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Clinical trial of photodynamic therapy for peripheral-type lung cancers using a new laser device in a pilot study
摘要： Introduction/Aim: Photodynamic therapy (PDT) involves the use of a tumor-specific photosensitizer and laser irradiation, and one of the treatment options recommended for early centrally located lung cancers, but not yet for peripheral-type lung cancers. We developed a new laser probe, the composite-type optical fiberscope (COF), which allows accurate laser irradiation of a cancer lesion with simultaneous visualization of the lesion. Methods: This phase I study was conducted in 7 patients with peripheral lung cancers (primary tumor ≤20 mm in diameter). We performed endobronchial PDT for these patients using the new laser probe and talaporfin sodium as the photosensitizer. Results: We performed PDT for 3 patients with peripheral lung cancer using a laser dose of 50 J/cm2 at 120 mW, and confirmed the feasibility of using this dose. Then, we escalated the laser dose to 100 J/cm2 in 4 additional patients. A total of 7 patients met our inclusion criteria. Evaluation at 2 weeks and 3 months after the PDT revealed no complication such as pneumonia or pneumothorax. At the evaluation conducted 6 months later, we found CR in 3 cases and SD in the remaining 4 cases. Conclusion: PDT was found to be a feasible and non-invasive treatment modality for early peripheral-type lung cancer. In the future, PDT could become a standard treatment option for peripheral-type lung cancer.
关键词： Photodynamic Therapy (PDT),laser,peripheral type lung cancer,clinical trial,photosensitizer,endobronchial treatment
更新于2025-09-23 15:21:01
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DaBlaCa-11: Photodynamic diagnosis in flexible cystoscopy - initial findings in a randomized controlled trial
摘要： Patients with non-muscle invasive bladder cancer (NMIBC) face the risk of having several transurethral resections of the bladder (TURBT) performed because of the high recurrence rate of the disease. Photodynamic diagnosis (PDD) is recommended in primary TURBTs because of a higher detection rate than white light (WL) cystoscopy. In the surveillance program, however, WL flexible cystoscopy is still the standard approach. The aim of this randomized controlled trial is to examine the potential benefits from a PDD guided flexible cystoscopy in the outpatient clinic in patients with previous NMIBC. From February 2016 to September 2017, 605 patients were enrolled from three urological department in Denmark. All patients were scheduled for a routine surveillance cystoscopy following a TURBT because of Ta bladder cancer (low or high grade) 4 months earlier. Patients were randomized 1:1 to either an intervention group where Hexaminolevulinate (Hexvix?Photocure, NO) was instilled in the bladder one hour before the cystoscopy with PDD video cystoscope (PDD 11272 VPI, D-Light C-Light Source; Karl Storz), or a control group where cystoscopy was performed with WL flexible cystoscope. In both patient groups, detection of multiple and large recurrences estimated > 1 cm were scheduled for a TURBT in general anesthesia whereas solitary or small multiple recurrences, as well as suspect mucosa, were biopsied or fulgurated directly in the flexible procedure. A total of 304 patients were allocated to the intervention group (flexible PDD) and 301 to the control group (flexible WL). Approximately half of all patients in both groups were recurrence free (control group, n= 150 and intervention group, n=157). The number of patients undergoing biopsy or fulguration because of suspect mucosa were higher in the intervention group compared to the control group (n=66 vs. n=36, p<0.05). Significantly more patients in the intervention group were treated in the outpatient clinic (n=95) compared to the control group (n=76) (n=95 vs n=76, p <0.05), whereas fewer patients were scheduled for a TURBT in the intervention group (n=52) than in the control group (n=75) (n=52 vs n=75, p<0.05). These initial results indicate that PDD guided flexible cystoscopy can reduce the need of TURBT when biopsy and fulguration of small tumors is possible in the outpatient clinic. Further follow-up data on recurrences in patients in the study will be needed to estimate the clinical impact on this regarding reduction of recurrence risk and repeated procedures.
关键词： randomized controlled trial,flexible cystoscopy,Photodynamic diagnosis,non-muscle invasive bladder cancer
更新于2025-09-23 15:19:57
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Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial
摘要： With increasingly precise radiotherapy and advanced medical imaging, the concept of radiotherapy target volume planning might be redefined with the aim of improving outcomes. We aimed to investigate whether target volume reduction is feasible and effective compared with conventional planning in the context of radical chemoradiotherapy for patients with locally advanced non-small-cell lung cancer.
关键词： chemoradiotherapy,Imaging-based target volume reduction,randomised,multicentre,controlled trial,open-label,PET-Plan,locally advanced non-small-cell lung cancer
更新于2025-09-23 15:19:57
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There does not seem to be any benefit from using low-level laser therapy to treat temporomandibular pain after 1??year
摘要： There does not seem to be any benefit from using low-level laser therapy to treat temporomandibular pain after 1 year.
