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Randomized Trials

RCT: In children with peanut allergy, initiation of peanut oral immunotherapy before age 4 years induced desensitization in 71% of patients and remission in 21%.

24 Jan, 2022 | 08:18h | UTC

Efficacy and safety of oral immunotherapy in children aged 1–3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study – The Lancet (link to abstract – $ for full-text)

News Release: Oral immunotherapy induces remission of peanut allergy in some young children – NIH News Releases

Commentary: Peanut Oral Immunotherapy at Younger Age Ups Desensitization in Children – HealthDay

 

RCT: The addition of trastuzumab to neoadjuvant chemoradiotherapy for HER2-overexpressing esophageal cancer did not improve outcomes.

24 Jan, 2022 | 08:04h | UTC

Trastuzumab with trimodality treatment for oesophageal adenocarcinoma with HER2 overexpression (NRG Oncology/RTOG 1010): a multicentre, randomised, phase 3 trial – The Lancet Oncology (link to abstract – $ for full-text)

Commentary: Trastuzumab with chemoradiation and surgery does not improve outcomes for esophageal cancer patients – NRG Oncology

 

Commentary on Twitter

 

A faster way to find good medical treatments is gaining ground – “A type of clinical trial that tests many therapies at once is being used for COVID and Alzheimer’s”.

24 Jan, 2022 | 07:50h | UTC

A Faster Way to Find Good Medical Treatments Is Gaining Ground – Scientific American

 

Reporting of physicians’ or investigators’ choice of treatment in oncology randomized clinical trials.

24 Jan, 2022 | 07:49h | UTC

Reporting of Physicians’ or Investigators’ Choice of Treatment in Oncology Randomized Clinical Trials – JAMA Network Open

 

Commentary from the author on Twitter (thread – click for more)

 

RCT: Immunogenicity and reactogenicity of different vaccine boosters after a first J&J vaccine.

21 Jan, 2022 | 10:12h | UTC

Immunogenicity and Reactogenicity of Vaccine Boosters after Ad26.COV2.S Priming – New England Journal of Medicine

 

Commentary on Twitter

 

RCT: Lenvatinib plus pembrolizumab improve outcomes compared to chemotherapy in patients with advanced endometrial cancer.

21 Jan, 2022 | 09:46h | UTC

Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer – New England Journal of Medicine

 

Commentary on Twitter

 

The validity of progression-free survival 2 as a surrogate trial end point for overall survival.

21 Jan, 2022 | 09:31h | UTC

The validity of progression-free survival 2 as a surrogate trial end point for overall survival – Cancer (link to abstract – $ for full-text)

 

RCT: In patients with previously untreated Diffuse Large B-Cell Lymphoma, a modified regimen of R-CHOP (pola-R-CHP), in which vincristine was replaced with polatuzumab, was associated with improved outcomes compared to standard R-CHOP treatment.

21 Jan, 2022 | 09:28h | UTC

Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma – New England Journal of Medicine (link to abstract – $ for full-text)

 

RCT: Among patients with recurrent Clostridioides difficile infection, the use of SER-109, an oral microbiome therapy, reduced recurrence rate compared to placebo (12% vs. 40%).

20 Jan, 2022 | 09:11h | UTC

SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection – New England Journal of Medicine (link to abstract – $ for full-text)

 

RCT: In very young children with Type 1 Diabetes, a hybrid closed-loop therapy (“artificial pancreas”) resulted in better glycemic control without increased risk of hypoglycemia vs. sensor-augmented pump therapy.

20 Jan, 2022 | 09:07h | UTC

Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Artificial pancreas proves ‘life-changing’ for very young children with type 1 diabetes and their families – University of Cambridge

 

Cumulative 5-year results of a randomized controlled trial comparing biological Mesh with primary perineal wound closure after extralevator abdominoperineal resection.

20 Jan, 2022 | 08:40h | UTC

Cumulative 5-year Results of a Randomized Controlled Trial Comparing Biological Mesh With Primary Perineal Wound Closure After Extralevator Abdominoperineal Resection (BIOPEX-study) – Annals of Surgery (link to abstract – $ for full-text)

 

Prolonged follow-up of RCT: Emission Tomography–driven strategy in advanced Hodgkin Lymphoma.

