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Randomized Trials

Levoketoconazole in the treatment of patients with endogenous Cushing’s syndrome: a double-blind, placebo-controlled, randomized withdrawal study.

13 Sep, 2022 | 13:02h | UTC

Levoketoconazole in the treatment of patients with endogenous Cushing’s syndrome: a double-blind, placebo-controlled, randomized withdrawal study – Pituitary

Related study: Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing’s syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

 

RCT | Sulopenem vs. Ciprofloxacin for the treatment of uncomplicated urinary tract infections in women.

13 Sep, 2022 | 13:00h | UTC

Sulopenem or Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infections in Women: A Phase 3 Randomized Trial – Clinical Infectious Diseases

Related: Sulopenem For The Treatment of Complicated Urinary Tract Infection Including Pyelonephritis: A Phase 3 Randomized Trial – Clinical Infectious Diseases

 

RCT | In patients with severe burns, supplemental glutamine did not improve outcomes.

11 Sep, 2022 | 22:59h | UTC

A Randomized Trial of Enteral Glutamine for Treatment of Burn Injuries – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

Two large clinical trials showed Vitamin D supplements do not reduce the risk of Covid-19.

11 Sep, 2022 | 22:56h | UTC

Study 1: Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT) – The BMJ

Study 2: Prevention of covid-19 and other acute respiratory infections with cod liver oil supplementation, a low dose vitamin D supplement: quadruple blinded, randomised placebo controlled trial – The BMJ

Editorial: Can vitamin D protect against covid-19? – The BMJ

News Release: No link between vitamin D supplements and reduced risk of covid-19 – BMJ Newsroom

 

A randomized crossover trial with 12 patients showed that a bihormonal “artificial pancreas” with closed-loop glucose control increases patients’ time on euglycemia after total pancreatectomy.

11 Sep, 2022 | 22:45h | UTC

Bihormonal Artificial Pancreas With Closed-Loop Glucose Control vs Current Diabetes Care After Total Pancreatectomy: A Randomized Clinical Trial – JAMA Surgery (free for a limited period)

Commentary: Novel Bihormonal Artificial Pancreas Beneficial After Pancreatectomy – HealthDay

 

RCT | Effects of Nicorandil administration on infarct size in patients with ST‐Segment–Elevation Myocardial Infarction undergoing primary percutaneous coronary intervention.

11 Sep, 2022 | 22:37h | UTC

Effects of Nicorandil Administration on Infarct Size in Patients With ST‐Segment–Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention: The CHANGE Trial – Journal of the American Heart Association

 

RCT | Adjuvant atezolizumab fails to improve outcomes in patients with renal cell carcinoma at increased risk of recurrence following resection.

11 Sep, 2022 | 22:28h | UTC

Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Commentaries:

Adjuvant atezolizumab falls short in renal cell carcinoma – Urology Times

IMmotion010 does not support adjuvant atezolizumab in intermediate-, high-risk RCC – medwire News

 

Commentary from the author on Twitter (thread – click for more)

 

RCT | Overall survival with maintenance Olaparib at a 7-year follow-up in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation.

11 Sep, 2022 | 22:21h | UTC

Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial – Journal of Clinical Oncology

Commentary: Olaparib Maintenance Provides Sustained OS Benefit in Newly Diagnosed, BRCA-Mutated, Advanced Ovarian Cancer – OncLive

 

RCT | Busulfan plus Cyclophosphamide is noninferior to total body irradiation plus Cyclophosphamide for adults Acute B Lymphoblastic Leukemia.

11 Sep, 2022 | 22:24h | UTC

Busulfan Plus Cyclophosphamide Versus Total Body Irradiation Plus Cyclophosphamide for Adults Acute B Lymphoblastic Leukemia: An Open-Label, Multicenter, Phase III Trial – Journal of Clinical Oncology

 

RCT | Sulopenem (it has both IV and oral formulations) did not meet the criteria for noninferiority compared to Ertapenen for treating complicated urinary tract infections, including pyelonephritis.

8 Sep, 2022 | 14:37h | UTC

Sulopenem For The Treatment of Complicated Urinary Tract Infection Including Pyelonephritis: A Phase 3 Randomized Trial – Clinical Infectious Diseases

 

RCT | Lenalidomide-dexamethasone vs. observation in high-risk smoldering myeloma after 12 years of median follow-up time.

8 Sep, 2022 | 14:34h | UTC

Lenalidomide-dexamethasone versus observation in high-risk smoldering myeloma after 12 years of median follow-up time: A randomized, open-label study – European Journal of Cancer (link to abstract – $ for full-text)

 

48-week follow-up of a RCT | Pegcetacoplan vs. Eculizumab in patients with paroxysmal nocturnal hemoglobinuria.

8 Sep, 2022 | 14:29h | UTC

Pegcetacoplan versus eculizumab in patients with paroxysmal nocturnal haemoglobinuria (PEGASUS): 48-week follow-up of a randomised, open-label, phase 3, active-comparator, controlled trial – The Lancet Haematology (link to abstract – $ for full-text)

Original Study: Pegcetacoplan versus Eculizumab in Paroxysmal Nocturnal Hemoglobinuria – New England Journal of Medicine

 

Commentary on Twitter (thread – click for more)

 

RCT | Ripretinib vs. Sunitinib in patients with advanced gastrointestinal stromal tumor after treatment with imatinib.

