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Background This study aimed to compare the efficacy of BRIX3000, Carisolv, and the conventional rotary-mechanical method for caries removal and to evaluate the intraoperative pain level and the requirement for local anesthesia during caries excavation in immature mandibular permanent first molars (PFMs) of pediatric patients aged 7 to 9. Materials and methods It was a single-blinded, randomized, parallel-group, active-controlled trial with three arms. Forty-five specimens were assigned randomly to three groups: Group 1: Chemomechanical caries removal (CMCR) utilizing Carisolv. Group 2: CMCR utilizing BRIX3000. Group 3: Control group, caries excavation utilizing conventional rotary-mechanical method. Lesions reaching the middle or inner third of the dentine (D2/3) were observed in immature mandibular PFMs with no pulpal and/or periodontal issues included. The efficacy of caries removal was considered the primary outcome measure. It was recorded using the Ericson et al. scale by visual-tactile examination and the caries detector, which includes five levels to rate the amount of carious dentin remaining. The secondary outcome measures were subjective and objective pain assessment and the requirement of local anesthesia. Continuous and categorical data were compared using the Kruskal–Wallis and chi-square tests, respectively. A significance level of p  < 0.05 was adjusted. Results All conventional-method cases (100%) and the majority of Carisolv and BRIX3000 cases (80%) showed complete caries removal and a mean score of (0.27 ± 0.59) and (0.20 ± 0.41) ( p  = 0.185), respectively. The conventional method group showed the highest mean score (2.07 ± 0.88) of the sound, eye, motor (SEM) scale compared with the Carisolv and BRIX3000 ( p  < 0.05) groups, which exhibit lower mean scores (0.80 ± 0.77), (0.67 ± 0.72), respectively. For the Wong-Baker FACES scale, the conventional method group recorded the highest mean (7.07 ± 3.01) compared to the Carisolv and BRIX3000 ( p  < 0.05) groups, which had considerably lower mean scores of (2.53 ± 2.77) and (2.00 ± 2.39), respectively. Consequently, the majority (80.00%) of conventional-method cases asked for local anesthesia ( p  < 0.05). Conclusions All methods were equally effective in removing caries. BRIX 3000 and Carisolv agents notably reduced pain in children. Trial registration ISRCTN registry, ISRCTN12761284, registered 6 November 2024, retrospectively.

BackgroundAspirin inhibits colorectal carcinogenesis. In a randomised double-blind placebo-controlled trial, daily soluble aspirin significantly reduced recurrence of colorectal adenomas at 1-year follow-up. In this study the results of daily intake of low-dose aspirin on polyp recurrence at 4-year follow-up are presented.Methods272 patients (naive for chronic aspirin use) with colorectal adenomas were randomly assigned to treatment with lysine acetylsalicylate 160 mg/day (n=73) or 300 mg/day (n=67) or placebo (n=132) for 4 years. The primary endpoints were adenoma recurrence and adenomatous polyp burden at year 4, comparing aspirin at either dose with placebo. The same endpoints were also assessed at year 1 or 4 (last colonoscopy performed for each patient).ResultsAt the final year 4 colonoscopy the analysis included 185 patients (55 receiving aspirin 160 mg/day, 47 aspirin 300 mg/day and 83 placebo). There was no difference in the proportion of patients with at least one recurrent adenoma between patients receiving aspirin at either dose and those treated with placebo (42/102 (41%) vs 33/83 (40%); NS) or in the adenomatous polyp burden (3.1±5.8 mm vs 3.4±6.2 mm; NS). Also, the proportion of patients with at least one advanced recurrent adenoma did not differ (10/182 (10%) in the aspirin group vs 7/83 (7%) in the placebo group; NS).ConclusionDaily low-dose aspirin decreased adenoma recurrence significantly at 1 year but not at year 4. This discrepancy might be explained by a differential effect of aspirin according to the natural history of the polyp.Trial Registration NumberNCT 00224679.

