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This study aimed to determine whether caffeine gum influenced perceptual-cognitive and physical performance during the extra-time period of simulated soccer match-play. Semiprofessional male soccer players (n = 12, age: 22 ± 3 years, stature: 1.78 ± 0.06 m, mass: 75 ± 9 kg) performed 120-min soccer-specific exercise on two occasions. In a triple-blind, randomized, crossover design, players chewed caffeinated (200 mg; caffeine) or control (0 mg; placebo) gum for 5 min following 90 min of soccer-specific exercise. Perceptual-cognitive skills (i.e., passing accuracy, reaction time, composure, and adaptability) were assessed using a soccer-specific virtual reality simulator, collected pre- and posttrial. Neuromuscular performance (reactive-strength index, vertical jump height, absolute and relative peak power output, and negative vertical displacement) and sprint performance (15 and 30 m) were measured at pretrial, half-time, 90 min, and posttrial. Caffeine gum attenuated declines in reaction time (pre: 90.8 ± 0.8 AU to post: 90.7 ± 0.8 AU) by a further 4.2% than placebo (pre: 92.1 ± 0.8 AU to post: 88.2 ± 0.8 AU; p <.01). Caffeine gum reduced composure by 4.7% (pre: 69.1 ± 0.8 AU to post: 65.9 ± 0.8 AU) versus placebo (pre: 68.8 ± 0.8 AU to post: 68.3 ± 0.8 AU; p <.01). Caffeine gum did not influence any other variables (p >.05). Where caffeine gum is consumed by players prior to extra-time, reaction time increases but composure may be compromised, and neuromuscular and sprint performance remain unchanged. Future work should assess caffeine gum mixes with substances like L-theanine that promote a relaxed state under stressful conditions. [ABSTRACT FROM AUTHOR]

The main objective of this placebo-controlled, triple-blind, balanced crossover study was to assess the acute effects of phenylcapsaicin (PC) intake (2.5 mg) on intraocular pressure (IOP), ocular perfusion pressure (OPP), and heart rate (HR) during a 30-min cycling task performed at 15% of the individual maximal power. Twenty-two healthy young adults performed the cycling task 45 min after ingesting PC or placebo. IOP was measured with a rebound tonometer before exercise, during cycling (every 6 min), and after 5 and 10 min of recovery. OPP was assessed before and after exercise. HR was monitored throughout the cycling task. We found an acute increase of IOP levels related to PC consumption while cycling (mean difference = 1.91 ± 2.24 mmHg; p =.007, η p 2 =.30), whereas no differences were observed for OPP levels between the PC and placebo conditions (mean difference = 1.33 ± 8.70 mmHg; p =.608). Mean HR values were higher after PC in comparison with placebo intake (mean difference = 3.11 ± 15.87 bpm, p =.019, η p 2 =.24), whereas maximum HR did not differ between both experimental conditions (p =.199). These findings suggest that PC intake before exercise should be avoided when reducing IOP levels is desired (e.g., glaucoma patients or those at risk). Future studies should determine the effects of different ergogenic aids on IOP and OPP levels with other exercise configurations and in the long term. [ABSTRACT FROM AUTHOR]

Purpose: There are multiple postexercise recovery technologies available in the market based on the assumption of blood-flow enhancement. Lower-limb intermittent pneumatic compression (IPC) has been widely used, but the available scientific evidence supporting its effectiveness remains scarce, requiring a deeper investigation into its underlying mechanisms. The aim of this study was to assess the hemodynamic effects caused by the use of IPC at rest. Methods: Twenty-two soccer and track and field athletes underwent two 15-minute IPC protocols (moderate- [80 mm Hg] and high-pressure [200 mm Hg]) in a randomized order. Systolic peak velocity, end-diastolic peak velocity, arterial diameter, and heart rate were measured before, during (at the eighth minute), and 2 minutes after each IPC protocol. Results: Significant effects were observed between before and during (eighth minute) the IPC protocol for measures of systolic (P <.001) and end-diastolic peak velocities (P <.001), with the greater effects observed during the high-pressure protocol. Moreover, 2 minutes after each IPC protocol, hemodynamic variables returned to values close to baseline. Arterial diameter presented significant differences between pressures during the IPC protocols (P <.05), while heart rate remained unaltered. Conclusion: IPC effectively enhances transitory blood flow of athletes, particularly when applying high-pressure protocols. [ABSTRACT FROM AUTHOR]

We aimed to investigate the effects of dual- and single-task training in older adults with age-related hearing loss. Intervention groups included single-, dual-task training, and control groups. The dual- and single-task trainings were held 2 days a week for 40 min for a total of 10 sessions for 5 weeks. We evaluated physical, cognitive, and auditory functions, quality-of-life, balance, concerns about falling, independence in activities of daily living, and dual-task performance. A total of 42 patients fully participated in this study. Statistically significant differences were observed in chair stand, chair sit-and-reach, global cognitive function, and delayed recall between the intervention groups and control group (p <.05). There was no statistically significant difference in quality-of-life, balance, falling concerns, independence in activities of daily living, and dual-task performance between all groups (p >.05). In conclusion, single- and dual-task training had a positive effect on physical and cognitive functioning in older adults with age-related hearing loss. [ABSTRACT FROM AUTHOR]

Whey protein ingestion during recovery from exercise increases myofibrillar but not muscle connective protein synthesis rates. It has been speculated that whey protein does not provide sufficient glycine to maximize postexercise muscle connective protein synthesis rates. In the present study, we assessed the impact of coingesting different amounts of collagen with whey protein as a nutritional strategy to increase plasma glycine availability during recovery from exercise. In a randomized, double-blind, crossover design, 14 recreationally active men (age: 26 ± 5 years; body mass index: 23.8 ± 2.1 kg·m−2) ingested in total 30 g protein, provided as whey protein with 0 g (WHEY), 5 g (WC05); 10 g (WC10), and 15 g (WC15) of collagen protein immediately after a single bout of resistance exercise. Blood samples were collected frequently over 6 hr of postexercise recovery to assess postprandial plasma amino acid kinetics and availability. Protein ingestion strongly increased plasma amino acid concentrations (p <.001) with no differences in plasma total amino acid availability between treatments (p >.05). The postprandial rise in plasma leucine and essential amino acid availability was greater in WHEY compared with the WC10 and WC15 treatments (p <.05). Plasma glycine and nonessential amino acid concentrations declined following whey protein ingestion but increased following collagen coingestion (p <.05). Postprandial plasma glycine availability averaged −8.9 ± 5.8, 9.2 ± 3.7, 23.1 ± 6.5, and 39.8 ± 11.0 mmol·360 min/L in WHEY, WC05, WC10, and WC15, respectively (incremental area under curve values, p <.05). Coingestion of a small amount of collagen (5 g) with whey protein (25 g) is sufficient to prevent the decline in plasma glycine availability during recovery from lower body resistance-type exercise in recreationally active men. [ABSTRACT FROM AUTHOR]

Surface contaminants on customized implant abutments could trigger an inflammatory response in the peri-implant tissues. The aim of this randomized controlled study was to assess the radiographic bone changes around implants restored with customized, platform-switched abutments, with and without autoclave treatment, 12 months after definitive restoration. Dental implants were placed 1 mm subcrestally in 64 systemically healthy patients (mean age: 63.3 ± 10.0 years; 31 patients had a history of periodontitis) to replace single or multiple missing teeth. According to a randomization list, abutments were subjected to steam and autoclave sterilization (43 implants, test group) or steam cleaning alone (44 implants, control group). Periapical standardized radiographs were taken at implant placement, prosthetic abutment connection, and 12 months after definitive cement-retained restoration. All implants were clinically stable without any sign of infection at the 12-month follow-up. An average marginal bone loss of 0.25 ± 0.19 mm was found in the test group compared to 0.35 ± 0.23 mm in the control group (no statistically significant difference), while the percentage of bleeding sites was significantly higher in the control group (8.7% ± 13.1% vs 19.1% ± 19.8%; P = .035). Autoclave treatment of customized abutments seems to reduce the inflammatory response around subcrestally placed implants. [ABSTRACT FROM AUTHOR]

There has been an increase in the use of commercially available multi-ingredient preworkout supplements (MIPS); however, there are inconsistencies regarding the efficacy of MIPS in resistance-trained women. Purpose: To determine the effect of varying doses of MIPS compared with caffeine only (C) and a placebo (PL) on resistance-training performance in trained women. Methods: Ten women (21.5 [2.3] y) completed 1-repetition-maximum tests at baseline for leg press and bench press. A within-group, double-blind, and randomized design was used to assign supplement drinks (ie, PL, C, MIPS half scoop [MIPS-H], and MIPS full scoop [MIPS-F]). Repetitions to failure were assessed at 75% and 80% to 85% of 1-repetition maximum for bench and leg press, respectively. Total performance volume was calculated as load × sets × repetitions for each session. Data were analyzed using a 1-way repeated-measures analysis of variance and reported as means and SDs. Results: There were no differences in repetitions to failure for bench press (PL: 14.4 [3.2] repetitions, C: 14.4 [2.9] repetitions, MIPS-H: 14.2 [2.6] repetitions, MIPS-F: 15.1 [3.1] repetitions; P =.54) or leg press (PL: 13.9 [7.8] repetitions, C: 10.8 [5.9] repetitions, MIPS-H: 13.1 [7.1] repetitions, MIPS-F: 12.4 [10.7] repetitions; P =.44). Furthermore, there were no differences in total performance volume across supplements for bench press (PL: 911.2 [212.8] kg, C: 910.7 [205.5] kg, MIPS-H: 913.6 [249.3] kg, MIPS-F: 951.6 [289.6] kg; P =.39) or leg press (PL: 4318.4 [1633.6] kg, C: 3730.0 [1032.5] kg, MIPS-H: 4223.0 [1630.0] kg, MIPS-F: 4085.5 [2098.3] kg; P =.34). Conclusions: Overall, our findings suggest that caffeine and MIPS do not provide ergogenic benefits for resistance-trained women in delaying muscular failure. [ABSTRACT FROM AUTHOR]

