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Results in Journal International Journal of Clinical Trials: 295

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Arivudainambi Veerappan Periasamy
Published: 26 October 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20174208

Abstract:
Background: Pleural infection is a clinical problem with high mortality and morbidity; 20% of patients with empyema die and approximately 20% require surgery to recover within 12 months of their infection. Studies on pleural infection and their outcome are relevant in developing a scoring system by which failing cases and cases at risk of death can be identified. Methods: The study is retrospective analysis of patient cohort admitted to the tertiary care institute from the period of July 2014 to July 2016 to determine the prognostic factors in the outcome of pleural space infection. The study included all complex, complicated parapneumonic effusion and empyema including tuberculosis above the age of fifteen years. The primary end of the present study was the success or failure. Possible predicting factors for the success or failure of therapy were assessed against this end. Pearson chi square test, χ2 (Fisher’s exact test when needed) test was used for discrete data. Logistic regression analysis was applied to adjust for confounding variables to assess the possible predicting factors. Survival plot and analysis using Kaplan Meier method was used.Results: 220 with parapneumonic effusion and empyema were analyzed. Successful outcome was seen in 107 and 113 had failed outcome. Mortality was 30.50%. By logistic regression method the odds of failed outcome were high with diabetes, hypoalbuminemia, loculation, tuberculosis which can predict the outcome especially complicated and complex parapneumonic effusion, empyema (pConclusions: Diabetes, hypoalbuminemia, loculation, tuberculosis should be used in the prediction scoring system.
Jagannath V. Dixit, Sanjiv Indurkar
Published: 26 October 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20174118

Abstract:
Background: National diabetes data group (NDDG) first introduced the concept of a metabolic state intermediate between normal glucose homeostasis and diabetes, called glucose intolerance. The expert committee on the diagnosis and classification of diabetes mellitus extended the concept in 1997 to include patients with impaired fasting glucose (IFG) and those with impaired glucose intolerance (IGT) and referred it as prediabetes. The rationale of the study is that if a person will eat only twice in the day, the insulin secretion will be less which will reduce the fasting insulin levels which are a proxy for prediabetes status. Methods: This is a self-controlled preventive trial. The study was conducted from 1st July 2016 to 30th June 2017. Prediabetes was diagnosed when person had HbA1C from 5.7 to 6.4. The participants with HbA1C level from 5.7 to 6.4 were included in the study. The participants were advised to eat twice in the day and walk 4.5 km in 45 minutes every day, at least 5 days a week. They were asked to repeat HbA1C and fasting insulin after 3 months. Sample size calculated was 38. The parameters used for evaluation were HbA1C and fasting insulin.Results: There were 33 males and 15 females in the study population. It was seen that there was significant reduction in HbA1C and fasting insulin levels of prediabetes patients. This difference was statistically significant with p value less than 0.01. All prediabetics converted to non-diabetic state in three months period. Conclusions: Eating twice a day and walking 4.5 km in 45 minutes every day causes statistically significant reduction in HbA1C and fasting insulin levels in patients with prediabetes. It was seen that all 48 participants converted to non-diabetic state within a period of 3 months.
Bhagwant K. Sekhon, Philip Beale, , Kellie A. Charles, Ross D. Brown, Henry Liang, ,
Published: 27 July 2017
International Journal of Clinical Trials, Volume 4, pp 111-115; https://doi.org/10.18203/2349-3259.ijct20173614

Abstract:
Background: AL is a traditional Chinese medicine (TCM) combination commonly used as an adaptogen to improve energy levels, immunity and quality of life in those suffering from chronic diseases such as cancer. While the combination Astragalus membranaceus and Ligustrum lucidum (AL) has been investigated in China as an adjunct to standard anticancer therapies in numerous clinical studies of variable quality reported in the Chinese literature, independent assessment of its effects on safety, tolerability and efficacy are lacking. Our objectives are to determine the safety and tolerability of AL and investigate its effects on inflammation, quality of life and immunity in people with advanced malignancy in the Australian healthcare setting.Methods: The AL study is a prospectively registered, open labelled pilot multi-centre study investigating AL in people with advanced malignancy. Inclusion criteria include participants with recurrent or metastatic cancer who are not undergoing chemotherapy or palliative chemotherapy. All participants (n=25) will receive 6 capsules of AL twice daily (equivalent to 25g raw herb) for 12 weeks. Follow up consultations will monitor safety, tolerability, quality of life, immune function and adverse events. Participants will be assessed at baseline and at weeks 3, 6, 9 and 12. The primary outcome will determine the effect of AL on safety and tolerability. Secondary outcomes will include inflammation, quality of life, immune function, disease status and survival. Appropriate statistical analysis will be conducted on the pilot study data. Potential associations will be investigated where relevant.Conclusions: This study will firstly establish the safety and tolerability of this TCM combination ‘AL’ in people with advanced malignancy in the Australian healthcare system and provide important information regarding its effect on markers that may affect survival as well as explore changes in quality of life and immune function. The impact of this research may allow the design of future studies integrating AL with standard therapy for people with advanced malignancy.
Shaheen Banu, Ismail H. M., Punam B., Lalitha S.
Published: 27 July 2017
International Journal of Clinical Trials, Volume 4, pp 127-130; https://doi.org/10.18203/2349-3259.ijct20173615

Abstract:
Background:The study was performed to assess the prevalence of dry eye syndrome in patients with non-insulin dependent diabetes in urban south Indian population.Methods:100 patients with non-insulin dependent diabetes in urban South Indian population were consecutively studied who attended OPD at Ideal Diabetes Care Center. Dry eyes were on the basis of history of ocular discomfort, including soreness, gritty sensation, itchiness, redness, blurred vision that improves with blinking and excessive tearing. The condition was confirmed by ocular surface dye staining pattern with fluorescein, tear film break up time (TBUT) and Schirmer test. All the patients were given artificial tears (carboxy methycellulose sodium eye drops).Results:Of 100 diabetic patients, 60 patients (60.0%) had dry eye syndrome. Dry eye syndrome was more common in older and female patients. A significant association was observed between duration of diabetes and frequency of dry eye syndrome. Of 60 patients with dry eye syndrome 43.0% suffered from gritty sensation, 41.0% had soreness. 26.0% complained from tearing, redness and 11.0% from pain. 60.0% had shimmer test positive. 8.0% had TBUT positive and none of the patients had abnormal corneal sensitivity test positive. Response after using artificial tears was good. Conclusions: Our finding strongly support diabetic patients have an elevated prevalence of dry eye syndrome. In this study the prevalence of dry eye syndrome was 60.0%. So, examination for dry eye should be an integral part of the assessment of dry eye disease. Further results showed management with artificial tears improved dry eye symptoms.
Michael E. Sadler, Rinah T. Yamamoto, Laura Khurana, Susan M. Dallabrida
Published: 27 July 2017
International Journal of Clinical Trials, Volume 4, pp 101-110; https://doi.org/10.18203/2349-3259.ijct20173133

Abstract:
Rater training is a well-recognized approach to minimizing inaccuracy and variability in clinical outcomes assessments common in clinical trials. However, there is a dearth of empirical research on the types of rater training and qualifications that contribute to improved accuracy, inter-rater reliability and intra-rater reliability. Herein, we discuss the need for rater training in clinical trials and review publications that report data on rater characteristics, training modalities and outcomes in terms of accuracy and reliability of clinical outcomes data.
Ramesh Babu, Suresh Kubavat, Poulose K. P., Srinivasa Kumar K. P., Sonika Handae, Vyas Dhamodaran, Balaji Elangovan
Published: 27 July 2017
International Journal of Clinical Trials, Volume 4, pp 116-121; https://doi.org/10.18203/2349-3259.ijct20173088

Abstract:
Background: Thrombocytopenia is defined as persistent decrease in the number of blood platelets. Thrombocytopenia usually serves as symptom for identifying hematologic malignancies, infectious diseases, auto-immune disorders and as common side effect of about 200 different disease types. There was neither a specific treatment available for thrombocytopenia, nor to increase the platelet count leading to mortality. Current methods are less effective and have their limitations. This study was conducted to prove that Carica papaya and Tinospora cordifolia leaf extract can increase the platelet count in study subjects with dengue, other microbial infections. Methods: Totally 250 patients were randomized, subjects within inclusion criteria and exclusion criteria were randomly assigned, in a 1:1 ratio, to receive orally thrombobliss in a dose of 5 ml syrup twice daily or placebo for five consecutive days. Platelet count was monitored every day.Results: The result showed that there is increase in the platelet count from day 2 in median platelet data and more evident after 72 hours seen in both mean and median platelet count. Even in the cancer patients undergoing chemotherapy, there has been significant increase in platelet count. The statistical analysis of the data showed that there is a significant increase in platelet count and is statistical significant p<0.05. Conclusions: This study showed that novel combination of Carica papaya and Tinospora cordifolia leaf extract effectively increases platelet count and can be used to treat thrombocytopenia. It is also evident that this combination is safe and effective in treating thrombocytopenia patients due to dengue and other microbial infection.
John Paul
Published: 27 July 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20172541

