Randomized Trial of Molnupiravir or Placebo in Patients Hospitalized with Covid-19

Molnupiravir is an oral agent a metabolite of which has activity against SARS-CoV-2. In a controlled trial in adults hospitalized for Covid-19 who had symptoms for 10 days or less prior to randomization, patients received placebo (n=75) or varying doses of molnupiravir (n=218) administered twice-daily for 5 days. There was no impact of treatment on death. Median time to sustained recovery was 9 days in all groups, with day 29 recovery rates ranging from 81.5%-85.2%. There were no dose-limiting side effects or adverse events.

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Magnesium Sulphate for Seizure Prophylaxis in Women With Preeclampsia

50 Studies Every Obstetrician-Gynecologist Should Know ◽

10.1093/med/9780190947088.003.0001 ◽

2021 ◽

pp. 1-6

Author(s):

Peter Lindner ◽

Shad Deering

Keyword(s):

Side Effects ◽

High Risk ◽

Randomized Trial ◽

Magnesium Sulphate ◽

Neonatal Death ◽

Maternal Morbidity ◽

Controlled Trial ◽

Before And After ◽

Secondary Outcomes ◽

High Risk Cohort

The article “Do Women With Pre-Eclampsia, and Their Babies, Benefit From Magnesium Sulphate? The Magpie Trial: A Randomized Placebo-Controlled Trial” is the first randomized trial that objectively evaluates the utility of magnesium sulphate therapy as prophylaxis against progression to eclamptic convulsions in a high-risk cohort of women. It specifically evaluates the effect of magnesium sulphate given before and after delivery on maternal progression to eclampsia and fetal/neonatal death. It also evaluates secondary outcomes such as maternal morbidity; magnesium toxicity; side effects of magnesium sulphate; and, for those who received magnesium sulphate prior to delivery, it evaluated complications of the labor process.

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A randomized controlled trial of cognitive behavior therapy for reducing anxiety and depressive symptoms in patients with locoregional advanced nasopharyngeal carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.12121 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 12121-12121

Author(s):

Feng Liu ◽

Shengnan Fu ◽

Yanzhu Chen ◽

Ouying Yan ◽

Xiangwei Wu ◽

...

Keyword(s):

Nasopharyngeal Carcinoma ◽

Adverse Events ◽

Randomized Trial ◽

Behavioral Therapy ◽

Controlled Trial ◽

Depression Scale ◽

Response Rates ◽

Anxiety And Depression ◽

Depression And Anxiety ◽

Treatment As Usual

12121 Background: The purpose of this randomized trial was to compare the efficacy of cognitive behavioral therapy (CBT) versus treatment as usual (TAU) on anxiety and depression, response rates and acute adverse events in patients with locoregional advanced nasopharyngeal carcinoma (NPC) receiving chemoradiotherapy. To the best of our knowledge, this is the first randomized trial evaluating the effect of CBT for depression and anxiety in patients with locoregional advanced NPC treated with chemoradiotherapy. Methods: A total of 202 patients with diagnosis of stage III-IVa (8th AJCC) NPC were randomly assigned to receive CBT plus chemoradiotherapy (CBT group, n = 101) or treatment as usual (TAU) plus chemoradiotherapy (TAU group, n = 101). Patients in the CBT group received a series of six CBT sessions for 6 weeks during concurrent chemoradiotherapy. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of chemoradiotherapy, 1 and 3 months after chemoradiotherapy. Response rates and adverse events were also evaluated. This trial is registered with chictr.org.cn, number ChiCTR2000034701. Results: Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of CBT (P < 0.01). Complete response (CR) rate was significantly higher in CBT group than in TAU group (100% vs. 93.1%，P = 0.014). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events including anemia, fatigue, mucositis, insomnia and weight losing (P < 0.05). Conclusions: The addition of CBT to chemoradiotherapy significantly reduced depressive and anxiety symptoms. CBT combined with chemoradiotherapy is associated with improved response rates, with reduced incidence of acute toxic effects in patients with locoregional advanced nasopharyngeal carcinoma. Clinical trial information: ChiCTR2000034701.

