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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Increased serum osteocalcin levels and vitamin K status by daily cheese intake
(Medip Academy, 2020-04) Lundberg, Helge E.; Holand, Trond; Holo, Helge; Larsen, Stig
Background:Cheese is a major source of long-chained vitamin K2 variants. How intake of vitamin K2 rich cheese affects vitamin K and osteocalcin has not been studied. The aim was to establish a maximum efficacy dose (MED) after daily intake of vitamin K2-rich cheese (Jarlsberg®) based on increase in ratio between carboxylated and undercarboxylated osteocalcin during a five-week diet.Methods:20 healthy healthy volunteers (HV) were recruited. The daily intake of Jarlsberg®cheese in the study varied from 20 to 152g. Clinical investigation was performed initially and after three, four and five weeks with measurement of vital signs, hematological and biochemical variables, carboxylatedand undercarboxylated osteocalcin and vitamin K. The ratio OR=carboxylated/undercarboxylated osteocalcin was the main variable.Results:The MED decreased with treatment duration and was estimated to 57 g/day (95% CI: 47-67)after five weeks diet, resulting in a mean OR increase of 30% (95% CI: 23.8-36.8). Both OR and serum osteocalcin followed a quadratic dose response curve. For osteocalcin,a maximal increase of 46% was estimated at 59 g/day for five weeks. The serum content of long-chained vitamin K2 increased significantly with increasing cheese dose. The increase were mainly obtained the first three weeks and kept unchanged the following two weeks. The cheese doses close to the MED caused nearly significant reductionsin total cholesterol, LDL-cholesterol, the LDL/HDL ratio and significant reduction in the blood pressures after five weeks diet (p?0.05). Conclusions: MED of Jarlsberg® cheese was estimated to 57g/day. Daily intake of Jarlsberg®cheese increasedthe osteocalcin level, vitamin K2andpositively affected the lipid patterns and blood pressure.
Comparing the effect of zinc gluconate and placebo in the treatment of tachypnea, dyspnea and fever in children aged 2 to 23 months with acute bronchiolitis
(Medip Academy, 2020-04) Ahadi, Adel; Mirzarahimi, Mehrdad; Barak, Manouchehr; Ahari, Saeid Sadeghieh; Reyhanian, Maryam
Background:Acute viral bronchiolitis is the most common infection of the lower respiratory tract in infants under 2 years and is one of the reasons for their admission all around the world. The aim of this study was comparing the effect of zinc gluconate and placebo in the treatment of tachypnea, dyspnea and fever in children aged 2to 23 months with acute bronchiolitis.Methods:This randomized clinical trial study has been done on 100 infants aged 2to 32 months with the diagnosis of bronchiolitis who divided in two groups. 50 patients received zinc gluconate and 50 patients received placebo. The symptoms and sign of the disease at baseline and then at 24, 72, and 7 days after starting treatment and duration of hospitalization were compared between the two groups.Results:The treatment and placebo groups were similar in respect to mean age and gender distribution. Two groups were similar in terms of clinical symptoms and signs at the time of admission. Bronchiolitis recovery was better in the treatment group than in the placebo group. This positive effect was statistically significant for vising (p=0.023) and rhinorrhea (p=0.027) at 72 hours after starting treatment. The mean duration of hospitalization was significantly less in the treatment group than in the placebo group (4.14±1.21 versus 4.64±1.2 days; p=0.016). Conclusions: Results showed that the use of zinc gluconate as a zinc supplement in infants with acute bronchiolitis could improve their clinical symptoms and signs and decrease the duration of hospitalization
Comparative evaluation of post-operative analgesic effects of intraperitoneal levobupivacaine plus fentanyl and levobupivacaine plus tramadol in patients undergoing laparoscopic cholecystectomy
(Medip Academy, 2020-01) Katoch, Madan lal; Kour, Loveleen
International Journal of Clinical Trials| January-March2020| Vol 7| Issue 1Page 28International Journal of Clinical TrialsKatoch ML et al. Int J Clin Trials. 2020Feb;7(1):28-31https://www.ijclinicaltrials.compISSN2349-3240| eISSN 2349-3259Original ResearchArticleComparative evaluation of post-operative analgesic effects of intraperitoneal levobupivacaine plus fentanyl and levobupivacaine plus tramadol in patients undergoing laparoscopic cholecystectomyMadan Lal Katoch, Loveleen Kour*INTRODUCTIONPain has been defined as an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage. Unrelieved postoperative pain may result in clinical and psychological changes that increase morbidity and decrease the quality of life.1Besides the distress caused, severe postoperative pain increases the work of breathing as it limits full chest expansion and impairs patient’s ability to cough effectively.2Many interventions have been tried to reduce such severe pain; including epidural analgesia, patient controlled analgesia, transversus abdominis plane block and local wound infiltration.Laparoscopic cholecystectomy is commonly performed procedure for treating symptomatic gallstones. The benefits of laparoscopic surgery include reduced haemmorhage, smaller and more cosmetic incision and shorter hospital stay. Pain after laparoscopy results from ABSTRACT
