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Jaundice clinical trials

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NCT ID: NCT06115564 Recruiting - Choledocholithiasis Clinical Trials

Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"

Microbile
Start date: July 1, 2022
Phase:
Study type: Observational

The study is a prospective evaluation of the microbial assessment in patients undergoing to ERC with naive papilla; the population includes all the indication to biliary drainage.

NCT ID: NCT06106724 Recruiting - Clinical trials for Calcular Obstructive Jaundice

Primary Precutting Versus Conventional Over-the-Wire Sphinchterotomy For Managment Of Large Common Bile Duct Stones

Start date: September 15, 2023
Phase: N/A
Study type: Interventional

During the last decades, endoscopic retrograde cholangiopancreatography (ERCP) has become the standard of care for the treatment of many pancreaticobiliary diseases [Canena et al., 2014]. However, ERCP is a challenging technique with a slow learning curve and is associated with complications, some of them lifethreatening [Chandrasekhara et al., 2017]. Post-ERCP pancreatitis (PEP) is the most common and serious complication after ERCP [Testoni et al., 2016]. A systematic survey of prospective studies including 16,885 patients reported an incidence of PEP of approximately 3.5%. Severe pancreatitis was found in 11% of the cases, and death occurred in 3% of PEP cases [Andriulli et al., 2007]. Therefore, many attempts to reduce the rate of this complication have been pursued. Selective cannulation of the common bile duct (CBD) is still considered to be a prerequisite for biliary sphincterotomy. Despite the use of various endoscopic retrograde cholangiopancreatography (ERCP) catheters and wire-guided sphincterotomes, CBD cannulation has been reported to fail in 5 % - 20 % of cases [Larkin and Huibregtse, 2001]. Precut sphincterotomy can allow access to the bile duct in such cases and is widely performed by expert endoscopists when there is a clear indication for endoscopic intervention. However, the use of precut sphincterotomy remains controversial because reported complication rates of the widely practiced needle-knife sphincterotomy (NKS) technique vary between 5 % and 20 % [Shakoor and Geenen, 1992]. Precut sphincterotomy, which includes needle-knife papillotomy (NKP), septotomy, and needle-knife fistulotomy (NKF), is often performed to facilitate access to the common bile duct of patients with difficult biliary access (DBA). Furthermore, NKF has been recommended as the preferred technique for precutting by the European Society of Gastrointestinal Endoscopy [Testoni et al., 2016] and the latest International Consensus[Liao et al., 2017]. The success of NKS also depends on the expertise of the endoscopist, and the consensus opinion is that this technique should only be performed by experienced endoscopists [Baillie,1997 ]. In contrast to NKS, incision of the papilla of Vater using an Erlangen-type precut sphincterotome has been previously reported by Binmoeller et al group to be an effective and safe auxiliary method for achieving access to the CBD after failed cannulation attempts [Binmoeller et al., 1996]. The definition of DBA varied widely [Mariani et al., 2016]. The latest guidelines for the definition of DBA differed widely from the latest guideline of The European Society of Gastrointestinal Endoscopy (defining DBA as the presence of ≥1 of the following: >5 contacts with the papilla while attempting to cannulate; >5 minutes spent attempting to cannulate following visualization of the papilla; >1 2 unintended pancreatic duct cannulation or opacification) [Testoni et al., 2016]. and the International Consensus Panel (defining DBA as the inability to achieve selective biliary cannulation by the standard ERCP technique within 10 minutes or up to 5 attempts or failure of access to the major papilla) [Liao et al., 2017 ].

NCT ID: NCT06075290 Recruiting - Neonatal Jaundice Clinical Trials

the Difference of Follow-up Methods of Neonatal Jaundice

NJFU
Start date: October 10, 2023
Phase:
Study type: Observational

The goal of this observational study is to compare the effectiveness and efficiency for precaution of severe hyperbilirubinemia in neonate by different follow-up methods of neonatal jaundice. There are two kinds of follow-up methods in the investigators clinical practice. The one is internet plus follow-up model, the other is conventional clinic follow-up method. Parents of the participant neonates can choose one by themselves. After parents of the participant signed informed consent, the investigators recorded several information including severe hyperbilirubinemia, length of phototherapy, follow-up times, et al. Then the investigators analysed these data in order to know what kind of follow-up method is better to prevent severe hyperbilirubinemia and more easy to be accepted.

NCT ID: NCT06073444 Recruiting - Neonatal Jaundice Clinical Trials

mHealth to Screen for Neonatal Jaundice in Low-resource Mexican Settings: a Feasibility Study

JAUND-EASE
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Neonatal jaundice (NNJ) is a common condition in newborns during the first week of life due to increased levels of bilirubin. Usually, it resolves without consequences after 7 to 10 days. However, around 10% of the newborns develop a severe form, which if is not detected on time, can lead to irreversible consequences including brain damage, disabilities and even death. The goal of this study is to determine the feasibility of implementing a smartphone app (Picterus JP) to screen for NNJ in low resource health facilities in Mexico and to evaluate its potential effectiveness to detect severe cases of the condition compared to the current used method that consists in visual assessment (VA). Research questions are: 1. Is it feasible to implement the smartphone app Picterus JP to screen for NNJ in low resource health facilities in Mexico? 2. Will Picterus JP increase the detection of severe NNJ compared to VA? Participants will include: 1. Newborns who attend the health facilities for neonatal check up 2. Health care workers (HCWs) using the app 3. Parents of newborns screened with Picterus JP Methodology: Mothers will be asked to consent their newborn's participation. The newborns will be then randomly assigned to either: 1. control group in which jaundice will be screened by healthcare workers using VA or 2. intervention group in which jaundice will be screened using Picterus JP in addition to VA If the bilirubin measurement with Picterus is >15 mg/dl or there is suspicion of severe NNJ by VA, newborns will be referred to emergency room for further evaluation by a doctor and/or measure the level of bilirubin in blood. Researchers will compare the number of bilirubin blood levels >15 mg/dl between the two groups. HCWs and newborns' parents will be interviewed to identify their perceptions and experiences towards the use of the app.

NCT ID: NCT06058910 Recruiting - Neonatal Screening Clinical Trials

Bilistick Point-of-care System 2.0 Bilirubin Validation

Start date: February 1, 2024
Phase:
Study type: Observational

This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.

NCT ID: NCT05979233 Recruiting - Clinical trials for Gall Bladder Disease

One Session Vs Staged Management of Calcular Obstructive Jaundice

Start date: August 5, 2023
Phase: N/A
Study type: Interventional

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management

NCT ID: NCT05955144 Recruiting - Neonatal Jaundice Clinical Trials

Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

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

The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

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