Search results for: randomized trials

Authors: Onur Ercan, Buket Askin, Erdogan Kucukoner

Abstract:

Blueberry (Vaccinium corymbosum, bluegold) has become popular beverage due to their nutritional values such as vitamins, minerals, and antioxidants. In the study, the effects of pressing, mashing, enzymatic treatment, and pasteurization on anthocyanins, colour, and polyphenolics of blueberry juice (BJ) were studied. The blueberry juice (BJ) was produced with two different methods that direct juice extraction (DJE) and mash treatment process (MTP) were applied. After crude blueberry juice (CBJ) production, the samples were first treated with commercial enzymes [Novoferm-61 (Novozymes A/S) (2–10 mL/L)], to break down the hydrocolloid polysaccharides, mainly pectin and starch. The enzymes were added at various concentrations. The highest transmittance (%) was obtained for Novoferm-61 at a concentration of 2 mL/L was 66.53%. After enzymatic treatment, clarification trials were applied to the enzymatically treated BJs with adding various amounts of bentonite (10%, w/v), gelatin (1%, w/v) and kiselsol (15%, v/v). The turbidities of the clarified samples were then determined. However, there was no significant differences between transmittances (%) for samples. For that, only enzymatic treatment was applied to the blueberry juice processing (DDBJ, depectinized direct blueberry juice). Based on initial pressing process made to evaluate press function, it was determined that pressing fresh blueberries with no other processing did not render adequate juice due to lack of liquefaction. Therefore, the blueberries were mash into small pieces (3 mm) and then enzymatic treatments and clarification trials were performed. Finally, both BJ samples were pasteurized. Compositional analyses, colour properties, polyphenols and antioxidant properties were compared. Enzymatic treatment caused significant reductions in ACN content (30%) in Direct Blueberry Juice Processing (DBJ), while there was a significant increasing in Mash Treatment Processing (MTP). Overall anthocyanin levels were higher intreated samples after each processing step in MTP samples, but polyphenolic levels were slightly higher for both processes (DBJ and MTP). There was a reduction for ACNs and polyphenolics only after pasteurization. It has a result that the methods for tried to blueberry juice is suitable into obtain fresh juice. In addition, we examined fruit juice during processing stages; anthocyanin, phenolic substance content and antioxidant activity are higher, and yield is higher in fruit juice compared to DBJ method in MTP method, the MTP method should be preferred in processing juice of blueberry into fruit juice.

Keywords: anthocyanins, blueberry, depectinization, polyphenols

Procedia PDF Downloads 74

Authors: Nagwa E. Abd Elazim, Maha S. El-naggar, Rania H. Mohamed, Sara M. Awad

Abstract:

Background: Radiodermatitis is a common side effect of radiation therapy for breast cancer. However, there is no current consensus about effective standard therapy for the prevention and management of radiation dermatitis. Topical ectoine has demonstrated efficacy in the treatment of atopic dermatitis owing to its anti-inflammatory activity. Objective: To evaluate the efficacy of topical ectoine in comparison to traditional topical dexpanthenol treatment in the management of acute radiodermatitis in breast cancer patients undergoing adjuvant radiotherapy. Methods: Fifty patients were randomized to use either dexpanthenol 0.5% cream (25 patients), or ectoin 7% cream (25 patients), applied twice daily to the irradiated area during the radiation period and continued for 2 weeks after cessation of radiotherapy. Assessment of radiation skin toxicity using Common Terminology Criteria of Adverse Events (CTCAE) v4.0, radiation-associated symptoms, and adverse events were undertaken weekly during radiotherapy and 2 weeks after the end of radiotherapy. Results: Topical ectoine showed some clinical benefit over dexpanthenol, as shown by delayed time to onset (at week 3 versus week 2, respectively) and larger number of patients who reached grade 0 at the end of treatment (64% vs. 48%, respectively). The clinical symptoms of pain (p = 0.003) and itching (p = 0.001) attributable to radiation were less pronounced with ectoine than with dexpanthenol. Burning and hyperpigmentation were the most common side effects with ectoine. However, no significant difference between dexpanthenol and ectoine treatments was found in any of the side effects (p = 0.1). Conclusion: Ectoin was overall more effective in improving radiation dermatitis than topical dexpanthenol in breast cancer patients. Ectoin could be proposed as a preventive or curative treatment for patients undergoing postoperative irradiation for breast cancer. Further clinical studies with a larger number of patients are recommended for the confirmation of these preliminary results.

Keywords: breast cancer, dexapanthenol, ectoin, radiation dermatitis

Procedia PDF Downloads 111

Authors: Hasanzadeh Tahraband F., Kheirkhah M.

Abstract:

The trauma resulting from abortion causes fear, frustration, inability, lack of self-confidence, and psychological distress in women. The present study was conducted to determine the effect of midwifery counseling based on the Gamble approach on coping strategies of women with abortion. This randomized controlled clinical trial was conducted on women with abortions in April–October 2021, Karaj, Iran. Ninety-six eligible women were randomly assigned to two 48-member groups with 4, 6, and 8 blocks. The women in the intervention group participated in two 45-75-minute Gamble counseling programs. They were asked to fill out the demographic and fertility information questionnaire before the intervention and the cope operations preference inquiry questionnaire before, immediately (in the 4-6th week of the study), and three months after the intervention. The analysis of the data was done through Chi-square, independent sample t-test. The significance level was considered P<0.05. The results showed that the differences between the two groups before the intervention were not statistically significant in terms of demographic and fertility variables (P>0.05). However, the total mean score of the problem-focused dimension in 3-month post-abortion (97/34±8/69) and the emotion-focused dimension in 4-6 weeks and 3-month post-abortion (34/14±3/48 and 32/41±3/41) in the intervention group was significantly different from the control group (P<0.001). According to the results of the repeated measures ANOVA, the level of coping and its dimensions significantly changed in the intervention group over time (P<0.001). The results of the present study showed that Gamble counseling promoted the problem-focused dimension score and reduced the emotion-focused dimension score in women with abortion. It is recommended that Gamble counseling should be used as midwife-led counseling to increase coping strategies and reduce the psychological distress of women who have experienced abortion.

Keywords: midwife-led counseling, coping strategies, post-abortion, psychological distress, Iran

Procedia PDF Downloads 85

Authors: Gordana Branković, Vesna Dragičević, Dejan Dodig, Desimir Knežević, Srbislav Denčić, Gordana Šurlan-Momirović

Abstract:

