Current Therapies for Premature Ejaculation
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Study Protocol and Statistical Analysis Plan
Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 RANDOMIZED CONTROLLED PILOT STUDY USING PROPRANOLOL TO DECREASE GENE EXPRESSION OF STRESS-MEDIATED BETA- ADRENERGIC PATHWAYS IN HEMATOPOIETIC STEM CELL TRANSPLANT RECIPIENTS Version 3.0 Principal Investigator: Jennifer M. Knight, MD Medical College of Wisconsin 8701 Watertown Plank Road Milwaukee, WI 53226 Telephone: 414-955-8908 Fax: 414-955-6285 Email: [email protected] Co-Investigator: J. Douglas Rizzo, MD, MS CIBMTR Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-0700 Fax: 414-805-0714 Email: [email protected] Co-Investigator: Parameswaran Hari, MD, MS Froedtert and the Medical College of Wisconsin Clinical Cancer Center 9200 W. Wisconsin Avenue Suite C5500 Milwaukee, WI 53226 Telephone: 414-805-4600 Fax: 414-805-4606 Email: [email protected] Consultant Steve W. Cole, PhD and Statistician: UCLA-David Geffen School of Medicine 10833 LeConte Ave 11-934 Factor Bldg Los Angeles, CA 90095-1678 Telephone: 310-267-4243 Email: [email protected] 1 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 Sponsor: Medical College of Wisconsin Funding Sponsor: This project has an offer of sponsorship from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. 2 Propranolol and Gene Expression in HCT Protocol v3.0, January 15, 2016 PROTOCOL SYNOPSIS Randomized Controlled Pilot Study Using Propranolol to Decrease Gene Expression of Stress-Mediated Beta-Adrenergic Pathways in Hematopoietic Stem Cell Transplant Recipients Principal Investigator: Jennifer M. Knight, MD Study Design: This is a randomized controlled pilot study designed to evaluate whether the beta-adrenergic antagonist propranolol is effective in decreasing gene expression of stress-mediated beta-adrenergic pathways among a cohort of individuals receiving an autologous hematopoietic stem cell transplant (HCT) for multiple myeloma. -
Avoid the Stop and Go of BPH Start and Stay on RAPAFLO® for BPH Symptom Relief
Avoid the Stop and Go of BPH Start and Stay on RAPAFLO® for BPH Symptom Relief Using RAPAFLO® RAPAFLO® is available only by prescription and is approved to treat male urinary symptoms due to BPH, also called an enlarged prostate. RAPAFLO® should not be used to treat high blood pressure. Important Safety Information Who should not take RAPAFLO® (silodosin) capsules? Do not take RAPAFLO® if you: • have certain kidney problems. • have certain liver problems. Please see additional Important Safety Information throughout this brochure and accompanying full Prescribing Information in pocket. Have BPH symptoms? What they may mean Enlarged prostate— uncomfortable but not uncommon Your doctor has diagnosed you with having BPH, benign prostatic hyperplasia, also known as an enlarged prostate. As men age, having BPH is not unusual. In fact, BPH is the most common prostate problem for men over 50. It affects about 50% of men aged 51-60 and up to 90% of men over 80. The prostate is about But it can grow to the size of a walnut the size of a baseball. in younger men. BLADDER The prostate is located below the bladder and surrounds the urethra, the tube that carries urine from the bladder. BPH symptoms occur when the “smooth” muscle of the prostate squeezes the urethra. This, in turn, can affect your bladder URETHRA control. Unfortunately, there is little you can do PROSTATE to avoid BPH. 2 Is BPH linked to prostate cancer? No. While many men share this belief, BPH is not linked to prostate cancer, and men with BPH are not more likely to get prostate cancer. -
Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products. -
2021 Step Therapy Criteria
SelectHealth Advantage 2021 Step Therapy Criteria Step Therapy Group Drug Name Criteria ACNE ADAPAL/BEN P Previous trial on at least ONE: AZELEX Generic topical acne treatment TRETINOIN ACTONEL RISEDRON SOD Previous trial on: RISEDRONATE alendronate ADAPALENE ADAPALENE Previous use of non-micronized tretinoin TAZAROTENE ANTICONVULSANT APTIOM Previous trial on at least TWO of the following: SPRITAM carbamezapine, divalproex, epitol, ethosuximide, felbamate, lamotrigine, XCOPRI levetiracetam, oxcarbazepine, phenytoin, tiagabine, topiramate, valproic acid, zonisamide ANTIDEPRESSION APLENZIN Previous trial on at least TWO of the following: EMSAM bupropion, citalopram, escitalopram, fluoxetine, fluvoxamine, maprotiline, FETZIMA mirtazapine, paroxetine, sertraline, venlafaxine, desvenlafaxine PEXEVA TRINTELLIX VIIBRYD ANTIPSYCHOTIC ARISTADA Previous trial on at least ONE of the following: ASENAPINE aripiprazole, clozapine, fluoxetine-olanzapine, haloperidol, olanzapine, FANAPT quetiapine, risperidone, ziprasidone LATUDA PALIPERIDONE SECUADO VRAYLAR BELSOMRA BELSOMRA Previous trial on at least ONE of the following: zaleplon, zolpidem, eszopiclone BUDESONIDE BUDESONIDE TAB Previous trial of ONE of the following: Mesalamine, Pentasa CADUET AMLOD/ATORVA Previous trial on at least ONE of the following: atorvastatin, lovastatin, pravastatin, simvastatin AND Previous trial on: amlodipine Updated 8/25/2021 1 SelectHealth Advantage 2021 Step Therapy Criteria Step Therapy Group Drug Name Criteria CAPEX CAPEX Previous trial on: clobetasol shampoo OR ciclopirox -
