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Author Toshimitsu Hamasaki

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Bridging Therapy With Heparin Before Starting Rivaroxaban in Ischemic Stroke or Transient Ischemic Attack With Non-Valvular Atrial Fibrillation.

Keisuke Tokunaga, Masahiro Yasaka, Kazunori Toyoda, Etsuro Mori, Teruyuki Hirano, Toshimitsu Hamasaki, Hiroshi Yamagami, Takehiko Nagao, Shinichi Yoshimura, Shinichiro Uchiyama, Kazuo Minematsu, ,

<h4>Background</h4>The present observational study aimed to clarify the association between bridging therapy with heparin before starting rivaroxaban and clinical outcomes after ischemic stroke or transient ischemic attack (TIA) in patients with non-valvular atrial fibrillation (NVAF).Methods and Results:Patients with NVAF who experienced acute ischemic stroke or TIA of the middle cerebral artery territory ... Read more >>

Circ J (Circulation journal : official journal of the Japanese Circulation Society)
[2021, :]

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ASPECTS-Region-Dependent Functional Outcomes after Endovascular Therapy in Patients with Cardioembolic Stroke.

Yoshiharu Oki, Fumihiro Sakakibara, Kazutaka Uchida, Hiroto Kageyama, Masahiro Yasaka, Kazunori Toyoda, Etsuro Mori, Teruyuki Hirano, Toshimitsu Hamasaki, Hiroshi Yamagami, Takehiko Nagao, Shinichiro Uchiyama, Kazuo Minematsu, Shinichi Yoshimura, ,

<h4>Objectives</h4>Cardioembolic stroke has a poor prognosis. We evaluated the region-dependent efficacy of endovascular therapy (EVT) based on diffusion-weighted imaging-Alberta Stroke Program Early CT Score (DWI-ASPECTS).<h4>Methods</h4>This post-hoc analysis of the RELAXED study, which investigated the optimal timing of rivaroxaban to prevent nonvalvular atrial fibrillation (NVAF) recurrence in patients with acute ischemic ... Read more >>

J Stroke Cerebrovasc Dis (Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association)
[2021, 30(7):105814]

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Sex Differences in Management and Outcomes of Cardioembolic Stroke: Post HOC Analyses of the RELAXED Study.

Takashi Okada, Kazutaka Uchida, Fumihiro Sakakibara, Hiroto Kageyama, Masahiro Yasaka, Kazunori Toyoda, Etsuro Mori, Teruyuki Hirano, Toshimitsu Hamasaki, Hiroshi Yamagami, Takehiko Nagao, Shinichiro Uchiyama, Kazuo Minematsu, Shinichi Yoshimura, ,

<h4>Introduction</h4>Experimental models have clearly demonstrated sex differences in the pathophysiology of stroke and prognosis, however clinical evidence remains elusive. In this study, we examined sex differences as a post hoc analysis of RELAXED (Recurrent Embolism Lessened by rivaroxaban, an anti-X agent, of Early Dosing for acute IS and TIA with ... Read more >>

J Stroke Cerebrovasc Dis (Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association)
[2021, 30(4):105613]

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On selecting the critical boundary functions in group-sequential trials with two time-to-event outcomes.

Toshimitsu Hamasaki, H M James Hung, Chin-Fu Hsiao, Scott R Evans,

We investigate selection of critical boundary functions for testing the hypotheses of two time-to-event outcomes as both primary endpoints or a primary and a secondary endpoint in group-sequential clinical trials, where (1) the effect sizes of endpoints are unequal, or (2) one endpoint is for short-term evaluation and the other ... Read more >>

Contemp Clin Trials (Contemporary clinical trials)
[2021, 101:106244]

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Magnetic Resonance Imaging-Guided Thrombolysis (0.6 mg/kg) Was Beneficial for Unknown Onset Stroke Above a Certain Core Size: THAWS RCT Substudy.

Kazunori Toyoda, Manabu Inoue, Sohei Yoshimura, Hiroshi Yamagami, Makoto Sasaki, Mayumi Fukuda-Doi, Kazumi Kimura, Koko Asakura, Kaori Miwa, Takao Kanzawa, Masafumi Ihara, Rei Kondo, Masayuki Shiozawa, Masafumi Ohtaki, Kenji Kamiyama, Ryo Itabashi, Toru Iwama, Junya Aoki, Kazuo Minematsu, Haruko Yamamoto, Masatoshi Koga, ,

<h4>Background and purpose</h4>We determined to identify patients with unknown onset stroke who could have favorable 90-day outcomes after low-dose thrombolysis from the THAWS (Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg) database.<h4>Methods</h4>This was a subanalysis of an investigator-initiated, multicenter, randomized, open-label, blinded-end point trial. Patients with ... Read more >>

Stroke (Stroke)
[2021, 52(1):12-19]

Cited: 1 time

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Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data.