Phytic acid is a major pool in the flux of phosphorus through agroecosystems and represents a sum equivalent to > 50% of all phosphorus fertilizer used annually. Nutrition rich in phytic acid can substantially decrease micronutrients apsorption as calcium, zink, iron, manganese, copper due to phytate salts excretion by human and non-ruminant animals as poultry, swine and fish, having in common very scarce phytase activity, and consequently the ability to digest and utilize phytic acid, thus phytic acid derived phosphorus in animal waste contributes to water pollution. The tested accessions consisted of 15 genotypes of bread wheat (Triticum aestivum L. ssp. vulgare) and of 15 genotypes of durum wheat (Triticum durum Desf.). The trials were sown at the three test sites in Serbia: Rimski Šančevi (RS) (45º19´51´´N; 19º50´59´´E), Zemun Polje (ZP) (44º52´N; 20º19´E) and Padinska Skela (PS) (44º57´N 20º26´E) during two vegetation seasons 2010-2011 and 2011-2012. The experimental design was randomized complete block design with four replications. The elementary plot consisted of 3 internal rows of 0.6 m2 area (3 × 0.2 m × 1 m). Grains were grinded with Laboratory Mill 120 Perten (“Perten”, Sweden) (particles size < 500 μm) and flour was used for the analysis. Phytic acid grain content was determined spectrophotometrically with the Shimadzu UV-1601 spectrophotometer (Shimadzu Corporation, Japan). Objectives of this study were to determine: i) variability and stability of the phytic acid content among selected genotypes of bread and durum wheat, ii) predominant source of variation regarding genotype (G), environment (E) and genotype × environment interaction (GEI) from the multi-environment trial, iii) influence of climatic variables on the GEI for the phytic acid content. Based on the analysis of variance it had been determined that the variation of phytic acid content was predominantly influenced by environment in durum wheat, while the GEI prevailed for the variation of the phytic acid content in bread wheat. Phytic acid content expressed on the dry mass basis was in the range 14.21-17.86 mg g-1 with the average of 16.05 mg g-1 for bread wheat and 14.63-16.78 mg g-1 with the average of 15.91 mg g-1 for durum wheat. Average-environment coordination view of the genotype by environment (GGE) biplot was used for the selection of the most desirable genotypes for breeding for low phytic acid content in the sense of good stability and lower level of phytic acid content. The most desirable genotypes of bread and durum wheat for breeding for phytic acid were Apache and 37EDUYT /07 No. 7849. Models of climatic factors in the highest percentage (> 91%) were useful in interpreting GEI for phytic acid content, and included relative humidity in June, sunshine hours in April, mean temperature in April and winter moisture reserves for genotypes of bread wheat, as well as precipitation in June and April, maximum temperature in April and mean temperature in June for genotypes of durum wheat.

Keywords: genotype × environment interaction, phytic acid, stability, variability

Procedia PDF Downloads 370

Authors: In Kyong Yi, Yun Jeong Chae, Jihoon Hwang, Sook-Young Lee, Jong-Yeop Kim

Abstract:

Background: Pentax airway scope (AWS) is a recently developed video laryngoscope for use in both normal and difficult airways, providing a good laryngeal view. The purpose of this randomized noninferior study was to evaluate the efficacy of the Pentax-AWS regarding intubation time, laryngeal view and ease of intubation in pediatric patients with normal airway, compared to Macintosh laryngoscope. Method: A total of 136 pediatric patients aged 1 to 10 with American Society of Anesthesiologists physical status I or II undergoing general anesthesia required orotracheal intubation were randomly allocated into two groups: Macintosh laryngoscope (n =68) and Pentax AWS (n=68). Anesthesia was induced with propofol, rocuronium, and sevoflurane. The primary outcome was intubation time. Cormack-Lehane laryngeal view grade, application of optimal laryngeal external manipulation (OELM), intubation difficulty scale (IDS), intubation failure rate and adverse events were also measured. Result: No significant difference was observed between the two groups regarding intubation time (Macintosh; 23[22-26] sec vs. Pentax; 23.5[22-27.75] sec, p=0.713). As for the laryngeal view grade, the Pentax group showed less number of grade 2a or higher grade cases compared to the Macintosh group (1/2a/2b/3; 52.9%/41.2%/4.4%/1.5% vs. 98.5%/1.5%/0%/0%, p=0.000). No optimal laryngeal external manipulation application was required in the Pentax group (38.2% vs. 0%, p=0.000). Intubation difficulty scale resulted in lower values for Pentax group (0 [0-2] vs. 0 [0-0.55], p=0.001). Failure rate was not different between the two groups (1.5% vs. 4.4%, p=0.619). Adverse event-wise, slightly higher incidence of bleeding (1.5% vs. 5.9%, p=0.172) and teeth injury (0% vs. 5.9%, p=0.042) occurred in the Pentax group. Conclusion: In conclusion, Pentax-AWS provided better laryngeal view, similar intubation time and similar success rate compared with Macintosh laryngoscope in children with normal airway. However, the risk of teeth injury might increase and warrant special attention.

Keywords: Pentax-AWS, pediatric, video laryngoscope, intubation

Procedia PDF Downloads 183

Authors: Nam Sze Cheng, P. C. Janita Chau

Abstract:

Background: Eczema is a chronic inflammatory disease with high global prevalence rates in many childhood populations. It is also the most common paediatric skin problem. Although eczema education and proper skin care were effective in controlling eczema symptoms, the lack of both sufficient time for patient consultation and structured eczema education programme hindered the transferability of knowledge to patients and their parents. As a result, these young patients and their families suffer from a significant physical disability and psychological distress, which can substantially impair their quality of life. Objectives: This integrative review is to examine the effects of educational interventions for children with eczema and identify the core elements associated with an effective intervention. Methods: This integrative review targeted all articles published in 10 databases between May 2016 and February 2017 that reported the outcomes of disease interventions of any format for children and adolescents with the clinical diagnosis of eczema who were under 18 years of age. Five randomized controlled trials (RCT) and one systematic review of 10 RCTs were identified for review. All these publications had high methodological quality, except one study of web-based eczema education that was limited by selection bias and poor subject blinding. Findings: This review found that most studies adopted nurse-led or multi-disciplinary parental eczema education programme at the outpatient clinic setting. The format of these programmes included individual lectures, demonstration and group sharing, and the educational materials covered basic eczema knowledge and management as well as methods to interrupt itch-scratch cycle. The main outcome measures of these studies included severity of eczema symptoms, treatment adherence and quality of life of both patients and their families. Nine included studies reported statistically significant improvement in the primary outcome of symptom severity of these eczematous children. On the other hand, all these reviews failed to identify an effective dosage of intervention under these educational programmes that was attributed to the heterogeneity of the interventions. One study that was designed based on the social cognitive theory to guide the interventional content yielded statistically significant results. The systematic review recommended the importance of measuring parental self-efficacy. Implication: This integrative review concludes that structured educational programme can help nurses understand the theories behind different health interventions. They can then deliver eczema education to their patients in a consistent manner. These interventions also result in behavioral changes through patient education. Due to the lack of validated educational programmes in Chinese, it is imperative to conduct an RCT of eczema educational programme to investigate its effects on eczema severity, quality of life and treatment adherence in Hong Kong children as well as to promote the importance of parental self-efficacy.

Keywords: children, eczema, education, intervention

Procedia PDF Downloads 98

Authors: Andreas Aceranti, Stefano Costa

Abstract:

The aim of this study was to demonstrate that manipulative treatment combined with therapeutic exercisetherapywas more effective than isolated therapeutic exercise in the short-term treatment of eye convergence disorders in boxers. A randomized controlled trial (RCT) pilot trial was performed at our physiotherapy practices. 30 adult subjects who practice the discipline of boxing were selected after an initial skimming defined by the Convergence Insufficiency Symptom Survey (CISS) test (results greater than or equal to 10) starting from the initial sample of 50 subjects; The 30 recruits were evaluated by an orthoptist using prisms to know the diopters of each eye and were divided into 2 groups (experimental group and control group). The members of the experimental group were subjected to manipulation of the lateral strain of sphenoid from the side contralateral to the eye that had fewer diopters and were subjected to a sequence of 3 ocular motor exercises immediately after manipulation. The control group, on the other hand, received only ocular motor treatment. A secondary outcome was also drawn up that demonstrated how changes in ocular motricity also affected cervical rotation. Analysis of the data showed that the experimental treatment was in the short term superior to the control group to astatistically significant extent both in terms of the prismatic delta of the right eye (0 OT median without manipulation and 10 OT median with manipulation) and that of the left eye (0 OT median without manipulation and 5 OT median with manipulation). Cervical rotation values also showed better values in the experimental group with a median of 4° in the right rotation without manipulation and 6° with thrust; the left rotation presented a median of 2° without manipulation and 7° with thrust. From the results that emerged, the treatment was effective. It would be desirable to increase the sample number and set up a timeline to see if the net improvements obtained in the short term will also be maintained in the medium to long term.

