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Trials

Title of trial Journal Ref. Intervention PRECIS-2 wheels
  Cimetidine in patients with gastric ulcer: a multi-centre controlled trial Frost F et al. Drug - cimetidine 1g/day
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  Reducing hospital admission through computer supported education for asthma patients. Grampian Asthma Study of Integrated Care (GRASSIC) Osman LM et al. Behavioural change (patients) - four printed booklets on asthma management covering both regular control and action in acute episodes
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  Nicardipine versus nitroprusside for breakthrough hypertension following carotid endarterectomy Dorman T et al. Drug - administration of nicardipine or nitroprusside
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  The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients Aronson S et al. Drug - IV clevidipine
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  Postoperative hypertension: a multicenter, prospective, randomized comparison between intravenous nicardipine and sodium nitroprusside Halpern NA et al. Drug - administration of iv nicardipine or sodium nitroprusside
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  Achieving lipid goals in real life: the Dutch DISCOVERY study Bots AFE et al. Drug - 12 week treatment with Rosuvastatin 10mg
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  Comparison of effects on low-density lipoprotein cholesterol and high-density lipoprotein cholesterol with rosuvastatin versus atorvastatin in patients with type IIa or IIb hypercholesterolemia Davidson M et al. Drug - 12 week treatment with Rosuvastatin 10mg
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  Postprandial anti-inflammatory and antioxidant effects of extra virgin olive oil Bogani P et al. Drug - 50mg Extra virgin olive oil together with 150g of potatoes
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  The effect of polyphenols in olive oil on heart disease risk factors: a randomized trial Covas MI et al. Drug - Extra Virgin Olive Oil (high phenolic content 366 mg/kg) for 3 weeks with 2 week wash out period
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  A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: the TAXi trial Goy J-J et al. Drug - Sirolimus and Paclitaxel Stents for Percutaneous Coronary Intervention (PCA)
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  A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization Morice MC et al. Drug - Sirolimus-eluting stent
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  Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitats Trial (BASKET). Kaiser C et al. Drug - third generation drug-eluting stents
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  TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Grube E et al. Drug - Slow-release Packlitaxel-eluting stent
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  Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Kedhi E et al. Drug - paclitaxel-eluting stents
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  Perioperative beta-blockade (POBBLE) for patients undergoing infrarenal vascular surgery: results of a randomized double-blind controlled trial Brady AR et al. Drug - Beta blocker during surgery
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  The effects of perioperative beta-blockade: results of the Metoprolol after Vascular Surgery (MaVS) study, a randomized controlled trial. Yang H et al. Drug - Beta blocker Metropolol 50mg - perioperatively for vascular surgery
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  Comparative dose efficacy study of atorvastatin versus simvastatin, pravastatin, lovastatin, and fluvastatin in patients with hypercholesterolemia (the CURVES study) Jones P et al. Drug - Arvorvostatin, up to 80mg a day
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  Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the alliance study Koren MJ et al. Drug - Arorvastatin to maximum 80mg/day
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  Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection?--results of a randomized controlled pilot trial Bleidorn J et al. Health services delivery and reconfiguration - GPs use ibuprofen 3 x 400 mg oral in the treatment of uncomplicated urinary tract infection (UTI)
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  Long-term follow-up of participants with heart failure in the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT) Piller LB et al. Drug - amlodipine (2.5-10 mg/d), lisinopril (10-40mg/d), and chlorthalidone 12.5-25mg/d)
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  Coronary stent restenosis in patients treated with cilostazol Douglas JS et al. Drug - cilostazol 100 mg BID for 6 months
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  Comparison of zotarolimus-eluting and everolimus-eluting coronary stents Serruys PW et al. Drug - Second generation Zotarolimus-eluting resolute stents
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  A randomized controlled trial in second-generation zotarolimus-eluting Resolute stents versus everolimus-eluting Xience V stents in real-world patients: the TWENTE trial von Birgelen C et al. Drug - Zotarolumus-eluting Resolute stents
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  Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: results of the CILON-T (influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial Suh J-W et al. Drug - Cilostazol (loading dose 200mg, then 100mg BD for 6 months)
