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1. Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial Full Text available with Trip Pro

Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial There are no studies on withdrawal of inhaled corticosteroids in patients on long-term triple therapy in the absence of frequent exacerbations.To evaluate the efficacy and safety of direct de-escalation from long-term triple therapy to indacaterol/glycopyrronium in nonfrequently exacerbating patients (...) with chronic obstructive pulmonary disease (COPD).This 26-week, randomized, double-blind, triple-dummy study assessed the direct change from long-term triple therapy to indacaterol/glycopyrronium (110/50 μg once daily) or continuation of triple therapy (tiotropium [18 μg] once daily plus combination of salmeterol/fluticasone propionate [50/500 μg] twice daily) in nonfrequently exacerbating patients with moderate-to-severe COPD. Primary endpoint was noninferiority on change from baseline in trough FEV1

2018 EvidenceUpdates

2. Slow Infusion of Low-dose Ketamine Reduces Bothersome Side Effects Compared to Intravenous Push: A Double-blind, Double-dummy, Randomized Controlled Trial Full Text available with Trip Pro

Slow Infusion of Low-dose Ketamine Reduces Bothersome Side Effects Compared to Intravenous Push: A Double-blind, Double-dummy, Randomized Controlled Trial We compared the analgesic efficacy and incidence of side effects when low-dose (0.3 mg/kg) ketamine (LDK) is administered as a slow infusion (SI) over 15 minutes versus an intravenous push (IVP) over 1 minute.This was a prospective, randomized, double-blind, double-dummy, placebo-controlled trial of adult ED patients presenting with moderate

2018 EvidenceUpdates

3. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study (Abstract)

Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study Multiple myeloma is characterised by monoclonal paraprotein production and osteolytic lesions, commonly leading to skeletal-related events (spinal cord compression, pathological fracture, or surgery or radiotherapy to affected bone). Denosumab, a monoclonal antibody targeting RANKL, reduces skeletal-related events (...) associated with bone lesions or metastases in patients with advanced solid tumours. This study aimed to assess the efficacy and safety of denosumab compared with zoledronic acid for the prevention of skeletal-related events in patients with newly diagnosed multiple myeloma.In this international, double-blind, double-dummy, randomised, active-controlled, phase 3 study, patients in 259 centres and 29 countries aged 18 years or older with symptomatic newly diagnosed multiple myeloma who had at least one

2018 EvidenceUpdates

4. Should breastfeeding babies be given pacifiers?

Should breastfeeding babies be given pacifiers? Should breastfeeding babies be given pacifiers? Toggle navigation Shared more. Cited more. Safe forever. Toggle navigation View Item JavaScript is disabled for your browser. Some features of this site may not work without it. Search MOspace This Collection Browse Statistics Should breastfeeding babies be given pacifiers? View/ Open Date 2012-05 Format Metadata Abstract Do not discourage the use of pacifiers by healthy infants who are breastfeeding

2018 PURLS

5. Effects of Pacifier Use on Breastfeeding and Health Outcomes: A Focused Practice Questions

, Lagercrantz H. Breastfeeding and dummy use have a protective effect on sudden infant death syndrome. Acta Paediatrica 2016;105(1):31-38. (7) Nelson AM. A comprehensive review of evidence and current recommendations related to pacifier usage. J Pediatr Nurs 2012;27(6):690-699. (8) Carlin RF, Moon RY. Risk factors, protective factors, and current recommendations to reduce sudden infant death syndrome: a review. JAMA Pediatrics 2017;171(2):175- 180. (9) Buccini GDS, Pérez-Escamilla R, Paulino LM, Araújo CL (...) Plus with Full Text S6 AB dummy Search modes - Boolean/Phrase View Results (906) View Details Edit Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - CINAHL Plus with Full Text S5 AB soother* Search modes - Boolean/Phrase View Results (17) View Details Edit Interface - EBSCOhost Research Databases Search Screen - Advanced Search Database - CINAHL Plus with Full Text S4 AB pacifier* Search modes - Boolean/Phrase View Results (317) View Details Edit Interface

