8,207 results match your criteria placebo cases

Repeated Remote Ischaemic Preconditioning Can Prevent Acute Mountain Sickness after Rapid Ascent to a High Altitude.

Eur J Sport Sci 2021 May 12:1-36. Epub 2021 May 12.

Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.

Background: Acute Mountain Sickness (AMS) is a syndrome with nonspecific neurological symptoms that can occur in unacclimatized persons after Rapid Ascent to a High Altitude. Since Repeated Remote Ischaemic Preconditioning (RIPC) can protect remote organs from subsequent hypoxic or ischaemic damage, the aim of the present study was to assess the effectiveness of 4 different RIPC protocols varying in duration and frequency for preventing AMS after Rapid Ascent to a High Altitude.

Methods: We designed a prospective but not blinded study in which we randomly divided participants into five groups. Read More

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Selective oestrogen receptor modulators (SERMs) for endometriosis.

Cochrane Database Syst Rev 2021 May 11;5:CD011169. Epub 2021 May 11.

Isala Hospitals Zwolle, Zwolle, Netherlands.

Background: Endometriosis is defined as the presence of endometrial tissue outside the uterine cavity. This chronic and recurring condition occurs in women of reproductive age. It is a common cause of pain or infertility and can cause non-specific symptoms such as lower back pain, dyspareunia (pain during or after intercourse), and dysmenorrhoea (menstrual pain). Read More

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[Imaging-based patient selection for mechanical thrombectomy based on time since symptom onset].

B Cheng G Broocks

Nervenarzt 2021 May 10. Epub 2021 May 10.

Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20251, Hamburg, Deutschland.

Background: In ischemic stroke due to large vessel occlusion (LVO), the indications for patient selection for endovascular mechanical thrombectomy (MT) are based on findings from brain imaging. Several imaging protocols from computed tomography (CT) or magnetic resonance imaging (MRI) are available to guide treatment decisions.

Objective: To recommend the optimal choice of imaging modalities and protocols for MT with respect to time windows from symptom onset. Read More

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Randomized controlled trials of remdesivir in hospitalized coronavirus disease 2019 patients: A meta-analysis.

Turk J Emerg Med 2021 Apr-Jun;21(2):43-50. Epub 2021 Feb 12.

Division of Research and Academic Affairs, Larkin Health System, South Miami, Florida, USA.

Background: The first cases of the coronavirus disease 2019 (COVID-19) were reported in Wuhan, China. No antiviral treatment options are currently available with proven clinical efficacy. However, preliminary findings from phase III trials suggest that remdesivir is an effective and safe treatment option for COVID-19 patients with both moderate and severe disease. Read More

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February 2021

Rapid amelioration of anorexia nervosa in a male adolescent during metreleptin treatment including recovery from hypogonadotropic hypogonadism.

Eur Child Adolesc Psychiatry 2021 May 9. Epub 2021 May 9.

Department of Child and Adolescent Psychiatry, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.

With this case report we support our medical hypothesis that metreleptin treatment ameliorates starvation related emotional, cognitive and behavioral symptomatology of anorexia nervosa (AN) and show for the first time strong effects in a male patient with AN. A 15.9 year old adolescent with severe AN of eight-month duration was treated off-label with metreleptin. Read More

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Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage.

CNS Drugs 2021 May 6. Epub 2021 May 6.

Henan Key Laboratory of Child Brain Injury and Henan Pediatric Clinical Research Center, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.

Background: Intraventricular hemorrhage (IVH) is a common complication in preterm infants that has poor outcomes, especially in severe cases, and there are currently no widely accepted effective treatments. Erythropoietin has been shown to be neuroprotective in neonatal brain injury.

Objective: The objective of this study was to evaluate the protective effect of repeated low-dose recombinant human erythropoietin (rhEPO) in preterm infants with IVH. Read More

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A randomized, controlled comparison of electrical versus pharmacological cardioversion for emergency department patients with acute atrial flutter.

CJEM 2021 May 18;23(3):314-324. Epub 2021 Jan 18.

Department of Emergency Medicine, University of Ottawa, Ottawa, ON, Canada.

Background: Acute atrial flutter has one-tenth the prevalence of acute atrial fibrillation in the emergency department (ED) but shares many management strategies. Our aim was to compare conversion from acute atrial flutter to sinus rhythm between pharmacological cardioversion followed by electrical cardioversion (Drug-Shock), and electrical cardioversion alone (Shock-Only).

