International Journal of Clinical Trials

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https://imsear.searo.who.int/handle/123456789/156145

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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Now showing 1 - 20 of 249

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, Sapna
Background: 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.
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, Debra
Background: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.
Addressing the unmet need in respiratory viruses: an interdisciplinary analysis of product development pipeline in Asia
(Medip Academy, 2018-10) Jelle, J. Feddema; Eric, Claassen
Background: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 optimal
Agreements in clinical studies at German university clinics
(Medip Academy, 2020-04) Ahmed, Raees; Thomas, Voigt; Matthias, Siegert; Christoph, Gerst
The 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.
AIM HD-CKD study: assessment of the efficacy and safety of ferric carboxymaltose in iron deficiency anemia management in haemodialysis patients with chronic kidney disease
(Medip Academy, 2025-06) Khanna, U; Perugu, PK; Kumar, A; Sheth, S; Gaikwad, A; Gajbe, P; Wangikar, P; Suryawanshi, S.
Background: Iron deficiency anemia (IDA) is a common complication in patients with chronic kidney disease (CKD) undergoing hemodialysis (HD). Intravenous (IV) iron supplementation is essential for managing IDA in these patients, and ferric carboxymaltose (FCM) has emerged as a promising treatment option.Methods: This multicentric, retrospective observational study was conducted from April to August 2023, involving 52 adult HD-CKD patients with IDA in India. During dialysis sessions, 48 patients received 4 weekly doses of 100 mg FCM IV push, while 4 patients received 3 doses. Hematological parameters, including haemoglobin (Hb), serum ferritin, transferrin saturation (TSAT), C-reactive protein (CRP), and estimated glomerular filtration rate (eGFR), were measured at baseline and after the final FCM dose. The primary outcome was the change in Hb levels, with secondary outcomes focusing on changes in ferritin, TSAT, CRP, eGFR, and the safety profile of FCM.Results: Following FCM administration, a significant increase was observed in Hb levels (+0.69 g/dl, p<0.001), serum ferritin (+8.61 ng/ml, p=0.003), and TSAT (+3.69%, p<0.001). CRP levels showed a slight, non-significant decrease, while eGFR slightly increased, and neither reached statistical significance. No serious adverse events were reported, indicating a favorable safety profile for FCM.Conclusion: The study demonstrated that 100 mg IV FCM is an effective and safe treatment for managing iron deficiency anemia in Indian HD-CKD patients. The significant improvement in Hb, ferritin, and TSAT levels post-FCM administration supports its use as a reliable therapeutic option in this patient population.
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, Foo
Background: 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.
Anti-ageing effects of CollabZen™ in healthy human volunteers: a randomized, double blind, placebo-controlled study
(2024-06) Gadani, Mihir C.; Badak, Sneha; Upadhyay, Ratna
Background: There are several concerns related to combating signs of ageing. Considering the long-term safety concerns of cosmetic formulations, a safe and effective approach using nutritional supplements and naturals should be of great help. CollabZenTMis one such a blend of three plant materials known as Phyllanthus emblica, Camellia sinensis, and Coffea arabica,earlier tested for collagen building in human cells in-vitro. The current study aims to explore its potential as a nutraceutical product for skin ageing.Methods:The study enrolled 64 volunteers both genders (mean age=45.75) with crow's feet wrinkles. One group (n=32) received a placebo capsule (Product A) and other group received CollabZenTMcapsules (Product B). Dermatological parameters were assessed at 0thday, 4thand 8thweek, and self-assessment questionnaires for efficacy and tolerance were collected on 4thand 8thweek. The trial is registered at https://ctri.nic.in/, CTRI/2022/10/046168.Results:The results showed that product B (CollabZenTM) was significantly effective than the placebo in improving deep skin hydration on the face (p=0.009), increasing facial skin elasticity (p=0.001), and enhancing firmness (p=0.001) after 8 weeks. Participants in Group B reported higher levels of satisfaction regarding their perceived skin health compared to group A based on self-assessment at the 8thweeks (p<0.01). Moreover, only one volunteer in each group experienced mild intolerance at the end of 8th week, demonstrating the safety of these nutraceutical ingredients and excipients.Conclusions:CollabZenTM, with its known antioxidant and collagen-boosting properties and current findings can be considered a valuable nutraceutical product for the anti-ageing sector of the cosmetic industryCollabZenTM
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, Gebrehiwot
Adherence 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.
