Additional file 1: of Clinical trial protocol of the ASTER trial: a double-blind, randomized, placebo-controlled phase III trial evaluating the use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

Kaja Tikk (5783993)
David Czock (5783999)
Walter Haefeli (3488264)
Annette Kopp-Schneider (331828)
Hermann Brenner (63649)

Open link

Publication date

September 2018

DOI

10.6084/m9.figshare.7125926.v1

Abstract

List of Ethics Committees who were involved in approval of the trial. (DOCX 20 kb

Extracted data

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Data Protection

Additional file 1: of Clinical trial protocol of the ASTER trial: a double-blind, randomized, placebo-controlled phase III trial evaluating the use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

Kaja Tikk (5783993)
David Czock (5783999)
Walter Haefeli (3488264)
Annette Kopp-Schneider (331828)
Hermann Brenner (63649)

Open link

Publication date

September 2018

DOI

10.6084/m9.figshare.7125926.v1

Abstract

List of Ethics Committees who were involved in approval of the trial. (DOCX 20 kb

Extracted data

Alexandros Papachristofilou (6317657)
Madeleine Hipp (6317660)
Ute Klinkhardt (6317663)
Martin FrĂźh (3880186)
Martin Sebastian (6317666)
Christian Weiss (2271790)
Miklos Pless (456537)
Richard Cathomas (456532)
Wolfgang Hilbe (80072)
Georg Pall (746305)
Thomas Wehler (3500834)
JĂźrgen Alt (6317708)
Helge Bischoff (6317672)
Michael GeiĂler (6317714)
Frank Griesinger (6317678)
Karl-Josef Kallen (6317681)
Mariola Fotin-Mleczek (3614228)
Andreas SchrĂśder (6317717)
Birgit Scheel (6317684)
Anke Muth (2823632)
Tobias Seibel (6317687)
Claudia Stosnach (6317690)
Fatma Doener (6317693)
Henoch Hong (6317696)
Sven Koch (95109)
Ulrike Gnad-Vogt (6317699)
Alfred Zippelius (805066)

February 2019

Table S7. Name of the Ethics Committees that approved the study and approval numbers. (PDF 255 kb

Additional file 1: of All-trans-retinoic acid (ATRA) plus oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX) versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controlled trial

Jie Shi (130059)
Juxian Sun (6648803)
Chang Liu (35901)
Zongtao Chai (6648806)
Nanya Wang (5594705)
Hui Zhang (7197)
Shuqun Cheng (151531)

April 2019

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documen...

Additional file 1: of Safety and antitumor activity of the antiâPD-1 antibody pembrolizumab in patients with advanced, PD-L1âpositive papillary or follicular thyroid cancer

Janice Mehnert (5319737)
Andrea Varga (514916)
Marcia S. Brose (6424007)
Rahul Aggarwal (4428457)
Chia-Chi Lin (1849147)
Amy Prawira (6424016)
Filippo Braud (6424019)
Kenji Tamura (224942)
Toshihiko Doi (616029)
Sarina A. Piha-Paul (524307)
Jill Gilbert (242061)
Sanatan Saraf (4723665)
Pradeep Thanigaimani (6424028)
Jonathan Cheng (763143)
Bhumsuk Keam (77141)

March 2019

Table S1. Institutional Review Board or Ethics Committee of Each Participating Site. Description of ...

Additional file 1: of Multicenter Phase II study of FOLFOX or biweekly XELOX and Erbitux (cetuximab) as first-line therapy in patients with wild-type KRAS/BRAF metastatic colorectal cancer: The FLEET study

Hitoshi Soda (3549392)
Hiromichi Maeda (559299)
Junichi Hasegawa (775868)
Takao Takahashi (59177)
Shoichi Hazama (3549395)
Mutsumi Fukunaga (3494948)
Emiko Kono (3549398)
Masahito Kotaka (3549389)
Junichi Sakamoto (2349769)
Naoki Nagata (3057)
Koji Oba (784642)
Hideyuki Mishima (3494939)

October 2015

Table listing the Central ethics committee and the IRBs of the participating institutes. The IRB of ...

