International Journal of Clinical Trials

From hurdles to high performance: overcoming day-to-day challenges for successful clinical trials at sites

2024-07-18T15:13:16+0530

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.

Histopathological spectrum of uterine lesions in hysterectomy specimens of patients with abnormal uterine bleeding

2024-09-08T02:36:03+0530

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

2024-09-10T17:44:55+0530

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.

Cytological spectrum of malignant lesions of lymph node

2024-09-04T14:14:45+0530

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.

Assessment of variations in upper and lower gonial angle in children with mouth breathing habit

2024-08-13T13:12:15+0530

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.

Histopathological spectrum of ovarian tumours

2024-09-08T03:09:09+0530

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.

Telerehabilitation in post-tuberculosis lung disease: a protocol for a randomized controlled clinical trial

2024-09-22T05:13:10+0530

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).

Functional echocardiography for management of shock in neonates - study protocol for a randomized controlled trial

2024-09-11T00:02:13+0530

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.

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

2024-07-05T13:17:13+0530

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.