The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A phase III randomised clinical trial

Abstract IntroductionAs the first randomized clinical trial, this study evaluated the effect of Famotidine on the improvement of outcomes of hospitalized patients with COVID-19.MethodThis phase III randomized clinical trial was designed with two parallel arms, placebo-controlled, single-blind, and concealed allocation, and recruited 20 patients. Oral Famotidine 160 mg four times a day was given to patients until the discharge day or for a maximum of 14 days. Patients’ temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase (LDH) level and complete blood count (CBC) were measured at the baseline (before the intervention) and on day 14 after the intervention or on discharge day. Length of stay in the hospital and length of stay in the ICU were also measured as secondary outcomes of the study.ResultsThe results showed a significant decrease in LDH (P = 0.01), mean WBC (P = 0.04) and length of stay (P = 0.04) of patients with COVID-19 in the group treated with Famotidine compared to the control group. There was also a significant increase in oxygen saturation (P = 0.01) in the group treated with Famotidine compared to the control group. Cough improvement was also higher in the oral Famotidine group compared to the control group (P = 0.02).ConclusionThis was the first clinical trial on the effect of Famotidine on the improvement of hospitalized COVID-19 patients, which indicated that high-dose Famotidine improves patients’ clinical signs and reduces the severity of the disease and duration of hospitalization.

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The Efficacy of Nebulized Furosemide and Salbutamol Compared with Salbutamol Alone in Reactive Airway Disease: A Double Blind Randomized, Clinical Trial

Emergency Medicine International ◽

10.1155/2014/638102 ◽

2014 ◽

Vol 2014 ◽

pp. 1-5 ◽

Cited By ~ 1

Author(s):

Kambiz Masoumi ◽

Arash Forouzan ◽

Maryam Haddadzadeh Shoushtari ◽

Samaneh Porozan ◽

Maryam Feli ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Clinical Signs ◽

Airway Disease ◽

Clinical Severity ◽

Control Group ◽

Old Patients ◽

Reactive Airway Disease ◽

Reactive Airway ◽

Nebulized Salbutamol

We undertook this randomized clinical trial to investigate whether adding furosemide to salbutamol could improve the peak expiratory flow rate (PEFR) and clinical signs of reactive airway disease (RAD) patients. Eligible 18- to 55-year-old patients were randomly divided into intervention and control groups. Patients received 5 mg of nebulized salbutamol and 40 mg of nebulized furosemide in the intervention group and 5 mg of nebulized salbutamol alone in the control group. Patients in both groups received 100 mg of methylprednisolone intravenously stat. Severity of the RAD was estimated before and 45 minutes after treatment in both groups. PEFR was estimated before treatment and at 15, 30, and 45 minutes later. Ninety patients were enrolled, 45 in each group. There were no significant differences between two groups regarding gender, mean age, and normalized PEFR. The baseline mean PEFR was not significantly different between groups (P=0.58). A repeated measure analysis of variance revealed that the differences between the two treatments was significant (P=0.0001) and the behavior of two treatments was not similar across the time (P=0.001). Comparison of clinical severity of acute RAD revealed no significant differences between groups at the end of the trial (0.06). This study showed that adding nebulized furosemide to salbutamol in RAD patients improved PEFR.

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A randomized clinical trial of low dose single antibiotic-loaded cement versus high dose dual antibiotic-loaded cement in patients receiving a hip hemiarthroplasty after fracture: A protocol for the WHiTE 8 COPAL study

Bone & Joint Open ◽

10.1302/2633-1462.22.bjo-2020-0174 ◽

2021 ◽

Vol 2 (2) ◽

pp. 72-78

Author(s):

Nickil Ramesh Agni ◽

Matthew L. Costa ◽

Juul Achten ◽

Heather O’Connor ◽

May Ee Png ◽

...

Keyword(s):

Clinical Trial ◽

Cost Effectiveness ◽

Hip Fracture ◽

Bone Cement ◽

Randomized Clinical Trial ◽

Hip Fractures ◽

Low Dose ◽

Absolute Difference ◽

Control Group ◽

High Dose

Aims Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. Methods The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group. Conclusion The results of this trial will provide evidence regarding clinical and cost-effectiveness between low dose single and high dose dual antibiotic-loaded bone cement, which will inform policy and practice guidelines such as the National Institute for Health and Care Excellence guidance on management of hip fractures. Cite this article: Bone Jt Open 2021;2(2):72–78.