Methods: We conducted a randomized, blinded, placebo-controlled comparison of attempted pharmacological cardioversion with IV procainamide followed by electrical cardioversion if necessary, and placebo infusion followed by electrical cardioversion. Read More

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Effect of Vitamin D Supplementation on Improvement of Symptoms in Mild-to-Moderate Asthma Patients with Vitamin D Insufficiency and Deficiency.

Tanaffos 2020 Dec;19(4):322-329

Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

Background: In the current study, we assessed the effect of vitamin D supplementation on improvement of symptoms in mild-to-moderate asthma patients with vitamin D insufficiency and deficiency.

Materials And Methods: This randomized, controlled clinical trial included 132 mild-to-moderate asthma patients with vitamin D insufficiency (n=66) and those with vitamin D deficiency (n=66). They were assigned randomly to two groups of cases (with two subgroups) and controls (with two subgroups). Read More

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December 2020

The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area.

BMC Pediatr 2021 May 4;21(1):220. Epub 2021 May 4.

Center for Clinical Research Dalarna - Uppsala University, Region Dalarna County, Falun, Sweden.

Background: Children with acute peripheral facial nerve palsy cannot yet be recommended corticosteroid treatment based on evidence. Adults with idiopathic facial nerve palsy are treated with corticosteroids, according to guidelines resulting from a meta-analysis comprising two major randomized placebo-controlled trials. Corresponding trials in children are lacking. Read More

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A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation.

Clin Transl Gastroenterol 2021 May 3;12(5):e00345. Epub 2021 May 3.

Departments of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, P.R. China.

Objectives: Management of constipation is still challenging in childhood. The pharmacological effect of XiaojiDaozhi Decoction, a prescription of Chinese Herbal Medicine (CHM), has been well described for the treatment of food and Qi stagnation which account for childhood constipation. However, the efficacy and safety of XiaojiDaozhi Decoction in childhood constipation remains unclear. Read More

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Tranexamic acid to reduce head injury death in people with traumatic brain injury: the CRASH-3 international RCT.

Health Technol Assess 2021 Apr;25(26):1-76

Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.

Background: Tranexamic acid safely reduces mortality in traumatic extracranial bleeding. Intracranial bleeding is common after traumatic brain injury and can cause brain herniation and death. We assessed the effects of tranexamic acid in traumatic brain injury patients. Read More

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A Placebo-Controlled, Double-Blind Randomized (Phase IIB) Trial of Oral Administration with HPV16 E7-Expressing , GLBL101c, for the Treatment of Cervical Intraepithelial Neoplasia Grade 2 (CIN2).

Vaccines (Basel) 2021 Apr 1;9(4). Epub 2021 Apr 1.

Department of Obstetrics and Gynecology, Nihon University School of Medicine, 30-1 Oyaguchi-kamimachi, Itabashi-ku, Tokyo 173-8610, Japan.

Cervical intraepithelial neoplasia (CIN), a precursor lesion to cervical cancer, is caused by high-risk human papillomavirus (HPV); high-grade CIN lesions (CIN2-3) are precancerous and require treatment. No globally approved therapy is available for CIN2-3 treatment. This study is a placebo-controlled randomized clinical trial of GLBL101c treatment for CIN2 in 40 patients with HPV16-positive CIN2 who were 1:1 randomized to receive GLBL101c (1 g/daily) or placebo for 5 days at 1, 2, 4, and 8 weeks. Read More

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Role of D-Mannose in the Prevention of Recurrent Uncomplicated Cystitis: State of the Art and Future Perspectives.

Antibiotics (Basel) 2021 Apr 1;10(4). Epub 2021 Apr 1.

Department of Human and Pediatric Pathology "Gaetano Barresi", Urology Section, University of Messina, 98168 Messina, Italy.

Background: Urinary tract infections (UTI) are highly frequent in women, with a significant impact on healthcare resources. Although antibiotics still represent the standard treatment to manage recurrent UTI (rUTI), D-mannose, an inert monosaccharide that is metabolized and excreted in urine and acts by inhibiting bacterial adhesion to the urothelium, represents a promising nonantibiotic prevention strategy. The aim of this narrative review is to critically analyze clinical studies reporting data concerning the efficacy and safety of D-mannose in the management of rUTIs. Read More

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Wound Management Strategy for Treatment of Localized Cutaneous Leishmaniasis Using the TIME Framework.

