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Randomized Trials

RCT: Safety and efficacy of Eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures.

20 Jun, 2022 | 01:01h | UTC

Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial – The Lancet Neurology (link to abstract – $ for full-text)

 


#CCR22 – RCT: Intravenous Vitamin C increases the risk of death or persistent organ dysfunction in adults with sepsis in the intensive care unit.

16 Jun, 2022 | 11:13h | UTC

Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit – New England Journal of Medicine

Related:

Effect of adjunctive vitamin C, glucocorticoids, and vitamin B1 on longer-term mortality in adults with sepsis or septic shock: a systematic review and a component network meta-analysis – Intensive Care Medicine

Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial – JAMA

Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial – JAMA

 

Commentary on Twitter

https://twitter.com/NEJM/status/1536991910006468608

 


RCT: Discontinuation of Infliximab therapy in patients with Crohn’s disease.

15 Jun, 2022 | 10:54h | UTC

Discontinuation of Infliximab Therapy in Patients with Crohn’s Disease – NEJM Evidence

 


RCT: Marine Omega-3 Fatty acid supplementation does not reduce the incidence of dry eye disease in healthy adults.

10 Jun, 2022 | 12:25h | UTC

Efficacy of Marine ω-3 Fatty Acid Supplementation vs Placebo in Reducing Incidence of Dry Eye Disease in Healthy US Adults: A Randomized Clinical Trial – JAMA Ophthalmology (free for a limited period)

Invited Commentary: Another Disappointment for ω-3 Fatty Acid and Dry Eye Disease – JAMA Ophthalmology (free for a limited period)

 

Commentary on Twitter

 


Neck circumference measurement for surveillance and early detection of hemorrhage after thyroidectomy: a diagnostic accuracy study.

10 Jun, 2022 | 11:39h | UTC

Neck Circumference Measurement for Surveillance and Early Detection of Hemorrhage After Thyroidectomy: A Diagnostic Accuracy Study – JAMA Otolaryngology-Head & Neck Surgery (free for a limited period)

 

Commentary on Twitter

 


RCT: Effect of electronic symptom monitoring on patient-reported outcomes among patients with metastatic cancer.

8 Jun, 2022 | 11:14h | UTC

Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial – JAMA (free for a limited period)

Related:

Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial – Nature Medicine (if the link is paywalled, try this one)

Key components of successful digital remote monitoring in oncology – Nature Medicine

Electronic Health Interventions for Patients With Breast Cancer: Systematic Review and Meta-Analyses – Journal of Clinical Oncology

Efficiency of Electronic Health Record Assessment of Patient-Reported Outcomes After Cancer Immunotherapy: A Randomized Clinical Trial – JAMA Network Open

 


Do we need to reconsider how we design and conduct randomized controlled trials?

8 Jun, 2022 | 10:56h | UTC

Do we need to reconsider how we design and conduct randomized controlled trials? – European Heart Journal – Quality of Care and Clinical Outcomes

 


RCT: Effect of intraoperative handovers of anesthesia care on mortality, readmission, or postoperative complications among adults.

6 Jun, 2022 | 11:04h | UTC

Effect of Intraoperative Handovers of Anesthesia Care on Mortality, Readmission, or Postoperative Complications Among Adults: The HandiCAP Randomized Clinical Trial – JAMA (free for a limited period)

Related Study: Association Between Handover of Anesthesia Care and Adverse Postoperative Outcomes Among Patients Undergoing Major Surgery – JAMA

 

Commentary on Twitter

 


RCTs: Efficacy, safety, and tolerability of Centanafadine sustained-release tablets in adults with attention-deficit/hyperactivity disorder.

3 Jun, 2022 | 11:21h | UTC

Efficacy, Safety, and Tolerability of Centanafadine Sustained-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder: Results of 2 Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Trials – Journal of Clinical Psychopharmacology

 


RCT: Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.

2 Jun, 2022 | 10:49h | UTC

Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract Cancer – NEJM Evidence

 

Commentary on Twitter

 


RCT: Effect of reflectance confocal microscopy for suspect lesions on diagnostic accuracy in melanoma.

2 Jun, 2022 | 10:41h | UTC

Effect of Reflectance Confocal Microscopy for Suspect Lesions on Diagnostic Accuracy in Melanoma: A Randomized Clinical Trial – JAMA Dermatology

 

Commentary on Twitter

 


Randomized Crossover Trial: Effect of a ketogenic diet vs. Mediterranean diet on HbA1c in individuals with prediabetes and type 2 diabetes mellitus.

2 Jun, 2022 | 10:37h | UTC

Effect of a Ketogenic Diet versus Mediterranean Diet on HbA1c in Individuals with Prediabetes and Type 2 Diabetes Mellitus: the Interventional Keto-Med Randomized Crossover Trial – American Journal of Clinical Nutrition

 

Commentary from one of the authors on Twitter (thread – click for more)

 


RCTs: Favipiravir treatment of uncomplicated influenza in adults.

1 Jun, 2022 | 11:27h | UTC

Favipiravir Treatment of Uncomplicated Influenza in Adults: Results of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials – Journal of Infectious Diseases

Commentary: Mixed Bag for Antiviral Favipiravir in Flu — Two phase III trials show conflicting results on clinical improvement – MedPage Today (free registration required)

 


RCT: Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease.

