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Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene—study protocol for a randomized controlled trial / Kristin Maier, Marius Selig, Andréa Haddouche, Martin Haunschild, Oliver Hauschild, Christoph Lutter, Wolfram Mittelmeier [und 6 weitere Personen]
2024
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Efficacy of supervised immersive virtual reality-based training for the treatment of chronic fatigue in post-COVID syndrome: study protocol for a double-blind randomized controlled trial (IFATICO Trial) / Jonas Tesarz, Hannah Lange, Marietta Kirchner, Axel Görlach, Wolfgang Eich, Hans-Christoph Friederich
2024
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The effects of cool roofs on health, environmental, and economic outcomes in rural Africa: study protocol for a community-based cluster randomized controlled trial / Aditi Bunker, Guillaume Compoaré, Maquins Odhiambo Sewe, Jose Guillermo Cedeno Laurent, Pascal Zabré, Valentin Boudo, Windpanga Aristide Ouédraogo, Lucienne Ouermi, Susan T. Jackson, Nicholas Arisco, Govind Vijayakumar, Ferhat Baran Yildirim, Sandra Barteit, Martina Anna Maggioni, Alistair Woodward, Jonathan J. Buonocore, Mekdim Dereje Regassa, Tilman Brück, Ali Sié and Till Bärnighausen
16 January 2024
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Effects of cognitive training under hypoxia on cognitive proficiency and neuroplasticity in remitted patients with mood disorders and healthy individuals: ALTIBRAIN study protocol for a randomized controlled trial / Kamilla Woznica Miskowiak, Viktoria Damgaard, Johanna Mariegaard Schandorff, Julian Macoveanu, Gitte Moos Knudsen, Annette Johansen, Pontus Plaven-Sigray, Claus Svarer, Caroline Bruun Fussing, Katrine Cramer, Martin Balslev Jørgensen, Lars Vedel Kessing and Hannelore Ehrenreich
03 October 2024
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A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial / Mareike Krämer, Laura Wohlhüter, Lina Hermeling, Jan Koetsenruijter, Martina Kamradt, Michel Wensing and Manuela Bombana
18 June 2024
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UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial / Johanna Wiedemann, Deniz Hos, Endrik Limburg, Ulrike Zettelmeyer, Thomas A. Fuchsluger [und 12 weitere Personen]
2024
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Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan / Emily J. J. Horn-Oudshoorn, Marijn J. Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B. te Pas, Stuart B. Hooper, Suzan C. M. Cochius-den Otter, Rene M. H. Wijnen, Kelly J. Crossley, Neysan Rafat, Thomas Schaible, Willem P. de Boode, Anne Debeer, Berndt Urlesberger, Calum T. Roberts, Florian Kipfmueller, Irma Capolupo, Carmen M. Burgos, Bettina E. Hansen, Irwin K. M. Reiss and Philip L. J. DeKoninck
20 March 2024
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Tranexamic Acid for reduction of intra- and postoperative TRansfusion requirements in elective Abdominal surgery (TATRA): study protocol for an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized superiority trial with two parallel groups / Ulrich Ronellenfitsch, Anita Kestel, Johannes Klose, Artur Rebelo, Michael Bucher, Daniel Ebert, Rafael Mikolajczyk, Andreas Wienke, Thomas Kegel, Julian Hering, Christian Haiduk, Michael Richter, Jörg Steighardt, Erich Grohmann, Lutz Otto & Jörg Kleeff
2024
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Process evaluation of an individually tailored complex intervention to improve activities and participation of older nursing home residents with joint contractures (JointConEval): a mixed-methods study / Regina Thalhammer, Natalie Nguyen, Gabriele Meyer, Stefanie Skudlik, Martin Müller & Katrin Beutner
2024
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Lomustine with or without reirradiation for first progression of glioblastoma, LEGATO, EORTC-2227-BTG: study protocol for a randomized phase III study / Matthias Preusser, Tomáš Kazda, Emilie Le Rhun, Felix Sahm, Marion Smits, Jens Gempt, Johan AF Koekkoek, Angelo F. Monti, Marcell Csanadi, János György Pitter, Helen Bulbek, Beatrice Fournier, Caroline Quoilin, Thierry Gorlia, Michael Weller, Giuseppe Minniti, and on behalf of the European Organisation for Research
07 June 2024
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Telemedicine-based antibiotic stewardship program in pediatrics: study protocol of a stepped wedge cluster randomized trial: the TeleKasper study / Sophie Diexer, Angelika Ihling, Delphina Gomes, Stefan Moritz, Arne Simon, Christian Dohna-Schwake, Rafael Mikolajczyk, Johannes Huebner, Ulrich von Both on behalf of the TeleKasper Consortium
