299 Clinical Trials for Various Conditions
The primary purpose of this study is to evaluate if eating a high fat meal versus not eating any food affects how the study drug (Nikkomycin Z) is absorbed into the body. The second purpose is to gain further information about the safety of Nikkomycin Z in healthy adults.
The purpose of this study is to compare the rate and extent of absorption of Dr. Reddy's Desloratadine 5 mg tablet to that of Clarinex® 5 mg tablet in healthy subjects under fed conditions.
The objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules when dosed with alcohol under fasting and fed conditions compared to water.
ARN-75039-103 is a comparative, randomized, single-dose, crossover study to assess the PK, safety, and tolerability of neat ARN-75039 in hydroxypropyl methylcellulose (HPMC) capsules against ARN 75039 with excipients in tablet form administered by the oral route in healthy adult participants. The safety assessments will include standard evaluations of vital signs, clinical laboratory values, and ECGs. Participants will be admitted to the study site on the morning of Day -1, prior to Period 1 study drug administration, and will remain on site until Day 15. Upon confirmation of eligibility, participants will be randomized into the study on Day 1. Study drug administration will be performed on the first day of Periods 1 and 2 (Study Days 1 and 8, respectively) with a 7-day washout period between the two periods. Participants will receive the randomized study drug in the morning following a meal. A total of 16 participants will be randomized 1:1 to the following two sequences: * Sequence 1: * Period 1: Neat ARN-75039 in HPMC capsules (reference product) * Period 2: ARN-75039 with excipients in tablet form (comparator) * Sequence 2: * Period 1: ARN-75039 with excipients in tablet form (comparator) * Period 2: Neat ARN-75039 in HPMC capsules (reference product) Participation in the study will be conducted in the following 5 defined periods: * Screening Period: The Screening Period begins upon completion of the informed consent form (ICF). During this period, participants will undergo baseline assessments to determine eligibility for study participation. The Screening Period duration will be up to 21 days; it will end after all evaluations required to meet eligibility have been completed. If a participant meets all eligibility criteria, they will be offered enrollment into the study. * Admission to Study Site: Participants will be admitted to the study site in the morning on the day prior to dosing of period 1 (Day -1). Participants that are eligible to participate in the study and are randomized into the study will remain at the study site until completion of the treatment period (Study Day 15). * Treatment Period: This study consists of two treatment days separated by a 7-day washout period. The first treatment day will begin on Day 1 of Period 1 with administration of the first dose of study drug. The second treatment day will occur on the first day of Period 2 (Study Day 8). Following the dosing of the study drug on each treatment day, fifteen venous blood samples will be withdrawn via an indwelling cannula or by venipuncture at regular time intervals. * End of Active Treatment (Day 15 Discharge Visit or Early Termination (ET) Visit): Upon successful completion of active treatment, participants will be discharged from the study site on Study Day 15. The Discharge Visit will include the completion of safety assessments, such as a physical examination, vitals, ECG recording, adverse event review, and clinical laboratory tests. Participants who complete both dosing days will be encouraged to complete all study visits. Participants who do not complete all study visits or terminate from the study prior to Day 15 will be asked to complete the Early Termination Visit within 1 day after withdrawal from the study. • Day 36 Telephone Follow Up Phone Call: Participants will be contacted by phone on Day 36-i.e., 28 days following the last study dose administered on Day 8. The purpose of this follow-up call is to assess for any adverse events.
The objective of this phase 1 study is to evaluate the food effect of 100 mg Hezkue Turbo® (ASP-001.1, sildenafil) under fed versus 100 mg of Hezkue Turbo® (ASP-001.1, sildenafil) under fasted conditions in healthy adult male subjects
This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, a painful inflammation of the pancreas. EPI occurs when the pancreas does not produce enough enzymes to help the body properly digest food. While pancreatic enzyme replacement therapy (PERT) is commonly used to manage EPI symptoms, it can be challenging for people who rely on feeding tubes. RELiZORB, could help these patients by simplifying the delivery of the enzymes they need. However, RELiZORB has only been studied in people with EPI caused by cystic fibrosis, so its effectiveness in pancreatitis patients remains unknown. This study aims to determine whether RELiZORB is effective for individuals requiring feeding tube support after pancreatitis.
