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NCT ID: NCT05013216 Recruiting - Pancreatic Cancer Clinical Trials

Mutant KRAS -Targeted Long Peptide Vaccine for Patients at High Risk of Developing Pancreatic Cancer

Start date: April 11, 2022
Phase: Phase 1
Study type: Interventional

This Phase 1 study will evaluate safety and the immune response to pooled mutant-KRAS peptide vaccine with poly-ICLC adjuvant.

NCT ID: NCT05022485 Recruiting - Tibial Fractures Clinical Trials

Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Start date: April 11, 2022
Phase:
Study type: Observational

Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.

NCT ID: NCT05071898 Recruiting - Obesity Clinical Trials

Pharmacogenetics of Response to GLP1R Agonists

PORT
Start date: April 11, 2022
Phase: Phase 1
Study type: Interventional

Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims: 1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug). 2. Specific Aim #2. To identify genetic variants associated with the effect of a GLP1R agonist to accelerate the rate of glucose disappearance as assessed in the two FSIGTs (before and after administration of drug). Genotyping will be conducted using a high-density array with comprehensive coverage of DNA sequence variants. In addition, the analysis will leverage a global imputation panel generated from 1,025 Amish individuals.

NCT ID: NCT05091866 Recruiting - Clinical trials for Recurrent Glioblastoma

Natural Progesterone for the Treatment of Recurrent Glioblastoma

Start date: April 11, 2022
Phase: Early Phase 1
Study type: Interventional

This early phase I trial identifies the best dose, possible benefits and/or side effects of natural progesterone in treating patients with glioblastoma that has come back (recurrent). Progesterone is a type of hormone made by the body that plays a role in the menstrual cycle and pregnancy. Progesterone may help control tumor growth and spread in patients with glioblastoma.

NCT ID: NCT05101174 Recruiting - Aging Clinical Trials

Exercise and Neurocognition in Adults Relative to ApoE Genotype

Start date: April 11, 2022
Phase: N/A
Study type: Interventional

The current project is a single-blinded, double-arm, 6-month randomized controlled trial aiming to assess the effects of a integrated intervention program on neurocognitive function with respect to event-related potential in adults aged 45-70 years. Additionally, the potential impacts of apolipoprotein epsilon-4 alleles and the brain-derived neurotrophic factor will be explored.

NCT ID: NCT05118295 Recruiting - Breast Lesions Clinical Trials

Single Step Lesion Annotation and Localization of Suspicious Breast Lesions

Start date: April 11, 2022
Phase: Early Phase 1
Study type: Interventional

The SAVI Reflector is a nonradioactive infrared (IR)-activated electromagnetic wave device that can be implanted in the breast or lymph nodes under image-directed guidance, typically by mammography or sonography. Intraoperatively, the SCOUT hand-held device is then percutaneously applied to the breast or lymph node, creating an audible signal on the device console with a gradient which correlates to distance (in mm) from the target lesion and marker. The Savi Scout surgical guidance system was approved by the U.S. Food and Drug Administration in 2014. Furthermore, it was approved for long term use, with no restrictions on the length of time in 2017. The system consists of an implantable reflector with a 4-mm body size, preloaded in a 16-gauge deliverable needle, a hand-held probe and a console. The reflector consists of an IR light receptor, resistor switch and two antennae. This is placed into or near the target through a 16G needle under mammographic or sonographic guidance. The hand-held probe detects pulses of infrared (IR) light and radar wave signals, received by the console system, which then emits and receives signals back to the reflector to provide real time localization and target proximity information to the surgeon. The SCOUT console provides audible and visual feedback intraoperatively, the frequency of which increases as the handheld reader approaches the implanted reflector. After excision of the breast lesion, the handheld reader can be used to immediately confirm removal of the reflector, present in the lumpectomy specimen, and subsequent quiescence of radar signal in the breast.

