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Randomized Trials

Phase 2 RCT | Efficacy of adjunctive D-Cycloserine to intermittent theta-burst stimulation for major depressive disorder.

19 Oct, 2022 | 14:16h | UTC

Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Major Depressive Disorder: A Randomized Clinical Trial – JAMA Psychiatry (link to abstract – $ for full-text)

Commentaries:

Effectiveness of iTBS for Major Depression May Be Improved by Addition of D-Cycloserine – Psychiatric News Alert

Adjunctive D-Cycloserine Improves Efficacy of Brain Stimulation in Patients with MDD – Consultant 360

 

Commentary on Twitter

 


RCT | Vonoprazan noninferior to Lansoprazole for healing and maintenance of healing of erosive esophagitis.

19 Oct, 2022 | 14:08h | UTC

VONOPRAZAN VERSUS LANSOPRAZOLE FOR HEALING AND MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS: A RANDOMIZED TRIAL – Gastroenterology

 


Cluster RCT | Primary prophylaxis with CSFs fails to improve outcomes in patients at intermediate risk for febrile neutropenia.

18 Oct, 2022 | 12:58h | UTC

A Pragmatic Cluster-Randomized Trial of a Standing Order Entry Intervention for Colony-Stimulating Factor Use Among Patients at Intermediate Risk for Febrile Neutropenia – Journal of Clinical Oncology

 


RCT | Two-year effects of Semaglutide in adults with overweight or obesity.

18 Oct, 2022 | 12:53h | UTC

Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial – Nature Medicine

Commentary: STEP 5: Sustained semaglutide treatment maintains weight loss – medwire News

Related:

RCT: Effect of continued weekly subcutaneous Semaglutide vs. placebo on weight loss maintenance in adults with overweight or obesity

RCT: High dose once a week Semaglutide (2.4 mg) in adults with overweight or obesity, and type 2 diabetes

RCT: Effect of high-dose subcutaneous Semaglutide vs. placebo in adults with overweight or obesity

RCT: Once-weekly, high-dose semaglutide is effective for improving overweight or obesity among non-diabetic adults

 

Commentary on Twitter

 


Perspective | Reducing bureaucracy in clinical trials.

18 Oct, 2022 | 12:41h | UTC

Reducing bureaucracy in clinical trials – UEG Journal

 


RCT | Adjuvant capecitabine following concurrent CTX-RT in locoregionally advanced nasopharyngeal carcinoma.

17 Oct, 2022 | 12:15h | UTC

Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial – JAMA Oncology

 


RCT | A low-intensity psychosocial intervention improved recovery from depression in older adults in Brazil.

14 Oct, 2022 | 14:09h | UTC

A task-shared, collaborative care psychosocial intervention for improving depressive symptomatology among older adults in a socioeconomically deprived area of Brazil (PROACTIVE): a pragmatic, two-arm, parallel-group, cluster-randomised controlled trial – The Lancet Health Longevity

Invited Commentary: Empowering older adults and their communities to cope with depression in resource-limited settings – The Lancet Health Longevity

 

Commentary on Twitter

Under a Creative Commons Attribution (CC BY 4.0) License

 


RCT | In abortion surgery, Esketamine plus Propofol can reduce hypotension compared to Fentanyl plus Propofol.

14 Oct, 2022 | 13:58h | UTC

Effect of different doses of esketamine compared with fentanyl combined with propofol on hypotension in patients undergoing painless abortion surgery: a prospective, randomized, double-blind controlled clinical trial – BMC Anesthesiology

Commentary: Esketamine as an adjunct with propofol and fentanyl to avoid perioperative hypotension – Physician’s Weekly

 


RCT | No difference in cardiovascular outcomes with evening vs. morning dosing of usual antihypertensives.

12 Oct, 2022 | 14:01h | UTC

Cardiovascular outcomes in adults with hypertension with evening versus morning dosing of usual antihypertensives in the UK (TIME study): a prospective, randomised, open-label, blinded-endpoint clinical trial – The Lancet

Related: [News release – not published yet] #ESCCongres – RCT | Evening dosing of blood pressure medication not better than morning dosing.

