Publisher: Medip Academy   (Total: 12 journals)   [Sort by number of followers]

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Intl. J. of Advances in Medicine     Open Access   (Followers: 5)
Intl. J. of Basic & Clinical Pharmacology     Open Access   (Followers: 3)
Intl. J. of Clinical Trials     Open Access   (Followers: 5)
Intl. J. of Community Medicine and Public Health     Open Access   (Followers: 8)
Intl. J. of Contemporary Pediatrics     Open Access   (Followers: 10)
Intl. J. of Otorhinolaryngology and Head and Neck Surgery     Open Access   (Followers: 1)
Intl. J. of Reproduction, Contraception, Obstetrics and Gynecology     Open Access   (Followers: 16)
Intl. J. of Research in Dermatology     Open Access   (Followers: 1)
Intl. J. of Research in Medical Sciences     Open Access   (Followers: 7)
Intl. J. of Research in Orthopaedics     Open Access   (Followers: 1)
Intl. J. of Scientific Reports     Open Access   (Followers: 4)
Intl. Surgery J.     Open Access   (Followers: 5)
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International Journal of Clinical Trials
Number of Followers: 5  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2349-3240 - ISSN (Online) 2349-3259
Published by Medip Academy Homepage  [12 journals]
  • Thyroid function test in relation with hypertension

    • Authors: Chandan Sharma
      Pages: 111 - 113
      Abstract: Background: The most common cause of cardiovascular disease affecting human is hypertension and reported that they may have tendency for impaired thyroid function. T3 acts directly on arterial smooth muscle of blood vessels to cause vasodilatation, when hypothyroidism occurs; declining T3 level increases the vascular resistance and the level of blood pressure. Clinically, hypertension may be defined as that level of blood pressure at which the institution of therapy reduces blood-pressure-related morbidity and mortality. The aim of our study was to assess the correlation and association of thyroid function with hypertension.Methods: This case-control study was conducted in the Department of Medicine Government Medical College Jammu from August 2017 to August 2018 on 75 subjects with hypertension.  Results: The male to female ratio was 62.7% to 37.3%.  Among total patients, 12 came out to be hyperthyroid, 6 cases were hypothyroid while 5 and 13 pertained to subclinical hyperthyroidism/ hypothyroidism respectively. The comparative values of T3 among Cases and Controls showed significant variation. However, the values of T4, TSH and FT3 showed no significant correlation. It was shown that hyperthyroidism can cause hypertension, i.e.  Hypothyroidism is positively related to hypertension.  Conclusions: Thus it was observed in our study that there was significant relation between thyroid dysfunction with hypertension. Screening should be recommended for all the hypertensive patients to rule out thyroid dysfunction.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20210494
      Issue No: Vol. 8, No. 2 (2021)
       
  • Efficacy of Habb-e-Hindi in low back pain: a comparative clinical trial
           with historical control

    • Authors: Fasihur Rehman Ansari, Mohd Aleemuddin Quamri, Kunwar Alam Chaudhary, Mariyam Ahad
      Pages: 114 - 120
      Abstract: Background: Low Back Pain is one of the common conditions encountered in clinical practice. An estimated 65% to 80% of population will experience it during lifetime. As far as the various documented side effects of analgesics and NSAIDs have been concerned, complementary and alternative treatment options have, therefore, gained popularity. In Unani classical literature, Habb-e-Hindi is being indicated for joint’s pain in general and can be evaluated as safe, effective and alternative treatment of LBP.Methods: This historical control clinical trial testing the superiority of Habb-e-Hindi with Unani formulation used in previous study carried out at NIUM Hospital, Bengaluru. The comparison of the efficacy was made between the test group and historical control group. Primary outcome measures were improvement in LBP (VAS in NRS) and the secondary outcome measures included improvement in QOL (ODI scores and QBPDS scores). Data were analyzed by using Fisher’s Exact/Chi-Square/Repeated measures and One-way ANOVA with Tukey post hoc multiple comparison test for both intergroup and intragroup comparisons.Results: The test and the control group both equally had significant results. Test drug showed better results (in VAS). LBP associated disability (in ODI) got reduced significantly in control group as compared to the test group. The Significant Disability Change (in QBPDS) was recorded in all 20 patients of the control group as compared to that of the test group where only 4 patients showed significant reduction.Conclusions: The results of this study suggest that the Unani formulations are effective in the treatment of Low back pain.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211386
      Issue No: Vol. 8, No. 2 (2021)
       
