International Journal of Clinical Trials
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Editor-in-Chief: Dr. K. N. Shah
ISSN: 2349-3240 (Print); 2349-3259 (Online)
Frequency: Quarterly
Language: English
Open Access Peer-reviewed journal
Web site: https://www.ijclinicaltrials.com/
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Item 8-Hydroxydeoxyguanosine (8-OHdG) levels in urinary samples of pesticide sprayers on exposure to organophosphorus pesticides.(2015-08) Mishra, B P; Badade, Z G; Anand, Bhupinder Kaur; Lingidi, Jhansi Lakshmi; Jaiswal, SapnaBackground: Free radicals and other reactive species are constantly generated in vivo and cause oxidative damage to biomolecules. DNA is probably the most biologically significant target of oxidative attack. Among numerous types of oxidative DNA damage the formation of 8-hydroxyguanosine (8-OHdG) is a sensitive biomarker of oxidative stress, an adduct formed as a result of biochemical reaction between ROS and DNA. Chronic exposure to Organophosphorus (OP) pesticides is implicated in many health conditions that result from the induction of oxidative stress, including cytogenetic damage. The main objective of the study was to evaluate the biochemical levels of 8-OHdG in spot urinary samples under the exposed OP pesticide sprayers and farm workers. Methods: In this study, 51 male pesticide sprayers and 39 farm workers in the age group of 18-47 years having exposure ranged from 3 to 15 years in duration were selected. The referents (n=31) were selected on the same criteria as well as they were never exposed to pesticides at any time. This study was conducted during the growing season (January, 2009 – September, 2010). The most commonly used OP pesticides like chlorpyriphos, Diazinon, Dimethioate, Monocrotofos etc., were used in this study. Urine samples from each participant were taken in sterile tubes and were stored at -200C till analysed. The concentration of 8-OHdG in samples were analyzed using ELISA. Results: The urinary levels of 8-OHdG were found to be significantly higher in the farm workers and pesticide sprayers in contrast to the level observed in the control group (p<0.05). When the data was analyzed in the exposed groups in relation to duration of exposure it was found that both the farm workers and sprayers who were exposed to OP pesticides for less than 5 years showed the maximum mean values of 8-OHdG in comparison to those exposed to for more than 10 years. Conclusions: In view of this regular bio monitoring studies in target human populations are imperative necessary due to frequent changes in pesticide formulations and introduction of newer pesticides. Despite that several life style factors may influence the urinary concentrations of 8-OHdG but still this non-invasive bio-marker 8-OHdG is preferred over other invasive techniques to evaluate the environmental and occupational exposure effect of OP pesticides on the genotoxicity of the exposed workers.Item Accelerometer-based facilitated walking program in addition to usual care for the management of patients with low back pain at medium or high risk of chronicity: a randomised controlled trial protocol(Medip Academy, 2019-01) Hosam, Alzahrani; Martin, Mackey; Emmanuel, Stamatakis; Pinheiro, Marina B.; Shirley, DebraBackground:The synergistic action of local anesthetics and morphine is well known, morphine probably more superior for postoperative analgesia, when compared to other opioids. Preservative-free morphine is now available in India making intrathecal administration possible. The present randomized double blind study was designed to evaluate the effect of adding preservative free morphine to hyperbaric bupivacaine given intrathecally for abdominal hysterectomy.Methods:Following approval by the institutional review board and institutional research grant committee, eighty patients presenting for elective abdominal hysterectomy were included in this randomized, double blind study. All drugs used for spinal anesthesia were autoclaved as per the departmental protocol. 3.5 ml of hyperbaric bupivacaine 0.5% [heavy] was given in both groups along with preservative free morphine accordingto study group.Results:27.5% (11/40) patients in group A, 17.5% (7/40) patients in group B received one dose of rescue analgesia (ketorolac 10 mg),during the 24 hours for pain relief while 29 patients is group A (72.5%) and 82.5% (33/40) patients in group B received 2 doses of rescue analgesia. 