Wounds 2021 Jan;33(1):E6-E9

Department of Dermatology, University of Pisa, Pisa, Italy.

Introduction: The current drugs available for the treatment of cutaneous leishmaniasis (CL) often cause several adverse events, and the risk-benefit ratio is low due to the risk of severe complications. Current treatment recommendations are based on data from areas endemic for leishmaniasis and are not always perfectly applicable, especially in cases of imported CL. Thus, it is crucial to assess the level of severity in each case to provide the most appropriate treatment modality. Read More

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January 2021

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study.

Rheumatol Ther 2021 Apr 28. Epub 2021 Apr 28.

Rheumatology, Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Foundation Trust, Bath, UK.

Introduction: Upadacitinib is a Janus kinase inhibitor under investigation in patients with psoriatic arthritis (PsA). This study assessed the 56-week efficacy and safety of upadacitinib in patients with PsA and an inadequate response or intolerance to biologic therapy.

Methods: In the phase 3 SELECT-PsA 2 study, patients were randomized to 56 weeks of blinded treatment with oral upadacitinib 15 or 30 mg once daily, or placebo switched to upadacitinib 15 or 30 mg once daily at week 24. Read More

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Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial.

Trials 2021 Apr 28;22(1):310. Epub 2021 Apr 28.

Sector Neurogastroenterología, Hospital de Clinicas José de San Martin Universidad de Buenos Aires, Buenos Aires, Argentina.

Objectives: This research aims to study the efficacy of tannins co-supplementation on disease duration, severity and clinical symptoms, microbiota composition and inflammatory mediators in SARS-CoV2 patients.

Trial Design: This is a prospective, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy of the administration of the dietary supplement ARBOX, a molecular blend of quebracho and chestnut tannins extract and Vit B12, in patients affected by COVID-19.

Participants: 18 years of age or older, admitted to Hospital de Clinicas Jose de San Martin, Buenos Aires University (Argentina), meeting the definition of "COVID-19 confirmed case" ( https://www. Read More

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Placebo-controlled trials of Covid-19 vaccines - Are they still ethical?

Indian J Med Ethics 2021 Apr-Jun;VI(2):1-8

Institute for Philosophical Research, National Autonomous University of Mexico, Circuito Mario de la Cueva s/n Ciudad Universitaria, Coyoacán, Mexico City 04510 MEXICO.

A World Health Organization (WHO) Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation recently recommended placebo-controlled trials (PCT) of Covid-19 vaccines. PCTs are ethically acceptable when there is no proven effective and safe treatment for a certain condition. However, there are already some vaccines that have been approved and which have high levels of efficacy and safety. Read More

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Trials for second generation Covid-19 vaccines: Revisiting the debate over placebo use in developing country clinical trials.

Peter Lurie

Indian J Med Ethics 2021 Apr-Jun;VI(2):1-10

Center for Science in the Public Interest, 1220 L Street, NW, Suite 300, Washington, DC 20005, USA.

This article compares the current debate over the use of placebos in developing country clinical trials of second generation Covid-19 vaccines with the debates over previous paradigmatic cases raising similar issues. Compared to the earlier zidovudine and Surfaxin trials, Covid-19 vaccine trials are likely to confer lower risk to placebo groups and to offer a greater number and variety of alternative study designs. However, turning to the developing world to conduct studies that would be unacceptable in developed countries, simply on the ground that Covid-19 vaccines are generally unavailable in developing countries, is not ethically justifiable. Read More

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Interleukin-1 blockade with RPH-104 in patients with acute ST-elevation myocardial infarction: study design and rationale.

J Transl Med 2021 04 26;19(1):169. Epub 2021 Apr 26.

Pauley Heart Center, Virginia Commonwealth University, Richmond, VA, USA.

Background: Myocardial injury of ST-segment elevation myocardial infarction (STEMI) initiates an intense inflammatory response that contributes to further damage and is a predictor of increased risk of death or heart failure (HF). Interleukin-1 (IL-1) is a key mediator of local and systemic inflammatory response to myocardial damage. We postulate that the use of the drug RPH-104, which selectively binds and inactivates both α and β isoforms of IL-1 will lead to a decrease in the severity of the inflammatory response which will be reflected by decrease in the concentration of hsCRP, as well as the rate of fatal outcomes, frequency of new cases of HF, changes in levels of brain natriuretic peptide (BNP) and changes in structural and functional echocardiographic parameters. Read More

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17 Alpha-hydroxyprogesterone caproate use in a rural state.