Abstract:
Background: Few antimicrobials are currently active to treat extensively drug resistant (XDR) gram-negative bacilli infections. This represents a serious global public health concern. Critically ill patients face the brunt of majority of these infections. Tigecycline has coverage for a majority of these XDR infections (with the exception of Pseudomonas aeruginosa), but is not currently approved for hospital-acquired pneumonia. Nevertheless it is being commonly used for this indication though many meta-analysis have suggested an increased risk of death in patients receiving this antibiotic. Methods: In this retrospective analysis we compared the mortality rates between a Tigecycline based and a non Tigecycline based therapy for XDR infections in the critically ill over a period of 12 months. A total of 93 patients were included in the study.Results: Tigecycline group had significantly increased risk for in hospital mortality with an odds ratio of 6.0 and 95% CI of 1.37 to 26.12 with a p value of 0.01. But such a difference was not evident in 14 day mortality. Conclusions: Initiation of Tigecycline for multidrug resistant, pneumonia needs to be re-thought. Only a small percentage of patients with pneumonia with in-vitro sensitivity having low minimum inhibitory concentration (MIC) would benefit from the drug. Even in this group the risk of increased mortality needs to be carefully considered before Initiation of therapy.
, Caoimhe O'leary, , Rachel Breen, , Laurence Freeman, Aine Carroll, Geraldine McMahon, Barry White
Published: 26 April 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20171919

Abstract:
Background: Work in a healthcare setting can affect the psychological wellbeing of healthcare professionals (HCPs). Emotional exhaustion among HCPs can have a significant negative impact on the quality of healthcare provided to patients in terms of increased medical errors and decreased patient satisfaction. There is a need for an effective stress-reducing intervention, such as mantra meditation. This feasibility study will examine the suitability of random controlled trial (RCT) methodology to assess the efficacy of mantra meditation at reducing emotional exhaustion among emergency department (ED) staff. Methods: This is a mixed methods, stratified feasibility study with intent-to-treat protocol, using two study arms (passive control and intervention), the purpose of which is to examine (1) recruitment, retention, and adherence; (2) outcome measures (psychological wellbeing and stress-related biological parameters such as blood pressure, heart rate variability and salivary cortisol); and (3) data management, control, and dissemination prior to conducting a full RCT.Results Eligible ED staff allocated to the intervention group (n = 30) will be taught mantra meditation and discuss prescribed texts (4 x 4 hour session over 6 weeks), as well as engage in 20 minutes of twice-daily mantra meditation practice. Participants in the passive control group (n = 30) will work as usual. Data will be collected pre (T1), post (week 11; T2) and at follow-up (week 19; T3). Conclusions: This study will pave the way for a larger RCT that will investigate mantra meditation as a definitive intervention to reduce emotional exhaustion among ED staff.
Mansur Ali Khan, Sadhana Joshi, Ashutosh Gupta
Published: 26 April 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20171920

Abstract:
Background: Central serous chorioretinopathy (CSC) is an idiopathic condition with an illdefined aetiopathogenesis and no clearly effective treatment. The choice of treatment include thermal laser photocoagulation, photodynamic therapy (PDT), subthreshold micropulse laser and anti VEGF. Methods: In a prospective nonrandomized pilot trial we evaluated two of these modalities subthreshold micropulse laser treatment and intravitreal anti VEGF in 20 consecutive cases of non-resolving CSC of duration 3 to 6 months with vision below 6/12 treated with either Bevacizumab for leakage close to fovea or subthreshold micropulse 810 diode laser for extrafoveal leakage (10% duty cycle, 100 µ spot size) as seen on fluorescein angiography.Results: At 6 months follow up complete resolution was seen in 9/10 in laser and 6/10 in Avastin group. The mean visual acuity improved from Log MAR 0.61 ± 0.17 at baseline to Log MAR 0.07± 0.11 post treatment in laser group and from Log MAR 0.59 ± 0.17 to Log MAR 0.18 ± 0.09 in the Avastin group . Similarly mean central macular thickness decreased from 607 µ ± 162.1 to 206 µ ± 55 in laser group and from 601 µ ± 182 to 262 µ ± 75 in those receiving Avastin. Both visual outcome and resolution of serous detachment was better with Micropulse laser as compared to Bevacizumab. Conclusions: Micropulse diode laser treatment of CSC has higher rate of resolution and better visual outcome as compared to Bevacizumab injections.
Camila Bonin Pinto, Faddi Ghassan Saleh Vélez, Melanie N. French, Dian Zeng, David Crandell, , ,
Published: 26 April 2017
International Journal of Clinical Trials, Volume 4, pp 72-79; https://doi.org/10.18203/2349-3259.ijct20171917

Abstract:
Phantom Limp Pain (PLP) was first described in 1551. To date, its mechanisms and novel interventions remain mostly untested. Only limited conclusions can be drawn from few and small randomized clinical trials (RCTs) on PLP. In this scenario, recruitment strategies are crucial in order to overcome inherent challenges to recruit PLP subjects for clinical trials. Although there are many methods to enhance recruitment and also retention, in this article we discuss these methods based on a common topic: dissemination. We summarize and discuss 10 strategies of recruitment related to the dissemination of information based on the notion that an increase in trial awareness may lead to both increased recruitment and also increased external generalizability. In addition, in our discussion we included insights based on our experience recruiting PLP patients for our large NIH-sponsored clinical trial. Although specific regulatory considerations need to be considered when choosing the methods of recruitment, which may vary across different countries and Institutional Review Boards (IRBs), these strategies may be applicable to most of research settings.
Alhadi M. Jahan
Published: 26 April 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20171918

Abstract:
Background: Knee osteoarthritis (OA) is the most important chronic rheumatic disease affecting human beings. It is more common among the older population. The objective of OA treatment is to control the symptoms, such as pain, mobility problems and consequently, to improve overall quality of life. Although, self-management patient education programs, such as educational workshops and other learning activities are effective approaches in some chronic diseases, the evidence for arthritis is still inconclusive. The aim of this trial is to compare the effectiveness of an OA of the knee self-management education program with a control group, as determined by improvements in pain and quality of life. Methods: In this study, we will perform a two-group, randomized (1:1 ratio), controlled study with repeated-measures to examine the differences between the two groups over time. The research sample will be selected from the patients who are referred to a physiotherapy department with a diagnosed mild to moderate knee(s) OA, aging from 45 to 65 years.Conclusions: Positive findings of this trial will pave the road for new methods of cooperation between patients and healthcare providers. Also, patient education ensures that patients are well-informed about their own health and they could avoid any deterioration and disability due to bad practices. Finally, an increased understanding helps patients to make informed decisions about their healthcare avenues.
Kamal Sonya, Davies C. V.
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170308

Abstract:
Background: Opioids are first introduced as additives to spinal anaesthesia in 1979, with intrathecal morphine as forerunner. Neuraxial opioids when added to local anaesthetics prolong the duration of sensory block, improve quality of block and no unwanted sympathetic blockade leading to hypotension. This prospective randomized double blind study was undertaken to evaluate the duration of analgesia, sensory and motor blocking properties and side effects of two opioids – Fentanyl and Buprenorphine, when used as adjuvant to spinal Bupivacaine in caesarean section.Methods: Sixty patients between the age group 18-35 years belonging to ASA I and II posted for elective LSCS were randomly divided into two groups. Each group consisting of 30 patients , received either 1.8 ml 0.5% Bupivacaine with 25 mcg Fentanyl (group F) or 1.8 ml 0.5% Bupivacaine with 75 mcg buprenorphine (Group B). The onset, maximum level and duration of sensory and motor blockade and hemodynamic parameters were monitored.Results: Maximum height of sensory block was achieved faster in fentanyl group (i.e. 4.09±1.12 minutes compared to 4.56±1.21 minutes in buprenorphine group). Duration of analgesia was significantly prolonged in buprenorphine group. It was 317±54 minutes and 214±35 minutes respectively for buprenorphine and fentanyl groups.Conclusions: The study thus concluded that although fentanyl produce faster sensory block, duration of analgesia is longer with buprenorphine, and both the drugs do not cause significant side effects.
Sunmeet Matkar, Ajit Gangawane
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170302

