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Randomized Trials

RCT | Platelet-rich plasma injections lack efficacy in 52-week ankle osteoarthritis study

2 Aug, 2023 | 13:43h | UTC

Platelet-Rich Plasma Injections for the Treatment of Ankle Osteoarthritis – The American Journal of Sports Medicine

 


RCT | Early vs. delayed intrauterine balloon tamponade: no difference in severe postpartum hemorrhage

2 Aug, 2023 | 13:42h | UTC

Efficacy of early intrauterine balloon tamponade for immediate postpartum hemorrhage after vaginal delivery: a randomized clinical trial – The American Journal of Obstetrics and Gynecology (link to abstract  – $ for full-text)

 


Review | Futility in clinical trials

1 Aug, 2023 | 14:32h | UTC

Futility in Clinical Trials – JAMA (free for a limited period)

 


RCT | Bictegravir regimen noninferior to dolutegravir regimen in HIV-1, HBV co-infection treatment

31 Jul, 2023 | 14:00h | UTC

Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, emtricitabine, and tenofovir disoproxil fumarate for initial treatment of HIV-1 and hepatitis B coinfection (ALLIANCE): a double-blind, multicentre, randomised controlled, phase 3 non-inferiority trial – The Lancet HIV (free registration required)

 


RCT | Niraparib after first-line platinum-based chemotherapy extends PFS vs. placebo in newly diagnosed advanced ovarian cancer

31 Jul, 2023 | 13:58h | UTC

Treatment With Niraparib Maintenance Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer: A Phase 3 Randomized Clinical Trial – JAMA Oncology

See also: Visual Abstract

Commentary: Niraparib Maintenance in Newly Diagnosed Advanced Ovarian Cancer – The ASCO Post

 


Phase 2 Trial | Oral orexin receptor 2 agonist shows promise in narcolepsy type 1, but raises hepatotoxic concerns

28 Jul, 2023 | 14:09h | UTC

Oral Orexin Receptor 2 Agonist in Narcolepsy Type 1 – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 


RCT | Liraglutide aids weight management in patients with suboptimal weight loss post metabolic surgery

28 Jul, 2023 | 14:05h | UTC

Safety and Efficacy of Liraglutide, 3.0 mg, Once Daily vs Placebo in Patients With Poor Weight Loss Following Metabolic Surgery: The BARI-OPTIMISE Randomized Clinical Trial – JAMA Surgery

See also: Visual Abstract

 


RCT – 2ry Analysis | Elevated intracranial bleeding risk with low-dose aspirin in older adults

27 Jul, 2023 | 13:09h | UTC

Low-Dose Aspirin and the Risk of Stroke and Intracerebral Bleeding in Healthy Older People: Secondary Analysis of a Randomized Clinical Trial – JAMA Network Open

See also: Visual Abstract

News Release: Low dose aspirin won’t help some older adults trying to avoid a stroke: study – Monash University

Commentary: Daily aspirin doesn’t prevent strokes in older, healthy people after all – The Conversation

Original Study: Randomized Trial: Effect of Aspirin on All-Cause Mortality in the Healthy Elderly

Related Guideline: USPSTF Recommendation Statement: Aspirin Use to Prevent Cardiovascular Disease.

Related Randomized Trials:

Randomized Trial: Aspirin for Primary Prevention of Cardiovascular Disease

Randomized Trial: Effects of Aspirin for Primary Prevention in Persons with Diabetes

Related Meta-Analysis:

Meta-Analysis: Association of Aspirin Use for Primary Prevention with Cardiovascular Events and Bleeding Events

Meta-Analysis: Efficacy and Safety of Aspirin for Primary Prevention of Cardiovascular Events

Aspirin for primary prevention of cardiovascular disease: a meta-analysis with a particular focus on subgroups – BMC Medicine

Related Opinions:

Aspirin for Primary Prevention: Is This the End of the Road?

Evidence evolving on aspirin as prevention – ACP Internist

#347 USPSTF Update: Aspirin for Primary Prevention of CVD – The Curbsiders

 


RCT | Limited antibiotic efficacy in children with sinusitis lacking nasopharyngeal pathogens

27 Jul, 2023 | 13:08h | UTC

Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Acute Bacterial Sinusitis: Limitations of Test-Based Treatment – JAMA (free for a limited period)

News Release: Bacterial testing in kids with sinusitis could slash antibiotic use – University of Pittsburgh

Commentary: Trial suggests bacterial test could reduce antibiotics in kids with sinusitis – CIDRAP

 

Commentary on Twitter

 


RCT | Cervical pessary fails to prevent preterm birth in short cervix singleton pregnancies