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Combination Of Lenalidomide, Dexamethasone and Cyclophosphamide as Treatment For The First Relapse Of Multiple Myeloma: Efficacy, Toxicity and Occurance Of Thyroid Abnormalities

Blood ◽

10.1182/blood.v122.21.3233.3233 ◽

2013 ◽

Vol 122 (21) ◽

pp. 3233-3233 ◽

Cited By ~ 1

Author(s):

Marta Krejci ◽

Zdenek Adam ◽

Ludek Pour ◽

Jana Pelcova ◽

Jiri Mayer

Keyword(s):

Multiple Myeloma ◽

Side Effects ◽

Partial Response ◽

Adverse Events ◽

Median Time ◽

Thyroid Dysfunction ◽

Conflicts Of Interest ◽

Thyroid Function Tests ◽

First Relapse ◽

Thyroid Abnormalities

Abstract Background Lenalidomide is immunomodulatory drug with a range of antineoplastic actions, it is highly effective in multiple myeloma (MM). Lenalidomide has been associated with various adverse side effects including fatigue, constipation, haematological and neurological toxicity. Thyroid dysfunction has been reported as a possible side effect of lenalidomide with incidence 5-10%. Symptoms of thyroid dysfunction can overlap with some side effects of lenalidomide. Thyroid hormone levels are not regularly evaluated in patients (pts) on lenalidomide. Aim In this report we have analysed a cohort of 73 MM pts treated with lenalidomide 25 mg daily (day 1-21, repeating of cycle on day +28) in combination with dexamethasone (160 mg or 320 mg per cycle) and cyclophosphamide 50 mg daily with aims to evaluate efficacy and adverse events of this treatment including of possible occurrance of thyroid impairment. Methods We have prospectively evaluated 73 pts with the first relapse of MM who received lenalidomide as a part of the second-line treatment between 2008 and 2012, median follow-up from start of treatment was 24 months (range 2-46), median age was 65 years. Median number of cycles was 6 (range 4-10). Thyroid function tests were checked in regular 2-month intervals from the start to the end of lenalidomide treatment - thyroid stimulating hormone (TSH) and free thyroxine (FT4). Results Overall response rate (ORR) was 53% (39/73), 10% (7/73) of pts were in complete remission (CR), very good partial response (VGPR) was achieved in 18% of pts (13/73), partial response (PR) in 25% of pts (19/73), minimal response (MR) or stable disease (SD) in 10% of pts (7/73), progression was observed in 37% of pts (27/73). Median time to progression (TTP) and overall survival (OS) from start of lenalidomide treatment were 18.4 and 29.6 months, respectively. Adverse events (AE) in time of lenalidomide treatment were frequent, but mostly grade 1 or 2. The most frequent AE were as follows: anemia (77%), neutropenia (67%), thrombocytopenia (54%), neuropathy (38%), fatigue (65%), infections (49%) and gastrointestinal toxicity (21%). Grade 3 or 4 adverse events included neuropathy (5%), thrombosis (4%), infections (15%), thrombocytopenia (10%), neutropenia (27%) and fatigue (6%). Previous diagnosis of thyroid dysfunction was presented in four MM pts (5%). New thyroid abnormalities grade 2 were developed on lenalidomide treatment in seven pts (10%). Hypothyreosis was presented in five pts, hyperthyreosis in two pts. Treatment of thyroid dysfunction was necesarry in all seven pts. Median time to occurrance of thyroid dysfunction was 4 months (range 2-8 months). Conclusion Lenalidomide is effective treatment for the first relapse of MM with ORR 53%, but lenalidomide can cause various adverse events and significant thyroid abnormalities. Regular routine monitoring of TSH could be recommended in MM patients treated with lenalidomide. Treatment of symptomatic thyroid dysfunction can improve the quality of life for patiens undergoing lenalidomide treatment. Disclosures: No relevant conflicts of interest to declare.

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Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer

50 Studies Every Urologist Should Know ◽

10.1093/med/9780190655341.003.0016 ◽

2021 ◽

pp. 89-94

Author(s):

Philipp Dahm

Keyword(s):

Prostate Cancer ◽

Overall Survival ◽

Adverse Events ◽

Randomized Trial ◽

Median Time ◽

Androgen Deprivation Therapy ◽

Androgen Deprivation ◽

Chemohormonal Therapy ◽

Androgen Ablation ◽

Hormone Sensitive

This chapter summarizes the findings of the landmark Chemohormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer (CHAARTED) trial conducted in men with metastatic, hormone-sensitive prostate cancer comparing docetaxel therapy plus systemic androgen-deprivation therapy to androgen-deprivation therapy alone. It demonstrated improved median overall survival and median time to progression in the chemotherapy arm at the price of some increased severe adverse events.

