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NCT04761822
Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: * To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and * If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders
NCT05413421
The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.
NCT02475213
The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.
NCT04325386
In a randomized controlled design with approximately 26 biweekly sessions over 12 months, the investigators propose to test the effectiveness of an ECHO-based intervention for improving the use of clozapine in people eligible for clozapine. The sessions will include: 1) active dissemination of knowledge and information by an expert "hub" followed by 2) clozapine case presentations and vignettes submitted by the "spokes". This intervention, Clozapine CHAMPION-ECHO (Center for Help and Assistance for Maryland Prescribers- Improving Outcomes Network using Extension for Community Healthcare Outcomes, will be referred to as "CHAMPION" throughout.. To minimize ANC monitoring barriers and maximize recruitment, the investigators will provide Food and Drug Administration (FDA)-cleared ANC point of care (POC) monitoring devices to all study sites, including those in the control condition. The investigators will enroll at least 300 prescribers and additional clinical team members (up to 300) from up to 60 mental health clinics (MHCs) and other treatment sites; approximately half the participants will be randomized to CHAMPION and half randomized to enhanced treatment as usual (ETAU).
NCT04136002
The ECLIPSE (Evaluation of the ctDNA LUNAR test in an Average Patient Screening Episode) study is a prospective, observational multi-site study without randomization. The primary objective of the study is to evaluate the performance characteristics of a blood-based ctDNA LUNAR-2 test to detect colorectal cancer in a screen-relevant, average risk population.
NCT05514548
The study is designed to assess the efficacy, safety, tolerability, and transformation within the human body of INV-202 investigational drug in the treatment of adult participants with a diagnosis of Diabetic Kidney Disease due to either Type 1 diabetes mellitus or Type 2 diabetes mellitus.
NCT06571045
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME) In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.
NCT05856331
Phase 2 study to compare SAR447537 (INBRX-101) to plasma derived A1PI therapy in adults with AATD emphysema
NCT05757856
An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE).
NCT04129125
The trial is designed to assess the safety and efficacy of using the Zoom Reperfusion System in subjects diagnosed with acute ischemic stroke and undergoing a thrombectomy procedure within 8 hours of last known well.
NCT03817970
This study is being done to determine 1) whether drugs to treat cisplatin-related nausea can influence harm to the kidneys, 2) whether cisplatin levels in the body can influence the risk of harm to the kidneys, and 3) whether a person's genetic make-up can increase or decrease the likelihood of kidney injury due to cisplatin therapy.
NCT03036254
An urgent need exists to identify effective interventions to arrest or reverse dementia and cognitive loss at its earliest stages. The proposed pilot randomized clinical trial will investigate the short and long-term effects of hyperbaric oxygen therapy on cognitive functioning, cerebral blood flow, and glucose uptake in diabetic elderly with mild cognitive impairment. and provide the basis for a large-scale multi-center study of hyperbaric oxygen therapy effects on cognition in diabetes. The potential to preserve, or even enhance, cognition in elderly at high risk of cognitive decline and dementia has major implications for the affected individuals and their support systems that bear the social and financial burdens of long-term caregiving.
NCT06655207
Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml (abnormal postpartum uterine bleeding) or cumulative blood loss of ≥1000ml (postpartum haemorrhage) at least 1 hour in advance of birth. This study is being undertaken to assess the performance of Oli measuring cumulative blood loss ≥500ml and ≥1000ml, as well as evaluate its safety profile.
NCT03507790
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group 36 week multicenter Phase 2 study of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease (AD).
NCT05948605
Multi-site, double-blinded, prospective, randomized, sham-controlled study
NCT06487962
Low-income adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to mitigate these inequities. To increase CGM uptake in low-income, adults with T1D receiving diabetes management in federally qualified health centers (FQHCs), this pilot randomized control trial (RCT), will assess the feasibility of our study protocol, including our multi-level intervention informed by the Socio-Ecological Model.
NCT04016389
This study will include patients with invasive cervical cancer that wish to keep their fertility as much as possible in the future after treatment. Patients who receive surgery alone may experience long-term side effects including infertility. The purpose of this research study is to determine whether giving neo-adjuvant chemotherapy prior to surgery can maintain fertility in patients with invasive cervical cancer. The neo-adjuvant chemotherapy will consist of a platinum-based chemotherapy drug cisplatin or carboplatin, with a chemotherapy drug called paclitaxel. These are common chemotherapy drugs used in the treatment of women with cervical cancers.
NCT02900651
The purpose of this Phase I/II study is to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and to evaluate the safety, antitumor activity and pharmacokinetic (PK) profile of MAK683 in patients with advanced malignancies such as Diffuse Large B cell Lymphoma (DLBCL), nasopharyngeal carcinoma (NPC) or other advanced solid tumors for whom no further effective standard treatment is available.
NCT03282097
The Decisions about Cancer screening in Alzheimer's Disease (DECAD) study tests if an evidence-based decision aid for dementia caregivers can support decision-making about mammography and improve the quality of medical decision-making about breast cancer screening. This large randomized controlled trial will recruit up to 450 dyads (900 individual participants) of older women with dementia and a family caregiver, for a goal of 426 dyad baselines (852 individual participants).
NCT03314935
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.