Nitrate ( NO 3 − ) has properties that can improve muscle function, leading to improvements in metabolic cost of exercise as well as enhance force production. Gymnastics is a whole-body sport, involving events that demand a high level of strength and fatigue resistance. However, the effect of NO 3 − supplementation on both upper- and lower-body function in gymnasts is unknown. This study examined the effect of acute beetroot juice (BRJ) supplementation on isokinetic strength and endurance of the upper- and lower-body in highly trained international-level male gymnasts. In a double-blind, randomized crossover design, 10 international-level male gymnasts completed two acute supplementation periods, consuming either 2 × 70 ml NO 3 − -rich (∼12.8 mmol/L of NO 3 − ) or NO 3 − -depleted (PLA) BRJ. Maximal strength of the upper-leg and upper-arm at 60°/s, 120°/s, 180°/s, and 300°/s, and muscular endurance (50 repeated isokinetic contractions at 180°/s) were assessed. Plasma NO 3 − (BRJ: 663 ± 164 μM, PLA: 89 ± 48 μM) and nitrite ( NO 2 − ) concentrations (BRJ: 410 ± 137 nmol/L, PLA: 125 ± 36 nmol/L) were elevated following BRJ compared to PLA (both p <.001). Maximal strength of knee and elbow extensors and flexors did not differ between supplements (p >.05 for all velocities). Similarly, fatigue index of knee and elbow extension and flexion was not different between supplements (all p >.05). Acute BRJ supplementation, containing ∼12.8 mmol/L of NO 3 − , increased plasma NO 3 − and NO 2 − concentrations, but did not enhance isokinetic strength or fatigue resistance of either upper or lower extremities in international-level male gymnasts. [ABSTRACT FROM AUTHOR]

Gingival recession treatment is one of the major clinical challenges in periodontics, and various surgical techniques have been proposed to correct it. Most of these techniques are suitable for isolated recession sites and involve harvesting an autogenous tissue graft, which increases patient morbidity and might result in inferior esthetics due to incision design. This study assessed the benefit of adding platelet-rich fibrin (PRF) to the vestibular incision subperiosteal tunneling approach (VISTA) in treating multiple gingival recession compared to using VISTA alone. A total of 41 teeth with Miller Class I and II defects were randomized in a split-mouth design. Multiple clinical parameters were tested, including the change in gingival thickness over time, keratinized tissue width, and gingival phenotype (using the transparency of a periodontal probe). Patient-centered outcomes were also assessed via visual analog scale. Multiple Miller Class I and II recessions in the maxilla can be effectively treated with VISTA. However, when used in conjunction with PRF, no significant differences were detected in any parameter. VISTA has been shown to be associated with a low level of postsurgical pain for patients and can be used for patients with high esthetic demands. [ABSTRACT FROM AUTHOR]

Introduction: The acute and isolated ingestion of sodium bicarbonate (NaHCO3) and caffeine (CAF) improves performance and delays fatigue in high-intensity tasks. However, it remains to be elucidated if the coingestion of both dietary supplements stimulates a summative ergogenic effect. This study aimed to examine the effect of the acute coingestion of NaHCO3 and CAF on repeated-sprint performance. Methods: Twenty-five trained participants (age: 23.3 [4.0] y; sex [female/male]: 12/13; body mass: 69.6 [12.5] kg) participated in a randomized, double-blind, placebo (PLA) -controlled, crossover study. Participants were assigned to 4 conditions: (1) NaHCO3 + CAF, (2) NaHCO3, (3) CAF, or (4) PLA. Thus, they ingested 0.3 g/kg of NaHCO3, 3 mg/kg of CAF, or PLA. Then, participants performed 4 Wingate tests (Wt), consisting of a 30-second all-out sprint against an individualized resisted load, interspersed by a 1.5-minute rest period between sprints. Results: Peak (Wpeak) and mean (Wmean) power output revealed a supplement and sprint interaction effect (P =.009 and P =.049, respectively). Compared with PLA, NaHCO3 + CAF and NaHCO3 increased Wpeak performance in Wt 3 (3%, P =.021) and Wt 4 (4.5%, P =.047), while NaHCO3 supplementation increased mean power performance in Wt 3 (4.2%, P =.001). In Wt 1, CAF increased Wpeak (3.2%, P =.054) and reduced time to Wpeak (−8.5%; P =.008). Plasma lactate showed a supplement plus sprint interaction (P <.001) when NaHCO3 was compared with CAF (13%, P =.031) and PLA (23%, P =.021). Conclusion: To summarize, although the isolated ingestion of CAF and NaHCO3 improved repeated-sprint performance, the coingestion of both supplements did not stimulate a synergic ergogenic effect. [ABSTRACT FROM AUTHOR]

Previous studies showed that collagen peptide supplementation along with resistance exercise enhance muscular recovery and function. Yet, the efficacy of collagen peptide supplementation in addition to standard nutritional practices in athletes remains unclear. Therefore, the objective of the study was to compare the effects of combined collagen peptide (20 g) and whey protein (25 g) supplementation with a similar daily protein dose (45 g) of whey protein alone on indices of muscle damage and recovery of muscular performance during eccentric exercise training. Young fit males participated in a 3-week training period involving unilateral eccentric exercises for the knee extensors. According to a double-blind, randomized, parallel-group design, before and after training, they received either whey protein (n = 11) or whey protein + collagen peptides (n = 11). Forty-eight hours after the first training session, maximal voluntary isometric and dynamic contraction of the knee extensors were transiently impaired by ∼10% (Ptime <.001) in whey protein and whey protein + collagen peptides, while creatine kinase levels were doubled in both groups (Ptime <.01). Furthermore, the training intervention improved countermovement jump performance and maximal voluntary dynamic contraction by respectively 8% and 10% (Ptime <.01) and increased serum procollagen type 1N-terminal peptide concentration by 10% (Ptime <.01). However, no differences were found for any of the outcomes between whey and whey protein + collagen peptides. In conclusion, substituting a portion of whey protein for collagen peptide, within a similar total protein dose, improved neither indices of eccentric muscle damage nor functional outcomes during eccentric training. [ABSTRACT FROM AUTHOR]

Context: Plantar intrinsic foot muscle strength training is difficult to master to a degree sufficient to elicit muscle hypertrophy in most individuals. It is possible that combining neuromuscular electrostimulation (NMES) and blood flow restriction (BFR) can elicit plantar intrinsic foot muscle hypertrophy regardless of the individual's technique. This study aimed to determine the effects of NMES training with BFR on acute muscle swelling in the abductor hallucis. Design: Randomized, controlled, single-blind trial design. Methods: Forty-eight participants were randomly allocated to the NMES + BFR, NMES, or Sham NMES + BFR groups. All participants received abductor hallucis NMES for 15 minutes. Participants in the NMES + BFR and Sham NMES + BFR groups received NMES with BFR. The intensity of NMES was the sensory threshold in the Sham NMES + BFR group. The cross-sectional area of the abductor hallucis was measured pretraining and posttraining using ultrasonography by a single investigator blinded to the participants' allocations. Results: After 15 minutes of training, the cross-sectional area of the abductor hallucis was significantly increased in the NMES + BFR (P<.001) and the Sham NMES + BFR (P = .004) groups. Moreover, the rate of increase was significantly higher in the NMES + BFR group than in the NMES or the Sham NMES + BFR groups (P<.001 and P = . 001, respectively). Conclusions: Since it is possible that the amount of muscle swelling immediately after training correlates with muscle hypertrophy when training is continued, the results of this study suggest that NMES training with BFR is a training method that can be expected to produce plantar intrinsic foot muscle hypertrophy. Further studies are needed to confirm the long-term effects of NMES training with BFR. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the effect of personalized sweat sodium replacement on drinking behavior, sodium and water balance, and thermophysiological responses during and after ultraendurance running in hot conditions. Methods: Nine participants (7 male, 2 female) completed two 5-hour treadmill runs (60% maximum oxygen uptake, 30°C ambient temperature), in a double-blind randomized crossover design, consuming sodium chloride (SODIUM) capsules to replace 100% of previously assessed losses or placebo (PLACEBO). Fluid was consumed ad libitum. Results: No effect of SODIUM was observed for ad libitum fluid intake or net fluid balance (P >.05). Plasma sodium concentration increased in both trials, but to a greater extent in SODIUM at 2.5 hours (mean [SD]: 4 [4] mmol·L−1 vs 1 [5] mmol·L−1; P <.05) and postexercise (4 [3] mmol·L−1 vs 1 [5] mmol·L−1; P <.05). Plasma volume change was not different between trials (P >.05) but was strongly correlated with sodium balance in SODIUM (r =.880, P <.01). No effect of sodium replacement was observed for heart rate, rectal temperature, thermal comfort, perceived exertion, or physiological strain index. During the 24 hours postexercise, ad libitum fluid intake was greater following SODIUM (2541 [711] mL vs 1998 [727] mL; P =.04), as was urinary sodium excretion (NaCl: 66 [35] mmol, Pl: 21 [12] mmol; P <.01). Conclusions: Personalized sweat sodium replacement during ultraendurance running in hot conditions, with ad libitum fluid intake, exacerbated the rise in plasma sodium concentration compared to no sodium replacement but did not substantially influence overall body-water balance or thermophysiological strain. A large sodium deficit incurred during exercise leads to substantial renal sodium conservation postexercise. [ABSTRACT FROM AUTHOR]

