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1.
Mov Disord ; 36(11): 2687-2692, 2021 11.
Article in English | MEDLINE | ID: mdl-34496081

ABSTRACT

BACKGROUND: Continuous, subcutaneous (SC) levodopa/carbidopa infusion with ND0612 is under development as a treatment for patients with Parkinson's disease (PD) and motor fluctuations. OBJECTIVE: Evaluate 1-year safety data. METHODS: BeyoND is an open-label study evaluating the long-term safety of two ND0612 dosing regimens. RESULTS: Of the 214 enrolled patients (24-hour SC infusion: n = 90; 16-hour SC infusion: n = 124), 120 (56%) completed 12 months of treatment. Leading causes for study discontinuation were consent withdrawal (19.6%) and adverse events (17.3%). Rates of discontinuation were reduced from 49% to 29% after a protocol revision and retraining. Systemic safety was typical for PD patients treated with levodopa/carbidopa. Most patients experienced infusion site reactions, particularly nodules (30.8%) and hematoma (25.2%), which were judged mostly mild to moderate and led to discontinuation in only 10.3% of the participants. CONCLUSIONS: Subcutaneous levodopa/carbidopa continuous infusion with ND0612 is generally safe, with typical infusion site reactions for SC delivery as the main adverse event. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.


Subject(s)
Levodopa , Parkinson Disease , Antiparkinson Agents/adverse effects , Carbidopa/adverse effects , Drug Combinations , Gels , Humans , Levodopa/adverse effects , Parkinson Disease/drug therapy
2.
Eur J Intern Med ; 24(3): 245-9, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23312963

ABSTRACT

BACKGROUND: Cancer is a leading cause of mortality worldwide. Screening is a key strategy for reducing cancer morbidity and mortality. METHODS: We aimed to describe the experience of an integrated cancer prevention center in screening an asymptomatic population for the presence of neoplasia. One-thousand consecutive asymptomatic, apparently healthy adults, aged 20-80 years, were screened for early detection of 11 common cancers that account for 70-80% of cancer mortality. RESULTS: Malignant and benign lesions were found in 2.4% and 7.1% of the screenees, respectively. The most common malignant lesions were in the gastrointestinal tract and breast followed by gynecological and skin. The compliance rate for the different screening procedures was considerably higher than the actual screening rate in the general Israeli population - 78% compared to 60% for mammography (p<0.001) and 39% compared to 16% for colonoscopy (p<0.001). Advanced age, family history of cancer and certain lifestyle parameters were associated with increased risk. Moreover, polymorphisms in the APC and CD24 genes indicated high cancer risk. When two of the polymorphisms existed in an individual, the risk for a neoplastic lesion was extremely high (OR 2.3 [95% CI 0.94-5.9]). CONCLUSIONS: One stop shop screening for 11 common cancers in the setting of a multidisciplinary outpatient clinic is feasible and can detect cancer at an early stage.


Subject(s)
Asymptomatic Diseases/epidemiology , Early Detection of Cancer/methods , Mass Screening , Neoplasms , Academic Medical Centers/methods , Adult , Age Factors , Aged , CD24 Antigen/genetics , Early Detection of Cancer/statistics & numerical data , Female , Genes, APC , Humans , Israel/epidemiology , Life Style , Male , Mass Screening/methods , Mass Screening/statistics & numerical data , Neoplasms/classification , Neoplasms/diagnosis , Neoplasms/epidemiology , Neoplasms/genetics , Polymorphism, Genetic , Preventive Health Services/methods , Risk Factors
3.
J Clin Periodontol ; 39(12): 1198-205, 2012 Dec.
Article in English | MEDLINE | ID: mdl-23020659

ABSTRACT

BACKGROUND: Universal strategies for managing peri-implantitis are yet to be adopted. The aim of this study is to examine a protocol of intensive application of chlorhexidine containing chips in sites with peri-implantitis. MATERIALS AND METHODS: This multi-centre, randomized, double-blind, parallel, two-arm clinical trial included 60 patients (77 implants) with probing depth (PD) 6-10 mm and bone loss ≥2 mm around 1-2 implants. One to two weeks following SRP, baseline measurements were made followed by implants' debridement. Patients were randomized to receive matrix chips (MatrixC) or chlorhexidine Chips (PerioC). Measurements and chips placement were repeated at weeks 2, 4, 6, 8, 12 and 18. At 6 months, patients returned for final examination. RESULTS: Probing depth reduction was greater in the PerioC (2.19 ± 0.24 mm) compared with MatrixC (1.59 ± 0.23 mm), p = 0.07. Seventy percentage of the implants in the PerioC and 54% in the MatrixC had PD reduction ≥ 2 mm. Likewise, 40% of the sites (PerioC) and 24% (MatrixC) had PD reduction ≥ 3 mm. Clinical attachment level gains for both groups were significant; however, the changes in the PerioC group were significantly greater than in MatrixC [2.21 ± 0.23 mm. and 1.56 ± 0.25 mm respectively, p = 0.05]. Bleeding on probing was reduced by half in both groups. CONCLUSION: Frequent placement of PerioC and MatrixC together with implants debridement resulted in a substantial improvement in sites with peri-implantitis. Further studies will be required to fully appreciate the mechanism of this treatment.


Subject(s)
Anti-Infective Agents, Local/therapeutic use , Chlorhexidine/analogs & derivatives , Peri-Implantitis/drug therapy , Adult , Aged , Anti-Infective Agents, Local/administration & dosage , Chlorhexidine/administration & dosage , Chlorhexidine/therapeutic use , Dental Plaque Index , Double-Blind Method , Female , Gelatin , Humans , Likelihood Functions , Linear Models , Male , Middle Aged , Periodontal Debridement , Periodontal Index , Treatment Outcome , Young Adult
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