scholarly journals Trattamento LVRC: nuovo imaging interventistico per il trattamento dell’enfisema polmonare

2019 ◽  
Author(s):  
Erika Vallefuoco ◽  
Andrea Caldeo
Keyword(s):  
Side Effects ◽  
Pulmonary Emphysema ◽  
Phase 1 ◽  
Phase 2 ◽  
Lung Volume Reduction ◽  
Phase 3 ◽  
Thoracic Imaging ◽  
Total Absence ◽  
Clinical Benefits

Background Background Treatment of pulmonary emphysema with Lung Volume Reduction Coil (LVRC) technique and related thoracic imaging preoperative, interventional, under radioscopic guidance, and postoperative. Materials and methods For the intervention, Nitinol coils are used, implanted through a catheter under radioscopic guidance using an Intensifier. The treatment is performed with induction of anesthesia, during one or two sessions. Results Coils are implanted on patients in different lobars regions, depending on the case. The patient's status is monitored in 3 phases: Phase 1 Preoperative; Phase 2 Intervention; Phase 3 Post-operative up to the following 5 years. This technique, given the effectiveness and an almost total absence of side effects, turns out to be a valid alternative to others methods for the treatment of severe pulmonary emphysema. Conclusions Through the analysis of the monitoring results, it is possible to infer that the patients subjected to LVRC (Coil) have high clinical benefits, but still not accompanied by significant long-term functional improvements.

Safety of TG-C: 12 years of follow-up safety data from phase 1, phase 2, ongoing phase 3, and long term safety trials

2021 ◽  
Vol 29 ◽  
pp. S253-S254
Author(s):  
D. Hunter ◽  
A. Mobasheri ◽  
S. Mareya ◽  
M. Wang ◽  
H. Choi ◽  
...  
Keyword(s):  
Phase 1 ◽  
Safety Data ◽  
Phase 2 ◽  
Phase 3 ◽  
Ongoing Phase

Long-Term Memory of Pigeons for Stimulus-Outcome Associations Involving Multiple Stimuli, each Seen in a Single Brief Trial

1992 ◽  
Vol 45 (2b) ◽  
pp. 81-98 ◽  
Author(s):  
Euan M. Macphail ◽  
Steve Reilly ◽  
Mark Good
Keyword(s):  
Recognition Memory ◽  
Phase 1 ◽  
Cycle Phase ◽  
Long Term Memory ◽  
Phase 2 ◽  
Phase 3 ◽  
Term Memory ◽  
The One ◽  
High Level

Experiment 1 explored performance of pigeons in two versions of a shortterm recognition memory procedure. In one version responding to entirely novel slides was rewarded, and responding to familiar slides (slides seen once, for 10 sec) was not rewarded; in the other version, responding to familiar slides was rewarded. Performance was initially below chance in both versions of the procedure. This result indicated that in this procedure associations were formed between the slides and the outcome (reward or non-reward) that followed their presentation. The result also suggested that the true capacity of pigeon recognition memory cannot be assessed using these procedures, as performance is inevitably disrupted by the bird's associative memory. The tendency of pigeons to form one-trial associations was exploited in Experiment 2. Phase 1 consisted of 16 two-session cycles: in Session 1 of each cycle, birds were shown 20 novel slides and were rewarded for responding to 10 of those slides; in Session 2, the same slides were shown again, with the same reinforcement contingencies. The birds showed significant overnight retention of the one-trial associations formed in Session 1 of each cycle. Phase 2 showed significant retention over periods of more than 20 days of associations involving 320 slides seen twice only. Phase 3 re-exposed for nine daily sessions one of the sets of 20 slides used in Phases 1 and 2; a high level of discrimination emerged rapidly and 4 (of 8) birds showed, by the end of training, no overlap in response rates to positive and negative slides. Comparative implications of the results are discussed.

