Archives of Clinical Trials (ISSN 2768-4598) is a broad-based open access journal that publishes clinical trial reports, clinical trial investigations, trial stages, developments, therapeutics, and the significance of the research. Journal provides a free to access platform disseminating information on all aspects of clinical trials including design, data collection, methodology, management, quality assurance, legal, ethical, and regulatory aspects of a clinical trial, data auditing methodologies, biostatistics, bioethics, randomized controlled trials, study protocols, statistical analysis, outcomes. Journal encourages new perspectives on existing research and has a broad coverage of articles from clinical, medical, and health practitioners, students, professionals, and researchers in medical, health science, and pharmaceutical sciences fields as a whole. The journal follows a strict double-blind peer-review process to provide unbiased recognition of the work. All the articles will be freely available online immediately after acceptance. Manuscripts could be submitted through our online portal or as directly to the editorial office as an attachment to email at publications@scienceexcel.org
Efficacies of two medicinal plants [Goma Guar Walmart (Cyamopsis tetragonolobus L.) and Cinnamon (Cinnamomum verum)] versus efficacy of allopathic treatment [Sil–Norboral (Glibenclamide 5 mg/Metformin 1000 mg plus Janumet (Sitagliptin 50 mg/Metformin 850
The objective of this study was to statistically compare –using the One–Way Analysis of Variance and Dunnett's multiple comparisons test– the efficacy of Cyamopsis tetragonolobus L. and Cinnamomum verum versus the efficacy of the allopathic treatment Sil–Norboral (Glibenclamide 5 mg/Metformin 1000 mg) + Janumet (Sitagliptin 50 mg/Metformin 850 mg) as hypoglycemic agents in patients with type 2 diabetes mellitus who attend the "Dr. Agustin O'Horán" General Hospital for medical care. The epistemological approach is quantitative, probabilistic or positivistic. The study design corresponds to that of a therapeutic experimental epidemiological study (therapeutic clinical trial) with prospective temporality. Forty–eight patients with type 2 diabetes mellitus were studied. The 48 patients were randomly assigned to three groups: two experimental groups and one control group. Each group was made up of 16 patients. The first experimental group was given Cyamopsis tetragonolobus L. (twelve dry leaves of Cyamopsis tetragonolobus L. and 500 ml of hot water); pour the 500 ml of hot water into a container and add the twelve dry leaves of Cyamopsis tetragonolobus L.; take 250 ml in the morning and 250 ml at night); the second experimental group was given Cinnamomum verum (two g of dry leaves of Cinnamomum verum and 500 ml of hot water; pour the 500 ml of hot water into a container and add two g of dry leaves of Cinnamomum verum; take 250 ml in the morning and 250 ml at night); and the control group was given the Sil–Norboral allopathic treatment (Glibenclamide 5 mg/Metformin 1000 mg) + Janumet (Sitagliptin 50 mg/Metformin 850 mg). In ascending numerical order, the arithmetic means of the hematic glucose values corresponded to the following treatments: Cyamopsis tetragonolobus L. (84.06 mg/100mL); Cinnamomum verum (88.63mg/100mL); and Sil–Norboral (Glibenclamide 5 mg/ Metformin 1000 mg) + Janumet (Sitagliptin 50 mg/Metformin 850 mg) (122.25 mg/100mL). The One– Way Analysis of Variance reported a value of F= 56.03 with a value of p= 0.0000, which indicates a statistically significant difference between a pair or between more than one pair of arithmetic means. Dunnett's multiple comparisons test showed statistically significant differences between the treatment with the medicinal plant Cyamopsis tetragonolobus L. and the allopathic treatment Sil–Norboral + Janumet: p= 0000. Likewise, Dunnett's multiple comparisons test showed a statistically significant difference between the treatment with the medicinal plant Cinnamomum verum and the allopathic treatment Sil–Norboral + Janumet: p= 0.0000. It is concluded that Cyamopsis tetragonolobus L. is, from a numerical and not a statistical point of view, the best hypoglycemic agent for the treatment of type 2 diabetes mellitus.