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  ATTMH Abernethy JD et al. Drug - antihypertensive therapy
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  BARRACLOUGH Barraclough M et al. Drug - bendrofluazide with potassium supplement, methyldopa, or debrisoquine
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  HSCSG 1974 Effect of antihypertensive treatment on stroke recurrence. Hypertension-Stroke Cooperative Study Group. JAMA 1974 et al. Drug - anti-hyptertensive
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  Carter Carter AB et al. Drug - Anti-hypertensive treatment
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  Dutch Dutch et al. Drug - Anti-hyptertensive
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  EWPHB Amery A et al. Drug - Anti hypertensive
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  HOPE Yusuf S et al. Drug - anti-hypertension drug
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  HYVET Beckett NS et al. Drug - Anti-Hypertensive
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  MRC-O Medical Research Council trial of treatment of hypertension in older adults et al. Drug - Anti-hypertensive
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  MRC-TMH MRC trial of treatment of mild hypertension et al. Drug - anti-hypertensive
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  Oslo Helgeland A et al. Drug - Anti-hyptertensive
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  PATS Post-stroke antihypertensive treatment study. A preliminary result. Chin Med J (Engl) 1995 et al. Drug - anti-hypertensive
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  SHEP Rationale and design of a randomized clinical trial on prevention of stroke in isolated systolic hypertension. The Systolic Hypertension in the Elderly Program (SHEP) Cooperative Research Group. J Clin Epidemiol 1988 et al. Drug - Anti-hypertensive
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  SHEP pilot Perry HM et al. Drug - Anti-hypertensive
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  SYST-EUR Staessen JA et al. Drug - anti-hypertensives
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  USPHSHCSG Smith WM et al. Drug - Anti-hypertensives
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  TEST Eriksson S et al. Drug - Anti-hypertensive
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  UKPDS Perry HM et al. Drug - Anti-hypertensive
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  VA-1 Effects of treatment on morbidity in hypertension. Results in patients with diastolic blood pressures averaging 115 through 129 mm Hg. JAMA 1967 et al. Drug - Anti-hypertensives
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  VA-11 Effects of treatment on morbidity in hypertension. II. Results in patients with diastolic blood pressure averaging 90 through 114 mm Hg. JAMA 1970 et al. Drug - Anti-hypertensives
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  Wolff Wolff FW et al. Drug - Anti-hypertensive
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  VA-NHLBI Evaluation of drug treatment in mild hypertension et al. Drug - Anti-hypertensives
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  HYVET pilot Bulpitt CJ et al. Drug - Anti-hypertensive
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  Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization Topol EJ et al. Drug - Tirofiban
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  COPERS, Effectiveness and cost-utility of a group self-management support intervention (COPERS) for people with chronic musculoskeletal pain: a randomised controlled trial Carnes D et al. Behavioural change (patients) - Self-management course
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  PALOMA - Drug - ALENDRONATE -vs- PLACEBO
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  GISSI Trial: EFFECTIVENESS OF INTRAVENOUS THROMBOLYTIC TREATMENT IN ACUTE MYOCARDIAL INFARCTION GRUPPO ITALIANO PER LO STUDIO DELLA STREPTOCHINASI NELL’INFARTO MIOCARDICO (GISSI)* Lancet 1986 Feb 22;1(8478) et al. Drug - Intravenous thrombolytic treatment in acute myocardial infarction
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  The Maintaining Musculoskeletal Health (MAmMOTH) Study Macfarlane et al. Behavioural change (patients) - CBT
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  SPPA trial (A multicenter, assessor-blinded, controlled, randomised, parallel group, superiority, pragmatic trial assessing the effectiveness of daily SMS-reminders in Pharmaceutical Care of older adults with hypertension on improving Patients’ Adherence to blood pressure-lowering medication) HARAMIOVA et al. Behavioural change (patients) - SMS reminders of blood pressure-lowering medicines intake
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  Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin and Paclitaxel in Patients With Optimally Resected Stage III Ovarian Cancer: A Gynecologic Oncology Group Study Ozols et al. Drug - Carboplatin (AUC 7.5mg/mL/min) + paclitaxel (175mg/m3) as a 3-hour infusion
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  The Bacteriuria in Renal Transplantation (BiRT) study: a prospective, randomized, parallel-group, multicenter, open-label, superiority trial comparing antibiotics versus no treatment in the prevention of symptomatic urinary tract infection in kidney transplant recipients with asymptomatic bacteriuria The BiRT study protocol has been published by The Lancet (http et al. Drug - Antibiotics (10 days): started according to the antibiogram results. The choice of antimicrobial agents is at the discretion of the physician.
