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Randomized Trials

RCT: Therapeutic drug monitoring during infliximab induction does not improve disease remission in patients with chronic immune-mediated inflammatory diseases

7 May, 2021 | 08:27h | UTC

Effect of Therapeutic Drug Monitoring vs Standard Therapy During Infliximab Induction on Disease Remission in Patients With Chronic Immune-Mediated Inflammatory Diseases: A Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Treatment Strategies for Patients With Immune-Mediated Inflammatory Diseases – JAMA (free for a limited period)

Commentary: Mixed Results with Refined Treatment Strategies for Rheumatic Diseases – Physician’s Weekly

 

Commentary on Twitter

 

RCT: Among patients with rheumatoid arthritis in remission, tapering conventional DMARDs using half-dose resulted in disease flares in 25% of patients compared with 6% of patients in the stable-dose group.

7 May, 2021 | 08:26h | UTC

Effect of Half-Dose vs Stable-Dose Conventional Synthetic Disease-Modifying Antirheumatic Drugs on Disease Flares in Patients With Rheumatoid Arthritis in Remission: The ARCTIC REWIND Randomized Clinical Trial – JAMA (free for a limited period)

Editorial: Treatment Strategies for Patients With Immune-Mediated Inflammatory Diseases – JAMA (free for a limited period)

Commentary: Mixed Results with Refined Treatment Strategies for Rheumatic Diseases – Physician’s Weekly

 

COVID has pushed medical research into remote trials, benefiting patients and scientists

5 May, 2021 | 08:38h | UTC

COVID Has Pushed Medical Research into Remote Trials, Benefiting Patients and Scientists – Scientific American

 

RCT: Closure vs. non-closure of mesenteric defects during laparoscopic gastric bypass surgery – In this single-center trial, routine closure of the mesenteric defects in laparoscopic Roux-en-Y gastric bypass with clips was associated with a lower rate of internal herniation

28 Apr, 2021 | 08:04h | UTC

Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery – British Journal of Surgery (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT: Intracytoplasmic sperm injection vs. conventional in-vitro fertilization in couples with infertility in whom the male partner has normal total sperm count and motility – no difference in livebirth rates between the strategies

25 Apr, 2021 | 21:14h | UTC

Intracytoplasmic sperm injection versus conventional in-vitro fertilisation in couples with infertility in whom the male partner has normal total sperm count and motility: an open-label, randomised controlled trial – The Lancet (link to abstract – $ for full-text)

Commentary: Standard IVF is fine for most people. So why are so many offered an expensive sperm injection they don’t need? – The Conversation

 

Commentary on Twitter

 

RCT: Promising results with vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischemic stroke

25 Apr, 2021 | 21:10h | UTC

Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial – The Lancet

Commentary: Vagus nerve stimulation: a potential new treatment for ischaemic stroke – The Lancet

 

Commentary on Twitter

 

New studies in patients with moderate-to-severe psoriasis show greater skin clearance with Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits both interleukin-17A and interleukin-17F

25 Apr, 2021 | 21:08h | UTC

Study 1: Bimekizumab versus Secukinumab in Plaque Psoriasis – New England Journal of Medicine

Study 2: Bimekizumab versus Adalimumab in Plaque Psoriasis – New England Journal of Medicine

Related studies: Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase trial – The Lancet AND Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial – The Lancet

 

RCT: Metformin vs. insulin in gestational diabetes – metformin was associated better glycemic control, lower risk of hypoglycemia, and less maternal weight gain

25 Apr, 2021 | 21:03h | UTC

MeDiGes Study. Metformin versus insulin in gestational diabetes: Glycemic control, and obstetrical and perinatal outcomes. Randomized prospective trial. – American Journal of Obstetrics & Gynecology (link to abstract – $ for full-text)

Related: Randomized trial tests metformin in women with type 2 diabetes in pregnancy AND Neonatal, infant, and childhood growth following metformin versus insulin treatment for gestational diabetes: A systematic review and meta-analysis – PLOS Medicine AND Case-Control Study: Metformin Exposure in First Trimester of Pregnancy is Not Associated with Congenital Anomalies