THE EFFECTS OF CIGARETTE SMOKING ON RABBIT TIBIAL VASCULAR ENDOTHELIUM

2001 ◽  
Vol 05 (04) ◽  
pp. 235-242 ◽  
Author(s):  
YUAN-KUN TU ◽  
STEVE WEN-NENG UENG
Keyword(s):  
Cigarette Smoking ◽  
Vascular Endothelium ◽  
Phase 1 ◽  
Phase 2 ◽  
Short Term ◽  
Phase 3 ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Cigarette smoking is hazardous for various tissues in human. The cigarette smoke inhalation has been proved to delay bone healing. However, no previous study demonstrates the smoking effect on bony microcirculation. In this study, we investigated the effect of cigarette smoking on tibial vascular endothelium and blood flow by using the bone chamber model. Eighteen adult New Zealand rabbits were divided into 3 groups. Group 1: Control, Group 2: 1 week smoking, and Group 3: 6 weeks smoking. All these rabbits were then anesthetized, and their nutrient arteries of tibia were identified and cannulated. We put the tibia into bone chamber after cannulation, perfused with Krebs-Ringer solution (phase 1), and then compared the effect of vasospasm by norepinephrine dose-response curve (NEDRC). Acetylcholine (phase 2) and L-NMMA (phase 3) were also perfused and the NEDRC recorded. Acetylcholine can stimulate the release of nitric oxide and lower the NEDRC. L-NMMA inhibits NO synthesis in vascular endothelium, and hence results in vasoconstriction under various stimuli. Data collection and statistic processing were performed by ANOVA analysis. The NEDRC data in Group 1 (control) was set to be 100%. In phase 1 study, our results showed that 1 week cigarette smoking significantly increased NEDRC in Group 2 (142.5%, p<0.01). However, 6 weeks smoking strikingly boosted the response of NEDRC in Group 3 (226.5%, p<0.01). In phase 2 study, Group 2 tibia showed the NEDRC under acetylcholine perfusion to be without any difference in comparison with Group 1 (p>0.05). Nevertheless, Group 3 tibia showed significant vasospasm even under acetylcholine perfusion. In phase 3 study, L-NMMA perfused data revealed that; Group 3 tibia had the highest NEDRC, i.e. the most severe vasospasm. Based on our study, both short-term and long-term cigarette smoking are hazardous to the bony vascular endothelium. The nitric oxide production significantly attenuated in Group 2 and 3 tibia. However, the adverse effect of smoking seems reversible in short-term (Group 2). Long-term smoking (Group 3) causes irreversible damage to vascular endothelium and muscarinic receptor.

scholarly journals Long-term Efficacy and Safety of Donepezil Dose Escalation for Patients with Alzheimer?s Disease in a Clinical Setting

2018 ◽  
pp. 1-6
Author(s):  
Nagaendran Kandiah ◽  
Laura Tan ◽  
Chathuri J Yatawara ◽  
Debby Ng ◽  
Nagaendran Kandiah
Keyword(s):  
Side Effects ◽  
Cognitive Decline ◽  
Dose Escalation ◽  
Clinical Setting ◽  
Phase 1 ◽  
Controlled Study ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Term Efficacy

Background: Donepezil is a routinely prescribed cognitive enhancer for patients with Alzheimer’s disease (AD), however the effectiveness and safety of long-term high doses remains largely unexplored. Objective: We investigated the long-term efficacy and safety of Donepezil dose escalation in reducing global cognitive decline for patients with AD in a clinical setting. Method: In a naturalistic, open-label, controlled study design, 71 mild to moderate AD patients from a tertiary clinic were prescribed Donepezil 5mg/day for 12 months (phase 1), while 9 AD patients received no treatment. Patients who showed limited benefits (N=30) with Donepezil 5mg/day were titrated up to 10mg/day for a subsequent 12 months (phase 2) and the remaining (N=41) patients continued on 5mg/day. The primary outcome was global cognition, indexed using the Mini-Mental State Examination (MMSE). Results: Phase 1 trends confirmed Donepezil 5mg/day was better than no treatment at reducing cognitive decline (p = .09, f=.18). Phase 2 trends indicated that for patients who showed limited response to Donepezil 5mg/day, Donepezil 10mg/day was more effective in reducing slope of cognitive decline (p = 0.13, f= .42). Additionally, the patients that were titrated up to 10mg/day had comparable treatment benefits to those patients that remained on 5mg/day during phase 2 (p = .32, f =.12). Side effects in the 10mg/day group were not significantly different from the side effects in the 5mg group (t (67)=-1.27, p=.21). Conclusion: Donepezil dose escalation in patients with AD is safe and may result in large noticeable effects on cognition, with effects comparable to patients who initially responded well to 5mg/day.