Guarana (GUA) seed extract, containing caffeine (CAF) and additional bioactive compounds, may positively affect mental performance, but evidence regarding exercise is limited. This investigation assessed acute GUA ingestion compared with CAF on endurance performance. Eleven endurance-trained noncyclists and cyclists (V ˙ O 2 peak = 49.7 ± 5.9, 60.4 ± 4.6 ml·kg·min−1) completed a double-blind, crossover experiment after ingesting (a) 100 mg CAF, (b) 500 mg GUA (containing 130 mg CAF), or (c) placebo (P) prior to 60-min fixed cycling workload (FIX) + 15-min time trial. Oxygen uptake, heart rate, respiratory exchange ratio, blood glucose, and lactate were not different (p ≥.052) during FIX. A significant interaction (p =.042) for perceived exertion was observed at 50-min FIX with lower rating (p =.023) for GUA versus CAF but not compared with P. Work accumulated over 15-min time trial was greater (p =.038) for GUA versus P due to higher early (1–11 min) work outputs. Work performance favored (effect size = 0.18; 95% confidence interval [0.003, 0.355], p =.046) GUA (241.4 ± 39.9 kJ) versus P (232.1 ± 46.6 kJ), but CAF (232.3 ± 43.9) was not different from GUA (effect size = 0.19; 95% confidence interval [−0.022, 0.410], p =.079) or P. Postexercise strength loss was not attenuated with GUA (−5.6 ± 8.5%) or CAF (−8.3 ± 9.4%) versus P (−10.3 ± 5.1%). Acute GUA ingestion improved work performance relative to P, but effects were trivial to small and unrelated to altered substrate oxidation or muscular strength. Ergogenicity may involve central mechanisms reducing perceived effort with GUA (containing 130 mg caffeine). Due to issues related to identical matching of dosage, whether GUA confers additional benefits beyond its CAF content cannot be determined at present. [ABSTRACT FROM AUTHOR]

The present randomized study investigated the effect of acute supplementation of 800 mg/kg of ketone monoester ingestion (KE) or placebo (PL) and 210 mg/kg of NaHCO3 co-ingestion on cycling performance of WorldTour cyclists during a road cycling stage simulation. Twenty-eight cyclists participated in the study (27.46 ± 4.32 years; 1.80 ± 0.06 m; 69.74 ± 6.36 kg). Performance, physiological, biochemical, and metabolism outcomes, gut discomfort, and effort perceived were assessed during a road cycling simulation composed of an 8-min time-trial (TT) performance + 30-s TT + 4.5 hr of outdoor cycling + a second 8-min TT + a second 30-s TT. Greater absolute and relative mean power during the first 8-min TT (F = 5.067, p =.033, η p 2 =.163 , F = 5.339, p =.029, η p 2 =.170 , respectively) was observed after KE than after PL (KE: 389 ± 34, PL: 378 ± 44 W, p =.002, d = 0.294 and KE: 5.60 ± 0.42, PL: 5.41 ± 0.44 W/kg, p =.001, d = 0.442). Additionally, greater concentration of β-hydroxybutyrate blood concentration (F = 42.195, p <.001, η p 2 =.619) was observed after KE than after PL during the first steps of the stage (e.g., after warm-up KE: 1.223 ± 0.642, PL: 0.044 ± 0.058 mM, p <.001, d = 2.589), although the concentrations returned to near baseline after 4.5 hr of outdoor cycling. Moreover, higher values of anion gap were observed (F = 2.333, p =.026, η p 2 =.080) after KE than after PL ingestion, after the warm-up and after the first 8-min and 30-s TT. Additionally, lower concentrations of HCO 3 − were reported in the KE condition after warm-up and after the first 8-min and 30-s TT. During the initial phase of the stage simulation, acute supplementation with KE + NaHCO3 co-ingestion enhanced 8-min TT cycling performance (3.1%) in WorldTour cyclists with a concomitant hyperketonaemia. [ABSTRACT FROM AUTHOR]

Purpose: To demonstrate a modified surgical approach for horizontal ridge augmentation that allows for safe manipulation and predictable management of the buccal plate and avoids creation of a secondary surgical site. Materials and Methods: This pilot randomized controlled clinical trial included 24 patients who required horizontal alveolar ridge augmentation. Patients were assigned to one of the three groups: Group A was treated with the buccal plate repositioning (BPR) technique and grafted with silica calcium phosphate nanocomposite (SCPC) graft, group B was similarly managed and grafted using demineralized freeze-dried bone allograft (DFDBA), and group C was augmented using mandibular ramus autogenous bone block graft (ABBG). The primary outcome was the coronal crest width, which was measured at 6 months using CBCT. Results: The BPR technique resulted in horizontal augmentation with a mean of 4.30 ± 0.94 mm for group A, showing no significant difference from either group B (4.98 ± 1.13 mm) or group C (3.68 ± 0.27 mm). All augmented ridges allowed for successful implant placement with good primary stability. Conclusions: The BPR technique resulted in horizontal bone gain in extremely narrow alveolar ridges. It allowed for implant placement in a vascular cancellous bed protected by intact cortical plate. Different types of bone grafts, whether alloplast or allograft, resulted in successful augmentation comparable to that gained from autogenous block grafting. [ABSTRACT FROM AUTHOR]

Context: Decreased muscle strength and balance in patients with functional ankle instability (FAI) can be effectively improved by ankle strength training. Low-load blood flow restriction (LL-BFR) training increases muscle size and strength, but there is limited evidence from studies on muscle strength and balance in FAI patients. Objective: To study the effects of LL-BFR training versus high-load training (HLT) on muscle strength and balance in FAI patients. Design: Randomized controlled trial. Participants: Forty-six young adults with a history of FAI. Interventions: Participants in the LL-BFR and HLT groups performed 4 sets (30 x 15 x 15 x 15) of ankle training at 20% to 40% of the one-repetition maximum and 70% to 85% one-repetition maximum, respectively, twice a week for 6 weeks. Main Outcome Measure(s): Plantar flexion, dorsiflexion, inversion, and eversion muscle strength, and the Y-balance test scores were assessed at baseline and after 3 and 6 weeks; the thickness of the tibialis anterior, triceps surae, and peroneus longus muscles were assessed at baseline and after 6 weeks. Results: Inversion, eversion, dorsiflexion, and plantar flexion muscle strength; tibialis anterior, triceps surae, and peroneus longus thickness; and Y-balance test scores were significantly increased in the LL-BFR group after 3 and 6 weeks compared with baseline (P < .05), with no significant difference between the LL-BFR and HLT groups after 6 weeks (P > .05). However, at the end of 3 weeks, eversion muscle strength and Y-balance test scores were significantly higher in the LL-BFR group than in the HLT group (P < .05). Conclusions: Over 6 weeks, LL-BFR training was as effective as HLT in improving ankle muscle strength, muscle thickness, and balance in FAI patients, but LL-BFR training improved the ankle eversion muscle strength and dynamic balance more than HLT did in the early stages of the intervention. This finding will provide a new intervention strategy for the clinical rehabilitation of FAI patients. [ABSTRACT FROM AUTHOR]

This study investigated the effects of an acute dose (900 mg) of New Zealand Blackcurrant (NZBC) extract on 5-km running performance, alongside associated physiological and metabolic responses. Sixteen trained male runners (age 26 ± 5 years, stature 173.4 ± 7.3 cm, body mass 73.7 ± 6.9 kg, maximal oxygen consumption [ V ˙ O 2 max ] 55.4 ± 6.1 ml·kg−1·min−1) ingested either capsules containing NZBC extract (3 × 300 mg CurraNZ, 315 mg anthocyanins) or a matched placebo (3 × 300 mg gluten-free flour) 2 hr before exercise in a double-blind, randomized, crossover design. Performance time, physiological, and metabolic responses were assessed in a 5-km time trial, preceded by 10-min exercise at the lactate threshold on a treadmill. NZBC extract did not alter the physiological or metabolic responses to exercise at the lactate threshold (oxygen uptake, respiratory exchange ratio, minute ventilation, carbohydrate oxidation, fat oxidation, heart rate, blood lactate, or rating of perceived exertion, p >.05). The 5-km time trial was completed in a faster time in the NZBC extract condition compared with placebo (NZBC: 1,308.96 ± 122.36 s, placebo: 1,346.33 ± 124.44, p =.001, d = −0.23, confidence interval range = [−0.46, 0.00 s]). No differences in physiological or metabolic responses were apparent between conditions for the 5-km time trial (p >.05). Ingesting 900 mg of NZBC extract as an acute dose improves performance in trained male runners without altering physiological or metabolic responses to exercise. Further research is needed to assess a wider range of possible mechanisms (e.g., cardiovascular function, metabolite profiles) to advance insight into improved performance following supplementation. [ABSTRACT FROM AUTHOR]

Previous observations demonstrate New Zealand blackcurrant (NZBC) extract to alter cardiovascular responses at rest without prior exercise. However, the prolonged effects of NZBC on blood pressure and heart rate variability following exercise are not known. Participants (n15 [five women], age: 31 ± 9 years, maximal oxygen uptake: 44 ± 9 ml·kg−1·min−1) undertook a control condition of 2 hr of lying supine rest. Subsequently, in a double-blind, placebo (PLA)-controlled, randomized crossover design participants completed 1 hr of treadmill exercise at 50% maximal oxygen uptake followed by 2-hr supine rest with blood pressure and heart rate variability measurement following a 7-day intake of NZBC and PLA. With NZBC, there was an increase in average fat oxidation (NZBC: 0.24 ± 0.11 vs. PLA: 0.17 ± 0.11 g/min, p =.005), and larger high-frequency relative power during the exercise (p =.037). In the 2-hr rest period, delta change for systolic pressure was larger with NZBC than PLA (Control vs. NZBC: −5.6 ± 6.4, Control vs. PLA: −3.5 ± 6.0 mmHg, p =.033) but was not different for diastolic or mean arterial pressure. There were no alterations in heart rate variabilities during the 2 hr following the exercise with NZBC. A 7-day intake of NZBC causes a larger postexercise hypotension response in young, physically active men and women following 1 hr of treadmill exercise at 50% maximal oxygen uptake. [ABSTRACT FROM AUTHOR]

Aging is associated with neurodegeneration and a loss of muscle function, especially in lower-limb muscles. While caffeine may augment muscle force generation through multiple effects on the central nervous system, no studies have yet compared the effects of caffeine on force-generating capacity between younger and older men, who might respond differently due to age-related changes in the structures on which caffeine acts. In a double-blind, controlled trial, 22 younger (25 ± 5 years) and 21 older (68 ± 6 years) men were tested for isometric plantarflexor torque on two separate days (2–7 days apart) before and 60 min after ingesting 3 mg/kg (∼2 cups of coffee) of caffeine or placebo. No effects of caffeine ingestion on peak torque or rate of torque development were detected in either older or younger men. Therefore, 3 mg/kg of caffeine may not acutely counteract age-related decreases in force capacity of the functionally important plantarflexor muscles. [ABSTRACT FROM AUTHOR]

