International Journal of Clinical Trials

Prevention and treatment for COVID-19 associated severe pneumonia in the Gambia (PaTS-COVID-19), a single-blinded randomized clinical trial: study protocol

2022-11-29T06:47:35+00:00

Background: The coronavirus disease (COVID-19) pandemic resulted in an unprecedent global response for the development of COVID-19 vaccines. However, as viral mutations continue to occur, potentially decreasing the efficacy of currently available vaccines, and inequity of vaccine access continues, identifying safe and effective drugs to minimise severity of COVID-19 disease remains a priority.

Methods: We designed an adaptive individually randomized single blinded non identical placebo-controlled trial to evaluate the safety and efficacy of repurposing licenced treatments for COVID-19 patients in an African setting. The trial has two cohorts: Cohort 1 recruits mild and moderate COVID-19 cases and their household contacts. Cases are actively followed up for 14 days, with a final visit at day 28. There are two co-primary endpoints: clinical progression to severe-pneumonia and persistence of the virus at day 14. The primary endpoint for household contacts is infection during a 14-day follow-up period. Cohort 2 recruits hospitalized patients with severe COVID-19 associated pneumonia followed up actively until discharge or death, and passively until day 90, with a final visit. The primary endpoint is clinical progression or death.

Conclusions: This randomized trial will contribute African-specific data to the global response to COVID-19. Besides the efficacy of drugs on clinical progression, the trial will provide information on the dynamics of intra-household transmission.

Trial registration: This study is registered with Clinical Trials.gov with registration number NCT04703608 and with Pan African clinical trials registry with registration number PACTR202101544570971.

Breaking up sedentary time to improve glucose control in a population at risk for developing type 2 diabetes (BURST2D study): a randomized controlled trial

2022-11-15T09:17:24+00:00

Background: To compare the acute and chronic effects of frequent, short physical activity (PA) bouts spread throughout the day to a time-matched intervention consisting in a single continuous daily bout of PA on glucose control and potential underlying mechanisms in adults at risk of developing type 2 diabetes (T2D).

Methods: BURST2D is a single-center, parallel-group, randomized controlled trial, in which sedentary adults with overweight/obesity and pre-diabetes (18-45 y, BMI: 25-40 kg/m², fasting glucose: 100-125 mg/dL or 2h glucose: 140-199 mg/dL or HbA1c: 5.7-6.4%) will be randomly assigned to one of two 3-month PA interventions: BREAK, nine bouts of 5-min brisk walking performed every hour for nine consecutive hours (45-min/d total), 5 days/wk; ONE, one continuous 45-min bout of brisk walking, 5 days/wk. Primary outcomes will be daily glycemic mean and variability, fasting glucose and HbA1c, postprandial plasma glucose and insulin, glucose kinetics, and content of skeletal muscle proteins related to insulin signaling and glucose uptake. Secondary outcomes will be whole-body insulin sensitivity, 24-h total substrate oxidation, postprandial triglycerides, daily PA and sedentary behavior (SB) patterns, knowledge and attitude towards PA and SB, barriers and facilitators to intervention compliance, self-perceived appetite, mood, and sleep. Outcomes will be assessed at baseline and after one month and/or three months of intervention.

Conclusions: This study will establish the acute and chronic effects of breaking up SB, independent of increases in PA, on glucose control and underlying mechanisms in adults with pre-diabetes. Results will advance the science of T2D prevention.

Trial registration: This study is registered with the ClinicalTrials.gov, registry number NTC05041491.

A multicomponent intervention to reduce internalized stigma in persons with a diagnosis of severe mental disorder: protocol of a pilot randomized mixed trial

2022-12-12T03:32:24+00:00

Background: People with mental disorders face stigma as a social obstacle in multiple areas of their lives. Therefore, stigma toward this population is a priority for global public health due to its numerous consequences for those affected. One of its manifestations is internalized stigma, which also has severe implications for people with mental disorders. This study presents the protocol of a multicomponent intervention aimed at reducing internalized stigma in people with severe mental disorders.

