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Jaundice clinical trials

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NCT ID: NCT05928286 Recruiting - Clinical trials for Obstructive Jaundice

Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice

Start date: December 1, 2022
Phase:
Study type: Observational

Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.

NCT ID: NCT05677477 Recruiting - Nursing Education Clinical Trials

The Effect of Hybrid Simulation on Evaluating Neonatal Jaundice

Start date: December 20, 2022
Phase: N/A
Study type: Interventional

This study will be conducted as a single-blind randomized control group intervention trial to determine the effectiveness of the hybrid simulation method using standard patient and low-fidelity baby simulators in the intervention of nursing students for neonatal physiologic jaundice.

NCT ID: NCT05630495 Recruiting - Jaundice, Neonatal Clinical Trials

Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia

Start date: December 12, 2022
Phase: N/A
Study type: Interventional

The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals: - Demonstrate that Picterus system performs accurately in Indonesian newborns - Ensure that Picterus is in line with users' needs in Indonesia

NCT ID: NCT05521607 Recruiting - Neonatal Jaundice Clinical Trials

Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)

Start date: January 6, 2023
Phase: N/A
Study type: Interventional

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

NCT ID: NCT05282394 Recruiting - Newborn Jaundice Clinical Trials

Newborn Abdominal Massage to Prevent Hyperbilirubinemia

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

The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia

NCT ID: NCT05257369 Recruiting - Jaundice, Neonatal Clinical Trials

Broad Band Emission LED Phototherapy Source Versus Narrow Band

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

Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device.

NCT ID: NCT05246176 Recruiting - Clinical trials for Obstructive Jaundice

Ultrasonography as a Single Tool for Guided Percutaneous Transhepatic Biliary Drainage in Obstructive Jaundice

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

Obstructive jaundice may be of malignant and benign etiologies. Carcinoma of the gall bladder, cholangiocarcinoma, pancreatic adenocarcinoma, metastasis, and lymph nodal compression of common bile duct (CBD) constitute the majority of malignant causes. Most of the patients with malignant obstructive jaundice are already advanced and inoperable by the time they are diagnosed, hence carry bad prognosis with palliation being the only option left. Obstruction needs to be drained even in such cases for reducing pain, cholangitis, anorexia and pruritus as well as to reduce the serum bilirubin levels in certain cases to initiate chemo or intrabiliary brachytherapy. Over the years, palliation has evolved with the introduction of newer methods and improvisation of existing techniques. Recent palliative measures prolong longevity and improve the quality of life, hence increasing the acceptance to such procedures; Methods of biliary drainage include: a. Surgical bypass b. Minimally invasive procedures; Endoscopic retrograde (ERCP) (cholangiopancreatography (ERCP), and Percutaneous transhepatic biliary drainage (PTBD). ERCP as well as PTBD are well-established and effective means for biliary drainage as palliative treatment in unresectable cases. With the current modern technique in experienced hands, Percutaneous Transhepatic Biliary Drainage (PTBD) equals endoscopic retrograde cholangio pancreatography (ERCP) regarding technical success and complications. In addition, there is a reduction in immediate procedure-related mortality with proven survival benefit. Moreover, it is the only immediate lifesaving procedure in cholangitis and sepsis.

NCT ID: NCT05127070 Recruiting - Prematurity Clinical Trials

Evaluating the NeoTree in Malawi and Zimbabwe

Start date: October 1, 2019
Phase:
Study type: Observational

Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor. Health systems strengthening through digitial quality improvement systems, such as the Neotree, are a potential solution. The overarching aim of this study is to complete the co-development of NeoTree-gamma with key functionalities configured, operationalised, tested and ready for large scale roll out across low resource settings. Specific study objectives are as follows: 1. To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe 2. To investigate HCPs and parent/carer view of the NeoTree, including how acceptable and usable HCWs find the app, and potential barriers and enablers to implementing/using it in practice. 3. To collect outcome data for newborns from representative sites where NeoTree is not implemented. 4. To test the clinical validity of key NeoTree diagnostic algorithms, e.g. neonatal sepsis and hypoxic ischaemic encephalopathy (HIE) against gold standard or best available standard diagnoses. 5. To add dashboards and data linkage to the functionality of the NeoTree 6. To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree 7. To initiate a multi-country network of newborn health care workers, policy makers and academics. 8. To estimate cost of implementing NeoTree at all sites and potential costs at scale

NCT ID: NCT04801238 Recruiting - Pancreatitis Clinical Trials

preGallstep - A Clinical Pilot Trial

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

NCT ID: NCT04620577 Recruiting - Clinical trials for The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

The Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive Jaundice

Start date: October 20, 2020
Phase:
Study type: Observational

To investigate the influence of antibiotics on the incidence of biliary tract infections after PTCD for malignant obstructive jaundice.