Objective Our objective was to evaluate the quality of obstetrical ultrasound images obtained with coconut oil compared with commercial ultrasound gel and to assess patient acceptability. Study Design This was a randomized two-period crossover study in which 40 pregnant patients had standard biometry images obtained with both coconut oil and commercial ultrasound gel during their growth or anatomy ultrasound. All images were then rated by two blinded maternal–fetal medicine physicians on quality, resolution, and detail using a 0 to 100 scale. Contrasts obtained from linear mixed models were used to estimate the differences in image parameters between the agents. Participant experience was evaluated with an acceptability survey which included five items measured on a five-point Likert scale. Results Image quality, as rated by physicians, was found to be equivalent between commercial ultrasound gel and coconut oil. Additionally, there was not a statistically significant difference in image resolution or detail between the two coupling agents. The overall patient experience was significantly lower for commercial ultrasound gel when compared with coconut oil (mean difference = − 5.48, 95% confidence interval = [−6.89, −4.06]). Conclusion Ultrasound images collected with coconut oil as the coupling agent are equivalent in quality to those collected using commercial ultrasound gel. Patients also preferred the use of coconut oil during their ultrasound, making its use a possible way to improve the patient ultrasound experience. Coconut oil has the potential as an alternative coupling agent that could significantly increase access to ultrasound use in resource-limited settings. Key Points Coconut oil produces quality images during obstetrical ultrasounds. Patients prefer the use of coconut oil to standard ultrasound gel during obstetrical ultrasounds. Coconut oil is a coupling agent that could increase ultrasound use in resource-limited settings. [ABSTRACT FROM AUTHOR]

Background: This study aims to investigate the short-term effects and safety of adjunct Suxiao Jiuxin Pills (SJPs) on conventional therapy in chronic coronary syndrome (CCS) patients who are intolerant to the adverse effects of long-acting nitrates. Methods: This was a multicenter, randomized, double-blind, placebo-controlled trial. A total of 174 CCS participants from eight clinical study centers in China were included in the modified intention-to-treat analyses. Participants with CCS and intolerance to the adverse effects of long-acting nitrates were recruited and randomized to either the SJPs or the placebo group for a duration of 4 weeks. Results: Compared to the placebo group, the SJPs group showed a significant improvement in the efficacy rate after 4 weeks (OR = 2.43, 95% CI = 1.32 to 4.47, P = 0.004). Besides, individuals without a history of alcohol consumption showed a greater improvement in the SAQ summary score compared to those with a history of alcohol consumption. Conclusion: Adjunctive SJPs enhance the effectiveness of short-term conventional anti-angina treatment for patients with CCS who experience intolerance to long-acting nitrates, without significant adverse effects during application. Trial registration: Chinese Clinical Trials Registry Platform, ChiCTR2100050066. Registered 16 August 2021, https://www.chictr.org.cn/showproj.html?proj=131470. [ABSTRACT FROM AUTHOR]

Background: Toothbrushing is the most commonly used method to physically remove dental plaque. However, there are many areas of the mouth that are difficult to reach with a toothbrush. The type of toothbrush is a critical factor influencing the effectiveness of oral care. The purpose of the study was to evaluate a toothbrush with a thin head, slender-neck and super-tapered bristles to target hard-to-reach areas in the oral cavity for reducing dental plaque and gingivitis. Methods: This crossover study included 58 adults aged 20 years and older. All participants were randomly assigned to use test and control toothbrushes (the latter had a normal head and round bristles) for two 4-week phases. Participants brushed their teeth twice daily in their habitual manner. At the start and end of each phase the Silness-Lӧe plaque index (PI), Lӧe -Silness gingival index (GI) and bleeding-on-probing index (BOP) were assessed and performed plaque fluorescence tests using quantitative light-induced fluorescence technology. Results: After using the test toothbrush, PI, GI and BOP decreased by 25%, 30% and 48%, respectively (P < 0.05). For the rearmost molars, PI, GI and BOP decreased by 18%, 26% and 47%, respectively (P < 0.05). For the implants, GI and BOP decreased by 31% and 57%, respectively (P < 0.05). The plaque fluorescence tests indicated that after using the test toothbrush, the dental plaque area for the anterior teeth and the simple plaque score for the rearmost molars decreased by 25% (P < 0.05) and 14% (P = 0.527), respectively. Conclusions: The test toothbrush was markedly better than the control toothbrush at reducing dental plaque and gingivitis. In particular, the test toothbrush produced an excellent reduction in dental plaque and gingivitis for the rearmost molars and the implants. Trial registration: KCT0009669, retrospectively registered 02/08/2024. [ABSTRACT FROM AUTHOR]

Aim: To assess the effectiveness of intraoperative lidocaine in reducing the incidence of post‐laparoscopic shoulder pain (PLSP) after gynecologic laparoscopy. Methods: Patients undergoing total laparoscopic hysterectomy were randomly divided into two groups: the lidocaine group, receiving an initial intravenous dose of lidocaine (1.5 mg/kg) before anesthesia induction, followed by a continuous infusion at 2 mg/kg/h, and the placebo group, receiving saline. The primary endpoint was the determination of PLSP incidence over a 72‐h period post‐surgery. Secondary endpoints included a comprehensive evaluation of pain intensity, as measured by the Numeric Rating Scale (NRS), for shoulder, abdominal, and incisional pain within a 72‐hour period postoperatively. Additionally, the endpoints involved the assessment of Lofencodeine or Parexib Sodium usage frequency, incidence of nausea and vomiting, duration of anesthesia and surgical procedure, as well as the duration of hospital stay. Results: Our study did not demonstrate any significant benefit in the incidence of PLSP during the postoperative period. PLSP occurred in 14 out of 41 patients (34.1%) in the lidocaine group, compared with 15 out of 41 patients (36.6%) in the placebo group (p = 0.817). Intravenous lidocaine reduced abdominal pain scores and decreased the need for postoperative analgesics within 72 h after surgery. No significant differences were found in incisional and shoulder pain intensity, nausea and vomiting rates, or hospitalization duration between groups. Conclusions: The infusion of lidocaine did not yield a reduction in the incidence or severity of PLSP in patients undergoing laparoscopic total hysterectomy. [ABSTRACT FROM AUTHOR]

Background and Aims: Potentially harmful polypharmacy is a growing public health concern. This article aims to evaluate the effectiveness of a structured Team Approach to Polypharmacy Evaluation and Reduction (AusTAPER) framework. Methods: We recruited patients at metropolitan hospitals for a randomised controlled trial with 12 months of follow‐up. The intervention included a comprehensive medicines history, multidisciplinary meeting and medicines review prior to discharge, with engagement with the participants' general practitioner extending after discharge. The primary outcome was the change in the number of regular medicines used at 12 months from baseline. A cost consequence was performed to estimate costs per participant during the study period. Results: There were 98 participants enrolled in the study. The number of regular medicines was significantly reduced from baseline in both groups (−1.7 ± 4.3, t = 2.38, P = 0.02 in the control group vs −2.7 ± 3.6, t = 4.48, P = 0.0001 in the intervention group), although there was no statistical difference detected between the two groups (1.0 (SE 0.9), t = 1.03, P = 0.31). The intervention was estimated to cost AU$644.17 and was associated with cost savings of AU$552.53 per participant in sustained reduced medicines cost. Health outcomes and healthcare costs were similar in both groups. Discussion: Medicines were significantly reduced in both groups, with a trend to a larger reduction in medicines at 12 months in the intervention group. The intervention cost was approximately offset by sustained reduced medicines cost, although these results should be regarded cautiously because of the absence of significance in the differences in outcomes between groups. [ABSTRACT FROM AUTHOR]

This randomized, placebo-controlled, double-blind, parallel trial investigated whether generally healthy adult, nonelite runners would have a greater time-to-exhaustion during submaximal treadmill running with probiotic versus placebo supplementation. It was hypothesized that the probiotic would impact training progression by reducing gastrointestinal (GI) and cold/flu symptoms. Participants who typically ran ≥24 km/week, ran or cross-trained 3–5 days per week, and had a maximal oxygen intake (V̇O2 max) in the 60–85th percentile were enrolled. V̇O2 max was used to establish individualized workload settings (85% of V̇O2 max) for the submaximal endurance tests at baseline and following 6 weeks of supplementation with a probiotic (Lactobacillus helveticus Lafti L10, 5×109 CFU/capsule/day) or placebo. Participants self-reported GI and cold/flu symptoms and physical activity via daily and weekly questionnaires. Outcomes were tested using a linear model to determine if mean response values adjusted for baseline differed between groups. Twenty-eight participants (n = 14/group), aged 25 ± 5 years (mean ± SD) with a body mass index of 23 ± 3 kg/m2, completed the study. At the final visit the probiotic group had a lower time-to-exhaustion versus the placebo group (P = 0.01) due to an increase in time-to-exhaustion with the placebo (1344 ± 188 to 1565 ± 219 s, P = 0.01) with no change with the probiotic (1655 ± 230 to 1547 ± 215 s, P = 0.23). During the intervention, the probiotic group completed fewer aerobic training sessions per week (P = 0.02) and trained at a lower intensity (P = 0.007) versus the placebo group. Few GI and cold/flu symptoms were reported with no differences between groups. Time-to-exhaustion increased in the placebo group, possibly due to differences in training habits. [ABSTRACT FROM AUTHOR]

The effects of exogenous ketones on appetite and food intake remain elusive, especially for people with type 2 diabetes (T2D). This study aimed to determine whether acute ingestion of an oral ketone monoester supplement (KME) affected appetite sensations, prospective food consumption and intake in T2D. Results showed that acute KME ingestion did not significantly alter appetite scores. However, there was a tendency for lower energy intake during an ad libitum meal 3 h following ketone ingestion compared to non-energetic placebo. Further research is warranted to understand the long-term effects of exogenous ketones for energy and macronutrient intake in T2D. [ABSTRACT FROM AUTHOR]