J Matern Fetal Neonatal Med 2021 Apr 25:1-3. Epub 2021 Apr 25.

Department of Obstetrics and Gynecology, University of Arkansas for Medical Sciences College of Medicine, Little Rock, AR, USA.

Background: 17 alpha-hydroxyprogesterone caproate (17OHP) is used to reduce the recurrent risk of preterm delivery in women with a history of preterm delivery. Meis et al. conducted a double-blind placebo controlled trial to evaluate the effectiveness of 17OHP and observed a significant reduction in the risk of recurrent preterm delivery. Read More

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Adverse Effects of Recreational and Medical Cannabis.

Psychopharmacol Bull 2021 Jan;51(1):94-109

Urits, MD, Berger, MD, Beth Israel Deaconess Medical Center, Department of Anesthesia, Critical Care, and Pain Medicine, Harvard Medical School, Boston, MA. Charipova, BS, Gress, BS, Georgetown University School of Medicine, Washington, DC. Li, BS, Medical College of Wisconsin, Wauwatosa, WI. Cornett, PhD, Louisiana State University Health Sciences Center, Department of Anesthesiology, New Orleans, LA. Kassem, MD, Mount Sinai Medical Center, Department of Anesthesiology, Miami Beach, FL. Ngo, MD, MBA, Harvard Medical School, Boston, MA, Pain Specialty Group, Newington, NH. Kaye, MD, PhD, Louisiana State University Health Shreveport, Department of Anesthesiology, Shreveport, LA. Viswanath, MD, Valley Anesthesiology and Pain Consultants - Envision Physician Services, Phoenix, AZ, University of Arizona College of Medicine-Phoenix, Phoenix, AZ, Creighton University School of Medicine, Department of Anesthesiology, Omaha, NE.

Purpose Of Review: This comprehensive review discusses the adverse effects known today about marijuana, for either medical or recreational use. It reviews the role of cannabis in the treatment of chronic pain, cognitive and neurological adverse effects, special cases and addiction.

Recent Findings: Cannabinoids work through the endocannabinoids system and inhibit the release of GABA and glutamate in the brain, impact neuromodulation, as well as dopamine, acetylcholine and norepinephrine release. Read More

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January 2021

Convalescent plasma therapy in COVID-19 critically ill patients during advanced phases of clinical trials and their preliminary results.

Einstein (Sao Paulo) 2021 19;19:eRW6186. Epub 2021 Apr 19.

Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.

The objective of this study was to highlight the global scientific effort to fight the SARS-CoV-2, addressing the preliminary results of passive immunization through convalescent plasma. We performed a search at the major databases of interventional clinical trial protocols about the transfusion of convalescent plasma in patients with COVID-19, as well as, published articles (n≥25), using the following search strategy: [(COVID-19 OR SARS-CoV-2 OR nCoV-2019) AND (Convalescent plasma OR Plasma exchange) AND (Treatment OR Therapy)]. A total of 24 interventional clinical trial protocols (advanced in phases II-III, III, and IV) were included in this review, as well as three studies that had enough outcomes to evaluate the efficacy of convalescent plasma therapy for patients with COVID-19. Read More

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Aspirin Responsiveness at a Dose of 80 mg and Its Impact on Birth Weight when Used in Twin Pregnancies: The GAP Pilot Randomized Trial.

Am J Perinatol 2021 Apr 21. Epub 2021 Apr 21.

Centre de recherche du Centre Hospitalier, Universiatire de Québec-Université Laval, Axe Santé Reproduction Mère et Enfant, Québec, Canada.

Objective:  Daily aspirin, started in the first trimester of pregnancy, is commonly used for the prevention of preeclampsia and fetal growth restriction in multiple gestation. However, the optimal dose remains controversial and the evidence for the use of aspirin in multiple pregnancies is scarce. We aimed to estimate the impact of 80 mg of aspirin in twin pregnancies. Read More

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[Non-metastatic castration-resistant prostate cancer (M0CRPC) - Apalutamide in high-risk M0CRPC: case reports from the SPARTAN study and the apalutamide compassionate use program].

Aktuelle Urol 2021 Apr 21. Epub 2021 Apr 21.

Universitätsklinikum Münster, Urology, Münster.