Methods: The intervention is based on a mixed-method experimental design. The main design is an external randomized pilot trial with two arms, parallel, double-blind, equally randomized, and single-center. Qualitative data before and after the completion of the intervention are included as a secondary component of the main design. The study will be carried out in health service of the secondary level of care in Gran Concepción, Biobío Region, Chile. Twelve people will participate in the qualitative pre-intervention stage and 34 in the intervention stage, 17 in the experimental group, and 17 in the control group. The experimental group will receive the intervention plus the usual treatment, and the control group will only receive the usual treatment. The intervention is carried out in 10 sessions lasting 90 minutes each and is administered by a health service professional.

Conclusions: The study will provide evidence on the acceptability and feasibility of the intervention in the Chilean context, advancing knowledge and understanding in the field.

Trial Registration: The study has been registered with trial registration no. ACTRN12622000919718.

The transfusion-associated dyspnea prospective observation and laboratory assessment study: a protocol for investigating and disambiguating cardiopulmonary and high-grade febrile transfusion reactions in adults

2022-12-10T04:23:07+00:00

Background: Cardiorespiratory transfusion reactions drive most transfusion-related morbidity and mortality. Transfusion-associated circulatory overload and transfusion-related acute lung injury have established causes, important impacts, mitigation options, and revised definitions, while non-conforming CRTRs fall into a category known as transfusion-associated dyspnea. Though procedures to investigate high-risk febrile transfusion reactions are typically rooted in detecting incompatibility or bacterial contamination, a common standard for examining CRTRs is lacking. CRTRs are further challenged by charting limitations, confounding (or enhanced susceptibility) by comorbidities, and/or overlapping insults. Deeper profiling of CRTRs could improve categorizations, reveal best-value diagnostics, and decipher the nature of (and/or minimize) reactions coded as TAD.

Methods: The primary objective of this multi-center study is to reduce uncertainty in final conclusions drawn on CRTRs (cases), defined by dyspnea with objective disturbances and/or significant hemodynamic insults, with/without fever (±F). HRFTRs (controls) represent higher-grade F (T≥39°C or chills/rigors or lower-grade F (≥38°C by +Δ1°C) with non-respiratory effects). Patients (goal: 200) consent to additional sampling (≤24h post-TR) to identify contributing factors in case/control presentations, and in diagnostic groups (TRALI, TACO±F, TAD). Mechanistic axes of interest are cardiorenal, hemolytic, leukoagglutinating, biolipid, vasoactive, and inflammatory. Secondary goals include elucidation of real-life “insult-multiplicity” in CRTRs, tests of greatest yield, and distinguishing features in TRALI/TACO/TAD.

Conclusions: A deep systematic CRTR probe may not only reduce diagnostic uncertainty but frame biomarker performance and pathologic signatures in definition-specific CRTRs. The re-classifiability or biology of TAD may be better understood. High-quality, mechanistic, true-to-quantity hemovigilance better exposes burdens and management options.

Trial Registration: The trial is registered with ClinicalTrials.gov. with registry number NCT04267029.

A randomized, double-blind, placebo-controlled, multicenter trial- DL-3-n-butylphthalide therapy for cerebral hypoperfusion from unilateral internal carotid system stenosis study: study protocol

2022-12-11T03:12:50+00:00

Background: Cerebral hypoperfusion caused by large-vessel stenosis is an important risk factor for ischemic stroke and vascular cognitive impairment. In vitro, animal and clinic studies demonstrated that DL-3-n-butylphthalide (NBP) can improve the collateral circulation and the cerebral perfusion. In this trial, the benefit of NBP to ameliorate the chronic cerebral hypoperfusion resulting from unilateral internal carotid system stenosis will be explored.

Methods: This trial is a randomized, double-blind, placebo-controlled, multicenter clinical study. A total 480 subjects with ≥70% stenosis or occlusion in unilateral internal carotid artery system, cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) territory, and no transient ischemic attacks (TIA) or ischemic strokes within 2 weeks will be enrolled in China. Patients will be assigned in a 1:1 ratio to NBP and placebo groups. Patients in NBP or placebo group received 200 mg or 20 mg of NBP capsules three times daily for 4 weeks respectively. The cerebral perfusion will be assessed again after 12 weeks. The primary efficacy outcome is the proportion of patients with cerebral blood flow (CBF) amelioration, stabilization and deterioration after treatment.

Conclusions: This trial will provide a high-level of evidence for NBP to treat the cerebral hypoperfusion, and a novel strategy to improve the cerebral hemodynamic impairment due to large intracranial and extracranial atherosclerotic stenosis in the surgical high-risk patients, especially in the aged and Asians.