Keywords: boxing, basilar spheno synchondrosis, ocular convergence deficit, osteopathic treatment

Procedia PDF Downloads 65

Authors: Madaki Umar Yusuf, Mohd Rizam B. Abubakar

Abstract:

The survival censored data with incomplete covariate data is a common occurrence in many studies in which the outcome is survival time. With model when the missing covariates are categorical, a useful technique for obtaining parameter estimates is the EM by the method of weights. The survival outcome for the class of generalized linear model is applied and this method requires the estimation of the parameters of the distribution of the covariates. In this paper, we propose some clinical trials with ve covariates, four of which have some missing values which clearly show that they were fully censored data.

Keywords: EM algorithm, incomplete categorical covariates, ignorable missing data, missing at random (MAR), Weibull Distribution

Procedia PDF Downloads 383

Authors: Md. Mustakimur Rahman

Abstract:

On the one hand, while dealing with temporally distant international crimes (TDICs), prosecutors are likely to encounter many defendants suffering from severe physical or mental disorders. The concept of a defendant's "fitness," on the other hand, is based on the notion that an alleged perpetrator must be protected from a conviction resulting from a lack of participation or competence in making proper judgments. As a result, if a defendant is temporarily or permanently mentally ill, going through a formal criminal trial may be highly unlikely. TheExtraordinary Chambers in the Courts of Cambodia(ECCC), for example, arrested and tried IengThirth for crimes against humanity, grave breaches of the 1949 Geneva Conventions, and genocide. Still, the Trial Chamber found her incompetent to stand trial and released her in 2011. Although the prosecution had a lot of evidence against her, she was free from prosecution. It suggests that alleged war criminals may be granted immunity due to their unfitness, implying that unfitness is a hurdle to combating impunity. Given the absence of a formal criminal trial, international criminal law (ICL) should take steps to address this issue. ICL, according to Mark A. Drumbl, has yet to develop its penology; hence it borrows penological rationales from domestic criminal law. For example, international crimes tribunals such as the Nuremberg Tribunal and the Tokyo Tribunal, ad hoc tribunals have used retribution, utilitarianism, and rehabilitation as punishment justifications. On the other hand, like in the case of IengThirth, a criminal trial may not always be feasible. As a result, instead of allowing impunity, this paper proposes informal trials. This paper, for example, suggests two approaches to dealing with unfit defendants: 1) trial without punishment and 2) punishment without trial. Trial without punishment is a unique method of expressing condemnation without incarceration. "Expressivism has a broader basis than communication of punishment and sentencing," says Antony Duff. According to Drumbl, we can untangle our understanding of punishment from "the iconic preference for jailhouses" to include a larger spectrum of non-incarcerative measures like "recrimination, shame, consequence, and sanction." Non-incarcerative measures allow offenders to be punished without going through a formal criminal trial. This strategy denotes accountability for unlawful behavior. This research concludes that in many circumstances, prosecuting elderly war crimes suspects is difficult or unfeasible, but their age or illness should not be grounds for impunity. They should be accountable for their heinous activities through criminal trials or other mechanisms.

Keywords: international criminal law, international criminal punishment, international crimes tribunal, temporally distant international crimes

Procedia PDF Downloads 61

Authors: Prakash M.N, Mahesh G, Muhammed Rafi K.M, Shiju P. Nair

Abstract:

Introduction: In launch vehicle missions, Reaction Control thrusters are being used for the three-axis stabilization of the vehicle during the coasting phases. A pressure-fed propulsion system is used for the operation of these thrusters due to its less complexity. In liquid stages, these thrusters are designed to draw propellant from the same tank used for the main propulsion system. So in order to regulate the propellant flow rates of these thrusters, flow control orifices are used in feed lines. These orifices are calibrated separately as per the flow rate requirement of individual thrusters for the nominal operating conditions. In some missions, it was observed that the thrusters were operated at higher thrust than nominal. This point was addressed through a series of cold flow and hot tests carried out in-ground and this paper elaborates the details of the same. Discussion: In order to find out the exact reason for this phenomenon, two flight configuration thrusters were identified and hot tested in the ground with calibrated orifices and feed lines. During these tests, the chamber pressure, which is directly proportional to the thrust, is measured. In both cases, chamber pressures higher than the nominal by 0.32bar to 0.7bar were recorded. The increase in chamber pressure is due to an increase in the oxidizer flow rate of both the thrusters. Upon further investigation, it is observed that the calibration of the feed line is done with ambient pressure downstream. But in actual flight conditions, the orifices will be subjected to operate with 10 to 11bar pressure downstream. Due to this higher downstream pressure, the flow through the orifices increases and thereby, the thrusters operate with higher chamber pressure values. Conclusion: As part of further investigatory tests, two numbers of fresh thrusters were realized. Orifice tuning of these thrusters was carried out in three different ways. In the first trial, the orifice tuning was done by simulating 1bar pressure downstream. The second trial was done with the injector assembled downstream. In the third trial, the downstream pressure equal to the flight injection pressure was simulated downstream. Using these calibrated orifices, hot tests were carried out in simulated vacuum conditions. Chamber pressure and flow rate values were exactly matching with the prediction for the second and third trials. But for the first trial, the chamber pressure values obtained in the hot test were more than the prediction. This clearly shows that the flow is detached in the 1st trial and attached for the 2nd & 3rd trials. Hence, the error in tuning the flow control orifices is pinpointed as the reason for this higher chamber pressure observed in flight.

Keywords: reaction control thruster, propellent, orifice, chamber pressure

Procedia PDF Downloads 184

Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

Abstract:

Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

Procedia PDF Downloads 219

Authors: Salwa Mohamed Salah Eldin, Howida Kamal Ibrahim

Abstract:

Introduction: Major depressive disorder affects high proportion of the world’s population presenting cost load in health care. Extended release venlafaxine is more convenient and could reduce discontinuation syndrome. The once daily dosing also reduces the potential for adverse events such as nausea due to reduced Cmax. Venlafaxine is an effective first-line agent in the treatment of depression. A once daily formulation was designed to enhance patient compliance. Complexing with a resin was suggested to improve loading of the water soluble drug. The formulated systems were thoroughly evaluated in vitro to prove superiority to previous trials and were compared to the commercial extended release product in experimental animals. Materials and Methods: Venlafaxine-resinates were prepared using Dowex®50WX4-400 and Dowex®50WX8-100 at drug to resin weight ratio of 1: 1. The prepared resinates were evaluated for their drug content, particle shape and surface properties and in vitro release profile in gradient pH. The release kinetics and mechanism were evaluated. Venlafaxine-Dowex® resinates were encapsulated using O/W solvent evaporation technique. Poly-ε-caprolactone, Poly(D, L-lactide-co-glycolide) ester, Poly(D, L-lactide) ester and Eudragit®RS100 were used as coating polymers alone and in combination. Drug-resinate microcapsules were evaluated for morphology, entrapment efficiency and in-vitro release profile. The selected formula was tested in rabbits using a randomized, single-dose, 2-way crossover study against Effexor-XR tablets under fasting condition. Results and Discussion: The equilibrium time was 30 min for Dowex®50WX4-400 and 90 min for Dowex®50WX8-100. The percentage drug loaded was 93.96 and 83.56% for both resins, respectively. Both drug-Dowex® resintes were efficient in sustaining venlafaxine release in comparison to the free drug (up to 8h.). Dowex®50WX4-400 based venlafaxine-resinate was selected for further encapsulation to optimize the release profile for once daily dosing and to lower the burst effect. The selected formula (coated with a mixture of Eudragit RS and PLGA in a ratio of 50/50) was chosen by applying a group of mathematical equations according to targeted values. It recorded the minimum burst effect, the maximum MDT (Mean dissolution time) and a Q24h (percentage drug released after 24 hours) between 95 and 100%. The 90% confidence intervals for the test/reference mean ratio of the log-transformed data of AUC0–24 and AUC0−∞ are within (0.8–1.25), which satisfies the bioequivalence criteria. Conclusion: The optimized formula could be a promising extended release form of the water soluble, short half lived venlafaxine. Being a multiple unit formulation, it lowers the probability of dose dumping and reduces the inter-subject variability in absorption.

