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Orthostatic Sodium Retention

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41. Sleep Disorders (PDQ®): Health Professional Version

vitamins, corticosteroids, neuroleptics for nausea and vomiting, and sympathomimetics for the treatment of dyspnea—as well as other treatment factors can negatively impact sleep patterns. Side effects of treatment that may affect the sleep-wake cycle include the following:[ ];[ ][ ] Pain. Anxiety. Night sweats/hot flashes (refer to the PDQ summary on for more information). GI disturbances (e.g., incontinence, diarrhea, constipation, or nausea). GU disturbances (e.g., incontinence, retention, or GU (...) irritation). Respiratory disturbances. Fatigue. Sustained use of the following can cause insomnia: Sedatives and hypnotics (e.g., glutethimide, benzodiazepines, pentobarbital, chloral hydrate, secobarbital sodium, and amobarbital sodium). Anticonvulsants (e.g., phenytoin). Corticosteroids. Oral contraceptives. Monoamine oxidase inhibitors. Methyldopa. Propranolol. Atenolol. Alcohol. Thyroid preparations. In addition, withdrawal from the following substances may cause insomnia: Central nervous system

2016 PDQ - NCI's Comprehensive Cancer Database

42. Empagliflozin / linagliptin (Glyxambi) - type 2 diabetes

cutaneous adverse reaction Summary of Clinical Efficacy SCS Summary of Clinical Safety SD Standard deviation SE Standard error SGLT SGOT Sodium-dependant glucose co-transporter Serum glutamic oxaloacetic transaminase SmPC Summary of Product Characteristics SMQ Standardised MedDRA query SOC T2DM System-organ class Type 2 diabetes mellitus TS Treated set UACR Urinary-albumin-to-creatinine ratio UGT Uridine 5'-diphospho-glucuronosyltransferases ULN Upper limit of normal USPI URTI UTI UV vPvB ZDF United (...) the Article 3(1) and point 3 of Annex of Regulation (EC) No 726/2004. The eligibility to the centralised procedure was agreed upon by the EMA/CHMP on 25 July 2013. The applicant applied for the following indication: Glyxambi is indicated in adults with type 2 diabetes mellitus to improve glycaemic control: • when diet and exercise, plus metformin and a sodium glucose co-transporter 2 (SGLT2) inhibitor do not provide adequate glycaemic control, • when diet and exercise, plus metformin and a dipeptidyl

2016 European Medicines Agency - EPARs

43. 2013 ACCF/AHA Guideline for the Management of Heart Failure

. Nonpharmacological Interventions e262 7.3.1.1. Education: Recommendation e262 7.3.1.2. Social Support e263 7.3.1.3. Sodium Restriction: Recommendation e263 7.3.1.4. Treatment of Sleep Disorders: Recommendation e263 7.3.1.5. Weight Loss e263 7.3.1.6. Activity, Exercise Prescription, and Cardiac Rehabilitation: Recommendations e264 7.3.2. Pharmacological Treatment for Stage C HF r EF: Recommendations e264 7.3.2.1. Diuretics: Recommendation e265 7.3.2.2. ACE Inhibitors: Recommendation e265 7.3.2.3. ARBs (...) and fatigue, which may limit exercise tolerance, and fluid retention, which may lead to pulmonary and/or splanchnic congestion and/or peripheral edema. Some patients have exercise intolerance but little evidence of fluid retention, whereas others complain primarily of edema, dyspnea, or fatigue. Because some patients present without signs or symptoms of volume overload, the term “heart failure” is preferred over “congestive heart failure.” There is no single diagnostic test for HF because it is largely

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2013 American Heart Association

45. Ascites due to cirrhosis, management

patients with enigmatic ascites are eventually found to have 2 or even 3 causes for ascites formation (e.g., heart failure, diabetic ne- phropathy, and cirrhosis due to nonalcoholic steatohe- patitis). In this setting, the sum of predisposing factors leads to sodium and water retention when each indi- vidual factor might not be severe enough to cause ?uid overload. The cancer antigen 125 (CA125) warrants mention. Essentially all patients including men with ascites or pleural ?uid of any cause have (...) whether it was diuretic-resistant or not. 87 However, large-vol- ume paracentesis does nothing to correct the underly- ing problem that led to ascites formation, i.e., sodium retention. Large-volume paracentesis predictably removes the ?uid more rapidly (minutes) than does careful diuresis (days to weeks). 88 A single large-vol- ume paracentesis followed by diet and diuretic therapy is appropriate treatment for patients with tense asci- tes. 87,88 In the diuretic-sensitive patient, to serially remove