  • Ischemic and hemorrhagic stroke: a comparative evaluation of lipid profile

    • Authors: Nipun Saproo, Roma Singh
      Pages: 121 - 124
      Abstract: Background: The scientific community often sees association of blood lipid levels with the risk of cardiovascular disease. Strong association has often been found between high levels of low density lipoproteins (LDL) and the development of atherosclerosis while elevated levels of high density lipoproteins (HDL) are understood to play protective role. This study was conducted to compare lipid profile among ischemic and hemorrhagic stroke patients.Methods: This observational study was conducted in Department of Neurology, Medanta, Medicity Gurugram, where 50 patients’ cases of infarct and 50 cases of hemorrhagic stroke were studied during: April 2020 to October 2020. All patients with clinically and radiologically proved cerebrovascular accident were included in the study.Results: Mean total cholesterol (TC) for hemorrhagic and ischemic stroke was 175.2 mg/dl and 192.4±41.6 mg/dl respectively. Deranged LDL among subjects with ischemic stroke was 32%. Deranged LDL was seen in 76% of patients reporting ischemic stroke. The mean values for triglycerides (TG) stood at 122±34.6 mg/dl and 141±43.3 mg/dl for hemorrhagic and ischemic stroke respectively. It was seen that the risk of developing ischemic stroke increased with rise in total cholesterol and LDL value. Lipid derangement thus formed an important risk factor for stroke.Conclusions: A significant association is found between raised LDL, abnormal HDL and ischemic stroke, however, a significant rise in total cholesterol level was found in case of both the groups. It is very apparent that patients under high risk should be regularly screened for serum lipid profile.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211403
      Issue No: Vol. 8, No. 2 (2021)
       
  • A prospective study on the role of epidural steroidal injections in
           backache with radiculopathy

    • Authors: Akhil Gupta, Nitin Choudhary, Fareed Hussain Malik
      Pages: 125 - 128
      Abstract: Background: Low backache (LBA) with lumbosacral radiculopathy is the most challenging musculoskeletal problem for its therapeutic management and cause of LBA with radiculopathy is a prolapsed disc. Epidural steroidal injection (ESI) are used in the management of the patients with sub-acute or chronic LBA with radiculopathy, not responding to conservative treatment. The most common cause being, lumbar disc disease, is confirmed via magnetic resonance imaging having high sensitivity and specificity.  The aim of study was to check the efficacy of ESI in patients of sub-acute or chronic low backache with radiculopathy due to herniated disc.Methods: The study was conducted over 200 patients reporting our OPD during Dec 2017- Feb 2018 with complaints of LBA with radiculopathy, not responding to conservative treatment. Maximum of 3 ESI were given with two weeks of interval in between. The patients were assessed using VAS scoring system.Results: 77.5% patients got improvement in symptoms, according to the VAS scores, while 22.5% patients got very little relief or no relief at all. 53.5% patients got significant improvement with the first dose of injection itself. Patients had a good relief from radicular pain immediately; however, sense of satisfaction of well-being was only after few months.Conclusions: Though results supported the relative benefit of epidural steroid, however conservative management should also be recommended as initial treatment. ESI procedure is effective in treating patients of sub-acute LBA with radiculopathy and is recommended before a patient is considered for surgery.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211460
      Issue No: Vol. 8, No. 2 (2021)
       
  • Comparison of three different techniques for internal jugular vein
           cannulation under real time ultrasound guidance