Abstract:
Clinical data management (CDM) is an indispensable part of clinical research. CDM activities lead to the collection of reliable, high-quality and statistically sound data generating from the clinical trials. Several studies suggest that such data helps in extreme reduction in time from drug development processes to the marketing stage. Several practices in CDM including CRF annotation, case report form (CRF) designing, data extraction, data entry, data validation, database designing, database locking, discrepancy management and medical coding are evaluated for quality checks at regular intervals during clinical trial. In recent times, the huge gap about improvements of the CDM standards for meeting the regulatory requirements remains to be filled. Fulfilling these requirements will help the clinical trial sector to stay ahead of the game. The current article accentuates the practices followed and activities involved in CDM. Therefore, it enables the reader an outline of management of data in the clinical research.
Ann V., Dominique M., Veeken L. V. D., Katrien D. M., Hilde C., Yves J., Verster A., Mannaerts D., Van Der Veken L., De Maeyer K., et al.
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170305

Abstract:
Background: To prevent hemorrhage after cesarean section uterotonics are often administered after fetal extraction. At this moment two frequently used and available products are short working oxytocin and its long working analogue, carbetocin. Both have proven and similar efficacy. Side effects are nausea, vomitus and arterial hypotension resulting in dizziness. Differences in nausea, vomitus and blood pressure changes between oxytocin and carbetocin have been studied as secondary outcome measures only and results have been conflicting. The aim of the present study is to compare nausea, vomiting and changes in blood pressure between carbetocin and oxytocin used as prevention for postpartum hemorrhage after cesarean section. Methods: Patients are women undergoing a planned term cesarean section for singleton pregnancy without other medical complications. One hundred patients will be randomized to receive either a single intravenous dose of 100 microgram carbetocin, either an intravenous bolus of 5 units of oxytocin followed by 10 units of oxytocin over 24 hours. As primary outcome nausea and vomitus are evaluated before, during and immediately after surgery, using a standard scale, blood pressure is automatically measured every three minutes. Secondary outcome measures are the difference between pre- and postoperative hemoglobin and the need for additional uterotonics. Analysis will be based on intention to treat.Conclusions: This study will offer data on the difference in clinically relevant side effects between carbetocin and oxytocin helping clinicians to choose between both products in low risk cesarean sections.
Varun K. Singh,
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4, pp 58-64; https://doi.org/10.18203/2349-3259.ijct20170310

Abstract:
Background: Lodhradi Kashaya (LKSD) is basically ayurvedic kwath dosage form, described as Madhumehajeet (winner of diabetes mellitus) in ayurvedic classics Basavarajeeyam and the same formulation in Vaidya Chintamani and Charaka Samhita too. The aim of this study was to assess prospectively the drug’s ability in management of type 2 diabetes. Methods: Total 31 patients were taken following the guideline mention in CCRAS protocol for diabetes mellitus research. They are divided into two groups, group A and B, given LKSD 4 g & 2 g TDS respectively for three-month follow up. They are investigated against their blood glucose, HbA1C and liver profile tests. Patients were also investigated for subjective parameters viz polyurea, polyphagia, exhaustion and constipation and their response has also been noted regarding palatability acceptance and ease of administration.Results: Patients has responded positively for formulation. Decrease in FBS and PPBS were found highly significant (P ˂ 0.001) in both groups but more in higher dose (group A). Decrease in HbA1C is also found highly significant in both groups. In LFT, SGOT level were also decreased more in group B in comparison to group A, and it is significant (P = 0.017 and 0.002). SGPT level were also decreased more in group B in comparison to group A, and it is significant in group B (P= 0.085 and 0.002). Conclusions: LKSD is having astringent taste due to tannins and phenols in it. It was found significant not only in controlling blood sugar but also in management of other factors related to diabetes mellitus.
Rahul Bhalke, Maroti S. Karale, Umesh Deshmukh
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4, pp 49-57; https://doi.org/10.18203/2349-3259.ijct20170309

Abstract:
Background: A number of cardiovascular responses occur during laryngoscopy and intubation which can have serious consequences during anaesthesia.We planned to conduct a study to evaluate effectiveness of intravenous Esmolol and intravenous Fentanyl in attenuating hemodynamic stress response to laryngoscopy and endotracheal intubation.Methods: A prospective, observational, randomized, double blind comparative clinical study, conducted on 60 cases of ASA grade I/II patients undergoing elective abdominal surgery under general anesthesia. The data obtained was divided in the two groups based on drug used 5 min prior to induction, Group 1 (I.V. Esmolol 2 mg/kg) and Group 2 (I.V. Esmolol 2 mg/kg & I.V. Fentanyl 2 µg/kg). Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) were measured at various time intervals.Results: There was no significant difference in HR, SBP, DBP, MAP after premedication and induction in both the groups. However at intubation, both groups showed an increase in HR, SBP, DBP and MAP but the rise was attenuated in both groups. Increase in HR was more in group 1 as compared to group 2 and it was statistically significant at 01 and 02 minutes post intubation. The increase in SBP was statistically significant at 00, 01 and 02 minutes post intubation. The increase in MAP was statistically significant immediately after induction, at 00, 01, 02, 05 and 10 minutes post intubation. Conclusions: Combination of intravenous Esmolol and intravenous Fentanyl is more effective in attenuating heart rate, systolic, diastolic and mean arterial pressure response to intubation than intravenous Esmolol alone.
Sugatha Prakash, Sreedevi J.
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170311

Abstract:
Background: The increasing emphasis on day care anaesthesia has led to the greater use of laryngeal mask airway (LMA) as an alternative to tracheal intubation for short procedure surgeries. Satisfactory insertion of LMA after induction of anaesthesia requires sufficient depth for suppression of airway reflexes. This study was performed to compare intravenous induction with Propofol to vital capacity breath induction with sevoflurane for LMA insertion. Methods: In this study 100 ASA 1 and ASA 2 patients aged between 20 and 40 years, undergoing short surgical procedures lasting 30 to 60 minutes, were included. The P group received Inj. Propofol 2.5 mg/kg IV whereas the S group received Sevoflurane 8% vital capacity breaths. After the loss of eyelash reflex, which was considered the end point of induction, the LMA insertion was attempted by an anaesthesiologist blinded to the induction technique. The data that was recorded was induction time with both the drugs, characteristics of LMA insertion, hemodynamic responses and complications if any. The number of attempts at insertion was also noted.Results: Induction time was 60.1±8.98 secs for propofol induction and 72.8±15.86 for sevoflurane vital capacity breath induction which was found statistically significant. The insertion conditions were found excellent in 88% in the propofol group and 90% in the sevoflurane group which was comparable. There was no statistically significant difference found in the time or characteristics of insertion between both the groups. No incidence of complications was found in both groups. Conclusions: Induction with sevoflurane vital capacity breath inhalation compared equally with induction with intravenous propofol for LMA insertion in patients undergoing short surgical procedures.
, Farnaz Rahimi, Bice Properzi, Giuseppe Regaldo, Ilaria Goitre, Valentina Ponzo, Stefano Boschetti, , , Antonella De Francesco, et al.
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170304

Abstract:
Background: Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesityMethods: This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m2), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach.Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables.Conclusions: The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.
, Michael D. Hughes, Yajing Bao, Evelyn Hogg, Uglas Shaffer, Jacob Phulusa, Tebogo Kakhu, Francesca Conradie, Margaret Kasaro, Rosie Mngqbisa, et al.
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170307

Abstract:
Background: Little is known about outcomes among clinical trial participants following completion of study-provided care and treatment in resource limited settings. We sought to describe outcomes among HIV clinical trial participants after transitioning to local routine care in Africa. Methods: In the OCTANE study, 741 women with CD4 <200 cells/mm3 in 7 African countries were randomized to initiate antiretroviral treatment (ART) with tenofovir/emtricitabine (TDF/FTC) plus either lopinavir/ritonavir (LPV/r) or nevirapine (NVP). When study-specified ART ended (48-191 weeks after study entry), participants transitioned to locally-provided HIV care and non-study ART. Consenting participants were interviewed and had toxicity labs, CD4 and HIV-1 RNA testing, and clinical outcomes assessed at 12 and 72 weeks after transition to local care.Results: Five hundred thirteen (77%) of the 669 women in follow-up at completion of the interventional trial participate in the extended follow-up. 513 women, 476 (93%) had HIV-1 RNA <400 cp/mL at time of transition, and 489 (95%) completed follow-up. Seventy-seven women (19%) had a total of 99 antiretroviral regimen changes during post-trial follow-up. 30% of the 99 regimen changes-were due to lack of local drug availability. Thirteen (3%) women had Grade ≥3 laboratory abnormalities and 3 experienced worsening of the WHO HIV stage. Two women died. Eighty-nine percent of 484 with results had HIV-1 RNA ≤400 cp/mL at 72 weeks after transition to local non-study HIV care and treatment. Conclusions: The vast majority of women were able to continue key components of their ART and to maintain virologic suppression through 72 weeks of locally-provided post-study care.Trial registration: ClinicalTrials.gov NCT00089505
Supriya Chopra, Nitin Shetty, , Reena Engineer, Karthick Rajamanickam, Suyash Kulkarni, Ashwin Polnaya, Shradha Patkar, , Mukta Ramadwar, et al.
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170306

