International Journal of Clinical Trials

Permanent URI for this collection

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 213

Immediate effects of bandha hasta utthanasana on cerebral hemodynamics in healthy individuals: a protocol for randomized controlled trial
(Medip Academy, 2024-09) Manickam, A; Kuppusamy, M; Mooventhan, A; Venkateswaran, ST; Lakshmi, KS.
Background: Functional near-infrared spectroscopy (fNIRS) is a tool to measure variations in cerebral hemodynamics. The study investigates the physiological changes in cerebral blood flow before, during, and after the practice of bantha hasta utthanasana among healthy participants. Methods: The proposed study is a hospital-based randomized controlled trial comparing bantha hasta utthanasana with the control group. A total of 60 participants will be randomly divided into an intervention group (n=30) and a control group (n=30) as per inclusion and exclusion criteria. The intervention group will practice bantha hasta utthanasana for 10 minutes. The control group will be instructed to sit for 10 minutes. Functional near-infrared spectroscopy will be performed before (5 minutes), during (10 minutes), and after (5 minutes) the practice in both groups. Conclusions: This study protocol aims to investigate whether the practice of bandha hasta utthanasana can enhance cerebral hemodynamics. The research seeks to determine if this simple practice can be used to manage individuals with cerebral hemodynamic impairment and potentially prevent such issues in the future. Trial Registration: CTRI/2023/10/059039.
Perioperative management of hyperglycemic patients undergoing surgery: an observational cross sectional study in a tertiary care hospital
(Medip Academy, 2024-09) Sayed, NA; Shetty, Y; Salgaonkar, S.
Background: Diabetes poses an additional risk during anesthesia, yet there is a lack of sufficient Indian data on perioperative antidiabetic drug use and its implications. This droves us to conduct the study. Methods: Cross-sectional, observational study, conducted in a tertiary care hospital's general surgery and orthopaedics wards. Data collected from the first anaesthetist visit to 24 hours postoperative period included antidiabetic medications, anesthesia drugs, blood sugar levels, co-morbidities, concomitant medications, and intravenous (IV) fluids. Descriptive statistics and parametric tests were used for analysis. Results: The study comprised 180 patients (62.8% males, median age 56 years), with diabetes duration predominantly between 1-5 years (28.3%). Preoperatively, metformin was the most prescribed oral hypoglycemic agent (72.2%), decreasing to 56.67% postoperatively. Intraoperatively, only 1.6% received insulin, while 98.4% received no drugs. Common postoperative antidiabetic agents included insulin BD (n=48). General surgery (73.3%) and orthopedics (26.7%) contributed 132 and 48 patients, respectively, with spinal anesthesia (68.3%) and bupivacaine (75.4%) being most prevalent. Blood glucose during surgery was effectively monitored. Hypertension (52.8%) was the most common co-morbidity, and Ringer lactate (60.8%) was the predominant IV fluid. Conclusions: Adequate perioperative antidiabetic management was observed in hyperglycemic patients.
Efficacy of 5% methylene blue photodynamic therapy in the treatment of potentially malignant oral disorders: a randomized, double-blind, controlled trial
(Medip Academy, 2024-09) Santos, de Freitas Silva B; Mendes, Rocha R; Paiva, Prudente T; Moraes, de Oliveira Lenza M; Lobato, Ferreira Ferraz D; Mezaiko, E; do Couto, Lima Moreira F; Yamamoto-Silva, FP.
Background: Potentially malignant oral disorders (PMOD) play a vital role in the secondary prevention of oral cancer, especially considering the difficulty in identifying specific risk factors. Oral leukoplakia (OL), the most common PMOD, has a variable malignant transformation rate. Photodynamic therapy (PDT) emerges as a promising alternative in treating these conditions. This approach is particularly valuable for extensive lesions or patients with contraindications to conventional treatments. Despite promising results, the choice of photosensitizer agent still lacks consensus. The aim of this study is to evaluate the efficacy of PDT with 5% methylene blue compared to 20% aminolevulinic acid (ALA) in the treatment of OL. Methods: This is a randomized, controlled, double-blind clinical trial with a non-inferiority testing approach. Patients will be allocated into two groups: leukoplakia experimental group (PDT with methylene blue) and leukoplakia control group (PDT with ALA). The analysis of results will be based on primary outcomes (clinical remission) and secondary outcomes (histological/cytological worsening, lesion appearance, symptoms, function, psychological impact, economic impact, treatment adherence, and adverse effects). Allocation will be performed in a randomized and stratified manner, ensuring equivalence between groups. Cost-effectiveness analysis will consider the direct costs of treatment from both professional and patient perspectives. Conclusions: This study aims to contribute to the establishment of an effective, safe, and accessible treatment protocol for the most prevalent PMOD, filling an important gap in the scientific literature and providing guidelines for future clinical practices.
