scholarly journals Safety review of 42 cases of COVID-19 treated with low-dose chloroquine

2020 ◽  
Author(s):  
Bo Zhou ◽  
Jing Zhang ◽  
Yanqing Liu ◽  
Wenxin Hong ◽  
Fengbi Jian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Low Dose ◽  
Information Management System ◽  
Controlled Clinical Trial ◽  
Global Pandemic ◽  
High Incidence ◽  
The Mean ◽  
Grade 3

Abstract BackgroundCoronavirus Disease 2019 (COVID-19) has become a global pandemic and caused over one hundred thousand death. Chloroquine (CQ) and hydroxychloroquine (HCQ) were recommended for off-label use in the treatment of COVID-19 in some countries despite their unclear benefit. However, the toxicity of these agents has been ignored, so the investigation of their safety in the treatment of COVID-19 is crucial for providing a reference for the rational use. MethodsThe medical records obtained from the information management system of Guangzhou Eighth People’s Hospital were reviewed to extract data about patients who received chloroquine phosphate tablets for COVID-19 treatment from January 20th to March 5th, 2020. The data were assessed to determine the correlation of adverse reaction with chloroquine phosphate based on Chinese CFDA standards as well as the severity of adverse events based on American CTCAE5.0 standard, and evaluate the safety of this medication.ResultsA total of 42 patients (23 males and 19 females, average 42.19±14.29 years old) with COVID-19 were treated with low-dose chloroquine phosphate (oral, 500 mg, once per day). Totally 18 patients（42.86%）experienced 20 adverse events. The mean duration of CQ administration was 6.57 days (SD, 3.16 days; range: 1 day to 16 days) and 52.4% received CQ for 7 to 9 days. The adverse events occurred within 6–8 days of treatment. For the 20 adverse events, 19 were not higher than grade 2 and only one was grade 3 because of the severely limited self-care ability in one patient. The most common adverse events were related to the digestive, circulatory, hepatic, and nervous systems.ConclusionOral chloroquine phosphate tablets resulted in a high incidence of adverse reactions. In the clinical trial of chloroquine phosphate for COVID-19 treatment, it should be used under pharmaceutical care; timely evaluation of the drug safety during the treatment process is necessary and a randomized controlled clinical trial should be conducted.

scholarly journals Effect of Prolonged-Release Pirfenidone on Renal Function in Septic Acute Kidney Injury Patients: A Double-Blind Placebo-Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Jonathan S. Chávez-Iñiguez ◽  
Jorge L. Poo ◽  
Miguel Ibarra-Estrada ◽  
Leonel García-Benavides ◽  
Guillermo Navarro-Blackaller ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Acute Kidney Injury ◽  
Adverse Events ◽  
Kidney Injury ◽  
Primary Objective ◽  
Controlled Clinical Trial ◽  
Prolonged Release ◽  
Double Blind ◽  
Septic Acute Kidney Injury ◽  
The Mean

Background. There is no treatment for septic acute kidney injury (sAKI). The anti-inflammatory activity of prolonged-release pirfenidone (PR-PFD) could be beneficial in this clinical setting. Methods. This study was a double-blind randomized clinical trial in sAKI patients with nephrology consultation at the Civil Hospital of Guadalajara, in addition to the usual treatment of AKI associated with sepsis; patients were randomized to receive either PR-PFD at 1,200 mg/day (group A) or 600 mg/day (group B) or a matched placebo for 7 consecutive days. The primary objective was the decrease in serum creatinine (sCr) and increase in urinary volume (UV); the secondary objectives were changes in serum electrolytes, acid-base status, and mortality. Results. Between August 2016 and August 2017, 88 patients were randomized. The mean age was 54 (17 ± SD) years, and 47% were male. The main site of infection was the lung (39.8%), septic shock was present in 39.1% of the cases, and the mean SOFA score was 8.8 points. 28 patients received PFD 1,200 mg, 30 patients received PFD 600 mg, and 30 patients received placebo. During the study, sCr did not differ among the groups. The reversion rate of sCr, UV, and mortality was not different among the groups ( p = 0.70 , p = 0.47 , and p = 0.38 , respectively). Mild adverse events were not different among the groups. Conclusion. PR-PFD did not improve the clinical course of sAKI and seemed to be safe in terms of adverse events. This trial is registered with NCT02530359.