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Cisplatin, Dacarbazine With or Without Subcutaneous Interleukin-2, and Interferon Alfa-2b in Advanced Melanoma Outpatients: Results From an Italian Multicenter Phase III Randomized Clinical Trial

Journal of Clinical Oncology ◽

10.1200/jco.2002.20.6.1600 ◽

2002 ◽

Vol 20 (6) ◽

pp. 1600-1607 ◽

Cited By ~ 38

Author(s):

Ruggero Ridolfi ◽

Vanna Chiarion-Sileni ◽

Michele Guida ◽

Antonella Romanini ◽

Roberto Labianca ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Low Dose ◽

Interleukin 2 ◽

Advanced Melanoma ◽

Interferon Alfa ◽

Phase Iii ◽

World Health ◽

High Dose ◽

Severe Toxicity

PURPOSE: Phase II and III studies have shown that the addition of interleukin-2 (IL-2) and interferon alfa-2b (IFNα-2b) in multiagent chemotherapy (CT) for advanced melanoma increases overall response (OR), albeit without clear evidence of an improvement in overall survival (OS). Treatment with high-dose IL-2 can cause severe toxicity and is normally administered in an inpatient setting. We conducted a multicenter prospective randomized clinical trial in outpatients with metastatic melanoma to compare CT with biochemotherapy (bioCT) using immunomodulant doses of IL-2 and IFNα-2b. PATIENTS AND METHODS: One hundred seventy-six eligible patients with advanced melanoma were randomized to receive CT (cisplatin and dacarbazine with or without carmustine every 21 days) or bioCT comprising the same CT regimen followed by low-dose subcutaneous IL-2 for 8 days and IFNα2b three times a week, both for six cycles. RESULTS: At a median follow-up of 18 (CT) and 16 (bioCT) months, median OS was 9.5 versus 11.0 months (P = .51), respectively. In the 89 CT-arm patients, 18 ORs (20.2%) (three complete responders [CRs] and 15 partial responders [PRs]) were observed according to World Health Organization criteria. In the 87 bioCT-arm patients, 22 ORs (25.3%) (three CRs and 19 PRs) (P = .70) were recorded. Treatment-related toxicity was fairly similar in both arms. CONCLUSION: The addition of low-dose immunotherapy did not produce a statistically significant advantage in OS, time to progression, or OR. However, the 11-month median OS in the bioCT arm does not differ greatly from the best results with high-dose IL-2–containing regimens reported in the literature. Furthermore, our treatment schedule was carried out on outpatients and had an acceptable level of toxicity.

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Music Therapy Reduced Nauseas and Pain Of The Patients Undergoing Hematopoietic Stem Cells Transplantation Autologous (Randomized Clinical Trial)

10.21203/rs.3.rs-25921/v1 ◽

2020 ◽

Author(s):

CARLOS ANTONIO DORO ◽

Jose Zanis Neto ◽

Sergio Kowalski

Keyword(s):

Clinical Trial ◽

Stem Cells ◽

Music Therapy ◽

Hematopoietic Stem Cells ◽

Randomized Clinical Trial ◽

Control Group ◽

High Dose ◽

Hematopoietic Stem ◽

Stem Cells Transplantation ◽

Hematopoietic Stem Cells Transplantation

Abstract Purpose: The autologous hematopoietic stem cell transplantation (HSCT Aut) is a therapeutic medical treatment for various neoplastic hematologic, congenital, genetic or acquired disorders. In this procedure which combines high-dose chemotherapy and/or radiotherapy and has a high degree of cytotoxicity, the patient experiences solitary confinement, which causes psychological distress, anxiety, mood, fatigue, nauseas, pain and can lead him/her to depression. Music therapy applied with the purpose of decreasing this social confinement. This is a randomized clinical trial. Method: n=45 patients were selected randomly. n=24 were selected for the Experimental Music Therapy Group (EMG) and n=21 received music therapy intervention for the Control Group (CG) who received the standard treatment. The intervention of live music was applied using music therapy methods and techniques. Assessment and quantification made using the visual analog scale (VAS). The dependent variables were nauseas and pain of patients. Results: The student t test applied, (p <0.05) considered statistically significant when comparing the groups, reducing nauseas and pain significantly Conclusion: Music therapy reduced nausea and pain of the patients undergoing hematopoietic stem cells transplantation autologous, providing bio-psychosocial welfare.

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