PENERAPAN MODEL QUANTUM LEARNING UNTUK MENINGKATKAN HASIL BELAJAR AUTOCAD SISWA KELAS X TEKNIK PEMESINAN SMK NEGERI 1 STABAT

2013 ◽  
Vol 5 (1) ◽  
Author(s):  
Abdul Hasan Saragih
Keyword(s):  
Positive Response ◽  
Phase 1 ◽  
First Grade ◽  
Learning Model ◽  
Second Phase ◽  
Phase 2 ◽  
Phase 3 ◽  
The Third ◽  
Third Phase ◽  
Quantum Learning

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst
Keyword(s):  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Drug Development ◽  
Phase 1 ◽  
Preclinical Studies ◽  
Phase 2 ◽  
Phase 3 ◽  
Preclinical Testing ◽  
New Drug ◽  
Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

scholarly journals PSVI-3 Dietary supplementation with coated omega-3 fatty acids has positive effects on growth performance and nutrients digestibility in weaned pigs

2020 ◽  
Vol 98 (Supplement_3) ◽  
pp. 196-197
Author(s):  
Woo Jung Seok ◽  
Je min Ahn ◽  
Jing Hu ◽  
Dexin Dang ◽  
Yanjiao Li ◽  
...  
Keyword(s):  
Fatty Acids ◽  
Growth Performance ◽  
Phase 1 ◽  
Dietary Supplementation ◽  
Basal Diet ◽  
Phase 2 ◽  
Omega 3 ◽  
Phase 3 ◽  
Linear Effect ◽  
Weaning Pigs

Abstract The objective of this study was to evaluate the effects of dietary supplementation of coated omega-3 fatty acid (n-3 CFA) by corn cob power silica on performance of weaning pigs. A total of 200 weaned pigs [(Landrace x Yorkshire) x Duroc, average initial body weight at 6.97 ± 1.22 kg] were randomly assigned to four experimental treatments in a 6-week experiment in 3 phases as follows: CON, basal diet; 2) 0.3CFA, CON + phase 1(0.3% n-3CFA), phase 2(0.2% n-3CFA), phase 3(0.1% n-3CFA); 3) 0.6CFA, CON + phase 1(0.6% n-3CFA), phase 2(0.4% n-3CFA), phase 3(0.2% n-3CFA); 4) 0.9CFA, CON + phase 1(0.9% n-3CFA), phase 2(0.6% n-3CFA), phase 3 (0.3% n-3CFA). Each treatment had 10 replicates with 5 pigs (three gilts and two barrows) per replicate. The data were analyzed using the GLM procedure of SAS as a randomized complete block design. Pen served as the experimental unit. Linear, quadratic and cubic polynomial contrasts were used to examine effect of dietary treatment with coated n-3FA in the basal diet. Variability in the data was expressed as the standard error of means and P&lt; 0.05 was considered to statistically significant. Increasing the level of n-3CFA in the diet linearly increased ADG and G/F of pigs (Table 1). Increasing the level of n-3CFA showed a linear increment in the digestibility of DM (83.59, 84.38, 85.13, 85.89 %) whereas nitrogen digestibility (81.79, 82.38, 82.96, 83.64 %) showed a trend (linear effect, p=0.0594) at the end of experiment. The fecal lactobacillus count was increased (7.22, 7.27, 7.33, 7.35 log10cfu/g) with the increase in the supplemental level of n-3CFA (linear effect; p&lt; 0.05). However, there were no differences in the concentration of serum haptoglobin, or fecal E. coli, Clostridium and Salmonella counts despite the increase in n-3CFA levels in the diet. Supplementation of the diet with coated n-3 fatty acids positively affected growth performance and digestibility of dry matter and nitrogen, and enhanced the count of lactobacillus in weaning pigs.

