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Randomized Trials

Phase 2 RCT | Non-hormonal drug reduces vasomotor symptoms in women taking oral adjuvant endocrine therapy after breast cancer.

15 Nov, 2022 | 12:58h | UTC

Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: a phase 2, randomised, double-blind, placebo-controlled trial – The Lancet

Commentary: Non-hormonal therapy reduces hot flashes and night sweats in women who have been diagnosed with breast cancer – Monash University 

 

RCT | Bivalirudin is superior to heparin in patients with ST-segment elevation myocardial infarction undergoing primary PCI.

15 Nov, 2022 | 13:00h | UTC

Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomised trial – The Lancet

Commentaries:

BRIGHT-4: Large, ‘Clean’ Trial Clarifies Bivalirudin Benefits in STEMI – TCTMD

Bivalirudin found to be safer and more effective than heparin for treating heart attack patients undergoing percutaneous coronary intervention – Mount Sinai School of Medicine

BivaliRudin with prolonged full-dose Infusion during primary PCI versus Heparin Trial – BRIGHT-4 – American College of Cardiology

 

RCT | Evaluation of two short, standardized regimens for the treatment of rifampicin-resistant tuberculosis.

15 Nov, 2022 | 12:57h | UTC

Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial – The Lancet

Commentary: 

Shorter treatment effective for drug-resistant tuberculosis – University College London

Shorter Treatment Regimen for Drug-Resistant TB is More Effective – Health Policy Watch

 

RCT | Genicular nerve block offers short-term pain relief in patients with knee osteoarthritis.

15 Nov, 2022 | 12:50h | UTC

Genicular Nerve Block for Pain Management in Patients With Knee Osteoarthritis: A Randomized Placebo-Controlled Trial – Arthritis & Rheumatology

Commentary: Genicular nerve block may provide short-term pain relief for knee osteoarthritis – medwire News

 

RCT | Indobufen vs. aspirin on top of clopidogrel after coronary drug-eluting stent implantation.

11 Nov, 2022 | 14:03h | UTC

Indobufen or Aspirin on Top of Clopidogrel after Coronary Drug-eluting Stent Implantation (OPTION): a Randomized, Open-label, Endpoint-blinded, Non-inferiority Trial – Circulation

 

Commentary on Twitter

 

RCT | Shortened course of radiation therapy safe and effective for men with high-risk prostate cancer.

11 Nov, 2022 | 13:55h | UTC

[News release – not published yet] Shortened course of radiation therapy safe and effective for men with high-risk prostate cancer – American Society for Radiation Oncology (ASTRO) Annual Meeting

 

RCT | Efficacy of Safinamide as add-on therapy to Levodopa in patients with Parkinson’s disease with motor fluctuations.

11 Nov, 2022 | 13:53h | UTC

The XINDI Study: A Randomized Phase III Clinical Trial Evaluating the Efficacy and Safety of Safinamide as Add-On Therapy to Levodopa in Chinese Patients with Parkinson’s Disease with Motor Fluctuations – CNS Drugs

 

RCT | Monofilament suture is no better than braided suture to improve pregnancy outcomes after vaginal cervical cerclage.

10 Nov, 2022 | 14:14h | UTC

Monofilament suture versus braided suture thread to improve pregnancy outcomes after vaginal cervical cerclage (C-STICH): a pragmatic randomised, controlled, phase 3, superiority trial – The Lancet

Invited Commentary: Suture choice for cervical cerclage – The Lancet (free registration required)

News Release: Single stranded suture threads could prevent pregnancy infection complications, C-STICH trial finds – University of Birmingham

Video Summary: Major trial finds purse-string wire in surgery can reduce miscarriage and stillbirth – University of Birmingham

Commentary: Monofilament Suture Not Superior for Vaginal Cervical Cerclage – HealthDay

 

Commentary on Twitter (thread – click for more)

 

RCT | Mindfulness-based stress reduction vs. escitalopram for the treatment of adults with anxiety disorders.

10 Nov, 2022 | 14:09h | UTC

Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial – JAMA Psychiatry (free for a limited period)

Commentaries:

Mindfulness worked as well for anxiety as drug in study – Associated Press

Meditation works as well as a popular drug to reduce anxiety, study finds – NPR

 

Commentary on Twitter

 

RCT | Tamponade dressing does not reduce bleeding or pain compared to no dressing after hemorrhoidectomy.

10 Nov, 2022 | 14:06h | UTC

Tamponade dressing versus no dressing after haemorrhoidectomy: multicentre, randomized clinical trial – BJS Open

 

Commentary on Twitter

 

RCT | Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases.

10 Nov, 2022 | 13:54h | UTC

Transbronchial needle aspiration combined with cryobiopsy in the diagnosis of mediastinal diseases: a multicentre, open-label, randomised trial – The Lancet Respiratory Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Preoperative ultrasound-guided percutaneous cryoneurolysis for the treatment of pain after mastectomy.

10 Nov, 2022 | 13:41h | UTC

Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study – Anesthesiology

Infographic: Tip of the Iceberg: The History of Cryoneurolysis – Anesthesiology

 

RCT | Prophylactic tranexamic acid did not decrease bleeding in patients with hematologic malignancy.