A cluster-controlled clinical trial of two prophylactic silicone sacral dressings to prevent sacral pressure injuries in critically ill patients

2019 ◽  
pp. 21-26 ◽  
Author(s):  
Monica Stankiewicz ◽  
Jodie Gordon ◽  
Joel Dulhunty ◽  
Wendy Brown ◽  
Hamish Pollock ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care ◽  
Similar Efficacy ◽  
Care Patient ◽  
Controlled Clinical Trial ◽  
Cost Difference ◽  
Increased Risk ◽  
Pressure Injury ◽  
Risk Patients ◽  
The Mean

Objective Patients in the intensive care unit (ICU) have increased risk of pressure injury (PI) development due to critical illness. This study compared two silicone dressings used in the Australian ICU setting for sacral PI prevention. Design A cluster-controlled clinical trial of two sacral dressings with four alternating periods of three months' duration. Setting A 10-bed general adult ICU in outer-metropolitan Brisbane, Queensland, Australia. Participants Adult participants who did not have a sacral PI present on ICU admission and were able to have a dressing applied for more than 24 hours without repeated dislodgement or soiling in a 24-hour period (>3 times). Interventions Dressing 1 (Allevyn Gentle Border Sacrum™, Smith & Nephew) and Dressing 2 (Mepilex Border Sacrum™, Mölnlycke). Main outcomes measures The primary outcome was the incidence of a new sacral PI (stage 1 or greater) per 100 dressing days in the ICU. Secondary outcomes were the mean number of dressings per patient, the cost difference of dressings to prevent a sacral PI and product integrity. Results There was no difference in the incidence of a new sacral PI (0.44 per 100 dressing days for both products, p = 1.00), the mean number of dressings per patient per day (0.50 for both products, p = 0.51) and product integrity (85% for Dressing 1 and 84% for Dressing 2, p = 0.69). There was a dressing cost difference per patient (A$10.29 for Dressing 1 and A$28.84 for Dressing 2, p < 0.001). Conclusions Similar efficacy, product use and product integrity, but differential cost, were observed for two prophylactic silicone dressings in the prevention of PIs in the intensive care patient. We recommend the use of sacral prophylactic dressings for at-risk patients, with the choice of product based on ease of application, clinician preference and overall cost-effectiveness of the dressing.

Comparision of two fluoride varnishes for controlling white spot lesions. Randomized clinical trial

2017 ◽  
Vol 16 (1) ◽  
Author(s):  
Jesús Alberto Luengo - Fereira
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
White Spot ◽  
Controlled Clinical Trial ◽  
White Spot Lesions ◽  
Randomized Controlled Clinical Trial ◽  
Chi Square ◽  
Randomized Controlled ◽  
Anterior Teeth ◽  
The Mean

Objective: To compare two fluorinated varnishes for the control of white spot lesions.Material and Methods: A randomized controlled clinical trial was conducted. A total of 103 active whitespot lesions on permanent upper anterior teeth from 24 patients, aged 7 to 9 years were randomly assigned totwo groups, G1: Duraphat® (n=52) and G2: DuraShield® (n=51). Weekly applications were perform for fourconsecutive weeks. Fifth week the dimension, regression and activity of the lesions were evaluated. Student’sT test, Wilcoxon Ranks and Chi square were used at 5% significance. Results: At the end of the study, the lesion reduction was observed in 69.7%, finding significant differences(p<0.05) in the mean of the initial and final dimensions in general (2.74 mm to 1.91 mm) and in each group, G1(2.84 mm to 2.03 mm), G2 (2.64 mm to 1.78 mm). In the activity of the lesions, it was found in the G1, 12 active and6 inactive lesions; while in G2, there were 14 active and 29 inactive; these differences were significant (p<0.05). Conclusions: The two evaluated products showed similar clinical efficacy in the remineralization of activewhite spot lesions after 4 weeks of therapy.

Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial

2021 ◽  
Vol 30 (Sup5) ◽  
pp. S7-S14
Author(s):  
Thomas E Serena ◽  
Neal M Bullock ◽  
Windy Cole ◽  
John Lantis ◽  
Lam Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Diabetic Foot ◽  
Oxygen Therapy ◽  
Wound Closure ◽  
Foot Ulcers ◽  
Controlled Clinical Trial ◽  
Diabetic Foot Ulcers ◽  
Open Label ◽  
Number Of Patients

Objectives: Perfusion and blood oxygen levels are frequently insufficient in patients with hard-to-heal wounds due to poor circulation, vascular disruption and vasoconstriction, reducing the wound's capacity to heal. This study aimed to investigate the effect of topical oxygen on healing rates in patients with hard-to-heal diabetic foot ulcers (DFUs) (i.e., non-responsive over four weeks). Method: This multicentre, open-label, community-based randomised clinical trial compared standard care (SOC) with or without continuous topical oxygen therapy (TOT) for 12 weeks in patients with DFUs or minor amputation wounds. SOC included debridement, offloading with total contact casting (TCC) and appropriate moisture balance. Primary endpoints were the number of patients to achieve complete wound closure and percentage change in ulcer size. Secondary endpoints were pain levels and adverse events. Results: For the study, 145 patients were randomised with index ulcers graded Infectious Diseases Society of America (IDSA) 1 or 2, or Wagner 1 or 2. In the intention-to-treat analysis, 18/64 (28.1%) patients healed in the SOC group at 12 weeks compared with 36/81 (44.4%) in the SOC plus TOT group (p=0.044). There was a statistically significant reduction in wound area between the groups: SOC group mean reduction: 40% (standard deviation (SD) 72.1); SOC plus TOT group mean reduction: 70% (SD 45.5); per protocol p=0.005). There were no significant differences in changes to pain levels or adverse events. Conclusion: This study suggests that the addition of TOT to SOC facilitates wound closure in patients with hard-to-heal DFUs.

A study of low-dose ivermectin and diethyl carbamazine (DEC): a double-blind controlled clinical trial in lymphatic filariasis

1990 ◽  
Vol 183 (5) ◽  
pp. 1654-1655
Author(s):  
V. Vijayasekaran ◽  
E.A. Ottesen ◽  
V. Kumaraswami ◽  
S.V. Perumal ◽  
A. Geethalakshmi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lymphatic Filariasis ◽  
Low Dose ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Diethyl Carbamazine

scholarly journals Rheumatological Adverse Events Following Immunotherapy for Cancer

Medicina ◽  
2022 ◽  
Vol 58 (1) ◽  
pp. 94
Author(s):  
Ioana Cretu ◽  
Bogdan Cretu ◽  
Catalin Cirstoiu ◽  
Adrian Cursaru ◽  
Mihaela Milicescu ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Cancer Treatments ◽  
Treatment Conditions ◽  
Clinical Presentations ◽  
Rheumatic Manifestations ◽  
Grade 3 ◽  
Dose Dependent ◽  
Rheumatological Manifestations

Background and Objectives: The occurrence of rheumatological side effects in a patient after receiving immunotherapy for cancer is becoming increasingly common. Oncologists often fail to diagnose and refer affected patients to rheumatologists. This paper presents the various rheumatological adverse events that occur after immunotherapy in patients as well as their treatment and evolution. Materials and Methods: A total of 36 patients were monitored between November 2018 and March 2020. The oncologist monitoring the immunotherapy-treated patients identified the occurrence of musculoskeletal side effects. The grading of toxicities was performed by both the oncologist and the rheumatologist using common terminology criteria for adverse events (CTCAE). Rheumatological treatment was administered, and for some patients, immunotherapy was discontinued. Results: The clinical presentations of the patients varied. Mild side effects (grade 1–2) were reported in a higher proportion than severe side effects (grade 3–5). Therefore, thirty-one patients had mild-to-moderate side effects, and five patients had severe side effects. Adverse reactions occurred, on average, 10 weeks after the initiation of immunotherapy; this indicated that the severity of the toxicity was dose dependent. Patients were treated with NSAIDs or prednisone, depending on the severity of the side effects, and for patients with severe manifestations, immunotherapy was discontinued. The remission of rheumatic manifestations varied depending on the grade of the manifestations. Conclusions: The clinical, biological, and ultrasound presentations of the patients with adverse events followed by cancer treatments differed from classic rheumatological manifestations. Thorough examinations of these patients by both oncologists and rheumatologists are needed in order to correctly diagnose and treat rheumatological adverse events. Multiple studies that include a larger number of participants are needed in order to better understand the pathogenesis and clinical evolution of these patients under different treatment conditions.

scholarly journals The Effect of Rhythmic Breathing on the Severity of Sternotomy Pain after Coronary Artery Bypass Graft Surgery: A Randomized Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Hassan Babamohamadi ◽  
Masoumeh Karkeabadi ◽  
Abbasali Ebrahimian
Keyword(s):  
Clinical Trial ◽  
Pain Control ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Artery Bypass Graft ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
The Mean

