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Randomized Trials

RCT | Early treatment with Molnupiravir did not reduce hospitalizations in high-risk adults with COVID-19

12 Jan, 2023 | 13:24h | UTC

Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial – The Lancet

Commentaries: 

Molnupiravir does not reduce COVID-19 hospitalisations or deaths in vaccinated, high risk people – National Institute for Health and Care Research

Molnupiravir doesn’t cut Omicron hospitalization, death but can speed recovery – CIDRAP

 

RCT | Effect of pessary vs. surgery in patients with symptomatic pelvic organ prolapse

12 Jan, 2023 | 13:16h | UTC

Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

Commentary: Findings question value of pessary for pelvic organ prolapse – MDedge

 

Commentary on Twitter

 

Phase 2 RCT | Upfront autologous HSCT vs. carfilzomib–cyclophosphamide–dexamethasone consolidation with carfilzomib maintenance in multiple myeloma

12 Jan, 2023 | 12:56h | UTC

Upfront autologous haematopoietic stem-cell transplantation versus carfilzomib–cyclophosphamide–dexamethasone consolidation with carfilzomib maintenance in patients with newly diagnosed multiple myeloma in England and Wales (CARDAMON): a randomised, phase 2, non-inferiority trial – The Lancet Haematology

Invited Commentary: Upfront autologous transplantation still improving outcomes in patients with multiple myeloma – The Lancet Haematology

 

Phase 2 RCT | No benefit from the Bruton’s tyrosine kinase inhibitor Evobrutinib in systemic lupus erythematosus

12 Jan, 2023 | 12:54h | UTC

Efficacy and Safety of the Bruton’s Tyrosine Kinase Inhibitor Evobrutinib in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Trial – ACR Open Rheumatology

 

RCT | In patients with AF undergoing ablation, the addition of posterior wall isolation to pulmonary vein isolation (PVI) was not better than PVI alone

11 Jan, 2023 | 14:33h | UTC

Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The CAPLA Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Catheter Ablation for Persistent Atrial Fibrillation – JAMA (free for a limited period)

See also: Visual abstract

 

RCT | Effect of prescriber notifications of patient’s fatal overdose on opioid prescribing at 4 to 12 months

10 Jan, 2023 | 14:50h | UTC

Effect of Prescriber Notifications of Patient’s Fatal Overdose on Opioid Prescribing at 4 to 12 Months: A Randomized Clinical Trial – JAMA Network Open

News Release: Study suggests one solution to America’s opioid epidemic: Tell doctors their patients fatally overdosed – University of Southern California

 

Commentary on Twitter

 

RCT | Adjuvant nab-Paclitaxel + Gemcitabine in resected pancreatic ductal adenocarcinoma

10 Jan, 2023 | 14:13h | UTC

Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial – Journal of Clinical Oncology

 

SR | Design and conduct of randomized clinical trials evaluating surgical innovations in ophthalmology

10 Jan, 2023 | 14:04h | UTC

Design and conduct of randomized clinical trials evaluating surgical innovations in ophthalmology: A systematic review – American Journal of Ophthalmology (free for a limited period)

 

11 clinical trials that will shape medicine in 2023

9 Jan, 2023 | 14:54h | UTC

11 clinical trials that will shape medicine in 2023 – Nature

 

ESC/AHA/ACC/WHF Joint Opinion | Randomized trials fit for the 21st century

9 Jan, 2023 | 14:44h | UTC

Randomized Trials Fit for the 21st Century: A Joint Opinion From the European Society of Cardiology, American Heart Association, American College of Cardiology, and the World Heart Federation – Circulation

Commentaries:

It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies – TCTMD

World Cardiology Societies Call for Reinvention of Randomized Clinical Trials – Cardiac Interventions Today

 

Commentary on Twitter

 

RCT | Nonoperative vs. operative treatment for displaced finger metacarpal shaft fractures

9 Jan, 2023 | 13:58h | UTC

Nonoperative Versus Operative Treatment for Displaced Finger Metacarpal Shaft Fractures: A Prospective, Noninferiority, Randomized Controlled Trial – The Journal of Bone and Joint Surgery

 

RCT | Chlorthalidone (12.5-25 mg) and Hydrochlorothiazide (25-50 mg) are similarly effective for the prevention of CVD in hypertensive patients.

16 Dec, 2022 | 13:49h | UTC

Chlorthalidone vs. Hydrochlorothiazide for Hypertension–Cardiovascular Events – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: ‘Burden-free’ study method finds two blood pressure drugs equally effective – Veterans Affairs Research Communications

Related (news release and commentaries before publication): RCT | Chlortalidone and Hydrochlorothiazide resulted in similar reductions of CVD in older patients with hypertension.

 

Commentary on Twitter

 

RCTs | Vaccines for Zaire Ebola virus disease.