Keywords: biodegradable polymers, cation-exchange resin, microencapsulation, venlafaxine hcl

Procedia PDF Downloads 381

Authors: Norimichi Nagano, Yoshio Hirano, Tsutomu Yasukawa

Abstract:

Mesenchymal stem cells are thought to confer neuroprotection, facilitate tissue regeneration and exert their effects on retinal degenerative diseases, however, adverse events such as proliferative vitreoretinopathy and preretinal membrane disease associated with cell suspension transplantation have also been reported. We have recently developed human (allogeneic) adipose tissue-derived mesenchymal stem cell (adMSC) sheets through our proprietary sheet transformation technique, which could potentially mitigate these adverse events. To clarify the properties of our adMSC sheets named PAL-222, we performed in vitro studies such as viability testing, cytokine secretions by ELISA, immunohistochemical study, and migration assay. The viability of the cells exceeded 70%. Vascular Endothelial Growth Factor (VEGF) and Pigment Epithelium-Derived Factor (PEDF), which are quite important cytokines for the retinal area, were observed. PAL-222 expressed type I collagen, a strength marker, type IV collagen, a marker of the basement membrane, and elastin, an elasticity marker. Finally, the migration assay was performed and showed negative, which means that PAL-222 is stably kept in the topical area and does not come to pieces. Next, to evaluate the efficacy in vivo, we transplanted PAL-222 into the subretinal space of the eye of Royal College of Surgeons rats with congenital retinal degeneration and assessed it for three weeks after transplantation. We confirmed that PAL-222 suppressed the decrease in the thickness of the outer nuclear layer, which means that the photoreceptor protective effect treated with PAL-222 was significantly higher than that in the sham group. (p < 0.01). This finding demonstrates that PAL-222 showed their retinoprotective effect in a model of congenital retinal degeneration. As the study suggested the efficacy of PAL-222 in both in vitro and in vivo studies, we are presently engaged in clinical trials of PAL-222 for myopic chorioretinal atrophy, which is one of the retinal degenerative diseases, for the purpose of regenerative medicine.

Keywords: cell sheet, clinical trial, mesenchymal stem cell, myopic chorioretinal atrophy

Procedia PDF Downloads 62

Authors: Nawaf Al Khashram, Graham Arnold, Weijie Wang

Abstract:

Background—Gait classifying allows clinicians to differentiate gait patterns into clinically important categories that help in clinical decision making. Reliable comparison of gait data between normal and patients requires knowledge of the gait parameters of normal children's specific age group. However, there is still a lack of the gait database for normal children of different ages. Objectives—The aim of this study is to investigate the kinematics of the lower limb joints during gait for normal children in different age groups. Methods—Fifty-three normal children (34 boys, 19 girls) were recruited in this study. All the children were aged between 5 to 16 years old. Age groups were defined as three types: young child aged (5-7), child (8-11), and adolescent (12-16). When a participant agreed to take part in the project, their parents signed a consent form. Vicon® motion capture system was used to collect gait data. Participants were asked to walk at their comfortable speed along a 10-meter walkway. Each participant walked up to 20 trials. Three good trials were analyzed using the Vicon Plug-in-Gait model to obtain parameters of the gait, e.g., walking speed, cadence, stride length, and joint parameters, e.g. joint angle, force, moments, etc. Moreover, each gait cycle was divided into 8 phases. The range of motion (ROM) angle of pelvis, hip, knee, and ankle joints in three planes of both limbs were calculated using an in-house program. Results—The temporal-spatial variables of three age groups of normal children were compared between each other; it was found that there was a significant difference (p < 0.05) between the groups. The step length and walking speed were gradually increasing from young child to adolescent, while cadence was gradually decreasing from young child to adolescent group. The mean and standard deviation (SD) of the step length of young child, child and adolescent groups were 0.502 ± 0.067 m, 0.566 ± 0.061 m and 0.672 ± 0.053 m, respectively. The mean and SD of the cadence of the young child, child and adolescent groups were 140.11±15.79 step/min, 129±11.84 step/min, and a 115.96±6.47 step/min, respectively. Moreover, it was observed that there were significant differences in kinematic parameters, either whole gait cycle or each phase. For example, RoM of knee angle in the sagittal plane in whole cycle of young child group is (65.03±0.52 deg) larger than child group (63.47±0.47 deg). Conclusion—Our result showed that there are significant differences between each age group in the gait phases and thus children walking performance changes with ages. Therefore, it is important for the clinician to consider age group when analyzing the patients with lower limb disorders before any clinical treatment.

Keywords: age group, gait analysis, kinematics, normal children

Procedia PDF Downloads 103

Authors: R. S. Giraddi, B. Thirupam Reddy, D. N. Kambrekar

Abstract:

Chilli (Capsicum annum L.) an important commercial vegetable crop is ravaged by a number of insect-pests during both vegetative and reproductive phase resulting into significant crop loss.Thrips, Scirtothripsdorsalis, mite, Polyphagotarsonemuslatus and whitefly, Bemisiatabaci are the key sap feeding insects, their infestation leads to leaf curl, stunted growth and yield loss.During flowering and fruit formation stage, gall midge fly, Asphondyliacapparis (Rubsaaman) infesting flower buds and young fruits andHelicoverpaarmigera (Hubner) feeding on matured green fruits are the important insect pests causing significant crop loss.The pest is known to infest both flower buds and young fruits resulting into malformation of flower buds and twisting of fruits.In order to manage these insect-pests a combi product consisting of imidacloprid and betacyfluthrin (Soloman 300 OD) was evaluated for its bio-efficacy, phytotoxicity and effect on predator activity.Imidacloprid, a systemic insecticide belonging to neo-nicotinoid group, is effective against insect pests such as aphids, whiteflies (sap feeders) and other insectsviz., termites and soil insects.Beta-Cyfluthrin is an insecticide of synthetic pyrethroid group which acts by contact action and ingestion. It acts on the insects' nervous system as sodium channel blocker consequently a disorder of the nervous system occurs leading finally to the death. The field experiments were taken up during 2015 and 2016 at the Main Agricultural Research Station of University of Agricultural Sciences, Dharwad, Karnataka, India.The trials were laid out in a Randomized Block Design (RBD) with three replications using popular land race of Byadagi crop variety.Results indicated that the product at 21.6 + 50.4% gai/ha (240 ml/ha) and 27.9 + 65% gai/ha (310 ml/ha) was found quite effective in controlling thrips (0.00 to 0.66 thrips per six leaves) as against the standard check insecticide recommended for thrips by the University of Agricultural Sciences, Dharwad wherein the density of thrips recorded was significantly higher (1.00 to 2.00 Nos./6 leaves). Similarly, the test insecticide was quite effective against other target insects, whiteflies, fruit borer and gall midge fly as indicated by lower insect population observed in the treatments as compared to standard insecticidal control. The predatory beetle activity was found to be normal in all experimental plots. Highest green fruit yield of 5100-5500 kg/ha was recorded in Soloman 300 OD applied crop at 310 ml/ha rate as compared to 4750 to 5050 kg/ha recorded in check. At present 6-8 sprays of insecticides are recommended for management of these insect-pests on the crop. If combi-products are used in pest management programmes, it is possible to reduce insecticide usages in crop ecosystem.