Götz Thomalla, Florent Boutitie, Henry Ma, Masatoshi Koga, Peter Ringleb, Lee H Schwamm, Ona Wu, Martin Bendszus, Christopher F Bladin, Bruce C V Campbell, Bastian Cheng, Leonid Churilov, Martin Ebinger, Matthias Endres, Jochen B Fiebach, Mayumi Fukuda-Doi, Manabu Inoue, Timothy J Kleinig, Lawrence L Latour, Robin Lemmens, Christopher R Levi, Didier Leys, Kaori Miwa, Carlos A Molina, Keith W Muir, Norbert Nighoghossian, Mark W Parsons, Salvador Pedraza, Peter D Schellinger, Stefan Schwab, Claus Z Simonsen, Shlee S Song, Vincent Thijs, Danilo Toni, Chung Y Hsu, Nils Wahlgren, Haruko Yamamoto, Nawaf Yassi, Sohei Yoshimura, Steven Warach, Werner Hacke, Kazunori Toyoda, Geoffrey A Donnan, Stephen M Davis, Christian Gerloff, ,

<h4>Background</h4>Patients who have had a stroke with unknown time of onset have been previously excluded from thrombolysis. We aimed to establish whether intravenous alteplase is safe and effective in such patients when salvageable tissue has been identified with imaging biomarkers.<h4>Methods</h4>We did a systematic review and meta-analysis of individual patient data ... Read more >>

Lancet (Lancet (London, England))
[2020, 396(10262):1574-1584]

Cited: 12 times

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Influence of Induction Therapy Using Basiliximab With Delayed Tacrolimus Administration in Heart Transplant Recipients - Comparison With Standard Tacrolimus-Based Triple Immunosuppression.

Takuya Watanabe, Masanobu Yanase, Osamu Seguchi, Tomoyuki Fujita, Toshimitsu Hamasaki, Seiko Nakajima, Kensuke Kuroda, Yuto Kumai, Koichi Toda, Keiichiro Iwasaki, Yuki Kimura, Hiroki Mochizuki, Eiji Anegawa, Yasumori Sujino, Nobuichiro Yagi, Koichi Yoshitake, Kyoichi Wada, Sachi Matsuda, Hiromi Takenaka, Megumi Ikura, Kazuki Nakagita, Shin Yajima, Yorihiko Matsumoto, Naoki Tadokoro, Takashi Kakuta, Satsuki Fukushima, Hatsue Ishibashi-Ueda, Junjiro Kobayashi, Norihide Fukushima,

<h4>Background</h4>Appropriate indications and protocols for induction therapy using basiliximab have not been fully established in heart transplant (HTx) recipients. This study elucidated the influence of induction therapy using basiliximab along with delayed tacrolimus (Tac) initiation on the outcomes of high-risk HTx recipients.Methods and Results:A total of 86 HTx recipients treated with Tac-based ... Read more >>

Circ J (Circulation journal : official journal of the Japanese Circulation Society)
[2020, 84(12):2212-2223]

Cited: 0 times

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Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic.

Toshimitsu Hamasaki, Frank Bretz, Freda Cooner, Lisa M LaVange, Martin Posch,

Stat Biopharm Res (Statistics in biopharmaceutical research)
[2020, 12(4):397-398]

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"BAX602" in Preventing Surgical Adhesion after Extracorporeal Ventricular Assist Device Implantation for Refractory Congestive Heart Failure: Study Protocol for a Multicenter Randomized Clinical Trial.