Related Consensus Statement: Bedtime dosing of antihypertensive medications: systematic review and consensus statement: International Society of Hypertension position paper endorsed by World Hypertension League and European Society of Hypertension – Journal of Hypertension

Related study (conflicting results): Bedtime Hypertension Treatment Improves Cardiovascular Risk Reduction in Randomized Trial

 


RCT | Toripalimab plus chemotherapy for patients with treatment-naive advanced non–small-cell lung cancer.

11 Oct, 2022 | 13:31h | UTC

Toripalimab Plus Chemotherapy for Patients With Treatment-Naive Advanced Non–Small-Cell Lung Cancer: A Multicenter Randomized Phase III Trial (CHOICE-01) – Journal of Clinical Oncology

Commentary: CHOICE-01: Toripalimab Plus Chemotherapy Improves Survival in Advanced NSCLC Without Actionable Mutations – The ASCO Post

 


RCT | Riociguat improved hemodynamics but increased dropouts in pulmonary hypertension and HFpEF.

11 Oct, 2022 | 13:26h | UTC

Riociguat in pulmonary hypertension and heart failure with preserved ejection fraction: the haemoDYNAMIC trial – European Heart Journal

 

Commentary on Twitter

Under a https://creativecommons.org/licenses/by-nc/4.0/ license

 


RCT | Cefepime/Enmetazobactam vs. Piperacillin/Tazobactam in patients with complicated urinary tract infections.

6 Oct, 2022 | 13:49h | UTC

Effect of Cefepime/Enmetazobactam vs Piperacillin/Tazobactam on Clinical Cure and Microbiological Eradication in Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Cefepime/Enmetazobactam for Complicated Urinary Tract Infections – JAMA (free for a limited period)

 

Commentary on Twitter

https://twitter.com/JAMA_current/status/1577372986188906522

 


RCT | Intravenous immune globulin reduces disease activity in dermatomyositis.

6 Oct, 2022 | 13:48h | UTC

Trial of Intravenous Immune Globulin in Dermatomyositis – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries:

NEJM: trial of IVIG for autoimmune disorder dermatomyositis – MedicalResearch.com

IV Immune Globulin Bests Placebo for Dermatomyositis – Drugs.com

 


RCT | Telmisartan did not improve walking performance in patients with lower extremity peripheral artery disease.

6 Oct, 2022 | 13:43h | UTC

Effect of Telmisartan on Walking Performance in Patients With Lower Extremity Peripheral Artery Disease: The TELEX Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Telmisartan and Walking Performance in Peripheral Artery Disease – JAMA (free for a limited period)

Audio interview: Treatment of Peripheral Artery Disease – JAMA

 

Commentary on Twitter

 


RCT | A postoperative multimodal opioid-sparing protocol can reduce opioid consumption after knee or shoulder arthroscopy.

5 Oct, 2022 | 13:57h | UTC

Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial – JAMA (free for a limited period)

News Release: Orthopedic surgery patients do fine without opioid painkillers – McMaster University

See also: Visual Abstract

Video Editor’s Note: Effect of an Opioid-Sparing Protocol vs Standard Prescribing on Opioid Consumption After Knee or Shoulder Arthroscopy

 


RCT | Analgesic efficacy of intravenous dexamethasone as an adjunct to paravertebral block in thoracoscopic surgery.

3 Oct, 2022 | 13:54h | UTC

Analgesic Efficacy of Intravenous Dexamethasone as an Adjunct to Ultrasound-Guided Paravertebral Block with Bupivacaine in Video-Assisted Thoracoscopic Surgery – Journal of Pain Research

 


RCT | Antibiotic prophylaxis vs. no prophylaxis in breast cancer surgery.