From hurdles to high performance: overcoming day-to-day challenges for successful clinical trials at sites
(Medip Academy, 2024-12) Gangurde, N; Bagde, D.
Randomized clinical trials are fundamental in testing new drugs, medical devices and treatment protocols. They help to determine the efficacy and safety of new treatments, leading to medical innovations that can significantly improve treatment outcomes. Clinical trial sites are the engines that drive medical advancements, but they face numerous challenges in their day-to-day operations and impact the study outcome as well as data quality. Continuous improvement through research and innovation ensures that clinical trials are conducted more effectively, leading to better healthcare advancements and patient outcomes. Execution of clinical trial at the hospital site is a critical task and associated with the new challenges every day which may include patient recruitment, retention and compliance to the data collection. GCP compliance is a soul of clinical research and difficult task to comply with. GCP is a harmonized guideline accepted by most of the countries all across the globe.
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.
A randomized clinical study comparing Trupler skin stapler and Trulon polyamide suture in post-surgical skin closure during orthopaedic and open abdominal surgeries
(Medip Academy, 2024-09) Chatterjee, D; Karmakar, N; Halder, T.
Background: The increasing demand for accelerated rehabilitation and shorter hospital stays emphasizes the importance of effective post-surgical skin closure techniques. Orthopaedic and open abdominal surgeries commonly use metal staples or polyamide sutures for wound closure. Surgical site infections (SSIs) remain a significant concern, impacting patient outcomes and healthcare costs. Methods: This prospective, randomized, single-centre trial aimed to compare clinical outcomes in 140 adult patients, randomized between Trupler skin stapler and Trulon polyamide sutures, undergoing orthopaedic and open abdominal surgeries. The primary endpoint was the incidence of SSI according to CDC criteria. Secondary outcomes included wound complications, post-operative pain, patient satisfaction, cosmetic appearance, time taken for closure, ease of use, and safety of the interventions. Results: The primary endpoint did not show any significant difference in the number of SSIs between the two groups. Both groups experienced wound complications, but the stapler group showed less severe outcomes. The stapler group demonstrated improved time efficiency and ease of closure, leading to reduced post-operative pain and higher patient satisfaction. Cosmetic outcomes were superior in the stapler group. Adverse events were reported in both groups, with a slightly higher incidence in the suture group. Conclusions: The Trupler skin stapler demonstrated advantages over Trulon polyamide sutures for wound closure. Despite similar SSI rates, the stapler group experienced improved time efficiency, lower post-operative pain, higher patient satisfaction, and superior cosmetic outcomes. The study supports the preference for Trupler skin stapler for wound closure in orthopaedic and open abdominal surgeries.
The effectiveness of video feedback intervention on mother-infant interactional quality for women with perinatal mental health illnesses: protocol for a pilot randomised control trial
(Medip Academy, 2024-09) Buhagiar, R; Bettenzana, K; Barlow, J.
Background: The literature strongly suggests that early parent-child relational interventions for at-risk dyads can support healthy infant development and attachment security. Video Feedback (VF) is a widely used attachment-based intervention, but evidence for its effectiveness with mother-baby dyads where there is maternal psychopathology remains limited. Methods: This study constitutes a two-armed pilot randomised controlled trial aimed at evaluating the feasibility, acceptability, and preliminary benefits of Video Interaction Guidance (VIG), a type of VF, on mother-child dyadic interactional quality for postpartum women and their infants in Malta. Participants must be mothers with a baby aged 0-12 months who meet criteria for one or more mental health disorders on diagnostic interview. Exclusions are severe maternal mental illness, active drug dependence, being in receipt of in-patient care or therapy, or inability to speak English or Maltese. Consenting, eligible mothers are randomly allocated (minimised by infant age, relationship and employment status, and number of children at home), to either 3 cycles of one-to-one VIG intervention and treatment-as-usual (TAU), or to TAU only. Outcome assessors are blind to study arm allocation. The primary outcomes are parental sensitivity and dyadic synchrony coded using the CARE-index. Secondary outcomes are maternal depression and anxiety, bonding experience, capacity for reflective functioning, and well-being. Conclusions: This is the first study on the preliminary effectiveness of VIG within perinatal services in Malta. Findings should guide future larger scale, definitive RCTs and subsequently inform health policy and management decisions in perinatal and infant mental health care. Trial registration: Registered 16th March 2023 in ISRCTN registry (Trial ID: ISRCTN26320951).