Evaluation of neo adjuvant chemotherapy response in patients with locally advanced breast cancer
(Medip Academy, 2020-01) Nallamothu, Murali Krishna; C., Mandava Radha Mani; Veera, Abhinav Chinta; T., Jaya Chandra
Background:Carcinoma of the breast from the very beginning has been a feared disease. Advanced disease is treated by neoadjuvant chemotherapy (NACT). With this, a study was conducted to evaluate the pathologic response to NACT in locally advanced breast cancer.Methods:Study was conducted in GSL Medical College, approved by institutional ethics committee, females aged >18 years with locally advanced breast cancer were included in the study. Female <18 years and breast cancer male were not considered. The dimensions are marked and size of the lump compared before and after NACT. Chi-square test was used to find out the significance of study parameters; p<0.05 was considered statistically significant.Results:Total 110 patients were included in the study, mean age was50.63±10.76 years and 53% were in pre menopausal women. When pathological response was considered, 12.7% had complete response, 66.4% had partial response and 20.9% had no response to NACT; statistically there was significant difference between pre and post treatment tumor sizes (p<0.05).Conclusions: Most of the individuals belonged to premenopausal group. Tumour size showed significant decrease after NACT. The overall response rate (completeand partial) after NACTwas significant in our study group
A quasi-experimental study on exploring the use of mobile phone technology for optimizing, tracking and responding to children's developmental progress in Korogocho, Nairobi, Kenya: study protocol
(Medip Academy, 2020-01) Patricia, Kitsao Wekulo; Margaret, Nampijja; Domnick, O. Okullo; Kenneth, O. Okelo; Njeri, Milka; Onyango, Silas; Murage, Elizabeth Kimani
Background:The massive use of technology can be leveraged to facilitate access to growth and development programs for children. Existing programs supporting such initiatives for children younger than three years are inadequate and not accessible to most families. In most cases, primary caregivers are unable to identify delayed milestones in their children’s growth and development due to inadequate information. They therefore often report the cases when they have become very severe and difficult to reverse. In order topromote early identification of possible developmental delays, African Population and Health Research Center together with Val Partners will develop, implement and evaluate the use of mobile phone technology to help caregivers track their children's developmental outcomes.Methods:The study will employ a quasi-experimental design and will use a mixed-methods approach combining quantitative and qualitative methodologies. In one arm, 110 caregivers will be trained on the use of a mobile phone application to assess child growth and development. The other arm, with 110 caregivers, will receive standard care provided by community health volunteers. Child developmental outcomes will be assessed in both arms. Feasibility of the intervention will be assessed qualitatively. Performance data will be compared across the two arms using mixed linear models to assess the effect of the intervention on child development.Conclusions: The findings are expected to provide evidence on whether the intervention is feasible and has an effect on child developmental outcomes. The results will inform the scalability and sustainability of the project.Trial Registration: The trial has been registered with the Pan African Clinical Trial Registry (www.pactr.org) database (ID number: PACTR201905787868050)
Response of osteoarthritis biomarkers after a rehabilitation program: study protocol
(Medip Academy, 2020-01) Eliane, Antonioli; Felipe, B. D. Oliveira; Campedelli, Rosana R.; Alessandro, R. Zorzi; Danielli, Specialli; Agarwal, Sudha; Ferretti, Mario
Background:Knee osteoarthritis is a progressive degenerative joint disease and remains a leading cause of pain, physical impairment and decline in health-related quality of lifein adults. Despite its incidence being amongst the highest in chronic diseases, effective biomarkers are not available to assist in its management. The main goal of this study is to identify mediators that serve as biomarkers and investigate if the levels of these biomarkers will be correlated to the efficacy of a rehabilitation program.Methods:This is a prospective cohort study with 65 participants. Patients with mild-to-moderate symptomatic knee osteoarthritis will be recruited. The Rehabilitation Program will consist of three session/week during eight weeks. Assessment about functional evaluation will be performed before and after treatment, using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)and