Silodyx, INN-Silodosin
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Silodyx 4 mg hard capsules Silodyx 8 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Silodyx 4 mg hard capsules Each hard capsule contains 4 mg silodosin. Silodyx 8 mg hard capsules Each hard capsule contains 8 mg silodosin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Silodyx 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm). Silodyx 8 mg hard capsules White, opaque, hard gelatin capsule, size 0 (approximately 21.7 x 7.6 mm). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men. 4.2 Posology and method of administration Posology The recommended dose is one capsule of Silodyx 8 mg daily. For special patient populations, one capsule of Silodyx 4 mg daily is recommended (see below). Elderly No dose adjustment is required in the elderly (see section 5.2). Renal impairment No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min). A starting dose of 4 mg once daily is recommended in patients with moderate renal impairment (CLCR ≥ 30 to < 50 mL/min), which may be increased to 8 mg once daily after one week of treatment, depending on the individual patient’s response. The use in patients with severe renal impairment (CLCR < 30 mL/min) is not recommended (see sections 4.4 and 5.2). Hepatic impairment No dose adjustment is required for patients with mild to moderate hepatic impairment. -
Chapter 6 Industrial Applications of Multicomponent Reactions (Mcrs)
University of Groningen Innovative multicomponent reactions and their use in medicinal chemistry Zarganes Tzitzikas, Tryfon IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2017 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Zarganes Tzitzikas, T. (2017). Innovative multicomponent reactions and their use in medicinal chemistry. University of Groningen. Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 24-09-2021 CHAPTER 6 INDUSTRIAL APPLICATIONS OF MULTICOMPONENT REACTIONS (MCRS) Chapter contained in the Rodriguez-Bonne book Stereoselectve Multple Bond-Forming Transformatons in Organic Synthesis 2015 by John Wiley & Sons, Inc. Tryfon Zarganes – Tzitzikas, Ahmad Yazbak, Alexander Dömling Chapter 6 INTRODUCTION Multcomponent reactons (MCRs) can be defned as processes in which three or more reactants introduced simultaneously are combined through covalent bonds to form a single product, regardless of the mechanisms and protocols involved.[1] Many basic MCRs are name reactons, for example, Ugi,[2] Passerini,[3] van Leusen,[4] Strecker,[5] Hantzsch,[6] Biginelli,[7] or one of their many variatons. -
Treatment Options for Motor and Non-Motor Symptoms of Parkinson’S Disease
biomolecules Review Treatment Options for Motor and Non-Motor Symptoms of Parkinson’s Disease Frank C. Church Department of Pathology and Laboratory Medicine, The University of North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] Abstract: Parkinson’s disease (PD) usually presents in older adults and typically has both motor and non-motor dysfunctions. PD is a progressive neurodegenerative disorder resulting from dopamin- ergic neuronal cell loss in the mid-brain substantia nigra pars compacta region. Outlined here is an integrative medicine and health strategy that highlights five treatment options for people with Parkinson’s (PwP): rehabilitate, therapy, restorative, maintenance, and surgery. Rehabilitating begins following the diagnosis and throughout any additional treatment processes, especially vis-à-vis consulting with physical, occupational, and/or speech pathology therapist(s). Therapy uses daily administration of either the dopamine precursor levodopa (with carbidopa) or a dopamine ago- nist, compounds that preserve residual dopamine, and other specific motor/non-motor-related compounds. Restorative uses strenuous aerobic exercise programs that can be neuroprotective. Maintenance uses complementary and alternative medicine substances that potentially support and protect the brain microenvironment. Finally, surgery, including deep brain stimulation, is pursued when PwP fail to respond positively to other treatment options. There is currently no cure for PD. In conclusion, the best strategy for treating PD is to hope to slow disorder progression and strive to achieve stability with neuroprotection. The ultimate goal of any management program is to improve the quality-of-life for a person with Parkinson’s disease. -