10% patients in Group A (4/40) and 10% patients in Group B (4/40) had a sedation score of 1(drowsy and arousable). Conclusions: The mean duration of analgesia in patients who received 250 μgms of intrathecal morphine was 18.725±1.38 hours while in patients who received 150 μgms it is 16.075±1.23 hours. We conclude that 250 μgms of preservative-free intrathecal morphine provides longer duration of analgesia when compared to 150 μgms morphine, with hardly any additional adverse effects.Item Addressing the unmet need in respiratory viruses: an interdisciplinary analysis of product development pipeline in Asia(Medip Academy, 2018-10) Jelle, J. Feddema; Eric, ClaassenBackground:Respiratory tract infections (RTIs) pose a significant burden on health systems worldwide. Progress has been booked in reducing RTI disease burden through development of diagnostics, therapeutics and vaccines, though most efforts often fail to address the contribution of non-influenza viruses. Increasing awareness and the prevailing unmet need has resulted in the establishment of initiatives that aim to explore ways in which to extend innovation efforts for influenza tothe broad range of respiratory viruses. This study will provide a detailed description of the state of the RTI market in Asia.Methods:By developing a dataset containing data from patent documents and clinical trials (CTs) we aimed to provide a detaileddescription of the RTI market in Asia.Results:We found a downward patent filing trend in respiratory diagnostics but a high number of phase 3 studies. A strong preference for the development of therapeutics and vaccines targeting bacterial pneumonia and influenza became apparent, whereas less attention is given towards product development targeting non-influenza viruses. Conclusions: The findings indicate a mature respiratory diagnostics market with minor industrial interest but at the same time an evolving RTI CT market with a strong late-stage pipeline. Asia represents only a handful of studies related to non-influenza viruses, mostly conducted by non-profit organisations. The business segment appears to focus upon product development for more profitable respiratory infections thereby suggesting that involvement and engagement of the industry within global initiatives and efforts to increase innovation for non-influenza viruses is not optimalItem Agreements in clinical studies at German university clinics(Medip Academy, 2020-04) Ahmed, Raees; Thomas, Voigt; Matthias, Siegert; Christoph, GerstThe article aims to give an overview of the contractual situation in Germany, which arise in clinical studies. The goal of the authors is to show any potential sponsor of a clinical study, who is interested in cooperation with German partners such as universities or other study sites, what kind of agreements may be expected and to give a brief overview about necessary themes included within the contractual negotiations. The different contractual settings are considered from the perspective each different type of agreement. The authors have chosen amongst all possible types the ones which are the most common in a clinical study, such as CDA, MTA, grant agreement, clinical study agreement, CRO-service agreement etc. The authors show the complexity of the contractual setting of a clinical study and emphasize to pay close attention to the contractual settings. Even though the content of the agreement is mostly universal in nature, in some cases, Germany has some very special rules (e.g. regarding employees’ inventions), which any potential sponsor should keep in mind.Item Aliskiren and losartan study in non-diabetic CKD: a comparison of patients in the clinical trial versus the usual care group(Medip Academy, 2018-01) Keng, Thye Woo; Choong, Meng Chan; Stephanie, Fook Chong; Cynthia, Lim; Jason, Choo; Lina, Choong; Suhail, Mohamad; Han, Khim Tan; Kok, Seng Wong; Marjorie, FooBackground: This is a comparative study of a 6 year retrospective analysis of the therapeutic efficacy and safety of Combined Aliskiren (150 mg a day) and Losartan (100 mg a day) in a Clinical Trial setting versus a Usual Care group of patients on Losartan (100 mg a day), Telmisartan (80 mg a day) and Combined Enalapril (10 mg a day) plus Losartan (100mg a day) in non-Diabetic Chronic Kidney Disease (CKD) patients. The objective of this study was to ascertain if there were any differences in the renal outcome of patients treated within a Clinical Trial setting versus a Usual Care setting. The study seeks to establish the relevance of having a Usual Care group as a comparator and whether its inclusion in the study would help to validate the findings in the Clinical Trial group Methods: This is a 2nd Phase follow up study three years after the initial 1st Phase study in the Clinical Trial Group. Patients in the 2nd Phase study were those who continued to have proteinuria and were treated with Losartan 100mg a day. The 2nd Phase study seeks to document the incidence of remission of proteinuria following their initial 1st Phase therapy for proteinuria compared to those in the Usual Care group where treatment remained unchanged from year 1 to end of year 6. The rates of remission of proteinuria and improvement of renal function as well as associated comorbidities between the 2 groups are compared. Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001). There were more patients with hypertension and yperkalaemia in the Clinical Trial group compared to the Usual Care group. Seven patients were in ESRF in the Usual Care group compared to only 3 in the Clinical Trial group but this difference was not significant. More patients in the Clinical Trial group compared to the Usual Care group had improvement in eGFR at the end of the 6 years (p<0.001). Conclusions: This study shows that patients in a Clinical Trial setting do better than those in the Usual Care setting as they are more likely to have improvement in renal function with remission of proteinuria.Item Antihypertensive medication non-adherence and its determinants among patients on follow up in public hospitals in Northern Ethiopia.(2014-11) Ali, Mediha Ahmedin; Bekele, Mebratu Legesse; Teklay, GebrehiwotAdherence to pharmacological treatment for hypertension is considered a key factor in guaranteeing successful therapy outcomes. Non-adherence to antihypertensive therapy can be determined by demographic, drug related, disease related and setting related factors. The primary aim of this study was to investigate antihypertensive medication non-adherence and its determinants among patients on follow up in Ayder referral hospital and Mekelle general hospital. Methods: A prospective cross-sectional study was conducted in Ayder Referral Hospital (ARH) and Mekelle General Hospital (MGH) from May to June, 2013. A total of 121 patients were interviewed with a structured standard questionnaire and patient medication charts were reviewed. The questionnaire contained of demographic questions, the 8-item Morisky medication adherence scale (MMAS) and questions about characteristics of hypertension and its therapy. The data collected were cleaned, entered and analyzed using Statistical Package for Social Science (SPSS) version 16 for windows with 95% confidence interval and P value <0.05. Results: Around one fourth (26.4%) of the study participants were found to be non-adherent to their treatment. Family support on adherence (AOR = 0.170, 95%CI = 0.030-0.905), spot blood pressure (AOR = 0.052, 95%CI = 0.003-0.242), place of patient residence (AOR = 0.184, 95%CI =0.024-0.597) and hypertension related complications (AOR = 21.737, 95%CI = 1.568-418.428) were found significantly and strongly associated with treatment non-adherence. Conclusions: A quarter of the participants of this study were completely non-adherent and only around half of them were adherent to their medications. The absence of family support, being at the prehypertension class of blood pressure, living in Mekelle city and presence of hypertensive heart disease were shown to decrease adherence to antihypertensive medications. Therefore, health care professionals should be adequately trained and resourced to offer proper counseling to hypertensive patients on their medication and disease conditions.Item Are we requesting the right consent.(2014-08) Pazare, Pradeep K; Dandge, Vithalrao P; Mujawar, Nilofer S; Girish, MeenakshiMedical treatment can only be administered with consent of a competent patient. Giving the treatment without consent is failure to respect patient’s autonomy; violating an individual’s right to self-determination. Methods: We conducted a cross sectional study to evaluate the consent forms from various hospitals. Consent forms of 372 out of 750 medical institutes in Nagpur were evaluated under 20 ethical and medico legal aspects of an ideal consent form. Results: Most of the consent forms lack important clauses of an ideal consent form that can go against the treating doctors in the court of law. Conclusions: Doctors need to be trained to design a consent form. They need to be made aware of the medico legal rights of the patient. The consent form is for the patients to acknowledge that the nature and purpose of treatment has been fully explained, understood and consented to. Remember patients never consent to doctor’s negligence but only to risks and complications.Item Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals(Medip Academy, 2018-01) Mahmood, E. Elrggal; Morooj, Al-Muwallad; Areej, Al-Otaibi; Jomanah, Alsiddik; Alaa, Shahbar; Ejaz, CheemaBackground: Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects. Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in Helicobacter pylori associated infections by using the CONSORT 2010 checklist. Methods: All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on Helicobacter pylori associated infections were included in the review. Results: 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%). The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively. Conclusions: The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.Item Attenuation of haemodynamic responses to endotracheal extubation-diltiazem versus lidocaine(Medip Academy, 2020-04) Farooq, Shaik Umar; Rani, B. Sandhya; Acharya, AnandBackground:Endotracheal extubation is one of the frequently performed procedure in the practice of anaesthesia.This study was done to observe the haemodynamic responses during tracheal extubation and to compare the efficacy of IV diltiazem 0.2mg/kg versusIV lidocaine 1mg/kg in attenuating the hemodynamic response to tracheal extubation.Methods:90 patients