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  The ENHANCE-D Study – ENHANCing smoking cEssation interventions in Dentistry - Behavioural change (patients) - 1. Very Brief Advice on Smoking 2. Single-visit smoking cessation behavioural intervention plus offer of 3 month course of combination Nicotine Replacement Therapy 3. Single-visit smoking cessation behavioural intervention plus offer of e-cigarette starter kit
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  E-ASSIST - Other - Offer of e-cigarette starter kit
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  Efficacy of an Active Geriatric Evaluation for Geriatric Syndromes to Prevent Functional Decline in Family - Health services delivery and reconfiguration - The AGE tool consists of a 20-minute clinical screening instrument (Brief Assessment Tool, BAT), which performances for identifying geriatric syndromes was already assessed in general practice along the AGE program, and a comprehensive approach that encompasses complementary diagnostic evaluations and propositions of management & treatment for each syndrome.
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  Manual therapy for chronic migraine: A pragmatic randomised controlled trial study protocol Odell Other - Manual Therapy - Mobilization, manipulation and soft tissue techniques
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  The IMPROVE-GAP trial Lloyd M et al. Health services delivery and reconfiguration - Control arm: Usual care. Intervention arm: Multidisciplinary CAP Service, tasked with implementation of four evidence-based treatments in conjunction with usual care.
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  Effectiveness and cost-effectiveness of the Initial Medication Adherence intervention: a cluster randomised control trial, economic model and process evaluation(IMA-cRCT). - Behavioural change (patients) - The IMA intervention is a shared-decision making intervention that promotes health literacy and patient participation in the decision making process during the recommendation and prescription of a new drug for the management of a cardiovascular disease and diabetes. The IMA intervention has four main components: training for healthcare professionals (general practitioners (GP), nurses and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; intervention decision aids (leaflets and website); implementation of the IMA intervention during the GP's consultation; and information support provided by the nurses and community pharmacists that will use the intervention decision aids to explore the patients's doubts and harmonise and standardise the discourse between primary healthcare professionals.
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  Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care https et al. Other - ADD-ON INTERVENTIONS TO A SPECIALIST CARE WAITING LIST: Usual care Participants randomised to usual care will continue to follow any diagnostic or treatment-related pathways as indicated by healthcare practitioners they may consult during the study period. All patients will eventually undergo a clinical examination at first consultation at the outpatient clinic. Based on this first consultation, a suitable treatment is offered to the patient at the clinicians’ discretion in accordance with current evidence-based guidelines. Treatment options include: no further treatment, adjusted recommendations for primary care treatment, outpatient multimodal rehabilitation, surgery and referral to other medical specialists (eg, orthopaedic, neurosurgery, neurology or rheumatology department). Therefore, the type, modality and length of treatment are expected to vary between patients. The SELFBACK app adjunct to usual care In addition to usual care, participants in this group will have access to the SELFBACK intervention throughout the study period.The SELFBACK app provides self-management tailored by a artificial intelligence algorithm. On a weekly basis, tailoring questions are asked via the app and used to revise the self-management plan for the upcoming week. The weekly plans generated encompass three main components: (1) advice on physical activity based on step counting, (2) educational messages based on a cognitive–behavioural approach, and (3) recommendations on strength and flexibility exercises. Additional resources, such as general information about low back pain / neck pain, mindfulness audios, goal-setting tool and pain relief exercises, are also available in the app. The e-Help website adjunct to usual care In addition to usual care, participants randomised to this group will have access to the e-Help intervention. The e-Help is a web-based resource based on the SELFBACK theoretical framework and content.The e-Help website involved no individual tailoring of the content but instructions in the first section emphasise self-tailoring techniques based on pacing and goal-setting strategies.
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  Household-based behaviour change communication intervention to improve plastic waste management practices (C-PASTE) in rural Guizhou - Behavioural change (patients) - Intervention group: provision of interpersonal communication, resource material (plastic waste collection bin, "Blue Bin") and health education pamphlets for separate collection of plastic waste whereas control group with only resource material ("Blue Bin")and health education pamphlets
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  Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS: More Learning) After Knee Injury: An Adaptive Randomized Controlled Trial - Behavioural change (patients) - The MOTIFS training consists of mental training integrated into physical rehabilitation training interventions. This includes performing physical exercises with simultaneous dynamic motor imagery based on the participant's own experiences and desires, creating an individually relevant activity specific exercise that is developed using shared decision-making between the physical therapist and patient. The intervention is performed in a clinical environment during the training session to ensure that the physical and mental training is performed correctly and safely. The physical therapists are educated in implementation of the intervention, during which they choose a relevant exercise, then discuss with the patient how the movement is relevant to their sport or activity, subsequently modifying the exercise to ensure proper rehabilitative execution as well as activity-specific relevance and realism. The Care-as-Usual training is performed according to established knee injury rehabilitation protocols at the discretion of the physical therapist.