2024
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Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) / Susan Ball, Tessa Reardon, Cathy Creswell, Lucy Taylor, Paul Brown, Tamsin Ford, Alastair Gray, Claire Hill, Bec Jasper, Michael Larkin, Ian Macdonald, Fran Morgan, Jack Pollard, Michelle Sancho, Falko F. Sniehotta, Susan H. Spence, Jason Stainer, Paul Stallard, Mara Violato and Obioha C. Ukoumunne
17 January 2024
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Sacral neuromodulation for constipation and fecal incontinence in children and adolescents - study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique / Manuel Besendörfer, Annemarie Kirchgatter, Roman Carbon, Christel Weiss, Hanna Müller, Klaus E. Matzel and Sonja Diez
22 March 2024
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Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies / Franz Schaefer, Giovanni Montini, Hee Gyung Kang, Johan Vande Walle, Joshua Zaritsky, Michiel F. Schreuder, Mieczyslaw Litwin, Andrea Scalise, Helen Scott, James Potts, Pablo Iveli, Stefanie Breitenstein and Bradley A. Warady
21 March 2024
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EFFects of exposure and cognitive behavioral therapy for chronic BACK pain (“EFFECT-BACK”): study protocol for a randomized controlled trial / Rabea Vogt, Julia Haas, Lukas Baumann, Anja Sander, Christina Klose, Jenny Riecke, Winfried Rief, Ulrike Bingel, Dustin Maser, Michael Witthöft, Jens Keßler, Marco Richard Zugaj, Beate Ditzen and Julia Anna Glombiewski
11 March 2024
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Reducing sick leave, improving work ability, and quality of life in patients with mild to moderate Long COVID through psychosocial, physiotherapeutic, and nutritive supportive digital intervention (MiLoCoDaS): study protocol for a randomized controlled trial / Adrian Krotz, Nadia Sosnowsky-Waschek, Stephanie Bechtel, Christine Neumann, Monika Lohkamp, Gabor Kovacs, Bernd Genser and Joachim E. Fischer
08 December 2023
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Case management and care expertise as a prevention approach for adults with intellectual disabilities (FaPP-MgB): study protocol for a randomized-controlled trial / Stephan Nadolny, Dirk Bruland, Marie Grunwald, Annika Gröndahl, Jessica Grammatico, Miriam Tariba Richter, Christian Grebe, Änne‑Dörte Latteck
2023
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Liver-HERO : hepatorenal syndrome-acute kidney injury (HRS-AKI) treatment with transjugular intrahepatic portosystemic shunt in patients with cirrhosis: a randomized controlled trial / Cristina Ripoll, Stephanie Platzer, Philipp Franken, Rene Aschenbach, Andreas Wienke, Ulrike Schuhmacher, Ulf Teichgräber, Andreas Stallmach, Jörg Steighardt, Alexander Zipprich, Liver-HERO Study Group
2023
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Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial / Rosa Klotz, Markus K. Diener, Thomas Schmidt, Thilo Hackert, Sandra Graf, Hans F. Fuchs, Peter Grimminger, Jan-Hendrick Egberts, Ines Gockel, Pieter C. van der Sluis, Colette Doerr-Harim, Christina Klose, Manuel Feißt and Andre L. Mihaljevic
10 March 2023
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Q-HAM: a multicenter upfront randomized phase II trial of quizartinib and high-dose Ara-C plus mitoxantrone in relapsed/refractory AML with FLT3-ITD / Sonia Jaramillo, Lucian Le Cornet, Markus Kratzmann, Johannes Krisam, Martin Görner, Mathias Hänel, Christoph Röllig, Maxi Wass, Sebastian Scholl, Mark Ringhoffer, Alexander Reichart, Björn Steffen, Sabine Kayser, Jan-Henrik Mikesch, Kerstin Schaefer-Eckart, Jörg Schubert, Thomas Geer, Sonja Martin, Meinhard Kieser, Tim Sauer, Katharina Kriegsmann, Michael Hundemer, Hubert Serve, Martin Bornhäuser, Carsten Müller-Tidow and Richard F. Schlenk
2023
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New ways to cope with depression - study protocol for a randomized controlled mixed methods trial of bouldering psychotherapy (BPT) and mental model therapy (MMT) / Leona Kind, Katharina Luttenberger, Vivien Leßmann, Lisa Dorscht, Christiane Mühle, Christian P. Müller, Eva-Maria Siegmann, Sophia Schneider and Johannes Kornhuber
22 September 2023
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PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant / Tom Degenhardt, Christoph Thomssen [und viele weitere]
2023