Guideline for Preoperative Medication Management
Guideline: Preoperative Medication Management Guideline for Preoperative Medication Management Purpose of Guideline: To provide guidance to physicians, advanced practice providers (APPs), pharmacists, and nurses regarding medication management in the preoperative setting. Background: Appropriate perioperative medication management is essential to ensure positive surgical outcomes and prevent medication misadventures.1 Results from a prospective analysis of 1,025 patients admitted to a general surgical unit concluded that patients on at least one medication for a chronic disease are 2.7 times more likely to experience surgical complications compared with those not taking any medications. As the aging population requires more medication use and the availability of various nonprescription medications continues to increase, so does the risk of polypharmacy and the need for perioperative medication guidance.2 There are no well-designed trials to support evidence-based recommendations for perioperative medication management; however, general principles and best practice approaches are available. General considerations for perioperative medication management include a thorough medication history, understanding of the medication pharmacokinetics and potential for withdrawal symptoms, understanding the risks associated with the surgical procedure and the risks of medication discontinuation based on the intended indication. Clinical judgement must be exercised, especially if medication pharmacokinetics are not predictable or there are significant risks associated with inappropriate medication withdrawal (eg, tolerance) or continuation (eg, postsurgical infection).2 Clinical Assessment: Prior to instructing the patient on preoperative medication management, completion of a thorough medication history is recommended – including all information on prescription medications, over-the-counter medications, “as needed” medications, vitamins, supplements, and herbal medications. Allergies should also be verified and documented. -
FOGSI FOCUS PTL-Final
Editors : President: Jaideep Malhotra Dr. Rishma Dhillon Pai Narendra Malhotra Contributors Preface Dr. Asha Reddy Dr. Ruchika Garg, Assistant Professor obs. & gynae, Dr. Apoorva Pallam Reddy, SN Medical College, Agra Consultant Preterm Labour is one of the 5 ‘P’ problem of pregnancy. Dr. Rajalaxmi Walavalkar, Dr. Anuradha Khar, Senior consultant, Cocoon fertility centre, Despite of understanding the problem, the prevalence is static Director, nurture IVF, Bangalore Thane even in developed countries. Dr. Arshi Iqbal, Dr. Raju Sahetya, Director Arshi fertility, Kota, Consultant obs. and gynae, Hinduja The problem of being born to soon is more in babies born Rajasthan Hospital, Mumbai before 33 weeks gestation and babies born in developing countries with low resource settings. Dr. Chaitanya Ganapule, Dr. Rakhi Singh, Pearl IVF, Pune Director Abalone clinic and IVF centre, Noida This multiauthored FOGSI focus is a comprehensive Dr. Kavita N Singh, collection of all aspects of Preterm Labour. The authors have Associate Professor, NSCB Medical Dr. Shalini Chauhan, done a great job in rehearsing each topic and compiling College, Jabalpur Assistant Professor, PGI Tanda relevant information which will be useful to the practising Dr. Kavitha Gautam, Dr. Seema Pandey, obstetrician. Director Bloom fertility, Chennai Director Seema Hospital and Eva fertility centre, Azamgarh Dr. Neema Acharya, We hope all FOGSIANS will benefit from this manuscript. Professor, DMIMS DU, Wardha Dr. Swati Upadhyay, SR KIMS, Trivendrum Dr. Niharika Malhotra Happy Reading Dr. Uma Pandey, Dr. Parul Mittal, specialist obs. & gynae, Professor obs. & gynae, IMS BHU, Aster D.M. Healthcare, Dubai, UAE Varanasi Jaideep Malhotra, Narendra Malhotra Dr. Paresh K Solanki Dr. -
Development and Validation of High Performance LCMS Methods For
