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  1. 42021
    “…Efficacy endpoints included overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) per independent radiology review committee in patients with intermediate/poor-risk disease (I/P; primary), intent-to-treat patients (ITT; secondary) and in patients with favourable-risk disease (FAV; exploratory). …”
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    Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial
  2. 42022
    “…Primary analyses were done in the intention-to-treat population. The REPLACE COVID trial is registered with ClinicalTrials.gov, NCT04338009. …”
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    Continuation versus discontinuation of renin–angiotensin system inhibitors in patients admitted to hospital with COVID-19: a prospective, randomised, open-label trial
  3. 42023
    “…At 24-weeks, 97.60% patients in the intent-to-treat (ITT) population (N = 125) and 97.41% patients in the per-protocol (PP) population (N = 116) lost < 15 letters from baseline visual acuity. …”
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    Safety and efficacy of Razumab™ (world’s first biosimilar ranibizumab) in wet age-related macular degeneration: a post-marketing, prospective ASSET study
  4. 42024
    “…Secondary outcomes included assessments of cardiorespiratory fitness (20-m shuttle run), cognitive performance (executive functions, relational memory and processing speed) and mental health (Strength and Difficulties Questionnaire and self-esteem measures). The primary intention-to-treat (ITT) analysis used linear models and structural equation models with cluster-robust standard errors to test for intervention effects. …”
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    The effect of a one-year vigorous physical activity intervention on fitness, cognitive performance and mental health in young adolescents: the Fit to Study cluster randomised controlled trial
  5. 42025
    “…Between March 1 and December 31, 2015, a total of 196 patients (from 274 patients screened) were included and randomly assigned to either the DT group (n = 99) or the TT group (n = 97). In the primary intention-to-treat (ITT) analysis at week 144, 95 patients (96%) in the DT group and 93 patients (95.9%) in the TT group achieved virological inhibition with plasma HIV-1 RNA <50 copies/ml (difference: 0.1%; 95% CI, –4.6–4.7%), meeting the criteria for non-inferiority. …”
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    Antiretroviral Long-Term Efficacy and Resistance of Lopinavir/Ritonavir Plus Lamivudine in HIV-1-Infected Treatment-Naïve Patients (ALTERLL): 144-Week Results of a Randomized, Open-Label, Non-Inferiority Study From Guangdong, China
  6. 42026
    “…Thereof, 212 patients were employed at baseline (modified intention to treat analysis set employed at baseline, mITTe). 61.3% of the mITTe patients had moderate and 17.0% had severe UC. …”
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    Golimumab improves work productivity in patients suffering from moderate to severe ulcerative colitis: results of a prospective study over 24 months
  7. 42027
    por Lopes, Renato D, de Barros e Silva, Pedro Gabriel Melo, Furtado, Remo H M, Macedo, Ariane Vieira Scarlatelli, Bronhara, Bruna, Damiani, Lucas Petri, Barbosa, Lilian Mazza, de Aveiro Morata, Júlia, Ramacciotti, Eduardo, de Aquino Martins, Priscilla, de Oliveira, Aryadne Lyrio, Nunes, Vinicius Santana, Ritt, Luiz Eduardo Fonteles, Rocha, Ana Thereza, Tramujas, Lucas, Santos, Sueli V, Diaz, Dario Rafael Abregu, Viana, Lorena Souza, Melro, Lívia Maria Garcia, de Alcântara Chaud, Mariana Silveira, Figueiredo, Estêvão Lanna, Neuenschwander, Fernando Carvalho, Dracoulakis, Marianna Deway Andrade, Lima, Rodolfo Godinho Souza Dourado, de Souza Dantas, Vicente Cés, Fernandes, Anne Cristine Silva, Gebara, Otávio Celso Eluf, Hernandes, Mauro Esteves, Queiroz, Diego Aparecido Rios, Veiga, Viviane C, Canesin, Manoel Fernandes, de Faria, Leonardo Meira, Feitosa-Filho, Gilson Soares, Gazzana, Marcelo Basso, Liporace, Idelzuíta Leandro, de Oliveira Twardowsky, Aline, Maia, Lilia Nigro, Machado, Flávia Ribeiro, de Matos Soeiro, Alexandre, Conceição-Souza, Germano Emílio, Armaganijan, Luciana, Guimarães, Patrícia O, Rosa, Regis G, Azevedo, Luciano C P, Alexander, John H, Avezum, Alvaro, Cavalcanti, Alexandre B, Berwanger, Otavio