 

RCT: Induction of Labor at Term with Vaginal Misoprostol or a PGE2 Pessary – little difference in outcomes, the clinical risk-benefit ratio justifies the use of both drugs

25 Apr, 2021 | 20:59h | UTC

Induction of Labor at Term With Vaginal Misoprostol or a PGE2 Pessary: a Noninferiority RCT – American Journal of Obstetrics & Gynecology (link to abstract – $ for full-text)

 

RCT: No benefit from immune checkpoint inhibitors in newly diagnosed stage III or IV ovarian cancer

25 Apr, 2021 | 20:57h | UTC

Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39) – Journal of Clinical Oncology

Editorial: Immune Checkpoint Inhibitors in Ovarian Cancer: Can We Bridge the Gap Between IMagynation and Reality?

 

Viewpoint | Remote Research and Clinical Trial Integrity During and After the Coronavirus Pandemic

23 Apr, 2021 | 08:34h | UTC

Remote Research and Clinical Trial Integrity During and After the Coronavirus Pandemic – JAMA

 

RCT: Effect of infusion set replacement intervals on catheter-related bloodstream infections – “Infusion set use can be safely extended to 7 days with resultant cost and workload reductions”

20 Apr, 2021 | 05:37h | UTC

Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)–non-inferiority (peripheral arterial catheter) trial – The Lancet (link to abstract – $ for full-text)

 

Commentaries on Twitter

 

RCT: No benefit from second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis

18 Apr, 2021 | 21:21h | UTC

Second intravenous immunoglobulin dose in patients with Guillain-Barré syndrome with poor prognosis (SID-GBS): a double-blind, randomised, placebo-controlled trial – The Lancet Neurology (link to abstract – $ for full-text)

 

RCT: Ravidasvir plus sofosbuvir are effective and well tolerated in patients with chronic HCV infection, with potential as an affordable treatment for these patients

18 Apr, 2021 | 21:19h | UTC

Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial – The Lancet Gastroenterology & Hepatology

 

Commentary on Twitter

 

RCT: Better continence after 3 months with robotic-assisted compared with laparoscopic radical prostatectomy

18 Apr, 2021 | 21:11h | UTC

Robotic-assisted Versus Laparoscopic Surgery: Outcomes from the First Multicentre, Randomised, Patient-blinded Controlled Trial in Radical Prostatectomy (LAP-01) – European Urology (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT: Continued versus discontinued oxytocin stimulation in the active phase of labor

16 Apr, 2021 | 06:18h | UTC

Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX): double blind randomised controlled trial – The BMJ

Commentaries: Study sheds more light on use of oxytocin during labour – The BMJ AND Study Explores Oxytocin Use in Active Phase of Induced Labor – HealthDay

 

Commentary on Twitter

 

Phase 2 RCT: Psilocybin, a psychedelic compound, shows promise for the treatment of depression in a study with 59 patients

16 Apr, 2021 | 06:17h | UTC

Trial of Psilocybin versus Escitalopram for Depression – New England Journal of Medicine (link to abstract – $ for full-text)

Commentaries: Magic mushroom compound performs as well as antidepressant in small study – Imperial College London AND First-of-its-kind study pits psilocybin against a common antidepressan – STAT AND Psilocybin Not Significantly Different from Escitalopram for Depression – NEJM Journal Watch AND Expert reaction to phase 2 trial comparing psilocybin and escitalopram for depression – Science Media Centre

 

RCT: An Enhanced Recovery After Surgery (ERAS) program in laparoscopic distal gastrectomy provided a faster recovery, a shorter postoperative hospitalization length, and lower medical costs without increasing complication and readmission rates

16 Apr, 2021 | 06:16h | UTC

Randomized Controlled Trial Comparing the Short-term Outcomes of Enhanced Recovery After Surgery and Conventional Care in Laparoscopic Distal Gastrectomy – Annals of Surgery