aged 20 to 60 yrs, belonging to ASA I and II, normotensive were included in the study and they were randomly allocated into 3 groups of 30each. Group I received normal saline and served as control. Group II received0.2mg/kg of IV diltiazem 2 min before extubation. Group III received 1mg/kg of lidocaine IV 2 min before extubation. At the end of the surgery, heart rate (HR), systolic blood pressure (SBP)and diastolic blood pressure(DBP)were recorded served as base line values.Results:After tracheal extubation, all the haemodynamic parameters increase from the basal level in the control group and decreased in the study group. The change in HR, SBP and DBP were significantly less in group II and group III compared to group I. The change in HR, SBP and DBP were significantly less in group II compared to group III. Conclusions: Diltiazem hydrochloride, a calcium channel blocker belongs to the benzothiazepine group given in dose of 0.2mg/kg IV 2 min before tracheal extubation in ASA grade I andgrade II patients is a simple, effective and practical method of blunting cardiovascular responses to tracheal extubation. This suppressive effect of diltiazem was comparable to or even more potent than that of lignocaine 1mg/kg IV 2 min before tracheal extubationItem Autologous chondrocyte transplantation: a phase 1 study protocol to validate the safety and feasibility of a new advanced cell therapy product for articular cartilage repair in Brazil(Medip Academy, 2020-04) Alessandro, Rozim Zorzi; Eliane, Antonioli; Moises, Cohen; Camila, Cohen Kaleka; Andrea, Tiemi Kondo; José, Mauro Kutner; Mario, FerrettiBackground:Membrane-assisted autologous chondrocyte transplantation is considered the gold standard surgical technique to treat greater than two millimetresdiameter cartilage lesions in the knee in patients after conservative treatment failure. However, this technique is only available in developed countries of North America, Europe and Japan. According to Brazilian law, it is considered an advanced cell therapy product. There is currently no product of this type enabled for clinical use in Brazil. Following the request of the Brazilian regulatory agency (ANVISA), this phase 1 study was developed. The objective is to access feasibility and safety of a new membrane-assisted autologous chondrocyte product.Methods:Three participants with a larger than two millimetresarticular cartilage lesion in the distal femur or the patella, which did not improvetheir symptoms with conservative treatment, will be submitted to an arthroscopically assisted cartilage biopsy. After isolation and expansion in a good manufacturing practicesfacility, chondrocyte seeded collagen membranes will be surgically inserted in the lesion and fixed with fibrin glue. The follow-up period will last 1 year. Primary outcome will be incidence and severity of complications according to NCI-CTCAE version4.0. Secondary outcomes will be Western-Ontario McMaster Universities Osteoarthritis Indexscale, International Knee Documentation Committeesubjective scale and magnetic resonance observation of cartilage repair tissuemagnetic resonancescale. Conclusions: This study, together with previous preclinical results and international experience, will allow patients in Latin America to have access to this advanced cell therapy.Trial Registration:Brazilian registry of clinical trials RBR-6fgy76 (https://www.ensaiosclinicos.gov.br/rg/RBR-6fgy76/). Ethical approval: CAAE: 73911617.2.0000.0071.Item Awareness and attitude of Saudi cancer patients toward participation in clinical research(Medip Academy, 2019-01) Sheblaq, Nagham; ElBagoury, Marwan; Elagouz, Ahmed M.; Kotb, MaryamInternational Journal of Clinical Trials| January-March 2019| Vol 6| Issue 1Page 1International Journal of Clinical TrialsGabrio JH et al. Int J Clin Trials. 2019Feb;6(1):1-9https://www.ijclinicaltrials.compISSN2349-3240| eISSN 2349-3259Original ResearchArticleTools and processes for tracking IRB approvals as a coordinating center for large multicenterclinical research networksJenna H. Gabrio1*, Jeanette Auman2, Lindsay Parlberg2, Margaret Crawford3, Kristin Zaterka-Baxter2INTRODUCTIONA data coordinating center (DCC) for a large multicenter research network takes on a variety of roles and responsibilities that contribute to the smooth and successful function of large clinical trials. Major responsibilities of a DCC can be categorized into four broad areas: trial operations, data management and analysis, quality control/quality assurance, and human subjects protection and regulatory affairs.1Findings from a Federal Demonstration Partnership survey of more than 6,000 faculty members who were lead investigatorson ABSTRACTItem Benzodiazepine premedication in general anaesthesia: a clinical comparative study(Medip Academy, 2019-04) Lahkar, Babita; Dutta, KalpajitBackground:The main aims of pre-anaesthetic medication are anxiolysis, analgesia, anti-emesis and reducing perioperative patient risk. Producing a state of amnesia for pre and post-operative events is