3 Oct, 2022 | 13:47h | UTC

Antibiotic prophylaxis in breast cancer surgery (PAUS trial): randomised clinical double-blind parallel-group multicentre superiority trial – British Journal of Surgery (link to abstract – $ for full-text)

 


RCT | Selumetinib plus adjuvant radioactive iodine in patients with high-risk differentiated thyroid cancer.

3 Oct, 2022 | 13:42h | UTC

Selumetinib Plus Adjuvant Radioactive Iodine in Patients With High-Risk Differentiated Thyroid Cancer: A Phase III, Randomized, Placebo-Controlled Trial (ASTRA) – Journal of Clinical Oncology

Commentary: Selumetinib Does Not Improve CR Rate in Differentiated Thyroid Cancer – Cancer Therapy Adviser

 

Commentary on Twitter

 


RCT | No benefit from hydrocortisone, vitamin C, and thiamine in adult patients with septic shock.

30 Sep, 2022 | 12:42h | UTC

Early administration of hydrocortisone, vitamin C, and thiamine in adult patients with septic shock: a randomized controlled clinical trial – Critical Care

Related:

Parenteral Vitamin C in Patients with Severe Infection: A Systematic Review – NEJM Evidence

Intravenous Vitamin C in Adults with Sepsis in the Intensive Care Unit – New England Journal of Medicine

Effect of adjunctive vitamin C, glucocorticoids, and vitamin B1 on longer-term mortality in adults with sepsis or septic shock: a systematic review and a component network meta-analysis – Intensive Care Medicine

Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial – JAMA

Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial – JAMA

 


RCT | Self-cut vs. Mesh-Kit titanium-coated polypropylene Mesh for transvaginal treatment of severe pelvic organ prolapse.

30 Sep, 2022 | 12:38h | UTC

Effectiveness of Self-cut vs Mesh-Kit Titanium-Coated Polypropylene Mesh for Transvaginal Treatment of Severe Pelvic Organ ProlapseA Multicenter Randomized Noninferiority Clinical Trial – JAMA Network Open

Commentary: Self-Cut Mesh Noninferior for Pelvic Organ Prolapse Procedure – HealthDay

 


Systematic Review | Randomized clinical trials of machine learning interventions in health care.

30 Sep, 2022 | 12:37h | UTC

Randomized Clinical Trials of Machine Learning Interventions in Health Care: A Systematic Review – JAMA Network Open

 


RCT | Doxycycline vs. placebo in patients with mild thyroid-associated ophthalmopathy.

30 Sep, 2022 | 12:35h | UTC

Doxycycline vs Placebo at 12 Weeks in Patients With Mild Thyroid-Associated Ophthalmopathy: A Randomized Clinical Trial – JAMA Ophthalmology (free for a limited period)

Invited commentary: Oral Doxycycline for Mild Thyroid Eye Disease – JAMA Opthalmology (free for a limited period)

 


RCT | Adjuvant Nivolumab plus Ipilimumab vs. Nivolumab alone in patients with resected Stage IIIB-D or Stage IV melanoma.

30 Sep, 2022 | 12:33h | UTC

Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915) – Journal of Clinical Oncology

 


RCT | In patients with Type 1 Diabetes, the use of a “bionic pancreas” reduced HbA1c without increasing hypoglycemia.

29 Sep, 2022 | 13:35h | UTC

Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes – New England Journal of Medicine (link to abstract – $ for full-text)

News Release: Bionic pancreas improves type 1 diabetes management compared to standard insulin delivery methods – National Institutes of Health

 


RCT | Abbreviated antiplatelet therapy after coronary stenting in patients with myocardial infarction at high bleeding risk.

29 Sep, 2022 | 13:32h | UTC

Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk – Journal of the American College of Cardiology

Original publication: #ESCCongress – RCT: In patients who underwent PCI at high bleeding risk, 1 month of dual antiplatelet therapy was noninferior to the continuation of dual therapy for at least 2 additional months and resulted in a lower incidence of bleeding events.

 


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