Additional file 4: of CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer

Flavius Sandra-Petrescu (3442181)
Florian Herrle (167200)
Axel Hinke (837661)
Inga Rossion (3442184)
Heiko Suelberg (3442178)
Stefan Post (745319)
Ralf-Dieter Hofheinz (3442175)
Peter Kienle (57754)

November 2015

Local ethics committees. List of all ethics committees which approved the study protocol. (PDF 14 kb

Additional file 1: Table S1. of Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial

Helen Tilbrook (3532466)
Rachael Forsythe (3532448)
Debbie Rolfe (3532475)
Laura Clark (331689)
Martin Bland (222260)
Hannah Buckley (318036)
Ian Chetter (3532478)
Liz Cook (2552587)
Jo Dumville (3532469)
Rhian Gabe (462397)
Keith Harding (2293927)
Alison Layton (3532454)
Ellie Lindsay (3532457)
Catriona McDaid (3532463)
Christine Moffatt (3532445)
Ceri Phillips (3417365)
Gerard Stansby (3532451)
Peter Vowden (3532460)
Laurie Williams (1367556)
David Torgerson (462403)
Robert Hinchliffe (3532472)

November 2015

Previous randomised trials investigating aspirin in the treatment of VLU. (DOCX 15 kb

Additional file 1: of Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial

Achim Kaasch (3529964)
Gerd FĂ¤tkenheuer (3410645)
Reinhild Prinz-Langenohl (3529970)
Ursula Paulus (3529961)
Martin Hellmich (223978)
Verena WeiĂ (3529973)
Norma Jung (364142)
Siegbert Rieg (445802)
Winfried Kern (3529967)
Harald Seifert (124680)

October 2015

List of Ethics Committees and Competent Authorities that approved the trial. (PDF 190 kb

Additional file 1: of Metabolomic and BH3 profiling of esophageal cancers: novel assessment methods for precision therapy

R. Taylor Ripley (5440436)
Deborah Surman (5440427)
Laurence Diggs (5440433)
Jane Trepel (471487)
Min-Jung Lee (279000)
Jeremy Ryan (5440442)
Jeremy Davis (2456887)
Seth Steinberg (5440424)
Jonathan Hernandez (5440439)
Choung Hoang (5440445)
Cara Kenney (5440448)
Colleen Bond (5440421)
Tricia Kunst (5440418)
Anthony Letai (1335960)
David Schrump (5440430)

June 2018

Consent to Participate in a Clinical Research Study: âMetabolomic and BH3 Profiling of Esophageal ...

Additional file 4: of A phase III wait-listed randomised controlled trial of novel targeted inter-professional clinical education intervention to improve cancer patientsâ reported pain outcomes (The Cancer Pain Assessment (CPAS) Trial): study protocol

Jane Phillips (3537983)
Nicole Heneka (6244805)
Melanie Lovell (6244811)
Lawrence Lam (6244814)
Patricia Davidson (2660965)
Frances Boyle (505085)
Nikki McCaffrey (552611)
Sally Fielding (6244826)
Tim Shaw (3537980)

January 2019

Items from the World Health Organization Trial Registration Data Set. (DOCX 15 kb

Additional file 1: of A single-arm phase II trial of combined chemotherapy with S-1, oral leucovorin, and bevacizumab in heavily pre-treated patients with metastatic colorectal cancer

Kazuhisa Yamaguchi (3473369)
Hiroya Taniguchi (3473354)
Azusa Komori (3473363)
Yukiya Narita (3473339)
Sohei Nitta (3473345)
Motoo Nomura (3473360)
Shigenori Kadowaki (3473348)
Daisuke Takahari (3473351)
Takashi Ura (3473366)
Masashi Andoh (3473357)
Kei Muro (3473336)
Keita Mori (428401)
Yoshinori Igarashi (3473342)

August 2015

Summary of chemotherapies for metastatic colorectal cancer in the various setting. (PDF 133Â kb

Additional file 1: of A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1- or BRCA2-mutated HER2-negative advanced breast cancer as first line treatment (REVIVAL): study protocol for a randomized controlled trial

Philip Schouten (3481448)
Gwen Dackus (3481442)
Serena Marchetti (3481445)
Harm van Tinteren (3481451)
Gabe Sonke (3481454)
Jan Schellens (62188)
Sabine Linn (832377)

June 2016

Revival study SPIRIT checklist. Description of the trial protocol with the SPIRIT checklist. (DOC 12...