2013 American Association for the Study of Liver Diseases

46. Implanting a baroreceptor stimulation device for resistant hypertension

cause of premature morbidity and death. It is a major, but modifiable, risk factor for cardiovascular disease (including stroke and myocardial infarction) and chronic kidney disease. The cause of primary hypertension, which is the most common form, is not fully understood. However, it is likely to involve multiple factors including an increase in sodium retention and a reduction in renal blood flow mediated by the sympathetic nervous system. Secondary hypertension, which is less common, is caused (...) considered that the following were theoretical adverse events: traumatic injury to the carotid artery or major neck veins; bleeding; cerebral embolisation causing stroke; wound dehiscence; late damage to the carotid artery; bradycardia; bradypnoea; excessive lowering of blood pressure; orthostatic hypotension; and device failure. 6 6 Committee comments Committee comments 6.1 The Committee reviewed the evidence separately for bilateral and unilateral implantation. It noted that much of the available

2015 National Institute for Health and Clinical Excellence - Interventional Procedures

48. KDOQI US Commentary on the 2012 KDIGO Clinical Practice Guideline for the Evaluation and Management of CKD

posture (orthostatic proteinuria) x 71 Vehaskari, V.M. Orthostatic proteinuria. Arch Dis Child . 1982 ; 57 : 729–730 | | | , x 72 Leung, A.K. and Wong, A.H. Proteinuria in children. Am Fam Physician . 2010 ; 82 : 645–651 | Other conditions increasing vascular permeability (e.g., septicemia) Intraindividual variability Intrinsic biological variability 73 x 73 Howey, J.E., Browning, M.C., and Fraser, C.G. Selecting the optimum specimen for assessing slight albuminuria, and a strategy for clinical

2012 National Kidney Foundation

50. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Acromegaly

[EL 2]). Hypertension is detected in up to 40% of patients, presumably attributable to an increase in plasma volume along with an increase in sodium retention (55 [EL 3]). Suppressed plasma renin activity and aldosterone con- centrations in acromegaly are consistent with a primary increase in total body sodium (56 [EL 3]). Of interest, acromegaly may be associated with an increase in carotid artery intima-media thickness, although the prevalence of atherosclerosis may be similar

2011 American Association of Clinical Endocrinologists

51. SGLT2 Inhibition in Diabetes and Heart Failure

(within the past month), which may induce volume and sodium retention; Chronic Kidney Disease (GFR<45 ml/kg*min); Uncontrolled thyroid dysfunction (TSH<0.4>4.5 mcIU/ml); Pregnancy or of child-bearing potential; Active or recent (within 2 weeks) genital/urinal infection; Concomitant conditions or treatment which would affect completion or interpretation of the study including physical inability to walk or run on a treadmill such as decompensated HF (edema, NYHA class IV), significant ischemic heart (...) Details Study Description Go to Brief Summary: To determine the effects of SGLT2 inhibition with empagliflozin on cardio-respiratory fitness in patients with systolic heart failure. Condition or disease Intervention/treatment Diabetes Mellitus, Type 2 Heart Failure, Systolic Other: Assessment of cardiorespiratory fitness Detailed Description: The investigators hypothesize that Sodium-GLucose coTransporters (SGLT)-2 inhibition will improve cardio-respiratory fitness (CRF) in patients with systolic

2016 Clinical Trials

52. Administration of medicinal products by non - medical personnel as part of Clinical Nuclear Medicine Procedures

flushing bradycardia, palpitations, tachycardia, orthostatic hypotension. mental clouding, confusion (with large doses), hallucinations, headache, vertigo, mood changes including dysphoria and euphoria. dry mouth, biliary spasm. blurred or double vision or other changes in vision, miosis. pruritus, urticaria, rash, sweating. Contact dermatitis has been reported and pain and irritation may occur on injection. difficulty with micturition, ureteric spasm, urinary retention, antidiuretic effect. Tolerance (...) Laxatives Gallium imaging Lugols iodine Iodine-labelled RPx Lysine/Arginine Peptide Receptor Radionuclide Therapy Methylphenidate F-18 Fallypride Morphine * Hepato-cholescintigraphy Omeprazole * Meckels Diverticulum Potasium iodide Iodine-labelled RPx Potasium iodate Iodine-labelled RPx Ranitidine * Meckels Diverticulum Regadenason* Myocardial perfusion imaging Sincalide* Hepato-cholescintigraphy Sodium Perchlorate Iodine-labelled RPx Thyrotropin Alpha Thyroid imaging and therapy Where adverse reactions