Keywords: Imidacloprid, Betacyfluthrin, gallmidge fly, thrips, chilli

Procedia PDF Downloads 140

Authors: Mohammad Javaherian, Siamak Bashardoust Tajali, Monavvar Hadizadeh

Abstract:

Objective: This systematic review study was conducted to evaluate the effects of Pulsed Electromagnetic (PEMF) and Static Magnetic Fields (SMG) on pain relief and functional improvement in patients with musculoskeletal Low Back Pain (LBP). Methods: Seven electronic databases were searched by two researchers independently to identify the published Randomized Controlled Trials (RCTs) on the efficacy of pulsed electromagnetic, static magnetic, and therapeutic nuclear magnetic fields. The identified databases for systematic search were Ovid Medline®, Ovid Cochrane RCTs and Reviews, PubMed, Web of Science, Cochrane Library, CINAHL, and EMBASE from 1968 to February 2016. The relevant keywords were selected by Mesh. After initial search and finding relevant manuscripts, all references in selected studies were searched to identify second hand possible manuscripts. The published RCTs in English would be included to the study if they reported changes on pain and/or functional disability following application of magnetic fields on chronic musculoskeletal low back pain. All studies with surgical patients, patients with pelvic pain, and combination of other treatment techniques such as acupuncture or diathermy were excluded. The identified studies were critically appraised and the data were extracted independently by two raters (M.J and S.B.T). Probable disagreements were resolved through discussion between raters. Results: In total, 1505 abstracts were found following the initial electronic search. The abstracts were reviewed to identify potentially relevant manuscripts. Seventeen possibly appropriate studies were retrieved in full-text of which 48 were excluded after reviewing their full-texts. Ten selected articles were categorized into three subgroups: PEMF (6 articles), SMF (3 articles), and therapeutic nuclear magnetic fields (tNMF) (1 article). Since one study evaluated tNMF, we had to exclude it. In the PEMF group, one study of acute LBP did not show significant positive results and the majority of the other five studies on Chronic Low Back Pain (CLBP) indicated its efficacy on pain relief and functional improvement, but one study with the lowest sessions (6 sessions during 2 weeks) did not report a significant difference between treatment and control groups. In the SMF subgroup, two articles reported near significant pain reduction without any functional improvement although more studies are needed. Conclusion: The PEMFs with a strength of 5 to 150 G or 0.1 to 0.3 G and a frequency of 5 to 64 Hz or sweep 7 to 7KHz can be considered as an effective modality in pain relief and functional improvement in patients with chronic low back pain, but there is not enough evidence to confirm their effectiveness in acute low back pain. To achieve the appropriate effectiveness, it is suggested to perform this treatment modality 20 minutes per day for at least 9 sessions. SMFs have not been reported to be substantially effective in decreasing pain or improving the function in chronic low back pain. More studies are necessary to achieve more reliable results.

Keywords: pulsed electromagnetic field, static magnetic field, magnetotherapy, low back pain

Procedia PDF Downloads 187

Authors: Mohamed Salaheldien Mohamed Alayat, Ahmed Mohamed Elsoudany, Roaa Abdulghani Sroge, Bayan Muteb Aldhahwani

Abstract:

Background: Neck pain is a common illness that could affect individual’s daily activities. Class IV laser with longer wavelength can stimulate tissues and penetrate more than the classic low-level laser therapy. Objectives: The aim of the study was to investigate the efficacy of class IV diode laser in the treatment of patients with chronic neck pain (CNP). Methods: Fifty-two patients participated and completed the study. Their mean age (SD) was 50.7 (6.2). Patients were randomized into two groups and treated with laser plus exercise (laser + EX) group and placebo laser plus exercise (PL+EX) group. Treatment was performed by Class IV laser in two phases; scanning and trigger point phases. Scanning to the posterior neck and shoulder girdle region with 4 J/cm2 with a total energy of 300 J applied to 75 cm2 in 4 minutes and 16 seconds. Eight trigger points on the posterior neck area were treated by 4 J/cm2 and the time of application was in 30 seconds. Both groups received exercise two times per week for 4 weeks. Exercises included range of motion, isometric, stretching, isotonic resisted exercises to the cervical extensors, lateral bending and rotators muscles with postural correction exercises. The measured variables were pain level using visual analogue scale (VAS), and neck functional activity using neck disability index (NDI) score. Measurements were taken at baseline and after 4 weeks of treatment. The level of statistical significance was set as p < 0.05. Results: There were significant decreases in post-treatment VAS and NDI in both groups as compared to baseline values. Laser + EX effectively decreased VAS (mean difference -6.5, p = 0.01) and NDI scores after (mean difference -41.3, p = 0.01) 4 weeks of treatment compared to PL + EX. Conclusion: Class IV laser combined with exercise is effective treatment for patients with CNP as compared to PL + EX therapy. The combination of laser + EX effectively increased functional activity and reduced pain after 4 weeks of treatment.

Keywords: chronic neck pain, class IV laser, exercises, neck disability index, visual analogue scale

Procedia PDF Downloads 288

Authors: Ritu Nambiar, Shazia Tariq, Sumaira Jamil, Farida Munawar, Imelda Israell

Abstract:

GBS has emerged as a leading cause of neonatal infections worldwide and clinical trials have demonstrated that giving IAP was effective in reducing early onset GBS (EOGBS) disease of the newborn. There is no available data on the prevalence of GBS in the UAE, therefore, a retrospective chart analysis of our parturients were done to look at our prevalence. The aim of this study is: 1. To study the prevalence of GBS colonization of parturients at al Rahba Hospital following universal screening between 35-37 week. 2. To look at efficacy of GBS intrapartum antibiotic prophylaxis by NICU admission for EO GBS disease of the newborn. 1) The prevalence of GBS in our patient population is 24.15%. 2) Incidence of EO GBS disease of the newborn was 0.6%.

Keywords: GBS Screening, universal intrapartum antibiotic prophylaxis, parturients, newborn

Procedia PDF Downloads 369

Authors: N. Schneider, M. Bruchhage, M. Hartweg, G. Mutungi, J. O Regan, S. Deoni

Abstract:

Observational neuroimaging studies suggest differences between breast-fed and formula-fed infants in developmental myelination, a key brain process for learning and cognitive development. However, the possible effects of a nutrient formulation on myelin development in healthy term infants in an intervention study have not been investigated. Objective was, therefore, to investigate the efficacy of a nutrient formulation with higher levels of myelin-relevant nutrients as compared to a control formulation with lower levels of the same nutrients on brain myelination and cognitive development in the first 6 months of life. The study is an ongoing randomized, controlled, double-blind, two-center, parallel-group clinical trial with a nonrandomized, non-blinded arm of exclusively breastfed infants. The current findings result from a staged statistical analysis at 6 months; the recruitment and intervention period has been completed for all participants. Follow-up visits at 12, 18 and 24 months are still ongoing. N= 81 enrolled full term, neurotypical infants of both sexes were randomized into either the investigational (N= 42) or the control group (N= 39), and N= 108 children in the breast-fed arm served as a natural reference group. The effect of a blend of docosahexaenoic acid, arachidonic acid, iron, vitamin B12, folic acid as well as sphingomyelin from a uniquely proceed whey protein concentrate enriched in alpha-lactalbumin and phospholipids in an infant nutrition product matrix was investigated. The main outcomes for the staged statistical analyses at 6 months included brain myelination measures derived from MRI. Additional outcomes were brain volume, cognitive development and safety. The full analyses set at 6 months comprised N= 66 infants. Higher levels of myelin-relevant nutrients compared to lower levels resulted in significant differences in myelin structure, volume, and rate of myelination as early as 3 and 6 months of life. The cross-sectional change of means between groups for whole-brain myelin volume was 8.4% for investigational versus control formulation (3.5% versus the breastfeeding reference) group at 3 months and increased to 36.4% for investigational versus control formulation (14.1% versus breastfeeding reference) at 6 months. No statistically significant differences were detected for early cognition scores. Safety findings were largely similar across groups. This is the first pediatric nutritional neuroimaging study demonstrating the efficacy of a myelin nutrient blend on developmental myelination in well-nourished term infants. Myelination is a critical process in learning and development. The effects were demonstrated across the brain, particularly in temporal and parietal regions, known to be functionally involved in sensory, motor and language skills. These first results add to the field of nutritional neuroscience by demonstrating early life nutrition benefits for brain architecture which may be foundational for later cognitive and behavioral outcomes. ClinicalTrials.gov Identifier: NCT03111927 (Infant Nutrition and Brain Development - Full-Text View - ClinicalTrials.gov).