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  Satisfactory clinical response after treatment of knee osteoarthritis with a standardized, closed-system and low-cost PRP product: characterization and 1-year follow-up pre-post test study - Drug - We have evaluated the clinical efficacy of a characterized PRP product prepared in a standardized manner and in a closed-system as knee osteoarthritis (KOA) treatment, and evaluated the association of the clinical response to PRP-related variables. PRP was prepared from a donation of autologous blood, obtaining three aliquots of approximately 10 mL of product that were stored frozen until administration. Patients were treated three consecutive times every four weeks with an intraarticular PRP knee infiltration under sterile conditions.
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  Effect of Osteopathic Manipulative Treatment vs Sham Treatment on Activity Limitations in Patients With Nonspecific Subacute and Chronic Low Back Pain : A Randomized Clinical Trial JAMA Internal Medicine Other - Each group received 6 sessions of standard or sham OMT, each session at 2-week intervals. For both, each session lasted 45 minutes and consisted of 3 periods: (1) interview focusing on pain location, (2) full osteopathic examination, and (3) intervention consisting of standard or sham OMT. Briefly, in both groups, practitioners assessed 7 anatomical regions for dysfunction (lumbar spine, root of mesentery, diaphragm, and atlantooccipital, sacroiliac, temporomandibular, and talocrural joints) and applied sham OMT to all areas or standard OMT to those that were considered dysfunctional.
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  REACH-HFpEF xxx Other - cardiac reahabilitation
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  REACH-HFpEF xxx Other - cardiac reahabilitation
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  BRICS: Brazilian Multicentric Pragmatic Randomised Trial of Surgical Interventions for displaced Diaphyseal Clavicle Fracture Study - MIO vs ORIF for the treatment of displaced midshaft clavicle fractures Protocol Published at BMJ Open 2021;11 et al. Surgical - Minimally invasive techniques for displaced fracture of the clavicle diaphysis or open reduction and internal fixation with plate and screws
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  Efetividade da Terapia Floral de Bach na Redução do Estresse em Profissionais de Enfermagem: Ensaio Clínico - Other - Ensaio Clínico randomizado, paralelo, duplo cego, placebo-controlado, a ser realizado em 35 Unidades Básicas de Saúde localizadas no município de Osasco-SP. A população será composta por enfermeiros, auxiliares e técnicos de enfermagem que se dispuserem a participar voluntariamente do estudo. Os participantes selecionados serão divididos em dois grupos. O Grupo Intervenção receberá os frascos contendo a fórmula floral e o Grupo Placebo receberá os frascos contendo um veículo inerte.
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  Effect of Biodentine Application as an Apical Plug on the Healing of Apical Lesions on Immature Permanent Molars (Randomized controlled clinical and radiographic trial) Alsayed tolibah et al. Other - Following the randomization procedure, patients will be assigned sequential numbers in the order of enrolment. Group I will include 12 immature molars treated with MTA (White ProRoot MTA, Dentsply, Tulsa, OK, USA) as apical plug, whereas group II will include 12 immature molars treated with Biodentine (Septodont, Saint-Maur-des-Fosses, France) as apical plug. All the apexification treatments will be performed by the researcher. Under local anesthesia and rubber dam isolation, all superficial caries will be removed with carbide fissure bur mounted on a low-speed hand-piece. Access cavity will be prepared using an endo-z bur mounted on high-speed hand-piece, and the cavity will be rinsed with 2.5% NaOCl. Working length will be calculated radiographically with K-files (Mani, INK, Japan) and recorded as reference. root canals will be instrumented gently with Fanta AF3 (Fanta Dental Materials Co., LTD, Shanghai, China) and copious irrigation with 1.3% sodium hypochlorite (NaOCI) (Merck, Darmstadt, Germany) by a 30- gauge endodontic irrigating needle (Sybron Endo, Crop, Orange, CA, USA). As final irrigation all canals will be filled up with NaOCl 1.3% and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 30 seconds for each canal, then all canals will be irrigated with normal saline, then all canals will be filled up with Q-mix (Dentsply Tulsa Dental, Tulsa, OK, USA) and activated with #40 U-file ultrasonic tip (Zipperer Co., Munchen, Germany) for 10 seconds. After drying with large sterile paper points apical plug will be done according to randomization MTA with 2 visits or Biodentine with one visit. Biodentine Group (performed in a single clinic visit of approximately 45 minutes): Biodentine will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the Biodentine plugs will be verified with a radiograph. After 12 min the setting of Biodentine