Are we requesting the right consent.
(2014-08) Pazare, Pradeep K; Dandge, Vithalrao P; Mujawar, Nilofer S; Girish, Meenakshi
Medical 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.
Assessing hypotension incidence and dosing strategies of sacubitril/valsartan in real-world heart failure management: protocol for a retrospective, multicentre and cohort study
(Medip Academy, 2024-09) Jadhav, UM; Shah, J; Mohanty, A; Chenniappan, M; Sattur, AG; Mukhopadhyay, M; Krishna, KN; Raikar, M; Mahale, SB; Majumdar, D; Shaila, S; Prakash, G; Hirapur, IS; Abdali, N; Surwade, H; Abid, MTK; Thakran, V; Sharma, A; Mahajan, N.
Background: The burden of heart failure (HF) and hypertension in India underscores the need for effective management strategies. Sacubitril/valsartan, an angiotensin receptor neprilysin inhibitor (ARNi), has emerged as a pivotal therapy for HF with reduced ejection fraction (HFrEF). However, concerns about hypotension often hinder optimal dosing in clinical practice. The primary objective of this study is to observe the incidence of hypotension in HFrEF patients and to evaluate the best clinical practice to achieve an optimal tolerated dose of sacubitril/valsartan without treatment discontinuation. Secondary objectives include evaluating treatment outcomes, tolerability, and factors influencing dosing adjustments. Methods: This is the protocol of a retrospective, multicentre cohort study aimed at assessing real-world usage patterns of sacubitril/valsartan among Indian HFrEF patients. Patients aged 18-80 years diagnosed with HFrEF (left ventricular ejection fraction (LVEF) ?40%) and initiated on sacubitril/valsartan between November 2023 and May 2024 will be included. Baseline and follow-up data, including demographics, medical history, and treatment outcomes, will be analysed using appropriate statistical tests. Data from approximately 150 healthcare facilities will be collected using a structured case report form (CRF). The study was initiated in February 2024. As of manuscript submission, 1039 individuals have been enrolled on the study. Data collection is expected to continue until the end of June 2024. Conclusions: This study aims to contribute valuable insights into optimizing sacubitril/valsartan therapy for HFrEF patients in India, addressing concerns about hypotension and dosage optimization. The study seeks to inform clinical practice and enhance patient care by elucidating real-world usage patterns and outcomes.
Assessing the role of cross-cultural communication in shaping patient perceptions in medical tourism hospitals
(Medip Academy, 2025-06) Tyagi, H; Mehra, P.
Background: Medical tourism has emerged as a key sector of the global healthcare industry, offering patients access to advanced treatments in foreign countries. While clinical outcomes are crucial, patient satisfaction is profoundly influenced by cross-cultural communication. This study investigates the impact of cultural competence on patient satisfaction in medical tourism, particularly focusing on communication styles and expectations. Methods: A cross-sectional design was used to survey 1,476 international medical tourists in a government-approved healthcare facility in New Delhi, India. Data collection employed a detailed questionnaire encompassing six main sections, subdivided into 71 items covering verbal and non-verbal communication, cultural beliefs and time orientation. Statistical analyses included exploratory and confirmatory factor analysis, structural equation modelling and multi-group analysis. Results: The findings revealed a significant positive relationship between patient beliefs in physicians’ cultural competence and patient satisfaction. Intercultural communication expectations partially mediated this relationship. Operational factors such as waiting and consultation times emerged as moderators. The results indicated that providers who adapted communication styles to patients' cultural expectations achieved higher satisfaction rates. Conclusions: This study highlights the importance of cultural competence in enhancing patient experiences and satisfaction in medical tourism. By addressing diverse cultural expectations and communication styles, healthcare providers can foster trust and improve outcomes. These findings underscore the need for systematic cross-cultural training as a strategic priority in the global medical tourism industry.