Additional file 1: of Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial

Caridad Pontes (3471266)
Jordi Gratacós (3442037)
Ferran Torres (180848)
Cristina Avendaño (3471260)
Jesús Sanz (307823)
Antoni Vallano (3471269)
Xavier Juanola (3471263)
Eugenio Miguel (3471254)
Raimon Sanmartí (368935)
Gonzalo Calvo (3471257)

August 2015

Table S1. Listing of the Ethics Committees that reviewed and approved the study protocol

Additional file 1: of Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Daniel Schlessinger (3525056)
Sanjana Iyengar (3525047)
Arianna Yanes (4244107)
Sarah Chiren (4244098)
Victoria Godinez-Puig (379364)
Brian Chen (149932)
Anastasia Kurta (4244104)
Jochen Schmitt (442705)
Stefanie Deckert (4244095)
Karina Furlan (4244101)
Emily Poon (3525038)
Todd Cartee (3525041)
Ian Maher (3525050)
Murad Alam (3525044)
Joseph Sobanko (3525053)

July 2017

SPIRIT checklist. Completed checklist of the study protocol for the development of a core outcome se...

Additional file 1 of Study protocol: fish oil supplement in prevention of oxaliplatin-induced peripheral neuropathy in adjuvant colorectal cancer patients – a randomized controlled trial. (OxaNeuro)

Nina Lykkegaard Gehr (17898280)
Páll Karlsson (17898283)
Signe Timm (5566946)
Signe Christensen (3605513)
Christian Andreas Hvid (17898286)
Jana Peric (17898289)
Torben Frøstrup Hansen (12987262)
Lotte Lauritzen (644882)
Nanna Brix Finnerup (12101776)
Lise Ventzel (16385814)

February 2024

Additional file 1: Supplementary Table 1. Overview of trial outcomes in the OxaNeuro project. Supple...

Additional file 1: of A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol

Inti Qurashi (3475592)
Imran Chaudhry (3475595)
Ameer Khoso (4583791)
Sana Farooque (4583788)
Steve Lane (4583779)
Mohammad Husain (335754)
Simon Chu (364382)
Jane Sarginson (4583782)
Munir Hamarani (4583785)
Haider Naqvi (32862)
Bushra Razzaque (4583794)
Fareed Minhas (4098577)
Alison Yung (3487757)
J. Deakin (3475589)
Nusrat Husain (3475586)

November 2017

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documen...

Alexandros Papachristofilou (6317657)
Madeleine Hipp (6317660)
Ute Klinkhardt (6317663)
Martin FrĂźh (3880186)
Martin Sebastian (6317666)
Christian Weiss (2271790)
Miklos Pless (456537)
Richard Cathomas (456532)
Wolfgang Hilbe (80072)
Georg Pall (746305)
Thomas Wehler (3500834)
JĂźrgen Alt (6317708)
Helge Bischoff (6317672)
Michael GeiĂler (6317714)
Frank Griesinger (6317678)
Karl-Josef Kallen (6317681)
Mariola Fotin-Mleczek (3614228)
Andreas SchrĂśder (6317717)
Birgit Scheel (6317684)
Anke Muth (2823632)
Tobias Seibel (6317687)
Claudia Stosnach (6317690)
Fatma Doener (6317693)
Henoch Hong (6317696)
Sven Koch (95109)
Ulrike Gnad-Vogt (6317699)
Alfred Zippelius (805066)

February 2019

Table S7. Name of the Ethics Committees that approved the study and approval numbers. (PDF 255 kb

Jie Shi (130059)
Juxian Sun (6648803)
Chang Liu (35901)
Zongtao Chai (6648806)
Nanya Wang (5594705)
Hui Zhang (7197)
Shuqun Cheng (151531)

April 2019

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documen...

Additional file 1: of Safety and antitumor activity of the antiâPD-1 antibody pembrolizumab in patients with advanced, PD-L1âpositive papillary or follicular thyroid cancer

Janice Mehnert (5319737)
Andrea Varga (514916)
Marcia S. Brose (6424007)
Rahul Aggarwal (4428457)
Chia-Chi Lin (1849147)
Amy Prawira (6424016)
Filippo Braud (6424019)
Kenji Tamura (224942)
Toshihiko Doi (616029)
Sarina A. Piha-Paul (524307)
Jill Gilbert (242061)
Sanatan Saraf (4723665)
Pradeep Thanigaimani (6424028)
Jonathan Cheng (763143)
Bhumsuk Keam (77141)

March 2019

Table S1. Institutional Review Board or Ethics Committee of Each Participating Site. Description of ...

Hitoshi Soda (3549392)
Hiromichi Maeda (559299)
Junichi Hasegawa (775868)
Takao Takahashi (59177)
Shoichi Hazama (3549395)
Mutsumi Fukunaga (3494948)
Emiko Kono (3549398)
Masahito Kotaka (3549389)
Junichi Sakamoto (2349769)
Naoki Nagata (3057)
Koji Oba (784642)
Hideyuki Mishima (3494939)

October 2015

Table listing the Central ethics committee and the IRBs of the participating institutes. The IRB of ...