medicinal plants versus allopathic treatment
Lidia Esther del Socorro Serralta–Peraza
Copyright (c) 2025 Archives of Clinical Trials
Preliminary Step towards COVID-19 Inactivated Vaccine Development in Egypt
The current worldwide COVID-19 pandemic is causing severe human health problems, with high mortality rates and huge economic burdens requiring the urgent development of a safe and effective vaccine. Here, preclinical evaluation of an inactivated SARS-CoV-2 vaccine candidate (EgySerVac-20) is reported. Oropharyngeal swabs and nasopharyngeal aspirates obtained from Egyptian patients with laboratory-confirmed SARS-CoV-2 infection were isolated using Vero cells and were then genetically characterized. Vaccine inactivation was performed using diluted formaldehyde, followed by safety testing for the inactivated vaccine. To determine the high humoral immune responses against SARSCOV-2 infection, the safety and capacity of the vaccine prepared with alum adjuvant were tested. The immunogenicity and efficacy of the vaccine candidate was tested in vitro by a neutralization assay and in vivo using mouse models. Our results revealed a cytopathic effect which was observed 48 hours post infection and the viral particles were identified by rRT-PCR as SARS-CoV-2. Propagation of the isolated virus in ten serial passages on the Vero cells yielded a virus titer 7.5 log10 TCID50/ml. Complete inactivation of SARS-CoV-2 was observed at 37°C in 24 hours post treatment by diluted formaldehyde. Inactivated SARS-CoV-2 infected fluid safety was determined by absence of cytopathic effect by repeated passage in Vero cell line, indicating loss of virus infectivity. Virus inactivated by diluted formaldehyde showed no deaths or clinical symptoms in mice groups post intraperitoneal inoculation (0.5ml/mouse). EgySerVac-20 inactivated vaccine has safely induced high levels of neutralizing antibodies titers in mice, where 0.1 ml immunization dose showed protective efficacy against SARS-CoV-2 challenge in mice. This finding will support the future preclinical and clinical trials evaluation for our SARS-CoV-2 vaccine candidate in primates and human, respectively.
Mental health issues in Pakistan and COVID-19 pandemic
Lung cancer and lambert Eaton syndrome concealed by COVİD-
COVID-19, which infects millions of people worldwide, can affect many organs and systems, mainly lungs, heart, brain, kidneys, vascular endothelium and bone marrow. As a result; it causes a wide range of complications such as ARDS, acute coronary syndrome, delirium, pancytopenia, DIC, kidney damage. Therefore, in the presence of COVID-19, some diseases that progress rapidly and which can cause similar complications may be concealed. In our article, we’re going to tell a patient who was missed due to the adverse effects of the pandemic period and because the COVID-19 infection may cause similar findings, although he admitted to emergency clinique twice before. In a pancytopenic patient suffering from intermittent fever, exhaustion, myalgia and arthralgia for several months, the diagnosis of small cell lung cancer, bone marrow metastasis and Lambert Eaton Myasthenic Syndrome (LEMS) was delayed due to the presence of COVID-19 infection. Therefore, the patient died in a short time. It was presented because it is a rare case and can lead to serious consequences if not imagined..
Comparison of Carbetocin with Ergometrine for the prevention of postpartum hemorrhage
Introduction: Postpartum hemorrhage (PPH) is the leading cause of maternal mortality and is mainly treated with contraceptive drugs. The aim of research was to compare Carbetocin versus Ergometrine in women who undergo caesarian section. Methodology: A single blind comparative prospective study was conducted at the G.N.M.A. "Elena Venizelou". The sample of the study consisted of 100 women of interest, who were randomly assigned to receive either Carbetocin or Ergometrine. The majority of the sample had not had a caesarean section in the past. Hematocrit levels, platelet count, blood loss, side effects, and frequency of rescue therapy were compared between the 2 groups. Results: The Carbetocin group had 52 interest rates and the Ergometrine group 48. There was a statistically lower blood loss in the Carbetocin group (p = 0.035). There were no statistically significant differences in hematocrit levels, platelet count, side effects and frequency of rescue therapy between the 2 groups (p> 0.05).The presence of a side effect was associated with greater blood loss (p≤0,017). The application of rescue therapy was associated with higher hematocrit levels before drug administration (p = 0.005) and greater reduction after administration (p = 0.007) as well as greater blood loss (p <0.001). Conclusions: Carbetocin resulted in statistically less blood loss compared to Ergometrine, and showed similar results in terms of side effects and the application of rescue therapy. More randomized clinical trials are needed to determine the appropriate choice of contraceptive drugs in women who undergo a cesarean section.
Pyoderma gangrenosum: mis-diagnosed as necrotizing fasciitis and review of local experience in patients’ characteristics, associated disease and therapy
Pyoderma gangrenosum (PG) is a rare non-infectious, inflammatory neutrophilic dermatosis that can be idiopathic or associated with underlying autoimmune or neoplastic disorders. It is often diagnosed by exclusion with no gold standard for diagnosis and treatment. We described a 38-year old diabetic lady who presented with rapidly deteriorating ulceration over right foot with extensive suppuration, misdiagnosed as ‘necrotizing fasciitis’ with multiple surgical debridement and amputation was planned. A clinical diagnosis of PG was made after skin biopsy reviewed. She responded significantly after systemic pulsed methylprednisolone therapy and her leg was salvaged. In our local experience of 12 cases with PG follow-up in 5-year period, 83.3% were associated with underlying systemic disease and lower limbs (91%) were the most common site of involvement. Non-healing ulcer (100%) was most frequent presenting symptoms followed by pustule or blister formation. An average of 1.67 skin biopsies were performed for diagnosis. The mean duration of disease before remission was 13.2 ± 6.4 months. Importantly, one-third of cases had experienced relapse. Systemic corticosteroid was mostly given during acute phase, followed by cyclosporin, mycophenolate, azathioprine and anti-tumor necrosis factor (TNF). Conclusion: PG should be considered in patients with non-healing ulcers, especially over lower limbs after exclusion of other cause(s). Systemic corticosteroid during acute phase followed by immunosuppressants resulted in disease control. Continuous monitoring is required as relapse may occur.