EuroQOL-5D(Euroquality of life -five dimension) scales, Visual Analog Scale (VAS), and physical function tests (time up and go, isometric strength testing and kinematic gait analysis). Serum levels of classical pro-inflammatory cytokines, hyaluronan and high mobility group box 1 protein(HMGB-1)will be evaluated. The primary outcome is the change in WOMAC scale from baseline to end. Statistical analyses will be used to determine correlation of physical improvement and serum biomarkers. Adverse events will be monitored throughout the study. Conclusions: This trial expect to study the correlation between the anti-inflammatory effects of rehabilitation program derived factors that may be involved in suppressing cytokine induction via suppressing HMGB-1.Trial registration:Clinicaltrials.gov -NCT02964624.
Community case management of chest indrawing pneumonia in children aged 2 to 59 months by community health workers: study protocol for a multi-country cluster randomized open label non-inferiority trial
(Medip Academy, 2020-04) Nisar, Yasir Bin
Background:The World Health Organization (WHO) integrated management of childhood illness (IMCI) protocol recommends treatment of chest indrawing in 2-59 months old children with oral amoxicillin by trained health facility workers. Whereas, the WHO/UNICEF integrated community case management (iCCM) protocol recommends referral by community level health workers (CLHWs) to a health facility. This study aims to evaluate whether CLHWs can treat chest indrawing pneumonia effectively and safely.Methods:Thismulti-centre cluster randomized controlled open label, non-inferiority trial will be conductedin Bangladesh, Ethiopia, India and Malawi. All sites will use a common protocol with the same study design, participants, intervention, control and outcomes. CLHWs will identify 2-59 months old children with chest indrawing. Study supervisors, trained in the iCCM protocol, will confirm CLHWs’ findings. Pulse oximetry will be used to identify hypoxaemic children. In the intervention group, enrolled children will be treated with oral amoxicillin for 5 days, and in the control group they will be referred to ahealth facility, after providing first dose of oral amoxicillin. An independent outcome assessor will visit each enrolled child on days 6 and 14 of enrolment, to assess study outcomes.Conclusions:If CLHWs can effectively and safely treat chest indrawing pneumonia in 2-59 months old children, it will increase access to pneumonia treatment substantially, as in many settings, health facilities and trained health workers are not easily accessible. Moreover, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with the IMCI protocol. Trial Registration:The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303
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.
Effectiveness of a 12-week physical exercise programme on blood pressure in adults with true resistant hypertension and high risk of obstructive sleep apnoea: a study protocol for a pre-post test non randomised clinical trial
(Medip Academy, 2020-04) Suranga, Dassanayake; Gerard, Wilkins; Gisela, Sole; Margot, Skinner
Background:Resistant hypertension, a special phenotype of hypertension, is associated with increased cardiovascular risk. Exercise and physical activity are recommended as non-pharmacological interventions to manage blood pressure in hypertension. Little is known about the effectiveness of exercise in resistant hypertension. A bidirectional relationship has been identified between resistant hypertension and obstructive sleep apnoea but the literature pertaining to the benefit of exercise for populations with both conditions, is minimal. This study aims to identify the effectiveness of exercise in reducing blood pressure in a cohort of adults with resistant hypertension and high risk of obstructive sleep apnoea.Methods:Dunedin based adults with resistant hypertension and high risk of obstructive sleep apnoea will be recruited from the community and health centres to participate in the study. Consenting volunteers (no. of fourteen) will participate in a 12-week exercise programme including aerobic and strength training. The primary outcome measure will be 24h ambulatory blood pressure while the secondary outcomes will be anthropometrics, activity parameters, sleep parameters, cardiac structure and function, and quality of life. The measurements at the end ofthe 12-week exercise programme will be compared with baseline to determine the effectiveness of exercise in reducing blood pressure in the cohort with resistant hypertension and risk of obstructive sleep apnoea. Conclusions: Exercise and physical activity are recommended to manage hypertension. Therefore, it is anticipated that the exercise programme will have a positive effect on the blood pressure of the participants. The findings have potential to change the direction of research in the area by fillingthe knowledge gaps.Trial Registration:The Ministry of Health, New Zealand (Ethics Ref: 18/CEN/257), Trial registry: ACTRN12618001881224p).