Background: The pericapsular nerve group (PENG) block offers effective postoperative pain relief following hip fracture surgery. This research investigated three doses of bupivacaine, all administered in the same total volume, for performing ultrasound-guided PENG blocks during hip fracture procedures. Methods: This randomized, double-blinded clinical trial was conducted on 135 patients aged between 18 and 70 years of both sexes who underwent hip fracture surgeries. Participants were randomized into three groups (n = 45). Ultrasound-guided PENG block was applied, the groups received 20 mL of local anesthetics. The first group received 0.5% bupivacaine, the second group received 0.375% bupivacaine, and the third group received 0.25% bupivacaine. The following parameters were recorded: onset of sensory block, resting NRS after passively raising the limb by 15° half an hour post-procedure, quality of recovery score (QoR-15) at 24 h postoperative. Results: The 0.25% bupivacaine group exhibited a longer sensory block onset than the other groups (p ≤.05). Significant differences were demonstrated between the groups regarding the time to 1st analgesia (p =.033) and total morphine consumption (p =.025). NRS at baseline and T30 post-block did not show significant differences between the studied groups. No significant differences were detected postoperatively in rest and dynamic NRS (p ≤.05). Patient satisfaction, QoR-15 score, and ease of spinal positioning did not differ between the groups. Conclusion: Compared to 0.25% bupivacaine, PENG block with 0.5% and 0.375% bupivacaine provided a rapid onset sensory block, delayed first analgesic requirements, and reduced total morphine consumption after hip surgeries. Protocol Registration: The trial was registered at the clinicaltrials.gov with study number (Trial ID: NCT05788458). [ABSTRACT FROM AUTHOR]

Background: Patients diagnosed with gynecological cancers often face a range of complications that can impact their quality of life and increase their anxiety. Nursing models combined with mobile phone applications have the potential to improve outcomes for these patients. This study aimed to assess the impact of a continuous care model utilizing a smartphone application on quality of life and anxiety levels among gynecologic cancer patients. Methods: This study involved two phases: (1) mobile App development and (2) implementation of the intervention. The two-group randomized controlled trial included 70 participants with gynecological cancers referred to medical centers affiliated with Shahrekord University of Medical Sciences in 2023. The participants were randomized into control or intervention groups (n = 35 per group). Finally, 68 patients completed the trial. The intervention group received an 8-week intervention incorporating the continuous care model, whereas the control group received routine care (the standard support provided by nurses both during and after hospitalization). The participants completed the Spielberger state-trait anxiety and quality of life (QLQ-C30) questionnaires before, immediately after, and two months after the intervention. The data were analyzed via the chi-square test, independent samples t test, analysis of covariance, and repeated-measures ANOVA. Results: There were no significant differences in the baseline data between the two groups. However, after the intervention, the intervention group reported a significant increase in quality of life, with mean scores rising from 68.90 ± 17.50 to 73.78 ± 16.79 immediately after the intervention and to 80.61 ± 9.90 at the two-month follow-up. In contrast, the control group showed no significant improvement. Additionally, state anxiety significantly decreased in the intervention group from 51.64 ± 14.97 to 40.20 ± 11.70 at the follow-up, and trait anxiety scores in the intervention group decreased significantly from 49.91 ± 14.96 to 39.82 ± 10.28 at the follow-up, whereas the scores of the control group worsened. Conclusion: The intervention improved quality of life and reduced anxiety in patients with gynecological cancers. Given the scant attention given to mobile application-based follow-up in gynecologic cancer patients in previous studies, this approach can be incorporated into routine care to support patients, and it is recommended for nurses, health care providers, and physicians. Trial registration: The study was registered as a randomized controlled trial in the Clinical Trial Registration Center of Iran. Registration Date: 2024-02-14, Registration Number: IRCT20231107059977N1. [ABSTRACT FROM AUTHOR]

Background: Few studies have evaluated the effectiveness of family functional care interventions among stroke caregiver dyads. This study aimed to examine the effect of a nurse‐led therapeutic conversation intervention on resilience, family function, self‐efficacy in managing the disease, and quality of life (QoL) in stroke family caregiver dyads. Aims: This study aimed to examine the effect of a nurse‐led therapeutic conversation intervention on resilience, family function, self‐efficacy in managing the disease, and QoL in stroke–family caregiver dyads. Design: This study was a single‐blind (evaluator) randomized controlled trial. The planned execution time was from August 2021 to December 2022, in the rehabilitation ward of a medical university hospital. Methods: A total of 82 dyads were included in this analysis. Dyads randomized to the intervention group received nurse‐led therapeutic conversations intervention one at four weeks after the patient's hospitalization for a stroke. The family caregiver dyads of stroke survivors in the control group received routine care. An effectiveness analysis that included patients' resilience, self‐efficacy, and patient–family caregiver dyads' family function and QoL was conducted at one month. We used the CONSORT Checklist for reporting parallel group randomized trials in this study. Results: The patients in the intervention group showed improvement in resilience and self‐efficacy after one month. Furthermore, the effects on resilience (Cohen's d = 0.49) and self‐efficacy (Cohen's d = 0.46) were significantly higher than in the control group. Family functioning was significantly higher in patient–family caregiver dyads in the intervention group than in the control group (Cohen's d = 0.55; Cohen's d = 0.50). However, no significant difference in QoL was found between patients and caregivers in either group. Conclusions: The intervention was effective in promoting family functioning and can also promote patient resilience and self‐efficacy in disease management. However, the intervention did not have a significant effect on the QoL of patient–family caregiver dyads. Summary statement: What is already known about this topic? Many interventional care treatments ignore the important psychological factors involved in caring for patients with stroke.Family nursing actions through conversations between nurses and patients/families are helpful for families dealing with the challenges and complex experiences of a patient's illness. What this paper adds? The present study demonstrated that a nurse‐led therapeutic conversation intervention could promote family functioning among patients and family caregivers.Nurse‐led therapeutic interventions can also promote patients' resilience and self‐efficacy in managing the disease.However, the therapeutic conversation intervention did not have a significant effect on the quality of life of the patient–family caregiver dyads. Implications of this study It is recommended to corroborate a nurse‐led therapeutic conversation intervention as a strength‐oriented family intervention in stroke rehabilitation practice.Nurses can identify the care requirements of patients and their family caregivers through therapeutic conversations and offer personalized care solutions.Nurse‐led therapeutic conversation interventions can be implemented in patient empowerment strategies, emphasizing its effectiveness in boosting patient resilience and self‐efficacy in disease management. [ABSTRACT FROM AUTHOR]

To evaluate Tonsitin (10% DL -lactic acid) safety, tolerability, and efficacy, as a treatment for recurrent tonsillitis (RT) in children. This is a clinical prospective, randomized, double blind pilot study, to evaluate the safety, tolerability and efficacy of Tonsitin in healthy children with RT. Safety evaluated in terms of adverse events (AEs), tolerability in terms of compliance, and efficacy in terms of tonsils' size and frequency of tonsillitis, and quality of life. The study included 51 children. The treatment regimen was tolerable among the participants. Six children experienced AEs, but mostly mild. Tonsil size declined in both groups, but these results did not reach statistical significance. Tonsillitis episodes' frequencies were random and not significant. Tonsitin treatment was found to be feasible in the clinical setup and was well tolerated, and appears to be safe. Study efficacy results did not reach statistical significance. [ABSTRACT FROM AUTHOR]

Introduction: Metabolic flexibility (MetF), defined as the ability to switch between fat and glucose oxidation, is increasingly recognised as a critical marker for assessing responses to dietary interventions. Previously, we showed that the consumption of multifibre bread improved insulin sensitivity and reduced low‐density lipoprotein cholesterol (LDLc) levels in overweight and obese individuals. As a secondary objective, we aimed to explore whether our intervention could also improve MetF. Methods: In this study, 39 subjects at cardiometabolic risk participated in a double‐blind, randomised, crossover trial lasting 8 weeks, repeated twice. During each phase, participants consumed either 150 g of standard bread daily or bread enriched with a mixture of seven dietary fibres. MetF response was assessed using a mixed‐meal tolerance test (MMTT), analysing changes in respiratory quotient (∆RQ) measured using indirect calorimetry. Results: Although there were no significant differences in ∆RQ changes induced by dietary fibre between the two diets, these changes were positively correlated with postprandial triglyceride excursion (∆TG) at baseline. Subgroup analysis of baseline fasting and postprandial plasma metabolites was conducted to characterise MetF responders. These responders exhibited higher baseline fasting LDLc levels and greater post‐MMTT ∆TG. Conclusion: In conclusion, although dietary fibres did not directly impact MetF in this study, our findings highlight potential determinants of MetF response, warranting further investigation in dedicated future interventions. Highlights: The term 'metabolic flexibility' (MetF) was initially used to describe the ability of helminths to generate energy through either aerobic respiration or anaerobic respiration, enabling them to adapt to environmental changes. This concept was later applied to human metabolism, emphasising the body's capacity to switch between different energy sources, such as carbohydrates and fats, based on energy requirements.MetF has been studied in the context of transitions between fasting and fed states, or in response to insulin stimulation. It refers to the body's ability to adapt its energy utilisation in response to changing metabolic demands.Research has shown that insulin resistance, often linked to type 2 diabetes and obesity, may be associated with reduced MetF, characterised by altered patterns of carbohydrate and fat oxidation. [ABSTRACT FROM AUTHOR]

Objective: Initiating urate‐lowering therapy (ULT) in gout can precipitate arthritis flares. There have been limited comparisons of flare risk during the initiation and escalation of allopurinol and febuxostat, administered as a treat‐to‐target strategy with optimal anti‐inflammatory prophylaxis. Methods: This was a post‐hoc analysis of a 72‐week randomized, double‐blind, placebo‐controlled, noninferiority trial comparing the efficacy of allopurinol and febuxostat. For this analysis, the occurrence of flares was examined during weeks 0 to 24 when ULT was initiated and titrated to a serum urate (sUA) goal of less than 6 mg/dl (<5 mg/dl if tophi). Flares were assessed at regular intervals through structured participant interviews. Predictors of flare, including treatment assignment, were examined using multivariable Cox proportional hazards regression. Results: Study participants (n = 940) were predominantly male (98.4%) and had a mean age of 62.1 years with approximately equal proportions receiving allopurinol or febuxostat. Mean baseline sUA was 8.5 mg/dl and all participants received anti‐inflammatory prophylaxis (90% colchicine). In a multivariable model, there were no significant associations of ULT treatment (hazard ratio [HR] 1.17; febuxostat vs allopurinol), ULT‐dose escalation (HR 1.18 vs no escalation), prophylaxis type, or individual comorbidity with flare and no evidence of ULT‐dose escalation interaction. Factors independently associated with flare risk during ULT initiation/escalation included younger age, higher baseline sUA, and absence of tophi. Conclusion: These results demonstrate that gout flare risk during the initiation and titration of allopurinol is similar to febuxostat when these agents are administered according to a treat‐to‐target strategy using gradual ULT‐dose titration and best practice gout flare prophylaxis. [ABSTRACT FROM AUTHOR]