na al A lyti tic ca u l e C c h a e Nair et al., Pharm Anal Chem 2016, 3:1 m m r i s a Pharmaceutical Analytical t DOI: 10.4172/2471-2698.1000118 h r y P ISSN: 2471-2698 Chemistry Research Article Open Access Development and Validation of High Performance LCMS Methods for Estimation of Silodosin and Silodosin β-D-Glucuronide in Human Plasma Sheeba Manoj Nair1*, Ravi Kumar P1, Malini Sharma1 and Denish Karia2 1Semler Research Center, Bangalore, Karnataka, India 2Department of Chemistry, Patel JDK Science College, Borsad, Gujarat, India Abstract The aim of present study is to development and validation of analytical methods for estimation of Silodosin and Silodosin β-D-Glucuronide in human plasma in API, method in LCMS. Silodosin is a prescription medication that acts as an alpha-adrenergic blockers used in the treatment for men with benign prostatic hyperplasia, presently commercially available and marketed as Rapaflo in USA and Rapilif, Silodal in other countries worldwide. Drug showed linearity in the concentration range of 0.502 ng/ml to 207.376 ng/ml for Silodosin and 4.121 ng/ml to 302.836 ng/ml for Silodosin β-D-Glucuronide with correlation coefficient consistently greater than 0.99 for Silodosin and Silodosin β-D-Glucuronide. Mass parameters, 496.2/261.0 and 672.2/479.3/261.2 were chosen for analysis by Solid phase extraction method. Different validation parameters to be considered are Accuracy, Precision, Repeatability, Intermediate Precision, Specificity, Detection Limit, Quantitation Limit, and Linearity Range. The results were found to be acceptable as per the guidelines of International Conference on Harmonization (ICH). -
Oxytocin Receptor OXTR
Oxytocin Receptor OXTR The oxytocin receptor belongs to the G-protein-coupled seven-transmembrane receptor superfamily. Its main physiological role is regulating the contraction of uterine smooth muscle at parturition and the ejection of milk from the lactating breast. The oxytocin receptors are activated in response to binding oxytocin and a similar nonapeptide, vasopressin. Oxytocin receptor triggers Gi or Gq protein-mediated signaling cascades leading to the regulation of a variety of neuroendocrine and cognitive functions. Oxytocin is a nonapeptide of the neurohypophyseal protein family that binds specifically to the oxytocin receptor to produce a multitude of central and peripheral physiological responses. In vivo, oxytocin acts as a paracrine and/or autocrine mediator of multiple biological effects. These effects are exerted primarily through interactions with G-protein-coupled oxytocin/vasopressin receptors, which, via Gq and Gi, stimulate phospholipase C-mediated hydrolysis of phosphoinositides. www.MedChemExpress.com 1 Oxytocin Receptor Agonists & Antagonists Atosiban Atosiban acetate (RW22164; RWJ22164) Cat. No.: HY-17572 (RW22164 acetate; RWJ22164 acetate) Cat. No.: HY-17572A Atosiban (RW22164; RWJ22164) is a nonapeptide Atosiban acetate (RW22164 acetate;RWJ22164 competitive vasopressin/oxytocin receptor acetate) is a nonapeptide competitive antagonist, and is a desamino-oxytocin analogue. vasopressin/oxytocin receptor antagonist, and is a Atosiban is the main tocolytic agent and has the desamino-oxytocin analogue. Atosiban is the main potential for spontaneous preterm labor research. tocolytic agent and has the potential for spontaneous preterm labor research. Purity: 99.09% Purity: 99.92% Clinical Data: Launched Clinical Data: Launched Size: 10 mM × 1 mL, 5 mg, 10 mg, 50 mg Size: 10 mM × 1 mL, 5 mg, 10 mg, 50 mg Carbetocin Epelsiban Cat. -
Blockers in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia
Journal name: Clinical Interventions in Aging Article Designation: Letter Year: 2015 Volume: 10 Clinical Interventions in Aging Dovepress Running head verso: Zhu et al Running head recto: Alpha -blockers for benign prostatic hyperplasia open access to scientific and medical research 1 DOI: http://dx.doi.org/10.2147/CIA.S82435 Open Access Full Text Article LETTER Personalized therapeutics of α1-blockers in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia Ling-ling Zhu1 Dear editor Zhi-jun Feng2 We read with great interest the multicenter, prospective, comparative cohort study by Quan Zhou3 Zhang et al1 who suggested that patients with uncontrolled or untreated hypertension 1Geriatric VIP Ward, Division and lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/ of Nursing, 2Department of Urology LUTS) should be warned about a decrease in blood pressure on initiation of alfuzosin Surgery, 3Department of Pharmacy, the Second Affiliated Hospital, School 10 mg therapy alone or concomitantly with antihypertensive medication. Here we of Medicine, Zhejiang University, discuss and share our perspectives on this issue. Hangzhou, People’s Republic of China α1-blockers are the most frequently prescribed medical therapy in the treatment of BPH/LUTS. A number of -blockers (alfuzosin, doxazosin, terazosin, tamsulosin, naf- For personal use only. α1 topidil, silodosin) have been approved for the treatment of BPH throughout the world; however, they exhibit different selectivity toward α1-adrenoceptor (AR) subtypes. Three types of α1-AR subtypes (α1A, α1B, and α1D) are found in human tissue. The α1A subtype is located in the human prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra, and mediates contraction of the smooth muscle in these tissues.