Value of 3T diffusion weighted MRI in comparison with CECT in detection of ovarian cancer and ovarian cancer recurrence
Purpose: To investigate the value of 3T diffusion weighted magnetic resonance imaging (DW-MRI) compared to contrast enhanced computed tomography (CECT), in the preoperative staging of patients with suspected ovarian cancer (OC) or with suspected recurrence of ovarian cancer (ROC). Materials and methods: Thirty-two women (mean age 65 ± 14) with suspected (n = 23) or recurrent (n = 9) ovarian cancer were included prospectively in a single center study. CECT and abdominal 3T DW-MRI were performed. Both methods were used to independently score the presence of 1) ovarian tumor, 2) peritoneal or omental carcinomatosis, 3) pathological lymph nodes (LN), along with 4) liver parenchymal, 5) liver capsular, 6) diaphragmatic, and 7) extra-abdominal metastases. Findings were scored as: 0=benign, 1=suspicious for malignancy, or 2=definitely malignant. In addition, the lowest ADC values were measured in existing primary tumors. The extent of disease burden and correlation to histopathological findings were analyzed. Results: The mean disease score was higher in DW-MRI than in CT (4.9 ± 2.6 vs. 3.5 ± 2.2, P < 0.001). Compared to CT, DW-MRI depicted more LN (P = 0.001) and diaphragmatic (P = 0.024) lesions. The lowest ADC values were significantly lower in malignant tumors (n = 18) than in benign tumors (n = 5) (0.640 x10-3mm2 /s ± 159 vs. 0.992 x10-3mm2 /s ± 218, P = 0.002). Conclusion: The results of our prospective single center study show incremental value of abdominal 3T DW-MRI in comparison with CECT, especially in detecting diaphragmatic and peritoneal ovarian cancer metastases, excluding lymph nodal metastases and in differentiating malignant adnexal tumors from benign.
Giant cystic hygroma of the neck in a 3-year-old child: Clinical case and literature review
Giant cystic hygroma of the neck often represents a pathology in children with severe potential complications and considerable technical difficulties in surgical therapy, which often makes it necessary because the alternative therapies provided are not available. A case of a cystic hygroma with a maximum diameter of 10 cm, located in the neck of a 3-year-old girl, with sudden rapid growth and an underlying inclusion cyst compressing the internal jugular vein, is described. The case was resolved with radical surgical therapy, without complications, without recurrence, and with acceptable aesthetic results.
The efficacy of pulsed radiofrequency stimulation of the glenohumeral joint and suprascapular nerve for chronic shoulder pain and function compared to physiotherapy and exercise program without pain management
Background: Degenerative tendon diseases are primarily treated conservatively in primary health care and the most important treatment modality is physiotherapy-guided therapeutic rehabilitation. Method: In this prospective observational study, we investigated the effect of two different treatment approaches in patients with chronic shoulder pain. Physiotherapy-guided treatment was compared to interventional pain treatment with radiofrequency nerve stimulation (pRF) before exercise therapy. The primary outcomes were active shoulder mobility and shoulder function assessed by SPADI questionnaire at two and 6-month controls. Results: The results of this study show that pRF treatment combined to physiotherapy seem to effect shoulder function more than physiotherapy alone. With regard to patients with chronic pain and decreased shoulder mobility (65%), pRF treatment showed a significant greater effect in relieving pain and increasing functional outcome assessed by SPADI. Also short-term pain and impairment reduction for 8-12 weeks occurred in patients with chronic rotator cuff lesions. A direct comparison between the rehabilitation programs strengthened the assumption that effective pain management could be necessary to obtain optimal effect of physiotherapy and physical training in patients with chronic (> 3 months) shoulder pain. Conclusion: PRF can be performed in an outpatient department and provides the clinician with an alternative or additional approach to oral drug treatment and intra-articular injection. Further, it may prove to be a useful treatment for patients who are unfit or unwilling to consider surgical intervention Level of evidence: IV.
A double blind, randomized, placebo-controlled study to evaluate efficacy and safety of “ViraCide” in the management of Corona Virus Disease 2019 (COVID-19)
Introduction: The purpose of this study was to evaluate the safety and efficacy of ViraCide in the management of Corona Virus Disease 2019. Methodology: The study was a randomized, multi center, parallel design, placebo controlled, double blind, clinical trial in patients diagnosed with corona virus disease 2019 with mild or no symptoms and with stable co-morbidities. 118 enrolled subjects were randomized in a 1:1 ratio to either placebo treatment or ViraCide (active treatment). Result: The primary efficacy parameters of National Early Warning Score (NEWS) and 7 point ordinal showed a significantly greater improvement in the active group at the end of the study (P < 0.05). In case of NEWS, in the ViraCide group at visit 3, 74.6 % of the subjects had score of “0” which was higher than the placebo in which only 49.2% showed the reduction. In case of the 7 point ordinal scale, in the active group 76.3 % of the subjects had score of 1 which is significantly higher than that of placebo group which is only 47.5%. Time taken for clinical improvement with respect to negative RT PCR test also showed significant difference in the active v/s placebo group. The mean time taken by patients in the active group to test negative was 5.47 days which was significantly lower than placebo which was 6.97 days. The adverse events rate and severity were comparable in both the groups and no clinically significant adverse event was found in the active or placebo group. Conclusion: The use of ViraCide in mild or asymptomatic COVID-19 patients showed time frame reduction with respect to RT-PCR test, as well as clinical improvement demonstrated by NEWS and 7-point ordinal scale and certain laboratory parameters. Further clinical trials are required to evaluate role of ViraCide in managing COVID-19 and establish its mode of action.