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Correction: An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study / Kenji Inoue, Jack Tan Wei Chieh, Lim Chiw Yeh, Shuo-Ju Chiang, Arintaya Phrommintikul, Pannipa Suwanasom, Sazzli Kasim, Bakhtiar Ahmad, Alzamani Mohammad Idrose, Farina Mohd Salleh, Shunsuke Oyamada, Yohei Hirano, Shohei Ouchi, Moriyuki Terakura, Naoyuki Yokoyama, Ken Kozuma, Mamoru Nanasato, Ryosuke Higuchi, Kazuhiko Yumoto, Tomoyuki Fukuzawa, Issei Shimada, Evangelos Giannitsis, Raphael Twerenbold and Tohru Minamino
2023
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Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence: a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial) / Sven Müller, Dirk Weyhe, Florian Herrle, Philipp Horvath, Robert Bachmann, Viktor von Ehrlich-Treuenstätt, Patrick Heger, Nadir Nasir, Christina Klose, Alexander Ritz, Anja Sander, Erich Grohmann, Colette Dörr-Harim and André L. Mihaljevic
01 February 2023
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Drainless robot-assisted minimally invasive oesophagectomy - randomized controlled trial (RESPECT) / B. Müssle, J. Kirchberg, N. Buck, O. Radulova-Mauersberger, D. Stange, T. Richter, B. Müller-Stich, R. Klotz, J. Larmann, S. Korn, A. Klimova, X. Grählert, E. Trips, J. Weitz and T. Welsch
02 May 2023
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Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers - study protocol for the randomised controlled TRIANGLE trial / Patrick Heger, Thilo Hackert, Markus K. Diener, Manuel Feißt, Christina Klose, Colette Dörr-Harim, Friedhelm Möhlenbrock, Markus W. Büchler and André L. Mihaljevic
2023
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Effectiveness of a community health worker-led low-sodium salt intervention to reduce blood pressure in rural Bangladesh: protocol for a cluster randomized controlled trial / Andrew Y. Chang, Mushfiqur Rahman, Animesh Talukder, Humyra Shah, Malay Kanti Mridha, Mehedi Hasan, Malabika Sarker and Pascal Geldsetzer
2023
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Peer PrEP referral + HIV self-test delivery for PrEP initiation among young Kenyan women: study protocol for a hybrid cluster-randomized controlled trial / Njeri Wairimu, Rachel C. Malen, Adriana M. Reedy, Peter Mogere, Irene Njeru, Carlos Culquichicón, Maureen McGowan, Fei Gao, Jared M. Baeten, Kenneth Ngure and Katrina F. Ortblad
04 November 2023
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IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET): study protocol / Zahra Nochi, Hossein Pia, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Francesca Fardo, Bernd Genser, Marcus Goetz, Anna V. Kostenko, Caterina Leone, Thomas Li, André Mouraux, Bernhard Pelz, Esther Pogatzki-Zahn, Andreas Schilder, Erik Schnetter, Karin Schubart, Alexandre Stouffs, Irene Tracey, Iñaki F. Troconiz, Andrea Truini, Johannes Van Niel, Jose Miguel Vela, Katy Vincent, Jan Vollert, Vishvarani Wanigasekera, Matthias Wittayer, Hatice Tankisi, Nanna B. Finnerup, Keith G. Phillips and Rolf-Detlef Treede
19 February 2022
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Correction: G-CuP: the effect of a forced oral glucose intake on alcohol craving and mesolimbic cue reactivity in alcohol dependence: study protocol of a randomized, double-blind, placebo-controlled crossover study / Lea Wetzel, Madeleine Pourbaix, Alisa Riegler, Anna-Maria Pfeifer, Iris Reinhard, Sabine Hofmann, Sabine Vollstädt-Klein, Falk Kiefer, Wolfgang Sommer, Jan Malte Bumb, Patrick Bach and Anne Koopmann
10 November 2022
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G-CuP: the effect of a forced oral glucose intake on alcohol craving and mesolimbic cue reactivity in alcohol dependence-study protocol of a randomized, double-blind, placebo-controlled crossover study / Lea Wetzel, Madeleine Pourbaix, Alisa Riegler, Anna-Maria Pfeifer, Iris Reinhard, Sabine Hoffmann, Sabine Vollstaedt-Klein, Falk Kiefer, Wolfgang Sommer, Jan Malte Bumb, Patrick Bach & Anne Koopmann
19 August 2022
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Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial) / Kornelia Götze, Claudia Bausewein, Berend Feddersen, Angela Fuchs, Amra Hot, Eva Hummers, Andrea Icks, Änne Kirchner, Evelyn Kleinert, Stephanie Klosterhalfen, Henrike Kolbe, Sonja Laag, Henriette Langner, Susanne Lezius, Gabriele Meyer, Joseph Montalbo, Friedemann Nauck, Christine Reisinger, Nicola Rieder, Jan Schildmann, Michaela Schunk, Henrikje Stanze, Christiane Vogel ... [und viele andere]
2022