Objective: The 48‐week, phase 2 SLEek study (NCT03978520) evaluated the efficacy and safety of upadacitinib (JAK inhibitor) and elsubrutinib (BTK inhibitor) alone or in combination (ABBV‐599) in adults with moderately to severely active systemic lupus erythematosus (SLE). Methods: Patients were randomized 1:1:1:1:1 to elsubrutinib 60 mg and upadacitinib 30 mg once daily (ABBV‐599 high dose), elsubrutinib 60 mg and upadacitinib 15 mg once daily (ABBV‐599 low dose), elsubrutinib 60 mg once daily (QD), upadacitinib 30 mg QD, or placebo QD. The primary endpoint was the proportion of patients achieving both Systemic Lupus Erythematosus Responder Index 4 (SRI‐4) and glucocorticoid dose ≤10 mg QD at week 24. Additional assessments through week 48 included British Isles Lupus Assessment Group‐Based Composite Lupus Assessment (BICLA) and Lupus Low Disease Activity State (LLDAS) responses, number of flares, time to first flare, and adverse events. Results: The study enrolled 341 patients. The ABBV‐599 low dose and elsubrutinib arms were discontinued after a planned interim analysis showed lack of efficacy (no safety concerns). More patients achieved the primary endpoint with upadacitinib (54.8%; P = 0.028) and ABBV‐599 high dose (48.5%; P = 0.081) versus placebo (37.3%). SRI‐4, BICLA, and LLDAS response rates were higher for both upadacitinib and ABBV‐599 high dose versus placebo at weeks 24 and 48. Flares were reduced, and time to first flare through week 48 was substantially delayed with both upadacitinib and ABBV‐599 high dose versus placebo. No new safety signals were observed beyond those previously reported for upadacitinib or elsubrutinib. Conclusion: Upadacitinib 30 mg alone or in combination with elsubrutinib (ABBV‐599 high dose) demonstrated significant improvements in SLE disease activity and reduced flares and were well tolerated through 48 weeks. [ABSTRACT FROM AUTHOR]

Context: Forward shoulder posture (FSP) is a risk factor for shoulder pathology. Manual therapists often use myofascial release (MFR) to elongate restricted pectoral fascia to reduce FSP and improve shoulder function; however, the effects of this treatment approach remain anecdotal. Objective: Determine the acute effects of 4-min of MFR, compared to a soft-touch control (CON), to the pectoral fascia on: 1) FSP, 2) shoulder horizontal abduction ROM (HA-ROM), and 3) muscle excitation of the trapezius (upper, middle, lower [UT, MT, LT]) and pectoralis major (PEC). Methods: Fifty-nine right-handed participants (27 ± 9 years, 30 female) with FSP, but otherwise asymptomatic shoulders participated in a randomized crossover clinical trial by attending two experimental sessions: one MFR and one CON treatment, each administered by a Registered Massage Therapist. FSP, HA-ROM, and muscle excitation during a reaching task, were measured before and after each treatment. Results: There was a significant interaction between treatment and time for FSP (p =.018, ηp =.093) with FSP decreasing from PRE MFR (128 ± 19 mm) to POST MFR (123 ± 19 mm; p <.001, ηp =.420) and PRE CON (126 ± 19 mm) to POST CON (124 ± 18 mm; p <.001, ηp =.191) interventions. There were no significant differences in HA-ROM or muscle excitation. Conclusion: Four minutes of MFR or CON to the pectoral fascia acutely reduces FSP. [ABSTRACT FROM AUTHOR]

Objective: This study investigated the effect of neuromuscular electrical stimulation on the frontal ankle motor control in individuals with chronic ankle instability during drop landing. Design: This was a randomized, controlled, double-blind trial. Thirtysix individuals with chronic ankle instability were randomly assigned to each group. Participants received 6-wk neuromuscular electrical stimulation intervention and sham stimulation in the neuromuscular electrical stimulation and control groups, respectively. Data were collected at week0 and week6. A mixed-effects model and analysis of covariance were employed to investigate the between-group differences in continuous and discrete outcome variables at week6, with the outcome variables at week0 as covariates. Results: Compared to control group, neuromuscular electrical stimulation group exhibited a 2.66° (2.45, 2.86) reduction in frontal ankle inversion angle, a 47.41°/sec (−16.05, −78.77) decrease in peak ankle inversion angular velocity, and a 0.43 Nm/kg (0.18, 0.68) increase in peak ankle eversion moment during drop landing at week6. Conclusions: Applying 6-wk neuromuscular electrical stimulation to the fibularis longus resulted in decreased ankle inversion angle and ankle inversion angular velocity and increased peak ankle eversion moment during drop landing. Consequently, neuromuscular electrical stimulation could be considered an effective modality for individuals with chronic ankle instability to enhance the frontal ankle movement patterns and overall ankle motor control. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to assess the impact of combining transcranial direct current stimulation with end-effector robot-assisted treatment on upper limb function, spasticity, and hand dexterity in chronic stroke patients. Design: This was a prospective, double-blind randomized trial with 20 equally allocated stroke patients. The experimental group received dual transcranial direct current stimulation (anode over affected M1, cathode over contralateral M1) alongside robot-assisted treatment, while the control group received sham transcranial direct current stimulation with the same electrode placement + robot-assisted treatment. Each patient underwent 20 combined transcranial direct current stimulation and robot-assisted treatment sessions. The primary outcome measure was the Fugl-Meyer Upper Limb motor score, with secondary outcomes including AMADEO kinematic measures, Action Research Arm Test, and Functional Independence Measure. Assessments were conducted at baseline, after rehabilitation, and 3 mos later. Results: Combining bilateral transcranial direct current stimulation with robot-assisted treatment did not yield additional improvements in Fugl Meyer Upper Limb motor score, Functional Independence Measure, or Action Research Arm Test scores among stroke patients. However, the real transcranial direct current stimulation group showed enhanced finger flexion in the affected hand based on AMADEO kinematic measures. Conclusions: The addition of transcranial direct current stimulation to robot-assisted treatment did not result in significant overall functional improvements in chronic stroke patients. However, a benefit was observed in finger flexion of the affected hand. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to assess the effect of mechanical ventilation based on predicted body weight (PBW) and driving pressure (DP) as directed in patients without acute respiratory distress syndrome (ARDS). Design: Experimental, single-blind design with pretest-posttest control group design to assess the effect of using PBW and DP as a guide in regulating the amount of tidal volume and airway pressure in mechanically ventilated patients without ARDS. Setting: We conducted this study in the Intensive Care Unit (ICU) at Dr. Wahidin Sudirohusodo General Hospital, Makassar, from November 2023 to March 2024. Patients and participants: Patients with respiratory failure who were admitted to the ICU of Dr. Wahidin Sudirohusodo General Hospital, Makassar. Intervention: Patients in the PBW group were given a tidal volume setting of 8 ml/kg PBW, adjusted to the lowest positive end-expiratory pressure (PEEP) with the largest lung compliance target, while the DP group did the same thing and adjusted the tidal volume regarding the driving pressure target. The oxygen partial pressure (pO2), carbon dioxide partial pressure (pCO2), oxygen partial pressure to fractional inspired oxygen ratio (P/F ratio), mechanical power, and ventilatory ratio were assessed at the first hour and 24th hour. Measurement and results: Thirty-two patients were divided into two groups, 16 patients each, recruited from November 2023 to March 2024. There was a significant difference in the P/F ratio in the DP group compared to the PBW group after 24 hours (p<0.001 vs p=0.190). Similarly, pCO2 after 24 hours significantly differed between the DP group (p=0.001) and the PBW group (p=0.658). Regarding mechanical power, the two groups had no significant difference (10.92±2.51 vs 11.68±1.21 Joules/min, p=0.284). The PBW group had a wider range of mechanical power values (range 8.4 J/min) than the DP group (range 4.6 J/min), suggesting the DP group had more consistent mechanical power magnitude. Conclusion: Mechanical ventilation guided by DP can improve oxygenation and ventilation outcomes. Even though both the PBW and DP methods resulted in similar mechanical power levels, the DP-guided approach provided more stable and predictable mechanical power values. This stability can benefit patient management in the ICU, as it suggests a reduced risk of lung injury and potentially better overall outcomes for patients receiving mechanical ventilation. [ABSTRACT FROM AUTHOR]

Background: The goal of post-stroke early rehabilitation is to regain ambulation, standing and balance. Objective: The purpose of this study was to investigate the effects of vestibular and somatosensory rehabilitation in addition to early rehabilitation on balance in patients with early subacute stroke. Design and setting: A randomized controlled trial was conducted at a university hospital. Methods: The study was included 52 hemiplegic hospitalized early suacute stroke patients. The experimental group (n: 30), was applied with vestibular and somatosensorial rehabilitation together with early rehabilitation. Vestibular exercises, included Cawthorne-Cooksey exercises, stimulate the vestibulo-ocular and vestibulo-spinal reflex. Somatosensory exercises, which included Frenkel exercises, stimulate the sensory proprioception and somatosensory systems. The control group (n: 22) patients with early subacute stroke were treated with the early rehabilitation program only. The balance parameters of the patients were evaluated with the Korebalance System, Functional Reach Test, Postural Assessment Scale for Stroke, and Functional Ambulation Scale. Results: The mean age of the patients was 67.32 ± 9.46 years, and the mean number of days that had passed since the stroke occurred was 17.90 ± 7.26. In calculating the balance scores, statistically significant differences were observed in the experimental and control groups, with a statistically greater improvement in the rehabilitation group. Statistically significant differences were determined between the groups in respect of the balance scores. Conclusions: Based on these findings, the use of vestibular and somatosensory rehabilitation can be recommended for better functioning of the compensatory mechanism of early subacute-stroke hemiplegic patients in early ambulation, and this can lead to considerably improved standing and dynamic upper and lower body balance. [ABSTRACT FROM AUTHOR]