desired by all. This study has been undertaken to evaluate the role of three of the benzodiazepines i.e. diazepam, lorazepam and midazolam during general anaesthesia, in providing anxiolysis, sedation and amnesia.Methods:The study included patients with ASA grade I and ASA grade II physical status of both sexes, age ranging between 18-60 years. Patients were divided into three groups of thirty patients each, every group receiving intramuscular injections of diazepam 0.1 mg/kg body weight, lorazepam 0.07 mg/kg body weight and midazolam0.08 mg/kg body weight respectively; 45 minutes prior to induction of general anaesthesia. Anxiety assessment before premedication along with assessment of sedation after premedication was done.Results:Before premedication the mean values of pulse rate, blood pressure and respiratory rate were not significantly different among the three groups (p>0.05). Maximum changes in these parameters were observed with Midazolam followed by lorazepam and diazepam. The dose of thiopentone used as inducing agent was also lowered significantly in case of midazolam (p<0.05). One patient in midazolam group showed respiratory depression whereas four patients receiving lorazepam and diazepam showed delayed recovery and prolonged sedation, but the effects were self-limiting. Conclusions: Midazolam offers the maximum advantage in allaying anxiety and providing excellent sedation and amnesia during general anaesthesia and proves to be the most suitable premedicant before general anaesthesia.Item Biparietal diameter (BPD) growth rate between the first and second trimester as a predictor of poor obstetric and neonatal outcome among the Indian population.(2014-05) Jamdade, Kshitij P; Amin, Sapna; Ferrao, Sinatra RThe Objective of this study was to evaluate the association of BPD at 11-14 weeks and pregnancy outcome and to determine the role of incremental BPD growth from 11-14 weeks and 17-20 weeks in pregnancy outcome. Methods: Women (n=910) with singleton pregnancies were included in this prospective observational study after an early anomaly scan (11 to 14 weeks). Outcomes noted were the incidence of adverse events and the neonatal birth weight. Results: Irrespective of their original BPD at 11 to 14 weeks, fetuses had acquired optimum BPD growth rate on a follow up scan at 17-20 weeks, i.e., a majority of them fell in the 10th to 90th percentile group (P value <0.001). Fetuses with BPD below the 10th percentile were small for gestational age (SGA) at birth despite an optimal growth rate. Also, a significant majority of the fetuses with BPD in the 10th to 90th percentile were Appropriate for Gestational Age (AGA) at birth. Conclusion: The BPD at 11 to 14 weeks scan predicts the incidence of SGA and AGA babies, independent of BPD growth rates between first and second trimester. The BPD growth rates were neither significantly different nor predictive of the birth weight or adverse pregnancy outcomes.Item A blinded, three-arm randomised trial assessing joint function and measuring three-dimensional knee joint kinematics in individuals six months after a total knee joint replacement; comparing a medially stabilised design, to standard fixed bearing conventional designs – posterior stabilising and cruciate retaining(Medip Academy, 2018-01) Dowsey, Michelle M.; Pandy, Marcus; Young, Tony J.; Gray, Hans; Guan, Shangyuanye; Choong, Peter F.Background: No randomised trial exists to assess the relative prosthetic performance of three fixed bearing total knee joint replacement construct designs through clinical functional outcomes and biomechanical gait analysis at six months after the index procedure.Methods: The design of a double blinded, prospective, randomised trial with three parallel patient groups is presented. Patients reviewed in consultant clinic with radiographic and clinical diagnosis of osteoarthritis of the knee, with the condition deemed severe enough to require a total knee joint replacement (TKJR) are eligible. Subjects enrolled in the trial are randomised to one of the three TKJR construct designs approximately ten days prior to scheduled date of surgery. Each subject is then followed up for at least twelve months. Repeated measure of Analysis of Variance (ANOVA), and Analysis of Covariance (ANCOVA) will be utilised to uncover any clinical functional differences in each trial group in each time interval.Results: Differences in clinical functional scores at each time interval compared to pre-intervention, as well as between group differences in clinical functional scores at each time interval will be examined. At six months after the operation, biomechanical measurements of joint motion, ground reaction forces, and muscle electromyographic (EMG) activity will be recorded simultaneously from each subject for four test conditions: level walking, stair ascent, stair descent, and chair rise.Conclusions: This randomised trial is designed to better understand the relationships between the clinical functional outcomes and replaced knee kinematics