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Generalizability and reach of a randomized controlled trial to improve oral health among home care recipients: comparing participants and nonparticipants at baseline and during follow-up / Jonas Czwikla, Alexandra Herzberg, Sonja Kapp, Stephan Kloep, Heinz Rothgang, Ina Nitschke, Cornelius Haffner and Falk Hoffmann
2022
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Supporting families to achieve a healthy weight development for their child with overweight/obesity using the STARKIDS intervention: study protocol for a cluster-randomized controlled trial / Katrin Ziser, Florian Junne, Anne Herschbach, Peter Martus, Johann Jacoby, Felicitas Stuber, Zahra Rahmani Azad, Isabelle Mack, Alisa Weiland, Inga Krauß, Constanze Greule, Gorden Sudeck, Lydia Kastner, Guido Zurstiege, Andreas Hoell, Wolfgang Bethge, Torben Sammet, Olaf Schliesing, Stephan Zipfel, Stefan Ehehalt and Katrin E. Giel
23 July 2022
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Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy: the MecMeth/NOA-24 trial / Thomas Zeyen, Anna-Laura Potthoff, Robert Nemeth, Dieter H. Heiland, Michael C. Burger, Joachim P. Steinbach, Peter Hau, Ghazaleh Tabatabai, Martin Glas, Uwe Schlegel, Oliver Grauer, Dietmar Krex, Oliver Schnell, Roland Goldbrunner, Michael Sabel, Niklas Thon, Daniel Delev, Hans Clusmann, Clemens Seidel, Erdem Güresir, Matthias Schmid, Patrick Schuss, Frank A. Giordano, Alexander Radbruch, Albert Becker, Johannes Weller, Christina Schaub, Hartmut Vatter, Judith Schilling, Frank Winkler, Ulrich Herrlinger and Matthias Schneider
19 January 2022
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ALIMUS - we are feeding!: Study protocol of a multi-center, cluster-randomized controlled trial on the effects of a home garden and nutrition counseling intervention to reduce child undernutrition in rural Burkina Faso and Kenya / Isabel Mank, Raissa Sorgho, Fanta Zerbo, Moubassira Kagoné, Boubacar Coulibaly, John Oguso, Michael Mbata, Sammy Khagayi, Erick M.O. Muok, Ali Sié and Ina Danquah
01 June 2022
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Animated, video entertainment-education to improve vaccine confidence globally during the COVID-19 pandemic: an online randomized controlled experiment with 24,000 participants / Simiao Chen, Sebastian Forster, Juntao Yang, Fengyun Yu, Lirui Jiao, Jennifer Gates, Zhuoran Wang, Haitao Liu, Qiushi Chen, Pascal Geldsetzer, Peixin Wu, Chen Wang, Shannon McMahon, Till Bärnighausen and Maya Adam
19 February 2022
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Primary care disease management for venous leg ulceration: study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126) / Jonas D. Senft, Thomas Fleischhauer, Jona Frasch, Wiebke van Rees, Manuel Feißt, Simon Schwill, Christine Fink, Regina Poß-Doering, Michel Wensing, Uwe Müller-Bühl and Joachim Szecsenyi
20 January 2022
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The impact of session-introducing mindfulness and relaxation interventions in individual psychotherapy for children and adolescents: a randomized controlled trial (MARS-CA) / Julia Kalmar, Ines Baumann, Elena Gruber, Eva Vonderlin, Hinrich Bents, Andreas B. Neubauer, Thomas Heidenreich and Johannes Mander
11 April 2022
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APOS - antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms / Oliver Ristow, Christof Hofele, Philipp Münch, Sylvia Danner, Anja Dietzel, Johannes Krisam, Christina Klose, Maximilian Pilz, Jürgen Hoffmann and Christian Freudlsperger
02 November 2021
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Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial / K. Seidensaal, M. Kieser, A. Hommertgen, C. Jaekel, S.B. Harrabi, K. Herfarth, G. Mechtesheimer, B. Lehner, M. Schneider, H. Nienhueser, S. Fröhling, G. Egerer, J. Debus and M. Uhl
12 February 2021
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Minimally Invasive Versus open AbdominoThoracic Esophagectomy for esophageal carcinoma (MIVATE): study protocol for a randomized controlled trial DRKS00016773 / Felix Nickel, Pascal Probst, Alexander Studier-Fischer, Henrik Nienhüser, Jana Pauly, Karl-Friedrich Kowalewski, Sebastian Weiterer, Philipp Knebel, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Thomas Schmidt and Beat P. Müller-Stich
11 Januar 2021
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Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial / Rezvan Ahmadi, Benito Campos, Mohammad Mehdi Hajiabadi, Colette Doerr-Harim, Solveig Tenckhoff, Dirk Rasche, Andreas Unterberg, Jan Vesper, Tom Bruckner and Volker Tronnier
