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NCT ID: NCT05470205 Recruiting - Liver Diseases Clinical Trials

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension; Renewal

Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

This is an open-label, non-randomized trial that will be conducted at three clinical sites, Thomas Jefferson University (TJU), the Hospital of the University of Pennsylvania (HUP) and University of Bern (UB). Enrollment will be allocated into one of 4 different cohorts depending on the inclusion criteria for each cohort. Cohort 1: Patients scheduled for hepatic vein pressure gradient (HVPG) measurements will subsequently undergo two consecutive SHAPE (subharmonic aided pressure estimation) procedures using different ultrasound contrast agents (Definity [Lantheus Medical Imaging, N Bilerica, MA, USA] and Sonazoid [GE Healthcare, Oslo, Norway] in randomized order) to estimate portal pressures with a Logiq E10 scanner (GE Healthcare, Waukesha, WI, USA) and determine the reproducibility of the SHAPE algorithm. Cohort 2: Patients identified as having clinically significant portal hypertension (CSPH) will be monitored by SHAPE with Sonazoid for the duration of this project (18-24 months on average). These subjects will have follow-up ultrasound scans every 6 ± 2 months to check for hepatocellular carcinoma (HCC) (using the Barcelona-Liver Cancer staging system) as well as ascites and at those times a repeat SHAPE examination will be performed. Liver stiffness values will be measured with elastography as well. This cohort will examine if serial SHAPE can accurately predict development of ascites and other liver related events in patients with compensated cirrhosis undergoing routine HCC surveillance in a multi-center setting. Cohort 3: Subjects newly diagnosed with portal hypertension and starting treatment with non-selective β-blockers will be monitored with SHAPE and results compared to elastography measurements of liver stiffness with standard assessments (e.g., serum liver function tests and measurement of spleen size as well as platelet count). This cohort will establish if SHAPE can be used to monitor treatment response in patients identified with portal hypertension. Cohort 4: Patients with compensated advanced chronic liver disease scheduled for an endoscopy examination for screening of varices relative to the Baveno VI and the expanded-Baveno VI criteria as well as the AST to Platelet Ratio Index will undergo a SHAPE examination. This cohort will compare the predictive ability of SHAPE for allocating patients with compensated advanced chronic liver disease to screening of varices compared to the current standard of care.

NCT ID: NCT05468684 Not yet recruiting - Neck Pain Clinical Trials

PROCO Neck: The Course and Neuroplasticity in Neck Pain-Associated Disorders and Whiplash-Associated Disorders

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

Neck pain-associated disorders (NAD) and whiplash-associated disorders (WAD) are major health problems. NAD has a lifetime prevalence of 54%. Although the majority of patients recovers within the first three months, a minority develops persistent pain. WAD, in contrast, is reported less frequently, but patients are often suffering more badly. Patients with chronic symptoms represent a considerable burden in terms of pain, suffering, health care needs, and social costs. Findings on the natural course of NAD and WAD reflect the necessity to identify factors besides pain related to the persistence of symptoms. First, alterations of input and processing of multiple sensory modalities causing movement control impairment can result in persistent symptoms and affect the quality of life. Besides, findings of psychosocial factors predictive of pain outcomes support the growing body of research proposing a bidirectional relationship between somatic and psychosocial variables. In particular, there is a pressing need to investigate pain-related activity patterns, besides fear-avoidance behavior in NAD and WAD. Maladaptive activity pattern have an impact on on pain and disability in the long-term prognosis. Mt important, given the high prevalence of NAD and WAD, the cortical representation of the cervical spine has not yet been investigated and, reports on neuroplasticity remain scarce. These shortcomings should be addressed to provide evidence for the temporal aspect of neuroplasticity and its involvement in pain persistence. Hypotheses: We hypothesize I. that impaired sensorimotor abilities, mental health at baseline increase pain intensity and disability during measurement. II. that maladaptive pain-related activity patterns avoidance and overactivity at baseline are prognostic factors for pain persistence and disability. III. that the WAD cohort shows more depression, anxiety and stress compared to the NAD cohort.

NCT ID: NCT05468294 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer (NSCLC)

F16IL2 in Combination With Nivolumab in Patients With Non-small Cell Lung Cancer

Nivokin
Start date: March 9, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Prospective, open label, non-randomized, phase I/IIb study of F16IL2 in combination with Nivolumab.