Faisability pilot study to explore inflammation with 18F-DPA-714 PET CT versus immunochemistry in triple negative breast cancer: Design protocol
The Triple Negative Breast Cancer (TNBC), despite a good initial response to conventional chemotherapy, relapses frequently and has a poor prognosis after the onset of metastases. It is therefore interesting to develop new relevant targets to establish a prognosis but also potentially to propose a targeted therapy for a theranostic approach. A high density of M2-type macrophages presence in the primary TNBC tumor predicted an unfavorable prognosis. The presence of activated M2-type macrophages can be evaluated by measuring the expression of a translocating protein (TSPO) with [18F]-DPA-714 PETCT. This proof-of-concept study with [18F]-DPA-714 PET-CT has a design to establish the correlation between immunohistochemistry tumor characterization and in vivo imaging. If a valid correlation will be established, [18F]-DPA-714 PET-CT could be a based image prognosis biomarker, apart from pathological data, which can be fragmented as biopsy or modified by previous treatments. It would allow adapting early the type/dose-intensity of treatment and considering developments of treatments targeting M2-type macrophages.
Assessment of the role of lipoprotein a level in the development of cardiovascular diseases
A comparative trial within 2 groups of patients with cardiovascular diseases who have high and normal levels of lipoprotein (a) was conducted to determine the link between high levels of Lp (a) and the nature of the development of cardiovascular events. According to the results of the study, conclusions about the significance of the level of Lp(a), as well as hypolipidemic therapy in patients with cardiovascular pathology were made. The features of the population of patients with an expected increase in Lp(a) and the predominance of lesions of the brachiocephalic arteries among individuals with increased Lp(a) were revealed. Hypolipidemic statin therapy with a passable correction of the lipid spectrum does not always allow to control the increase in Lp(a).
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment: Clinical Randomized Trial
Objective: The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than treatment with alprazolam alone. Description: We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments than those who did not. The objective is to compare the efficacy of a pharmacological monotherapy (alprazolam), which is one of the options for the pharmacological treatment of panic disorder, with another treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response. Methods: 150 outpatients with panic disorder were randomly assigned to 4 mg of alprazolam or 4 mg of alprazolam associated to a programmed aerobic exercise reaching a heart rate between 50% and 75% of their maximum. Both groups completed their treatments in 12 weeks and were scored using the Hamilton Anxiety Rating Scale (H.A.R.S./14) and the Clinical Global Impression (CGI) before the study and during weeks 1, 4, 8, and 12. Patients assigned to the pharmacological plan received 4 mg alprazolam daily for 12 weeks. Two weeks after the first interview they had their first baseline psychiatric control, where all the patients were evaluated. Then, at the same visit, all the patients were prescribed 4 mg of alprazolam. The dose was gradually increased from 1 to 4 mg throughout the first week of treatment. The test was repeated during weeks 2, 4, 8 and 12. Patients assigned to exercise had to pass an ergometric test to determine their functional capacity expressed in METs for future indication of exercise. Two weeks after the first interview they had their first baseline psychiatric control and at the same time a 4 mg dose of alprazolam was prescribed, gradually increased from 1 to 4 mg along the first week of treatment. The test was repeated during weeks 2, 4, 8 and 12. Then they followed a protocolized aerobic exercise plan for this study for 12 weeks. The type of exercise consisted of a brisk walk for 30 minutes divided into stages. After each stage, the patient must control his own heart frequency, which must be between 50 and 75% of its maximum to ensure an aerobic condition (according yo American Cardiological Association criteria) Results: 106 of the 150 selected patients managed to fulfill both treatments: 51 for the alprazolam + exercise group (dropout rate 32%) and 55 for the alprazolam group (dropout rate 27 %). The group treated with alprazolam + exercise experienced a significant improvement (p < 0.001) respect to the group treated only with alprazolam, reaching lower Hamilton Anxiety Scale scores (4,16 ± 1,06 and 8.57 ± 2,39 respectively) and Global Clinical Evaluation scores (Severity 1,86 ± 0,60 and 2.71 ± 0,62 ; Improvement 2,19 ± 0,49 and 2,87 ± 0,63 respectively for each group). Also, the remission rates were higher for the first group. Conclusion: Aerobic physical exercise in addition to pharmacological treatment (alprazolam) is more effective than the alprazolam treatment alone, and could be a useful alternative to treat this disorder.