The goal of this clinical trial is to learn if implementation of an eye screening program at Federally Qualified Health Center (FQHC) clinics provides results that participants may have glaucoma, and/or other eye conditions (diabetic retinopathy, cataract, visual acuity impairment). The glaucoma screening will incorporate use of an artificial intelligence (AI)-assisted screening tool. This project is called AI-RONA. The main questions it aims to answer are: * How does this eye screening program compare to the rate of glaucoma and other eye conditions detected at other FQHC clinics where the screening program has not been implemented? * Do particpants who screen positive for these conditions adhere to the physician's recommendation for a follow-up examination by an optometrist or ophthalmologist? * Are referral rates for a follow-up comprehensive eye exam by an optometrist or ophthalmologist similar to those implemented by an ophthalmologist using telemedicine (that is, using the results of the screening to make a diagnosis remotely)? * What is the cost-effectiveness of the AI-assisted screening program in diagnosing glaucoma as compared to a physician-guided program? * Are participants completing the screening satisfied with it? * Are physicians at the FQHC clinics administering the screening satisfied with it? Participants will: * Undergo an ocular screening whose goal is to detect glaucoma, diabetic retinopathy, cataract, and/or impairment in visual acuity. If the screening indicates that participants may have these conditions, participants will be referred for a comprehensive eye examination by an optometrist or ophthalmologist. * Following the screening, participants and physicians will complete a survey on their satisfaction with the program.
The purpose of this study is to determine the provider- and practice-level characteristics that influence the impact of implementation strategies guided by practice facilitation in each clinical practice, to test whether the facilitator-driven provider- and practice-level implementation strategies increase provider recommendations and Human Papilloma Virus (HPV) vaccination rates and to evaluate implementation and future sustainability of the facilitator-driven implementation strategies across nine clinical practice sites
This clinical trial evaluates a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect for improving follow-up colonoscopy rates in patients at a Federally Qualified Health Center (FQHC) who have an abnormal fecal immunochemical test (FIT) result. Colorectal cancer screening reduces colorectal cancer incidence and mortality but is underutilized.The most accessible, feasible, and common colorectal cancer screening modality for average-risk individuals in low resource settings such as FQHCs is the stool-based FIT. However, the benefit of FIT screening on colorectal cancer risk is realized only if individuals with abnormal FIT results undergo timely follow-up colonoscopy. Follow-up colonoscopy rates are low and there are many barriers to follow-up colonoscopy in safety net settings such as FQHCs. Effective interventions that are multi-component and improve care coordination are needed to improve abnormal FIT follow-up rates in FQHCs. The Primary Care-GI Connect intervention includes components that enhance care coordination, standardize the referral process, and engage both primary care and specialist physicians. This clinic-wide intervention may improve rates of follow-up colonoscopy after abnormal FIT results in patients seen at FQHCs.
HCM FLIP study is a two-phase protocol focusing on the detection of Hypertrophic Cardiomyopathy using Electrocardiograms and Echocardiograms through Federated Learning.
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
The purpose of this study is to evaluate safety and pharmacokinetics (PK) effect of belumosudil on the uridine diphosphate glucuronosyltransferase (UGT)1A1 (Part 1), P glycoprotein (P-gp) (Part 2) and breast cancer resistance protein (BCRP)/organic anion transporting polypeptide (OATP)1B1 (Part 3) inhibition in the fed state in healthy male subjects.
The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.
The purpose of this study is to test the feasibility of implementing acupuncture intervention in federally qualified health centers oncology clinics for breast cancer survivors.
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
The purpose of this research is to study the safety and tolerability and to establish the maximum tolerated dose (MTD) of the combination of two drugs, fedratinib and decitabine, for the treatment of advanced-phase MPNs.