2019 Peel Health Library

6. Infant pacifiers for reduction in risk of sudden infant death syndrome. Full Text available with Trip Pro

, SIDS remains a leading cause of infant mortality. In 1994, a 'triple risk model' for SIDS was proposed that described SIDS as an event that results from the intersection of three factors: a vulnerable infant; a critical development period in homeostatic control (age related); and an exogenous stressor. The association between pacifier (dummy) use and reduced incidence of SIDS has been shown in epidemiological studies since the early 1990s. Pacifier use, given its low cost, might be a cost-effective (...) Infant pacifiers for reduction in risk of sudden infant death syndrome. Sudden infant death syndrome (SIDS) has been most recently defined as the sudden unexpected death of an infant less than one year of age, with onset of the fatal episode apparently occurring during sleep, that remains unexplained after a thorough investigation, including the performance of a complete autopsy and a review of the circumstances of death and clinical history. Despite the success of several prevention campaigns

2017 Cochrane

7. Analgesic efficacy and pharmacokinetics of epidural oxycodone in pain management after gynaecological laparoscopy-A randomised, double blind, active control, double-dummy clinical comparison with intravenous administration. (Abstract)

Analgesic efficacy and pharmacokinetics of epidural oxycodone in pain management after gynaecological laparoscopy-A randomised, double blind, active control, double-dummy clinical comparison with intravenous administration. Early pain after laparoscopy is often severe. Oxycodone is a feasible analgesic option after laparoscopy, but there are sparse data on epidural administration. The aim was to evaluate the analgesic efficacy and pharmacokinetics of a single dose of epidural oxycodone (...) as a part of multimodal analgesia after gynaecological laparoscopy.Women (n = 60), aged 23-71 years, undergoing elective gynaecological laparoscopy, were administrated either epidural oxycodone 0.1 mg kg-1 and intravenous (i.v.) saline (EPI-group n = 31), or epidural saline and i.v. oxycodone 0.1 mg kg-1 (IV-group = 29) in a randomised, double blind, active control, double dummy clinical trial. A pharmacokinetic model was developed using population modelling of plasma and cerebrospinal fluid (CSF

2019 British journal of clinical pharmacology Controlled trial quality: predicted high

8. Effect of opioid exposure on efficacy and tolerability of sublingual fentanyl and subcutaneous morphine for severe cancer pain episodes. Secondary analysis from a double-blind double-dummy, randomized trial. (Abstract)

Effect of opioid exposure on efficacy and tolerability of sublingual fentanyl and subcutaneous morphine for severe cancer pain episodes. Secondary analysis from a double-blind double-dummy, randomized trial. Few studies have addressed the impact of previous opioid exposure on the effect of opioids for the treatment of severe cancer pain episodes.We aimed to test whether previous exposure to higher opioid doses was associated with a reduced analgesic effect of fentanyl sublingual tablets (FST

2019 Journal of pain and symptom management Controlled trial quality: uncertain

9. Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol. Full Text available with Trip Pro

Randomised, placebo-controlled, double-blind, double-dummy, multicentre trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine: the ECSMOKE trial protocol. Electronic cigarettes (EC) mainly with nicotine content are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking (...) cessation are lacking. METHODS AND ANALYSIS: Design: randomised, placebo and reference treatment-controlled, multicentre, double-blind, double-dummy, parallel-group trial. Participants: smokers smoking at least 10 cigarettes/day in the past year and motivated to quit, aged 18-70 years. Interventions: (A) EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: placebo condition, (B) EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition. Voltage

2019 BMJ open Controlled trial quality: predicted high

10. Intramuscular versus oral diclofenac for acute pain in adults with acute musculoskeletal injuries presenting to the ED setting: a prospective, double-blind, double-dummy, randomised controlled trial. Full Text available with Trip Pro

Intramuscular versus oral diclofenac for acute pain in adults with acute musculoskeletal injuries presenting to the ED setting: a prospective, double-blind, double-dummy, randomised controlled trial. The current study aimed to ascertain differences in early postmedication pain reduction in participants presenting with acute musculoskeletal injuries (MSI) to the ED receiving intramuscular (IM) versus per oral (PO) diclofenac.This was a prospective, double-blinded, randomised controlled trial