19 Jan, 2022 | 08:16h | UTC

Positron Emission Tomography–Driven Strategy in Advanced Hodgkin Lymphoma: Prolonged Follow-Up of the AHL2011 Phase III Lymphoma Study Association Study – Journal of Clinical Oncology (link to abstract – $ for full-text)

 

RCT: Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia.

19 Jan, 2022 | 08:11h | UTC

Safety and efficacy of lower-sodium oxybate in adults with idiopathic hypersomnia: a phase 3, placebo-controlled, double-blind, randomised withdrawal study – The Lancet Neurology (link to abstract – $ for full-text)

Commentary: Mixed Salts Oxybate Improves Daytime Performance in Individuals with Idiopathic Hypersomnia – Practical Neurology

 

Cluster-randomized trial: Antiseptic bathing with 2% chlorhexidine-impregnated cloths and 0.08% octenidine wash mitts were not effective for preventing central-line associated bloodstream infections in intensive care patients.

18 Jan, 2022 | 09:18h | UTC

Effect of antiseptic bathing with chlorhexidine or octenidine on central-line associated bloodstream infections in intensive care patients: a cluster-randomised controlled trial – Clinical Microbiology and Infection

 

Adjuvant Capecitabine for early breast cancer: 15-year overall survival results from a randomized trial.

18 Jan, 2022 | 09:11h | UTC

Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial – Journal of Clinical Oncology

 

RCT: Paclitaxel and Carboplatin noninferior to Paclitaxel and Ifosfamide in patients with carcinosarcoma of the uterus or ovary.

18 Jan, 2022 | 09:10h | UTC

Randomized Phase III Trial of Paclitaxel and Carboplatin Versus Paclitaxel and Ifosfamide in Patients With Carcinosarcoma of the Uterus or Ovary: An NRG Oncology Trial – Journal of Clinical Oncology (link to abstract – $ for full-text)

Commentary: Paclitaxel Plus Carboplatin Is Reportedly Non-Interior to Paclitaxel and Ifosfamide in Uterine Carcinosarcoma – Cancer Network

 

RCT: Sirolimus plus prednisolone vs. sirolimus monotherapy for kaposiform hemangioendothelioma.

18 Jan, 2022 | 09:08h | UTC

Sirolimus plus prednisolone vs sirolimus monotherapy for kaposiform hemangioendothelioma: a randomized clinical trial – Blood (link to abstract – $ for full-text)

 

RCT: Oral Vitamin D supplementation (60.000 IU per month) did not reduce mortality in patients 60 years or older (unscreened individuals in Australia, many without insufficiency, average 30ng/mL). Exploratory analyses pointed towards an increased risk of death from cancer.

16 Jan, 2022 | 23:13h | UTC

The D-Health Trial: a randomised controlled trial of the effect of vitamin D on mortality – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

Related:

Randomized Trial: Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease

Meta-Analysis: Vitamin D Not Effective for Cardiovascular Disease Prevention

Association between vitamin D supplementation and mortality: systematic review and meta-analysis – The BMJ

USPSTF Draft Statement: Insufficient evidence to recommend multivitamin supplements for the prevention of CVD or cancer. The statement also recommends against the use of beta-carotene (increases risk of CVD mortality and lung cancer) or vitamin E (clear evidence of no benefit)

Vitamin D, calcium, other vitamins, and supplements do not prevent cardiovascular diseases

Research: Circulating vitamin D concentration and risk of seven cancers

Research: Vitamin D and risk of total and site specific cancers

 

RCT: Vitamin D supplementation is not beneficial for the prevention of cardiovascular disease and cancer.