This trial is being completed to develop a stepped-care talk therapy model for patients with PTSD. Specifically, this study is testing whether beginning with one type of therapy is better than beginning with another type of therapy, and whether moving to a different therapy after four sessions is more helpful than staying with the same therapy, depending on how well it is working. The central hypothesis is that beginning with a low- or medium-intensity PTSD intervention and then titrating intensity based on early indications of response will result in clinically significant PTSD symptom reduction with parsimony of resources.
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of encapsulated caffeine when consumed in the fasted and fed states.
The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.
The purpose of the study is to evaluate the effectiveness, safety, and tolerability of a study drug called fedratinib in participants with myelodysplastic/myeloproliferative neoplasms (MDS/MPNs) and chronic neutrophilic leukemia (CNL).
The primary objective of the present research is to determine the effectiveness of Family Health Center of San Diego's Long COVID and Fatiguing Illness Recovery Program (LC\&FIRP) on clinician- and patient-level outcomes. LC\&FIRP is comprised of a teleECHO program focused on multi-specialty case-consultation and peer-to-peer sharing of emerging best practices to support management of complex cases associated with Long COVID, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and other post-infectious fatiguing illnesses (PIFI). Our secondary objective is to determine the feasibility, acceptability, and sustainability of LC\&FIRP. Our findings should provide a fuller understanding of the potential impact of innovative technology enabled multi-disciplinary team-based care models in low-resource, community-based primary care settings.
The purpose of the study is to evaluate the effectiveness and safety of fedratinib as maintenance therapy in participants with myeloproliferative neoplasms (MPNs) after allogeneic hematopoietic cell transplant (HCT).
A 2-part, crossover design, open-label treatment trial with 4 periods, 4 sequences (Part A) to evaluate MR formulations of CVL-231 and a 2 periods, 2 sequences (Part B) to understand effect of food on CVL-231 exposures from an MR formulation.
The purpose of this study is to evaluate the relative bioavailability of fedratinib in healthy adult participants.
This observational study will examine the relationship between aircraft noise exposure in the bedroom and objectively assessed sleep disturbance. Surveys will be mailed to randomly selected households around selected airports to recruit individuals for a 5 night in-home sleep study. Eligible survey respondents interested in participating in the sleep study will record nighttime indoor sounds using a portable audio recorder and wear a small device that collects heart rate and movement data for 5 consecutive nights. They will also complete brief morning questionnaires about their previous night's sleep and their sleep quality and a participant characteristics questionnaire. Collected data will be used to create an exposure-response model between aircraft noise exposure and sleep disturbance.
The purpose of this research is to gather information on the safety and effectiveness of fedratinib (a drug called a "jak inhibitor" ) in combination with ivosidenib or enasidenib (two anti-cancer drugs). While all three drugs are FDA-approved for various conditions, the US Food and Drug Administration (FDA) has not approved the combination of these drugs for the treatment of rare blood cancers that present Isocitrate dehydrogenase (IDH) mutations, and therefore these drugs can only be given in a research study.
To assess the effects of partially hydrolyzed whey protein-based infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants.
The purpose of this study is to assess the safety, tolerability, and efficacy of BMS-986158 alone and in combination with either Ruxolitinib or Fedratinib in participants with Dynamic International Prognostic Scoring System (DIPSS)-intermediate or high risk blood cancer. Part 1 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and Part 2 consists of BMS-986158 in combination with either Ruxolitinib or Fedratinib and BMS-986158 alone.
This study is designed to test the effect of fluconazole (a dual CYP2C19 and CYP3A4 inhibitor) on the Pharmacokinetics (PK) of fedratinib. Knowledge of these effects can be used to determine if dose adjustments should be considered when fedratinib is coadministered with drugs that are dual CYP2C19 and CYP3A4 inhibitors. Subjects will be screened for eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will return to the clinical site on Day -1 for protocol-specified assessments, and will be domiciled at the clinical site from Day -1 to Day 27.