    Publicado 2021
    “…The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. …”
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    Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial
  8. 42028
    “…The primary analysis was by intention-to-treat. In a secondary analysis, we evaluated associations between BASC-3 composite indices and modeled trimester-specific PM(2.5) concentrations inside residences. …”
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    Portable HEPA filter air cleaner use during pregnancy and children’s behavior problem scores: a secondary analysis of the UGAAR randomized controlled trial
  9. 42029
    “…Descriptive statistics will be conducted for primary outcomes, whereas intention-to-treat, multilevel mixed effects analysis for repeated measures will be performed for secondary outcomes. …”
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    A Web-Based Cognitive Bias Modification Intervention (Re-train Your Brain) for Emerging Adults With Co-occurring Social Anxiety and Hazardous Alcohol Use: Protocol for a Multiarm Randomized Controlled Pilot Trial
  10. 42030
    “…A change in treatment has been proposed with the intention to use more effective evidence-based methods that target symptoms of the long-standing presentation and improve prognosis. …”
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    Lived experience perspectives on labeling and defining long-standing anorexia nervosa
  11. 42031
    “…CONCLUSIONS: Results of the premenopausal subgroup in the MONARCH 2 trial were consistent with the improved clinical outcomes observed in the intent-to-treat population. The analysis provides support for the use of abemaciclib plus fulvestrant (with ovarian suppression) as an effective treatment option for premenopausal patients with HR+, HER2- ABC who are ET-resistant. …”
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    Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial
  12. 42032
    por Ashraf, Sohaib, Ashraf, Shoaib, Akmal, Rutaba, Ashraf, Moneeb, Kalsoom, Larab, Maqsood, Aadil, Imran, Muhammad Ahmad, Farooq, Iqra, Ashraf, Sidra, Siddiqui, Uzma Nasim, Ghufran, Muhammad, Akram, Muhammad Kiwan, Majeed, Nighat, Rafique, Sundas, Habib, Zaigham, Shahab, Muhammad Sarmad, Akmal, Adeen, Shaukat, Zeeshan, Abdin, Zain ul, Khaqan, Ayesha, Arshad, Shahroze, Rehman Virk, Muhammad Abdul, Gul, Mehak, Awais, Abeer bin, Hassan, Muhammad, Khalid, Noman, Iqbal, Qurrat Ul Ain, Ahmad, Tausif, Akram, Muaaz, Muhammad, Ameer, Khalil, Musa, Aslam, Aneeq, Umer, Muhammad, Sherazi, Syed Sami Hussain, Safdar, Zartasha, Ahmad, Sohail, Bilal, Muhammad, Zahid, Muhammad Nauman, Koshak, Abdulrahman E., Hilal, Abubakar, Malik, Ahmad Azam, Iqbal, Usman, Baig, Atif Amin, Alahmadi, Yaser Masuod, Humayun, Ayesha, Malik, Amber, Ahmad, Ali, Ashraf, Muhammad, Saboor, Qazi Abdul, Izhar, Mateen
    Publicado 2021
    “…FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. …”
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    Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial
  13. 42033
    “…Inclusion criteria were curative treatment intent, (18)F-FDG PET/CT and EBUS-TBNA prior to start of treatment. …”
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    Patterns of nodal spread in stage III NSCLC: importance of EBUS-TBNA and (18)F-FDG PET/CT for radiotherapy target volume definition
  14. 42034
    “…While likely reflective of intent to optimize resource allocations during the pandemic, maintenance of new practice patterns remains subject to future investigation.…”
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    The Impact of the COVID-19 Pandemic on Practice Patterns in Breast Radiation Oncology: A Case-Based Survey Study in the United States
  15. 42035