Abstract:
Background: Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable disease. In the last decade results of randomized trials and subsequent meta-analyses established trans-arterial chemoembolization (TACE) as standard of care in patients with Barcelona clinic liver cancer (BCLC) stage B. However, there is clearly a need to investigate additional therapeutic options that would consolidate the initial response to TACE. A recent meta-analyses concluded that addition of radiation to TACE had 10-35% improvement in two-year overall survival, however as results of meta-analyses were based on small studies, the need for conducting a high quality randomized study was highlighted. The present study is designed to investigate the role of high dose stereotactic radiation as consolidation therapy after TACE in patients with non-metastatic unresectable HCC. Methods: Patients diagnosed with non-metastatic unresectable HCC with BCLC stage B/A (medically inoperable) and Child-Pugh’s score A-B7 will be eligible. The trial will randomize patients into TACE alone arm or TACE followed by stereotactic body radiation therapy (SBRT). The primary aim is to compare in-field progression free survival (PFS) in phase II and overall survival in phase III between the control (TACE) and intervention arm (TACE+SBRT). The secondary aim is to compare cause specific survival, imaging response and quality of life in control and intervention arms.Results: First analysis of the study has been planned when patient accrued under phase II study have completed 1 year follow up. Trail Registration: Clinicaltrials.gov,NCT02794337
Supriya Chopra, Reena Engineer, Ashwathy Susan Mathew, Shaesta Mehta, , , Karthick Rajamanickam, Prachi Patil, Sudeep Gupta, Nitin Shetty, et al.
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4; https://doi.org/10.18203/2349-3259.ijct20170303

Abstract:
Background: Systemic doublet chemotherapy constitutes the current standard of care for patients with unresectable non-metastatic cholangiocarcinoma. The use of doublet chemotherapy is associated with median survival of 11.7 months. Concurrent chemo-radiation in this cohort is associated with similar overall survival however the impact of combination of chemoradiation and systemic chemotherapy on overall survival has not been investigated. The present phase III randomized study investigates the impact of chemoradiation in addition to systemic chemotherapy on overall survival.Methods: Patients older than 18 years of age with diagnosis of unresectable non-metastatic cholangiocarcinoma with performance status 0-2and preserved liver function (Child Pugh score up to B7) will be eligible for study participation. The trial is designed such that patients will undergo stratified randomization (extra-hepatic vs. intrahepatic) either into systemic chemotherapy (standard arm) or chemo-radiation and systemic chemotherapy arm (experimental arm). The primary aim of the study is to compare difference in overall survival. The secondary aims of the study will focus on loco regional progression free survival and cause specific survival. The study will also report on the acute and late toxicity, quality of life and resectability rates in both the study arms. To demonstrate 7-month improvement in overall survival from 11 to 18 months a sample size of 142 is needed. Accounting for attrition a total of 155 patients will be accrued. All study subjects will be accrued after written informed consent. The trial is approved by the institutional ethics review board.This trial is registered with ClinicalTrials.gov as NCT02773485
, Kevin Kupzyk, Bob Parker, Amber McCall, Collene Hergott, Margaret Blagg
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 210-216; https://doi.org/10.18203/2349-3259.ijct20163959

Abstract:
Background: Delayed admission to palliative and hospice services is prevalent and, especially in rural areas, contributing to poor quality of care, caregiver stress and burden, reducing patients’ and their caregivers' quality of life and increasing healthcare costs. A reliable and sensitive screening tool would help clinicians identify patients in need of palliative care services. The purpose of the study is to develop and test a screening tool to be used by healthcare professionals in rural clinics and hospitals to identify patients with progressive, multiple chronic illnesses in need of primary palliative care services.Methods: A longitudinal, sequential mixed-method methods design will be used to achieve the purpose of the study. A rural community hospital and its affiliated community clinics in the Midwestern United Sates are selected for the study. In Phase I, we will conduct a cohort study using existing electronic health records. The cross-sectional and correlational quantitative data analysis will be used to test the psychometric properties of the current and modified palliative care screening tools. In Phase II, we will prospectively collect functioning and physical activity level data from the patients admitted to the palliative care program over time (monthly for 6 months). Again, the primary focus is to conduct correlational quantitative analysis to evaluate the psychometric properties of the modified palliative screening toolConclusions: The implication of this project is to 1) reduce healthcare disparities, 2) improve quality of care for rural patients with chronic serious illness; 3) inform the development of a hybrid (both inpatient and outpatient) screening tool for identifying palliative care needs that can be integrated into primary palliative care programs; and 4) enhance our understanding of mechanisms and relevant variables related to palliative care in rural patients living with chronic serious illness, leading to future program research in this field.
Priscila Godoy Januário Martins Alves, Ricardo De Carvalho Cavalli, Daiane Munhoz Mira Bertacini,
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 203-209; https://doi.org/10.18203/2349-3259.ijct20163958

Abstract:
Background: The objective of the present study was to compare the effects of perineal massage, vaginal dilator and pelvic floor muscles training on the perineal integrity of primiparae women. Methods: Primigravidae women over 18 years old will be selected, from the 32th gestational week and wishing to have a vaginal delivery.Pregnant women will be randomly allocated from a sequence generated by a computer program into three groups: perineal massage, vaginal dilator and pelvic floor muscles training. The technique should be practiced from the 34th week of pregnancy until the beginning of labor. Randomization will be done by a researcher who was not involved with the recruitment, assessment and treatment of the participants. All participants will undergo a clinical and functional assessment of the pelvic floor before the beginning of the technique practice, as well as a reassessment of these items and an assessment of perineal integrity between 45 and 60 days after delivery for a blind physiotherapist regarding the interventional procedures. The evaluative procedures will be done by a ‘blinded’ physiotherapist in relation to the intervention procedures. The outcome will be determined by the perineal integrity by the presence or absence of perineal laceration as well as their characteristics observed immediately after delivery. Conclusions: The knowledge of the effects of antenatal pelvic floor preparation techniques on the perineal integrity and pelvic floor muscles function after delivery, will allow a better choice about which approach is the best to pregnant women to prevent perineal trauma.
, Firoz Tadvi, Mitesh Maurya, Sunil Bhojne, Pragya Chandrakar
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 238-243; https://doi.org/10.18203/2349-3259.ijct20163187

Abstract:
Background: Clinical trial registry of India (CTRI) was launched in 2007. In this audit we attempted to assess the clinical research scenario over the past decade by looking at the information about clinical studies registered at the CTRI from 2007 to 2016.Methods: We accessed the official website of the CTRI i.e. www.ctri.nic.in and the required information was downloaded and descriptive statistics were used.Results: We found that the number of studies went on increasing from 31 in 2007 to 7060 in 2016 (as on 22nd June 2016). Majority studies were of interventional in nature as compared to observational and bioavailability and bioequivalence (BABE) studies. Pharmaceutical industry sponsored studies were comparatively higher in number than any other sponsored studies. However their number went on decreasing, while increase in registration of post graduate thesis and investigator sponsored studies was observed.Conclusions: Though a decrease in Pharmaceutical industry sponsored studies was observed the overall clinical research scenario appears to have improved due to investigator initiated studies and post graduate thesis.
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 180-186; https://doi.org/10.18203/2349-3259.ijct20163954

Abstract:
Why is so much attention now being given to the ethics of clinical trial? Why does debate continue over the ethics and regulation of research involving human subjects? Are there societal duties to support the conduct of clinical research? Why was this protocol good enough for X, or Y, or Z, but not good enough for this university or institution? What is the rationale for public bioethics? As shown even though all the rights and obligations of all parties of clinical trial – the researching physician, the volunteering patient, the industry, research institution- have been assured with ethico-legal regulations, there still exist many problems in the world of clinical research, and suggestions of solutions to the said problems. It is obvious that medical trials on human beings, on the one hand, accelerate developments in medicine and offer benefits for the present and future generations, but on the other hand, they can lead to acts that may endanger human dignity and human value. The objective of this paper is to discuss the rights of human subjects in clinical drug trials; to review the researcher-physician/subject-patients relationship from several aspects; to consider the dynamics which exist in this relation; and to reach some practical solutions that might be conveyed to the applications in the context of medical ethics in Turkey.
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 169-173; https://doi.org/10.18203/2349-3259.ijct20163952

