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Randomized Trials

RCT: Dolutegravir or Darunavir in combination with Zidovudine or Tenofovir to treat HIV.

23 Jul, 2021 | 10:25h | UTC

Dolutegravir or Darunavir in Combination with Zidovudine or Tenofovir to Treat HIV – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Dolutegravir Confirmed as Effective Second-Line HIV Therapy; Recycling Tenofovir Noninferior to Zidovudine – Medscape (free registration required)

 

RCT: Sintilimab plus a bevacizumab biosimilar versus sorafenib in unresectable hepatocellular carcinoma.

22 Jul, 2021 | 10:47h | UTC

Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2–3 study – The Lancet Oncology (link to abstract – $ for full-text)

Commentary: Sintilimab Plus Bevacizumab Biosimilar vs Sorafenib in Unresectable or Metastatic HBV-Associated Hepatocellular Carcinoma – The ASCO Post

 

Commentary on Twitter

 

RCT: Immediate oral refeeding in patients with mild and moderate acute pancreatitis.

22 Jul, 2021 | 10:32h | UTC

Immediate Oral Refeeding in Patients With Mild and Moderate Acute Pancreatitis: A Multicenter, Randomized Controlled Trial (PADI trial) – Annals of Surgery (link to abstract – $ for full-text)

 

RCT: No benefit from platelet-rich plasma injection for patients with debilitating Achilles tendinopathy.

18 Jul, 2021 | 23:13h | UTC

Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial – JAMA (free for a limited period)

Commentary: No benefit from PRP treatment for patients with debilitating Achilles tendon pain – University of Warwick

 

Commentary on Twitter

 

RCT: Effect of neurofeedback facilitation on poststroke gait and balance recovery.

16 Jul, 2021 | 10:30h | UTC

Effect of Neurofeedback Facilitation on Poststroke Gait and Balance Recovery: A Randomized Controlled Trial – Neurology

Commentary: Neurofeedback Facilitation Improves Gait and Balance in Post-Stroke Patients – BrainPost

 

RCT: Bamlanivimab plus Etesevimab reduce mortality and hospitalization in ambulatory patients with early Covid-19 (within 3 days of a positive test) who are at risk for clinical deterioration (i.e., older people, obese, diabetics, immunocompromised, with CV disease).

15 Jul, 2021 | 09:26h | UTC

Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19 – New England Journal of Medicine

 

RCT: Intravitreal ranibizumab vs. aflibercept vs. bevacizumab for macular edema due to central retinal vein occlusion.

15 Jul, 2021 | 09:09h | UTC

Intravitreal ranibizumab versus aflibercept versus bevacizumab for macular oedema due to central retinal vein occlusion: the LEAVO non-inferiority three-arm RCT – Health Technology Assessment

 

Another RCT evaluating the efficacy and quality of life of antibiotic-only treatment of acute uncomplicated appendicitis.

13 Jul, 2021 | 09:33h | UTC

A Randomized Clinical Trial Evaluating the Efficacy and Quality of Life of Antibiotic-only Treatment of Acute Uncomplicated Appendicitis: Results of the COMMA Trial – Annals of Surgery (link to abstract – $ for full-text)

Related: A Randomized trial comparing antibiotics with appendectomy for appendicitis AND Antibiotics alone for uncomplicated appendicitis: Oral Moxifloxacin almost as good as intravenous Ertapenem + oral Levofloxacin AND Observational study: 67.1% success rate with nonoperative management of children with uncomplicated appendicitis AND Randomized Trial: Quality of Life and Patient Satisfaction at 7-Year Follow-up of Antibiotic Therapy vs. Appendectomy for Uncomplicated Acute Appendicitis AND Meta-Analysis: Antibiotic Treatment vs. Appendectomy for Uncomplicated Acute Appendicitis in Adults and Children AND Nonoperative treatment for nonperforated appendicitis in children: a systematic review and meta-analysis – Pediatric Surgery International

 

Commentary on Twitter

 

RCT: Traditional plaster casting immobilization not superior to removable brace in adults with an ankle fracture.