Introduction: Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED®) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of the necessary tools. Methods: We conducted a single-blinded, randomized controlled non-inferiority trial including 61 patients at two hospitals in Kisumu, Kenya, to validate Chloe SED® for administration of PCB during MVA. PCB administered with Chloe SED® was compared to PCB administered with a standard spinal needle. Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs--three with the Chloe SED® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01 (https://ctr.pharmacyboardkenya.org/applications/index/protocol_no: RUNDVC8xOS8wMy8wMQ__/filter:/investigator:/sites:/pages:5/start_date:/end_ date:/disease_condition:/users:/ercs:/stages). An intention-to-treat analysis was completed. The primary outcome was the non-inferiority of the pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included the non-inferiority of the pain score at four other time points and patient satisfaction. Results: Chloe SED® showed non-inferiority of the primary outcome with a mean pain score during evacuation of 3.8 [90% confidence interval (CI): 3.1-4.6] compared with the spinal needle at 4.1 (90% CI: 3.5-4.7). Non-inferiority of the pain score was shown at all time points. Most patients expressed a desire for the continued use of the device toadministerPCBforMVA.Noadverse eventswere noted. Conclusion: In summary, the Chloe SED® appears non-inferior to the spinal needle and desirable for the administration of PCB during MVA. [ABSTRACT FROM AUTHOR]

Background: Before every sporting event, almost all athletes engage in a routine practice of warming up to prepare the body for peak performance. There has been a surge in popularity within the athletic world around the use of percussive massage therapy (PMT). Objectives: The objectives of this study were to see if using percussive massage therapy, foam rolling (FR), and hamstring stretching (HStr) as part of a warm-up routine had any acute effects on flexibility, jumping performance, and range of motion in junior athletes, and if so, whether there was a significant difference in the acute effects of these treatment methods. Methods: Thirty-nine junior athletes with at least 3 years of experience, male gender, age range above 17, seated flexion test < 40 cm, and a willingness to participate were all considered for admittance. Participants were randomly divided into three groups. Before and after the treatment, the seated flexion test, vertical jump test, active SLR, and active knee extension were measured. Results: The study found significant improvement in all three groups when comparing them within the groups in the sit and reach test (PMT p < 0.001, FR p = 0.002, and HStr p = 0.001), active SLR (PMT p < 0.001, FR p < 0.001, and HStr p = 0.001), active knee extension (PMT p < 0.001, FR p = 0.002, and HStr p = 0.004), and vertical jump test (PMT p < 0.001, FR p = 0.011, and HStr (p < 0.001). Comparisons between groups showed significant differences among PMT vs. FR (p = 0.041) in vertical jump height and PMT vs. HStr (p = 0.034) in active SLR. Conclusion: We detected a notable disparity in hamstring flexibility between the PMT and FR groups, as well as in vertical jump height between the PMT and HStr groups. However, there was no apparent alteration in active knee extension in all three groups. [ABSTRACT FROM AUTHOR]

Background: Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor and non-motor symptoms that can impact daily activities. Objectives: Activity-based interventions, particularly when combined with motivational strategies, may enhance upper extremity function and participation in people with PD. Methods: This study will include forty-five patients with PD aged 35 to 85 years, categorized as stages I to III according to the Hoehn and Yahr Scale. Patients will be recruited from neurological and rehabilitation centers and randomly assigned to one of three intervention groups: Activity-based interventions with motivational strategy, activity-based interventions without motivational strategy, and conventional interventions. All participants will undergo a 24-session intervention, three times a week. The study will assess various outcomes at multiple time points, including baseline, session 10, session 18, post-intervention (week 9), and follow-up (week 17). Primary outcome measures will focus on motor control of the upper extremity and participation, while secondary outcome measures will include cognitive function and quality of life. Results: This proposed randomized controlled trial (RCT) aims to investigate the potential beneficial effects of activity-based interventions, combined with motivational strategies, on upper extremity function and participation in activities of daily living (ADLs) for individuals with PD. Conclusions: The expected outcome of this study is to provide valuable insights that can assist occupational therapists in making informed decisions regarding intervention plans for people with PD. [ABSTRACT FROM AUTHOR]

Background: Chest physiotherapy for airway clearance is not recommended in children hospitalized with bronchiolitis. The updated Cochrane meta-analysis suggests that slow expiratory techniques could slightly improve clinical severity, but the evidence certainty is low and the clinical significance of this change is unknown. We investigated whether the prolonged slow expiration technique (PSET) would impact the 24-h food intake of these children. Methods: We conducted a two-arm double-blind randomized controlled trial. Hospitalized children aged from 1 to 12 months, bottle-fed or diversified and referred for airway clearance were included. Both groups received upper airway clearance at inclusion and standard treatments. The experimental group received PSET including rhinopharyngeal unclogging and targeted unprovoked cough. The primary outcome was the 24-h food intake. Clinical severity, vomit episodes and sleep quality were also recorded. An ordinary least squares linear regression for quantitative variables was modelled for between-group comparisons. Results: From January 9, 2019, to December 1, 2022, 42 children were randomized with a 1:1 ratio (mean age: 5.0 (± 2.9) months). The 24-h food intake did not differ between groups (estimate: 1.8% (95%CI -7.0 to 10.6); p = 0.68). PSET had no effect on SpO2, clinical severity, RR and HR at the follow-up assessments (5 min, 30 min and 24 h after intervention), nor on the number of vomit episodes, total sleep time and SpO2 during sleep. Conclusions: PSET did not affect food intake or the 24-h course of bronchiolitis more than standard treatment in children hospitalized for moderate bronchiolitis. Trial registration: NCT03738501 registered on 13/11/2018, Slow Expiratory Technique to Improve Alimentation in Children With Bronchiolitis (BRONCHIOL-EAT); https://classic.clinicaltrials.gov/ct2/show/NCT03738501. [ABSTRACT FROM AUTHOR]

Background: Depression is a prevalent perioperative psychiatric complication among elderly hip fracture patients. Esketamine has rapid and robust antidepressant effects. However, it is unknown whether it can alleviate depressive symptoms in elderly patients who undergo hip fracture surgery. This study aimed to explore whether the adjunctive esketamine in patient-controlled intravenous analgesia (PCIA) could improve depressive symptoms in elderly patients undergoing hip fracture surgery. Methods: A single-center, prospective, double-blind and randomized controlled clinical trial was carried out from July 2022 to August 2023 at the Wenzhou People's Hospital among 90 patients, aged ≥ 65 years with hip fracture undergoing elective surgery. Participants were randomly allocated to either the esketamine group (group S) or the control group (group C). In Group S, patients were administered 0.5 mg/kg of esketamine as a PCIA adjuvant for 48 h, while the control group received saline. The primary outcome was the assessment of depressive symptoms using the Geriatric Depression Scale-15 (GDS-15) on postoperative day 2. The secondary outcomes were assessments of depressive symptoms on postoperative day 7 and postoperative day 30, serum levels of brain-derived neurotrophic factor (BDNF) and 5-hydroxytryptamine (5-HT), postoperative pain intensity, the number of effective PCIA presses, sufentanil consumption, and adverse events. Results: The prevalence and GDS-15 scores of depression were significantly lower in group S on postoperative day 2 (28.6% vs. 53.5%; 3.5 ± 1.8 vs. 4.3 ± 1.7, P < 0.05). In group S, the number of effective PCIA presses was significantly lower on postoperative day 2 than that in group C [2(1–4) vs. 1(0–2), P<0.05]. Higher levels of BDNF (23.8 ± 1.7 ng/mL vs. 25.3 ± 2.0 ng/mL, P < 0.05) and 5-HT (219.5 ± 19.5 ng/mL vs. 217.0 ± 22.2 ng/mL, P < 0.05) in the blood were observed on postoperative day 2 in group S. Conclusion: In elderly patients aged ≥ 65 years undergoing hip fracture surgery, the administration of adjunctive esketamine in PCIA could improve depressive symptoms and increase levels of BDNF and 5-HT in the blood. Trial registration: Chinese Clinical Trial Registry, ChiCTR2200061956 (Date: 13/07/2022). [ABSTRACT FROM AUTHOR]

Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA and RNA debris persist in viral reservoirs for weeks to months following infection, potentially triggering interferon production and chronic inflammation. RSLV-132 is a biologic drug composed of catalytically active human RNase1 fused to human IgG1 Fc and is designed to remain in circulation and digest extracellular RNA. We hypothesized that removal of SARS-CoV-2 viral RNA from latent reservoirs may improve inflammation, neuroinflammation, and fatigue associated with post-acute sequelae of SARS-CoV-2 infection (PASC). Methods This was a phase 2, double-blind, placebo-controlled randomized clinical trial in participants with a 24-week history of PASC and severe fatigue. The primary endpoint of the trial assessed the impact of 6 intravenous doses of RSLV-132 on the mean change from baseline at day 71 in the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a). Results A statistically significant difference on day 71 was not observed with respect to the primary or secondary endpoints. This was likely due to a placebo response that increased during the trial. Statistically significant improvement in fatigue as measured by the PROMIS Fatigue SF 7a, Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue), and Physicians Global Assessment (PGA) instruments were observed earlier in the trial, with women demonstrating greater responses to RSLV-132 than men. Conclusion While fatigue was not statistically significantly improved at Day 71, earlier timepoints revealed statistically significant improvement in fatigue and physician global assessment. The data suggest eliminating latent viral RNA by increasing serum RNase activity may improve fatigue in PASC patients. Women may respond better to this approach than men. Future studies will aim to confirm these findings. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effectiveness of radial extracorporeal shock wave therapy (r ESWT) as an additional treatment modality for spastic equinus deformity in chronic hemiplegic patients. Methods: 100 eligible stroke patients with calf muscles spasticity were randomized into 2 groups. Group I: 50 patients exposed to rESWT 1.500 pulses, 0.10 mJ to 0.3mJ/mm2, with a frequency 4 Hz once weekly for one month. Group II: 50 patients exposed to Sham rESWT once weekly for one month. Clinical, electrophysiological & musculoskeletal ultrasound assessments were done for all patients. Results: After controlling baseline as covariate, the trend for modified Ashworth scale (MAS), Passive ankle dorsiflexion motion (PADFM), 10 meters walk test (10-MWT), and Ratio of maximum H reflex to maximum M response (H/M ratio) after one & two months was significantly different between the two groups, with improvement of all clinical and electrophysiological parameters in group I. Conclusion: ESWT represents a useful non-invasive, additional modality for the reduction of foot spasticity and equinus deformity in stroke patients. Implications for Rehabilitation: Extracorporeal shock wave therapy represents a useful non-invasive, additional modality for reduction of foot spasticity and equinus deformity in chronic stroke patients. The application of such a modality improves limb posture, range of motion, and muscle extensibility. Early extracorporeal shock wave rehabilitative intervention in stroke patients reduces fat infiltration and fibrosis replacement of spastic muscle. [ABSTRACT FROM AUTHOR]