Trial registration: This trial is registered as ChiCTR2100053112 on November 12^th, 2021.

Effects of sleep hygiene education and lavender oil inhalation on sleep quality, fatigue, and health-related quality of life in adults with an ostomy: a randomized controlled trial protocol

2022-11-30T23:49:35+00:00

Background: It has been shown that the formation of an ostomy affects sleep quality, and sleep problems or insomnia cause fatigue in daily life, reducing the health-related quality of life. This trial aims to investigate the effects of sleep hygiene education and lavender oil inhalation alone and in combination on sleep quality, fatigue, and health-related quality of life in adults with an ostomy.

Methods: This trial has been planned as a randomized controlled clinical trial and will use a 2×2 factor design in which an equal number of participants meeting the inclusion criteria will be randomly allocated to one of four groups. The study sample will comprise 120 adult patients who have undergone ostomy surgery in a city hospital in Turkey. Lavender oil inhalation together with sleep hygiene education will be applied in the first group (n=30), only sleep hygiene education in the second group (n=30), only lavender oil inhalation in the third group (n=30), and no intervention in the fourth group (n=30). The sleep quality of the groups will be evaluated using the Pittsburgh sleep quality index, their fatigue levels with the chalder fatigue scale, and their quality of life with the ostomy a quality-of-life scale.

Conclusions: Non-pharmacological interventions are needed to prevent sleep and/or other problems that may develop due to insomnia in adults with ostomy. By evaluating the effects of these interventions, this trial will provide valuable evidence to guide clinical practice.

Trial registration: This trial was registered in October 2022 (NCT05573256).

A preliminary evaluation of unified protocol in anxiety disorders in India: a multiple baseline study protocol

2022-12-06T04:55:21+00:00

Background: Anxiety disorders are highly prevalent with high rates of comorbidity. Single disease protocols have been the predominant choice of psychological treatment, however, there has been an increasing focus on transdiagnostic, shared mechanisms. Unified protocol is an emotion-focused CBT that addresses core vulnerabilities by training individuals in adaptive emotion regulation skills. UP has gained research attention in the management of emotional disorders with its modular approach. A challenge in psychotherapy research has been to understand the mechanisms of interventions and their effect on symptoms. Thus single-case experimental design has the potential to address some of the key questions. We present a research protocol that aims to examine the effectiveness of the unified protocol, using the SCED.

Methods: A single-case experimental design, with multiple baseline assessments, will be employed, with random allocation to 2- or 3-week baselines. Patients with a primary diagnosis of anxiety disorder, consenting to baseline assessments, and stabilized at least for 4 weeks of medication will be recruited. Assessments will be carried out at baseline, post, and three months, in addition to weekly assessments on the primary outcome measure, anxiety by an independent blind rater. Secondary outcomes include intolerance to uncertainty, neuroticism, emotion regulation, and anxiety sensitivity.

Conclusions: The findings of this study would contribute to the empirical status of transdiagnostic interventions in symptom reduction and in addressing shared mechanisms, enhancing its clinical relevance for co-morbid disorders.

Trial Registration: The study has been registered in clinical trials registry of India, No. CTRI/2021/01/030803; 28 January 2021.

A randomized study of consolidation chemo-radiotherapy versus observation after first-line chemotherapy in advanced gall bladder cancers (RACE-GB Study): trial protocol

2022-12-02T01:18:53+00:00

Background: Chemotherapy (CT) is the standard of care for advanced gall bladder cancer (GBC). However, after completion of 6 cycles of CT, a proportion of patients with good performance status progress within a few months. Retrospective data in locally advanced cases revealed that consolidation chemo-radiotherapy (CTRT) in responders to CT and with good performance status improves overall survival.

Methods: FNA proven advanced GBC with predefined clinical-radiological features will be administered 4 cycles CT (cisplatin-gemcitabine combination). After completion of CT, those in good Karnofsky performance status (KPS) will be randomised to consolidation CTRT versus observation (standard of care). The primary end point of the study is to compare OS between the two arms. The secondary end point is to compare progression free survival (PFS), toxicity, and quality of life between the two study arms. The trial is designed to detect an improvement in 2-year overall survival (OS) from 8% in the control arm to 25% in study arm with 80.0% power at a 0.05 significance level. The resultant sample size to achieve this aim is 140 (70 in each arm) over a duration of 4-5 years with a 10% attrition rate. Accrual has been from January 2019 to October 2022.