NCT ID: NCT05467423 Completed - Clinical trials for Iron Deficiency (Without Anemia)

Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome

Start date: January 4, 2023
Phase: N/A
Study type: Interventional

Iron deficiency is a common problem that is often treated with the administration of oral iron. Most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria. This influence is usually undesirable and should be kept as small as possible. With lower iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the intestinal bacteria composition is to be expected.

NCT ID: NCT05463406 Recruiting - Clinical trials for Lower Respiratory Tract Infection

Procalcitonin and Lung Ultrasonography Guided Antibiotherapy in Emergency Departments

PLUS-IS-LESS
Start date: December 5, 2022
Phase: N/A
Study type: Interventional

Acute respiratory infections are a common reason of attendance at emergency departments. It is also the main reason of unnecessary antibiotic prescription. Antibiotics save lives, but can also directly harm patients by causing antibiotic-associated adverse events. Antibiotic use is directly related to resistance, which is one of the major threats of our century. In addition, some microorganisms live in and on the human body and promote many aspects of our health. Antibiotic treatment can disturb those microorganisms and therefore have long-lasting negative effects on our health. Unfortunately, it is difficult to differentiate between viral infections, which usually heal spontaneously, and bacterial pneumonia, which needs antibiotics treatment. This is one of the reasons of this over-prescribing of antibiotics. This project aims to reduce widespread use of antibiotics in the emergency department through a new diagnostic strategy of bacterial pneumonia. This strategy includes sequential use of well-known techniques: a clinical score, lung ultrasound and finally a biomarker, procalcitonin. The latter tends to be higher in bacterial infections. The combination of these different tests improves the diagnostic process and allows improved use of targeted antibiotics, with the ultimate goal of better patient management. The study will compare the antibiotic prescription rate and the clinical course of patients managed using this new diagnostic approach with those managed as usual. The project will also evaluate the acceptability and feasibility of this strategy and its cost-effectiveness. These two aspects are essential for a wider implementation of this innovative diagnostic approach and decrease antibiotic resistance.

NCT ID: NCT05461079 Completed - Infertility, Male Clinical Trials

Sperm Phenotype and Differentially Methylated Regions

Epigenetics
Start date: November 1, 2017
Phase:
Study type: Observational

Testicular dysgenesis syndrome (TDS) is known to cause epigenetic abnormalities in spermatozoa. Anogenital distance (AGD) is considered to be a suitable clinical marker of TDS, but the direct link between AGD and epigenetic abnormalities is still missing. Infertile men (n=10) presenting with shortened AGD and a control group of normal semen donors (n=10) with normal AGD will then be asked to provide one semen sample each. Using a flow cytometer and sorter (FACS) their spermatozoa will be sorted into populations of spermatozoa with/without DNA fragmentation or with/without chromatin decondensation. These sorted populations of spermatozoa will then be examined for differences in epigenetic imprinting differences using whole genome expression analysis. Whereas the sorting of spermatozoa will be carried out in Basel, the epigenetic analysis will be carried at the University of Geneva.

NCT ID: NCT05460598 Active, not recruiting - Itch Clinical Trials

The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine

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

This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch. The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.

NCT ID: NCT05460585 Completed - Healthy Clinical Trials

Cerebral Oxygenation Values in Healthy Adults Volunteers Measured With RheoPatch and NIRO-200NX

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

Noninvasive measurement of cerebral tissue oxygen saturation levels by near infrared spectroscopy (NIRS) is clinical routine in perioperative medicine. One of the main technical challenges of NIRS measurements is to eliminate the influence of signals of the skin and skull. A new device (RheoPatch, Luciole Medical AG, Zurich) has been developed by a company that also developed an intracranial NIRS probe, which allowed measurements directly in the brain and thus improved algorithms for elimination of the extracranial signals. The investigators aim to determine baseline values and performance of the new device (RheoPatch) compared with a more established NIRS device (NIRO-200NX, Hamamatsu Phototonics, Hamamatsu City, Japan)

NCT ID: NCT05459948 Recruiting - Knee Replacement Clinical Trials

The Medacta GMK SpheriKA Post-Marketing Surveillance Study

Start date: July 30, 2022
Phase:
Study type: Observational

This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.

NCT ID: NCT05459662 Completed - Healthy Clinical Trials

Impact of Consuming a Plant-based Enriched Meal on the Adult Gut Microbiome

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

The aim of this study is to evaluate the impact of a diversified plant-based meal on the gut microbiome and its composition.