Abstract:
Predicting the sample size needed to pass the Food and Drug Administration’s current requirements for the preoperative skin preparation can be very difficult. The purpose of the original FDA formula is detect if the test and positive control products are different and if the test product achieves greater reductions than the control product. The new Tentative Final monograph includes specific requirements for the lower bounds of the 95% confidence interval and the 70% responder rates. To meet these requirements, it is important to first conduct a pilot study to determine whether the products will pass the 70% responder rate and then determine the correct sample size correctly to ensure the 95% confidence level is 70% or above.
Sophie E. Rowbotham, Bernie Bourke, Michael Bourke, Rene Jaeggi, Jason S. Jenkins, , Jenna L. Pinchbeck, Christopher M. Reid, Ramesh Velu,
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 217-224; https://doi.org/10.18203/2349-3259.ijct20163960

Abstract:
Background: Abdominal aortic aneurysms (AAAs) are a leading cause of mortality worldwide but have no recognised medical therapy. Pre-clinical studies indicate that osteopontin plays an important role in the pathogenesis of AAA via a number of mechanisms. This trial aims to assess the potential of fenofibrate to favourably alter biomarkers associated with AAA pathology. Methods: Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME)-2 is a multi-centre, prospective, randomised, double-blind, placebo-controlled clinical trial to assess the effect of 24 weeks of oral therapy with 145 mg of fenofibrate on key pathological markers of AAA. A total of 140 participants with an AAA measuring between 35-49 mm will be randomly assigned to either 145 mg of fenofibrate once per day or identical placebo for a period of 24 weeks. Primary outcome measures will be serum concentrations of osteopontin and kallistatin. Secondary outcome measures will include serum levels of resistin, lipids, matrix metalloproteinases and pro-inflammatory cytokines, circulating concentrations of AAA biomarkers, and AAA diameter as assessed by ultrasound.Conclusions: This study represents the next step in the assessment of a potential novel medical therapy for AAA.
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 199-202; https://doi.org/10.18203/2349-3259.ijct20163957

Abstract:
As the clinical trial industry is evolving from a traditional 100% SDV (source data verification) approach to reduced SDV & Centralized Monitoring by applying a risk based monitoring (RBM) approach, hence forth leveraging of e-Solutions and real time data integrations would be critical in RBM. Technological considerations are critical to collect data real time to assess, monitor and mitigate risk in compliance with Good Clinical Practices. This article will examine the importance of e-Solutions and real time analytics in alignment with various systems for developing an effective RBM strategy.
, Mohammed Saleem Khan, Bharat Kumar Shukla, Pranjal R. Chaturvedi
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 187-193; https://doi.org/10.18203/2349-3259.ijct20163955

Abstract:
Envision dedicating fifteen years to a critical interest and emptying staggering amount of funds into it, at the same time confronting a disappointment rate of 95 percent. That is the crippling reality for pharmaceutical organizations, which toss billions of dollars consistently toward medications that possible won't work – and after that do a reversal to the planning phase and do it once more. Today's medications go to the business sector after an extensive, very costly process of drug development. It takes anywhere in the range of 10 to 15 years, here and there significantly more, to convey a medication from introductory revelation to the hands of patients – and that voyage can cost billions up to 12 billion, to be correct. That is just a lot to spend, and excessively yearn for patients to hold up. Patients can hardly wait 15 years for a lifesaving drug, we require another productive focused on medication revelation and improvement process. Artificial Intelligence, can significantly reduce the time included, and also cut the expenses by more than half. This is made conceivable through a totally distinctive way to deal with medication revelation. With the present technique, for each 100 medications that achieve first stage clinical trials, only one goes ahead to wind up a genuine treatment. That is stand out percent, it's an unsustainable model, particularly when there are ailments, for example, pancreatic malignancy which has a normal five-year survival rate of 6%.
, Padma Alaganandam, S. Yasodha
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 244-249; https://doi.org/10.18203/2349-3259.ijct20163963

Abstract:
Background: Menstrual disorders are the most common gynecological condition resulting in hospital referrals. Dysfunctional Uterine Bleeding is an abnormal uterine bleeding, in the absence of any organic, systemic or iatrogenic cause. Among women in reproductive age, one in 20 consults her general practitioner each year with menorrhagia. This condition can be managed both medically and surgically. Pharmacological treatment options available for DUB are combined oral contraceptive pills, progestogens, danazol, gonadotrophin releasing hormone (GnRH) agonists, prostaglandin synthetase inhibitor, anti-fibrinolytics and ethamsylate. Role of ormeloxifene in dysfunctional uterine bleeding (DUB) is still in an exploring level.The purpose of the study was to evaluate the efficacy of ormeloxifene in the treatment of DUB and compare the effects of ormeloxifene with combined oral contraceptive pills for the control of DUB. Methods: Sixty women presenting with DUB were randomly allocated to 2 equal groups, Group A were given ormeloxifene tablet @ 60 mg twice a week for 12 weeks, followed by 60 mg once a week for 12 weeks. Group B were given low dose combined oral contraceptive pills (OCP) containing 30 microgram ethinyloestradiol and 150 microgram levonorgestrel from day 1 to day 21st of the menstrual cycle for 6 cycles. The various parameters studied were reduction in menstrual blood loss which was measured by fall in pictorial blood loss assessment chart (PBAC) score, rise in haemoglobin (Hb) level and reduction in endometrial thickness, any drug side effects, compliance with the drug, dosage schedule and effect on quality of life after each month and at the end of trial period of 6 months. Patient’s level of satisfaction was assessed by improvement in Hb concentration, sense of wellbeing as well as overall general health, quality of life, sexual life and comfort with the continuation of the same drug.Results: Mean blood loss (PBAC score) following treatment showed significant reduction in both the groups, however this reduction was comparatively high in ormeloxifene treated group. The various parameters to assess the subjective and clinical improvement at the end 3 and 6 months post treatment showed significant improvement in both the treatment groups; however ormeloxifene group showed significantly better improvement in comparison to OCP group. Mean endometrial thickness also showed reduction in both the groups but more significant reduction was observed in ormeloxifene group as compared to OCP group following 6 months of treatment. Symptomatic relief and subjective feelings in relation to improvement of menstrual abnormalities, any undesirable side effects, about dosage compliance and any thought of discontinuing the drug by the patients indicated excellent control of menorrhagia in both the study group, which accounted for 86.66% in ormeloxifene group and 80% of individuals in OCP group. Conclusions: ORM is effective in control of DUB and can be used as an alternative to OCP for treatment of DUB with possibly minimal side effects and better dosage compliance.
Hardik R. Patel, Kalapi Patel, Mansi Patel, S. N. Gupta, Janmejay Patel, Payal Patel, Apurva Patel
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 267-273; https://doi.org/10.18203/2349-3259.ijct20163966

Abstract:
Background: Epidemiological studies of Indian population show that dementia, anxiety, and depression are largely a major hidden problem in India. Ayurveda claims several plants are beneficial in cognitive disorders. The prime objective of study was to clinically evaluate polyherbal formulation (Dr. Brain syrup) and compare it with the Placebo. It was randomized, placebo controlled, single blinded clinical study, approved by Institutional Human Ethics Committee.Methods: 60 outpatients from P. D. Patel Ayurveda Hospital (8-70 years) ready to sign Informed consent form were included in study. All these patients were given either Placebo syrup or Dr. Brain syrup at similar dose of 10 ml twice a day for 6 weeks. They were evaluated based on the HADS (hospital anxiety depression scale), EDQ (early dementia questionnaire) and symptoms assessment parameters on weekly basis.Results: Result showed that there was significant reduction in HADS score at the end of the study. Moreover, the sensitivity and specificity of the HADS was observed highly relevant to detect the level of anxiety and depression by obtaining ROC curve. Numerical analysis of the EDQ was also shown eye-catching differences in patient receiving Dr. Brain syrup improved their memory at the end of the study compared to placebo group. Conclusions: This study prooves the efficacy and safety of the Dr. Brain syrup in improving the memory and reducing the level of anxiety and depression in particular diseased patients without any side effects.
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 194-198; https://doi.org/10.18203/2349-3259.ijct20163956

Abstract:
As the current trends in clinical trial industry, is evolving day by day and adopting upcoming technology to integrate data from different sources into risked based monitoring (RBM) Portal, to increase efficient tracking system in a way that help in understanding site characteristic and make on-site monitoring visit more focused and accurate. Transformation from traditional monitoring method to RBM solution will significantly improve quality of data and will also reduce study risk and time. RBM is a standardized, systematic approach to identify and assess potential risk.
, Srinivas Reddy Boreddy, Tushar Deshpande
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 254-266; https://doi.org/10.18203/2349-3259.ijct20163965

