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Randomized Trials

[News release – not published yet] RCT: Minimally invasive approach to hysterectomy in cervical cancer is associated with poorer disease-free survival than open surgery.

24 Mar, 2022 | 08:47h | UTC

Minimally Invasive Approach to Hysterectomy in Cervical Cancer Associated with Poorer Disease-Free Survival Than Open Surgery – Society of Gynecologic Oncology

 


RCT: Effect of a physical activity and behavior maintenance program on functional mobility decline in older adults.

22 Mar, 2022 | 09:47h | UTC

Effect of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: the REACT (Retirement in Action) randomised controlled trial – The Lancet Public Health

See also: Cost-effectiveness of a physical activity and behaviour maintenance programme on functional mobility decline in older adults: an economic evaluation of the REACT (Retirement in Action) trial – The Lancet Public Health

News Release: Landmark study demonstrates long-term positive impacts and cost effectiveness of tailored group exercise for over-65s with mobility limitations

Invited Commentary: Considerations for maintaining functional mobility in older populations – The Lancet Public Health

 


RCT: Levothyroxine is not beneficial for euthyroid thyroid peroxidase antibody positive women with recurrent pregnancy loss.

22 Mar, 2022 | 08:24h | UTC

Levothyroxine in euthyroid thyroid peroxidase antibody positive women with recurrent pregnancy loss (T4LIFE trial): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

Commentary: Levothyroxine No Boon for Birth Rates in Women With Possible Thyroid Disorder – MedPage Today (free registration required)

 


Phase 2 RCT: Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy.

22 Mar, 2022 | 07:59h | UTC

Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial – The Lancet

Commentary: Cellular therapy improves signs and symptoms of Duchenne muscular dystrophy – University of California – Davis Health

 

Commentary on Twitter

 


RCT: Efficacy and acceptability of dietary therapies in non-constipated irritable bowel syndrome: a randomized trial of traditional dietary advice, the low FODMAP diet and the gluten-free diet.

21 Mar, 2022 | 08:53h | UTC

Efficacy and Acceptability of Dietary Therapies in Non-Constipated Irritable Bowel Syndrome: A Randomized Trial of Traditional Dietary Advice, the Low FODMAP Diet and the Gluten-Free Diet – Clinical Gastroenterology and Hepatology

Commentary: Traditional Dietary Advice Optimal as an Irritable Bowel Syndrome Therapy – HCPLivre

Related:

10 mistakes in dietary management of irritable bowel syndrome and how to avoid them.

Supplement: Irritable bowel syndrome and related conditions.

RCT: FODMAPs, but not gluten, elicit modest symptoms of irritable bowel syndrome.

RCT: Among patients with diarrhea-predominant irritable bowel syndrome, a low FODMAP diet achieved earlier symptomatic improvements in stool frequency and excessive wind.

British Society of Gastroenterology guidelines on the management of irritable bowel syndrome

Guidelines for the treatment of irritable bowel syndrome

ACG Clinical Guideline: Management of irritable bowel syndrome

M-A: Efficacy of a low-FODMAP diet in adult irritable bowel syndrome

 


RCT: Imaging modality (CT vs. MRI) and frequency (seven scans over 60 months vs. three scans over 36 months) in surveillance of Stage I Seminoma Testicular Cancer.

21 Mar, 2022 | 08:39h | UTC

Imaging Modality and Frequency in Surveillance of Stage I Seminoma Testicular Cancer: Results From a Randomized, Phase III, Noninferiority Trial (TRISST) – Journal of Clinical Oncology (link to abstract – $ for full-text)

 


RCT: Early symptomatic improvement after ustekinumab therapy in patients with ulcerative colitis.

21 Mar, 2022 | 08:26h | UTC

Early symptomatic improvement after ustekinumab therapy in patients with ulcerative colitis: 16-week data from the UNIFI trial – Clinical Gastroenterology and Hepatology (link to abstract – $ for full-text)

 


RCT: Nebulized Poractant Alfa in premature babies with respiratory distress syndrome.