Treatment of cutaneous photoaging lesions with autologous platelet concentrate
Background: Facial aging causes a devastating physical and mental impact on quality of life. Objective: To evaluate the efficacy and safety of autologous platelet concentrate (APC) in the treatment of cutaneous photoaging (SCF). Method: Between March 1, 2017 and March 31, 2021, at the “Hermanos Ameijeiras” hospital, a randomized, single-center, double-blind and controlled clinical trial was carried out in 164 patients with ECF. A group treated with CPA was compared to another treated with fresh autologous plasma (AFP). The treatment was applied monthly for 1 year. Results: Three months after the end of the treatment, there were significant differences between the patients treated with CPA compared to those treated with PFA in terms of the improvement in the degree of photodamage and the degree of satisfaction (p <0.001). All adverse events were of mild intensity, did not imply changes before the intervention and were completely resolved. Conclusions: The autologous platelet concentrate proved to be effective and safe to reduce the signs of skin aging, associated with a high degree of patient satisfaction.
Effects of physical exercise on sarcopenia after bariatric surgery: Study protocol of a randomized controlled trial
Introduction: Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. By treating overweight allows a better and even reversal of pathologies associated with obesity. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. The aim of this randomized clinical trial will be to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery Method: This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined. Results: Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.
PEGylated COVID-19 vaccines and cell-cell fusion
Reversible Acute Onset Coma Following Iodinated Contrast Agent During Carotid Angioplasty And Stenting: Unusual Case Report
Contrast-induced encephalopathy (CIE) is a rare complication of angiographic contrast use that occurs during or after in various angiographic procedures and can result in a range of neurological symptoms. Important diagnostic radiological signs include brain edema and cortical enhancement. Neurotoxicity appears to be due to disruption of the blood-brain-barrier by the high osmolarity of the contrast agent. Here, we present a case of transient contrast encephalopathy “coma of unknown etiology” following carotid angioplasty and stenting (CAS). A 78-year-old right-handed man soon after the procedure of CAS, he developed rapidly aphasia and right faciobrachial hemiparesis. Immediately following neurological focal event, the patient developed psychomotor agitation and delirium. The patient subsequently developed a state of coma. The total amount iomeprol intravascular administered during the procedure was of 190 ml. An emergency nonenhanced CT showed bilateral cortical enhancement and edema in the left cerebral hemisphere. On the second post-procedure day, the patient was transferred to the intensive care unit. Fortunately, her clinical manifestations disappeared gradually, and the patient recovered with complete resolution of contrast enhancement after seven days of conservative treatment. The patients received IV hydration, IV mannitol as part of is treatment protocol. Urgent neuroimaging is important to obtain the correct diagnosis and treated with supportive management as soon as possible. This is an unusual report of neurotoxicity mimicking massive vascular causes of coma clinically. The findings suggest that CIE should be considered in the differential diagnosis if any acute neurological symptoms are noted during and immediately after of angiography examinations. To our knowledge, the development of prolonged coma by neurotoxicity cause, after application of intravascular radiographic contrast is a rare complication of endovascular treatment. This case highlights that severe symptom can persist for many days after endovascular intervention. A high index of suspicion should be maintained for patients with angiographic procedures and rapidly developing neurological deterioration postprocedure. We herein report a case of prolonged coma following procedure of CAS. This case illustrates the diagnostic challenges for a patient that they fall into a coma because of angiographic procedures and raises awareness for CIE as an exclusion diagnosis.
Huangqi-Guizhi-Wuwu Decoction in the Treatment of Diabetic Nephropathy (CKD2-4): A Study Protocol for a Prospective, Open, Multicenter and Controlled Trail
Background: In recent years, the disease spectrum has been changing with the change of people's lifestyle. In terms of kidney diseases, the incidence of diabetic nephropathy is increasing year by year and has replaced chronic glomerulonephritis as the primary cause of uremia. Therefore, it is important to delay the progression of renal function in patients with diabetic nephropathy to reduce the occurrence of uremia. Objective: To investigate the efficacy of the treatment of diabetic nephropathy (CKD2-4) with the addition and subtraction of Huangqi-Guizhi-Wuwu Decoction. Method: The 100 patients with diabetic nephropathy were divided into two groups to compare the clinical efficacy. The control group was basic treatment + dapagliflozin, and the observation group was treated with Huangqi-Guizhi-Wuwu Decoction to compare the clinical efficacy, traditional Chinese Medicine (TCM) syndrome integral change, creatinine and urinary protein quantification of the two groups. Expected results: Compared with the dapagliflozin, the addition and subtraction of Huangqi-GuizhiWuwu Decoction can significantly reduce the glomerular filtration rate, lower proteinuria of diabetic nephropathy (CKD2-4) and delay the progression of diabetic nephropathy.