Keywords: brain development, infant nutrition, MRI, myelination

Procedia PDF Downloads 171

Authors: Arief, Noovirman Jamarun, Benni Satria

Abstract:

Background: The main problem in the development of livestock in Indonesia is feed both in terms of quality and quantity. On the other hand, conventional feed ingredients are expensive and difficult to obtain. Therefore, it is necessary to find alternative feed ingredients that have good quality, potential, and low cost. Feed ingredients that meet the above requirements are by-products of the palm oil industry, namely palm kernel cake (PKC). This study aims to obtain the best PKC composition for Etawa goat concentrate ration. Material and Methode : This research consists of 2 stages. Stage I is invitro study using Tilley and Terry method. The study used a Completely Randomized Design (CRD) with 4 treatments of rations and 4 replications. The treatment is the composition of the use of palm kernel cake (PKC) in the ration, namely, A). 10%, B). 20%, C). 30%, D). 40%. Other feed ingredients are corn, rice bran, tofu waste and minerals. The measured variables are the characteristics of the rumen fluid (pH, VFA and NH3). Stage II was done using the best ration of stage I (Ration C), followed by testing the use of Tithonia (Thitonia difersifolia) and agricultural waste of sweet potato leaves as a source of forage for livestock by in-vitro. The study used a Completely Randomized Design (CRD) with 3 treatments and 5 replications. The treatments were: Treatment A) Best Concentrate Ration Stage I + Titonia (Thitonia difersifolia), Treatment B) Best Concentrate Ration Stage I + Tithonia (Thitonia difersifolia) and Sweet potato Leaves, Treatment C) Best Concentrate Ration Stage I + Sweet potato leaves. The data obtained were analyzed using variance analysis while the differences between treatments were tested using the Duncant Multiple Range Test (DMRT) according to Steel and Torrie. Results of Stage II showed that the use of PKC in rations as concentrate feed combined with forage originating from Tithonia (Thitonia difersifolia) and sweet potato leaves produced pH, VFA and NH3-N which were still in normal conditions. The best treatment was obtained from diet B (P <0.05) with 6.9 pH, 116.29 mM VFA and 15mM NH3-N. Conclussion From the results of the study it can be concluded that PKC can be used as feed ingredients for dairy goat concentrate with a combination of forage from Tithonia (Tithonia difersifolia) and sweet potato leaves.

Keywords: palm oil by-product, palm kernel cake, concentrate, rumen fluid, Etawa goat

Procedia PDF Downloads 155

Authors: Todd Jackson

Abstract:

In this randomized control trial, we tested the effectiveness of a peer-facilitated version of the Body Project (BP) intervention among body-dissatisfied young women in China. Participants were randomly assigned to a peer-facilitator BP condition (N = 94) versus an educational video minimal intervention control condition (N = 89). Questionnaire measures of two primary outcomes (i.e., disordered eating and body dissatisfaction) and six secondary outcomes (thin-ideal internalization, pressure to be thin, negative affect, body surveillance, body shame, body appreciation and interest in cosmetic surgery) were administered at a pre-treatment baseline, a post-treatment assessment, and at a 12-month follow-up. A series of 2 (Group) x 2 (Time) analyses of variance indicated women in the peer-facilitated BP condition reported significant improvements in primary outcome measures of disordered eating and body dissatisfaction compared to women in the educational video control condition following treatment and at the 12-month follow-up. Furthermore, women in the peer-facilitated BP condition reported significant improvements in measures of body surveillance, body shame and body appreciation) compared to educational video controls that extended to the 12-month follow-up. Finally, although women in the peer-facilitated BP condition showed significant post-treatment improvements in thin-ideal internalization, negative affect, perceived pressure to be thin, and interest in cosmetic surgery compared to video controls, these differences were no longer statistically significant at the 12-month follow-up. In conclusion, findings supported the overall effectiveness of a peer-facilitated group version of the BP as an intervention for reducing disordered eating and several associated risk factors among at-risk young women in China.

Keywords: body project, disordered eating, body dissatisfaction, risk factors, prevention, China

Procedia PDF Downloads 42

Authors: Patrick Louie Robles, Jerry Suls, Ciaran Friel, Mark Butler, Samantha Gordon, Frank Vicari, Joan Duer-Hefele, Karina W. Davidson

Abstract:

Physical activity guidelines focus on increasing moderate-intensity activity for older adults, but adherence to recommendations remains low. This is despite the fact that scientific evidence finds increasing physical activity is positively associated with health benefits. Behavior change techniques (BCTs) have demonstrated some effectiveness in reducing sedentary behavior and promoting physical activity. This pilot study uses a personalized trials (N-of-1) design, delivered virtually, to evaluate the efficacy of using five BCTs in increasing low-intensity physical activity (by 2,000 steps of walking per day) in adults aged 45-75 years old. The 5 BCTs described in habit formation theory are goal setting, action planning, rehearsal, rehearsal in a consistent context, and self-monitoring. The study recruited health system employees in the target age range who had no mobility restrictions and expressed interest in increasing their daily activity by a minimum of 2,000 steps per day at least five days per week. Participants were sent a Fitbit Charge 4 fitness tracker with an established study account and password. Participants were recommended to wear the Fitbit device 24/7 but were required to wear it for a minimum of ten hours per day. Baseline physical activity was measured by Fitbit for two weeks. Participants then engaged remotely with a clinical research coordinator to establish a “walking plan” that included a time and day interval (e.g., between 7am -8am on Monday-Friday), a location for the walk (e.g., park), and how much time the plan would need to achieve a minimum of 2,000 steps over their baseline average step count (20 minutes). All elements of the walking plan were required to remain consistent throughout the study. In the 10-week intervention phase of the study, participants received all five BCTs in a single, time-sensitive text message. The text message was delivered 30 minutes prior to the established walk time and signaled participants to begin walking when the context (i.e., day of the week, time of day) they pre-selected is encountered. Participants were asked to log both the start and conclusion of their activity session by pressing a button on the Fitbit tracker. Within 30 minutes of the planned conclusion of the activity session, participants received a text message with a link to a secure survey. Here, they noted whether they engaged in the BCTs when prompted and completed an automaticity survey to identify how “automatic” their walking behavior had become. At the end of their trial, participants received a personalized summary of their step data over time, helping them learn more about their responses to the five BCTs. Whether the use of these 5 ‘habit formation’ BCTs in combination elicits a change in physical activity behavior among older adults will be reported. This study will inform the feasibility of a virtually-delivered N-of-1 study design to effectively promote physical activity as a component of healthy aging.