12 Jul, 2021 | 01:22h | UTC

Use of cast immobilisation versus removable brace in adults with an ankle fracture: multicentre randomised controlled trial – The BMJ

News release: Cast no better than brace for broken ankles – University of Warwick

 

RCT: MRI can cut overdiagnoses in prostate-cancer screening by half.

9 Jul, 2021 | 10:03h | UTC

MRI-Targeted or Standard Biopsy in Prostate Cancer Screening – New England Journal of Medicine (link to abstract – $ for full-text)

News release: MRI can cut overdiagnoses in prostate-cancer screening by half – Karolinska Institutet

Related articles: RCT: MRI-targeted biopsy safely reduces the need for biopsy in more than one-third of men at risk for prostate cancer AND Meta-Analysis: Negative Predictive Value of MRI in the Detection of Clinically Significant Prostate Cancer AND Study: MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis AND Review: The Use of MRI and PET Imaging Studies for Prostate Cancer Management AND Meta-Analysis: MRI plus Targeted Biopsy vs. Systematic Biopsy Alone for the Diagnosis of Prostate Cancer AND Cochrane Review: MRI Pathway vs. Systematic Biopsy for Detecting Prostate Cancer AND Meta-analysis: Clinical Utility of MRI in the Decision-making Process Before Radical Prostatectomy AND Research: Biparametric MRI (simpler, faster) May Be Used to Exclude Aggressive Disease and Avoid Unnecessary Biopsies in Men with Clinical Suspicion of Prostate Cancer AND Research: MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis AND Multiparametric MRI in the Detection of Clinically Significant Prostate Cancer

 

RCT: Cardiovascular and renal outcomes with Efpeglenatide (a GLP-1 receptor agonist) in Type 2 Diabetes.

7 Jul, 2021 | 08:45h | UTC

Cardiovascular and Renal Outcomes with Efpeglenatide in Type 2 Diabetes – New England Journal of Medicine

Commentary: Efpeglenatide Cuts Risk of CV Events and Kidney Disease in High-Risk T2D Patients, Regardless of SGLT2 Status – AJMC

 

RCT: Daratumumab-based treatment for immunoglobulin light-chain amyloidosis.

7 Jul, 2021 | 08:44h | UTC

Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis – New England Journal of Medicine

 

RCT: Similar long-term survival after combined epidural–general anesthesia vs. general anesthesia alone.

7 Jul, 2021 | 08:39h | UTC

Long-term Survival after Combined Epidural–General Anesthesia or General Anesthesia Alone: Follow-up of a Randomized Trial – Anesthesiology

See also: Delirium in Older Patients after Combined Epidural–General Anesthesia or General Anesthesia for Major Surgery: A Randomized Trial – Anesthesiology

 

Commentary on Twitter

 

RCT: Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19 – no difference in intubation rates compared to standard care.

5 Jul, 2021 | 02:24h | UTC

Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19: the PROFLO multicenter randomized clinical trial – Critical Care

Related: Feasibility and Physiological Effects of Prone Positioning in Non-intubated Patients with Acute Respiratory Failure due to COVID-19

 

RCT: Prophylactic manual rotation of occiput posterior and transverse positions was associated with a reduced risk of operative delivery.

5 Jul, 2021 | 01:28h | UTC

Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial – American Journal of Obstetrics & Gynecology (link to abstract – $ for full-text)

 

Single-center, open-label RCT: Stimulant and osmotic laxatives after colorectal surgery results in earlier recovery of gastrointestinal function and reduces the incidence of prolonged postoperative ileus, without effects in the duration of hospital day or 30-day postoperative complications.

5 Jul, 2021 | 01:26h | UTC

Impact of STIMUlant and osmotic LAXatives (STIMULAX trial) on gastrointestinal recovery after colorectal surgery: randomized clinical trial – British Journal of Surgery (link to abstract – $ for full-text)

 

RCT: Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache.

5 Jul, 2021 | 01:24h | UTC

Safety and efficacy of occipital nerve stimulation for attack prevention in medically intractable chronic cluster headache (ICON): a randomised, double-blind, multicentre, phase 3, electrical dose-controlled trial – The Lancet Neurology (link to abstract – $ for full-text)

Commentary: Nerve stimulation effective in patients with untreatable cluster headaches – Leiden University

 

RCT: Novavax vaccine conferred 89.7% protection against symptomatic SARS-CoV-2 infection and 100% protection against hospitalizations or deaths.