8 Sep, 2022 | 14:24h | UTC

Ripretinib Versus Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor After Treatment With Imatinib (INTRIGUE): A Randomized, Open-Label, Phase III Trial – Journal of Clinical Oncology

Editorial: Ripretinib and the Failure to Advance GI Stromal Tumor Therapy in the Age of Precision Medicine – Journal of Clinical Oncology

 

Commentary on Twitter

 

RCT | Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes.

7 Sep, 2022 | 12:30h | UTC

Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study – The Lancet Endocrinology (link to abstract – $ for full-text)

Commentary: ‘Artificial Pancreas’ Best in Poorly Controlled Type 1 Diabetes – Medscape (free registration required)

 

Commentary on Twitter

 

RCT | Among patients with inguinal hernia, pain with sexual activity is reduced similarly with total extraperitoneal repair without mesh fixation and Lichtenstein repair.

6 Sep, 2022 | 14:30h | UTC

Pain with sexual activity at 1 and 3 years: Comparing total extraperitoneal with Lichtenstein inguinal hernia repair in a randomized setting (TEPLICH trial) – Surgery

Commentary: Pain during sexual engagement improves among inguinal hernia patients after hernia repair – Medical Dialogues

 

RCT | Weekly Somapacitan is noninferior to daily GH in children with GH deficiency.

6 Sep, 2022 | 14:25h | UTC

Weekly Somapacitan is Effective and Well Tolerated in Children with GH Deficiency: The Randomized Phase 3 REAL4 Trial – The Journal of Clinical Endocrinology & Metabolism

 

Phase 2 RCT | Safety, tolerability, and efficacy of pirfenidone in patients with rheumatoid arthritis-associated interstitial lung disease.

6 Sep, 2022 | 14:22h | UTC

Safety, tolerability, and efficacy of pirfenidone in patients with rheumatoid arthritis-associated interstitial lung disease: a randomised, double-blind, placebo-controlled, phase 2 study – The Lancet Respiratory Medicine

 

Commentary on Twitter

 

RCT | Efficacy of prednisolone for Bell Palsy in children.

5 Sep, 2022 | 14:39h | UTC

Efficacy of Prednisolone for Bell Palsy in Children: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial – Neurology (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Bronchodilators don’t improve smoking-related respiratory symptoms in people without COPD.

5 Sep, 2022 | 14:40h | UTC

News Release: Bronchodilators don’t improve smoking-related respiratory symptoms in people without COPD – NIH News Releases

Original Study: Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function – New England Journal of Medicine (link to abstract – $ for full-text)

 

Commentary on Twitter

 

5-year follow-up of a RCT | Five-year outcomes of FOLFIRINOX vs. Gemcitabine as adjuvant therapy for pancreatic cancer.

5 Sep, 2022 | 14:26h | UTC

Five-Year Outcomes of FOLFIRINOX vs Gemcitabine as Adjuvant Therapy for Pancreatic Cancer: A Randomized Clinical Trial – JAMA Oncology (link to abstract – $ for full-text)

 

Commentary on Twitter

 

RCT | Maintaining continuous endotracheal cuff pressure control through an automated electronic device did not reduce the incidence of ventilator-associated respiratory infection.

5 Sep, 2022 | 14:25h | UTC

Effectiveness of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator-Associated Respiratory Infections: An Open-Label Randomized, Controlled Trial – Clinical Infectious Diseases

 

RCT | Reduction of nonoperative time using the induction room, parallel processing, and Sugammadex.

5 Sep, 2022 | 14:24h | UTC

Reduction of Nonoperative Time Using the Induction Room, Parallel Processing, and Sugammadex: A Randomized Clinical Trial – Anesthesia & Analgesia

 

RCT | Comparison of rhomboid intercostal block, erector spinae plane block, and serratus plane block on analgesia for video-assisted thoracic surgery.

5 Sep, 2022 | 14:22h | UTC

Comparison of Rhomboid Intercostal Block, Erector Spinae Plane Block, and Serratus Plane Block on Analgesia for Video-Assisted Thoracic Surgery: A Prospective, Randomized, Controlled Trial – International Journal of Clinical Practice

 

30-month follow-up analysis of a RCT | Pembrolizumab vs. placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma.

5 Sep, 2022 | 14:20h | UTC

Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet Oncology

Invited Commentary: Adjuvant immunotherapy for renal cell carcinoma – The Lancet Oncology

Original Article: Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma – New England Journal of Medicine

 

RCT | Daily written care summaries for families of critically ill patients.

5 Sep, 2022 | 14:12h | UTC

Daily Written Care Summaries for Families of Critically Ill Patients: A Randomized Controlled Trial – Critical Care Medicine

Editorial: More Documentation? Who Needs It? – Critical Care Medicine

 

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