Conclusions: This trial aims to assess the incremental gain in outcomes with consolidation CTRT versus observation in responders to first-line CT in advanced GBCs. This is the first randomised study to evaluate role of consolidation chemoradiation.

Trial Registration: The trial is registered with clinical trials registry India (CTRI/2019/04/025204) and clinical trials.gov (NCT05493956).

Effect of teacher-led activity-based learning on road safety education among school children protocol for a mixed-methods study

2022-12-14T02:53:23+00:00

Background: Road traffic injuries are the single biggest contributor of fatality among age 10 to 24 years worldwide. Also, there is no standardized education system for providing road safety education in schools. This study aims to check the effectiveness of teacher-led activity-based road safety educational intervention to the school children of age 11-15 years will improve their knowledge, attitude, self-reported practice and self-reported parent practice, compared to the existing curriculum and to find the feasibility, perception of children and teachers in implementing this intervention as a part of routine curriculum.

Methods: This mixed-methods study has stratified cluster randomized trial as quantitative part and focused group discussions as qualitative part. This will be carried out in co-education English medium schools located in urban Puducherry. Study participants are school children of age 11-15 years in the class 7, 8 and 9 of the selected schools. The data will be collected using pre-tested semi-structured questionnaire. Assessments will be done at three time points in the intervention schools and at baseline and end-line in the control schools. The module for intervention will be developed by principal investigator and provided to the teachers after prior sensitization.

Conclusions: This study protocol is designed to test the hypothesis that, the teacher-lead activity-based learning for school children will improve their road safety knowledge, practices and behavior compared to existing curriculum if any.

Trial Registration: The trial is registered in Clinical Trials Registry, India (REF/2018/01/016902).

Τhe effect of task oriented approach on gait of hemiplegic patients: a case series study

2022-11-01T06:41:41+00:00

The last few years, the main purpose of the treatment of the hemiplegic patient, is to regain his ability to execute functional activities of daily living independently. According to the latest studies, the effectiveness as well as the importance of task-oriented approach (TOA), is apparent and determining to reacquire the patient’s lost independency, through the practice of the specified functional activities. The aim of this study is to investigate a program of TOA on gait of hemiplegic patients. A sample of 5 post stroke patients was selected from according to the inclusion criteria. A TOA intervention was executed through the practice of 10 functional activities, related to gait, from Monday to Friday for 4 weeks. At the end of each week, gait and balance assessments were performed through the 10-meter walk test (10 MWT), the Berg balance scale (BBS), and the timed up and go test (TUG). The analysis indicates that TOA is extremely effective for stroke patients with mediocre and minor gait and balance deficits, as the difference was statistically significant (p<0.05). The statistically significant difference was from the first assessment T1 to the final assessment T5 and was proven through BBS, TUG and 10 MWT. In conclusion, TOA is a quite beneficial and a cost-effective intervention for the rehabilitation of gait and balance for stroke patients, while consequently improving the quality of their everyday life, independently from their original functional status.

Investigator’s gender and clinical trials performance in recruitment of patients

2022-12-01T06:39:17+00:00

Mostly of attraction to gender is related with participant subjects of clinical trials. Based on percentage of subject of each gender it is calculating enrollment fracture, bias and some other indexes. Enrollment is very important parameter and genders is considering as one of the internal factors which is influencing to enrollment. Authors also marking the more prevalence of male above the female in some aspects of clinical trials. It is obviously that investigators also has a differences in gender and this could have a differences in some parameters and enrollment is one of them. Enrolment parameters also not developed very much. We stepped forward to find out the relations of gender’s investigator and the enrollment. Materials and methods: Data of four clinical trials II-III phases in oncology and hematology, conducted since 2007 to 2017 years has been used for retrospective analysis. Study objectives: to investigate the study recruitment rate using different parameters and it’s changes along with acting of gender’s of investigator; to develop new parameters and values (derivatives) which could be sensitive for evaluation of enrollment. Statistical analysis: data had been collected from feasibility questionnaires, open statistical sources. Results: It was showed the values of enrollment parameters in perspective of investigator’s gender. Discussion: Statistical differences in some existing and developed enrollment parameters has been found. Gender’s influence to enrollment also was investigated.