2019 Emergency Medicine Journal Controlled trial quality: predicted high

11. Rapid Recurrence of Eosinophilic Esophagitis Activity After Successful Treatment in the Observation Phase of a Randomized, Double-blind, Double-dummy Trial. (Abstract)

Rapid Recurrence of Eosinophilic Esophagitis Activity After Successful Treatment in the Observation Phase of a Randomized, Double-blind, Double-dummy Trial. Eosinophilic esophagitis (EoE) is chronic and recurs if treatment is discontinued. We aimed to determine rates of recurrence, and whether initial treatment with oral viscous budesonide (OVB) resulted in less recurrence than fluticasone from a multi-dose inhaler (MDI).This was the observation phase of a randomized, double-blind, double-dummy

2019 Clinical Gastroenterology and Hepatology

12. A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Full Text available with Trip Pro

A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Tenofovir disoproxil fumarate (TDF) has been widely recommended as a first-line antiviral agent to treat chronic hepatitis B (CHB). Qingzhong and Viread, formulations of TDF commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd and GlaxoSmithKline, respectively, have both been (...) approved by the State Food and Drug Administration, China. This study analyzed the efficacy and safety of these 2 TDF agents in Chinese patients with CHB.In this multicenter, randomized, double-blind, double-dummy, noninferiority phase 3 clinical trial (ClinicalTrials.gov identifier: NCT02287857), 330 Chinese patients with CHB [hepatitis B envelope antigen-positive (HBeAg) (+): 232] were randomly assigned to receive Qingzhong (group A: 161 patients) or Viread (group B: 169 patients) 300 mg once daily

2019 Medicine Controlled trial quality: predicted high

13. Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial. Full Text available with Trip Pro

Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial. Acute uncomplicated lower urinary tract infection (UTI) is one of the most common bacterial infections. Patients usually present with dysuria, urinary urgency, urinary frequency, and suprapubic pain or tenderness. Approximately 150 million people are diagnosed (...) the use of antibiotics, and reduce the recurrence rate in the treatment of acute uncomplicated lower UTI.In this study, a randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical study will be established. A total of 252 patients with acute uncomplicated lower UTI (syndrome of dampness-heat in the lower jiao) will be randomly allocated in the ratio of 1:1:1 to three groups: experimental group; control group 1; and control group 2. The experimental group receives

2019 Trials Controlled trial quality: predicted high

14. Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial. Full Text available with Trip Pro

Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial. Loxoprofen (LOX) is a nonsteroidal anti-inflammatory drug (NSAID). Although oral administration of LOX has been widely prescribed, clinical guidelines for osteoarthritis generally recommend topical rather than oral NSAIDs in specific patients. However, there is limited information (...) on the effects of loxoprofen sodium oral (LOX-O) versus loxoprofen sodium hydrogel transdermal patch (LOX-T) in myalgia patients. Hence, this non-inferiority study was designed to compare the efficacy and safety of LOX-O versus LOX-T in Chinese patients with myalgia.In this double-blind, double-dummy, parallel-group, randomized controlled trial, 182 Chinese patients were enrolled and randomized equally to either LOX-T or LOX-O treatment for 2 weeks. Patients in the LOX-T group applied one sheet of the active

2019 Clinical drug investigation Controlled trial quality: predicted high

15. Exclusive breast-feeding is associated with reduced pacifier sucking in children: Breast-feeding and pacifier-sucking habit. (Abstract)

Exclusive breast-feeding is associated with reduced pacifier sucking in children: Breast-feeding and pacifier-sucking habit. Studies suggest that when children do not achieve the emotional satiety and adequate stimulus provided by breast-feeding, they exhibit sucking behaviors. This study aimed to estimate the association from 4 through 6 months of exclusive breast-feeding (EB) postpartum and pacifier-sucking behavior at 12 months of life.A cohort study was conducted with 1,037 infants, born (...) alive and monitored up to 12 months. At 4 and 6 months after birth, the children were classified according to the type of breast-feeding they had received: exclusive, predominant, complementary, or none. The prevalence of pacifier-sucking behavior was calculated, and the association between the 2 events was estimated. Mothers' socioeconomic-demographic characteristics, delivery features, and prenatal care, as well as the biological characteristics of the children, were determined. Relative risk (RR