Satsuki Fukushima, Koko Asakura, Toshimitsu Hamasaki, Kaori Onda, Takuya Watanabe, Akira Shiose, Minoru Ono, Norihide Fukushima, Haruko Yamamoto, Tomoyuki Fujita,

<h4>Background</h4>The high surgical risk in redo cardiac surgery is largely attributed to adhesions around the epicardium and the great vessels. BAX602 is an adhesion prevention reagent composed of two synthetic polyethylene glycols. Spraying BAX602 over the epicardium and the great vessels reportedly contributes to adhesion prevention after pediatric cardiac surgery. ... Read more >>

Cardiovasc Drugs Ther (Cardiovascular drugs and therapy)
[2020, 34(5):651-657]

Cited: 0 times

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The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A Julious, Adrian P Mander, Christopher J Weir, Franz Koenig, Marc K Walton, Jon P Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael A Proschan, John A Scott, Yuki Ando, Daniel Hind, Douglas G Altman, ,

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to ... Read more >>

BMJ (BMJ (Clinical research ed.))
[2020, 369:m115]

Cited: 7 times

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The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A Julious, Adrian P Mander, Christopher J Weir, Franz Koenig, Marc K Walton, Jon P Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael A Proschan, John A Scott, Yuki Ando, Daniel Hind, Douglas G Altman, ,

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to ... Read more >>

Trials (Trials)
[2020, 21(1):528]

Cited: 4 times

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A Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients With Advanced Heart Failure - Initial Clinical Experience.

Osamu Seguchi, Tomoyuki Fujita, Nana Kitahata, Keiichiro Iwasaki, Kensuke Kuroda, Seiko Nakajima, Takuya Watanabe, Masanobu Yanase, Satsuki Fukushima, Tomonori Tsukiya, Nobumasa Katagiri, Toshihide Mizuno, Yoshiaki Takewa, Toshimitsu Hamasaki, Kaori Onda, Teruyuki Hayashi, Haruko Yamamoto, Eisuke Tatsumi, Junjiro Kobayashi, Norihide Fukushima,

<h4>Background</h4>Bridge-to-decision (BTD) devices providing temporary mechanical circulatory support should be introduced to patients with advanced heart failure. This study evaluated the effectiveness and safety of a BTD device comprising an innovative extracorporeal continuous-flow temporary ventricular assist device (VAD) driven by a novel hydrodynamically levitated centrifugal flow blood pump.Methods and Results:Nine patients, comprising ... Read more >>

Circ J (Circulation journal : official journal of the Japanese Circulation Society)
[2020, 84(7):1090-1096]

Cited: 0 times

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Thrombolysis With Alteplase at 0.6 mg/kg for Stroke With Unknown Time of Onset: A Randomized Controlled Trial.

Masatoshi Koga, Haruko Yamamoto, Manabu Inoue, Koko Asakura, Junya Aoki, Toshimitsu Hamasaki, Takao Kanzawa, Rei Kondo, Masafumi Ohtaki, Ryo Itabashi, Kenji Kamiyama, Toru Iwama, Taizen Nakase, Yusuke Yakushiji, Shuichi Igarashi, Yoshinari Nagakane, Shunya Takizawa, Yasushi Okada, Ryosuke Doijiri, Akira Tsujino, Yasuhiro Ito, Hideyuki Ohnishi, Takeshi Inoue, Yasushi Takagi, Yasuhiro Hasegawa, Yoshiaki Shiokawa, Nobuyuki Sakai, Masato Osaki, Yoshikazu Uesaka, Shinichi Yoshimura, Takao Urabe, Toshihiro Ueda, Masafumi Ihara, Takanari Kitazono, Makoto Sasaki, Akira Oita, Sohei Yoshimura, Mayumi Fukuda-Doi, Kaori Miwa, Kazumi Kimura, Kazuo Minematsu, Kazunori Toyoda, ,

Background and Purpose- We assessed whether lower-dose alteplase at 0.6 mg/kg is efficacious and safe for acute fluid-attenuated inversion recovery-negative stroke with unknown time of onset. Methods- This was an investigator-initiated, multicenter, randomized, open-label, blinded-end point trial. Patients met the standard indication criteria for intravenous thrombolysis other than a time ... Read more >>

Stroke (Stroke)
[2020, 51(5):1530-1538]

Cited: 10 times

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Does a computed tomography-based navigation system reduce the risk of dislocation after total hip arthroplasty in patients with osteonecrosis of the femoral head? A propensity score analysis.

Kazuma Takashima, Takashi Sakai, Shu Amano, Hidetoshi Hamada, Wataru Ando, Masaki Takao, Toshimitsu Hamasaki, Nobuo Nakamura, Nobuhiko Sugano,

This study aimed to investigate whether use of a computed tomography (CT)-based navigation system reduce the risk of dislocation after total hip arthroplasty (THA) in patients with osteonecrosis of the femoral head (ONFH). A total of 271 hips from 192 consecutive patients that underwent primary THA for ONFH were included. ... Read more >>

J Artif Organs (Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs)
[2020, 23(3):247-254]

Cited: 0 times

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Interim Monitoring for Futility in Clinical Trials with Two Co-primary Endpoints Using Prediction.

