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NCT ID: NCT05315557 Not yet recruiting - Septic Shock Clinical Trials

Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial

Start date: April 5, 2022
Phase: N/A
Study type: Interventional

Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis. Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of septic shock in these group of patients is still higher. At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor. Terlipressin is also shown to be effective in septic shock in cirrhotics3. Other vasoactive agents are not preferred in cirrhotics - dopamine due to high risk of arrhythmias and dobutamine as baseline cardiac output of cirrhotics is high which further increases in sepsis and dobutamine would further add to it. However, it may be given in myocardial dysfunction. Noradrenaline is recommended as the first vasopressor to be started in general in septic shock population. No study has compared the effectiveness of vasopressin and Terlipressin when added to noradrenaline in patients with cirrhosis. Acute kidney injury is a very common complication of septic shock in cirrhotics.

NCT ID: NCT05304182 Not yet recruiting - Cataract Clinical Trials

Clinical Study - ES 900 - 2020-1

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

EYESTAR 900 is a device developed by Haag-Streit which utilises 3D OCT for quantitative measurements of the geometry of the entire eye, including ocular biometry and corneal topography. It is the most recent in a series of successful biometry devices by Haag-Streit (HS Pachymeter, Lenstar LS 900, LS 900 T-cone and LS 900 APS) and also allows for advanced corneal tomography examinations. The EYESTAR 900 is CE marked. These measurement results of this device are used for the planning of the medical treatment of patients. Depending on the application, the benefits of this device may include improved visual acuity (after cataract surgery), reduced risk of complications (after refractive surgery or implant of a phakic intraocular lens), early identification of pathological deformations of the cornea (keratoconus detection). The primary objective of this clinical trial is to assess the clinical performance of the investigational device in dense cataracts. To that end, for each measurand, the in-vivo repeatability will be quantified, as well as limits of agreement and the mean measurement deviation, with respect to the current gold standard device. As a secondary objective of the study, raw measurement data will be collected to allow for the improvement of existing algorithms, development of additional measurands and for retrospective analysis. No diseases are studied.

NCT ID: NCT05289609 Not yet recruiting - Clinical trials for Liver Transplant Disorder

Developing Prediction Models for Allograft Failure After Liver Transplantation

IMPROVEMENT
Start date: April 1, 2022
Phase:
Study type: Observational

Prompt identification of allograft failure (AF) is highly desirable to address patients to liver retransplantation, in order to maximize results and preserve patients safety. Recently, sophisticated kinetic models became available, offering the possibility to predict 90-day AF with unprecedented accuracy, by computing data from the first 10 days after liver transplant (LT). The growing utilization of extended criteria and cardiac death donors stimulates the transplant community to further refine such predictive models and validate them on a larger scale population of patients across the nations. This study aims to develop new algorithms for the timely prediction of AF at 90 and 365 days using a prospective international cohort from high-volume centers, to validate them on a large retrospective cohort, to identify the best time for retransplantation, to stratify the risk of AF according to the graft type (i.e. DBD, ECD, DCD, LD), to weigh the effect of risk-mitigation strategies, and to assess the correlation with post-LT morbidity and mortality.

NCT ID: NCT05268588 Not yet recruiting - Breastfeeding Clinical Trials

mHealth India Postnatal Health Intervention Effectiveness

Kushal Maa
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to assess the effectiveness of a culturally-tailored mobile interactive education and support group intervention to supplement standard postpartum care activities in comparison to standard care alone on health-related behaviors and health outcomes in a randomized controlled trial among 2100 postpartum Indian women living in 3 geographically diverse Indian states to estimate the impact on maternal and neonatal health-related knowledge, health-related behaviors, and health outcomes. The investigators also seek to characterize mechanisms of impact including knowledge, social support, self-efficacy, and behavior change, and determine the cost-effectiveness.

NCT ID: NCT05229289 Not yet recruiting - Clinical trials for Hepatic Encephalopathy

Efficacy and Safety of Fecal Microbiota Transplant for Secondary Prophylaxis of Hepatic Encephalopathy

Start date: January 31, 2022
Phase: N/A
Study type: Interventional

Despite standard of care, the recurrence of hepatic encephalopathy remains the primary cause for readmissions in individuals with cirrhosis. Patients with cirrhosis have disturbed gut microbiota, which is exacerbated by repeated antibiotic usage. FMT is a promising therapy to restore a healthy microbiota. FMT causes change in composition of gut microbiota which will lead to increase in commensal bacterial diversity which will increase colonization resistance to pathogenic bacteria and thereby decrease the bacterial overgrowth. Healthy bacteria also increase the SCFA production in colon with is and nutrient for endothelial cells and thereby protect the endothelial integrity and decreases bacterial translocation and endotoxemia. Current standard of care mainly focuses on the treatment of precipitating factors of the HE. The goal of our open-label, randomised clinical trial is to evaluate the safety, efficacy of addition of FMT to SOC in preventing subsequent episodes of hepatic encephalopathy.