    por Ahmed, Tahmeed, Chisti, Mohammod Jobayer, Rahman, Muhammad Waliur, Alam, Tahmina, Ahmed, Dilruba, Parvin, Irin, Kabir, Md. Farhad, Sazawal, Sunil, Dhingra, Pratibha, Dutta, Arup, Deb, Saikat, Chouhan, Aishwarya, Sharma, Anil Kumar, Jaiswal, Vijay Kumar, Dhingra, Usha, Walson, Judd L., Singa, Benson O., Pavlinac, Patricia B., McGrath, Christine J., Nyabinda, Churchil, Deichsel, Emily L., Anyango, Maurine, Kariuki, Kevin Mwangi, Rwigi, Doreen, Tornberg-Belanger, Stephanie N., Kotloff, Karen L., Sow, Samba O., Tapia, Milagritos D., Haidara, Fadima Cheick, Mehta, Ashka, Coulibaly, Flanon, Badji, Henry, Permala-Booth, Jasnehta, Tennant, Sharon M., Malle, Dramane, Bar-Zeev, Naor, Dube, Queen, Freyne, Bridget, Cunliffe, Nigel, Ndeketa, Latif, Witte, Desiree, Ndamala, Chifundo, Cornick, Jennifer, Qamar, Farah Naz, Yousafzai, Mohammad Tahir, Qureshi, Shahida, Shakoor, Sadia, Thobani, Rozina, Hotwani, Aneeta, Kabir, Furqan, Mohammed, Jan, Manji, Karim, Duggan, Christopher P., Kisenge, Rodrick, Sudfeld, Christopher R., Kibwana, Upendo, Somji, Sarah, Bakari, Mohamed, Msemwa, Cecylia, Samma, Abraham, Bahl, Rajiv, De Costa, Ayesha, Simon, Jonathon, Ashorn, Per
    Publicado 2021
    “…Primary analysis included all randomized participants by intention to treat. INTERVENTIONS: Enrolled children were randomly assigned to receive either oral azithromycin, 10 mg/kg, or placebo once daily for 3 days in addition to standard WHO case management protocols for the management of acute watery diarrhea. …”
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    Effect of 3 Days of Oral Azithromycin on Young Children With Acute Diarrhea in Low-Resource Settings: A Randomized Clinical Trial
  16. 42036
    “…Analysis was performed on an intention-to-treat basis. RESULTS: Totally, 40 participants were enrolled (20 in the placebo group and 20 in the sildenafil group); 33 [82.5%] were male; and median age was 57 [IQR 41–68] years. …”
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    Sildenafil for treating patients with COVID-19 and perfusion mismatch: a pilot randomized trial
  17. 42037
    “…Secondary outcomes are alcohol and drug knowledge and intentions, alcohol-related harms, binge drinking, cannabis use, well-being, empowerment, appreciation of cultural diversity, and truancy. …”
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    A Web-Based Alcohol and Other Drug Prevention Program (Strong & Deadly Futures) for Aboriginal and Torres Strait Islander School Students: Protocol for a Cluster Randomized Controlled Trial
  18. 42038
    “…To address the ceiling effect of the PRO/satisfaction data following clavicle injuries, a priori thresholds for ‘suboptimal’ scores were established (ASES scores <90, QuickDASH scores >10, EQ-5D <0.80). According to ‘intention to treat’ statistical principles, one post-operative complication (and a subsequent secondary operation) was analyzed within the non-operative cohort, given that the patient represented a ‘crossover’ from the non-operative to the operative treatment group. …”
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    Two-year Functional Outcomes Of Operative Vs. Non-operative Treatment Of Completely Displaced Midshaft Clavicle Fractures In Adolescents: Results From A Prospective, Multicenter, Level 2 Study
  19. 42039
    “…The primary outcome was weekly rate of GWG expressed as excess GWG, per Institute of Medicine guidelines and mean assessed in the intention-to-treat population. The trial is registered at ClinicalTrials.gov, NCT02130232. …”
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    A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial
  20. 42040
    “…Those effects were not observed in intention-to-treat analyses adjusted for age. Interviewees from the intervention arm (N = 12) reported positive results of iSupport on knowledge and on experiencing positive feelings. …”
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    Feasibility of an online training and support program for dementia carers: results from a mixed-methods pilot randomized controlled trial
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