Abstract:
Background: Control arm selection is difficult for devices clinical trial due to the complexity and uniqueness of every device. Therefore, we propose RADHIKa - ratio-based analysis deriving basis for comparison of historical or parallel interdependent reported ken of studies that can be used to compare the relative performance or safety of independent studies.Methods: A ken (set of studies) has four basic prerequisites to qualify for RADHIKa. Comparison and calculations are based upon assessment of two major factors, effect and influence. RADHIKa is a three step methodology that includes construction of ken, ratio calculations, and plotting box plots.Results: Inferences of RADHIKa has ratio and box plot interpretation. When the RADHIKa ratio is 1 or close to 1, both the control arm and the evaluation arm are equal. The box plot indicates the tendency of the parameter along with the difference in two arms. When the dark box is above line of unity, it indicates that the evaluation arm has performed better or if it’s vice versa the predicate has performed better. The tails of the box indicate significance of the outcome in each direction.Conclusions: RADHIKa method is a useful tool to compare the relative performance or safety of independent studies, especially single arm device studies.
Vilena Barros De Figueiredo, Cristine Homsi Jorge Ferreira,
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 233-237; https://doi.org/10.18203/2349-3259.ijct20163962

Abstract:
Background: Pelvic floor muscle training can be practiced in an individual format or in a group. The research question for this randomised, controlled trial will be: pelvic floor muscle training format including individualized and group training, would be more effective than an individualized training only or groups only? Additionally, it will be evaluated the adherence and follow up (results after 3 and 6 months of the end of training). Methods: This is a randomized clinical trial. Data collection will be performed at the Women's Health Research Laboratory, allocated in the Department of Physical Therapy of Federal University of São Carlos, from January 2016 to December 2016. It will be included, women with stress urinary incontinence, older than 18 years old. The participants will be will be allocated into three groups. In Group 1 sessions will be only individualized and Group 2 will perform individualized treatment and then the volunteer will be referred to join the group training sessions. Group 3 only group treatment. Later, all volunteers will be reassessed after 12 sessions, three months and six months from the discharge date. The primary outcome is the severity measures of the King's Health Questionnaire. The secondary outcomes are miccional diary, PERFECT scheme, perineometry, self-efficacy scale for pelvic floor exercises practice, exercise diary and presence of the participants in the surpevisioned sessions. Data normality will be tested by the Shapiro-Wilk test. The comparison between the evaluations will be performed by ANOVA, and the comparison between groups will be performed by Student t-test (independent Measures). In order to measure the practical significance of the date, the size effect and the confidence interval will be calculated. A 5% significance level will be assumed. The data are presented as mean ± standard deviation.Conclusions: A combined treatment format including individualized and group training, would be more effective than an individualized training only or groups only.Trial registration: The study was approved by the Research Ethics Committee of Federal University of São Carlos (UFSCar) (Number 1207393) and Clinical Trials (NCT02664714).
Fernanda A. Ribeiro, Raquel M. Boff, Ana M. P. Feoli, Andreia S. Gustavo, Márcio Vinícius Fagundes Donadio,
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 225-232; https://doi.org/10.18203/2349-3259.ijct20163961

Abstract:
Background: Obesity worldwide has more than doubled between 1980 and 2014, and this number has grown substantially in adolescents. An increase in this number can be prevented with the modification of lifestyle, healthy food choices and regular physical activity. The aim of this study is to evaluate the effect of a motivational interdisciplinary intervention based on the transtheoretical model of change for lifestyle modification in overweight/obese adolescents. Methods: A randomized, single-blind clinical trial with a control group, which aims to recruit 120 overweight/obese adolescents aged between 15-18 years (BMI ≥ 85th percentile). The sample will be selected through announcements in print media, social networks, television and radio. Groups will meet weekly over three months. The control group will receive a traditional health education intervention using pedagogy of transmission. The experimental group will receive a group-based motivational interdisciplinary intervention using a motivational interdisciplinary protocol based on the transtheoretical model of change.Conclusions: The results of this randomized clinical trial will determine if the motivational interdisciplinary intervention based on the transtheoretical model of change has an impact on lifestyle modification of the overweight/obese adolescents. If successful, the MERC program has the potential for application in different treatment scenarios, including that of the public health system. Trial Registration: The protocol for this study is registered with the Clinical Trial Registry (NTC02455973) and the Brazilian Registry of Clinical Trials (RBR-234nb5).
, Matthew Reaney
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 174-179; https://doi.org/10.18203/2349-3259.ijct20163953

Abstract:
NIH funded PROMIS measures are increasingly at the forefront of discussions in clinical trial endpoint measurement. In the US alone, 242 clinical trials have included PROMIS measures 2016. Regulatory agencies also recently appear to have more interest in the applications and interpretations of PROMIS tools. This paper provides an overview of the PROMIS tools, how and when they can be used, how they are scored, what modalities exist and what considerations one should make before choosing to use a PROMIS instrument. PROMIS spans across a wide range of areas ranging from mental, physical and social health status, from short form to profile instruments, and to electronic IRT scoring based methods. Psychometric properties measurement testing in a few therapeutic areas has also been evident and continues to develop. The regulatory agency and governmental bodies continue to focus their efforts on having a more profound understanding of the application and use of this patient reported toolbox. PROMIS measures are promising for use within the context of clinical trials, but stakeholders should prudently consider their use, thinking about both the pros and cons. It is likely that for endpoint measurement, PROMIS tools may be used on a case by case basis, but that a consideration of additional disease specific instruments may be recommended.
Mohan Bansal
Published: 22 October 2016
International Journal of Clinical Trials, Volume 3, pp 250-253; https://doi.org/10.18203/2349-3259.ijct20163964

Abstract:
Background: Dizziness is one of the most common complaints in medicine just second to headache. It frightens not only the patient but also frustrates the physicians. There is a long list of causes of dizziness but the common causes vary from place to place. The aim of this study was to know the common causes of dizziness and vertigo in Gujarat to generate the awareness among the doctors who get the patients with this common ailment so that they can better manage dizzy patients.Methods: This prospective study included thirty-five patients with dizziness and vertigo that came to the Department of ENT for their management.Results: Patients were divided into three categories. The first group of patients was having associated cochlear symptoms. Second group patients had isolated vertigo. Third group patients had associated CNS or medical conditions. The largest was the second group (37.5%) of isolated vertigo patients. The commonest diagnosis (18.75%) in this group was benign paroxysmal positional vertigo, followed by acute vestibular neuritis. Meniere’s disease and migraine and its variant were the most common causes in first and third group respectively. Conclusions:The overall scenario of causes of dizziness and vertigo in our study follow the international trend. Benign paroxysmal positional vertigo, acute vestibular neuronitis, Menieres disease and migraine were found the most common causes of vertigo.
John Molly, Silvia Edison, R. Vijajaraghavan, Thekuttuparambil Ananthanarayanan Ajith
Published: 25 January 2017
International Journal of Clinical Trials, Volume 4, pp 7-13; https://doi.org/10.18203/2349-3259.ijct20164059

Abstract:
Background: Hyperlipidemia increases the risk of developing cardiovascular diseases (CVD). This study was aimed to determine the effect of curry leaves powder and slicing cucumber fruit on hyperlipidemia in the menopausal women of rural communities.Methods: Thirty menopausal healthy women of rural communities (45–65 years of age) with mild hyperlipidemia were divided and randomly assigned into control group, subjects without any treatment and 2 experimental groups, one group treated with cucumber (100-125 g) and other group treated with curry leaves powder (5 g), once daily for 45 consecutive days. The demographic variables were collected using questionnaire. Fasting blood samples were collected before and after the intervention and determined total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein- cholesterol (HDL-C) and triacyl glycerol (TAG).Results: TC, LDL-C and TAG were significantly (p <0.05) reduced in the curry leaves powder and cucumber treated groups. HDL-C level (46.1±9.2 mg/dl) was significantly (p <0.05) elevated (average 12%) only in the curry leaves powder treated group. Though the mean values of TC, LDL-C and TAG were elevated in the control group, the elevation was statistically non-significant. Comparing the efficacy of the test substances at the tested doses, HDL-C level in the curry leaves treated group showed statistically significant elevation (p =0.09). Conclusions: Curry leaves and cucumber were effective in improving HDL-C and lowering of LDL-C and TAG levels in menopausal women with hyperlipidemia, suggest the potential neutraceutical role in treating CVD.
, , Steven Booth
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 77-88; https://doi.org/10.18203/2349-3259.ijct20162790