Background: Some recent trials have reported high efficacy for nonsteroidal anti-inflammatory drugs (NSAIDs) in relieving medical abortion-related pain. The aim of this study was to determine the beneficial effect of oral NSAIDs (ibuprofen lysine) in reduction of pain and hemorrhage in first-trimester medical abortion. Methods: This randomized triple-blinded clinical trial was performed on 98 pregnant women who were candidate for medical abortion within the first-trimester period (gestational age<12 weeks). The participants were randomly assigned to receive ibuprofen lysine (684 mg orally every 4 hours) or placebo. All patients were initially treated with misoprostol (800 µg every 3 hours). Pain intensity and rate of hemorrhage were assessed every hour up to 15 hours after receiving the first dose of misoprostol by visual analogue scaling (VAS) and pictorial blood loss assessment chart (PBAC), respectively. Results: Assessing the mean pain score within 15 hours of receiving misoprostol showed significantly lower pain intensity within the first 10 hours of assessment in the group receiving NSAID in comparison with the control group (P<0.001). The bleeding rate was also significantly lower in the NSAID group at the fifth (P=0.013) and ninth (P=0.040) hour of receiving misoprostol compared to the control group. We found no difference in abortion-related complication rate between the NSAID and placebo groups (8.3% versus 8.0%, P=0.952). Conclusion: The use of NSAIDs (ibuprofen lysine) is a good pharmacological analgesic option for relieving medical abortionrelated pain and hemorrhage.

Background and objectives. The efficacy of commonly prescribed analgesic and adjuvant drugs for the management of patients with radiculopathy has not been well established. Oral steroids are commonly used to treat sciatica or radiculopathy due to a herniated disk but the effect remains controversial. L-lysine aescinate showed superiority over placebo or baseline therapy with NSAIDs alone in treating sciatica, but have not been evaluated in an appropriately powered clinical trial. Materials and Methods. Randomized, double-blind clinical trial conducted in two health centers in collaboration with Uzhhorod Natioanl University in Ukraine. Adults (N = 90) with acute radicular pain and a herniated disk confirmed by MRI were eligible. Participants were randomly assigned to three groups (N = 30 in each) to receive a baseline therapy with lornoxicam (16 mg per day) and adjunctive 5-day course of IV dexamethasone (first group: 8 mg per day/40 mg total) or 0,1% solution of L-lysine aescinate (5 mL and 10 mL for group 2 and 3 respectively). Primary outcomes were Visual Analogue Scale changes and the straight leg raise angle at 15th and 30th day. Results. The level of pain improvement at 15th days after initiation of therapy with dexamethasone or solution of L-lysine aescinate at doses of 5 or 10 mL was not significantly different. The lowest levels of pain were achieved in patients who received the L-lysine aescinate 10 mL, but the range of decrease in pain was slightly greater in the group administered dexamethasone. Conclusions. Among patients with acute radiculopathy due to a herniated lumbar disk a short course of IV dexamethasone or L-lysine aescinate resulted in pain improvement at 15th and 30th day. Dexamethasone may be preferable if a longer-term analgesic effect is needed. Taking into account side effects of dexamethasone, a solution of L-lysine aescinate can be used to relieve pain symptoms.

Summary Aspirin is commonly used to treat migraine attacks, although sumatriptan, a much more expensive treatment, is also effective. We compared a combination of lysine acetylsalicylate (equivalent to 900 mg aspirin) and 10 mg metoclopramide (LAS+MTC) with oral sumatriptan (100 mg) and placebo in 421 patients with migraine. LAS+MTC was as effective as sumatriptan with a decrease of headache from severe or moderate to mild or none of 57% and 53%, respectively, for the first migraine attack treated. Both treatments were better than placebo (success rate 24%, p<0·0001). LAS+MTC was significantly more effective in the treatment of nausea than sumatriptan (p<0·0001) and was better tolerated (adverse events in 18% and 28%, respectively, p<0·05). LAS+MTC is as effective as sumatriptan in the treatment of migraine attacks. It is also much cheaper.

