim analysis of a pilot 24 hour MR service showed that only 20% of errors upon admission were intercepted before discharge in the control group, compared to 98.6% within the intervention arm. The MR service was estimated to contribute to cost …

    east-anglia Repository record for Optimising medicine reconciliation at the healthcare interface (opens in a new tab)

  6. Renal and Blood Pressure Effects of Xanthine Oxidase Inhibitors in the FAST trial

    … maximum tolerated dose of allopurinol. This analysis of FAST patients looked at the proportion of patients who required up-titration, the number of up-titrations required and any associated side effects. 2) FAST Blood Pressure Sub-Study. Home monitored blood pressure was measured in FAST …

    dundee Repository record for Renal and Blood Pressure Effects of Xanthine Oxidase Inhibitors in the FAST trial (opens in a new tab)

  7. Resource Allocation Decision-Making in Sequential Adaptive Clinical Trials

    … of drug testing for benefit or futility at interim analysis points. The option to stop the trial early enables the trial sponsor to mitigate investment risks on ineffective drugs, and to shorten the development time line of effective drugs, hence reducing expenditures and expediting patient …

    vt Repository record for Resource Allocation Decision-Making in Sequential Adaptive Clinical Trials (opens in a new tab)

  8. The Association Between Soft Tissue Releases and Bony Resections Performed During Total Knee Arthroplasty and Patients' Pain and Satisfaction Postoperatively

    … and pain at three months. We performed an interim analysis on 100 patients who had undergone a TKA. Using multiple regression models, we showed no association between degree of releases and satisfaction or pain. These results were limited by sample size such that we are unable to make …

    uwo Repository record for The Association Between Soft Tissue Releases and Bony Resections Performed During Total Knee Arthroplasty and Patients' Pain and Satisfaction Postoperatively (opens in a new tab)

  9. A PHASE III PROSPECTIVE RANDOMIZED TRIAL TO EVALUATE THE IMPACT OF AUGMENTED REALITY DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY ON THE RATES OF POSTOPERATIVE SURGICAL MARGINS

    … alternative to intraoperative frozen section analysis (IFS) for real-time margin evaluation. Methods This is a Phase III, monocentric, prospective and randomized trial that compares augmented reality (AR) RARP with standard approach (standard RARP) for reducing the rates of PSMs. A total of …

    milano Repository record for A PHASE III PROSPECTIVE RANDOMIZED TRIAL TO EVALUATE THE IMPACT OF AUGMENTED REALITY DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY ON THE RATES OF POSTOPERATIVE SURGICAL MARGINS (opens in a new tab)

  10. Exploiting p53 mutation in colorectal cancer: clinical positioning of Cdc7 inhibitors

    … of care chemotherapeutic regimens.<br/><br/>Interim analysis of the first 30 patients recruited to the first-in-human phase I trial of LY3143921 monotherapy is also discussed. Future work should explore underlying biologic mechanisms which associate with specific TP53 mutations and result in …

    qu-belfast Repository record for Exploiting p53 mutation in colorectal cancer: clinical positioning of Cdc7 inhibitors (opens in a new tab)

  11. A Randomized Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen For Persistent Dyspnea In

    … the median baseline Borg score was 4/10 (3-7). Interim analysis revealed that BiPAP was associated with a median change in numeric rating score of -3 (N=10, IQR -6.3 to -1, p=0.007) and modified Borg score of -1 (N=10, IQR -3 to 0.3, p=0.058), while Vapotherm was associated with a median change …

    uthsc Repository record for A Randomized Trial of Bilevel Positive Airway Pressure Device and High Flow Oxygen For Persistent Dyspnea In (opens in a new tab)

  12. Home-based exergames to improve cognitive function in Multiple Sclerosis: the EXTREMUS Study ​

    … assessed for eligibility in this pre-planned interim analysis; of these, 47 were randomized to the three treatment groups. The three treatment groups were comparable in terms of demographic and clinical characteristics at baseline (all p values >0.2). Preliminary analyses show statistically …

    cagliari Repository record for Home-based exergames to improve cognitive function in Multiple Sclerosis: the EXTREMUS Study ​ (opens in a new tab)

  13. Improving the efficiency of clinical trial designs by using historical control data or adding a treatment arm to an ongoing trial

    … size calculations, but are not used in the analysis of the new trial. Incorporating historical control data into the design and analysis could potentially lead to more efficient trials. When the historical and current control data agree, incorporating historical control data could reduce the …

    cambridge Repository record for Improving the efficiency of clinical trial designs by using historical control data or adding a treatment arm to an ongoing trial (opens in a new tab)

  14. The surgical management and prevention of laparoscopic cholecystectomy associated bile duct injuries

    … to continue to the end of 2020; however, an interim analysis is presented. A previously published scoring system for assessing quality of the critical view of safety achieved during LC, a critical component of a safe LC, is applied and validated in a large cohort of LC patients. A prospective …

    cape-town Repository record for The surgical management and prevention of laparoscopic cholecystectomy associated bile duct injuries (opens in a new tab)

  15. Preparing, Executing, and Designing Complex Clinical Trials Using Simulations

    … R, allowing us to collect study data, perform interim analyses by extracting and analyzing the most up-to-date data, and adjust the new allocation sequence for the subsequent participants with minimal interruption to the study sites. We then continued the work after trial completion to provide …

    ku Repository record for Preparing, Executing, and Designing Complex Clinical Trials Using Simulations (opens in a new tab)

  16. Placental growth factor; potential for its use in twin pregnancy and evaluation of its benefit in singletons with suspected preterm pre-eclampsia

    … can be clinically applied. The result of the interim analysis from the PARROT Ireland trial is of no significant reduction in either maternal or neonatal morbidity with the integration of point of care PlGF based testing. These are interim results only however and the final results may differ. …

    cork Repository record for Placental growth factor; potential for its use in twin pregnancy and evaluation of its benefit in singletons with suspected preterm pre-eclampsia (opens in a new tab)

  17. Evaluation of probiotic and vaginal Lactobacillus species for the treatment of bacterial vaginosis and promotion of vaginal health in South African women

    … of metronidazole treatment is vaginal thrush. An interim analysis of the first 24 participants who have completed the trial is included in this dissertation, as the trial is still ongoing. The probiotic was found to be well accepted and no product related adverse events were reported, although …

    cape-town Repository record for Evaluation of probiotic and vaginal Lactobacillus species for the treatment of bacterial vaginosis and promotion of vaginal health in South African women (opens in a new tab)

  18. Non-invasive and minimally invasive techniques for urodynamic stress incontinence of urine in women

    … up.Results: 24 patients were available for analysis. A rising failure rate was noted as early as 3 months, leading to a cumulative cure rate of 36% at 12 months follow up. No major complications were encountered and pain scores were mild.Conclusions: The effectiveness of transvaginal …

    hull Repository record for Non-invasive and minimally invasive techniques for urodynamic stress incontinence of urine in women (opens in a new tab)

  19. Curtailed phase II binary outcome trials and adaptive multi-outcome trials

    Phase II clinical trials are a critical aspect of the drug development process. With drug development costs ever increasing, novel designs that can improve the efficiency of phase II trials are extremely valuable. Phase II clinical trials for cancer treatments often measure a binary outcome. The …

    cambridge Repository record for Curtailed phase II binary outcome trials and adaptive multi-outcome trials (opens in a new tab)