COVID-19 mRNA vaccines and pathological cell-cell fusion: an unintended consequence
pathological syncytia formation in COVID-19 mRNA vaccines
Effects of zolpidem administration on postoperative pain in patients after total knee arthroplasty: Study protocol for a randomized controlled trial
Background: Postoperative patients commonly have sleep disturbances. Sleep quality is associated with pain intensity. Thus, a vicious cycle of poor sleep quality that increases pain and disrupts sleep quality occurs. However, little is known about the impact of postoperative sleep management on postoperative pain and functional recovery after total knee arthroplasty (TKA). Here, we designed a randomized controlled trial to investigate the effects of zolpidem on postoperative pain control and functional recovery after TKA. We hypothesized that zolpidem would decrease postoperative pain and simultaneously improve knee ROM and sleep quality. Methods: This randomized, prospective, controlled trial will include 88 patients scheduled to undergo unilateral TKA. Patients will be randomized to one of the two groups, one of which will receive zolpidem postoperatively. The primary endpoint will be the visual analogue scale (VAS) pain score on postoperative day 2. Secondary outcomes are sleep quality (nocturnal arousal, frequency of body movements, and sleep effects), knee joint range of motion, opioid consumption, incidence of postoperative nausea and vomiting (PONV), and rescue analgesic consumption. Protocols were developed in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Discussion: Sleep quality significantly affects pain intensity. Therefore, it is hypothesized that postoperative administration of hypnotics to improve sleep quality may reduce pain intensity. In this study, we hypothesized that zolpidem administration will decrease postoperative pain, which will simultaneously improve knee joint ROM and sleep quality. This randomized, controlled trial will provide insight into optimizing perioperative sleep management strategies by evaluating the effects of postoperative hypnotic administration in patients post-TKA. These results of the study may improve clinical practice in terms of perioperative sleep management and enhance patient recovery and satisfaction. Name of the registry: Effects of Sleep Management on Postoperative Pain in patients after total knee arthroplasty. A randomized controlled study. Trial Registration: UMIN000039116 Date of registration: 2020/Jan/15 URL of trial registry: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044407.
A Unified Primary Care Approach for the Management of Insomnia and Confusion Using the Clinical Pathway
Background: Delirium and confusion are risk factors for falls and its related injuries. Therefore, we designed a unified clinical pathway to reduce the risk of delirium among hospitalized patients. Methods: A unified approach of pharmacotherapy for managing insomnia and confusion, which is subdivided based on the patients’ age (<70 versus ≥70 years) and presence of diabetes mellitus, was implemented in Nagoya Memorial Hospital, Japan. Risk factors for delirium were assessed via a multidisciplinary approach. For older high-risk patients, suvorexant or trazodone was prophylactically prescribed to promote sleep. If delirium occurred, either quetiapine or perospirone was administered prior to the usage of risperidone or haloperidol. The amounts of prescribed sleep inducers and antipsychotic agents were examined. The application rate of the clinical pathway and incidence of falls were compared before and after its introduction. Results: The application of a unified approach for the management of insomnia and confusion significantly decreased the prescribed amounts of benzodiazepines and may be associated with the reduced incidence of falls among hospitalized patients. Conclusions: A clinical pathway assisted the selection of sleep inducers and antipsychotic agents. This is useful for managing inpatients safely by preventing delirium and subsequent falls.
Segmental muscle innervation as a basic anatomophysiological knowledge for diagnostic procedure of neuromuscular disorders and thus, a way for accurate EMG diagnosis of single root injury. Retrospective study in patients with radicular symptoms
Background: An accurate identification of the injured nerve roots by EMG in patients with symptomatic CSD requires that the examined muscles are innervated by a single nerve root. In the present retrospective study, the authors address the question of whether such innervation of chosen muscles in the upper extremity can be identified. Methods: Scored EMG results of chosen muscles with the hypothesized innervation by C6, C7 or C8 nerve roots, collected from 42 patients, were compiled as single EMG variables and compared with the respective MRI data, possibly responsible for injury of those roots, using Spearman’s rho (SRC) analysis. Subsequently, each EMG variable was adopted as specific diagnostic method for single root injury and tested for its specificity and then sensitivity in relation to the data of the highest ranked MRI, used as a ‘gold standard method’ Results: SRC results showed positive rank correlation, with the highest p-values, between EMG and the respective MRI variables, in 64 included extremities. Consequently, the assumed EMG-C6, -C7 and -C8 methods showed a high specificity (97% - 100%) against the respective highest ranked MRI. The relative sensitivity of the EMG methods calculated in this way were 38% for the C6-root, 87% for the C7 and 50% for the C8. Conclusions: The results corroborate the presumed innervation of the chosens muscles by single C6, C7, or C8 nerve root, thus allowing the use of needle EMG examination of those muscles for accurate identification of injured single nerve roots in patients with symptomatic CSD.
Diagnosis Of Inflammatory Bowel Disease in Mildly Elevated Faecal Calprotectin: Observation From A Clinical Audit In District Hospital In The UK
Faecal Calprotectin (FC) is a marker to diagnose inflammatory bowel disease (IBD), that is ulcerative colitis & Crohn’s disease. Identifying IBD from other gut related disorder is of prime importance in managing the condition. FCis cheap and non-invasive, it also helps in assessing the further need of any possible invasive procedure such as colonoscopy or imaging studies. The main objective of this observational study was to diagnose new IBD in mildly raised FC value (60ug/g-300ug/g). This study was done in a district-level hospital in the UK. During the study, we noticed that a large number of patients had numerous investigations including colonoscopy and MRI imaging, and only one patient was diagnosed with new IBD in mildly elevated FC. These findings were presented at gastroenterology audit meeting held at our hospital. For further improvement of clinical practice and to reduce number of invasive investigation, below recommendation can be followed.