Takotsubo cardiomyopathy: a rare neuro-cardiological entity with its challenges

2022-11-04T00:40:25+00:00

Takotsubo cardiomyopathy (TCM) is a type of neuro cardiological disorder that evince as acute but reversible heart failure. On the whole, it occurs by stress-related cardiomyopathy which illustrates the heart-brain connection. It was first discovered in 1990, by a Japanese cardiovascular specialist. That's the beginning of this heart disease in gaining worldwide acceptance as an independent disease entity. TCM is entirely different from acute myocardial infarction as usually occurs in postmenopausal elderly women due to emotional or physical stress. It is characterized by transient hypokinesis of the left ventricular apex. However, there are complications too that need to be addressed. Some reports of serious TCM include hypotension, thrombosis involving LV apex, heart failure, and ventricular rupture. It is also suggested that coronary spasms, myocarditis, and coronary microvascular dysfunction might contribute to the pathogenesis of TCM. But in total, its pathophysiology is unclear. In this review article, we review the pathogenesis and etiology of this rare complex disorder along with its clinical features, findings, challenges in diagnosis, and a comprehensive discussion on the same.

Spermatic cord block in open inguinal hernioplasty

2022-12-22T05:50:29+00:00

Background: Spermatic cord block is a useful technique for providing anesthesia with scrotal pain and it has been described and published in the urology and anesthesia literature for more than 40 years. Spermatic cord block for inguinal hernioplasty along with spinal anaesthesia avoids the potential risks of neuraxial and general anesthesia and provides long-lasting postoperative analgesia. The aim of this study is to evaluate the postoperative effect of 0.5% Bupivacaine for spermatic cord block along with spinal anaesthesia in inguinal hernioplasty.

Methods: This study was carried out in KPC medical college and hospital on 100 patients with ASA physical status I and II, age older than or equal to 18 years undergoing elective open inguinal hernioplasty from September 2021 to August 2022. Patients were randomly allocated into two equal groups: 50 patients received spermatic cord block after mesh placement by bupivacaine 5 ml (0.5%), and 1 ml normal saline (group 1), and 50 patients received 6 ml saline injection in spermatic cord.

Results: There was no significant difference between the demographic data, patient characteristics, heart rate, mean arterial blood pressure, and oxygen saturation in the studied groups. There was significantly rapid onset and prolonged duration of blockade, significant decrease in visual analog scale score at 6 h and 12 h postoperatively and the amount of rescue analgesia in group 1 respectively.

Conclusions: Spermatic cord block in inguinal hernioplasty surgery improves onset of the block, prolongs postoperative analgesia and reduces the consumption of of postoperative rescue analgesics.

Study of correlation between gallstones and bactibilia

2023-01-14T18:17:21+00:00

Background: Now a days Cholecystectomy is one of the commonly performed operations. Most common cause is Gallstones. So, we planned this study to determine to find out any association between gallstone and microbiological spectrum in bile in cholelithiasis patients undergoing laparoscopic or open cholecystectomy.

Methods: Total 140 patients of chronic calculous cholecystitis admitted in the department of general surgery, KPC medical college & hospital, Jadavpur, Kolkata, during August 2021 to July 2022 for cholecystectomy were included in this study. All patients underwent either laparoscopic or open cholecystectomy. During cholecystectomy bile was collected and sent to the department of microbiology for bacteriological profile of bile. Gallstone is classified based on morphology following gallstone retrieved from the gall bladder.

Results: Out of 140 cases 115 cases done laparoscopic cholecystectomy and 25 cases done open cholecystectomy. In this study bile culture test negative in 105 cases and positive in 35 of cases. Escherichia coli was the most common micro-organism found in 20 cases, Enterococcus species in 8 cases, in 5 cases Staphylococcus aureus and 2 mixed infections. In culture negative case mostly gallstones were larger, 2 to 3 in number and yellowish in colour. In culture positive cases mostly, gallstone was more than 3 in number, smaller, black and brown in colour.

Conclusions: In the light of above obtained results, the authors concluded that multiple, small, dark and brown in colour gallstone in cholelithiasis patients often show bactibilia. The low incidence of bacterbilia may suggest restriction of use of antibiotics in mild biliary pain.