1 Jul, 2021 | 09:59h | UTC

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine – New England Journal of Medicine

Audio interview: Audio Interview: Another New Covid-19 Vaccine – New England Journal of Medicine

Related: Opinion | The mRNA vaccines are extraordinary, but Novavax is even better

 

RCT: Similar outcomes with 5 vs. 2 years of zoledronate treatment following adjuvant chemotherapy in early breast cancer.

1 Jul, 2021 | 09:50h | UTC

Outcomes With 5 vs 2 Years of Zoledronate Treatment Following Adjuvant Chemotherapy in Early Breast Cancer – The ASCO Post

Original Study: Prognosis of Patients With Early Breast Cancer Receiving 5 Years vs 2 Years of Adjuvant Bisphosphonate Treatment: A Phase 3 Randomized Clinical Trial – JAMA Oncology (link to abstract – $ for full-text)

 

RCT: Similar outcomes with mycophenolate mofetil vs. azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression.

29 Jun, 2021 | 09:50h | UTC

Mycophenolate mofetil versus azathioprine in kidney transplant recipients on steroid-free, low-dose cyclosporine immunosuppression (ATHENA): A pragmatic randomized trial – PLOS One

 

Guidelines for reporting trial protocols and completed trials modified due to the COVID-19 pandemic and other extenuating circumstances: The CONSERVE 2021 Statement.

22 Jun, 2021 | 10:04h | UTC

Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances: The CONSERVE 2021 Statement – JAMA

 

Commentaries on Twitter

 

RCT: Routine use of prophylactic postoperative continuous positive airway pressure (CPAP) does not prevent pneumonia, re-intubation, and death after major abdominal surgery.

21 Jun, 2021 | 08:32h | UTC

Postoperative continuous positive airway pressure to prevent pneumonia, re-intubation, and death after major abdominal surgery (PRISM): a multicentre, open-label, randomised, phase 3 trial – The Lancet Respiratory Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter (thread – click for more)

 

RCT: Effects of intravenous Eptinezumab vs. placebo on headache pain and most bothersome symptom when initiated during a migraine attack.

18 Jun, 2021 | 08:16h | UTC

Effects of Intraven.ous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Acute Treatment for Migraine: Contemporary Treatments and Future Directions (free for a limited period)

Commentary: Migraine Prevention Drug Eptinezumab Shows Efficacy in Treating Acute Attacks – Physician’s Weekly

 

Commentary on Twitter (thread – click for more)

 

[Preprint] RECOVERY trial finds Regeneron’s monoclonal antibody combination reduces deaths for hospitalized COVID-19 patients who have not mounted their own immune response.

17 Jun, 2021 | 09:55h | UTC

News release: RECOVERY trial finds Regeneron’s monoclonal antibody combination reduces deaths for hospitalised COVID-19 patients who have not mounted their own immune response

Original study (preprint): Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial – medRxiv

Commentaries: Monoclonal antibodies cut risk of dying from COVID-19—but only in some patients – Science AND Antibody combo cuts COVID deaths by 20% in very ill seronegative patients – CIDRAP AND Regeneron antibody saves lives in some hospitalized Covid patients, study finds – STAT AND Expert reaction to press release from the RECOVERY trial reporting that Regeneron’s monoclonal antibody combination reduces deaths for hospitalised COVID-19 patients who have not mounted their own immune response – Science Media Centre

 

Commentary on Twitter

 

RCT: In patients with coma after out-of-hospital cardiac arrest, targeted hypothermia did not improve outcomes.

17 Jun, 2021 | 09:39h | UTC

Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest – New England Journal of Medicine

News release: Induced hypothermia after cardiac arrest did not improve survival – Lund University

Infographic: The TTM2 Trial – CanadianEM

Commentary: Hypothermia or Normothermia after Cardiac Arrest – NEJM Resident 360

Video: TTM2 Results Presentation Livestream – Critical Care Reviews

 

Commentary on Twitter (thread – click for more)

 

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