in three fixed bearing total knee replacement construct designs at six months postoperatively.Item Challenges and threats of investigator-initiated multicenter randomized controlled trials: the BACE trial experience(Medip Academy, 2019-10) Vermeersch, Kristina; Bénédicte, Demeyere; Karen, Denaux; Katelijne, De Nys; Thierry, Troosters; Guy, G. Brusselle; Wim, JanssensBackground:Investigator-initiated clinical research has become a complex environment. Increasing administrative tasks and costs, imposed by stringent regulatory demands, risk to reduce this creative, independent and indispensable research field. The objective of the present study was to illustrate the burden of non-scientific challenges associated with an investigator-initiated multicentre randomized controlled trial, based on the Belgian trial with azithromycin for Chronic obstructive pulmonary disease (COPD) Exacerbations requiring hospitalization (BACE) trial experience.Methods:The trial enrolled 301 patients with COPD, hospitalized for an acute exacerbation between 2014-2017, and assessed the potential of azithromycin, an off-patent antibiotic. Key experienced challenges were complemented with registry data from the Clinical Trial Centre of the University Hospital Leuven to outline the local clinical respiratory research field, quotations for the trial protocol obtained from 3 pharmaceutical companies to provide insight into the budget restraints and a participation survey to capture the consortium’s perspective.Results:60% of the required sample size was enrolled. Key challenges included trial implementation, study drug and database management. Industry-initiated trials dominated the local research field (61%), whereas investigator-initiated prospective interventional and multicentertrials accounted for 19% and 13%, respectively. The triple quotation revealed the BACE trial to require 1.6 to 2.1-fold the amount when executed by the pharmaceutical industry. The survey identified the lack of a local study team as an important obstacle for participation, along with inadequate financial compensation and excessive administrative workload.Conclusions: Without an adaptation of current regulatory and funding policies to overcome non-scientific challenges, investigator-initiatedclinical research is risking to further declineItem Challenges of conducting clinical trials in Asia(Medip Academy, 2018-10) Ali, Sheraz; Egunsola, Oluwaseun; Babar, Zaheer Ud Din; Hasan, Syed ShahzadUnlike North America and European Union (EU), Asian continent appears to be an ideal destination for conducting cost-effective clinical trials utilizing the pool of treatment naïve subjects. With a population approaching 4.5 billion, recruitment of subjects can be done without a fear of limited patient pool across Asia. The burden of infectious and chronic diseases is also higher in Asian countries. The emerging clinical trial markets particularly China, South Korea, and Taiwan offers genetic diversity in population group, thus promoting the quality and generalizability of clinical trial’s data. Nonetheless, several challenges also exist for the Western sponsors in majority of the Asian countries; regulatory, operational and infrastructural challenges are atthe forefront. Challenges under the heads regulatory, operational, infrastructural, language and cultural, ethics, and future challenges have been discussed. SWOT analysis of Asian clinical trial’s market exhibits enormous opportunities for study sponsorswith manageable threats.Item Clinical research in Latin America: scientific production in high impact clinical research journals from 2000 to 2010.(2015-05) Coronel, Emmanuel; Fregni, FelipeBackground: Scientific production has long been dominated by a few countries such as the United States, Europe and Japan. Historically Latin American countries have contributed marginally to the world’s scientific production, however important changes are now taking place in the geography of scientific research. Methods: In order to determine the current contribution of Latin America to global clinical research and whether the region has been participating in the growth of internationally collaborative research we reviewed the literature in 10 high-impact medical journals between 2000 and 2010. We manually searched original articles in 10 journals that have a strong focus on clinical research and had the highest impact factors in their fields during the study period. We identified a total of 1047 original articles published. Results: Our results show that Latin America was a minor contributor of research published in high impact journals with only 4 (0.38%) of the articles citing a corresponding author affiliated with a Latin American institution. Furthermore, only 23 articles (2.2%) cited non-corresponding authors from Latin America in contrast to 358 articles (34.2%) in which all the authors were affiliated with US institutions. Conclusions: Although these results show limited contribution from Latin America to the production of