Oncology patient preferences in reporting on symptoms
(Medip Academy, 2020-01) Alyssa, L. Peechatka; Millie, Gerzon; Jenny, J. Ly; Dallabrida, Susan M.
Background:Collecting patient reported outcomes (PROs) in oncology clinical trials is becoming increasingly important. However, there is limited consensus on the most appropriatefrequency of PRO administration in oncology trials. The aim of this preliminary study is to examine the perspective of participants with a cancer diagnosis on the importance of completing PROs and to identify at what frequency participants prefer to report on their cancer-related symptoms.Methods:166 participants with a self-reported cancer diagnosis completed a multiple-choice online survey regarding perceptions of symptom importance and reporting preferences.Results:When asked about the benefit of reporting oncology-related symptoms daily, 44% of participants indicated there would be “very much” a benefit, 29% indicated there would be “quite a bit” of benefit, and 17% indicated there would be “somewhat” of a benefit. When asked about how frequently they would prefer to report symptoms, 41% of participants preferred “as they occur,” 36% preferred “once a day,” 18% preferred “once a week,” 4% preferred “twice a day,” and 1% preferred “every 4 hours”. Conclusions: PROs in oncology clinical research are most often collected at weekly, monthly, or longer intervals; however, meaningful fluctuations in cancer-related symptoms can occur more frequently. While concerns regarding patient burden are often raised to support infrequent reporting, these data suggest that participants would like to report symptoms with greater frequency, as episodic and daily reporting options were most popular. Based on these data, more frequent PRO data capture is not only feasible but perceived as important by individuals with cancer
Randomized response surface pathway design with skewed starting point and stochastic dose window
(Medip Academy, 2020-01) Trond, Holand; Øystein, Evensen; Dewi, Sagita; Larsen, Stig
Background:The aim was to introduce response surface pathway(RSP)-design with skewed starting value and stochastic dose-window to estimate optimal efficacy dose (OED) of BP-C2 after IL-1? stimulation in Atlantic salmon.Methods:54 healthy smolt of Atlantic salmon between 50 and 100g before habituated to saltwater were included. The study was conducted as a one-dimensional, randomized between-patient three-level RSP designed trial with one interventional-and one response variable and odd outcomes. The interventional variable was intraperitoneal injected BPC2 with skewed starting dose of 0.10 mg/100g related to the initial dose-window <0.02-0.5 mg/100g. The response variable was the Ct-value of mRNA IL-1? expression 24 hours after injection.Results:Skewed starting value of 0.10 mg/100g was chosen in the first design-level with a dose-window of <0.0-0.20].The three smolt obtained a reduction in Ct-value above 15%, and the dose-window adjusted with the lower boundary equals the previous dose. The five smolt at second esign-level received 0.16 mg/100g with a dose-window [0.10-0.22]. Four smolt obtained above 15% and one of 0.5% reduction in cycle threshold (Ct)-value. Six smolt in the third design-level received 0.21 mg/100g and one 0.16 mg/100g. The mean Ct-value was reduced from 30.0 in the nstimulated situation to 25.0, 24.8 and 26.4 after BP-C2 stimulation of 0.10, 0.16 and 0.21mg/100g, respectively. The OED of BP-C2 related to IL-1? was estimated to 0.14 mg/100g.Conclusions: Skewed starting value in the initial dose-window made the K-adjustment factor and dose-window stochastic. The RSP-procedure works in accordance to the expectation and estimated OED of BP-C2 sufficiently.