27 Jul, 2023 | 13:06h | UTC

Cervical Pessary for Prevention of Preterm Birth in Individuals With a Short Cervix: The TOPS Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: The Vexing Problem of Preterm Birth Prevention – JAMA (free for a limited period)

See also: Visual Abstract

News Release: Cervical pessary no more effective than usual care in preventing preterm birth risk – NIH News Releases

 


RCT | Zuranolone, a potential rapid-acting oral treatment for severe postpartum depression

27 Jul, 2023 | 13:00h | UTC

Zuranolone for the Treatment of Postpartum Depression – American Journal of Psychiatry (link to abstract – $ for full-text)

Commentary: Postpartum Depression Pill Zuralonone Shows Promise in Women With Severe Symptoms – Psychiatric News Alert

Related: RCT | Zuranolone outperforms placebo in major depressive disorder treatment

 


RCT | Pitavastatin effective in the primary prevention of cardiovascular disease in HIV-infected individuals

26 Jul, 2023 | 13:35h | UTC

Pitavastatin to Prevent Cardiovascular Disease in HIV Infection – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

Pitavastatin lowers risk of cardiovascular events in people living with HIV – Aidsmap

Statins reduce cardiovascular risk in people living with HIV, new global study finds – STAT

Pitavastatin Cuts MACE in HIV-Infected Patients: REPRIEVE – TCTMD

 

Commentary on Twitter

 


ISCHEMIA Trial 2ry Analysis | Patients with CCD and daily/weekly angina seem to benefit most from complete revascularization

26 Jul, 2023 | 13:33h | UTC

Complete Revascularization and Angina-Related Health Status in the ISCHEMIA Trial – Journal of the American College of Cardiology (link to abstract – $ for full-text)

Commentaries:

Complete Revascularization and Angina-Related Health Status – American College of Cardiology

More Angina Relief With Complete Revascularization in Stable CAD: ISCHEMIA – TCTMD

Related/Original Articles:

Follow-up of the ISCHEMIA trial | Similar survival after invasive vs. conservative management of stable coronary disease.

ISCHEMIA Trial: Health-Status Outcomes with Initial Invasive vs. Conservative Care in Stable Coronary Disease

ISCHEMIA Trial: Initial Invasive vs. Conservative Strategy for Stable Coronary Disease

ISCHEMIA Trial: Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease

ISCHEMIA Trial: Management of Coronary Disease in Patients with Advanced Kidney Disease

 


RCT | High-power radiofrequency improves AF ablation results vs. standard-power, but may increase asymptomatic cerebral emboli

26 Jul, 2023 | 13:16h | UTC

A Randomized Trial of High vs Standard Power Radiofrequency Ablation for Pulmonary Vein Isolation: SHORT-AF – JACC: Clinical Electrophysiology (link to abstract – $ for full-text)

Commentary: A Randomized Trial of High vs Standard Power Radiofrequency Ablation for Pulmonary Vein Isolation – SHORT-AF – American College of Cardiology

 


RCT | Vitamin D supplementation shows no cognitive benefit in mild cognitive impairment intervention

25 Jul, 2023 | 14:00h | UTC

Effects of Exercise Alone or Combined With Cognitive Training and Vitamin D Supplementation to Improve Cognition in Adults With Mild Cognitive Impairment: A Randomized Clinical Trial – JAMA Network Open

Commentary: Exercise and Cognitive Training Slow Thinking Declines. Vitamin D? Not So Much – HealthDay

Related:

RCT | No statistically significant impact of vitamin D on major cardiovascular events

2ry analysis of a RCT | Vitamin D supplementation does not affect cognitive function in older adults

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.

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

 


RCT | Dysphagia-optimized intensity-modulated radiotherapy better preserves swallowing function in pharyngeal cancer patients

25 Jul, 2023 | 13:52h | UTC

Dysphagia-optimised intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in patients with head and neck cancer (DARS): a phase 3, multicentre, randomised, controlled trial – The Lancet Oncology

Commentaries:

Dysphagia-Optimized vs Standard IMRT in Newly Diagnosed Patients With Head and Neck Cancer – The ASCO Post

Radiation approach improves swallowing in head, neck cancer – MDedge

 

Commentary on Twitter

 


RCT | No significant impact of low-dose 0.01% atropine on myopia progression in children

25 Jul, 2023 | 13:40h | UTC

Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control: A Randomized Clinical Trial – JAMA Ophthalmology (link to abstract – $ for full-text)

See also: Visual Abstract

Author Interview: Low-Dose 0.01% Atropine Eye Drops vs Placebo for Myopia Control – JAMA

Commentary: Atropine 0.01 Percent Eye Drops Do Not Slow Myopia Progression – HealthDay

Related:

RCT | 0.01% atropine effective in reducing progression of myopia in children over 3 years

RCT | Effect of repeated low-level red light on myopia prevention among children in China with premyopia

Efficacy of atropine for myopia control in children: A meta-analysis of randomized controlled trials – Journal of Family Medicine and Primary Care

Interventions for myopia control in children: a living systematic review and network meta‐analysis – Cochrane Library

RCT | Effect of low-concentration atropine eyedrops vs. placebo on myopia incidence in children

Crossover RCT | Spectacle lenses with highly aspherical lenslets for slowing myopia.