Perception of ethics committee members and investigators on implementation of e-EC software for ethics committees
(Medip Academy, 2024-09) Shetty, Y; Marathe, P; Lad, M; Auti, P; Katkar, J; Singh, V.
Background: An e-EC software (Create 4) was introduced since past 4 years at few institutional ethics committees (EC) in India. The software provided facilities for submission, online review and communication between investigator and EC. The study was to assess the perception of different stakeholders: investigators, chairperson, member secretary (MS), EC members, administrative staff regarding their experiences of using software, challenges faced and recommendations for improvisation. Methods: Following approval of the institutional EC, the participants were enrolled after obtaining their written informed consent. The questionnaires specifically designed and validated for each category of investigators, EC members and administrative staff were administered. Strict confidentiality was maintained. The data was analysed using descriptive statistics. Results: A total of 64 stakeholders who participated, there were 34 investigators, 18 EC members, 2 Chairpersons, 4 member secretaries, 6 administrative staff. The e-software was accepted well by majority of the stakeholders. Overall, the software was found to be user-friendly. A few challenges faced were: lack of adequate training for investigators and new EC members, inconvenience faced while downloading study documents one by one and the need to ensure uninterrupted internet access at workplace. The user ECs should ensure that the investigators and EC members are tech-savvy and they receive prior training. It was suggested that there needs to be an autofill option built-in while uploading document/s. Conclusions: E-software was found to be useful by the stakeholders and provided suggestions to optimize its us.
Functional echocardiography for management of shock in neonates - study protocol for a randomized controlled trial
(Medip Academy, 2024-12) Mir, YA; Chawla, D; Jain, S; Khurana, S.
Background: Shock is common in sick neonates and is associated with a high mortality. Detection and management of shock by monitoring clinical parameters may be inadequate due to inconsistent association with tissue perfusion. We hypothesize that objective assessments of cardiac functions may help to match the pathophysiology of shock with the pharmacological action of a vasoactive drug. This may lead to earlier resolution of shock and reduced incidence of mortality or brain injury. To test this hypothesis, this study aims to evaluate the efficacy of adding functional echocardiography to standard clinical assessment in improving short-term outcome of neonates with clinical features of shock. Methods: This study will be an open-labeled randomized controlled trial, conducted in all inborn neonates born at >27 weeks of gestation who develop clinical signs of shock. Enrolled neonates will be randomized into two groups: the echo group and the control group. Neonates in the echo group will be assessed for management of shock by both standard clinical evaluation and functional echocardiography. Neonates in the control group will be assessed for the management of shock by standard clinical evaluation. Primary outcome will be survival without requirement of inotropic support at 72 hours of randomization. Secondary outcomes include time to hemodynamic stability, duration of inotropic support and incidence of abnormal cranial ultrasound. Conclusions: The trial intends to deduce the advantages, if any, of addition of functional echocardiography to standard clinical assessment to guide management of shock among preterm and term neonates. Trial registration: CTRI number: CTRI/2023/08/056672.
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.
Telerehabilitation in post-tuberculosis lung disease: a protocol for a randomized controlled clinical trial
(Medip Academy, 2024-12) Torres, DFM; Guimarães, FS; Cardoso, AP; Mello, FCQ.
Background: Few studies have evaluated structured telerehabilitation programs for individuals with post-tuberculosis lung disease (PTLD), resulting in a lack of specific guidelines. This protocol aims to evaluate the physical capacity and quality of life (QoL) of PTLD patients undergoing telerehabilitation. Methods: This randomized, controlled clinical trial has received internal review board approval and will recruit participants between December 2024 and June 2025, from a referral center in Brazil. Individuals thought to have PTLD, with a mini-mental state examination score >24 and no physical limitations or comorbidities unrelated to pulmonary tuberculosis (TB) will be screened using imaging, total blood count, and biochemical profile. Those with confirmed PTLD will undergo the assessments of: QoL, and physical capacity (spirometry, body composition, calf circumference, six-minute walk test (6MWT), five-times-sit-to-stand test (FTSST), handgrip and isokinetic dynamometry). After that, the participants will be randomly allocated to control or intervention groups. While both groups will receive general guidance on health education and TB prevention, the intervention group will also receive a physiotherapy booklet with instructions for exercises to be performed five times a week for eight weeks. Participants of both groups will be monitored by videoconference, and the same assessment tools will be used to reevaluate QoL and physical capacity outcomes. Conclusions: The results may demonstrate the benefits of a telerehabilitation program on the physical capacity and QoL of PTLD patients, and may improve accessibility, cost savings, and personalized care through home-based therapy by videoconferencing. Trial registration: CAAE: 10481219.9.0000.5257. This study was registered at ClinicalTrials.gov (NCT04844502).