25 January 2021
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Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWERMS2): study protocol for a randomised controlled trial / Anne Christin Rahn, Lisa Wenzel, Andrea Icks, Alexander Stahmann, Jutta Scheiderbauer, Kristina Grentzenberg, Markus Vomhof, Joseph Montalbo, Tim Friede, Christoph Heesen & Sascha Köpke
2021
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Peritoneal flap for lymphocele prophylaxis following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: study protocol and trial update for the randomized controlled PELYCAN study / M. Neuberger, K.F. Kowalewski, V. Simon, F. Wessels, F. Siegel, T.S. Worst, N. Westhoff, J. von Hardenberg, M. Kriegmair, M.S. Michel, P. Honeck and P. Nuhn
29 March 2021
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Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial) / Markus W. Haun, Justus Tönnies, Regina Krisam, Dorothea Kronsteiner, Michel Wensing, Joachim Szecsenyi, Markus Vomhof, Andrea Icks, Beate Wild, Mechthild Hartmann and Hans-Christoph Friederich
05 May 2021
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Understanding and breaking the intergenerational cycle of abuse in families enrolled in routine mental health services: study protocol for a randomized controlled trial and two non-interventional trials investigating mechanisms of change within the UBICA II consortium / C. Neukel, F. Bermpohl, M. Kaess, S. Taubner, K. Boedeker, K. Williams, A. Dempfle, S.C. Herpertz and the UBICA-II consortium
28 October 2021
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Rationale and design of the 2 by 2 factorial design GnG-trial: a randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare double-blinded intensive postremission therapy with or without glasdegib in older patients with newly diagnosed AML / Sonia Jaramillo, Johannes Krisam, Lucian Le Cornet, Markus Kratzmann, Lukas Baumann, Tim Sauer, Martina Crysandt, Andreas Rank, Dirk Behringer, Lino Teichmann, Martin Görner, Ralf-Ulrich Trappe, Christoph Röllig, Stefan Krause, Maher Hanoun, Olaf Hopfer, Gerhard Held, Sebastian Buske, Lars Fransecky, Sabine Kayser, Christoph Schliemann, Kerstin Schaefer-Eckart, Yousef Al-Fareh, Jörg Schubert, Thomas Geer, Martin Kaufmann, Arne Brecht, Dirk Niemann, Meinhard Kieser, Martin Bornhäuser, Uwe Platzbecker, Hubert Serve, Claudia D. Baldus, Carsten Müller-Tidow and Richard F. Schlenk
03 November 2021
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Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery$astudy protocol of a randomized multi-center phase III trial-AkniPro 2 / Christian Scheller, Christian Strauss, Sandra Leisz, Pia Hänel, Ariane Klemm, Simone Kowoll, Iris Böselt, Torsten Rahne, and Andreas Wienke
2021
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RENaBack: low back pain patients in rehabilitation: study protocol for a multicenter, randomized controlled trial / Laura Puerto Valencia, Diamantes Arampatzis, Heidrun Beck, Karsten Dreinhöfer, David Drießlein, Wilfried Mau, Julia-Marie Zimmer, Michael Schäfer, Friedemann Steinfeldt and Pia-Maria Wippert
2021
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Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling / Andreas Deckert, Simon Anders, Manuela De Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Matthias Meurer, Robin Burk, Matthias Sand, Lisa Koeppel, Lena Maier Hein, Tobias Roß, Tim Adler, Tobias Siems, Lucia Brugnara, Stephan Brenner, Konrad Herbst, Daniel Kirrmaier, Yuanqiang Duan, Svetlana Ovchinnikova, Kathleen Boerner, Michael Marx, Hans-Georg Kräusslich, Michael Knop, Till Bärnighausen, Claudia Denkinger
26 September 2021
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Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial / Pia Grabbe, Kathrin M. Gschwendtner, Imad Maatouk, Sophia B. Strobel, Martin Salzmann, Julia Bossert, Wolfgang Eich, Beate Wild, Friedegund Meier, Jessica C. Hassel, and Christiane Bieber
20 April 2021
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Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial / Mitho Müller, Lina Maria Matthies, Maren Goetz, Harald Abele, Sara Yvonne Brucker, Armin Bauer, Johanna Graf, Stephan Zipfel, Lena Hasemann, Markus Wallwiener and Stephanie Wallwiener
17 November 2020
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Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study / A. Isselhard, M. Töpper, B. Berger-Höger, A. Steckelberg, H. Fischer, F. Vitinius, K. Beifus, J. Köberlein-Neu, R. Wiedemann, K. Rhiem, R. Schmutzler, S. Stock
2020