scholarly journals Dietary Inclusion of Blood Plasma with Yeast (Saccharomyces cerevisiae) Supplementation Enhanced the Growth Performance, Nutrient Digestibility, Lactobacillus Count, and Reduced Gas Emissions in Weaning Pigs

Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 759
Author(s):  
Vetriselvi Sampath ◽  
Dong Heon Baek ◽  
Sureshkumar Shanmugam ◽  
In Ho Kim
Keyword(s):  
Saccharomyces Cerevisiae ◽  
Phase 1 ◽  
Average Daily Gain ◽  
Nutrient Digestibility ◽  
Phase 2 ◽  
Phase 3 ◽  
Yeast Saccharomyces Cerevisiae ◽  
Yeast Phase ◽  
Weaning Pigs ◽  
Daily Gain

This experiment was performed to examine the hypothesis that blood plasma (BP) with yeast (Saccharomyces cerevisiae) supplement in the diet of weaning pigs could provoke the growth performance, nutrient digestibility, fecal microbial, and reduce harmful gas excretion. A total of one hundred and eighty healthy piglets were taken and assigned (complete random blocks) to three dietary treatments as: Phase 1: Treatment (TRT) 1-6% BP; TRT 2-3% BP + 3% yeast; TRT 3-6% yeast. Phase 2: TRT 1-3%; BP., TRT 2-1.5% BP + 1.5% yeast; TRT 3- 3% yeast. Phase 3: TRT 1- Control (CON) (Basal diet); TRT 2- CON; TRT 3- CON for six- weeks. Each treatment had twelve replicates and five (three gilts and two barrows) pigs per pen. Dietary inclusion of BP with yeast supplementation significantly increased the body weight of piglets during phase 2 (p = 0.003) and phase 3 (p = 0.032). In addition, TRT2 group piglets had a significant improvement in average daily gain at the end of each phase and overall (p = 0.047, 0.025, 0.018 and 0.012, respectively). At phase 3, TRT2 group piglets showed a significant improvement on nutrient digestibility of dry matter (p = 0.012) and nitrogen (p = 0.040). The fecal microbiota of TRT2 group piglets showed a tendency to increase the number of Lactobacillus counts at phase 1 (p = 0.07) and phase 2 (p = 0.06) as well as, a significant improvement at phase 3 (p = 0.021). In addition, TRT2 group piglets had trend to decrease NH3 (p = 0.074) and H2S (p = 0.069) during phase 2, and significantly reduced NH3 (p = 0.038) and H2S (p = 0.046) at phase 3. However, the fecal score of piglets remains unaffected during the entire trial. At the end of phase 1 piglets’ IgG (p = 0.008) was significantly increased with the inclusion of BP with yeast supplementation. Based on the positive effects on body weight, average daily gain, nutrient digestibility, Lactobacillus count, and reduced gas emission, we suggest that dietary supplement with BP and yeast in the diet of weaned piglet could serve as an excellent alternative to antibiotics growth promoters.

scholarly journals Phase 1 and Phase 2 Studies of Salmonella enterica Serovar Paratyphi A O-Specific Polysaccharide-Tetanus Toxoid Conjugates in Adults, Teenagers, and 2- to 4-Year-Old Children in Vietnam

2000 ◽  
Vol 68 (3) ◽  
pp. 1529-1534 ◽  
Author(s):  
Edward Y. Konadu ◽  
Feng-Ying C. Lin ◽  
Vô Anh Hó ◽  
Nguyen Thi Thanh Thuy ◽  
Phan Van Bay ◽  
...  
Keyword(s):  
Side Effects ◽  
Bactericidal Activity ◽  
Tetanus Toxoid ◽  
Salmonella Enterica ◽  
Phase 1 ◽  
Geometric Mean ◽  
Age Groups ◽  
Significant Rise ◽  
Phase 2 ◽  
Specific Polysaccharide