Abstract:
First-in-human (FIH) oncology clinical trials are crucial to the development of small-molecule oncology candidates. However, there is a dearth of research investigating how these trials vary from one-another and therefore whether one approach may be better than another. This review aims to investigate variation of FIH trials published over the last decade with respect to four areas: publication particulars; trial design; patient particulars and drug administration and formulation.
Mohanakrishnan Kandasamy, Sowmya Nasimuddin, Jeevan Malayan, Nithyalakshmi J, Sumathi Gnanadesikan, Mayuri Chandrasekar
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 165-168; https://doi.org/10.18203/2349-3259.ijct20162799

Abstract:
Background: Grape seeds are proposed to have antimicrobial activity, antioxidant effect and various other benefits to mankind. A study was done to assess the antibacterial effect of grape seed extract against common clinical isolates and drug resistant pathogenic strains.Methods: Grape seed extract prepared was investigated for its antibacterial effect against 65 bacterial isolates obtained from clinical specimens by agar well diffusion assay and the results were compared with routinely used antibiotics namely, Gentamicin for the common clinical isolates, Vancomycin for MRSA strains and Amikacin for ESBL organisms respectively.Results: Grape seed extract produced moderate zone of inhibition ranging between 11-15 mm among the 35 test common clinical isolates namely Staphylococcus aureus, Escherichia coli, Klebsiella sp and Pseudomonas aeruginosa. E.coli showed the highest susceptibility with zone ranging from 12-14 mm with increasing concentration of the extract starting from2 mg/ml to the highest being 20 mg/ml. Among the 30 drug resistant pathogenic strains like MRSA and ESBL producing organisms, the grape seed extract was found to be effective against 3 out of the 10 of MRSA and 2 out of the 10 of ESBL-E.coli at the highest concentration of 20 mg/ml. However, ESBL producing Klebsiella species were found to be resistant even to the highest concentration of the extract. Conclusions: The results provide evidence that the grape seed extract could be a potential antibacterial agent and this effect can further be made evident with improved methodologies.
Peter Douglas Klassen, Robert Hes, , Sandro Eustacchio, Martin Barth, Adisa Kursumovic, Senol Jadik, Volkmar Heidecke, Richard Bostelmann, Claudius Thomé, et al.
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 120-131; https://doi.org/10.18203/2349-3259.ijct20162794

Abstract:
Background: Same-level reherniation and progressive degeneration with disc height loss are main causes of poor outcome after discectomy and may necessitate reoperation. A novel prosthesis for anular closure was developed to address these causes.Methods: The design of a multicenter, prospective, randomized, post-market superiority trial comparing limited lumbar discectomy augmented with this device (intervention group) with limited lumbar discectomy alone (control group) is presented.Results: Patients with single-level (L1-S1) posterior or posterolateral disc herniation and radiologic confirmation of neural compression for whom at least six weeks of conservative treatment has failed are eligible. Patients must have posterior disc height ≥5 mm at index level and baseline Oswestry and VAS leg pain scores of ≥40/100. Intraoperatively, subjects meeting anular defect size criteria post-discectomy (4-6 mm tall and 6-10 mm wide) will be randomized to study groups in a 1:1 ratio using centralized, web-based software. A Bayesian statistical approach will be used to enroll 400 to 800 subjects who will be followed for at least 24 months. Two co-primary endpoints will be assessed at 24 months: 1) a composite of leg pain, clinical function, disc height maintenance, and absence of reherniation, reoperation, and device failure; and 2) absence of reherniation based upon independent radiologic analysis. Conclusions: This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.
Manish B. Kotwani, Kanchan Rupwate, Prashanth Shivananda, Jyoti Magar
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 140-146; https://doi.org/10.18203/2349-3259.ijct20162795

Abstract:
Background: For performing inguinal hernia surgeries, giving spinal anesthesia is a well known technique as it easy and provides fast onset, effective sensory and motor blockade in an awake patient. Now-a-days Bupivacaine is gaining importance as an effective spinal anaesthetic agent in combination with opioid analgesic Fentanyl to reduce the postoperative pain and side effects associated with surgery. This study aims to compare the effectiveness of intrathecal Bupivacaine alone versus combination of Bupivacaine with Fentanyl.Methods: The study designed was a prospective, randomized, double blinded comparative study. Patients were randomly divided into two groups of 25 each. Group B received hyperbaric intrathecal Bupivacaine 12.5 mg and Group BF received diluted hyperbaric intrathecal Bupivacaine 7.5 mg and Fentanyl 25 µg for spinal anesthesia . Parameters like sensory and motor block were assessed. Side effects produced during perioperative and postoperative period were observed and noted. Satisfactory criteria by the surgeons and patients were considered.Results: The time taken to attain surgical anesthesia and peak sensory levels in minutes was statistically significant in Group B compared to Group BF. Due to higher dose of Bupivacaine, it was observed that degree of motor blockade is also higher in group B when compared to group BF. The incidence of hypotension, nausea, vomiting and hypothermia are significantly higher in group B due to high dose of Bupivacaine. The surgeons and patients satisfaction was good in both the groups. Conclusions: Low dose Bupivacaine in combination with Fentanyl is safe and effective alternative for spinal anesthesia for inguinal herniorrphaphy as compared to conventional high dose Bupivacaine alone.
Michael D. Wood, David Maslove, , , Andrew Day,
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 98-105; https://doi.org/10.18203/2349-3259.ijct20162792

Abstract:
Background: Acute and chronic neurological complications amongst survivors of critical illness is common, however, the underlying etiology of this neurological dysfunction is unknown. This is the first study to use near-infrared spectroscopy to non-invasively measure brain tissue oxygenation, as a surrogate marker of cerebral perfusion, and correlate these values with subsequent neurological dysfunction. We will test the hypothesis that poor cerebral oxygenation during the first 24 hours of critical illness is correlated with acute and chronic neurological complications.Methods: This single-centre prospective observational study will be performed in a 33-bed medical/surgical intensive care unit (ICU). Adult patients are eligible for enrolment if they are admitted to the ICU within 24 hours, require mechanical ventilation, and/or vasopressor support. For 24 hours, cerebral oxygenation levels will be measured with the FORESIGHT oximeter; vital signs and tissue oxygenation will be captured with data monitoring software. Participants will be screened daily for delirium with the confusion assessment method-ICU. Long-term neurological function will be assessed with the Repeatable Battery for the Assessment of Neuropsychological Status and the kinesiological instrument for normal and altered reaching movements (KINARM) robot.Conclusions: This study will provide novel information regarding the determinants of cerebral oxygenation during the acute phase (i.e. 24 hours) of critical illness, and its potential relationship with subsequent neurological complications. Should a relationship exist between cerebral oxygenation and neurological complications, future studies will be aimed at using brain tissue oxygenation as a therapeutic target to prevent acute and chronic neurological dysfunction. Clinical Trial Registration: This trial is registered on clinicaltrials.gov (Identifier: NCT02344043), retrospectively registered January 8, 2015.
Vihang S. Chawan, , , Maheshi U. Chhaya
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 155-158; https://doi.org/10.18203/2349-3259.ijct20162797

Abstract:
Background: Clinical trials are gold standard in the field of evidence based medicine. Registration of clinical trials facilitates the dissemination of information among clinicians, researchers and patients. Earlier, researchers were interested only in publishing positive results of their study. The negative results were never published resulting in bias in reporting the results of such clinical trials. It is now mandatory to register all clinical trials done in India at National Institute of Medical Statistics (NIMS) hosted at Clinical Trial Registry - India (CTRI) website to ensure transparency, accountability and accessibility of clinical trials. This study was planned to analyze the number of clinical trials registered under CTRI from 2007 to 2015. The information regarding the registration of clinical trials was accessed from the website www.ctri.nic.in.Methods: The information on registered clinical trials was obtained from the website www.ctri.nic.in. The clinical trials registered with CTRI from 2007 to 2015 were noted for analysis.Results: Maximum number of clinical trials registered in the year 2015 (1113), followed by year 2014 (1089), 2013 (990), 2012 (959) and 2011 (748) while least number of clinical trials registered in the year 2007 (32). Results revealed that there is wide gap the number of clinical trials registered in between year 2007 to 2015 and also revealed that number of clinical trials registered are increasing in order from year 2007 to year 2015. Conclusions: The registrations of clinical trials improve the reliability of data generated, assist clinicians to interpret research, minimizes duplication of trials and prevents exposure of volunteers to potential risks.
, Joanna M. Sneed, R.L. Felipe Lobelo, Gregory A. Hand, Wesley D. Dudgeon, Vivek K. Prasad, Stephanie Burgess, Steven N. Blair
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 106-119; https://doi.org/10.18203/2349-3259.ijct20162793