will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless-steel crown (3M ESPE, Dental Products, St. Paul, MN, USA). MTA Group (performed in 2 clinic visits, each visit will be approximately 30 minutes): MTA will be placed with MAP-One System (Produits Dentaires, sa vevey, switzerland) into the apical portion of canals with about 4 mm thickness and adapted to the canal walls with an endodontic hand plugger (Dentsply, Tulsa, OK, USA). Correct placement of the MTA plugs will be verified with a radiograph. After inserting MTA, a moist cotton pellet will be placed in the canal, and the access cavity will be restored with temporary filling (TG, Germany). Next day, under local anesthesia and rubber dam isolation, the temporary filling and the cotton pellet will be removed and the setting of MTA will be detected gently with #40 k-file (Mani, INK, Japan). The coronal and middle third of the root canal will be filled with gutta-percha in conjunction with AH Plus sealer (Dentsply Sirona Endodontics) using lateral condensation technique. The coronal restoration will be completed with GIC Fuji IX (GC Corporation, Tokyo, Jappan), then bonded resin composite (3M ESPE, Dental Products, St. Paul, MN, USA), and stainless steel crown (3M ESPE, Dental Products, St. Paul, MN, USA). Patients of both groups will be recalled for radiographical follow-up after the end of treatment at 1, 3, 6 and 12 months. Periapical radiographs will be obtained under standard exposure conditions (60 kVp, 7 mA and 0.32 s) using a dental X-ray machine (Gendex GX, Lake Zurich, IL, USA) and intraoral sensor (VATECH. Gyeonggi-do, Korea) . The radiographic assessment will be done with two pre-trained independent investigators. Each investigator will determine the size of apical lesion using “Image J” program and scored in both groups blindly, independently and will repeat the radiographic scoring after 1 month to assess the intraobserver reliability. Any disagreement on apical lesion size for a particular root resulted in joint evaluation until agreement will be reached. Patients of both groups will be recalled for clinical follow-up after the end of treatment at 1 day, 3 days, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months to detect pain, swelling, tenderness to percussion, abscess, fistula, and abnormal tooth mobility Finally, the numerical data of the apical lesions sizes and ranked data of clinical variables will be statistically analyzed using SPSS, and any statistically significant values will be investigated.
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  Chaiqin Chengqi Decoction for Acute Pancreatitis (CQCQDAP trial): study protocol of a randomized, double-blind, placebo-controlled, parallel-group trial Unpublished Drug - Chaiqin Chengqi Decoction (CQCQD) and placebo CQCQD will be used for the treatment of acute pancreatitis.
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  FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): A master protocol of two randomised trials to evaluate the non-inferiority of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care - Other - High flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care
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  OSTEOPATHY AND PHYSIOTHERAPY COMPARED TO PHYSIOTHERAPY ALONE ON FATIGUE IN LONG COVID: STUDY PROTOCOL FOR A PRAGMATIC RANDOMIZED CONTROLLED SUPERIORITY TRIAL International Journal of Ostheopatic Medicine Health services delivery and reconfiguration - All patients with long COVID referred to the rehabilitation service will be received by a social assistant to allocate the participants in two groups PT or OMT+PT, present the informed consent form and apply the questionnaires that will be used to assess the groups. The interventions will be conducted according to each patient’s clinical presentation, following their usual care and without creating any changes that could denature the routine clinical practice (Table 1). Participants in both groups are not restricted to access other interventions (e.g., medications or self-guided physical activity). In the follow-up questionnaire they may report other interventions in the last three months if any. The criteria for discontinuing the treatment in both groups include participants request to withdraw from the research, any condition that prevents the participant from reaching the treatment setting, hospitalization, or death. The number of consultations/appointments for each participant will be recorded, as well as possible absences from scheduled appointments. To reduce attrition rate, on every absence the social worker will contact the participant via phone call to inquire about the reason for the absence and encourages the participant to continue the treatment. In the follow-up questionnaire they may report reasons for dropping out of the trial to be categorized as cost, health improvement, aggravation of symptoms, death, or others (e.g., relatives sickness, no allowance work leave).
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  NEPTUNE - Other - Tailored intravenous hydration
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