Testing for baseline differences in clinical trials
(Medip Academy, 2020-04) Henian, Chen; Yuanyuan, Lu; Nicole, Slye
Reporting statistical tests for baseline measures of clinical trials does not make sense since the statistical significance is dependent on sample size, as a large trial can find significance in the same difference that a small trial did not find to be statistically significant.We use 3 published trials using the same baseline measures to provide the relationship between trial sample size and p value.For trial 1 sequential organ failure assessment (SOFA)score, p=0.01, 10.4±3.4 vs. 9.6±3.2, difference=0.8; p=0.007 for vasopressors, 83.0% vs. 72.6%. Trial 2 has SOFA score 11±3 vs. 12±3, difference=1, p=0.42. Trial 3 has vasopressors 73% vs. 83%, p=0.21. Based on trial 2, supine group has a mean of 12 and an SD of 3 for SOFA score, while prone group has a mean of 11 and an SD of 3 for SOFA score. The pvalues are 0.29850, 0.09877, 0.01940, 0.00094, 0.00005, and <0.00001 when n (per arm) is 20, 50, 100, 200, 300 and 400, respectively.Based on trial 3 information, the vasopressors percentages are 73.0% in the supine group vs. 83.0% in the prone group. The pvalues are 0.4452, 0.2274, 0.0878, 0.0158, 0.0031, and 0.0006 when n (per arm) is 20, 50, 100, 200, 300 and 400, respectively.Small trials provide larger pvalues than big trials for the same baseline differences. We cannot define the imbalance in baseline measures only based on these pvalues. There is no statistical basis for advocating the baseline difference tests
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.
Management of fast breathing pneumonia in young infants aged 7 to 59 days by community level health workers: protocol for a multi-centre cluster randomized controlled trial
(Medip Academy, 2020-04) Nisar, Yasir Bin
Background:WHO does not recommend community-level health workers (CLHWs) using integrated community case management (iCCM) to treat 7-59 days old infants with fast breathing with oral amoxicillin, whereas World Health Organization (WHO)integrated management of childhood illness (IMCI) recommends it. We want to collect evidence to help harmonization of both protocols.Methods:A cluster, randomized, open-label trial will be conducted in Africa and Asia (Ethiopia, Malawi, Bangladesh and India) using a common protocol with the same study design, inclusion criteria, intervention, comparison, and outcomes to contribute to the overall sample size. This trial will also identify hypoxaemia in young infants with fast breathing. CLHWs will assess infants for fast breathing, which will be confirmed by a study supervisor. Enrolled infants in the intervention clusters will be treated with oral amoxicillin, whereas in the control clusters they will be managed as per existing iCCM protocol. An independent outcome assessor will assess all enrolled infants on days 6 and 14 of enrolment for the study outcomes in both intervention and control clusters. Primary outcome will be clinical treatment failure by day 6. This trial will obtain approval from the WHO and site institutional ethics committees. Conclusions: If the research shows that CLHWs can effectively and safely treat fast breathing pneumonia in 7-59 days old young infants, it will increase access to pneumonia treatment substantially for infants living in communities with poor access to health facilities. Additionally, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with IMCI protocol.Trial Registration:The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.
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
Role of punctal plugs as a primarily treatment modality in moderate to severe dry eye
(Medip Academy, 2020-04) Kumar, Sonali V.