16 Jan, 2022 | 23:11h | UTC

Vitamin D supplementation and prevention of cardiovascular disease and cancer in the Finnish Vitamin D Trial-a randomized controlled trial – American Journal of Clinical Nutrition

News Release: Five years of high-dose vitamin D did not affect incidence of cardiovascular disease or cancer – University of Eastern Finland

Related:

Randomized Trial: Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease

Meta-Analysis: Vitamin D Not Effective for Cardiovascular Disease Prevention

Association between vitamin D supplementation and mortality: systematic review and meta-analysis – The BMJ

USPSTF Draft Statement: Insufficient evidence to recommend multivitamin supplements for the prevention of CVD or cancer. The statement also recommends against the use of beta-carotene (increases risk of CVD mortality and lung cancer) or vitamin E (clear evidence of no benefit)

Vitamin D, calcium, other vitamins, and supplements do not prevent cardiovascular diseases

Research: Circulating vitamin D concentration and risk of seven cancers

Research: Vitamin D and risk of total and site specific cancers

 

RCT: In patients undergoing emergency endotracheal intubation, 7-day survival was significantly lower with etomidate vs. ketamine (77.3% versus 85.1%), but 28 survival rates were not significantly different (etomidate 64.1% vs. ketamine 66.8%, p = 0.294).

16 Jan, 2022 | 23:09h | UTC

Etomidate versus ketamine for emergency endotracheal intubation: a randomized clinical trial – Intensive Care Medicine

Commentary: SGEM#356: Drugs are gonna knock you out – etomidate vs. ketamine for emergency endotracheal intubation – The Skeptics’ Guide to EM

 

Commentary on Twitter

 

RCT: Ketamine induced remission in 46% of patients but was NOT non-inferior to electroconvulsive therapy for the treatment of hospitalized patients with unipolar depression.

16 Jan, 2022 | 23:01h | UTC

Racemic Ketamine as an Alternative to Electroconvulsive Therapy for Unipolar Depression: A Randomized, Open-Label, Non-Inferiority Trial (KetECT) – International Journal of Neuropsychopharmacology

News Release: ECT more effective than ketamine in severe depression – Lund University

 

Commentary on Twitter

 

Cluster randomized trial: no added value of duloxetine for patients with chronic pain due to hip or knee osteoarthritis.

16 Jan, 2022 | 22:59h | UTC

No added value of duloxetine for patients with chronic pain due to hip or knee osteoarthritis: a cluster randomised trial – Arthritis & Rheumatism

 

RCT: Colchicine did not significantly reduce the need for intubation or 28-day mortality in patients hospitalized with Covid-19.

14 Jan, 2022 | 08:35h | UTC

Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19: A Randomized Clinical Trial – JAMA Network Open

Related:

M-A: Colchicine doesn’t lessen COVID-19 severity or stave off risk of death.

RECOVERY Trial: In patients admitted to hospital with COVID-19, Colchicine did not reduce 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death.

[Preprint] PRINCIPLE RCT: Colchicine does not improve time to recovery in outpatients with Covid-19 at higher risk of complications.

COLCORONA RCT: Colchicine for community-treated patients with COVID-19 – findings suggest it may lower death and hospital admission rates, but further studies are required.

[Preprint] RECOVERY Trial: Colchicine does not improve outcomes in patients admitted to hospital with COVID-19.

 

Commentary on Twitter

 

RCT: In patients with Parkinson disease uncontrolled with Levodopa, MAO-B inhibitors or dopamine agonists as adjuvant therapies were associated with better patient-rated quality of life compared to COMT inhibitors.

14 Jan, 2022 | 08:15h | UTC

Long-term Effectiveness of Adjuvant Treatment With Catechol-O-Methyltransferase or Monoamine Oxidase B Inhibitors Compared With Dopamine Agonists Among Patients With Parkinson Disease Uncontrolled by Levodopa Therapy: The PD MED Randomized Clinical Trial – JAMA Neurology

 

Commentary on Twitter

 

Phase 2 RCT: In patients with generalized pustular psoriasis, Spesolimab improved lesions at one week but was associated with infections and systemic drug reactions.

14 Jan, 2022 | 08:01h | UTC

Trial of Spesolimab for Generalized Pustular Psoriasis – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Trial of Spesolimab for Generalized Pustular Psoriasis – Mount Sinai

 

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