NCT ID: NCT05166317 Not yet recruiting - Clinical trials for Acute Variceal Bleed

Comparative Efficacy of Various Non-invasive Methods in Assessing Response to Beta-blockers as Secondary Prophylaxis for Acute Variceal Bleed.

Start date: January 10, 2022
Phase:
Study type: Observational

Portal hypertension (PH) is a common complication of chronic liver disease and a major cause of morbidity and mortality in cirrhotic patients. One of the most serious complications of liver cirrhosis is esophageal varices (EV) bleeding. The hepatic venous pressure gradient (HVPG) is the gold standard for detecting portal hypertension and its complications. Furthermore, HVPG is the most reliable method for assessing the efficacy of treatment with nonselective -blockers (NSBB), which is the preferred therapy in patients with EV who are at high risk of bleeding (HRV) and as a secondary prophylaxis in the prevention of rebleed. However, the HVPG is an invasive method that is not widely used and necessitates specialized skills. For these reasons, clinical research over the last decade has been focused on identifying non-invasive tests (NITs) capable of evaluating the PH degree and its changes. The most investigated non-invasive tests are liver and splenic stiffness measurement. In advanced cirrhosis, the increase in portal pressure is less dependent on intrahepatic resistance to portal flow due to fibrosis progression and more dependent on extra-hepatic factors such as hyperdynamic circulation and splanchnic vasodilation hence correlation between LSM and PH decreases for HVPG values higher than 12 mmHg.

NCT ID: NCT05144100 Not yet recruiting - Clinical trials for Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Surgery Vs Chemoradiation for Oropharyngeal Cancer- A Phase II/III Integrated Design Randomized Control Trial

SCOPE
Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The oropharyngeal areas mainly comprises of the tonsil, base tongue (BOT), soft palate and the posterior pharyngeal wall. Traditionally, surgical resection of oropharyngeal cancers (OPC) was a standard procedure, often performed through mutilating incisions with mandibulotomies, rendering significant post-operative functional deficits. Over the past 2 decades, there has been a major shift in treatment strategy with a majority of these cancers now being treated by primary concurrent chemoradiation (CCRT) with a trend towards organ and function preservation.

NCT ID: NCT05142982 Not yet recruiting - Seminoma Clinical Trials

Radiotherapy vs Observation for Post Chemotherapy Residual Mass in Advanced Seminoma

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

Testicular tumors account for 1% of all cancers in males and germ cell tumors comprise 95% of all testicular cancers. Seminomas consist of around 50% of cases. However,adequate information is not there as 60- 80% residual disease is seen even after with the standard management of chemotherapy. With the advent of functional imaging there was hope that it could aid in more accurately targeting these tumors to systematically evaluate the role of PET-CT imaging in identifying patients diagnosed with stage IIB-IIIC seminomatous germ cell tumor, with residual visible tumor post chemotherapy who would benefit with loco regional radiotherapy. The therapeutic research in Seminomashas been relatively slow and such structured studies can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30) in these cancers. We hope that we will get help in identifying thrust areas for future research through this study.

NCT ID: NCT05055765 Not yet recruiting - Thin Gingiva Clinical Trials

Comparative Evaluation of Microneedling and Injectable Platelet Rich Fibrin in Thin Periodontal Phenotype

Start date: November 2021
Phase: N/A
Study type: Interventional

Evaluation of microneedling vs injectable -platelet rich fibrin on gingival phenotype in thin periodontal phenotype.

NCT ID: NCT05021861 Not yet recruiting - Periodontitis Clinical Trials

Evaluation of Periodontal Status and hsCRP Levels in Females With PCOS on CPA/EE Combination Drug Regimen

Start date: November 2021
Phase:
Study type: Observational

PCOS is a widely reported condition among young female population and anti-androgen agents are increasingly being used as part of the medical management of such cases. However, Clinical studies have reported higher prevalence of gingival inflammation, loss of attachment and gingival enlargement in women taking hormone based oral contraceptives. Additionally, CPA has been reported to have an osteoclastic action. Therefore, it is necessary to explore whether these medications affect the periodontal condition of PCOS patients, who already are pre-disposed to systemic inflammation. Therefore, the present study aims to evaluate the periodontal status of female patients diagnosed with Polycystic Ovary syndrome on Cyproterone acetate/ethinyl estradiol combination regimen.