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Process evaluation of a complex intervention to promote advance care planning in community-dwelling older persons (the STADPLAN study): study protocol / Katharina Silies, Rieke Schnakenberg, Almuth Berg, Änne Kirchner, Henriette Langner, Juliane Köberlein-Neu, Gabriele Meyer, Falk Hoffmann & Sascha Köpke
2020
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A randomized open label phase-II clinical trial with or without infusion of plasma from subjects after convalescence of SARS-CoV-2 infection in high-risk patients with confirmed severe SARS-CoV-2 disease (RECOVER): a structured summary of a study protocol for a randomised controlled trial / Maike Janssen, Ulrike Schäkel, Carine Djuka Fokou, Johannes Krisam, Jacek Stermann, Katharina Kriegsmann, Isabella Haberbosch, Jan Philipp Novotny, Stefan Weber, Maria Vehreschild, Martin Bornhäuser, Lars Bullinger, Michael Schmitt, Tobias Liebregts, Peter Dreger, Hanns-Martin Lorenz, Anna Plaszczyca, Ralf Bartenschlager, Barbara Müller, Hans-Georg Kräusslich, Niels Halama, Dirk Jäger, Richard F. Schlenk, Albrecht Leo, Stefan Meuer, Markus A. Weigand, Johann Motsch, Uta Merle, Claudia M. Denkinger and Carsten Müller-Tidow
06 October 2020
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Family conferences and shared prioritisation to improve patient safety in the frail elderly (COFRAIL): study protocol of a cluster randomised intervention trial in primary care / Achim Mortsiefer, Stefan Wilm, Sara Santos, Susanne Löscher, Anja Wollny, Eva Drewelow, Manuela Ritzke, Petra Thürmann, Nina-Kristin Mann, Gabriele Meyer, Jens Abraham, Andrea Icks, Joseph Montalbo, Birgitt Wiese, Attila Altiner and on behalf of the COFRAIL study group
2020
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Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis / Jonathan Wickel, Ha-Yeun Chung, Stephanie Platzer, Thomas Lehmann, Harald Prüss, Frank Leypoldt, Albrecht Günther, André Scherag, Christian Geis
08 July 2020
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Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185] / Natalie Nguyen, Regina Thalhammer, Katrin Beutner, Susanne Saal, Ricarda Servaty, Hanna Klingshirn, Andrea Icks, Kristina Freyberg, Markus Vomhof, Ulrich Mansmann, Lien Le, Martin Müller, Gabriele Meyer
2019
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Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial / Joerg Kaiser, Willem Niesen, Pascal Probst, Thomas Bruckner, Colette Doerr-Harim, Oliver Strobel, Phillip Knebel, Markus K. Diener, André L. Mihaljevic, Markus W. Büchler and Thilo Hackert
07 June 2019
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Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training / Nicole Müller, Kathrin M. Gschwendtner, Sarah Dwinger, Corinna Bergelt, Wolfgang Eich, Martin Härter and Christiane Bieber
7 January 2019
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Evaluation of an international classification of functioning, disability and health-based rehabilitation for thermal burn injuries: a prospective non-randomized design / Hubert Neubauer, Annette Stolle, Sabine Ripper, Felix Klimitz, Hans Ziegenthaler, Mareike Strupat, Ulrich Kneser and Leila Harhaus
20 December 2019
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Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial / Jutta S. Mayer, Katharina Hees, Juliane Medda, Michael Colla, Johannes Thome [und viele weitere]
2018
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(1,3)-β-D-glucan-based diagnosis of invasiveCandida infection versus culture-based diagnosis in patients with sepsis and with an increased risk of invasive Candida infection (CandiSep): study protocol for arandomized controlled trial / Frank Bloos, Jürgen Held, Peter Schlattmann, Nicole Brillinger, Oliver Kurzai, Oliver A. Cornely and Daniel Thomas-Rüddel
2018
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Whole brain radiation therapy alone versus radiosurgery for patients with 1-10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial / Denise Bernhardt, Adriane Hommertgen, Daniela Schmitt, Rami El Shafie, Angela Paul, Laila König, Johanna Mair-Walther, Johannes Krisam, Christina Klose, Thomas Welzel, Juliane Hörner-Rieber, Jutta Kappes, Michael Thomas, Claus Peter Heußel, Martin Steins, Meinhard Kieser, Jürgen Debus and Stefan Rieken
16 July 2018
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Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial / Ulla Klaiber, Lisa M. Stephan-Paulsen, Thomas Bruckner, Gisela Müller, Silke Auer, Ingrid Farrenkopf, Christine Fink, Colette Dörr-Harim, Markus K. Diener, Markus W. Büchler and Phillip Knebel