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Once-Daily, Controlled-Release Tramadol and Sustained-Release Diclofenac Relieve Chronic Pain due to Osteoarthritis: A Randomized Controlled Trial

Pain Research and Management ◽

10.1155/2008/903784 ◽

2008 ◽

Vol 13 (2) ◽

pp. 103-110 ◽

Cited By ~ 35

Author(s):

André D Beaulieu ◽

Paul M Peloso ◽

Boulos Haraoui ◽

William Bensen ◽

Glen Thomson ◽

...

Keyword(s):

Chronic Pain ◽

Controlled Release ◽

Side Effects ◽

Adverse Events ◽

Sustained Release ◽

Controlled Trial ◽

Hip Osteoarthritis ◽

Visual Analogue Scale Pain ◽

Serious Adverse Events ◽

Once Daily

OBJECTIVE: The present study was a randomized, parallel, double-blind comparison between controlled-release (CR) tramadol and sustained-release (SR) diclofenac in patients with chronic pain due to osteoarthritis of the hips and/or knees.METHODS: Patients with at least moderate pain intensity, and having received analgesics over the past three months, underwent a two-to seven-day washout of current analgesics before initiation of 200 mg CR tramadol or 75 mg SR diclofenac. During the eight-week study, patients returned to the clinic biweekly. CR tramadol doses were titrated to a maximum of 200 mg, 300 mg or 400 mg per day. SR diclofenac doses were titrated to 75 mg or 100 mg once daily, or 75 mg twice a day based on pain relief and the presence of side effects. For rescue analgesic, patients took acetaminophen as needed, up to 650 mg three times a day.RESULTS: Forty-five patients on CR tramadol and 52 patients on SR diclofenac were evaluable. Significant improvements from prestudy treatment were shown for visual analogue scale pain (P=0.0001), stiffness (P<0.0005) and physical function (P=0.0001) scores for both treatments. There were no significant differences between the two treatments in the Western Ontario and McMaster Universities subscales, overall pain, pain and sleep, or the clinical effectiveness evaluation. Overall incidence of adverse events was similar in both groups, with more opioid-related adverse events with CR tramadol, and two serious adverse events occurring with the use of SR diclofenac.CONCLUSIONS: CR tramadol is as effective as SR diclofenac in the treatment of pain due to knee or hip osteoarthritis, with the potential for fewer of the serious side effects that characterize nonsteroidal anti-inflammatory drug administration.

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Routine Early Antibiotic use in SymptOmatic preterm Neonates (REASON): a prospective randomized controlled trial

10.1101/2020.04.17.20069617 ◽

2020 ◽

Cited By ~ 3

Author(s):

J. Lauren Ruoss ◽

Catalina Bazacliu ◽

Jordan T. Russell ◽

Diomel de la Cruz ◽

Nan Li ◽

...

Keyword(s):

Adverse Events ◽

Randomized Trial ◽

Premature Infants ◽

Neonatal Intensive Care ◽

Late Onset ◽

Controlled Trial ◽

Antibiotic Use ◽

Preterm Neonates ◽

Serious Adverse Events ◽

Late Onset Sepsis

AbstractObjectiveWe aim to assess the feasibility of a pragmatic randomized trial of antibiotics vs. no antibiotics in symptomatic premature infants after birth. Most premature infants are exposed to antibiotics after birth without evidence of benefit or harm for this practice. No study to date has attempted to randomize premature infants to antibiotics vs no antibiotics after birth.Study DesignInfants <33 weeks’ gestation admitted to the University of Florida Neonatal Intensive Care Unit were assigned to one of three groups after birth: (A) high risk – antibiotics indicated (B) low risk – antibiotics not indicated (C) eligible for un-blinded randomization (no antibiotics vs antibiotics). The primary outcome is a composite of serious adverse events including (necrotizing enterocolitis, late onset sepsis, bronchopulmonary dysplasia, and death). Odds ratios (and 95% CI’s) were calculated to compare adverse event rates between the two randomized groups.Results186 subjects were enrolled (98 infants and 88 mothers) were enrolled over a 2-year period. 56% of infants (n=55) were randomized; 48% of infants randomized to the no antibiotics arm were switched and received antibiotics within the first 48 hours after birth. Serious adverse events were not significantly different between the randomization arms.ConclusionThis is the first prospective randomized trial of antibiotics vs no antibiotics after birth in symptomatic premature infants. The results of this trial establish a framework of feasibility for a larger multicentered trial that is needed to evaluate the risks and benefits of routine antibiotic exposure in premature infants.

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