Cost effectiveness and functional outcomes of smartphone cardiac rehabilitation assisted self-management versus centre based cardiac rehabilitation among patients with coronary heart disease in Southern India: a multicentre randomized clinical trial protocol
(Medip Academy, 2024-12) Mariarathinam, P; Kiran, A; Sannasi, R; Kumar, A.
Background: To attain the world specific indicators of quality on programs which brings rehabilitation for cardiac diseases and surgeries in India are to be brought to meet the international standards. Dearth of published research on cost effectiveness of smart phone application oriented CR assisted self-management (SCRAM) over centre based (CBCR) in Indian Population drives this study to be done. This study aims to analyze cost effectiveness of SCRAM versus CBCR in coronary artery disease (CAD) patients. Methods: In this multicentre randomized clinical trial, 100 subjects with uncomplicated CAD will be recruited through purposive sampling and divided into group A and B through block randomization. Group A will be treated with CBCR whereas group B with SCRAM. Outcome measures of 6 minutes’ walk test distance, talk test values and SF 36 scores, high density lipoprotein level and 3 months’ average blood glucose level were documented pre and post interventions and 3, 6, 12 months follow up for data analysis. This study will follow human study ethical consideration based on Declaration of Helsinki. Conclusions: Cost effectiveness of experimental group where SCRAM given as intervention may be better post intervention than control group where CBCR given. By this way this RCT protocol may bring the execution cost down with coronary heart disease patients which play a major role in participation of these patients in CR programs. Trial registration: The trial was registered with CTRI – Clinical Trial Registry of India (ICMR) - CTRI/2022/11/047143 (registered on: 09 November 2022) - trial registered prospectively.
Histopathological spectrum of ovarian tumours
(Medip Academy, 2024-12) Gautam, KB; Mishra, RT; Totade, S.
Background: Ovarian neoplasms include wide spectrum of various tumors, which differ in their histo-morphological features, also in their biological behaviour, tumorigenesis, clinical course, and prognosis. Aim of the study was to study the histopathological features of various ovarian tumors and correlate preoperative serum CA125 tumor marker level with histopathological types. Also to study fallopian tubes for fallopian tube precursor lesions such as serous tubal intraepithelial carcinoma (STIC) in serous carcinoma ovary. Methods: This cross-sectional observational study of the 80 specimens of ovarian tumors was conducted in department of pathology, Netaji Subhash Chandra Bose medical college Jabalpur (M.P.). The relevant data of the patients was collected and analysed as per designed proforma. Results: Out of 80 cases; majority cases 22 (27.5%) were seen in a 31-40 years age group, followed by 41-50 years age group 18 cases (22.5%). Youngest patient was 7 years old and oldest patient was 88 years old, forming the range of 7 years to 88 years. Epithelial tumors were the most common category, followed by germ cell tumors, sex cord stromal tumors and metastatic tumors. Benign tumors were much higher than borderline and malignant tumors mature cystic teratoma was the most common tumor encountered, followed by mucinous cystadenoma. The commonest malignant tumor was serous carcinoma followed by mucinous carcinoma. Conclusions: Ovarian neoplasms constitute a wide spectrum of tumors therefore exact categorization is important to adopt appropriate treatment protocols for the proper management of the patient. Histopathological examination is the gold standard for diagnosis and categorization of ovarian neoplasm.
Cytological spectrum of malignant lesions of lymph node
(Medip Academy, 2024-12) Mishra, RT; Nayak, R; Totade, S.