24 May 2018
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Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial / Tanja Sprave, Stefan Ezechiel Welte, Thomas Bruckner, Robert Förster, Tilman Bostel, Ingmar Schlampp, Nils Henrik Nicolay, Jürgen Debus and Harald Rief
22 January 2018
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Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial / Michael C. Tanner, Raban Heller, Fabian Westhauser, Matthias Miska, Thomas Ferbert, Christian Fischer, Simone Gantz, Gerhard Schmidmaier and Patrick Haubruck
30 May 2018
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Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial / Sandra Funcke, Bernd Saugel, Christian Koch, Thomas Mencke, Amelie Zitzmann, Benedikt Neukirch, Daniel Arnulf Reuter, Sebastian Alois Haas [und viele weitere]
2018
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Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial / Eva Meyerhof, Tanja Sprave, Stefan Ezechiel Welte, Nils H. Nicolay, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Jürgen Debus and Harald Rief
3 March 2017
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Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training?: study protocol for a randomized controlled trial / Javier Rodrigo De La Garza, Karl-Friedrich Kowalewski, Mirco Friedrich, Mona Wanda Schmidt, Thomas Bruckner, Hannes Götz Kenngott, Lars Fischer, Beat-Peter Müller-Stich and Felix Nickel
21 March 2017
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Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial / Stefan Ezechiel Welte, Joachim Wiskemann, Friederike Scharhag-Rosenberger, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Eva Meyerhof, Tanja Sprave, Nils H. Nicolay, Jürgen Debus and Harald Rief
31 March 2017
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Erratum to The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion / U. Teichgräber, R. Aschenbach, D. Scheinert, T. Zeller, K. Brechtel, M. Thieme, E. Blessing, M. Treitl, M. Lichtenberg, P. von Flotow, B. Vogel, M. Werk, V. Riambau, A. Wienke, T. Lehmann and S. Sixt
26 April 2017
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Adjunctive use of physostigmine salicylate (Anticholium®) in perioperative sepsis and septic shock: study protocol for a randomized, double-blind, placebo-controlled, monocentric trial (Anticholium® per Se) / Johannes B. Zimmermann, Nadine Pinder, Thomas Bruckner, Monika Lehmann, Johann Motsch, Thorsten Brenner, Torsten Hoppe-Tichy, Stefanie Swoboda, Markus A. Weigand and Stefan Hofer
10 November 2017
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Intravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial / Rosa Klotz, Stefan Hofer, Alexander Schellhaaß, Colette Dörr-Harim, Solveig Tenckhoff, Thomas Bruckner, Christina Klose, Markus K. Diener, Markus A. Weigand, Markus W. Büchler and Phillip Knebel
11 April 2016
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Acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy in patients without systemic sedation: results of a single-center, double-blinded, randomized controlled trial (DRKS00000164) / Anja Schaible, Katja Schwan, Thomas Bruckner, Konstanze Plaschke, Markus W. Büchler, Markus Weigand, Peter Sauer, Christian Bopp and Phillip Knebel
26 July 2016
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START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial / Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M. Freitag, Robert L. Trestman and Christina Stadler
1 December 2016
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High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial / Harald Rief, Sonja Katayama, Thomas Bruckner, Stefan Rieken, Tilman Bostel, Robert Förster, Ingmar Schlampp, Robert Wolf, Jürgen Debus and Florian Sterzing
2015
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Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial / Felix J. Hüttner, Tom Bruckner, Ingo Alldinger, Roland Hennes, Alexis Ulrich, Markus W. Büchler, Markus K. Diener and Phillip Knebel
2015
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A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial$nElektronische Ressource / Nadja Klafke, Cornelia Mahler, Cornelia von Hagens, Justine Rochon, Andreas Schneeweiss, Andreas Müller, Hans-Joachim Salize and Stefanie Joos
15 February 2015