Total Wrist Replacement: State of the Art, Challenges and Pitfalls: A Comparative Review
Background: Total wrist replacement (TWR) as motion-preserving procedure continues to be critically discussed in the literature, although the complication rates have been significantly reduced with the current 3rd generation designs compared with older types. Possible reasons for this are often also a lack of knowledge about the currently available evidence, the complication management, and the lack of practical experience by the surgeons. Methods: Based on an extended review of literature and own experience, the aim of this article is to give practicable insights for the clinician on: (1) biomechanical fundamentals, (2) differences in design, survivorship and functional outcome between the recent types, (3) possible pitfalls, and (4) failures and salvage options. Results: The goal of TWR is that the overall wrist motion is maintained respectively improved despite it works with a locked midcarpal joint. Regarding survivorship and functional outcome the Maestro is (was) being superior over all other types that is (was) based on features in design. There is no scientific evidence as to why the Maestro was withdrawn from the marketplace by the company. For assessment of instability and/or impingement the use of dynamic radiographs is recommended. The problem of TWR is unchanged failure of the carpal components primarily based on mechanical dysbalance, and secondarily followed by metal and/or polyethylene wear, but surgical revision of asyptomatic periprosthetic osteolysis without safe radiagraphic signs of loosening is only required in not more than 20% of cases. For a failed TWR, revision TWR or conversion to total wrist arthrodesis are viable salvage options. Conclusion: The knowledge about recent evidence and features in design of the available types, exact assessment of radiographic findings, presence of technical skills by the surgeons, and observance of the patient's expectations are the basic requirements for a successful TWR.
Multicenter Randomized Controlled (Comparative) Open Prospective Study to Evaluate The Efficacy of The R-DA-EPOCH-21 And R-mNHL-BFM-90 ± Autologous Hematopoietic Stem Cell Transplantation Programs in Untreated Patients With De Novo Diffuse B-Cell Large Ce
Background: NHL-BFM-90 chemotherapy is highly effective in pediatric aggressive B-cell lymphomas. Purpose: To evaluate the efficacy and toxicity of the R-mNHL-BFM-90 and R-DAEPOCH-21 programs in adult patients with de novo DLBCL. Patients and methods: Inclusion criteria: newly diagnosed DLBCL (NOS), no previous chemotherapy, 2 or more signs of poor prognosis, age 18-60. The protocol included 140 patients from 13 medical centers in Russia: R-DA-EPOCH-21 – 33; R-DAEPOCH-21+auto-HSCT - 29; R-mNHL-BFM-90 - 33; R-mNHL-BFM-90+ auto-HSCT -35 patients. R-DA-EPOCH-21 branch: 6 courses were performed. If CR was not achieved, 2 courses of R-DHAP were performed ± auto-HSCT. Branch R-mNHL-BFM-90 included 6 cycles: RA-RB-RA-RB-RA-RB. If CR was not achieved, 2 courses of R-DHAP ± auto-HSCT.
Comparison of The Use of Carvedilol Versus Nebivolol in The Treatment of Acute Decompensation in The Patient With Chronic Heart Failure: Evaluation of Clinical Variables
Previous trials demonstrated the safety of using beta-blockers in the acute decompensation of heart failure; it is unknown whether the use of nebivolol translates into an improvement in clinical parameters at 96 hours, compared to the use of carvedilol in a similar study group. Objectives: To compare the effect of 2 treatment strategies, where the difference is made by the type of beta-blocker, in patients with acutely decompensated chronic heart failure. Methods: A single-center, prospective, experimental, randomized, double-blind clinical trial was carried out, 22 patients with LVEF ≤ 40% were randomly assigned to receive carvedilol or nebivolol with daily dose increase, clinical variables were measured for 96 hours. Results: The carvedilol group reached a maximum dose of 33.3 ± 10 mg and nebivolol 9.37 ± 1.25 mg, with both treatment strategies compensation was achieved in more than 50% of the patients in both groups, without statistically significant differences for the majority of patients. clinical variables, except for greater weight loss in the carvedilol group, reaching an absolute reduction of 5.62 kg (95% CI 3.22-8.02 kg) versus nebivolol with 2.54 kg (95% CI 0. 14-4.94 kg) at 96 hours of follow-up (p 0.001). Conclusions: In patients with acutely decompensated chronic heart failure and reduced LVEF, the use of beta-blockers is safe and well tolerated, guarantees clinical improvement and rapid compensation, with doses diuretic drops. The group with carvedilol showed greater weight reduction, compared to the nebivolol group in the study population.