Background: Fine needle aspiration cytology (FNAC) is a safe, simple, non-invasive and inexpensive procedure for diagnosing the lesions of lymph nodes. It helps in the diagnosis of benign, infectious lesions as well as malignant lesions. It not only confirms or excludes metastasis in a case of a known primary malignancy but, also, helps to detect occult primary malignancy. Aim of the present study was to determine the frequency of malignant lesions of lymph nodes in FNAC. Methods: Retrospective study included all cervical lymph node lesions reported on FNAC, in the department of pathology, NSCB Medical College, Jabalpur from January 2023 to June 2024 (18 months). Results: Total cases of 414 lymph node aspiration were done, of which 78 cases (18.84%) were positive for malignancy. Among malignant lesion metastasis was the predominant lesion. Majority of cases were seen in 51-60 years age group with male predominance and male: female ratio was 6.1:1. The most common metastasis was from squamous cell carcinoma which was reported in 65 cases (84%), followed by 4 cases of adenocarcinoma and malignancy of epithelial origin each. One case each of metastasis from papillary carcinoma thyroid, anaplastic carcinoma thyroid and malignant melanoma was reported. In two cases cytological diagnosis of lymphoma (NHL) was made. Conclusions: FNAC gives early and accurate results with minimal invasion and reduces the need for surgical biopsies, thus saves cost and time to reach the final diagnosis. It is concluded that FNAC is a useful tool in diagnosing malignant lesions of lymph nodes with a good certainty.
Histopathological spectrum of uterine lesions in hysterectomy specimens of patients with abnormal uterine bleeding
(Medip Academy, 2024-12) Shrivastava, K; Mishra, RT; Tiwari, P; Totade, S; Dhakar, JS.
Background: Abnormal uterine bleeding (AUB) is an overarching term that reflects any departure from normal menstruation or regular menstrual cycle patterns. Treatment depends upon the cause. Hysterectomy being a definite treatment for structural uterine pathology. Methods: This cross-sectional observational study was conducted in department of pathology, Netaji Subhash Chandra Bose medical college Jabalpur (M.P.). The study comprised of 140 hysterectomy specimens with or without salpingo-oophorectomy obtained from AUB patients and submitted for histopathological examination in our department during study period of 18 months. The relevant data of the patients was collected and analyzed as per designed proforma. Results: Out of 140 cases, majority of the patients were in 41-50 years age group 63 cases (45%), followed by 31-40 years age group 59 cases (42.14%). Most common clinical presentation was heavy menstrual bleeding in 83 cases (59.28%), followed by intermenstrual bleeding and pain in abdomen in 66 cases (47.14%) each. Commonest lesion found was leiomyoma, 83 cases (59.28%), second being dual pathology of adenomyosis with leiomyoma 23 cases (16.42%) followed by adenomyosis, 19 cases (13.57%). Four cases (2.85%) of benign endometrial polyp and endometrial carcinoma each and 1 case of adenomyoma, simple endometrial hyperplasia and endometrial stromal sarcoma, each, were reported. Conclusions: A wide spectrum of histopathological findings, ranging from normal cyclic endometrium to benign pathology and malignancy were seen. In some patients, dual pathologies, incidental findings and occult malignant lesions, which were missed clinically or radiologically, was diagnosed on histopathological examination, thus making it a gold standard for definite diagnosis.
Effectiveness of video making to enhance infection control skills by undergraduate MBBS students
(Medip Academy, 2024-12) Tripathi, PC; Singh, HR; Suryawanshi, RK.
Background: Competency-based medical education (CBME) Microbiology second MBBS curriculum, infection control practices are core competencies for certification of the second MBBS student. E-learning through video making can help students to achieve these infection control skills upto certifiable level. Educational videos which are of short duration, created in a step wise manner have shown to improve skill acquisition and augment observational learning. The aim and objectives were to study the effectiveness of video making as a teaching learning tool, to enhance infection control skills in undergraduate second MBBS students through video making and to evaluate the students’ infection control skills by giving them a prior checklist. Methods: Second MBBS students after taking informed consent were enrolled for the study. Ten infection control and prevention topics were included in the study for video making. All the 100 second MBBS students in 5 groups of 20 students had made all the 10 videos of duration 2 minutes. A self-administered, validated pre-test and post-test, multiple choice question (MCQ) test and objective structured practical examination (OSPE) checklist were used. Results: Mean post-test marks improved by a mean of 5.91 with significant p value (<0.001, using statistical package for the social sciences (SPSS) software version 29). Mean MCQ and OSPE scores also improved. In almost all the questions on feedback of student’s perception and assessment feedback, percentage of students who agreed and strongly agreed were far more than those who disagreed. Conclusions: Second phase MBBS students learning and performance of infection control skills greatly improved when they created their own videos.
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.
The effectiveness of the therapeutic exercise Clinical Pilates in adult patients with multiple sclerosis: a systematic review
(Medip Academy, 2024-09) Matsouki, E; Kyriakatis, GM.