health and clinical research, it also shows that Latin America is represented in the most competitive journals given the relative lack of research infra-structure, training and challenges with language. Factors such as GDP and investment in research may play a significant role, but may not be the only contributing factors for this scenario.Item Clinical study of community acquired pneumonia at MNR medical college and hospital, Sangareddy(Medip Academy, 2018-01) Jain, SonalBackground: This study is done to study the clinical profile of community acquired pneumonia in patients admitted in medical wards at MNR Hospital, Sangareddy and to find out the associated risk factors of community acquired pneumonia.Methods: 75 Patients admitted in the department of medicine of MNR Medical college and Hospital, Sangareddy with clinical manifestations of Community acquired pneumonia from august 2012 to January 2015 (Two years and 6 months) were taken into the study. All adult patients of both genders aged above 14 yrs, who presented with acute onset of fever associated with chills and rigors, having cough with expectoration and/ or chest pain and breathlessness were included in the study. All the patients were subjected for detailed clinical examination to make a provisional diagnosis of community acquired pneumonia (CAP). Patients with hospital acquired pneumonia, aspiration pneumonia and PCP pneumonia in patients with HIV were excluded.Results: Among 75 cases studied, the mean patient age was 52.1 years with Male: Female patient ratio 3.17:1. The associated diseases in this study are COPD (30.67%) and DM (12.0%).The most common presenting symptoms were fever (100%), cough (100%), and expectoration (100%); other symptoms included chest pain (60%), dyspnoea (61.33%). The respiratory signs included bronchial breath sounds, increased VF and VR, and presence of whispering pectorolique in all subjects. Conclusions: Identification and determining the clinical patterns of community acquired pneumonia helps in adoption of regionally optimized diagnostic approach.Item Clinical trial of combination therapy for the efficacy, safety, tolerability and improvements in quality of life in patients with moderate to severe plaque psoriasis(Medip Academy, 2018-07) G. V., Amruthavalli; V., Aruna; R, GayathriBackground:Psoriasis is an autoimmune disorder with clinical manifestations scales, inflammation and dryness. The psoriatic skin behaves differently in concurrence with circadian rhythm. Cell division increases in late night and early morning hours. Enzymatic activity will be more during day time. To balance these variations a 24×7 protection is required. The objective of the present study is to find the improvement in Psoriasis condition with the Combination therapy compared to single drug usage.Methods:A clinical trial for 4 weeks was conducted among psoriasis patients with psorolin oil vs. combination therapy (Dr.JRK’s 777 oil, psorolin ointment, psorolin oil and psorolin medicated bathing bar) and the clinical relief was measured among both groups by following parameters like psoriasis area and severity index (PASI), Physician’s global assessment (PGA), dermatology life quality index (DLQI), subjective self-assessment questionnaire (SSAQ) and subject investigational product feedback questionnaire (SIPFBQ).Results:Combination therapy (1-3-2 topical therapy) of Dr.JRK’s 777 oil, psorolin ointment, psorolin oil and psorolin medicatedbathing bar as a treatment regimen was found to be more effective in the treatment of psoriasis. Conclusions: 1-3-2 topical therapy is useful in severe psoriasis conditions and recommended for long term effective treatment of psoriasisItem Clinical trials in Ghana: evolution and current landscape.(2014-11) Adjei, George O; Sulley, Abdul MA review of published clinical trials from Ghana shows the earliest trials initiated in the 1970s, were mainly trials of interventions against onchocerciasis and childhood Burkitt’s lymphoma. Subsequent trials in the 1980s and 1990s were more diverse, comprising of preventive as well as therapeutic interventions against major communicable diseases of the period. In more recent times, trials of interventions against malaria have since 2000, been the most dominant and have included some of the most recently developed vaccines. There has, since the early days of clinical trial history in Ghana, been a consistent presence of trials of reproductive health interventions and surgically-related trials. There have been few trials of tuberculosis, or neonatal-related interventions, and trials against major non-communicable diseases such as hypertension, cardiovascular diseases, and mental health disorders have been virtually non-existent. The clinical trial evolution in Ghana has reflected global health initiatives and external funding exigencies and there is an urgent need for trials that are dynamic and directed towards addressing other significant and especially non-communicable disease causes of morbidity and mortality in Ghana.