Background:In dry eye syndrome tear film disrupts which lead to ocular discomfort. Treatment of dry eye is very challenging and time consuming.Multiple treatment options are available for treating dry eye and one of them is punctal plugs.It blocks the drainage of tear by occluding puncta which helps in the preservation of natural tears on the ocular surface and relieve dry eye symptoms.This study was conducted to assess the safety and efficacy of punctal plugs as a primary treatment modality in moderate to severe dry eye.Methods:Fifty patients were included in this study and they were divided into two groups.In group A which included 25 patients punctal plugs were inserted and in group B (25 patientsor 50 eyes) artificial tear drop was prescribed.The primary treatment outcome was the improvement in dry eye symptoms and secondary outcome was Schirmer test score,tear break up time and rose bengal staining score.Results:There was drastic improvement in dry eye symptoms in group A (punctal plugs) compared to group B(artificial tear group).Schirmer test score,tear break up and rose bengalstaining score also improved in punctal plug group. Conclusions: This study has shown that punctal plug can be used as a primary treatment modality in moderate to severe dry eye as it improves greater symptomatic relief and also improves the condition ofdamaged ocular surface
Study protocol of a single-arm pre-post study to assess the preliminary effectiveness and feasibility of a home-based bimodal prehabilitation program on preoperative aerobic fitness in high-risk patients scheduled for liver or pancreatic resection
(Medip Academy, 2020-04) Annefleur, E. M. Berkel; Laura, Van Wijk; Bart, C. Bongers; Job, Van Der Palen; Carlijn, I. Buis; Muriel, Reudink; Mike, S. L. Liem; Gerrit, D. Slooter; Nico, L. U. Van Meeteren; Joost, M. Klaase
Background:Controversial evidence currently exists regarding the feasibility and effectiveness to improve preoperative aerobic fitness during home-based prehabilitation in patients scheduled for liver or pancreatic resection, whereas morbidity rates are high following these resections. The primary aim of this study is to evaluate the preoperative oxygen uptake (VO2) at the ventilatory anaerobic threshold before and after a four-week home-based preoperative training program with nutritional supplementation in high-riskpatients scheduled for elective liver or pancreatic resection. Secondary aims are to evaluate program feasibility, immune system function, cardiopulmonary exercise test responses, individual progression profiles on training responses, quality of life, andpostoperative course.Methods:In this multicenter study with a pretest-posttest design, patients with a liver or pancreatic tumor scheduled for elective resection will be recruited. To select the high-risk fraction of this surgical population, their VO2at the ventilatory anaerobic threshold should be <11 ml/kg/min for final inclusion. A planned total of 24 high-risk patients will participate in a four-week (three sessions per week) home-based bimodal prehabilitation program. The partly supervised home-based preoperative training program consists of individualized goal setting followed by titration of interval and endurance training on an advanced cycle ergometer, combined with functional task exercises. Additionally, patients will be given protein and vitamin/mineral supplementation.Discussion: Effects of a partly supervised home-based bimodal prehabilitation regimen are unknown in high-risk patients opting for liver or pancreatic resection. Improved preoperative aerobic fitness might translate into improved postoperative outcomes and a reduced demand on care resources.Trial Registration:The study is registered in the Netherlands Trial Registry (NL6151) and was approved by the Institutional Ethics Committee, Twente, Enschede, the Netherlands (P17-08)
Thyroid profile in pulmonary tuberculosis patients: a prospective study in a tertiary medical college of southern Odisha
(Medip Academy, 2020-04) Dash, Manoranjan; Behera, Bibhu P.; Sen, Ranjan Kumar
Background:Globally, an estimated 10.0 million (range, 9.0to 11.1 million) people infected with tuberculosis(TB). Developing country like India accounts for one fourth of the global tuberculosis burden. TB is associated with diffuse functional impairment of most endocrine organs.Methods:We conducted a study to evaluate the thyroid profile status in new sputum positive pulmonary tuberculosis patients, aged 12 years and above; attended and admitted to chest and TB, Medicine Department of SLN MCH, Koraput, Odisha from January 2019 to December 2019. Patients with H/o old pulmonary tuberculosis, patient with known neurological, hypothalamic-pituitary or thyroid disorders, kidney disease, malignancies and patients receiving medications known to interfere with thyroid hormone metabolism were excluded from the study.Statistical analysis was done by using SPSS version 21.0 software. Results were expressed in average±SD, frequencies and percentages. Continuous data were compared using Student’s t-test. A p value <0.05 was considered as statistically significant and p value <0.001 was considered as statistically extremely significant.Results:Mean age of the study group was 37.31±15.63 years. 54 patients (40.30%) were in 20to 40 years of age group. We found, 48 (35.82%) pulmonary tuberculosis patients had sick euthyroid syndrome out of 134 pulmonary tuberculosis patients. Conclusions: Sick euthyroid syndrome occurs commonly in pulmonary tuberculosis patients with increasing incidence with advanced age, and also seen in patients with advanced pulmonary tuberculosis patients; therefore, requires monitoring of thyroid functiontest for its timely initiation of therapy.