Existing literature supports various forms of exercise as appropriate for treating people with multiple sclerosis (MS) with mild or more severe symptoms. In recent years, Pilates is a form of therapeutic exercise used more and more often in rehabilitating people with MS. The purpose of this systematic review is to explore the effectiveness of the clinical Pilates method in adult people with MS. Research was performed in 4 scientific databases (PubMed/MEDLINE, ScienceDirect, PEDro and Scopus) using the following keywords: multiple sclerosis, MS, Pilates and Clinical Pilates. Inclusion criteria were studies randomized controlled, written in English, published in 2012-2022, with adult people with MS and where the intervention should have been only the Pilates method and the results had to be relevant to physiotherapy. The methodological quality of the studies included was assessed by PEDro Scale. From a total of 329 initial records, only 12 studies were included. Results show that Pilates can improve balance, gait, functionality, physical and cognitive capacity, quality of life and body composition in adult people with MS and with mild to moderate disability. Fatigue, anxiety and depression levels did not show clear improvement after the application of the Pilates exercises in comparison with other therapeutic exercises. Pilates is a safe method of exercise for adult people with MS and can improve many symptoms. It is necessary more research to be conducted so that the effectiveness of the Pilates exercises be explored further on different parameters in patients with MS, like fatigue.
Conservative therapy and physiotherapy in children with toe walking: a systematic review
(Medip Academy, 2024-09) Besios, P; Kyriakatis, GM; Besios, T.
The purpose of this systematic review was to study all the randomized controlled trials on the effects of conservative treatment and physiotherapy programs on children with toe walking. A literature search was performed in the databases: PubMed, Scopus, PsychInfo, SportDiscus, and ResearchGate. Toe-walking and toe walking were the keywords searched. Furthermore, explicit inclusion and exclusion criteria were established, and the research selection procedure was carried out by two distinct reviewers. The physiotherapy evidence data-base (PEDro) scale was used to assess the quality of the final studies included in the systematic review. Out of the total of 2079 studies initially identified, 6 studies were finally included. The results showed that physiotherapy interventions and conservative therapy, such as botulinum toxin, ankle foot orthosis or foot orthosis and electric stimulation therapy can help reduce toe walking especially when these methods are combined with classic physiotherapeutic exercises and stretches. Conservative treatment and physiotherapy have positive effect on children who have toe walking symptoms. However, further research is needed in this area to determine the most effective treatment methods to reduce the symptoms of toe walking and find the best treatment to improve the daily lives of these patients, focusing on avoiding surgical procedures.
Perception of decentralized clinical trials and home nursing in oncology clinical research: insights from a survey of clinical research professionals across experimental sites
(Medip Academy, 2024-09) Stabile, S; Franchina, V; Testoni, S; Mannozzi, F; Fabbri, F; Federici, I; Betti, M; Zepponi, F; Frazzetto, A; Micallo, G; Bertolotti, R; Sangalli, C; Cagnazzo, C; Nanni, O.
Background: Post-COVID-19, rapid technological progress enabled remote healthcare interactions, fostering DCT activities. Sponsors and sites adapted by digitizing traditional model, utilizing wearables and home nursing. However, challenges like staff oversight and logistics demand careful evaluation for regulatory compliance. Methods: Italian association of medical oncology's study coordinators working group, in collaboration with Italian group of data managers, conducted an anonymous online survey among Italian oncology professionals. Survey aimed to explore their perceptions of remote patient monitoring, trial activities, and home nursing in oncology clinical trials. Results: Out of 111 professionals (42.3% coordinators, 27.0% physicians, 18.8% nurses), 29.7% lacked prior experience in remote patient data capture, while 61.3% had low or medium experience. On a 0-10 VAS scale, 58.6% found remote modalities very useful, with high scores (8-10) for various remote activities like quality of life data capture (71.2%), vital signs transmission (66.7%), and home nursing tasks (65.8%). Regarding home nursing in oncology clinical trials 73.0% of participants (n=81) have declared no previous experience. However this remote activity is considered highly useful for tasks such as biological samples collection (76.6%), vital signs collection (73.9%), quality of life evaluation (71.2%), and adverse events monitoring (65.8%). Conclusions: Electronic devices for remote data capture are prevalent in oncology trials, positively perceived by a significant portion of staff. Remote data collection correlates with improved workload perception. Although home nursing is less common in Italy, healthcare professionals show a positive perception, indicating potential benefits for clinical trial efficiency and workload improvement.

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