关键词： low-level laser therapy,orofacial pain,randomized clinical trial,pain,General dentistry
更新于2025-09-23 15:19:57
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Femtosecond Laser-assisted Preparation of Conjunctival Autograft for Pterygium Surgery
摘要： Femtosecond laser-assisted conjunctival autografts (CAG) preparation was recently proposed. This study reports the outcomes of the first clinical trial on the use of laser to prepare CAG in pterygium surgery, and to compare the outcomes with those of manual technique. Forty eyes undergoing primary pterygium excision with laser-assisted CAG transplantation were prospectively included (L group). Two historical matched cohorts whose cAGs were prepared manually were compared (n = 78 eyes by the same experienced surgeon, M group; n = 78 eyes by trainees; TM group). We found the laser-created CAGs had only 11 μm deviation from the targeted thickness. The best-corrected visual acuity improved, and the astigmatism significantly decreased after surgery, with comparable efficacy across 3 groups. The 1-year recurrence rate was 2.5%, 3.8% and 7.7% in the L, M and TM groups, respectively (P = 0.12). There was no significant difference between the L and M groups in the complication rate (5.0% and 1.3%, respectively), surgical time (19.4 ± 5.1 and 19.1 ± 6.2 minutes, respectively), and postoperative discomfort scores (0.1 ± 0.3 and 0.2 ± 0.3, respectively), but these outcomes were significantly less favorable in the TM group. The results of this first comparative clinical trial suggest that femtosecond laser-assisted CAG preparation can be considered as an alternative technique for CAGs preparation.
关键词： femtosecond laser,conjunctival autograft,recurrence rate,clinical trial,pterygium surgery
更新于2025-09-23 15:19:57
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Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial
摘要： Background: Myopia is increasing in prevalence and is currently recognized as a significant public health issue worldwide, particularly in China. Once myopia develops, appropriate clinical interventions need to be prescribed to slow its progression. Currently, several publications indicate that myopic defocus (MD) retards eye growth and myopia progression. However, no clinical trials have compared the outcomes of different MD spectacle lenses in the same observational group, especially in mainland China. The aim of the present study is to compare the myopia control efficiency of two different MD spectacle lenses: defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition lenses (PALs). Methods: The trial is designed as a 3-year, prospective, randomized, multicenter clinical trial of schoolchildren treated with DIMS lenses and PALs. A total of 600 Chinese primary school children aged 6–12 years will be recruited, and each group is intended to include 300 subjects. The inclusion criteria are myopia between ? 1.00 and ? 5.00 diopters and astigmatism ≤ 1.50 diopters. The follow-up time points will be 1 month (m), 3 m, 6 m, 12 m, 18 m, 24 m, 30 m, and 36 m. The primary outcome will be determined by the difference between the two groups in cycloplegic spherical equivalent refraction between baseline and the last follow-up visit. The secondary outcome is the axial length, and the exploratory outcomes include ocular biometric measures, peripheral refraction, binocular vision, accommodation, compliance, and the results of questionnaires related to wearing experiences.
关键词： Multicenter,Trial,Spectacle lens,Prospective,Myopic defocus,Myopia,Progression
更新于2025-09-23 15:19:57
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Low-level laser-aided orthodontic treatment of periodontally compromised patients: a randomised controlled trial
摘要： Low-level laser irradiation (LLLI) shows effects in orthodontic pain relief and periodontal inflammation control. The aim of this article is to investigate the analgesic and inflammation-modulatory effects of low-level laser irradiation among orthodontic patients with compromised periodontium. A randomised controlled trial with split-mouth design was conducted in 27 adults with treated and controlled chronic periodontitis over 6 months. One side of the dental arch underwent repeated treatment under a 940-nm diode laser (EZlase; Biolase Technology Inc.) with a beam size of 2.8 cm2 for 60 seconds at 8.6 J/cm2, whilst the other side received pseudo-laser treatment. Laser irradiation was applied repeatedly for 8 times during the first 6 weeks after bracket bonding and monthly thereafter until the end of orthodontic treatment. Subjective pain (assessed by visual analogue scale in pain diary and by chairside archwire activation), periodontal status (assessed by periodontal clinical parameters), cytokines in gingival crevicular fluid (interleukin 1β, prostaglandin E2, substance P) and periodontopathic bacteria (Porphyromonas gingivalis and Treponema denticola) in supragingival plaque were assessed. The intensity of pain was lower on the laser-irradiated side at multiple follow-up visits (P < 0.05). The pain subsided 1 day earlier on the laser side, with a lower peak value during the first week after initial archwire placement (P < 0.05). The laser side exhibited a smaller reduction in bite force during the first month (mean difference = 3.17, 95% CI: 2.36–3.98, P < 0.05 at 1-week interval; mean difference = 3.09, 95% CI: 1.87–4.32, P < 0.05 at 1-month interval). A smaller increase was observed in the plaque index scores on the laser side at 1-month (mean difference = 0.19, 95% CI: 0.13–0.24, P < 0.05) and in the gingival index scores at the 3-month follow-up visit (mean difference = 0.18, 95% CI: 0.14–0.21, P < 0.05). Laser irradiation inhibited the elevation of interleukin-1β, prostaglandin E2 and substance P levels during the first month (P < 0.05). However, no intergroup difference was detected in the bacteria levels. Low-level laser irradiation exhibits benefits in pain relief and inflammation control during the early stage of adjunctive orthodontic treatment in periodontally compromised individuals.