Investigation on nutrition status and clinical outcome of patients with common cancers in Chinese patients: a multicenter prospective study protocol
(Medip Academy, 2020-04) Hongxia, Xu; Chunhua, Song; Chang, Wang; Zhenming, Fu; Zengqing, Guo; Yuan, Lin; Yingying, Shi; Wen, Hu; Yi, Ba; Suyi, Li; Zengning, Li; Kunhua, Wang; Jing, Wu; Ying, He; Jiajun, Yang; Conghua, Xie; Fuxiang, Zhou; Xinxia, Song; Gongyan, Chen; Wenjun, Ma; Suxia, Luo; Zihua, Chen; Minghua, Cong; Hu, Ma; Chunling, Zhou; Wei, Wang; Qi, Luo; Yongmei Shi; Yumei Qi; Haiping Jiang; Wenxian Guan; Junqiang Chen; Jiaxin Chen; Yu Fang; Lan Zhou; Yongdong Feng; Rongshao Tan; Tao Li; Junwen Ou; Qingchuan Zhao; Jianxiong, Wu; Min, Weng; Qinghua, Yao; Wei, Li; Hanping, Shi
Background:Malnutrition is common in patients with cancer, whichadversely affectsthesurvival and quality of life ofcancer patients.However, there is no national data on the prevalence of malnutrition inChinese cancer patients. Thisstudy aims to evaluate the prevalenceof malnutrition and quality of life(QOL)ofChinese patients with localregional, recurrentor metastatic cancer,to address the prognostic value of nutritional status and QOLon the survival of cancer patients in China and to validate the patient-generated subjective global assessment (PG-SGA) questionnaire in Chinese cancer patients.Methods:Thisisanobservational,multi-centered,and hospital-based prospective cohort study.We aimed to recruit 50,000 cancer patients (age 18and above)overan 8-year period.Data collection will occur within 48hrafter patientsare admitted to hospital, 30-days after hospital admission, and the follow-up will be conducted1-8years after enrolment. The primary outcomeisoverall survival, and secondaryoutcomes arelength of hospital stay and hospital costs. Factors measured are demographic characteristics, tumor characteristics, anthropometry measurements,hematological measurement, body composition, PG-SGAscores,Karnofsky performance status scores,and QLQ C30 scores. This protocol wasapproved by local ethical committees of all the participant hospitals.Conclusions: This multi-centered, large-scale, long-time follow-up prospective study will help diagnose malnutrition in cancer patients in China, and identify the related risk factors associated with the negative outcomes. The anticipated results will highlight the need for a truly scientific appraisal of nutrition therapy, and help to improve outcomes among cancer patients in China.Trial Registration: The trial has been registered with the Chinese Clinical Trial Registry, ChiCTR1800020329. Registered on 19 December 2018
Dihydroartemisinin-piperaquine for the routine treatment of uncomplicated malaria in Northern Ghana
(Medip Academy, 2020-01) Oduro, Abraham R.; Chatio, Samuel; Ayamba, Emmanuel; Anyorigiya, Thomas; Binka, Fred; Lucas, Amenga-Etego
Background:Dihydroartemisinin-piperaquine is a first line treatment for uncomplicated malaria in Ghana. A facility-based study was undertaken to examine the effectiveness of thetreatment in the routine health care system.Methods:The study was undertaken at the Navrongodemographic surveillance area. Patients presenting with acute febrile illness were enrolled after informed consented and confirmation by microscopy. Patients were randomized into supervised group who received treatment under direct observation and unsupervised group which had only the first treatment given under supervision. Treatment was according to bodyweight and 42 days follow-up was undertaken.Results:A total of 194 patients were enrolled; 54.1% were females and 51% had supervised treatment. The median age and weight were 6.7 years and 20.0kg respectively. Mean baseline temperature, haemoglobin concentration and parasite density were, 37.6oC, 11.1 g/dl and 11,098 parasites per microliter of blood respectively. Study completion rate was 93.3%, day 42 polymerase chain reaction-unadjusted adequate clinical and parasitological responses rate (ACPR) was 93.4% by evaluable and 87.1 % by intention-to-treat (ITT). The day 42 ACPR by evaluable was 92.3% in the supervised arm compared to 94.4% in the unsupervised arm. The day 42 ACPR by ITT was 85.7% in the supervised and 88.5% in the unsupervised arms. The fever resolution and haemoglobin concentration changes for the two arms were similar.Conclusions: The results show that dihydroartemisinin-piperaquine iseffective and good first-line antimalarial in the routine health delivery system

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