Flavius Sandra-Petrescu (3442181)
Florian Herrle (167200)
Axel Hinke (837661)
Inga Rossion (3442184)
Heiko Suelberg (3442178)
Stefan Post (745319)
Ralf-Dieter Hofheinz (3442175)
Peter Kienle (57754)

November 2015

Local ethics committees. List of all ethics committees which approved the study protocol. (PDF 14 kb

Additional file 1: Table S1. of Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial

Helen Tilbrook (3532466)
Rachael Forsythe (3532448)
Debbie Rolfe (3532475)
Laura Clark (331689)
Martin Bland (222260)
Hannah Buckley (318036)
Ian Chetter (3532478)
Liz Cook (2552587)
Jo Dumville (3532469)
Rhian Gabe (462397)
Keith Harding (2293927)
Alison Layton (3532454)
Ellie Lindsay (3532457)
Catriona McDaid (3532463)
Christine Moffatt (3532445)
Ceri Phillips (3417365)
Gerard Stansby (3532451)
Peter Vowden (3532460)
Laurie Williams (1367556)
David Torgerson (462403)
Robert Hinchliffe (3532472)

November 2015

Previous randomised trials investigating aspirin in the treatment of VLU. (DOCX 15 kb

Additional file 1: of Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial

Achim Kaasch (3529964)
Gerd FĂ¤tkenheuer (3410645)
Reinhild Prinz-Langenohl (3529970)
Ursula Paulus (3529961)
Martin Hellmich (223978)
Verena WeiĂ (3529973)
Norma Jung (364142)
Siegbert Rieg (445802)
Winfried Kern (3529967)
Harald Seifert (124680)

October 2015

List of Ethics Committees and Competent Authorities that approved the trial. (PDF 190 kb

Additional file 1: of Metabolomic and BH3 profiling of esophageal cancers: novel assessment methods for precision therapy

R. Taylor Ripley (5440436)
Deborah Surman (5440427)
Laurence Diggs (5440433)
Jane Trepel (471487)
Min-Jung Lee (279000)
Jeremy Ryan (5440442)
Jeremy Davis (2456887)
Seth Steinberg (5440424)
Jonathan Hernandez (5440439)
Choung Hoang (5440445)
Cara Kenney (5440448)
Colleen Bond (5440421)
Tricia Kunst (5440418)
Anthony Letai (1335960)
David Schrump (5440430)

June 2018

Consent to Participate in a Clinical Research Study: âMetabolomic and BH3 Profiling of Esophageal ...

Jane Phillips (3537983)
Nicole Heneka (6244805)
Melanie Lovell (6244811)
Lawrence Lam (6244814)
Patricia Davidson (2660965)
Frances Boyle (505085)
Nikki McCaffrey (552611)
Sally Fielding (6244826)
Tim Shaw (3537980)

January 2019

Items from the World Health Organization Trial Registration Data Set. (DOCX 15 kb

Additional file 1: of A single-arm phase II trial of combined chemotherapy with S-1, oral leucovorin, and bevacizumab in heavily pre-treated patients with metastatic colorectal cancer

Kazuhisa Yamaguchi (3473369)
Hiroya Taniguchi (3473354)
Azusa Komori (3473363)
Yukiya Narita (3473339)
Sohei Nitta (3473345)
Motoo Nomura (3473360)
Shigenori Kadowaki (3473348)
Daisuke Takahari (3473351)
Takashi Ura (3473366)
Masashi Andoh (3473357)
Kei Muro (3473336)
Keita Mori (428401)
Yoshinori Igarashi (3473342)

August 2015

Summary of chemotherapies for metastatic colorectal cancer in the various setting. (PDF 133Â kb

Philip Schouten (3481448)
Gwen Dackus (3481442)
Serena Marchetti (3481445)
Harm van Tinteren (3481451)
Gabe Sonke (3481454)
Jan Schellens (62188)
Sabine Linn (832377)

June 2016

Revival study SPIRIT checklist. Description of the trial protocol with the SPIRIT checklist. (DOC 12...