21 Mar, 2022 | 08:25h | UTC

A Randomized, Controlled Trial to Investigate the Efficacy of Nebulized Poractant Alfa in Premature Babies with Respiratory Distress Syndrome – The Journal of Pediatrics

Commentary: Should we give up on nebulised surfactant? – Neonatal Research

 

Commentary on Twitter

 


RCT: Cocoa flavanol supplementation shows promise for the prevention of cardiovascular disease events.

18 Mar, 2022 | 08:54h | UTC

Effect of cocoa flavanol supplementation for prevention of cardiovascular disease events: The COSMOS randomized clinical trial – American Journal of Clinical Nutrition

Commentary: New trial finds signs of preventive cardiovascular effects for cocoa flavanols – Brigham and Women’s Hospital

 

Commentary on Twitter (thread – click for more)

 


Phase 2 RCT: Prophylactic use of garadacimab in patients with hereditary angioedema.

18 Mar, 2022 | 08:09h | UTC

Prophylactic use of an anti-activated factor XII monoclonal antibody, garadacimab, for patients with C1-esterase inhibitor-deficient hereditary angioedema: a randomised, double-blind, placebo-controlled, phase 2 trial – The Lancet (link to abstract – $ for full-text)

Commentary: Garadacimab significantly reduces frequency of hereditary angioedema exacerbations – Physician’s Weekly

 


RCT: Oral contezolid vs. linezolid in adults with complicated skin and soft tissue infections.

18 Mar, 2022 | 07:54h | UTC

A Phase III multicentre, randomized, double-blind trial to evaluate the efficacy and safety of oral contezolid versus linezolid in adults with complicated skin and soft tissue infections – Journal of Antimicrobial Therapy (link to abstract – $ for full-text)

 

Commentary on Twitter

 


RCT: Short-term radiotherapy plus chemotherapy vs. long-term chemoradiotherapy in locally advanced rectal cancer.

18 Mar, 2022 | 07:39h | UTC

Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR) – Journal of Clinical Oncology

 


RCT: In women undergoing cytoreductive surgery for ovarian cancer, the addition of hyperthermic intraperitoneal chemotherapy did not improve progression-free and overall survival.

16 Mar, 2022 | 09:41h | UTC

Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial – JAMA Surgery

Related:

M-A: Secondary cytoreductive surgery in platinum-sensitive recurrent ovarian cancer.

RCT: Cytoreductive surgery for relapsed ovarian cancer.

Guide to enhanced recovery for cancer patients undergoing surgery: ERAS for Patients Undergoing Cytoreductive Surgery with or Without hyperthermic intraperitoneal chemotherapy.

 


Open Label RCT: Azithromycin for poorly controlled asthma in children.

15 Mar, 2022 | 08:39h | UTC

Azithromycin for Poorly Controlled Asthma in Children: A randomized controlled trial – CHEST (link to abstract – $ for full-text)

Commentary: Adding azithromycin to standard care improves asthma control, exacerbations in children – Healio

Related: Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma

 


RCT: Vortioxetine 5, 10, and 20 mg significantly reduces the risk of relapse compared with placebo in patients with remitted major depressive disorder.

14 Mar, 2022 | 01:03h | UTC

Vortioxetine 5, 10, and 20 mg significantly reduces the risk of relapse compared with placebo in patients with remitted major depressive disorder: The RESET study – Journal of Affective Disorders

 

Commentary on Twitter

 


RCT: Methenamine Hippurate (a non-antibiotic preventive treatment) is noninferior to prophylactic antibiotics for treating recurrent urinary tract infections in women.

11 Mar, 2022 | 10:21h | UTC

Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial – The BMJ

News Release: Antiseptic drug as good as antibiotics for preventing recurrent urinary tract infections – BMJ Newsroom

Editorial: Methenamine hippurate for recurrent urinary tract infections – The BMJ

Commentaries:

Trial supports antibiotic alternative for recurrent urinary infections – CIDRAP

Nonantibiotic Prophylaxis Noninferior for Recurrent UTI – HealthDay

 

Commentary on Twitter

 


RCT: Overall survival with Ribociclib plus Letrozole in advanced breast cancer.