30 May, 2022 | 11:14h | UTC

Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial – The Lancet (link to abstract – $ for full-text)

 


RCTs: Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis.

30 May, 2022 | 11:12h | UTC

Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials – The Lancet (link to abstract – $ for full-text)

 


Randomized crossover trial: Thrice daily consumption of a premeal shot containing a low dose of whey protein increases time in euglycemia during 7 days of free-living in individuals with type 2 diabetes.

30 May, 2022 | 10:57h | UTC

Thrice daily consumption of a novel, premeal shot containing a low dose of whey protein increases time in euglycemia during 7 days of free-living in individuals with type 2 diabetes – BMJ Open Diabetes Research & Care

News Release: Protein supplement helps control Type 2 diabetes – Newcastle University

 


RCT: Efficacy and safety of TRC105 plus pazopanib vs. pazopanib alone for treatment of patients with advanced angiosarcoma.

27 May, 2022 | 11:15h | UTC

Efficacy and Safety of TRC105 Plus Pazopanib vs Pazopanib Alone for Treatment of Patients With Advanced Angiosarcoma: A Randomized Clinical Trial – JAMA Oncology

Commentaries:

Addition of Carotuximab to Pazopanib in Advanced Angiosarcoma – The ASCO Post

Carotuximab addition to pazopanib does not improve survival in advanced angiosarcoma patients – Physician’s Weekly

 

Commentaries on Twitter

 


RCT: The addition of Metformin to standard therapy did not improve outcomes in patients with breast cancer.

25 May, 2022 | 11:49h | UTC

Effect of Metformin vs Placebo on Invasive Disease–Free Survival in Patients With Breast Cancer: The MA.32 Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Who Will Benefit From Metformin? – JAMA Oncology

News Release: Common diabetes drug not effective against early-stage breast cancer, landmark trial reveals – Lunenfeld-Tanenbaum Research Institute

 


RCT: Tenecteplase vs. alteplase for the management of acute ischemic stroke.

20 May, 2022 | 10:43h | UTC

Tenecteplase versus alteplase for the management of acute ischaemic stroke in Norway (NOR-TEST 2, part A): a phase 3, randomised, open-label, blinded endpoint, non-inferiority trial – The Lancet Neurology (link to abstract – $ for full-text)

Commentary: Tenecteplase yields worse safety and functional outcomes compared to alteplase in ischaemic stroke: Lancet – Medical Dialogues

 


Perspective: The need for increased pragmatism in cardiovascular clinical trials.

19 May, 2022 | 10:48h | UTC

The need for increased pragmatism in cardiovascular clinical trials – Nature Reviews Cardiology (if the link is paywalled, try this one)

Related: A roadmap of strategies to support cardiovascular researchers: from policy to practice – Nature Reviews Cardiology (if the link is paywalled, try this one)

 

Commentary on Twitter

 


Study designs for clinical trials applied to personalized medicine: a scoping review.

19 May, 2022 | 10:36h | UTC

Study designs for clinical trials applied to personalised medicine: a scoping review – BMJ Open

 


Visualizing harms in publications of randomized controlled trials: consensus and recommendations.

17 May, 2022 | 10:47h | UTC

Visualising harms in publications of randomised controlled trials: consensus and recommendations – The BMJ

Commentary: Visualising harms: barely scratching the surface – The BMJ

 


RCT: Efficacy and safety of fenfluramine for the treatment of seizures associated With Lennox-Gastaut Syndrome.

16 May, 2022 | 01:29h | UTC

Efficacy and Safety of Fenfluramine for the Treatment of Seizures Associated With Lennox-Gastaut Syndrome: A Randomized Clinical Trial – JAMA Neurology

Commentaries:

Fenfluramine Found Effective for Treatment of Lennox-Gastaut Syndrome Seizures – NeurologyToday

Fenfluramine Seems Effective for Lennox-Gastaut Syndrome – HealthDay

 

Commentary on Twitter

 


Endometrial scratch to increase live birth rates in women undergoing first-time in vitro fertilization: RCT and systematic review.

12 May, 2022 | 07:53h | UTC

Endometrial scratch to increase live birth rates in women undergoing first-time in vitro fertilisation: RCT and systematic review – Health Technology Assessment

Related:

Survey: Despite insufficient evidence of benefit, many fertility specialists still perform endometrial scratching before in vitro fertilization.

Endometrial scratching: what’s the latest evidence? – “we are uncertain whether endometrial injury has an effect on the probability of getting pregnant and having a baby”.

A Randomized Trial of Endometrial Scratching before In Vitro Fertilization – New England Journal of Medicine

 


Phase 2 RCT: Anti-tumor necrosis factor therapy for early-stage Dupuytren’s disease.

9 May, 2022 | 01:38h | UTC

Anti-tumour necrosis factor therapy for early-stage Dupuytren’s disease (RIDD): a phase 2b, randomised, double-blind, placebo-controlled trial – The Lancet Rheumatology

News Release: Breakthrough in treatment for Dupuytren’s disease – University of Oxford

Commentary: Treatment for finger-bending disease may be ‘gamechanger’ – The Guardian

 

Commentary on Twitter

 


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