Ibuprofen is used for treatment and prevention of patent ductus arteriosus in low-birthweight infants. Its effects on regional circulations differ from those of indometacin. Because prophylactic indometacin reduces the frequency of severe intraventricular haemorrhage and patent ductus arteriosus, we aimed to study the efficacy of early ibuprofen in reducing these outcomes in a double-blind, multicentre trial. Within 6 h after birth, 415 low-birthweight infants (gestational age <31 weeks) were randomly allocated ibuprofen-lysine (10 mg/kg then two doses of 5 mg/kg after 24 h and 48 h) or placebo intravenously. The primary outcome was occurrence of severe intraventricular haemorrhage; secondary outcomes were occurrence of patent ductus arteriosus and possible adverse effects of ibuprofen. Analysis was by intention to treat. 17 (8%) of 205 infants assigned ibuprofen and 18 (9%) of 210 assigned placebo developed severe intraventricular haemorrhage (relative risk 0·97 95% CI 0·51–1·82). In 172 (84%) infants of the ibuprofen group, the ductus was closed on day 3 compared with 126 (60%) of the placebo group (relative risk 1·40 [1·23–1·59]). No important differences in other outcomes or side-effects were noted; however, urine production was significantly lower on day 1 and concentration of creatinine in serum was significantly higher on day 3 after ibuprofen. Ibuprofen prophylaxis in preterm infants does not reduce the frequency of intraventricular haemorrhage, but does decrease occurrence of patent ductus arteriosus.

The cuff tendon that is most prone to full-thickness rotator cuff tears is the supraspinatus (SSP). Arthroscopic SSP repair ensures good to satisfactory mid- to long-term clinical outcomes. However, the intense postoperative pain reduces rehabilitation compliance and is cause of patient dissatisfaction. Many natural compounds act by inhibiting inflammatory pathways in a similar way to anti-inflammatory drugs This was a prospective randomized trial designed to assess the analgesic effect of a dietary supplement (DS) containing Boswellia serrata and Curcuma longa in a population of subjects with full-thickness SSP tendon tear treated by arthroscopy. Three weeks before surgery, patients were randomized to receive Tendisulfur(®) (group T) or a placebo (group P) for 2 months. The primary outcome measure was subjective VAS pain. Secondary outcomes measures were Constant-Murley score simple shoulder test, and patient global assessment (PGA) scores. Patients were assessed immediately at baseline and subsequently at 1, 2, 4, 6, 8, 12, and 24 weeks. Stratification of pain scores and subscores demonstrated significantly lower overall pain scores in group T versus group P at 1 week (p = 0.0477), and lower but not significantly different scores on week 2 (p = 0.0988); at subsequent time points, differences were not significant (p > 0.05). PGA scores were good in all subjects. In conclusion, this study provides objective data on the effect of a DS containing natural substances, added to standard analgesics, on postoperative RC pain. DS alleviated short and partially mid-term pain, while long-term pain was unchanged. This limitation can probably be addressed by a dosage increase over the first 4 weeks and by extending treatment by 1 or 2 months.

The treatment of bacterial infections is hindered by the presence of biofilms and metabolically inactive persisters. Here, we report the synthesis of an enantiomeric block co-beta-peptide, poly(amido-D-glucose)- block -poly(beta-L-lysine), with high yield and purity by one-shot one-pot anionic-ring opening (co)polymerization. The co-beta-peptide is bactericidal against methicillin-resistant Staphylococcus aureus (MRSA), including replicating, biofilm and persister bacterial cells, and also disperses biofilm biomass. It is active towards community-acquired and hospital-associated MRSA strains which are resistant to multiple drugs including vancomycin and daptomycin. Its antibacterial activity is superior to that of vancomycin in MRSA mouse and human ex vivo skin infection models, with no acute in vivo toxicity in repeated dosing in mice at above therapeutic levels. The copolymer displays bacteria-activated surfactant-like properties, resulting from contact with the bacterial envelope. Our results indicate that this class of non-toxic molecule, effective against different bacterial sub-populations, has promising potential for the treatment of S. aureus infections. The authors report the synthesis of an enantiomeric block co-beta-peptide that kills methicillin-resistant Staphylococcus aureus , including biofilm and persister bacterial cells, and disperses biofilms. The copolymer displays antibacterial activity in human ex vivo and mouse in vivo infection models without toxicity.