Background: Gingival diseases, encompassing a spectrum of oral health concerns, represent a prevalent issue within the global population. Despite their widespread occurrence, the research landscape concerning effective interventions, particularly those rooted in herbal products, remains somewhat limited. Addressing this knowledge gap, the current study undertook a comprehensive evaluation aimed at assessing the clinical efficacy of a novel intervention: a 5% thymoquinone (TQ) gel. This investigation specifically focused on the application of TQ gel as an adjunctive measure to the standard protocol of scaling (SC) in individuals afflicted with plaque-induced gingivitis. Through rigorous examination and analysis, this study seeks to provide valuable insights into the potential utility and therapeutic benefits of this herbal-based intervention in managing gingival diseases. Objective: To evaluate the efficacy of 5% TQ gel using a novel liposome drug delivery as a topical application following SC in gingivitis patients. Methods: A double-blinded, parallel, randomized controlled clinical trial. The study was performed at the Faculty of Dentistry, King Abdulaziz University, and Qassim University, Saudi Arabia. This trial enrolled 63 participants in an age group between 18 and 40 years attending the outpatient clinics of the Faculty of Dentistry, Qassim University, Saudi Arabia, and a clinical diagnosis of gingivitis was made. The enrolled subjects were categorized into three groups: Group I—TQ gel with SC, Group II—Placebo with SC, and Group III—SC alone, and clinical outcomes were measured at baseline and two-week follow-up visits. Plaque index (PI), papillary bleeding index (PBI), and any adverse events with TQ gel are categorized as mild, moderate, and severe. 63 patients. Group I (n = 21); Group II (n = 21); Group III (n = 21). Results: The paired t-test compared the mean differences in PI and PBI at two time points and it was observed that there were significant differences in Group I with p-values of 0.04 and 0.05, respectively. A one-way ANOVA test was performed and it showed significant differences in the mean scores between the three groups for PI (p-value—0.01) and PBI (p-value—0.05). The post hoc Tukey's test compared the mean differences in PI and PBI between the groups and the results were in favor of Group I which used TQ gel with SC. Conclusions: The clinical trial concluded that the plaque and gingival bleeding scores were significantly reduced in the group of patients who intervened with TQ gel following SC when compared to SC-alone and placebo groups. Also, there were significant reductions in the scores from the baseline to the two-week follow-up visit in patients treated with TQ gel and SC. [ABSTRACT FROM AUTHOR]

Background: Active drugs and nutraceutical supplements commonly induce various gastrointestinal illnesses, and constipation is a major gastrointestinal symptom accompanied with functional gastrointestinal disorders. Drug-induced imbalance in gut microbiota may play critical role in such physiological disturbances. Probiotics have been known for resuming normal and healthy gut microbiome. Objective: To investigate the clinical efficacy and safety of Bacillus coagulans LBSC in the treatment of drug induced constipation associated with functional gastrointestinal disorder (FGID) symptoms. Methods: A prospective, interventional, randomized, double-blind, parallel, multi-arm, controlled trial with 168 patients experiencing drug induced constipation associated with FGID symptoms (DICAWFGID) screened through Rome IV criteria were randomized into 2 arms, i.e. placebo arm (n = 28) and atorvastatin, atenolol, metformin, amitriptyline, and calcium in test arm (n = 28/arm). Patients in both arms received similar dosages (1 g sachet, 3 times a day) for 35 days. The occurrence of constipation using Bristol Stool Form Scale, assessment of degree of constipation on 4-point Likert scale, occurrence of hard stool and degree of stool expulsion on 3-point scale, and defecation frequency were primary endpoints. While, secondary outcomes consisted of the changes in severity of FGID symptoms, visual analogue scale and tolerance to IP, along with reports of adverse events (AEs) and severe adverse events (SAEs). Results: There was a significant reduction in occurrence of constipation (≥98.6% and P -value <0.05) in test arm over the placebo arm. Assessment of co-primary endpoints showed significant improvements in degree of stool consistency (P -value 0.0232; CI: 0.1870, 1.1629), borderline significantly superior in degree of stool expulsion (P -value 0.0553; CI: 0.0378, −0.4939), while the other co-primary efficacy endpoints displayed considerably improved advancement (non-significant, P -value ≥0.05). The intra group analysis of symptoms at start of treatment (SOT) and end of treatment (EOT) revealed a significant reduction in scores for occurrence of constipation and degree of constipation, whereas significant improvement in the scores for degree of stool consistency and degree of stool expulsion (P -value <0.001) after the intervention period. In secondary endpoints, the processed responses clearly signified a considerable positive improvement (non-significant, P -value ≥0.05) in other symptoms of constipation associated with FGIDs as determined by the changes in the EOT-SOT score. The study data also highlighted the safety o f Bacillus coagulans LBSC at the studied dose. No AEs and/or SAEs were documented during the investigation. Conclusion: At the studied dose, Bacillus coagulans LBSC was safe for oral consumption and effective in the management of the drug induced constipation associated with FGIDs symptoms. [ABSTRACT FROM AUTHOR]

Introduction: Total knee arthroplasty (TKA) is accompanied by severe postoperative pain, which is reported to be an important cause of chronic pain. Ultrasound-guided adductor canal block (ACB) combined with infiltration between the popliteal artery and posterior capsular of the knee (IPACK) has been proven to have a better effect on relieving acute pain after TKA. However, whether it has a significant effect on the incidence of chronic pain after TKA has not been reported. This trial was designed to investigate the effect of ultrasound-guided ACB combined with IPACK on the incidence and intensity of chronic pain after TKA. Methods: In this prospective, randomized, double-blind, placebo-controlled study, 100 subjects scheduled for TKA were randomly (1:1) divided into two groups: the ropivacaine group and the placebo group. Patients in each group received ultrasound-guided ACB + IPACK procedures with 0.25% ropivacaine or equal volume normal saline. All patients received multimodal analgesia. Pain intensity was assessed using the Numerical Rating Scale (NRS). The primary outcome was the incidence of chronic pain at 3 months after TKA by telephone follow-up. In addition, pain intensity in early resting and mobilized states, chronic pain intensity, the time to first rescue analgesia; opioid consumption; CRP and IL-6 after the operation; length of postoperative hospital stay; and cost of hospitalization and postoperative complications; as well as the function of the knee in the early stage after the operation, were recorded. Results: Ninety-one participants were included in the final analysis. At 3 months, the incidence of chronic pain was 30.4% in the ropivacaine group, significantly lower than 51.1% in the placebo group. Compared with the placebo group, the ACB + IPACK with ropivacaine group had significantly lower pain scores at 4 hours, 8 hours, 16 hours, and 24 hours after the operation; increased the knee range of motion at 8 hours and 24 hours after the operation; and a significantly decreased incidence of chronic pain at 3 months after the operation. During the follow-up period, there were no nerve block-related complications in either group. Conclusion: In the context of multimodal analgesia protocols, ACB combined with IPACK before surgery decreases the incidence and intensity of chronic pain 3 months after TKA compared with placebo injection. In addition, it reduces the NRS scores, whether at rest or during mobilization, and improves knee function within 24 hours after TKA. Trial registration: This trial was registered in the China Clinical Trial Center (registration number ChiCTR2200065300) on November 1, 2022. [ABSTRACT FROM AUTHOR]

Background: This single-blind randomized controlled trial was aimed to evaluate the microbiological and clinical effects of Zeger therapy on gingival health. Methods: Twenty-four adults with gingivitis were recruited and monitored micro-biologically and clinically at baseline (Day 0), 4 weeks (Day 29) after therapy. All volunteers received one-stage full-mouth supragingival scaling as basic oral health care for baseline, and then randomly divided into experimental (koumiss, n = 12) or control (none, n = 12) group. The koumiss was used once a day for 4 weeks. Results: The microbial diversity of the experimental group increased significantly after drinking koumiss (p < 0.05), mainly owing to increasing of Gram-positive bacteria (p = 0.038) and oral health-related microbes (Rothia, Corynebacterium, Actinomyces, Saccharibacteria_TM7, etc.), decreasing of Gram-negative bacteria (p = 0.009) and periodontal disease-related microbes (Porphyromonas, Fusobacterium, Veillonella, etc.), while the microbial diversity of the control group had no significant change (p > 0.05). However, there was no significant difference between the two groups in the clinical parameters (p > 0.05). Conclusions: Zeger therapy promotes the diversity of supragingival microbiome in adults with gingivitis and increases the abundance of some beneficial flora while decreasing some harmful without clinical parameters marked changing, which holds promise for improving of gingivitis and may be a valuable oral health care approach in the future. Trial registration: The clinical trial was approved by the Medical Ethics Committee of West China Hospital of Stomatology, Sichuan University, batch No. WCHSIRB-D-2021-428. Before patient registration began, the prospective clinical trial was registered in www.clinicaltrials.gov public repository in China under the registration number ChiCTR2200060555 on 04/06/2022. [ABSTRACT FROM AUTHOR]