    • Authors: Reena Mahajan, Suchitra Malhotra
      Pages: 129 - 133
      Abstract: Background: Ultrasound (USG) guided Internal jugular venous (IJV) cannulation is preferred than traditional approach due to increase in success rate, reduction in time taken and attempts of successful cannulation and less complications. The purpose of our study was to observe and compare three different real time 2-dimensional US-guided approaches and to determine which approach improves rate of successful cannulation, decreases complications along with shorter average time taken for the procedure. Primary outcomes of the study were venous access time, catheterization time and success rate. Secondary outcomes were number of patients requiring second attempt and complications observed.Methods: 120 adult patients were randomly divided into three groups according to real time US guided cannulation done with SAX-OP approach, LAX-IP approach and OAX-IP approach. Parameters like venous access time, catheterization time, number of patients requiring second attempt and complications were noted.Results: Venous access time was shortest in LAX group 21.84±3.67 seconds which was just significant statistically. Catheterization time was shortest in LAX group 241±123 seconds. Cannulation success rate was highest in LAX group 98% and was statistically significant. Patients requiring second attempt was least in LAX group 2.5%. Posterior IJV wall puncture was observed in 10% patients in SAX group and none in LAX and OAX group which was statistically significant.Conclusions: LAX-IP showed better performance in terms of higher cannulation success, lesser average venous access time and catheterization time and lesser complications. On toggling USG probe, both IJV and carotid artery can be differentiated and carotid puncture could be avoided. Hence LAX approach is safer and effective approach.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211461
      Issue No: Vol. 8, No. 2 (2021)
       
  • Pulmonary function tests: a study among healthy individuals of different
           age groups in Akhnoor Tehsil

    • Authors: Chandan Sharma, Ashima Badyal
      Pages: 134 - 137
      Abstract: Background: Pulmonary function tests may be affected by many factors like age, gender, race and body surface area of an individual. Lung functions decline throughout adult life, and healthy people are no exception. Aging is a universal progressive decline, but it is not a disease. The present study was done with an aim to establish the age effect on lung function test of healthy non-smoking people belonging to the rural belt of Jammu region.Methods: A prospective study was conducted on 180 patients attending the OPD of department of medicine, sub-district hospital Akhnoor. With age ranging from 11 to 70 years, healthy individuals, non-smokers were selected for the study. Pulmonary tests like forced vital capacity (FVC), forced expiratory volume in 1st second (FEV1) and peak expiratory flow rates (PEFR) were conducted.Results: Younger population had a high value for FEV1 and PEFR showed a rise among age groups: 11-20, 21-30 and 31-40 years, reaching up to 7.23±1.75 (L/sec), and then declining to reach 3.93±0.98 (L/sec) for the age group: >60 years. Almost all parameters showed a resembling ascends and decline with ageing. Lung function has further variability in older people, depending upon lung capacity at maturation time. This study was quite in line with the most of the research findings in the field, but done under a different social set up.Conclusions: Considerable differences in the respiratory patterns of healthy individuals with ageing suggest that pulmonary function tests have to become a part of routine health examinations in elderly population. 
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20210967
      Issue No: Vol. 8, No. 2 (2021)
       
  • Defining the older patient population that require, but do not undergo
           emergency laparotomy: an observational cohort study protocol

    • Authors: Nicola Reeves, Susan Chandler, Elizabeth McLennan, Angeline Price, Jemma Boyle, Stephen Knight, Lyndsay Pearce, Susan Moug
      Pages: 138 - 144
      Abstract: Background: Despite older adults (65 years and above) accounting for almost half of emergency laparotomies and an ageing population, there remains a paucity of research in the older adult emergency surgery population. One key clinical area that requires urgent assessment is the older patient who presents with acute abdominal pathology treatable by laparotomy, but who does not undergo surgery (NoLAP). Methods: This multicentre prospective cohort study [defining the denominator: emergency laparotomy and frailty study 2 (ELF2)] will recruit consecutive older adults that require but do not undergo emergency laparotomy (NoLAP). We will recruit from 47 national health service hospitals over a 3-month timeframe. The same criteria as NELA for inclusion and exclusion will be applied. The primary aim is 90-day mortality. Secondary aims include characterisation of the NoLAP group, frailty and sarcopenia with comparison to those older adults that have undergone emergency laparotomy (ELAP). Decision-making will also be explored. Assuming a NoLAP rate of 32% and 10% dropout, a minimum of 700 patients are required for 95% power (alpha=0.05).Conclusions: The UK national emergency laparotomy audit has provided vital information on those patients undergoing emergency laparotomy and driven standards in operative and perioperative care. However, little is known of outcomes in those patients who do not undergo emergency laparotomy.  Improved understanding of this NoLAP population would aid shared decision-making and improve standards for this otherwise poorly understood vulnerable patient group.Trial registration: This study is registered online at www.clinicaltrial.gov (Reg number: ISRCTN14556210). 
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20210977
      Issue No: Vol. 8, No. 2 (2021)
       
