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NCT ID: NCT05180578 Recruiting - Clinical trials for Eosinophilic Esophagitis

Tolerability of Goat Milk Protein in Eosinophilic Esophagitis Patients With Cow Milk Protein Trigger

Start date: November 12, 2020
Phase: N/A
Study type: Interventional

Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction. While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease. The most frequent dietary trigger for EoE is milk, but there is limited data on the cross-reactivity of milk from other species. Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of non-bovine milk in patients with cow's milk triggered EoE. Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Our own, anecdotal experience in two patients with milk triggered EoE who requested to introduce goat's milk into the patients' diet were that reintroduction did not trigger a clinical or histological flare of EoE. These cases of successful introduction of non-bovine milk introduces the possibility that a milk-free diet need not necessarily be exclusive of all species. The aim of this study is to assess tolerability and safety of goat's milk in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.

NCT ID: NCT05180240 Recruiting - Acute Myocarditis Clinical Trials

Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

ARCHER
Start date: June 22, 2022
Phase: Phase 2
Study type: Interventional

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo. CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests. The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

NCT ID: NCT05178862 Suspended - Candidemia Clinical Trials

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

MARIO
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

NCT ID: NCT05176834 Recruiting - Clinical trials for Head and Neck Cancer

Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies

PBM&OM-01
Start date: January 31, 2022
Phase: N/A
Study type: Interventional

Patients with head and neck malignancy that are treated with Radiation Therapy [RT] are expected to develop Oral Mucositis (OM) in 60% of cases. Mucositis is a side effect of radiation and / or chemotherapy that causes severe pain and inability to eat and drink and a decrease in quality of life. In addition it may impair the treatment protocol and treatment outcomes. Photobiomodulation is a non-ionizing optical radiation in the near or near-infrared range used for acceleration of wound healing and pain reduction. Photobiomodulation therapy for the reduction of mucositis is included in the International Guidelines of the MASCC / ISOO Association and the British NICE. To date the treatment has been performed by members of professional medical staff in hospitals or clinics. The study device is home-used photobiomodulation device approved for indications of pain reduction and acceleration of wound healing. The device has shown efficacy in treating mucositis around dental implants in a clinical trial and after oncological treatments in a limited number of cases as reported in the scientific literature.

NCT ID: NCT05176691 Withdrawn - Follicular Lymphoma Clinical Trials

HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL

Start date: February 15, 2022
Phase: Phase 1
Study type: Interventional

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL

NCT ID: NCT05176483 Recruiting - Colorectal Cancer Clinical Trials

Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors

STELLAR-002
Start date: December 14, 2021
Phase: Phase 1
Study type: Interventional

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect of biomarkers of XL092 administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in subjects with advanced solid tumors. In the Expansion Stage, the safety and efficacy of XL092 as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

NCT ID: NCT05175989 Recruiting - COVID-19 Vaccine Clinical Trials

SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following Vaccination Against COVID-19

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

There are few data on the immunogenicity of the Pfizer-Biontec BNT162b2 vaccine for the prevention of COVID-19 disease and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years for a period of six and half months following the first dose of the vaccine.

NCT ID: NCT05175105 Recruiting - Clinical trials for Pediatric Pyruvate Kinase Deficiency

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

ACTIVATE-Kids
Start date: June 6, 2022
Phase: Phase 3
Study type: Interventional

Study ACTIVATE-Kids (AG348-C-023) will evaluate the efficacy and safety of orally administered mitapivat as compared with placebo in pediatric participants with pyruvate kinase deficiency (PKD) who are not regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to < 6 years, 6 to < 12 years, 12 to < 18 years). Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 12-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat for up to 5 years in the open-label extension (OLE) period.

NCT ID: NCT05174676 Recruiting - Paresis Clinical Trials

Robotic Enhanced Error Training of Upper Limb Function in Post-stroke Patients

Start date: December 20, 2021
Phase: N/A
Study type: Interventional

Background: Stroke is a common cause of morbidity, including paresis, and stroke survivors often have reduced function in their paretic arm. Many do not regain full recovery of their arm function, which negatively impacts their quality of life. Recent studies have indicated that robotic training may improve upper limb function abilities among stroke survivors, by enabling repetitive, adaptive, and intensive training and more accurate control of task complexity. Robotic training in addition to standard rehabilitative care has shown promise for improving functional skills among stroke survivors. One type of robotic training is error enhancement, whereby an error made by the patient is exaggerated, increasing the signal to noise ratio which causes errors to be more noticeable. This, in turn, enhances movement correction. Previous studies have found that error enhancement has promise as a clinical treatment for patients with motor deficits. Objectives: This study aims to evaluate the effect of a robotic device (DeXtreme) on the functional capabilities of the paretic arm of stroke survivors. This device aims to improve arm function by utilizing error enhancement techniques. Methods: A double-blind randomized placebo-controlled study comparing treatment outcomes between two groups to assess the effect of error enhancement robotic training on functional use of the arm and hand in patients after stroke. Forty stroke patients will undergo 6 sessions of 25 minutes each with the Dextreme device. One group will receive training with error enhancement forces applied, while the control group will receive similar training without error enhancement. Outcomes (motor function, speed, tone, and spasticity) will be assessed twice prior to and following the treatment sessions,

NCT ID: NCT05173987 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

Start date: February 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).