11 Mar, 2022 | 09:47h | UTC

Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

Ribociclib plus endocrine therapy offers survival benefit for postmenopausal patients with metastatic breast cancer – University of Texas MD Anderson Cancer Center / News Medical

Adding Ribociclib to Letrozole Prolongs Survival in Advanced Breast Cancer – HealthDay

 


RCT: In pediatric ICUs, a bundled intervention that emphasized a physiologically focused cardiopulmonary resuscitation training did not improve outcomes in cardiac arrest.

11 Mar, 2022 | 09:37h | UTC

Effect of Physiologic Point-of-Care Cardiopulmonary Resuscitation Training on Survival With Favorable Neurologic Outcome in Cardiac Arrest in Pediatric ICUs: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

Commentary: CPR Intervention Failed to Improve Survival in Kids With Cardiac Arrest — Physiologically focused CPR training did not lead to difference in survival to discharge – MedPage Today (free registration required)

 

Commentary on Twitter

 


RCT: In patients with refractory out-of-hospital cardiac arrest, a strategy of intra-arrest transport, extracorporeal cardiopulmonary resuscitation, and immediate invasive assessment did not significantly improve survival with a favorable neurological outcome (OR 1.63; 95% CI 0.93 to 2.85; P = .09).

10 Mar, 2022 | 10:57h | UTC

Effect of Intra-arrest Transport, Extracorporeal Cardiopulmonary Resuscitation, and Immediate Invasive Assessment and Treatment on Functional Neurologic Outcome in Refractory Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

Commentary: Early Invasive Therapy for Out-of-Hospital Cardiac Arrest – American College of Cardiology

 

Commentary on Twitter

 


RCT: Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis.

10 Mar, 2022 | 10:27h | UTC

Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial – The Lancet Rheumatology (link to abstract – $ for full-text)

Commentary: COMPLETE-PsA: Adding leflunomide to methotrexate may improve outcomes – medwireNews

 

Commentary on Twitter

 


RCT: Reliever-triggered inhaled glucocorticoid reduces severe exacerbations in black and latinx adults with moderate-to-severe asthma.

9 Mar, 2022 | 10:06h | UTC

Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma – New England Journal of Medicine (link to abstract – $ for full-text)

Commentary: Patient-centered intervention improved asthma outcomes for Black and Latinx adults – Brigham and Women’s Hospital

 


RCT: Combination treatment with Varenicline and Nicotine patch may increase smoking cessation rates among smokers who drink heavily.

9 Mar, 2022 | 08:44h | UTC

Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily: A Randomized Clinical Trial – JAMA Network Open

Commentary: Combination treatment is effective for treating smokers who drink heavily – University of Chicago Medical Center

 

Commentary on Twitter

 


RCT: Elective upper-neck vs. whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma.

9 Mar, 2022 | 08:17h | UTC

Elective upper-neck versus whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial – The Lancet Oncology (link to abstract – $ for full-text)

Commentaries:

Elective Upper-Neck vs Whole-Neck Irradiation in Nasopharyngeal Carcinoma – The ASCO Post

Lower Neck-Sparing RT Succeeds in Nasopharyngeal Carcinoma— Phase III trial also shows that upper-neck irradiation leads to fewer late toxicities – MedPage Today (link to abstract – $ for full-text)

 


RCT: Little long-term benefit from a small change approach to prevent weight gain in adults with overweight and obesity.

8 Mar, 2022 | 08:37h | UTC

A small change approach to prevent long-term weight gain in adults with overweight and obesity: a randomized controlled trial – Canadian Medical Association Journal

 


RCT: Efficacy and safety of switching to the 2-drug regimen Dolutegravir/Lamivudine vs. continuing a 3- or 4-Drug regimen for maintaining virologic suppression in adults living with HIV-1.

7 Mar, 2022 | 00:32h | UTC

Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With HIV-1: Week 48 Results From the Phase 3, Non-inferiority SALSA Randomized Trial – Clinical Infectious Diseases

 


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