Purpose Prostate-specific membrane antigen (PSMA) is a recognized target for imaging prostate cancer. Here we present initial safety, biodistribution, and radiation dosimetry results with [ 18 F]DCFPyL, a second-generation fluorine-18-labeled small-molecule PSMA inhibitor, in patients with prostate cancer. Procedures Biodistribution was evaluated using sequential positron-emission tomography (PET) scans in nine patients with prostate cancer. Time-activity curves from the most avid tumor foci were determined. The radiation dose to selected organs was estimated using OLINDA/EXM. Results No major radiotracer-specific adverse events were observed. Physiologic accumulation was observed in known sites of PSMA expression. Accumulation in putative sites of prostate cancer was observed (SUV max up to >100, and tumor-to-blood ratios up to >50). The effective radiation dose from [ 18 F]DCFPyL was 0.0139 mGy/MBq or 5 mGy (0.5 rem) from an injected dose of 370 MBq (10 mCi). Conclusions [ 18 F]DCFPyL is safe with biodistribution as expected, and its accumulation is high in presumed primary and metastatic foci. The radiation dose from [ 18 F]DCFPyL is similar to that from other PET radiotracers.

Purpose Gallium-68 (Ga-68)-labeled tracers for imaging expression of the prostate-specific membrane antigen (PSMA) such as the [ 68 Ga]Ga-PSMA-HBED-CC have already demonstrated high potential for the detection of recurrent prostate cancer. However, compared to Ga-68, a labeling with fluorine-18 (F-18) would offer advantages with respect to availability, production amount, and image resolution. [ 18 F]DCFPyL is a promising F-18-labeled candidate for PSMA-positron emission tomography (PET) imaging that has been recently introduced. In the current study, we aimed to compare [ 68 Ga]Ga-PSMA-HBED-CC and [ 18 F]DCFPyL for clinical use in biochemically relapsed prostate cancer. Procedures In 14 selected patients with PSA relapse of prostate cancer, [ 18 F]DCFPyL PET/X-ray computed tomography (CT) was performed in addition to [ 68 Ga]Ga-PSMA-HBED-CC PET/CT. A systematic comparison was carried out between results obtained with both tracers with regard to the number of detected PSMA-positive lesions, the standardized uptake value (SUV) max and the lesion to background ratios. Results All suspicious lesions identified by [ 68 Ga]Ga-PSMA-HBED-CC were also detected with [ 18 F]DCFPyL. In three patients, additional lesions were observed using [ 18 F]DCFPyL PET/CT. The mean SUV max in the concordant [ 18 F]DCFPyL PSMA-positive lesions was significantly higher as compared to [ 68 Ga]Ga-PSMA-HBED-CC (14.5 vs. 12.2, p  = 0.028, n  = 15). The mean tumor to background ratios ( n  = 15) were significantly higher for [ 18 F]DCFPyL compared to [ 68 Ga]Ga-PSMA-HBED-CC using kidney, spleen, or parotid as reference organs ( p  = 0.006, p  = 0.002, p  = 0.008), but no significant differences were found using the liver ( p  = 0.167) or the mediastinum ( p  = 0.363) as reference organs. Conclusion [ 18 F]DCFPyL PET/CT provided a high image quality and visualized small prostate lesions with excellent sensitivity. [ 18 F]DCFPyL represents a highly promising alternative to [ 68 Ga]Ga-PSMA-HBED-CC for PSMA-PET/CT imaging in relapsed prostate cancer.