Keywords: aging, exercise, habit, walking

Procedia PDF Downloads 119

Authors: Esther Friedlander, Philip Friedlander

Abstract:

The use of immunotherapy that inhibits programmed death-1 (PD-1) or its ligand PD-L1 confers survival benefits in patients with non-small cell lung cancer (NSCLC). However, approximately 45% of patients experience primary treatment resistance, necessitating the development of strategies to improve efficacy. While the renin-angiotensin system (RAS) has systemic hemodynamic effects, tissue-specific regulation exists along with modulation of immune activity in part through regulation of myeloid cell activity, leading to the hypothesis that RAS inhibition may improve anti-PD-1/L-1 efficacy. A retrospective analysis was conducted that included 173 advanced solid tumor cancer patients treated at Valley Hospital, a community Hospital in New Jersey, USA, who were treated with a PD-1/L-1 inhibitor in a defined time period showing a statistically significant relationship between RAS pathway inhibition (RASi through concomitant treatment with an ACE inhibitor or angiotensin receptor blocker) and positive efficacy to the immunotherapy that was independent of age, gender and cancer type. Subset analysis revealed strong numerical benefit for efficacy in both patients with squamous and nonsquamous NSCLC as determined by documented clinician assessment of efficacy and by duration of therapy. A PUBMED literature search was now conducted to identify studies assessing the effect of RAS pathway inhibition on anti-PD-1/L1 efficacy in advanced solid tumor patients and compare these findings to those seen in the Valley Hospital retrospective study with a focus on NSCLC specifically. A total of 11 articles were identified assessing the effects of RAS pathway inhibition on the efficacy of checkpoint inhibitor immunotherapy in advanced cancer patients. Of the 11 studies, 10 assessed the effect on survival of RASi in the context of treatment with anti-PD-1/PD-L1, while one assessed the effect on CTLA-4 inhibition. Eight of the studies included patients with NSCLC, while the remaining 2 were specific to genitourinary malignancies. Of the 8 studies, two were specific to NSCLC patients, with the remaining 6 studies including a range of cancer types, of which NSCLC was one. Of these 6 studies, only 2 reported specific survival data for the NSCLC subpopulation. Patient characteristics, multivariate analysis data and efficacy data seen in the 2 NSLCLC specific studies and in the 2 basket studies, which provided data on the NSCLC subpopulation, were compared to that seen in the Valley Hospital retrospective study supporting a broader effect of RASi on anti-PD-1/L1 efficacy in advanced NSLCLC with the majority of studies showing statistically significant benefit or strong statistical trends but with one study demonstrating worsened outcomes. This comparison of studies extends published findings to the community hospital setting and supports prospective assessment through randomized clinical trials of efficacy in NSCLC patients with pharmacodynamic components to determine the effect on immune cell activity in tumors and on the composition of the tumor microenvironment.

Keywords: immunotherapy, cancer, angiotensin, efficacy, PD-1, lung cancer, NSCLC

Procedia PDF Downloads 51

Authors: Aliya Hisam, Zia Ul Haq, Sohail Aziz, Patrick Doherty, Jill Pell

Abstract:

Objective: To determine the effectiveness of Mobile health augmented Cardiac rehabilitation (MCard) on health-related quality of life (HRQoL) among post-acute coronary syndrome(post-ACS) patients. Methodology: In a randomized controlled trial, post-ACS patients were randomly allocated (1:1) to an intervention group (received MCard; counseling, empowering with self-monitoring devices, short text messages, in addition to standard post-ACS care) or control group (standard post-ACS care). HRQoL was assessed by generic Short Form-12 and MacNew quality of life myocardial infarction (QLMI) tools. Participants were followed for 24 weeks with data collection and analysis at three-time points (baseline, 12 weeks and 24 weeks). Result: At baseline, 160 patients (80 in each group; mean age 52.66+8.46 years; 126 males, 78.75%) were recruited, of which 121(75.62%) continued and were analyzed at 12-weeks and 119(74.37%) at 24-weeks. The mean SF-12 physical component score significantly improved in the MCard group at 12 weeks follow-up (48.93 vs. control 43.87, p<.001) and 24 weeks (53.52 vs. 46.82 p<.001). The mean SF-12 mental component scores also improved significantly in the MCard group at 12 weeks follow-up (44.84 vs. control 41.40, p<.001) and 24 weeks follow-up (48.95 vs 40.12, p<.001). At 12-and 24-week follow-up, all domains of MacNew QLMI (social, emotional, physical and global) were also statistically significant (p<.001) improved in the MCard group, unlike the control group. Conclusion: MCard is feasible and effective at improving all domains of HRQoL. There was an improvement in physical, mental, social, emotional and global domains among the MCard group in comparison to the control group. The addition of MCard programs to post-ACS standard care may improve patient outcomes and reduce the burden on the health care setting.

Keywords: acute coronary syndrome, mobile health augmented cardiac rehabilitation (MCard), cardiovascular diseases, cardiac rehabilitation, health-related quality of life, short form 12, MacNew QLMI

Procedia PDF Downloads 146

Authors: Michael Wagner, Philipp Steinbauer, Andrea Katharina Lietz, Alexander Hoffelner, Johannes Fessler

Abstract:

Background: Cardiopulmonary resuscitations are stressful situations in which vital decisions must be made within seconds. Lack of routine due to the infrequency of pediatric emergencies can lead to serious medical and communication errors. Virtual reality can fundamentally change the way simulation training is conducted in the future. It appears to be a useful learning tool for technical and non-technical skills. It is important to investigate the use of VR in providing a strong sense of presence within simulations. Methods: In this randomized study, we will enroll doctors and medical students from the Medical University of Vienna, who will receive learning material regarding the resuscitation of a one-year-old child. The study will be conducted in three phases. In the first phase, 20 physicians and 20 medical students from the Medical University of Vienna will be included. They will perform simulation-based training with a standardized scenario of a critically ill child with a hypovolemic shock. The main goal of this phase is to establish a baseline for the following two phases to generate comparative values regarding cognitive load and stress. In phase 2 and 3, the same participants will perform the same scenario in a VR setting. In both settings, on three set points of progression, one of three predefined events is triggered. For each event, three different stress levels (easy, medium, difficult) will be defined. Stress and cognitive load will be analyzed using the NASA Task Load Index, eye-tracking parameters, and heart rate. Subsequently, these values will be compared between VR training and traditional simulation-based training. Hypothesis: We hypothesize that the VR training and the traditional training groups will not differ in physiological response (cognitive load, heart rate, and heart rate variability). We further assume that virtual reality training can be used as cost-efficient additional training. Objectives: The aim of this study is to measure cognitive load and stress level during a real-life simulation training and compare it with VR training in order to show that VR training evokes the same physiological response and cognitive load as real-life simulation training.

Keywords: virtual reality, cognitive load, simulation, adaptive virtual reality training

Procedia PDF Downloads 94

Authors: Teris Cheung, Joyce Yuen Ting Lam, Kwan Hin Fong, Yuen Shan Ho, Tim Man Ho Li, Andy Choi-Yeung Tse, Cheng-Ta Li, Calvin Pak-Wing Cheng, Roland Beisteiner

Abstract:

Transcranial pulse stimulation (TPS) is a non-intrusive brain stimulation technology that has been proven effective in older adults with mild neurocognitive disorders and adults with major depressive disorder. Given these robust evidences, TPS might be an adjunct treatment options in neuropsychiatric disorders, for example, autism spectrum disorder (ASD) – which is a common neurodevelopmental disorder in children. This trial aimed to investigate the effects of TPS on right temporoparietal junction, a key node for social cognition for Autism Spectrum Disorder (ASD), and to examine the association between TPS, executive functions and social functions. Design: This trial adopted a two-armed (verum TPS group vs. sham TPS group), double-blinded, randomized, sham-controlled design. Sampling: 32 subjects aged between 12 and 17, diagnosed with ASD were recruited. All subjects were computerized randomized into either verum TPS group or the sham TPS group on a 1:1 ratio. All subjects undertook functional MRI before and after the TPS interventions. Intervention: Six 30-min TPS sessions were administered to subjects in 2 weeks’ time on alternate days assessing neural connectivity changes. Baseline measurements and post-TPS evaluation of the ASD symptoms, executive functions, and social functions were conducted. Participants were followed up at 2-weeks, at 1-month and 3-month, assessing the short-and long-term sustainability of the TPS intervention. Data analysis: Generalized Estimating Equations with repeated measures were used to analyze the group and time difference. Missing data were managed by multiple imputations. The level of significance was set at p < 0.05. To our best knowledge, this is the first study evaluating the efficacy and safety of TPS among adolescents with ASD in Hong Kong and nationwide. Results emerging from this study will develop insight on whether TPS can be used as an adjunct treatment on ASD in neuroscience and clinical psychiatry. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT05408793.