RCT | Effect of text messaging parents of school-aged children on outdoor time to control myopia.

RCT | Myopia control effect of repeated low-level red-light therapy in children.

RCT: Spectacle lenses with aspherical lenslets for myopia control vs. single-vision spectacle lenses.

Randomized trial: Effect of High add power, medium add power, or single-vision contact lenses on myopia progression in children

 


RCT | Planned delivery from 34 weeks’ gestation effectively reduces pre-eclampsia related morbidity and mortality in LMICs

24 Jul, 2023 | 13:10h | UTC

Planned delivery or expectant management for late preterm pre-eclampsia in low-income and middle-income countries (CRADLE-4): a multicentre, open-label, randomised controlled trial – The Lancet

Related:

RCT | Planned delivery for pre-eclampsia between 34 and 37 weeks of gestation

M-A | Planned delivery or expectant management in preeclampsia.

Randomized Trial: Planned Early Delivery vs. Expectant Management for Late Preterm Pre-eclampsia

 


RCT | Combined pre-operative olanzapine regimen lowers postoperative nausea in high-risk cancer patients

24 Jul, 2023 | 12:49h | UTC

Olanzapine as an add-on, pre-operative anti-emetic drug for postoperative nausea or vomiting: a randomised controlled trial – Anaesthesia

 


RCT | Online emotion regulation therapy yields significant reduction in adolescent self-injury

24 Jul, 2023 | 12:39h | UTC

Effect of Internet-Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial – JAMA Network Open

See also: Visual Abstract

News Release: Internet-based therapy effective against self-harm in adolescents – Karolinska Institutes

 


RCT | Hearing intervention fails to impact 3-year cognitive decline in older adults

20 Jul, 2023 | 11:09h | UTC

Hearing intervention versus health education control to reduce cognitive decline in older adults with hearing loss in the USA (ACHIEVE): a multicentre, randomised controlled trial – The Lancet (link to abstract – $ for full-text)

 

Commentary on Twitter

 


RCT | Preterm infants show same feeding tolerance with NCPAP or HHHFNC

20 Jul, 2023 | 11:01h | UTC

Effect of Nasal Continuous Positive Airway Pressure vs Heated Humidified High-Flow Nasal Cannula on Feeding Intolerance in Preterm Infants With Respiratory Distress Syndrome: The ENTARES Randomized Clinical Trial – JAMA Network Open

Commentary: Changing oxygenation strategies not associated with differences in feeding intolerance in preterm infants – Physician’s Weekly

 


RCT | Ischemic stroke patients benefit from Panax notoginseng saponins therapy

20 Jul, 2023 | 10:57h | UTC

Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China: A Randomized Clinical Trial – JAMA Network Open

See also: Visual Abstract

Commentary: Do Panax notoginseng saponins (Xuesaitong soft capsules) improve function in patients with ischemic stroke? – News Medical

 


RCT | Solanezumab fails to slow cognitive decline in preclinical Alzheimer’s disease

19 Jul, 2023 | 14:26h | UTC

Trial of Solanezumab in Preclinical Alzheimer’s Disease – New England Journal of Medicine (link to abstract – $ for full-text)

Related:

RCT | Donanemab slows early symptomatic Alzheimer’s progression, but raises serious safety concerns

RCT | Lecanemab slows cognitive decline in early Alzheimer’s disease but raises safety concerns

 

Commentary on Twitter

 


RCT | Placebo equally effective as cognitive-behavioral therapy and aripiprazole in preventing psychosis transition

18 Jul, 2023 | 13:37h | UTC

Prevention of First-Episode Psychosis in People at Clinical High Risk: A Randomized Controlled, Multicentre Trial Comparing Cognitive-Behavioral Therapy and Clinical Management Plus Low-Dose Aripiprazole or Placebo (PREVENT) – Schizophrenia Bulletin (link to abstract – $ for full-text)

Commentary: Aripiprazole or CBT Not More Effective Than Placebo at Preventing Transition to Psychosis – Neurology Advisor

 


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