  • Effects of irradiation doses

    • Authors: Laure Kuntz, Audrey Keller, Clara Le Fèvre, Inès Menoux, Gianandrea Pietta, Alicia Thiery, Catherine Schumacher, Manon Voegelin, Georges Noel
      Pages: 145 - 151
      Abstract: Background: Bone marrow is one of the organs at risk of complications during irradiation due to its radiosensitivity. Hematopoietic toxicity remains one of the main toxicities during irradiation of pelvis. Modern radiotherapy techniques, such as intensity modulation and three-dimensional conformal radiotherapy, allow for better dose compliance in target volumes while optimally sparing organs at risk. There is a lack of prospective studies and comparative trials specifying the dose constraints according to the presence or absence of chemotherapy and correlating with the patient’s bone marrow potential.Methods: This monocentric and prospective study conducted by the Strasbourg Europe Cancerology Institute aims to evaluate the hematological toxicity in patients treated with pelvic irradiation for prostate, rectum, anal canal, endometrium, or cervix cancer. One hundred patients will be included. The primary objective is to quantify the relationship between acute hematological toxicity and delivered doses and irradiated volumes in pelvic bone marrow for pelvic cancers. The prescribed dose to the pelvis depends on the tumor location, from 25 Gy in 5 fractions for rectal cancer to 78 Gy in 39 fractions for low-risk prostate cancer. Hematological toxicity will be measured by weekly blood count during radiotherapy and at one month and three months after the end of radiotherapy.Conclusions: The aim of this study is to improve and optimize radiotherapy if a dose limit or volume constraint is imposed by the results of the study. To our knowledge, this is the first study including several types of pelvic cancers and involving patients treated exclusively with radiotherapy, chemoradiotherapy or radiohormonotherapy.Trial Registration: Trial registration number is NCT04626466.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211462
      Issue No: Vol. 8, No. 2 (2021)
       
  • Validation of generalized anxiety disorder-2 as a screening tool for
           generalized anxiety disorder in the primary health care setting: study
           protocol

    • Authors: Mohammad J. M. A. Tamimi, Anna R. Sharif, Saad T. Sedeeq, Ehab Hamed
      Pages: 152 - 155
      Abstract: Background: Anxiety screening in primary care is crucial for the identification and management of the condition. The generalized anxiety disorder-2 (GAD-2) is an abridged version of the tool composed of the first two questions of the GAD-7 for screening for anxiety in the general adult population in primary care settings. Patients who score more than 3 points are further evaluated for anxiety. Although there is a growing body of literature documenting the psychometric properties of the GAD-2 against a structured interview and the GAD-7, no earlier studies have assessed the performance of the GAD-2 in Qatar. This cross-sectional study primarily aims to examine the sensitivity, specificity, positive (PPV) and negative predictive values (NPV) of GAD-2 scores for detecting anxiety among patients attending PHCC in Qatar.Methods: The study will employ a periodic cross-sectional study of electronic medical record data of adult patients attending the primary health care settings between January of 2017 and December of 2019. The study population will include all adult population with documented GAD-7 scores. We will exclude all patients with other mental health diagnoses, including mental disability, schizophrenia, and dementia.Conclusions: GAD-2 questionnaire forms an easy to administer screening tool. The cut-off value in various international settings is set at a score of equal to or more than 3. The study will report on the diagnostic properties of GAD-2 scores against the documented diagnosis of anxiety by health care professionals. The result helps to tailor the cut-off value to its local settings.Trial Registration: Trial registration number is PHCCDCR202003019.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211463
      Issue No: Vol. 8, No. 2 (2021)
       
  • Efficacy of yoga in controlling subclinical-hypothyroidism: a randomized
           controlled trial