NCT ID: NCT05135377 Recruiting - Anaphylaxis Clinical Trials

Canadian Anaphylaxis Network- Predicting Recurrence After Emergency Presentation for Allergic REaction

CAN-PREPARE
Start date: April 11, 2022
Phase:
Study type: Observational

BACKGROUND: Anaphylaxis is the most severe form of allergy that rapidly affects multiple body systems and can be deadly. The highest incidence of anaphylaxis is in children and adolescents. In Canada, approximately every 10 minutes there is an Emergency Department (ED) visit for food allergy, and up to 80% of anaphylactic reactions in children are triggered by food. The ambiguity in how physicians manage anaphylaxis adds a huge burden to health care and further contributes to ED crowding. Current Canadian and international treatment guidelines universally recommend that all patients present to the ED for a prolonged period (6-24 hours) of in-hospital monitoring after initial reactions have been treated, to increase detection of biphasic anaphylaxis (BA). BA is a second wave of symptoms after initial resolution. These guidelines are based on poor or little evidence and have unintended negative impacts on patient safety and quality of life. Furthermore, this 'one-size fits all' approach to care leads to wasteful resource utilization that provides low value care. OBJECTIVE: The main objective of the study is to derive a clinical prediction rule that identifies children with anaphylaxis who are at risk of BA. METHODS: This prospective multicenter cohort study will enroll 1682 patients from 7 pediatric EDs that are members of the Pediatric Emergency Research Canada (PERC) network. We will enroll patients < 18 years of age presenting to the ED with an allergic reaction that matches the diagnostic criteria of anaphylaxis. Research assistants (RA) present in the ED will screen, obtain consent, and prospectively collect all study data. The Research Assistant or Research Nurse will follow patients during their ED visit and ascertain, in conjunction with the medical team, if the patient developed biphasic anaphylaxis in the ED. A standardized follow-up survey conducted within 2-5 days of ED or hospital discharge will determine if a biphasic reaction occurred following ED disposition. We established an advisory council comprised of end-users and community partners external to the project team to monitor project milestones. STUDY TEAM: We have established an international multidisciplinary team of experts in pediatrics, emergency medicine, allergy/immunology, research methodology and statistics, and knowledge translation. Our team is supported by the PERC network. EXPECTED OUTCOME: Providing the best evidence-based, value care at the lowest cost is a moral and ethical imperative. Therefore, in alignment with national and international research priorities, we propose to develop a robust prediction model for BA. This model will address a significant gap in current knowledge and practice, with anticipated benefit for patient care and health system efficiency worldwide. This trial will generate novel, clinically relevant data on optimal ED management of children with anaphylaxis that integrates best value care with patient safety.

NCT ID: NCT05183464 Recruiting - Hypersomnia Clinical Trials

Analysis of New Salivary Biomarkers to Evaluate Excessive Diurnal Sleepiness in Children With Hypersomnia

BIOSOM
Start date: April 11, 2022
Phase:
Study type: Observational

Excessive diurnal sleepiness is characterized by an incapacity to stay awake, in favour of sleep occurrence. This sleepiness might be secondary to a sleep disorder; when it is not the case, it is primary hypersomnia (including narcolepsy and idiopathic hypersomnia). To date, objective measures of sleepiness can only be achieved in laboratory. Subjective techniques as scales and questionnaires are highly sensitive to inter-individual differences and cannot constitute a reliable diagnosis tool of sleepiness. Recent studies suggested that some salivary biomarkers are sensitive to sleep characteristics and thus, may allow the objective and easy evaluation of sleepiness. The objective of the study is to explore the usability of salivary biomarkers (a-amylase and oxalate) as a new non-invasive technique to evaluate sleepiness and to diagnose primary hypersomnia in children. The hypothesis of this study is that there will be a modification of salivary biomarkers concentrations with the variations of diurnal sleepiness.

NCT ID: NCT05204251 Recruiting - Clinical trials for Chronic Liver Disease

Evaluation of the Quality of Life in Patients Referred for Transjugular Intrahepatic Portosystemic Shunt

TIPS
Start date: April 11, 2022
Phase:
Study type: Observational

Patient with Advanced Chronic Liver Disease often present portal hypertension which may lead to bleading or ascites. One of the treatment of portal hypertension in these patients is the placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS). The indications for placing TIPS take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites. TIPS placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life. Very few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales. The main objective of this study is to evaluate the quality of life of patients who have undergone TIPS using a validated and standardised quality of life questionnaire (the SF-36 questionnaire).

NCT ID: NCT05228535 Recruiting - Preterm Birth Clinical Trials

Human Milk in Preterm Infants

Start date: April 11, 2022
Phase: N/A
Study type: Interventional

Current NICU protocol introduces human milk fortifier at 8 days of feeding. This study will introduce human milk fortifier at day 1. The primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.