Background. Moderate-to-severe pain is reported in up to 75% of the patients in the first 48 hours after cardiac surgery. Evidence suggests that distraction is an effective nursing intervention for controlling short-term and transient pain. Distraction can be achieved by various techniques, including progressive muscle relaxation, meditation, and rhythmic breathing (RB). The present research aimed at evaluating the impacts of RB on the severity of sternotomy pain after Coronary Artery Bypass Graft (CABG). Methods. This randomized, controlled clinical trial was conducted on 60 patients after CABG surgery at the open-heart surgery Intensive Care Unit (ICU) of Kowsar Hospital, affiliated to Semnan University of Medical Sciences in Semnan, Iran. The patients were selected through convenience sampling and randomly assigned to two groups, including (1) intervention or RB and (2) control groups. RB was performed in the intervention group every 12 hours (9 a.m. and 9 p.m.) for three consecutive days after the surgery. The control group received only routine care for pain control (opioid analgesics) with no additional interventions. The severity of pain was measured every day in both groups of patients before and after the interventions using the Visual Analog Scale (VAS). Results. The mean postintervention pain scores were significantly different from the mean preintervention scores in the intervention group ( p  < 0.05). The changes in the mean pain score in the intervention group were also significantly different from the corresponding changes in the controls ( p  < 0.05). Conclusion. Based on the results, the severity of pain after the intervention was significantly lower in the RB group compared to the control. RB was found to be an effective technique for reducing the patients’ pain and is therefore recommended as a post-CABG pain control technique. Iranian Registry of Clinical Trials: this trial is clinically registered with IRCT20120109008665N7, registered 3 September 2018.

scholarly journals Management of Advanced Medullary Thyroid Carcinoma with Vandetanib: Case Series

2021 ◽  
Vol 5 (1) ◽  
pp. 01-07
Author(s):  
Andrés Flórez R
Keyword(s):  
Partial Response ◽  
Adverse Events ◽  
Thyroid Carcinoma ◽  
Medullary Thyroid Carcinoma ◽  
Stable Disease ◽  
Case Series ◽  
Medullary Thyroid ◽  
The Mean ◽  
Grade 3

Objective: To describe the tumor response and adverse events in patients with advanced medullary thyroid carcinoma (MTC) treated with vandetanib at the National Cancer Institute in Bogotá, Colombia. Materials and Methods: Case series including five patients with advanced MTC treated with vandetanib from April 2011 to August 2018 and a minimum follow-up of 6 months. Results: 5 patients met the inclusion criteria, including 3 women. The mean age was 49 years. A total of 4 patients underwent total thyroidectomy prior to starting vandetanib. The main indication for vandetanib was progression of liver metastasis (4 patients). Regarding treatment response, 3 patients presented stable disease, 1 patient showed partial response, and 1 had disease progression. The mean treatment duration was 16.5 months. Grade 3 or 4 adverse events were observed in three patients, 1 with diarrhea, 1 with hypertension, and 1 with rash. All symptoms improved with dose reduction or temporary suspension of vandetanib. Conclusions: The management of advanced MTC with vandetanib allows for prolonged disease control (stable disease or partial response). Although adverse events are frequent, most are mild and severe cases are manageable.

Safety and efficacy outcomes with nivolumab plus ipilimumab in patients with advanced renal cell carcinoma and low Karnofsky performance status: Results from the CheckMate 920 trial.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 315-315
Author(s):  
Thomas E. Hutson ◽  
Bradley Curtis Carthon ◽  
Jeffrey Yorio ◽  
Sunil Babu ◽  
Heidi Ann McKean ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Adverse Events ◽  
Clear Cell ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Objective Response ◽  
Safety And Efficacy ◽  
Grade 3