The occurrence of distant metastases represents a prognostically unfavourable turning point in non-metastatic castration-resistant prostate cancer (M0CRPC). M0CRPC patients with a short PSA doubling time have a particularly high risk of progression. For a long time, there was no further treatment option for these patients apart from watchful waiting while maintaining classic androgen deprivation therapy (ADT). Read More

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Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19.

N Engl J Med 2021 Apr 21. Epub 2021 Apr 21.

From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J.R.G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); the National Institute of Allergy and Infectious Diseases, Rockville (K.L.T., M.A.M.), Walter Reed Army Institute of Research, Silver Spring (M.L.R.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); Janssen Research and Development, Raritan, NJ (J. Stoddard); and Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.).

Background: The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. Read More

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Efficacy of Yangyin Yiqi Huoxue Granule () in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial.

Chin J Integr Med 2021 Apr 21. Epub 2021 Apr 21.

Chinese Medicine Department, the Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, 310000, China.

Objective: To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule (, YYHG) in the treatment of ischemic stroke (IS) patients with qi-yin deficiency and blood stasis syndrome (QYDBSS), and to explore its effective dosage.

Methods: The total of 288 patients were randomly assigned to the YYHG high-dose, YYHG low-dose, positive control (administered Xiaoshuantong Granule, XSTG, ), or placebo control (administered inert granule) groups (72 cases per group) by software-drived competitive block randomization. The trial was conducted for a 28-day period, with a 180-day follow-up period. Read More

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Breast Cancer Incidence Reduction in Women Treated with Subcutaneous Testosterone: Testosterone Therapy and Breast Cancer Incidence Study.

Eur J Breast Health 2021 Apr 31;17(2):150-156. Epub 2021 Mar 31.

Institute for Hormonal Balance, Arlington, Texas, USA.

Objective: Testosterone (T) therapy has been shown to be breast protective in both pre- and post-menopausal patients. Additionally, estradiol (E) does not cause breast cancer (BC) in the majority of the world's literatures. This study aimed to investigate the incidence of invasive BC (IBC) in pre- and postmenopausal women treated with T therapy and T in combination with E (T/E). Read More

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Budget Impact Analysis of Vericiguat for the Treatment of Chronic Heart Failure with Reduced Ejection Fraction Following a Worsening Event.

Adv Ther 2021 May 16;38(5):2631-2643. Epub 2021 Apr 16.

Center for Observational and Real-World Evidence, Merck & Co, Inc, Kenilworth, NJ, USA.

Introduction: In the USA, patients with chronic heart failure (HF) with reduced ejection fraction (HFrEF) following a worsening HF event (WHFE) have significantly increased healthcare resource use and medical costs. This analysis aimed to estimate the budget impact of vericiguat as an add-on therapy to guideline-directed medical therapy (GDMT) for the treatment of chronic HFrEF following a WHFE from a US commercial payer perspective.

Methods: A model was developed to estimate the budget impact of adding vericiguat to the formulary by comparing a current scenario (GDMT) and a new scenario (vericiguat plus GDMT) to a hypothetical 10-million-member commercial payer over a 3-year time horizon. Read More

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The effect of propolis plus Hyoscyamus niger L. methanolic extract on clinical symptoms in patients with acute respiratory syndrome suspected to COVID-19: A clinical trial.

Phytother Res 2021 Apr 15. Epub 2021 Apr 15.

Physiology Research Center, Kashan University of Medical Sciences, Kashan, Iran.

The outbreak of Coronavirus disease 2019 (COVID-19) has caused a global health crisis. Nevertheless, no antiviral treatment has yet been proven effective for treating COVID-19 and symptomatic supportive cares have been the most common treatment. Therefore, the present study was designed to evaluate the effects of propolis and Hyoscyamus niger L. Read More

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Cabergoline in Treatment of Methamphetamine-Dependent Patients and Its Effect on Serum Level of Glial Cell-Derived Neurotrophic Factor: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Eur Addict Res 2021 Apr 15:1-12. Epub 2021 Apr 15.

Department of Psychiatry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.

Background: Methamphetamine use disorder is an important public health problem, especially in the younger generation, and associated with various psychiatric, cognitive, social, economic, and legal issues. Cabergoline, a drug with dopaminergic properties and long half-life, has been considered for the treatment of stimulant dependence. The systemic use of cabergoline has been shown to increase glial cell-derived neurotrophic factor (GDNF) expression. Read More

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