10 Nov, 2022 | 13:36h | UTC

Prophylactic tranexamic acid in patients with hematologic malignancy: a placebo-controlled, randomized clinical trial – Blood

Commentary: Tranexamic Acid (TXA) Prophylaxis in Patients with Hematologic Malignancies – Physician’s Weekly

 

RCT | In infants undergoing heart surgery, prophylactic methylprednisolone did not significantly improve outcomes.

9 Nov, 2022 | 12:31h | UTC

Methylprednisolone for Heart Surgery in Infants — A Randomized, Controlled Trial – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Steroids during surgery may not be helpful for infants having heart bypass – American Heart Association

 

Commentary on Twitter

 

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

9 Nov, 2022 | 12:26h | UTC

Effect of Text Messaging Parents of School-Aged Children on Outdoor Time to Control Myopia: A Randomized Clinical Trial – JAMA Pediatrics

 

Commentary on Twitter

 

Phase 2 RCT | Concurrent Bevacizumab and reirradiation vs. Bevacizumab alone as treatment for recurrent glioblastoma.

9 Nov, 2022 | 12:21h | UTC

NRG Oncology/RTOG1205: A Randomized Phase II Trial of Concurrent Bevacizumab and Reirradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma – Journal of Clinical Oncology (link to abstract – $ for full-text)

Commentary: Bevacizumab Plus Reirradiation Improves PFS in Glioblastoma Multiforme – OncLive

 

RCT | Chronic remote ischemic conditioning is not beneficial for patients with symptomatic intracranial atherosclerotic stenosis.

9 Nov, 2022 | 12:18h | UTC

Chronic remote ischaemic conditioning in patients with symptomatic intracranial atherosclerotic stenosis (the RICA trial): a multicentre, randomised, double-blind sham-controlled trial in China – The Lancet Neurology (link to abstract – $ for full-text)

 

RCT | Comparison of two chemotherapy regimens in patients with newly diagnosed Ewing sarcoma.

9 Nov, 2022 | 12:12h | UTC

Comparison of two chemotherapy regimens in patients with newly diagnosed Ewing sarcoma (EE2012): an open-label, randomised, phase 3 trial – The Lancet (link to abstract – $ for full-text)

 

RCT | Efficacy of 9 months of delamanid, linezolid, levofloxacin, and pyrazinamide for treatment of fluoroquinolone-sensitive MDR-TB.

9 Nov, 2022 | 12:11h | UTC

9 months of delamanid, linezolid, levofloxacin, and pyrazinamide versus conventional therapy for treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis (MDR-END): a multicentre, randomised, open-label phase 2/3 non-inferiority trial in South Korea – The Lancet (link to abstract – $ for full-text)

 

RCT | Moxidectin and albendazole vs. ivermectin and albendazole in adolescents infected with Trichuris trichiura.

9 Nov, 2022 | 12:10h | UTC

Efficacy and safety of moxidectin and albendazole compared with ivermectin and albendazole coadministration in adolescents infected with Trichuris trichiura in Tanzania: an open-label, non-inferiority, randomised, controlled, phase 2/3 trial – The Lancet Infectious Diseases

Invited Commentary: Alternative treatment strategies for trichuriasis – The Lancet Infectious Diseases

 

RCT | Efficacy and safety of methylphenidate and behavioral parent training for children aged 3–5 years with ADHD.

9 Nov, 2022 | 12:09h | UTC

Efficacy and safety of methylphenidate and behavioural parent training for children aged 3–5 years with attention-deficit hyperactivity disorder: a randomised, double-blind, placebo-controlled, and sham behavioural parent training-controlled trial – The Lancet Child & Adolescent Health (link to abstract – $ for full-text)

 

Commentary on Twitter (thread – click for more)

 

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

8 Nov, 2022 | 12:32h | UTC

Survival After Invasive or Conservative Management of Stable Coronary Disease – Circulation (free for a limited period)

Original Articles:

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

See also:

RCT | In patients with severe ischemic left ventricular systolic dysfunction under optimal medical therapy, revascularization by PCI did not improve outcomes.

 

Commentary on Twitter

 

RCT | In patients with paroxysmal, untreated AF, cryoballoon ablation reduced recurrence compared to drug therapy.

8 Nov, 2022 | 12:29h | UTC

Progression of Atrial Fibrillation after Cryoablation or Drug Therapy – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Surgery reduced major adverse limb events vs. endovascular therapy in patients with chronic limb-threatening ischemia.

8 Nov, 2022 | 12:34h | UTC

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Bypass surgery favorable for initial treatment of chronic limb-threatening ischemia – National Institutes of Health

 

Commentary on Twitter

https://twitter.com/NEJM/status/1589621195632439296

 

Phase 2 RCT | Small interfering RNA to reduce Lipoprotein(a) in cardiovascular disease.

8 Nov, 2022 | 12:30h | UTC

Small Interfering RNA to Reduce Lipoprotein(a) in Cardiovascular Disease – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Clinical trial finds novel therapy markedly reduced lipoprotein(a) levels in people with cardiovascular disease – Brigham and Women’s Hospital

 

Commentary on Twitter

 

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