Related: Consensus guidelines for enhanced recovery after gastrectomy – British Journal of Surgery AND Current status of the “enhanced recovery after surgery” program in gastric cancer surgery – Annals of Gastroenterological Surgery

See also: Enhanced Recovery After Surgery (ERAS) Society Guidelines

 

RCT: Comparison of Levetiracetam vs. Zonisamide vs. Lamotrigine for newly diagnosed focal epilepsy shows Lamotrigine should remain the first-line treatment option

12 Apr, 2021 | 00:51h | UTC

The SANAD II study of the effectiveness and cost-effectiveness of levetiracetam, zonisamide, or lamotrigine for newly diagnosed focal epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial – The Lancet

Commentary: Clinical trials assess best first-line drugs for epilepsy – University of Liverpool

 

RCT: Comparison of Valproate vs. Levetiracetam for newly diagnosed generalized and unclassifiable epilepsy shows Valproate should remain the first-line treatment option

12 Apr, 2021 | 00:52h | UTC

The SANAD II study of the effectiveness and cost-effectiveness of valproate versus levetiracetam for newly diagnosed generalised and unclassifiable epilepsy: an open-label, non-inferiority, multicentre, phase 4, randomised controlled trial – The Lancet

Commentary: Clinical trials assess best first-line drugs for epilepsy – University of Liverpool

 

RCT: New shorter regimens of benznidazole monotherapy and in combination with fosravuconazole for treatment of Chagas disease

8 Apr, 2021 | 08:47h | UTC

New regimens of benznidazole monotherapy and in combination with fosravuconazole for treatment of Chagas disease (BENDITA): a phase 2, double-blind, randomised trial – The Lancet Infectious Diseases

Commentary: Chagas disease: Shorter treatment just as effective as longer one, according to study in Bolivia published by The Lancet – Drugs for Neglected Diseases Initiative

 

RCT: Among patients with peripheral artery disease, low-intensity exercise was significantly less effective than high-intensity exercise for improving 6-minute walk distance

7 Apr, 2021 | 01:31h | UTC

Effect of Low-Intensity vs High-Intensity Home-Based Walking Exercise on Walk Distance in Patients With Peripheral Artery Disease: The LITE Randomized Clinical Trial – JAMA (free for a limited period)

Commentary: No pain, no gain in exercise for peripheral artery disease – ‘You’ve got to walk with pain to reap benefits’ – Northwestern University

 

Commentary on Twitter

 

RCT: Effect of intravitreous anti–vascular endothelial growth factor vs. sham treatment for prevention of vision-threatening complications of diabetic retinopathy

6 Apr, 2021 | 01:02h | UTC

Effect of Intravitreous Anti–Vascular Endothelial Growth Factor vs Sham Treatment for Prevention of Vision-Threatening Complications of Diabetic Retinopathy: The Protocol W Randomized Clinical Trial – JAMA Ophthalmology

Commentaries: Preventive treatment reduces diabetic retinopathy complications – NIH News Releases AND Prevention of Severe Nonproliferative Diabetic Retinopathy Progression With More at Stake Than Visual Acuity – JAMA Ophthalmology AND Practicality of Prophylactic Aflibercept to Reduce Diabetic Retinopathy Progression – JAMA Ophthalmology

Author interview: Randomized Trial of Anti-VEGF to Prevent Proliferative Diabetic Retinopathy (PDR) and Diabetic Macular Edema (DME) – JAMA

 

Commentary on Twitter

 

RCT: Postoperative pain control is improved with Methadone + Ketamine vs. Methadone alone in spinal surgical patients

5 Apr, 2021 | 00:49h | UTC

Perioperative Methadone and Ketamine for Postoperative Pain Control in Spinal Surgical Patients: A Randomized, Double-blind, Placebo-controlled Trial – Anesthesiology (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT: Upadacitinib vs. Adalimumab for Psoriatic Arthritis

5 Apr, 2021 | 00:57h | UTC

Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis – New England Journal of Medicine (link to abstract – $ for full-text)

 

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