2013 British Nuclear Medicine Society

53. Gastrointestinal Complications (PDQ®): Health Professional Version

that mineral oil be avoided because it can cause lipid pneumonitis. It can interfere with postoperative healing of anorectal surgery. Avoid giving with docusate sodium. Docusate sodium causes increased systemic absorption of mineral oil. Use: Prophylactically to prevent straining in patients for whom straining would be dangerous. Drugs and dosages: - Mineral oil: 5 to 30 cc at bedtime. Fecal softeners Fecal softeners promote water retention in the fecal mass, thus softening the stool. Up to 3 days may pass (...) of molasses enema with magnesium citrate 8 oz by mouth. Consider bowel management consult. If patient is neutropenic or thrombocytopenic, arrange for bowel management consult. Start one of the following regimens if the patient has not had a stool in 3 days or on the first day that any patient starts taking drugs associated with constipation: - Stool softeners (e.g., docusate sodium, one to two capsules per day). For opioid-related constipation, stool softeners may be used in combination with a stimulant

2015 PDQ - NCI's Comprehensive Cancer Database

54. Primary Care Corner with Geoffrey Modest MD: Tighter Blood Pressure Control? The SPRINT Trial

% of diabetics have hypertension: hypertension is associated with insulin resistance, and in therefore part of the Metabolic Syndrome; insulin causes renal sodium retention and contributes to hypertension). So, excluding diabetics effectively excludes a very large % of patients with hypertension. Other important exclusions affecting the study’s generalizability include: all participants were >50yo, none had SBP>180 mmHg, none had a prior stroke or had predominantly diastolic hypertension (though they did (...) difference by prior hx of CKD, age < or >75, sex, race, previous hx of cardiac disease, or baseline systolic pressure Rates of serious adverse events were higher in those in the intensive group: hypotension (2.4 vs 1.4%), syncope (2.3 vs 1.7%), electrolyte disturbances (10.1 vs 7.4%), acute kidney injury or failure (4.1 vs 2.5%), but not injurious falls, and orthostatic hypotension more common in standard treatment group (18.3 vs 16.1%) ​Study stopped early, after 3.26 years, because of statistically

2015 Evidence-Based Medicine blog

55. Jinarc - tolvaptan

- polycystic kidney disease; ERK - extracellular signal-regulated kinase; Na - sodium; NGAL - neutrophil gelatinase-associated lipocalin; NHK - normal human kidney; OPC-41061 - tolvaptan; P-ERK - phosphorylated extracellular signal-regulated kinase; SD - Sprague Dawley. sessment Report EMA/154879/2015 Page 20/124 In the PCK rat, an animal model of ARPKD, oral administration of tolvaptan resulted in a decrease in kidney levels of cAMP and a reduction in cyst volume and cyst fibrosis. Increases in urine (...) volume and water intake and decreased urinary osmolality also were evident and are consistent with the established pharmacological action of tolvaptan. Slight changes in BUN, creatinine, and sodium levels were observed in the treated rats, although the changes were not considered to be biologically meaningful. In the mouse models for ADPKD (Pkd2WS25/-, pcy and cpk) similar results are observed as with the PCK rat. Decreases in kidney weights, cyst volume, and fibrotic volume were observed in the pcy

2015 European Medicines Agency - EPARs

56. Farydak - panobinostat

tolerance of panobinostat after single intravenous, intra-arterial and perivenous injections were investigated in New Zealand White rabbits. The concentration of panobinostat solution injected Assessment report EMA/CHMP/496296/2015 Page 38/124 was 0.78 mg/mL freebase in vehicle. The control site received the control item, 7.206 mg DL lactic acid, 34.46 mg mannitol, 200 mg propylene glycol, sodium hydroxide q.s. to pH4 and water for injection q.s. with 5% dextrose in water. The outcome of the study