315 Background: Combination therapy with nivolumab + ipilimumab (NIVO+IPI) has demonstrated long-term efficacy and tolerability for patients (pts) with previously untreated advanced renal cell carcinoma (aRCC). Most pivotal clinical trials in pts with aRCC have excluded pts with low Karnofsky performance status (KPS; < 70%). CheckMate 920 is a multi-arm, phase IIIb/IV, open-label clinical trial of NIVO+IPI treatment in pts enrolled in a community practice setting with aRCC and a high unmet medical need. We present safety and efficacy results for the cohort of pts with aRCC of any histology and KPS 50%–60% from CheckMate 920 (NCT02982954). Methods: Pts with previously untreated advanced/metastatic RCC and KPS 50%–60% received NIVO 3 mg/kg + IPI 1 mg/kg Q3W × 4 doses followed by 480 mg NIVO Q4W for ≤ 2 years or until disease progression/unacceptable toxicity. The primary endpoint was incidence of grade ≥ 3 immune-mediated adverse events (imAEs) within 100 days of last dose of study drug. Key secondary endpoints included progression-free survival (PFS) and objective response rate (ORR) by RECIST v1.1 (both per investigator). Exploratory endpoints included overall survival (OS). Results: Of 25 treated pts with KPS 50%–60%, 76% were men; median age was 67 years (range, 34–81). IMDC risk was favorable in 0%, intermediate in 32%, and poor in 68% of pts; 84% had clear cell and 16% had non-clear cell RCC histology. With a minimum follow-up of 25 months, median duration of therapy (95% CI) was 2.3 months (2.1–7.7) for NIVO and 2.1 months (2.1–2.1) for IPI. The median number of doses (range) received was 4 (1–27) for NIVO and 4 (1–4) for IPI; 76% of pts received ≥ 4 NIVO doses and 68% received all 4 IPI doses. The only grade 3–4 imAEs by category were hepatitis (4.0%) and adrenal insufficiency (4.0%). No grade 5 imAEs occurred. Overall, 4 (16%) pts discontinued due to any-grade adverse events (n = 1 each for elevated AST, malignant neoplasm progression, back pain, and acetabulum fracture). Of 18 evaluable pts, ORR was 33.3% (95% CI, 13.3–59.0); no pts had a complete response and 6 had partial response. Median time to objective response was 4.5 months (range, 2.5–24.7). Median duration of objective response was 20.6 months (range, 0.03+–24.2+). Median PFS was 4.6 months (95% CI, 2.5–14.8). Median OS was 15.6 months (95% CI, 5.3–25.1). Conclusions: NIVO+IPI demonstrated an acceptable safety profile and promising antitumor activity in pts with previously untreated aRCC and KPS 50%–60%. The combination was tolerated at a dose intensity similar to that observed in clinical trials conducted in pts with higher KPS (≥ 70%). These data support the value of NIVO+IPI in pts who may not be considered ideal candidates for this therapy and consequently may have limited treatment options. Clinical trial information: NCT02982954 .

scholarly journals Apheresis-Adverse Events in Man and Machine Individualities

2020 ◽  
Vol 14 (1) ◽  
pp. 27-30
Author(s):  
Md Ashraful Hoque ◽  
Kashfia Islam ◽  
Selina Akter
Keyword(s):  
Adverse Reaction ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Key Factors ◽  
Serious Adverse Events ◽  
Female Ratio ◽  
The Mean ◽  
Male To Female ◽  
Citrate Toxicity ◽  
Common Adverse Reaction

Adverse events due to platelet pheresis are not unheard of citrate related reactions being the most common. Most of these events are mild and self limiting. The current study describes adverse events in platelet pheresis using modern apheresis systems. This prospective study included 1455 platelet pheresis procedures done from July 2016 to December 2017. Procedures were performed on Hemonetics MCS+, Trima Accel and Cobe spectra cell separators. The endpoint of each procedure was a yield of 3 × 1011 platelets (PLTs) per unit. Donor adverse reaction if any was managed, reported, and documented. The median age of donors was 31 years with male to female ratio of 13:1. The median body surface area and body mass index were 1.64 m2 and 22.4 kg/m2, respectively. The mean PLT count of donors was 199.8 × 103/uL with a mean hemoglobin value of 13.6 g/dl. ACD infusion was significantly more in the Hemonetics MCS+, (P< 0.01). Donation time was least with the Trima compared to Hemonetics MCS+ (P< 0.01) and Cobe (P< 0.001). Total whole blood volume processed was higher in Hemonetics MCS+, (P< 0.01). Paresthesia due to citrate toxicity was the most common adverse reaction (65.3%), and vascular injury was observed in only five donors. The overall incidence of adverse reaction was 3.4%. Serious adverse events were not observed. The modern generation apheresis machines are more donors friendly and cause less adverse reactions compared to the older versions. Good donor screening, optimized donor physiognomic and hematological values and skilled operators are the key factors in reaction reduction by apheresis. Faridpur Med. Coll. J. Jan 2019;14(1): 27-30

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