16 Dec, 2022 | 13:46h | UTC

Randomized Trial of Vaccines for Zaire Ebola Virus Disease – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Ebola vaccine regimens safe, immunogenic in adults and children – NIH News Releases

Commentaries: 

Ebola vaccine strategies show safety and immune response – CIDRAP

Trial on safety and immunogenicity of Ebola vaccines yields promising results – Institut National de la Sante et de la Recherche Medicale

 

Commentary on Twitter

 

Intrapatient RCT | Beremagene Geperpavec (B-VEC) vs. placebo for dystrophic epidermolysis bullosa.

16 Dec, 2022 | 13:34h | UTC

Trial of Beremagene Geperpavec (B-VEC) for Dystrophic Epidermolysis Bullosa – New England Journal of Medicine (link to abstract – $ for full-text)

 

RCT | Zanubrutinib vs. Ibrutinib in relapsed or refractory chronic lymphocytic leukemia.

16 Dec, 2022 | 13:33h | UTC

Zanubrutinib or Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Zanubrutinib Found Superior to Ibrutinib for CLL and SLL – The ASCO Post

 

RCT | Hypophosphataemia following ferric derisomaltose vs. ferric carboxymaltose in patients with iron deficiency anemia due to IBD.

16 Dec, 2022 | 13:15h | UTC

Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD): a randomised clinical trial – Gut

 

Polled analysis of RCTs | Linaclotide reduced response time for irritable bowel syndrome with constipation symptoms.

16 Dec, 2022 | 13:17h | UTC

Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials – The American Journal of Gastroenterology

 

RCT | Mindfulness training and exercise did not improve cognitive function in older adults.

15 Dec, 2022 | 13:48h | UTC

Effects of Mindfulness Training and Exercise on Cognitive Function in Older Adults: A Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual Abstract

News Release: Exercise, mindfulness don’t appear to boost cognitive function in older adults – Washington University School of Medicine

 

Guidelines for reporting outcomes in trial reports: The CONSORT-Outcomes 2022 Extension.

15 Dec, 2022 | 13:45h | UTC

Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension – JAMA (free for a limited period)

See also: Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension – JAMA (free for a limited period)

 

Commentary on Twitter

 

Guidelines for reporting outcomes in trial protocols: The SPIRIT-Outcomes 2022 Extension.

15 Dec, 2022 | 13:46h | UTC

Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension – JAMA (free for a limited period)

See also: Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension – JAMA (free for a limited period)

 

Commentary on Twitter

 

RCT | Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson’s disease.

15 Dec, 2022 | 13:38h | UTC

Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson’s disease: a randomised, double-blind, active-controlled, phase 3 trial – The Lancet Neurology (link to abstract – $ for full-text)

Commentary: Continuous Subcutaneous Carbidopa/Levodopa Demonstrates Benefits in Parkinson Disease Motor Fluctuations, OFF Time – Neurology Live

 

Commentary on Twitter

 

RCT | Comparing bupivacaine alone to liposomal bupivacaine plus bupivacaine in interscalene blocks for total shoulder arthroplasty.

15 Dec, 2022 | 13:36h | UTC

Comparing bupivacaine alone to liposomal bupivacaine plus bupivacaine in interscalene blocks for total shoulder arthroplasty: a randomized, non-inferiority trial – Regional Anesthesia & Pain Medicine

 

RCT | US-guided pudendal nerve block vs. US-guided penile nerve block for analgesia during pediatric circumcision.

15 Dec, 2022 | 13:31h | UTC

Randomized controlled trial (RCT) comparing ultrasound-guided pudendal nerve block with ultrasound-guided penile nerve block for analgesia during pediatric circumcision – Regional Anesthesia & Pain Medicine (link to abstract – $ for full-text)

 

RCT | A calorie-unrestricted low-carbohydrate, high-fat diet resulted in short-term weight loss and better glycemic control.

14 Dec, 2022 | 15:08h | UTC

Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial – Annals of Internal Medicine (link to abstract – $ for full-text)

Commentary: Low-Carbohydrate, High-Fat Diet Beneficial in T2DM in Short Term – HealthDay

Summary for Patients: Effect of Calorie-Unrestricted Low-Carbohydrate, High-Fat Diet Versus High-Carbohydrate, Low-Fat Diet on Type 2 Diabetes and Nonalcoholic Fatty Liver Disease – Annals of Internal Medicine

 

Commentary on Twitter

 

RCT | Optimal treatment duration of bevacizumab as front-line therapy for advanced ovarian cancer.

14 Dec, 2022 | 14:44h | UTC

Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial – Journal of Clinical Oncology (link to abstract – $ for full-text)

Commentary: Treatment With Bevacizumab for 30 Months Provides No Benefit Over 15 Months in Ovarian Cancer – Cancer Network

 

Commentary on Twitter

 

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