Keywords: adolescents, autism spectrum disorder, neuromodulation, rct, transcranial pulse stimulation

Procedia PDF Downloads 53

Authors: Adnan A. Y. Mustafa

Abstract:

In this paper we present a quick technique to measure the similarity between binary images. The technique is based on a probabilistic mapping approach and is fast because only a minute percentage of the image pixels need to be compared to measure the similarity, and not the whole image. We exploit the power of the Probabilistic Matching Model for Binary Images (PMMBI) to arrive at an estimate of the similarity. We show that the estimate is a good approximation of the actual value, and the quality of the estimate can be improved further with increased image mappings. Furthermore, the technique is image size invariant; the similarity between big images can be measured as fast as that for small images. Examples of trials conducted on real images are presented.

Keywords: big images, binary images, image matching, image similarity

Procedia PDF Downloads 171

Authors: Xinli Chi, Xiaoqi Wei

Abstract:

Background: Body-mind theory refers to the concept that the mind and body are interconnected; in this case, combining aerobic exercise and mindfulness-based training may be beneficial for mind-body health; however, there is limited evidence regarding their effects and potential mechanisms among Chinese university students. Therefore, the current study aims to examine the preliminary effects and feasibility of the combined intervention on depressive and insomnia symptoms, as well as to explore the underlying mechanisms. Methods: This is a two-arm pilot study of a randomized, controlled trial. Sixty-one Chinese university students were randomly allocated to 8-week combined intervention group (aerobic exercise plus mindfulness, N = 36) or control group (N = 36). In addition, 8 participants in combined intervention group were later volunteer to engage in semi-structured interview. The Self-Rating Depression Scale (SDS) and the Youth Self-Rating Insomnia Scales (YSIS) were used to measure depressive and insomnia symptoms, respectively. The intervention outcome and feasibility were tested by repeated-measures ANOVA, mediation model, and qualitative analysis. Results: The study included 31 participants in the intervention group and 30 participants in the control group, all of whom completed pre-test and post-test questionnaires. The results of the repeated-measures ANOVA showed that the combined intervention was effective in reducing depressive and insomnia symptoms among university students. Moreover, the mediation analysis suggested that improvement in insomnia symptoms might be a significant mechanism for the combined intervention. Qualitative analysis identified two main themes: “Helpful aspects of mind-body state” (including 7 sub-themes) and “Factors that influence the training effects” (including 3 sub-themes). Conclusions: The study confirmed the preliminary effect and feasibility of the combined intervention of mindfulness and aerobic exercise, while also exploring the potential mechanisms underlying this effect. Additionally, qualitative data provided valuable insights for optimizing future protocols.

Keywords: combined intervention, mindfulness, aerobic exercise, depressive symptoms, insomnia symptoms

Procedia PDF Downloads 73

Authors: Mohammad Khazaei, Reza Rostami, Hasan Gharayagh Zandi, Rouhollah Basatnia, Mahbubeh Ghayour Najafabadi

Abstract:

Objective: Methylphenidate has been demonstrated to enhance attention and cognitive processes, and placebo treatments have also been found to improve attention and cognitive processes. Additionally, methylphenidate may have positive effects on motion perception and sports performance. Nevertheless, additional research is needed to fully comprehend the neural mechanisms underlying the effects of methylphenidate and placebo on cognitive and motor functions. Methods: In this randomized controlled trial, 18 young semi-professional basketball players aged 18-23 years were randomly and equally assigned to either a Ritalin or Placebo group. The participants performed 20 consecutive free throws; their scores were recorded on a 0-3 scale. The participants’ brain activity was recorded using electroencephalography (EEG) for 5 minutes seated with their eyes closed. The Ritalin group received a 10 mg dose of methylphenidate, while the Placebo group received a 10mg dose of placebo. The EEG was obtained 90 minutes after the drug was administere Results: There was no significant difference in the absolute power of brain waves between the pre-test and post-tests in the Placebo group. However, in the Ritalin group, a significant difference in the absolute power of brain waves was observed in the Theta band (5-6 Hz) and Beta band (21-30 Hz) between pre- and post-tests in Fp2, F8, and Fp1. In these areas, the absolute power of Beta waves was higher during the post-test than during the pre-test. The Placebo group showed a more significant difference in free throw scores than the Ritalin group. Conclusions: In conclusion, these results suggest that Ritalin effect on brain activity in areas associated with attention and cognitive processes, as well as improve basketball free throws. However, there was no significant placebo effect on brain activity performance, but it significantly affected the improvement of free throws. Further research is needed to fully understand the effects of methylphenidate and placebo on cognitive and motor functions.

Keywords: methylphenidate, placebo effect, electroencephalography, basketball free throw

Procedia PDF Downloads 62

Authors: Jesryl B. Paulite, Irene Alcantara-Papa, Teofila O. Zulaybar, Jocelyn T. Zarate, Virgie Ugay

Abstract:

Banana is one of the major fruits in the Philippines in terms of volume of production and export earnings. The Philippines export of fresh Cavendish banana ranked No.1 with 22% share. One major threat to the industry is Fusarium wilt caused by Fusarium oxysporum f. sp. cubense. It tops as a major concern today affecting the Philippine banana industry since 2002 up to the present in Mindanao. Because of environmental and health issues concerning the use of chemical pesticides in the control of diseases, utilization of microorganisms has been significant in recent years as a promising alternative. This study aims to evaluate the potential of actinomycetes to control Fusarium wilt in Cavendish banana. The in-vitro experiments was carried out in Complete Randomized Design (CRD) while field experiment was laid out in a Randomized Complete Block Design (RCBD) with three treatments and three replications. Actinomycetes were isolated from mangrove soils in areas in Quezon and Bataan, Philippines. A total of 199 actinomycetes were isolated and 82 actinomycetes showed activity against the local Fusarium oxysporum (Foc) by agar plug assay. The test for antagonisms (AQ6, AQ30, and AQ121) of three best isolates Foc to were selected inhibiting Foc by 21.0mm, 22.0mm and 20.5mm, respectively. The same actinomycetes inhibited well Foc Tropical Race 4 showing 24.6 mm, 20.2mm and 19.0 mm zones of inhibition by agar plug assay, respectively. Combinations of the three isolates yielded an inhibition of 13.5 mm by cup cylinder assay. These findings led to the formulation of the mixed actinomycetes as biocontrol agents against Foc. A field experiment to evaluate the formulated mixed actinomycetes against Foc in a Foc infested field in Kinamayan, Sto Tomas, Davao Del Norte, Philippines. was conducted. Results showed that preventive method of application of the mixed actinomycetes against Foc showed promising results. A 56.66% mortality was observed in control set-up (no biocontrol agent added) compared to 33.33% mortality in preventive method. Further validation of the effectiveness of the mixed actinomycetes as biocontrol agent is presently being conducted in Asuncion, Davao Del Norte, Philippines.

Keywords: actinomycetes, biocontrol agents, cavendish banana, Fusarium oxysporum f. sp. cubense

Procedia PDF Downloads 559