Abstract:
Background: The purpose of this investigation was to test the feasibility of a home-based moderate-intensity physical activity (MPA) program for people living with HIV/AIDS (PLWHA) currently taking antiretroviral therapy (ART).Methods: 68 participants recruited for a 9-month home-based PA intervention aimed to reduce risk factors of cardiovascular disease for PLWHA taking ART. All participants received an educational weight loss workbook and a pedometer for self-monitoring of physical activity. The intervention group received elastic Therabands® for strength training in addition to telephone based behavioural coaching. Clinical assessments were conducted at baseline and each follow-up which also included psychometric questionnaires and PA levels via the SenseWear® armband accelerometer.Results: Of the 57 completing the study, 29 of those were in the intervention group and 28 were in the standard care group. Results show that the home-based PA intervention was not successful in increasing the total amount of MPA for PLWHA. However there was a trend (p=0.08) of decreasing sedentary time. In a secondary analysis those who increased PA by >10% observed decreases in waist circumference and improved functioning at 18 weeks. None of the changes observed were significant after controlling for all potential confounders. Conclusions: A home-based exercise approach with telephone-based coaching may not be a feasible method for increasing MPA among PLWHA. Slight decreases in sedentary time indicate some positive changes in activity habits. A possible strategy to improve studies similar to this is to incorporate a group based social interaction each week similar to that of a support group.
Hardik R. Patel, Manish Patel, Mansi M. Patel, Janmjay H. Patel, Payal G. Patel, Apurva N. Patel
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 147-154; https://doi.org/10.18203/2349-3259.ijct20162796

Abstract:
Background: This was a randomized, placebo controlled, single blinded clinical trial undertaken in 60 male patients in the age group of 18-70 years diagnosed with benign prostatic hyperplasia (BPH) in the department of at P.D. Patel Kayachikitsha, Ayurveda Hospital, India.Methods: A medical history, especially on urinary symptoms was obtained from all patients on first visit along with Blood tests. 60 Patients were randomized into two groups. Uricare tablet was administered at the dose of 2 tablets twice a day for the period of 6 weeks to treatment group and Placebo tablet was administered with same doses to the remaining patients group. They were evaluated on BPH assessment parameters, IPSS (International prostate symptom score), quality of life (QOL), level of serum PSA and the prostate volume.Results: Percentage reduction in IPSS score was observed 25.62% and 1.80% in treatment and placebo group respectively. Percentage improvement in QOL was also observed 31.67% and 2.82% in treatment and placebo groups respectively. BPH assessment parameters also show moderate changes in before and after treatment in both groups. However, the reduction in prostate volume was identified up to -4.612cc and -1.427cc in treatment and placebo group respectively at the end of the trial. Prostate significant antigen (PSA) was significantly reduced in the treatment group than Placebo group. Conclusions:There were no serious adverse effects observed during the study. Hence, the therapy was assumed to be well tolerated by patients and can be considered as a drug of choice in the management of BPH.
, Marina Malikova
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 89-97; https://doi.org/10.18203/2349-3259.ijct20162791

Abstract:
Background: Systematic analysis of risk factors in multiple wound care clinical trials was performed to develop proactive risk mitigation strategies and improve the quality of trials conducted.Methods: This internal, single center internal quality control (QC) audit of eight recently completed prospective, randomized wound care clinical trials assessed the rate of serious adverse events (SAEs) and compared two wound indications: diabetic foot ulcers (DFU) and venous leg ulcers (VLU). Additionally, adherence to study protocol and compliance with current regulatory requirements was examined based on the rate of protocol deviations over time.Results: A comparison of SAE occurrences between DFU and VLU studies showed twice as many SAEs per subject in the DFU studies as compared to the VLU studies. The most common categories were infections, both of the wound and of other anatomic locations. The onboarding of new study coordinators and multiple coordinators working independently on one trial over time consistently showed an increase in the number of deviations per active subject, particularly immediately following the date of hire. The most common categories for deviations were out-of-window visits and missed study procedures. Conclusions: Assessment of potential issues in prospective wound care studies can lead to earlier mitigation of risks, quality improvement in data obtained and increased efficiency of studies conducted in this field. Effective training and retention of research coordinators can reduce the number of deviations, and an understanding of the frequency and types of adverse events can provide an expectation for those conducting trials in a particular indication.
, Mohan Lal Kanojia, Sajjan Lal Verma, Jhansi Lakshmi Lingidi
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3, pp 159-164; https://doi.org/10.18203/2349-3259.ijct20162798

Abstract:
Background: The impact of acute and sub lethal toxicity of synthetic Rogor on some biochemical and hematological parameters of a fish Amphipnous cuchia was estimated aquatic environment by various pollutants like pesticides, detergents, discharge of effluents and heavy metals induce changes in the biochemical, hematological and behavioral aspects of inhabitants. These pollutants cause serious effects on growth, biochemistry, physiology, neurochemistry and survival rate of the aquatic organism. Methods: The present research work is one such attempt to investigate the effect of organophosphorous pesticide Rogor on biochemical and hematological parameters of fish Amphipnous cuchia. The main objective of this study was to investigate the level of AST, ALT, hematocrit and TLC in fish Amphipnous cuchia exposed 24 to 96 hours to four different concentrations of Rogor pesticide. Results: Rogor toxicity resulted in a significant maximum increase (89.15%) in level of aspartate amino transferase (7.87±0.14/18.31±0.09) and alanine amino transferase (76.65%, 5.28±0.11/3.03±0.14) enzyme. Regarding to hematological parameter, significant maximum increase (77.12%) in total leukocyte count (27,400±298/15,470±286) and maximum decrease (66.07%) in hematocrit (6.20±0.04 /18.31±0.09) level was observed. Conclusions: In this studyit is concluded that exposure to sublethal/lethal concentration of Rogor results in a significant alterations in different biochemical and hematological parameters and this kind of biochemical and physiological changes may directly affect the survivability of these fishes in these natural habitat.
Geeta A. Patkar, , Anusha M. S., Bharati Anil Tendolkar
Published: 6 August 2016
International Journal of Clinical Trials, Volume 3; https://doi.org/10.18203/2349-3259.ijct20162238

Abstract:
Background: Surgical repair of faciomaxillary trauma requires intraoperative occlusion of teeth that precludes orotracheal intubation. Airway management options in these patients are either nasotracheal intubation or tracheostomy. However nasal intubation is contraindicated in nasal bone fractures, skull base fractures. Tracheostomy, being a morbid procedure is not always a good option. Submental intubation allows a safe alternative in such patients.Methods: 25 Patients were studied with faciomaxillary trauma where submental intubation was indicated. After standard anesthesia induction patients were intubated with reinforced endotracheal tube (ETT), which is converted to submental route by a paramedian incision. At the end of the procedure, all patients had inter-maxillary wiring, were shifted to recovery room. Once they are recovered from the neuromuscular blockade ETT was removed through the submental tunnel.Results: This was a prospective observational study in 25 adult patients undergoing faciomaxillary surgeries requiring submental intubation. The mean apnoea time was 1.28±0.38 minutes and induction to submental intubation time was 9.68±1.82 minutes. In one case there was damage to the pilot balloon while pulling the tube through the submental tunnel. Two patients had right endobronchial migration of the ETT. On postoperative follow up, one patient had infection at the submental incision site. Conclusions: Submental intubation is a safe, effective, alternative for short term tracheostomy in faciomaxillary sugeries. Careful handling of the ETT is must to avoid damage while passing through the submental tunnel. Avoid extra length of the tube introrally to prevent endobronchial migration of the ETT.
, Mohammed Saleem Khan, Bharat Kumar S Shukla
Published: 9 May 2016
International Journal of Clinical Trials, Volume 3; https://doi.org/10.18203/2349-3259.ijct20161412

Abstract:
The essential thought of risk based quality administration is the recognizable proof of risks on a ceaseless premise for risk bearing exercises all through the configuration, behaviour, assessment and reporting of clinical trials. The procedure ought to begin at the season of convention outline so moderation can be incorporated with the convention and other trial related archives. Clinical Research is about creating information to bolster choices for creating and changing medicinal items and rehearses while ensuring the security, rights, prosperity of taking part subjects are ensured and coming about information are dependable. Choice making must be in the same class as the procedures used to deal with the clinical trials. Scholastic and industry driven clinical exploration is gradually adjusting quality danger administration forms for ahead of schedule recognizable proof of components with potential to influence subject wellbeing and convention consistence; preparing for those leading, directing and observing the study; ceaseless re-evaluation of needs; and corrective and preventive action (CAPA). Flawless control of exercises is once in a while conceivable to accomplish, yet a quality controlled and organized danger based methodology can be next best to flawlessness.
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