Koko Asakura, Scott R Evans, Toshimitsu Hamasaki,

We discuss using prediction as a flexible and practical approach for monitoring futility in clinical trials with two co-primary endpoints. This approach is appealing in that it provides quantitative evaluation of potential effect sizes and associated precision, and can be combined with flexible error-spending strategies. We extend prediction of effect ... Read more >>

Stat Biopharm Res (Statistics in biopharmaceutical research)
[2020, 12(2):164-175]

Cited: 1 time

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Analysis of ordered composite endpoints.

Dean Follmann, Michael P Fay, Toshimitsu Hamasaki, Scott Evans,

Composite endpoints are frequently used in clinical trials, but simple approaches, such as the time to first event, do not reflect any ordering among the endpoints. However, some endpoints, such as mortality, are worse than others. A variety of procedures have been proposed to reflect the severity of the individual ... Read more >>

Stat Med (Statistics in medicine)
[2020, 39(5):602-616]

Cited: 3 times

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Landiolol, an ultra-short acting beta-1 blocker, for preventing postoperative lung cancer recurrence: study protocol for a phase III, multicenter randomized trial with two parallel groups of patients.

Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Takashi Nojiri, Masato Aragaki, Nao Horie, Norihiro Sato, Yasuhiro Hida,

BACKGROUND:Recurrence of cancer after curative surgery is a major problem after most cancer treatments. Increased sympathetic activity during the perioperative period could promote cancer cell invasion to blood vessels and angiogenesis, resulting in cancer metastasis. Recent studies showed that use of beta blockers can be associated with the prolonged survival ... Read more >>

Trials (Trials)
[2019, 20(1):715]

Cited: 2 times

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Antenatal Therapy for Fetal Supraventricular Tachyarrhythmias: Multicenter Trial.

Takekazu Miyoshi, Yasuki Maeno, Toshimitsu Hamasaki, Noboru Inamura, Satoshi Yasukochi, Motoyoshi Kawataki, Hitoshi Horigome, Hitoshi Yoda, Mio Taketazu, Masaki Nii, Akiko Hagiwara, Hitoshi Kato, Wataru Shimizu, Isao Shiraishi, Heima Sakaguchi, Keiko Ueda, Shinji Katsuragi, Haruko Yamamoto, Haruhiko Sago, Tomoaki Ikeda, ,

<h4>Background</h4>Standardized treatment of fetal tachyarrhythmia has not been established.<h4>Objectives</h4>This study sought to evaluate the safety and efficacy of protocol-defined transplacental treatment for fetal supraventricular tachycardia (SVT) and atrial flutter (AFL).<h4>Methods</h4>In this multicenter, single-arm trial, protocol-defined transplacental treatment using digoxin, sotalol, and flecainide was performed for singleton pregnancies from 22 to <37 weeks ... Read more >>

J Am Coll Cardiol (Journal of the American College of Cardiology)
[2019, 74(7):874-885]

Cited: 5 times

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Effects of Teneligliptin on the Progressive Left Ventricular Diastolic Dysfunction in Patients with Type 2 Diabetes Mellitus in Open-Label, Marker-Stratified Randomized, Parallel-Group Comparison, Standard Treatment-Controlled Multicenter Trial (TOPLEVEL Study): Rationale and Study Design.

Miki Imazu, Atsushi Nakano, Shin Ito, Toshimitsu Hamasaki, Masafumi Kitakaze, ,

<h4>Background and aims</h4>Diabetes mellitus (DM) can cause left ventricular (LV) diastolic dysfunction, leading to heart failure with preserved ejection fraction (HFpEF). Dipeptidyl peptidase IV (DPP-IV) inhibitors have failed to reduce hospitalization due to HF in type 2 DM (T2D) patients in a large-scale clinical trial, despite their cardiovascular protective effects. ... Read more >>

Cardiovasc Drugs Ther (Cardiovascular drugs and therapy)
[2019, 33(3):363-370]

Cited: 1 time

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Development and Validation of an Ischemic and Bleeding Risk Evaluation Tool in East Asian Patients Receiving Percutaneous Coronary Intervention.