ABSTRACT Salmonella enterica serovar Paratyphi A O-specific polysaccharide (O-SP) was activated with 1-cyano-4-dimethylaminopyridinium tetrafluoroborate (CDAP) and bound to tetanus toxoid (TT) with adipic acid dihydrazide as a linker (SPA-TT1) or directly (SPA-TT2). In mice, these two conjugates elicited high levels of immunoglobulin G (IgG) anti-lipopolysaccharide (LPS) in serum with bactericidal activity (E. Konadu, J. Shiloach, D. A. Bryla, J. B. Robbins, and S. C. Szu, Infect. Immun. 64:2709–2715, 1996). The safety and immunogenicity of the two conjugates were then evaluated sequentially in Vietnamese adults, teenagers, and 2- to 4-year-old children. None of the vaccinees experienced significant side effects, and all had preexisting LPS antibodies. At 4 weeks after injection, there were significant increases of the geometric mean IgG and IgM anti-LPS levels in the adults and teenagers: both conjugates elicited a greater than fourfold rise in the IgG anti-LPS level in serum in ≥80% of the volunteers. SPA-TT2 elicited slightly higher, though not statistically significantly, levels of IgG anti-LPS than did SPA-TT1 in these age groups. Accordingly, only SPA-TT2 was evaluated in the 2- to 4-year-old children. On a random basis, one or two injections were administered 6 weeks apart to the children. No significant side effects were observed, and the levels of preexisting anti-LPS in serum were similar in children of all ages. A significant rise in the IgG anti-LPS titer was elicited by the first injection (P = 0.0001); a second injection did not elicit a booster response. Representative sera from all groups had bactericidal activity that could be adsorbed by S. enterica serovar Paratyphi A LPS.

Maturation promoting factor in ascidian oocytes is regulated by different intracellular signals at meiosis I and II

Development ◽  
1996 ◽  
Vol 122 (7) ◽  
pp. 1995-2003 ◽  
Author(s):  
G.L. Russo ◽  
K. Kyozuka ◽  
L. Antonazzo ◽  
E. Tosti ◽  
B. Dale
Keyword(s):  
Kinase Activity ◽  
Phase 1 ◽  
Polar Body ◽  
Calcium Transients ◽  
Phase 2 ◽  
Phase 3 ◽  
First Polar Body ◽  
Second Polar Body ◽  
Polar Body Extrusion ◽  
Maturation Promoting Factor

Using the fluorescent dye Calcium Green-dextran, we measured intracellular Ca2+ in oocytes of the ascidian Ciona intestinalis at fertilization and during progression through meiosis. The relative fluorescence intensity increased shortly after insemination in a single transient, the activation peak, and this was followed by several smaller oscillations that lasted for approximately 5 minutes (phase 1). The first polar body was extruded after the completion of the phase 1 transients, about 9 minutes after insemination, and then the intracellular calcium level remained at baseline for a period of 5 minutes (phase 2). At 14 minutes postinsemination a second series of oscillations was initiated that lasted 11 minutes (phase 3) and terminated at the time of second polar body extrusion. Phases 1 and 3 were inhibited by preloading oocytes with 5 mM heparin. Simultaneous measurements of membrane currents, in the whole-cell clamp configuration, showed that the 1–2 nA inward fertilization current correlated temporally with the activation peak, while a series of smaller oscillations of 0.1-0.3 nA amplitude were generated at the time of the phase 3 oscillations. Biochemical characterization of Maturation Promoting Factor (MPF) in ascidian oocytes led to the identification of a Cdc2-like kinase activity. Using p13suc1-sepharose as a reagent to precipitate the MPF complex, a 67 kDa (67 × 10(3) Mr) protein was identified as cyclin B. Histone H1 kinase activity was high at metaphase I and decreased within 5 minutes of insemination reaching a minimum level during phase 2, corresponding to telophase I. During phase 3, H1 kinase activity increased and then decayed again during telophase II. Oocytes preloaded with BAPTA and subsequently inseminated did not generate any calcium transients, nonetheless H1 kinase activity decreased 5 minutes after insemination, as in the controls, and remained low for at least 30 minutes. Injection of BAPTA during phase 2 suppressed the phase 3 calcium transients, and inhibited both the increase in H1 kinase activity normally encountered at metaphase II and second polar body extrusion.

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