Clinical Diagnosis of Pleuroparenchymal Fibroelastosis
Pleuroparenchymal fibroelastosis (PPFE) is an extremely rare interstitial lung disease (ILD) characterised by fibroelastotic changes predominating in the subpleural lung parenchyma with visceral pleural fibrosis involving the upper lobes. It has distinctive clinical, radiological, and pathological manifestations. Diagnosis constitutes literally a stalemate because of its rarity, unavailability of an agreed diagnostic consensus, and requirement of tissue biopsy for an accurate final diagnosis that can not be performed in most of the patients owing to the comorbid complications of the disease itself. Identification of PPFE may also pose great difficulties due to the coexistence of other interstitial lung diseases. PPFE usually exhibits a persistently deteriorating prognostic course culminating in fatal complications including respiratory failure, pulmonary hypertension, cor pulmonale, or pneumothorax. Presence of disease relevant complications frequently preclude invasive tissue biopsy interventions in these patients leading to a diagnostic challenge for clinicians. This review aims to provide a definitive diagnosis based on entirely the clinical manifestatins of PPFE by shedding light on the pathogenesis, clinical, and radiologic findings of the disease. Histopathological tissue evaluation was also included in the diagnostic approach for patients whose condition was suitable for an invasive biopsy intervention. With this review, it is concluded that an approach consisting of exclusively clinical manifestations will ensure adequate support for an accurate PPFE diagnosis without any requirement for histopathological tissue examination.
The Matryoshka code of COVID-19 mRNA vaccines: overlapping viral sequences?
Risk of ovarian hyperstimulation syndrome in infertile patients with PCOS treated by HP HMG
Polycystic ovarian syndrome (PCOS) is the commonest endocrinopathy affecting women in reproductive age group. The prevalence may vary from 8.7% to 17% depending on clinical criteria used. PCOS in women having IVF presents multiple challenges ranging from a poor to an exaggerated response, poor fertilization, poor blastocyst conversion and ovarian hyperstimulation syndrome (OHSS). OHSS is at increased risk in PCOS patients receiving fertility treatments varying from mild to severe cases which can be life threatening. Aim of the study: The presence of OHSS in infertile PCOS patients who followed non-pituitary down regulation protocol by using HP HMG injections. Materials and methods: The study type was case series study. It was done in Lamis IVF center - Misurata / Libya during the period 1- 9 -2021 to 31- 8 -2022. 118 infertile patients with PCOS were randomly selected for the study. All patients were selected started ovulation induction with non-pituitary down regulation protocol using highly purified HMG injections. Results: The age of the patients ranges between 18 and 45 years with a mean age of 30 years. The mean number of retrieved oocytes was 19.33 ± 10. The study also showed that the mean number of mature oocytes picked up was 9.41 ± 5.5 with mean success of 77.6%. Hyperstimulation syndrome was reported only in one case (prevalence of 0.8%) which was mild (needed no admission). Regarding the embryo, the mean number of transfers was 2.36 ± 0.6 with two cases showed no fertilization and 82 cases were associated with poor sperm. Conclusion: In our study OHSS in PCOS patients treated by highly purified HMG injections developed in only one case which was mild (needed no admission).
Does gender selection works? An observational study
Sex selection is an option for couples who want to avoid passing a sex- linked genetic disease to their baby. For example, some females are carriers for over 350 X-linked diseases, even if the disease does not directly affect them. Hemophilia and Duchenne muscular dystrophy are examples of diseases that occur with a recessive gene on the X chromosome. Some choose the sex of their baby because of a personal preference like "Family balancing." Many studies were done before to prefer one gender upon another. When we look at the statistics the chances of having a boy or a girl are almost the same and there is no medical evidence to suggest we can influence Design: Prospective randomized controlled study. Setting: The study was conducted at LAMIS Clinic for Obstetrics & Gynecology from January 2015 to February 2022 and still continue up today. The study started after observation that use of cyclofert female capsules before conceptions leads to more probability to male sex embryos. Our study contains five thousand patients who received cyclofert female capsules at dose of two capsules per day for at least two months before conceptions. The data was compared with another one thousands patients who receive placebo. The two groups divided into three according to the age group. All patient included were on natural cycles and no ovulation inductions used, irrespective of the parity. Objectives: To rule out that the observation which is noted that increase male gender embryos related to use of cyclofertfemal capsules or not. Results: The overall pregnancy rate irrespective of the age was 86.02% (4301/5000) & 66.6% (666/1000) for the cyclofert group and the placebo group respectively. Overall abortion rate for cyclofert group was 1.4% (60/4301) while 9.3% (62/666) for placebo group. 89.69% (3804/4241) of the total pregnancy were male gender in cyclofert Group, while at placebo group it was 41.23 % (249/604), (p<0.05 statistically significant). Conclusion: Gender selection could be work by non-invasive, not expensive, effective, affordable, and available without complication method by giving cyclofert female capsules, which is, increases the pregnancy rate, reduces the rate of abortion and increases the male gender embryos. Although, there is no guarantee that the baby will actually be one sex or the other, but cyclofertfemal capsules can influence what type of sperm cell will reach an ovum, and fertilize it. Therefore, yes, male gender selection may be technically possible.