Jeehoon Kang, Kyung Woo Park, You-Jeong Ki, Jiesuck Park, Taemin Rhee, Chee-Hoon Kim, Jung-Kyu Han, Han-Mo Yang, Hyun-Jae Kang, Bon-Kwon Koo, Masato Nakamura, Toshimitsu Hamasaki, Hiroyoshi Yokoi, David Cohen, Hyo-Soo Kim,

<h4>Background</h4> The ischemic/bleeding risk of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is still uncertain. We sought to develop a tool to predict ischemic and bleeding events in East Asians receiving 2nd generation drug-eluting stents (DESs) PCI.<h4>Methods</h4> A pooled cohort of 13,172 East Asian patients receiving PCI with 2nd generation ... Read more >>

Thromb Haemost (Thrombosis and haemostasis)
[2019, 119(7):1182-1193]

Cited: 3 times

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Evaluating the safety and technical effectiveness of a newly developed intravascular 'flow isolator' stent for the treatment of intracranial aneurysms: study protocol for a first-in-human single-arm multiple-site clinical trial in Japan.

Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Yasuhide Nakayama, Akira Ishii, Hidenori Oishi, Nobuyuki Sakai, Tetsu Satow,

<h4>Introduction</h4>Wide-neck or large intracranial aneurysms are difficult to cure by conventional surgical or endovascular procedures. A flow diverter (FD) is an implantable, stent-like, fine-mesh medical device for the treatment of intracranial aneurysms. Although endovascular treatment with FDs is becoming a routine first-line option, a systematic review noted the heterogeneity and ... Read more >>

BMJ Open (BMJ open)
[2019, 9(5):e020966]

Cited: 1 time

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Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS).

Scott R Evans, Dean Follmann, Ying Liu, Thomas Holland, Sarah B Doernberg, Nadine Rouphael, Toshimitsu Hamasaki, Yunyun Jiang, Judith J Lok, Thuy Tien T Tran, Anthony D Harris, Vance G Fowler, Helen Boucher, Barry N Kreiswirth, Robert A Bonomo, David Van Duin, David L Paterson, Henry Chambers,

Patient management is not based on a single decision. Rather, it is dynamic: based on a sequence of decisions, with therapeutic adjustments made over time. Adjustments are personalized: tailored to individual patients as new information becomes available. However, strategies allowing for such adjustments are infrequently studied. Traditional antibiotic trials are ... Read more >>

Clin Infect Dis (Clinical infectious diseases : an official publication of the Infectious Diseases Society of America)
[2019, 68(11):1961-1967]

Cited: 2 times

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Association of CYP2C19 Polymorphisms With Clopidogrel Reactivity and Clinical Outcomes in Chronic Ischemic Stroke.

Tomotaka Tanaka, Hiroshi Yamagami, Masafumi Ihara, Toshiyuki Miyata, Shigeki Miyata, Toshimitsu Hamasaki, Shu Amano, Kazuki Fukuma, Haruko Yamamoto, Jyoji Nakagawara, Eisuke Furui, Shinichiro Uchiyama, Boohan Hyun, Yasumasa Yamamoto, Yasuhiro Manabe, Yasuhiro Ito, Ryuzo Fukunaga, Takeo Abumiya, Masahiro Yasaka, Kazuo Kitagawa, Kazunori Toyoda, Kazuyuki Nagatsuka,

<h4>Background</h4>CYP2C19variants are associated with the antiplatelet effects of clopidogrel against recurrent cardiovascular events. However, it remains unknown whether the elapsed time from stroke onset affects the relationship between the genetic variants and such events. To address this, we conducted a prospective cohort study to determine the effect ofCYP2C19variants on clinical ... Read more >>

Circ J (Circulation journal : official journal of the Japanese Circulation Society)
[2019, 83(6):1385-1393]

Cited: 6 times

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The Adaptive designs CONSORT Extension (ACE) Statement: A checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven Julious, Adrian Mander, Christopher Weir, Franz Koenig, Marc Walton, Jon Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael Proschan, John Scott, Yuki Ando, Daniel Hind, Douglas Altman,

<h4>Background: </h4> Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are ... Read more >>

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Group-sequential logrank methods for trial designs using bivariate non-competing event-time outcomes.

Tomoyuki Sugimoto, Toshimitsu Hamasaki, Scott R Evans, Susan Halabi,

We discuss the multivariate (2L-variate) correlation structure and the asymptotic distribution for the group-sequential weighted logrank statistics formulated when monitoring two correlated event-time outcomes in clinical trials. The asymptotic distribution and the variance-covariance for the 2L-variate weighted logrank statistic are derived as available in various group-sequential trial designs. These methods ... Read more >>

Lifetime Data Anal (Lifetime data analysis)
[2020, 26(2):266-291]

Cited: 1 time

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