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  1. Randomized Clinical Trials

    Observational studies suffer from biases and confounding, which can never be completely eliminated. Whenever feasible and ethically appropriate, a...
    Walter R. Palmas in Pocket Evidence Based Medicine
    Chapter 2023
  2. Common Clinical Trial Designs

    Clinical Trials are studies conducted for the purpose of assessing the effect of an intervention in a defined population, or to evaluate one or more...
    Chapter 2023
  3. NeuroEPO plus (NeuralCIM®) in mild-to-moderate Alzheimer’s clinical syndrome: the ATHENEA randomized clinical trial

    Background

    NeuroEPO plus is a recombinant human erythropoietin without erythropoietic activity and shorter plasma half-life due to its low sialic acid...

    Saily Sosa, Giosmany Bringas, ... Daymys Estévez in Alzheimer's Research & Therapy
    Article Open access 13 December 2023
  4. A randomized clinical trial investigating the impact of magnesium supplementation on clinical and biochemical measures in COVID-19 patients

    Background

    This study sought to examine the impact of magnesium supplementation on clinical outcomes and biochemical factors among hospitalized...

    Sepideh Rostami, Seyed Mohammad Alavi, ... Seyed Ahmad Hosseini in Virology Journal
    Article Open access 23 April 2024
  5. Elements of Clinical Trial Protocol Design

    Clinical trials are conducted for many reasons, including to determine whether a new drug is safe and effective for a therapeutic use. A clinical...
    Chapter 2023
  6. AI-enabled electrocardiography alert intervention and all-cause mortality: a pragmatic randomized clinical trial

    The early identification of vulnerable patients has the potential to improve outcomes but poses a substantial challenge in clinical practice. This...

    Chin-Sheng Lin, Wei-Ting Liu, ... Chin Lin in Nature Medicine
    Article 29 April 2024
  7. Bayesian interim analysis for prospective randomized studies: reanalysis of the acute myeloid leukemia HOVON 132 clinical trial

    Randomized controlled trials (RCTs) are the gold standard to establish the benefit-risk ratio of novel drugs. However, the evaluation of mature...

    Niek G. van der Maas, Jurjen Versluis, ... Jan J. Cornelissen in Blood Cancer Journal
    Article Open access 27 March 2024
  8. A randomized clinical trial of mindfulness meditation versus exercise in Parkinson’s disease during social unrest

    Clinical practice guidelines support resilience training and exercise for patients with Parkinson’s disease (PD). This assessor-blinded, randomized...

    Jojo Yan Yan Kwok, Edmond Pui Hang Choi, ... Man Auyeung in npj Parkinson's Disease
    Article Open access 21 January 2023
  9. Novel technique for arterial reconstruction in simultaneous pancreas-kidney transplantation, a randomized clinical trial

    Introduction

    Simultaneous pancreas kidney (SPK) transplantation is an invaluable procedure to enhance the quality of life of insulin-dependent...

    Hassan Karar, Mojtaba Shafiekhani, ... Hamed Nikoupour in BMC Research Notes
    Article Open access 26 October 2023
  10. Effects of intensive lifestyle changes on the progression of mild cognitive impairment or early dementia due to Alzheimer’s disease: a randomized, controlled clinical trial

    Background

    Evidence links lifestyle factors with Alzheimer’s disease (AD). We report the first randomized, controlled clinical trial to determine if...

    Dean Ornish, Catherine Madison, ... Steven E. Arnold in Alzheimer's Research & Therapy
    Article Open access 07 June 2024
  11. Phase I non-randomized clinical trial of allogeneic natural killer cells infusion in acute myeloid leukemia patients

    Introduction

    A new type of immune cell transplantation called allogeneic NK cell infusion is proposed as a potential universal off-the-shelf cell...