Role of computed tomography imaging in the diagnosis of blunt and penetrating abdominal trauma injuries

2022-11-04T03:02:55+00:00

Background: The present study was conducted with the primary aim of evaluating the role of computed tomography imaging in the assessment of blunt abdominal trauma (BAT) and penetrating abdominal trauma injuries.

Methods: This prospective study comprised 53 patients with BAT and PAT injuries referred from the emergency department to the department of radio-diagnosis for ultrasonography and CT. Multidetector computed tomography scans were performed on GE Bright Speed Elite 16 slice CT Scanner. The various injuries seen on the CT images were grouped and examined based on the injury site and the organs involved.

Results: The majority of the study subjects, i.e., 17/53 (32.08%) belonged age group of 20-30 yrs. Out of the 53 study subjects, 48 had BAT and 5 had PAT. The majority of study subjects who had BAT, i.e., 26/48 RTA, was the cause of trauma, and 5 out of 5 who had PAT assault was the cause of trauma. The most common organ injured was the spleen (18), followed by the liver (17), bowel (15), Anterior abdominal wall (6), pancreas (1), Kidney (1), Uterus (2), Multiple organs (1) and Hemoperitoneum without solid organ injury (1). CT showed 100% accuracy in the diagnosis of abdominal organ injuries.

Conclusions: CT imaging plays a pivotal role in the rapid identification of life-threatening injuries and is helpful for prompt initiation of appropriate care, which leads to an increase in the chance of survival of patients with BAT and PAT injuries.

Influence of COVID-19 on cardiac clinical trials: an observational study from clinical trials registry India

2022-12-12T00:10:32+00:00

Background: Clinical trials on drugs for cardiac diseases becomes essential as coronary artery disease is the most common cause of death globally. This study observes if COVID-19 has influenced the number and pattern of cardiac trials conducted prior to and during COVID-19 from clinical trial registry of India web portal.

Methods: The CTRI website was searched for the key words “myocardial infarction”, “heart failure”, “cardiac arrhythmia”, “myocarditis” and “pulmonary embolism” and the trials registered were reviewed. Data was collected for every trial registered from 1st January 2019 to 16th April 2021.

Results: 156 Clinical trials were registered in the specified period. Of which 104 were on myocardial infarction, 24 on pulmonary embolism, 13 on cardiac arrhythmia, 9 on cardiac failure and 6 on myocarditis. Among the 156 trials, 98 were observational, 53 were interventional and 5 Post marketing surveillance type. 83% of the interventional studies were randomized controlled trials. Karnataka had the maximum number of trials registered 57, followed by Delhi 37 trials. 135 trials were done in India alone and 21 trials involved other countries as well. Among the interventions, 25 were drugs, 19 medical devices, 2 cardiac rehabilitations, 2 based on Yoga, 95 trials mentioned their intervention as NA and remaining 13 were adjuvant, standard treatment, physiotherapy, homeopathy and others.

Conclusions: It was observed that COVID-19 pandemic did not have an influence on the conduct and pattern of cardiac trials in India.

Effect of intra-peritoneal instillation of bupivacaine in laparoscopic cholecystectomy

2022-12-22T05:52:19+00:00

Background: Laparoscopic cholecystectomy is a minimally invasive surgical procedure for removal of a diseased gall bladder. This technique essentially has replaced the open technique for routine cholecystectomies since the early 1990s. Laparoscopic cholecystectomy has become the gold standard for cholecystectomy in the past decade. Most patients are being discharged on the first or second post-operative day. The aim of the study was to evaluate effect of instillation of intra-peritoneal bupivacaine for pain relief in laparoscopic cholecystectomy. The primary outcome is to evaluate pain scores after this procedure.

Methods: It’s an institutional based, observational and randomised control study was conducted in a patients undergoing laparocopic cholecystectomy with gall bladder disease in KPCMCH between 18-70 years of age. The study period was 12 months (from June 2021 to May 2022). 100 patients were included in this study.

Results: Our study showed that, less number of patients had right shoulder tip pain (in Numerical rating scale) and requirement of rescue analgesia in case compared to control group.

Conclusions: We concluded that instillation of intra-peritoneal bupivacaine reduces pain scores after difficult laparoscopic cholecystectomy.