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, Cheema
Background: 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.
Assessment of variations in upper and lower gonial angle in children with mouth breathing habit
(Medip Academy, 2024-12) Saleem, S; Belchada, DK; Ayilliyath, A; Azhikoden, F.
Background: Mouth breathing is one of the most common deleterious oral habits in children. The habitual position of muscles inside and outside the mouth will affect dental development. Mouth breathing influences skeletal growth and thereby affects the cephalometric parameters. The present study aimed to assess if there is any variation in upper and lower gonial angles in children with mouth breathing habit. Methods: The 33 patients in the age group of 8 to 12 years reporting to the Department of Pediatric and Preventive Dentistry with chief complaint of mouth breathing was selected for the study based on inclusion and exclusion criteria. Lateral cephalograms of these children were taken with a digital panoramic system under standard exposure factors, as recommended by the manufacturer. Upper and lower gonial angles were determined on the lateral cephalograms. The values obtained were tabulated and subjected to statistical evaluation. Results: The mean upper and lower gonial angles were seen to increase from the normal in children with mouth breathing habit. However, independent sample t test showed no statistically significant difference in upper and lower gonial angles with a p value of 0.598 in upper gonial angle and 0.714 in lower gonial angle. Contusions: Early detection of the changes in the upper and lower gonial angles can help a pediatric dentist in effectively framing a treatment plan in children with mouth breathing habit, to prevent further deterioration in the dental and skeletal structures and be able to correct the already occurred unfavourable changes in them.
Attenuation of haemodynamic responses to endotracheal extubation-diltiazem versus lidocaine
(Medip Academy, 2020-04) Farooq, Shaik Umar; Rani, B. Sandhya; Acharya, Anand
Background: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 extubation
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, Ferretti
Background: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.
Awareness and attitude of Saudi cancer patients toward participation in clinical research
(Medip Academy, 2019-01) Sheblaq, Nagham; ElBagoury, Marwan; Elagouz, Ahmed M.; Kotb, Maryam
International 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 ABSTRACT
B12 deficiency epidemic? Should B12 level lower limit reference values be decreased?
(Medip Academy, 2024-09) Yan?k, K; Özkan, A.
Background: This study aims to examine B12 levels in general in our society, to determine the rates of B12 deficiency, and to determine and recommend new B12 reference range values according to current data. Methods: A total of 16497 patients who were admitted to our secondary care hospital for various reasons in the three-year period between January 2021 and December 2023 and whose B12 levels were tested in their serum were included in the study. B12 levels of all patients were measured in the hospital biochemistry laboratory on Architect i1000SR and i2000 SR (Abbott diagnostics, Ireland) devices. Results: The reference ranges for B12 levels, determined as 2.5% and 97.5%, were 130-1084 pg/ml for adult men, and as 137-993 pg/ml for adult women. Considering 200 pg/ml as the normal lower limit for B12 level, low levels were found in 14.6% of all patients. Conclusions: Our study is one of the rare studies in which B12 reference ranges are investigated up-to-date with a large patient participation. Our findings showed that the rate of B12 deficiency in the society is very high compared to the generally accepted reference lower limit values, that B12 levels in the society are very low compared to these reference values, and perhaps that the reference lower limit values may need to be reduced to 149-138 pg/ml in individuals under 18 years of age, 130-137 pg/ml in adults, and 123-125 pg/ml in the elderly.
Benzodiazepine premedication in general anaesthesia: a clinical comparative study
(Medip Academy, 2019-04) Lahkar, Babita; Dutta, Kalpajit
Background: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.
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 R
The 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.
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.

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