Caridad Pontes (3471266)
Jordi Gratacós (3442037)
Ferran Torres (180848)
Cristina Avendaño (3471260)
Jesús Sanz (307823)
Antoni Vallano (3471269)
Xavier Juanola (3471263)
Eugenio Miguel (3471254)
Raimon Sanmartí (368935)
Gonzalo Calvo (3471257)

August 2015

Table S1. Listing of the Ethics Committees that reviewed and approved the study protocol

Daniel Schlessinger (3525056)
Sanjana Iyengar (3525047)
Arianna Yanes (4244107)
Sarah Chiren (4244098)
Victoria Godinez-Puig (379364)
Brian Chen (149932)
Anastasia Kurta (4244104)
Jochen Schmitt (442705)
Stefanie Deckert (4244095)
Karina Furlan (4244101)
Emily Poon (3525038)
Todd Cartee (3525041)
Ian Maher (3525050)
Murad Alam (3525044)
Joseph Sobanko (3525053)

July 2017

SPIRIT checklist. Completed checklist of the study protocol for the development of a core outcome se...

Nina Lykkegaard Gehr (17898280)
Páll Karlsson (17898283)
Signe Timm (5566946)
Signe Christensen (3605513)
Christian Andreas Hvid (17898286)
Jana Peric (17898289)
Torben Frøstrup Hansen (12987262)
Lotte Lauritzen (644882)
Nanna Brix Finnerup (12101776)
Lise Ventzel (16385814)

February 2024

Additional file 1: Supplementary Table 1. Overview of trial outcomes in the OxaNeuro project. Supple...

Additional file 1: of A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol

Inti Qurashi (3475592)
Imran Chaudhry (3475595)
Ameer Khoso (4583791)
Sana Farooque (4583788)
Steve Lane (4583779)
Mohammad Husain (335754)
Simon Chu (364382)
Jane Sarginson (4583782)
Munir Hamarani (4583785)
Haider Naqvi (32862)
Bushra Razzaque (4583794)
Fareed Minhas (4098577)
Alison Yung (3487757)
J. Deakin (3475589)
Nusrat Husain (3475586)

November 2017

SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documen...

Alexandros Papachristofilou (6317657)
Madeleine Hipp (6317660)
Ute Klinkhardt (6317663)
Martin FrĂźh (3880186)
Martin Sebastian (6317666)
Christian Weiss (2271790)
Miklos Pless (456537)
Richard Cathomas (456532)
Wolfgang Hilbe (80072)
Georg Pall (746305)
Thomas Wehler (3500834)
JĂźrgen Alt (6317708)
Helge Bischoff (6317672)
Michael GeiĂler (6317714)
Frank Griesinger (6317678)
Karl-Josef Kallen (6317681)
Mariola Fotin-Mleczek (3614228)
Andreas SchrĂśder (6317717)
Birgit Scheel (6317684)
Anke Muth (2823632)
Tobias Seibel (6317687)
Claudia Stosnach (6317690)
Fatma Doener (6317693)
Henoch Hong (6317696)
Sven Koch (95109)
Ulrike Gnad-Vogt (6317699)
Alfred Zippelius (805066)

February 2019

Table S7. Name of the Ethics Committees that approved the study and approval numbers. (PDF 255 kb

Jie Shi (130059)
Juxian Sun (6648803)
Chang Liu (35901)
Zongtao Chai (6648806)
Nanya Wang (5594705)
Hui Zhang (7197)
Shuqun Cheng (151531)

April 2019

SPIRIT 2013 checklist: Recommended items to address in a clinical trial protocol and related documen...

Additional file 1: of Safety and antitumor activity of the antiâPD-1 antibody pembrolizumab in patients with advanced, PD-L1âpositive papillary or follicular thyroid cancer

Janice Mehnert (5319737)
Andrea Varga (514916)
Marcia S. Brose (6424007)
Rahul Aggarwal (4428457)
Chia-Chi Lin (1849147)
Amy Prawira (6424016)
Filippo Braud (6424019)
Kenji Tamura (224942)
Toshihiko Doi (616029)
Sarina A. Piha-Paul (524307)
Jill Gilbert (242061)
Sanatan Saraf (4723665)
Pradeep Thanigaimani (6424028)
Jonathan Cheng (763143)
Bhumsuk Keam (77141)

March 2019

Table S1. Institutional Review Board or Ethics Committee of Each Participating Site. Description of ...

Additional file 1: of Clinical trial protocol of the ASTER trial: a double-blind, randomized, placebo-controlled phase III trial evaluating the use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

Abstract

Extracted data

Additional file 1: of Clinical trial protocol of the ASTER trial: a double-blind, randomized, placebo-controlled phase III trial evaluating the use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms

Abstract

Extracted data

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