    Mohammad Ahmadvand, Mahdieh Shokrollahi Barough, ... Ramin Sarrami-Forooshani in BMC Cancer
    Article Open access 10 November 2023
  12. Effects of flexor reflex stimulation on gait aspects in stroke patients: randomized clinical trial

    Background

    Gait deficits are very common after stroke and therefore an important aspect in poststroke rehabilitation. A currently little used method...

    Aida Sehle, Christian Salzmann, Joachim Liepert in Journal of NeuroEngineering and Rehabilitation
    Article Open access 28 May 2024
  13. Evaluation of a new topical cream to psoriasis treatment: randomized clinical trial

    The aim of this study is to develop a new topical cream for psoriasis and to test its results. Experimental clinical trial. Phase I: hypersensitivity...

    Elizabeth Benites, Esmeralda Carrillo, ... Doménica Bourne in Advances in Traditional Medicine
    Article Open access 17 November 2023
  14. Insights adjusting for non-adherence in randomized clinical trials: a reanalysis of an adjuvant trial of tamoxifen duration in early breast cancer

    Background

    Several randomized clinical trials provide evidence of the survival benefit of extended adjuvant tamoxifen in women with estrogen receptor...

    Fabiola Giudici, Barbara Pistilli, ... Aurelie Bardet in British Journal of Cancer
    Article Open access 11 September 2023
  15. Alliance for clinical trials in Oncology (Alliance) trial A022101/NRG-GI009: a pragmatic randomized phase III trial evaluating total ablative therapy for patients with limited metastatic colorectal cancer: evaluating radiation, ablation, and surgery (ERASur)

    Background

    For patients with liver-confined metastatic colorectal cancer (mCRC), local therapy of isolated metastases has been associated with...

    Kathryn E. Hitchcock, Eric D. Miller, ... Paul B. Romesser in BMC Cancer
    Article Open access 13 February 2024
  16. Safety and efficacy of levetiracetam and carbamazepine monotherapy in the management of pediatric focal epilepsy: a randomized clinical trial

    Due to the limited number of studies in children with focal epilepsy and the importance of choosing the most suitable drug to control seizures in...

    Hadi Montazerlotfelahi, Arsh Haj Mohamad Ebrahim Ketabforoush, ... Sanaz Tajfirooz in Naunyn-Schmiedeberg's Archives of Pharmacology
    Article 24 January 2024
  17. Thyroid V40 is a good predictor for subclinical hypothyroidism in patients with nasopharyngeal carcinoma after intensity modulated radiation therapy: a randomized clinical trial

    Background

    Hypothyroidism (HT) and subclinical HT after radiotherapy is frequent in nasopharyngeal carcinoma (NPC) patients, results in negative...

    Yun Xu, Hewei Peng, ... Jiangfeng Ke in Radiation Oncology
    Article Open access 25 August 2023
  18. Considerations and Advances in Huntington’s Disease Clinical Trial Design

    The characterization of the Huntingtin gene in 1993, 10 years after it was the first disease-associated gene to be mapped to a chromosome in humans,...
    Georgia M. Parkin, Jody Corey-Bloom in Biomarkers for Huntington's Disease
    Chapter 2023
  19. Clinical Trial with Synbiotics in Various Disease State

    Simultaneous use of prebiotics and probiotics for human health benefit is generally called synbiotic. Prebiotics is nonviable nutritional food...
    Satish Shilpi, Prinali Chimaniya, ... Gaurav Saraogi in Synbiotics in Human Health: Biology to Drug Delivery
    Reference work entry 2024
  20. Consolidation chemotherapy after definitive concurrent chemoradiotherapy in patients with inoperable esophageal squamous cell carcinoma: a multicenter non-inferiority phase III randomized clinical trial

    Background

    Definitive concurrent chemoradiotherapy (dCCRT) is the gold standard for the treatment of locally advanced esophageal squamous cell...

    Chengcheng Fan, Xu Wang, ... Hong Ge in BMC Cancer
    Article Open access 07 March 2024
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