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Intl. J. of Advances in Medicine     Open Access   (Followers: 2)
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Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 7)
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International Journal of Clinical Trials
Number of Followers: 3  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2349-3240 - ISSN (Online) 2349-3259
Published by Medip Academy Homepage  [12 journals]
  • 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

    • Authors: Adel Ahadi, Mehrdad Mirzarahimi, Manouchehr Barak, Saeid Sadeghieh Ahari, Maryam Reyhanian
      Pages: 50 - 54
      Abstract: 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 2 to 23 months with acute bronchiolitis.Methods: This randomized clinical trial study has been done on 100 infants aged 2 to 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.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201711
      Issue No: Vol. 7, No. 2 (2020)
       
  • Increased serum osteocalcin levels and vitamin K status by daily cheese
           intake

    • Authors: Helge E. Lundberg, Trond Holand, Helge Holo, Stig Larsen
      Pages: 55 - 65
      Abstract: 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 152 g. Clinical investigation was performed initially and after three, four and five weeks with measurement of vital signs, hematological and biochemical variables, carboxylated and 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 reductions in 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 57 g/day. Daily intake of Jarlsberg® cheese increased the osteocalcin level, vitamin K2 and positively affected the lipid patterns and blood pressure.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201712
      Issue No: Vol. 7, No. 2 (2020)
       
  • Thyroid profile in pulmonary tuberculosis patients: a prospective study in
           a tertiary medical college of southern Odisha

    • Authors: Manoranjan Dash, Bibhu P. Behera, Ranjan Kumar Sen
      Pages: 66 - 71
      Abstract: Background: Globally, an estimated 10.0 million (range, 9.0 to 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 20 to 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 function test for its timely initiation of therapy. 
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20200538
      Issue No: Vol. 7, No. 2 (2020)
       
  • Role of punctal plugs as a primarily treatment modality in moderate to
           severe dry eye

    • Authors: Sonali V. Kumar
      Pages: 72 - 76
      Abstract: 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 patients or 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 bengal staining 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 of damaged ocular surface.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201713
      Issue No: Vol. 7, No. 2 (2020)
       
  • Attenuation of haemodynamic responses to endotracheal extubation-diltiazem
           versus lidocaine

    • Authors: Shaik Umar Farooq, B. Sandhya Rani, Anand Acharya
      Pages: 77 - 82
      Abstract: 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 0.2 mg/kg versus IV lidocaine 1 mg/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 30 each. Group I received normal saline and served as control. Group II received 0.2 mg/kg of IV diltiazem 2 min before extubation. Group III received 1 mg/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 0.2 mg/kg IV 2 min before tracheal extubation in ASA grade I and grade 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 1 mg/kg IV 2 min before tracheal extubation.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201714
      Issue No: Vol. 7, No. 2 (2020)
       
  • 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

    • Authors: Yasir Bin Nisar
      Pages: 83 - 93
      Abstract: 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.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201715
      Issue No: Vol. 7, No. 2 (2020)
       
  • Investigation on nutrition status and clinical outcome of patients with
           common cancers in Chinese patients: a multicenter prospective study
           protocol

    • Authors: 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
      Pages: 94 - 102
      Abstract: Background: Malnutrition is common in patients with cancer, which adversely affects the survival and quality of life of cancer patients. However, there is no national data on the prevalence of malnutrition in Chinese cancer patients. This study aims to evaluate the prevalence of malnutrition and quality of life (QOL) of Chinese patients with local regional, recurrent or metastatic cancer, to address the prognostic value of nutritional status and QOL on the survival of cancer patients in China and to validate the patient-generated subjective global assessment (PG-SGA) questionnaire in Chinese cancer patients.Methods: This is an observational, multi-centered, and hospital-based prospective cohort study. We aimed to recruit 50,000 cancer patients (age 18 and above) over an 8-year period. Data collection will occur within 48 hr after patients are admitted to hospital, 30-days after hospital admission, and the follow-up will be conducted 1-8 years after enrolment. The primary outcome is overall survival, and secondary outcomes are length of hospital stay and hospital costs. Factors measured are demographic characteristics, tumor characteristics, anthropometry measurements, hematological measurement, body composition, PG-SGA scores, Karnofsky performance status scores, and QLQ C30 scores. This protocol was approved 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.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201052
      Issue No: Vol. 7, No. 2 (2020)
       
  • 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

    • Authors: 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
      Pages: 103 - 111
      Abstract: 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-risk patients 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, and postoperative 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 VO2 at 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).
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201716
      Issue No: Vol. 7, No. 2 (2020)
       
  • 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

    • Authors: Suranga Dassanayake, Gerard Wilkins, Gisela Sole, Margot Skinner
      Pages: 112 - 122
      Abstract: 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 of the 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 filling the knowledge gaps.Trial Registration: The Ministry of Health, New Zealand (Ethics Ref: 18/CEN/257), Trial registry: ACTRN12618001881224p).
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201717
      Issue No: Vol. 7, No. 2 (2020)
       
  • 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

    • Authors: Alessandro Rozim Zorzi, Eliane Antonioli, Moises Cohen, Camila Cohen Kaleka, Andrea Tiemi Kondo, José Mauro Kutner, Mario Ferretti
      Pages: 123 - 130
      Abstract: Background: Membrane-assisted autologous chondrocyte transplantation is considered the gold standard surgical technique to treat greater than two millimetres diameter 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 millimetres articular cartilage lesion in the distal femur or the patella, which did not improve their symptoms with conservative treatment, will be submitted to an arthroscopically assisted cartilage biopsy. After isolation and expansion in a good manufacturing practices facility, 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 version 4.0. Secondary outcomes will be Western-Ontario McMaster Universities Osteoarthritis Index scale, International Knee Documentation Committee subjective scale and magnetic resonance observation of cartilage repair tissue magnetic resonance scale.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 (http://www.ensaiosclinicos.gov.br/rg/RBR-6fgy76/). Ethical approval: CAAE: 73911617.2.0000.0071.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201718
      Issue No: Vol. 7, No. 2 (2020)
       
  • 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

    • Authors: Yasir Bin Nisar
      Pages: 131 - 141
      Abstract: 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: This multi-centre cluster randomized controlled open label, non-inferiority trial will be conducted in 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 a health 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.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201719
      Issue No: Vol. 7, No. 2 (2020)
       
  • Agreements in clinical studies at German university clinics

    • Authors: Raees Ahmed, Thomas Voigt, Matthias Siegert, Christoph Gerst
      Pages: 142 - 149
      Abstract: 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.
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201495
      Issue No: Vol. 7, No. 2 (2020)
       
  • Testing for baseline differences in clinical trials

    • Authors: Henian Chen, Yuanyuan Lu, Nicole Slye
      Pages: 150 - 153
      Abstract: 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 p values 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 p values 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 p values than big trials for the same baseline differences. We cannot define the imbalance in baseline measures only based on these p values. There is no statistical basis for advocating the baseline difference tests
      PubDate: 2020-04-22
      DOI: 10.18203/2349-3259.ijct20201720
      Issue No: Vol. 7, No. 2 (2020)
       
 
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