2015 European Medicines Agency - EPARs

57. Aripiprazole Zentiva

/232319/2015 Page 7/36 RCT randomised controlled trial RH Relative Humidity RMS Reference Member State RP Restricted Part (or Closed Part) of a DMF RR relative risk RRT Relative retention time RSD Relative standard deviation SAE serious adverse event SF-12 short form health survey (short form of SFSF36) SLS sodium lauryl sulphate SmPC Summary of Product Characteristics SPC Summary of Product Characteristics TGA Thermo-Gravimetric Analysis US NF Unites States National Formulary USP United States (...) . Introduction The finished product is presented in the form of 5 mg, 10 mg, 15 mg or 30 mg tablets and 10 mg, 15 mg or 30 mg orodispersible tablets (ODT), containing aripiprazole as active substance. Other ingredients of the tablets are: lactose monohydrate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, silica colloidal anhydrous, croscarmellose sodium and magnesium stearate. The orodispersable tablets contain, in addition, acesulfame potassium and mango flavour. The product

2015 European Medicines Agency - EPARs

58. Intuniv - guanfacine

The Predicted no effect concentrations PSD Particle size distribution PVC Polyvinyl chloride RH Relative Humidity RTT Relative retention time QT c Corrected QT Interval s.c. Subcutaneous SH Spontaneously hypertensive SmPC Summary of Product Characteristics t 1/2 Half-life TCL Thin-layer chromatography USP United States Pharmacopoeia WASTEWinhab Amount of wastewater per inhabitant per day WKY Wistar Kyoto Assessment report EMA/CHMP/534329/2015 Page 4/86 1. Background information on the procedure 1.1 (...) monohydrate, povidone, crospovidone type A, microcrystalline cellulose, silica colloidal anhydrous, sodium laurisulfate, polysorbate 80, fumaric acid, glycerol dibehenate, indigo carmine aluminium lake (E132) (3 and 4 mg tablets), iron oxide yellow (E172) (3 and 4 mg tablets). The product is available in PCTFE/PVC/alu blisters as described in section 6.5 of the SmPC. 2.2.2. Active substance General information The chemical name of guanfacine hydrochloride is N-(Diaminomethylidene)-2-(2,6-dichlorophenyl

2015 European Medicines Agency - EPARs

59. Latuda - lurasidone

effects, or non-compliance, hence the need for additional treatments that are effective and well tolerated. Latuda Assessment report (EMA/113836/2014) Rev05.13 Page 9/147 2.2. Quality aspects 2.2.1. Introduction The finished product is presented as film-coated tablets available in three strengths designated as, 18.5 mg, 37 mg and 74 mg, corresponding to 18.6 mg, 37.2 mg and 74 g mg of lurasidone base. Other ingredients are mannitol, pregelatinised starch, croscarmellose sodium, hypromellose, magnesium

2014 European Medicines Agency - EPARs

60. Vokanamet - canagliflozin / metformin

RH Relative Humidity RLG Radioluminography RRT Relative retention time RSD Relative standard deviation RTG/RT G renal threshold for glucose RTT(s) renal tubular tumor(s) S9 exogenous mammalian metabolic activation system SAP statistical analysis plan SBP systolic blood pressure SCE Summary of Clinical Efficacy SD standard deviation SE standard error Sec Section SEM standard error of the mean SGLT1 sodium-glucose co-transporter-1 SGLT2 sodium-glucose co-transporter -2 SMIT1 sodium/myo-inositol co (...) hSGLT2 human SGLT2 hSGLT4 human sodium glucose co-transporter-4 hSGLT6 human sodium glucose co-transporter-6 hSMIT1 human sodium/myo-inositol co-transporter-1 IAS Integrated Analysis of Safety IC50 inhibiting concentration at 50% ICH International Conference on Harmonisation IPC In-process control IR Infrared ISE Integrated Summary of Efficacy ISS Integrated Summary of Safety J&JPRD Johnson & Johnson Pharmaceutical Research & Development, LLC JNJ- 28431754 Canagliflozin JRD Janssen Research

2014 European Medicines Agency - EPARs

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