2019 Journal of the American Dental Association

16. A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD. (Abstract)

A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD. Glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI), formulated using co-suspension delivery technology, is the only approved fixed-dose combination long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) delivered via MDI. Direct comparisons of GFF MDI versus other LAMA/LABAs have not previously been (...) performed. We assessed the efficacy and safety of GFF MDI relative to umeclidinium/vilanterol dry powder inhaler (UV DPI) in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD).In this phase IIIb randomized, double-blind, double-dummy, multicenter, 24-week study, patients received GFF MDI 18/9.6 μg (equivalent to glycopyrronium/formoterol fumarate dihydrate 14.4/10 μg; two inhalations per dose, twice-daily; n = 559) or UV DPI 62.5/25 μg (one inhalation, once-daily; n = 560

2019 Advances in therapy Controlled trial quality: predicted high

17. Post-marketing Re-evaluation of Tongxiening Granules () in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial. (Abstract)

Post-marketing Re-evaluation of Tongxiening Granules () in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial. To evaluate the efficacy and safety of Tongxiening Granules (, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea (IBS-D).A randomized, double-blind, double-dummy, and positive parallel controlled clinical trial was conducted from October 2014 to March 2016. Totally 342

2019 Chinese journal of integrative medicine Controlled trial quality: predicted high

18. Thermosensitive liposomal doxorubicin plus radiofrequency ablation increased tumor destruction and improved survival in patients with medium and large hepatocellular carcinoma: A randomized, double-blinded, dummy-controlled clinical trial in a single cent Full Text available with Trip Pro

Thermosensitive liposomal doxorubicin plus radiofrequency ablation increased tumor destruction and improved survival in patients with medium and large hepatocellular carcinoma: A randomized, double-blinded, dummy-controlled clinical trial in a single cent Lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) consists of doxorubicin encapsulated contained within a heat-sensitive liposome.We sought to evaluate whether the use of combined radiofrequency ablation (RFA) and LTLD would result (...) in larger coagulation volume and longer overall survival (OS) compared with the use of RFA alone in patients with 3-7 cm unresectable hepatocellular carcinoma (HCC).Between 2010 and 2012, 22 HCC patients were randomly assigned to one of two treatments in our center: (1) ultrasound-guided percutaneous RFA plus intravenous (IV) infusion of LTLD (combination, n = 11) or (2) RFA plus IV dummy (RFA, n = 11). Four patients withdrew from the study, and the remaining 18 patients entered the final analysis

2019 Journal of cancer research and therapeutics Controlled trial quality: predicted high

19. Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. Full Text available with Trip Pro

Safety and efficacy of oral nemonoxacin versus levofloxacin in treatment of community-acquired pneumonia: A phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial. Nemonoxacin is a novel nonfluorinated quinolone with excellent in vitro activity against most pathogens in community-acquired pneumonia (CAP), especially Gram-positive isolates. The purpose of this study was to assess the efficacy and safety of nemonoxacin compared with levofloxacin

2019 Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi Controlled trial quality: predicted high

20. Chinese herbal medicine bi min fang for allergic rhinitis: protocol for a double-blind, double-dummy, randomized controlled trial. Full Text available with Trip Pro

Chinese herbal medicine bi min fang for allergic rhinitis: protocol for a double-blind, double-dummy, randomized controlled trial. People with allergic rhinitis (AR) often seek help from Chinese medicine due to dissatisfaction with conventional treatments. Lung-spleen qi deficiency syndrome (LSQDS) is the most common type of AR, and the Chinese herbal medicine formula bi min fang (BMF) is commonly prescribed for AR patients with LSQDS. However, direct evidence supporting its efficacy and safety (...) is not available, and its potential mechanism of action remains unclear.This paper presents a double-blind, double-dummy, randomized controlled trial. After a 2-week run-in period, 80 AR patients with LSQDS will be recruited and randomly allocated to the BMF group or the control group in a 1:1 ratio. The patients in the BMF group will receive BMF and the placebo for levocetirizine hydrochloride orally, while the control group participants will receive levocetirizine hydrochloride and the placebo for BMF orally

2019 Trials Controlled trial quality: predicted high

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