关键词： Orthodontic-periodontal joint treatment,Randomised clinical trial,Low-level laser irradiation,Orthodontic pain,Periodontal inflammation
更新于2025-09-23 15:19:57
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Variational method of energy level calculation in pyramidal quantum dots
摘要： We suggest a variational method for finding the ground state energy in pyramidal quantum dots. The method is based on using a Gaussian trial wavefunction. We developed an analytical expression for the expectation value of the carrier energy in quantum dots with a constant confining potential (within a single-band model). The problem of finding the ground state energy was reduced to the minimization of an analytical function of three trial function parameters. The proposed variational approach is much faster than the direct approach when solving the three-dimensional Schr?dinger equation, does not demand any special software, and produces quite accurate values of the carrier ground state energy (an error does not exceed 2% of the potential well depth). Generalization of the method to multi-band models, spatially inhomogeneous potentials, effective mass discontinuity, and excited states is discussed. Applicability of the method to different quantum dot systems is considered.
关键词： Gaussian trial wavefunction,single-band model,Schr?dinger equation,variational method,energy level calculation,pyramidal quantum dots
更新于2025-09-23 15:19:57
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Photobiomodulation therapy increases functional capacity of patients with chronic kidney failure: randomized controlled trial
摘要： Photobiomodulation (PBM) has been used in different populations as a strategy to attenuate muscle fatigue and improve exercise performance. Recent findings demonstrated that a single session with specific PBM doses during hemodialysis (HD) increased the upper limb muscle strength of chronic kidney failure (CKF) patients. Now, the primary objective of this study was to evaluate the chronic effect of PBM on the functional capacity of this population. Secondarily, we aimed at investigating the effects of PBM on the patients’ strength, muscle thickness and echogenicity, perception of pain, fatigue, and quality of life. A randomized controlled trial was conducted in which the intervention group (IG, n = 14) received 24 sessions of PBM (810 nm, 5 diodes × 200 mW, 30 J/application site) on lower limb during HD. The control group (CG, n = 14) did not receive any physical therapy intervention, it only underwent HD sessions. As a result, there was an increase in the functional capacity (assessed through the six-minute walk test) for the IG compared with the CG [50.7 m (CI95% 15.63; 85.72), p = 0.01, large effect size, d = 1.12], as well as an improvement on lower limb muscle strength (assessed through the sit-and-stand test) [? 7.4 s (CI95% ? 4.54; ? 10.37), p = 0.00, large effect size, d = 1.99]. For other outcomes evaluated, no significant difference between-group was observed. Finally, PBM applied as monotherapy for 8 weeks in the lower limb improves functional capacity and muscle strength of CKF patients.
关键词： chronic . Renal dialysis . Low-level light therapy . Randomized controlled trial,Renal insufficiency
更新于2025-09-23 15:19:57
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Influence of lowa??level laser therapy on implant stability in implants placed in fresh extraction sockets: A randomized clinical trial
摘要： Background: Low-level laser therapy (LLLT) has been suggested to improve primary stability at the early stages of osseointegration in animal models. However, there is still scarce evidence about its influence on implant stability in humans. Purpose: To assess the influence of LLLT on implant stability in implants placed in fresh extraction sockets. Material and methods: A randomized controlled trial was designed according to the SPIRIT guidelines and is reported following the CONSORT. Patients were randomly allocated according to control or LLLT groups. LLLT consisted in the application of GaAlAs laser (808 nm, avg. power density: 50 mW, circular spot diameter and area: 0.71 cm/0.4cm2) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing. The total dose resulted in 66 J per application moment. This LLLT protocol was applied only in the dental implant placement session. Implant stability was by ISQ at implant placement (T0) and the abutment selection (Ta). Digital radiographs for T0 and Ta were used to assess the distance between the implant platform and alveolar bone crest, in millimeters. T-test and Shapiro-Wilk test were used to analyze data between groups using the implant as a unit of analysis. Results: Fifty implants were placed in 44 patients. The insertion torque ranged from 15 to 60 N.cm (mean 35.64 ± 13.34). Two implants of the LLLT and one of the control groups were lost to follow-up and one implant of the control group failed to osseointegrate (4.3%). ISQ at T0 ranged from 17 to 79 (mean 59.33 ± 13.05) and from 40 to 89 (mean 66.46 SD ± 11.56) at Ta. No differences were observed when comparing the groups with ISQ difference (P = .433) or radiographical peri-implant alterations (P = .261). Conclusions: LLLT did not influence implant stability in implants placed in fresh extraction sockets when assessed at healing abutment installation.
关键词： osseointegration,gallium aluminum arsenide lasers,dental implants,controlled clinical trial
更新于2025-09-23 15:19:57