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A multicenter, randomized, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (CMV, ADV, HSV)-specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients (IVIST01-trial): study protocol for a randomized controlled trial / Thurid Ahlenstiel-Grunow, Armin Koch, Anika Großhennig, Cornelia Frömke, Martina Sester, Urban Sester, Christoph Schröder, Lars Pape
2014
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Tailored implementation for chronic diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries / Cornelia Jäger, Tobias Freund, Jost Steinhäuser, Eivind Aakhus, Signe Flottorp, Maciek Godycki-Cwirko, Jan van Lieshout, Jane Krause, Joachim Szecsenyi and Michel Wensing
21 March 2014
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One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery?: Study protocol for a randomized controlled trial - DRKS00004675 / Felix Nickel, Felix Jede, Andreas Minassian, Matthias Gondan, Jonathan D Hendrie, Tobias Gehrig, Georg R Linke, Martina Kadmon, Lars Fischer and Beat P Müller-Stich
23 April 2014
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Single dental implant retained mandibular complete dentures - influence of the loading protocol: study protocol for a randomized controlled trial / Nicole Passia, Miha Brezavšček, Elfriede Fritzer, Stefanie Kappel, Thomas Kern, Ralph G Luthardt, Nadine Frfr. von Maltzahn, Torsten Mundt, Michael Rädel, Axel von Stein-Lausnitz and Matthias Kern
24 May 2014
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Evaluation of a community health worker intervention and the World Health Organization’s Option B versus Option A to improve antenatal care and PMTCT outcomes in Dar es Salaam, Tanzania: study protocol for a cluster-randomized controlled health systems implementation trial / David Sando, Pascal Geldsetzer, Lucy Magesa, Irene Andrew Lema, Lameck Machumi, Mary Mwanyika-Sando, Nan Li, Donna Spiegelman, Ester Mungure, Hellen Siril, Phares Mujinja, Helga Naburi, Guerino Chalamilla, Charles Kilewo, Anna Mia Ekström, Wafaie W Fawzi, Till W Bärnighausen
15 September 2014
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The calcineurin inhibitor-sparing (CIS) trial - individualised calcineurin-inhibitor treatment by immunomonitoring in renal allograft recipients: protocol for a randomised controlled trial / Claudia Sommerer, Matthias Schaier, Christian Morath, Vedat Schwenger, Geraldine Rauch, Thomas Giese, Martin Zeier
2014
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Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial / Kayvan Bozorgmehr, Joachim Szecsenyi, Dominik Ose, Werner Besier, Manfred Mayer, Johannes Krisam, ..., Hans-Joachim Salize, Ralf Brandner, Sandra Schmitt, Marion Kiel, Martina Kamradt and Tobias Freund
2014
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Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial) / Christine Fink, Markus K. Diener, Thomas Bruckner, Gisela Müller, Lisa Paulsen, Monika Keller, Markus W. Büchler and Phillip Knebel
26 August 2013
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INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder: a multicenter randomized controlled trial / Martina de Zwaan, Stephan Herpertz, Stephan Zipfel, Brunna Tuschen-Caffier, Hans-Christoph Friederich, Frauke Schmidt, Olaf Gefeller, Andreas Mayr, Tony Lam, Carmen Schade-Brittinger, and Anja Hilbert
2012
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The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand / Annelies Wilder-Smith, Peter Byass, Phanthip Olanratmanee, Pongsri Maskhao, Luechai Sringernyuang, James G. Logan, Steve W. Lindsay, Sarah Banks, Duane Gubler, Valérie R. Louis, Yesim Tozan and Pattamaporn Kittayapong
2012
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LigaSure Impact versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial / Tobias Gehrig, Phillip Knebel, Verena Scheel, Ulf Hinz, Christoph M Seiler, Beat P Müller-Stich, Markus W Büchler and Carsten N Gutt
29 June 2011
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Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial (ISRCTN56104508) / Tobias Freund, Frank Peters-Klimm, Justine Rochon, Cornelia Mahler, Jochen Gensichen, Antje Erler, Martin Beyer, Annika Baldauf, Ferdinand M. Gerlach and Joachim Szecsenyi
29 June 2011
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Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration / Andrew J. Vickers, Angel M. Cronin, Alexandra C. Maschino, George Lewith, Hugh Macpherson, Norbert Victor, Karen J. Sherman, Claudia Witt, Klaus Linde, the Acupuncture Trialists' Collaboration
28 September 2010