    • Authors: Rukamani Nair, Ranjna Chawla, Vipin Rai Sood, B. K. Roy, Somnath Mukherjee
      Pages: 156 - 162
      Abstract: Background: A huge population in India is at high-risk of developing thyroid related disorders. Unhealthy lifestyle (lack of physical activity and consumption of junk food) is common among Indian population. Yoga is a form of physical activity and helps prevent many lifestyle disorders. The research question to be addressed by this randomised controlled trial (RCT) is whether yoga based intervention is effective in preventing overt hypothyroidism among sub clinical hypothyroid people in India as compared to untreated participants.Methods: This is a single-blinded, two-arm, parallel-group RCT. Eligible participants should be aged 21-59 years, suffering from sub clinical hypothyroidism (serum thyroid stimulating hormone i.e. TSH level 4.2 mIU/l >TSH level <10 mIU/l; T3 and T4 within normal range). At least 100 participants will be randomised either to the intervention group or the control group. Intermediate follow up at 3 month and final follow-up will be at six month post intervention. This study is designed to study the effect of yoga intervention on biochemical tests {thyroid function tests (fT3, fT4 and TSH)}, physical parameters (waist circumference, waist hip ratio, fat percentage and BMI) and psychological parameters {quality of life (QOL) as assessed by World Health Organization (WHO)-QOL, sleep quality (assessed by PSQI) and depression (assessed by BDI-II)} in sub-clinical hypothyroid patients.Conclusions: We are now conducting a RCT in Delhi, India to assess the efficacy of yoga in preventing progression of subclinical- hypothyroidism to overt hypothyroidism. If the yoga intervention used in this study is effective, it will be a low-cost feasible treatment for subclinical hypothyroidism in India.Trial registration: Trial registration number is CTRI/2020/03/024023.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211464
      Issue No: Vol. 8, No. 2 (2021)
       
  • Clinical data monitoring during COVID-19 pandemic: an experience from a
           regulatory trial in India

    • Authors: Divya Pillai, Monika Bahl, Padmapriyadarsini C, Ranjan Kumar, Supriya Semwal, Shirali Raina Labroo, Jeyadeepa B.
      Pages: 163 - 166
      Abstract: The essence of any clinical or healthcare related discovery is its methodologically sound clinical research and clinical data monitoring. This eventually helps the clinicians to understand the best possible clinical management pathways or patient management at all the levels of healthcare system. The pandemic has had an impact on clinical trial data monitoring as well. New or mixed approaches to routine monitoring have been introduced to ensure the quality of the overall research in these challenging times and are being tested for efficacy, cost-effectiveness while keeping ethical considerations as the main priority. This write up intends to highlight a few steps taken to ensure data integrity and participants’ safety and rights.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211465
      Issue No: Vol. 8, No. 2 (2021)
       
  • Clinical trial visits in the age of COVID-19: implementation of research
           participant safety measures

    • Authors: Kathryn J. Krueger, Faith Rahman, Qiuhua Shen, John B. Hiebert, Janet D. Pierce
      Pages: 167 - 173
      Abstract: The COVID-19 pandemic is having a major impact on how current clinical trials are being conducted in the United States. Researchers have experienced the effects of COVID-19 through the halting and delaying of clinical trials, the lack of personal protection equipment (PPE), the closing of clinical sites, and a decrease in participant recruitment. Many clinical trials will have more missing data because of a participant’s inability to attend in-person visits, discontinuation of trial activities, or interruption of time-sensitive study collection data due to COVID-19. All of these events affect the data quality of trials. Government agencies such as the Food and Drug Administration (FDA), centers for disease control and prevention (CDC), and National Institutes Of Health (NIH) have issued recommendations for investigators conducting clinical trials to combat the spread of COVID-19 and to maintain data integrity. Institutions sponsoring clinical trials have also provided guidelines to continue, modify, or pause research studies that are essential to ensure participant and research team safety. Key recommendations include implementing telehealth appointments, wearing a protective mask and face shield, quarantining for 14 days if exposed to COVID-19 or having travelled, and, if possible, maintaining a 6-foot distance. It is also recommended that investigators implement COVID-19 screening questionnaires prior to and during on-site visits. This includes participants and research personnel completing a temperature check and questionnaire screen before in-person data collection. This article will discuss the challenges encountered by researchers conducting clinical trials and provide resources and examples to assist investigators during the COVID-19 pandemic.
      PubDate: 2021-04-22
      DOI: 10.18203/2349-3259.ijct20211466
      Issue No: Vol. 8, No. 2 (2021)
       
 
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