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NCT02736409
This is a multicenter, double- blind extension study of Oral Budesonide Suspension (OBS) in adults and adolescents (11 to 55 years of age, inclusive) with Eosinophilic Esophagitis (EoE) who have completed participation in the SHP621-301 induction study (NCT02605837). The primary objective is to evaluate the maintenance of efficacy of OBS over 36 weeks. Maintenance of efficacy will be measured by the peak eosinophilic count and Dysphagia Symptom Questionnaire (DSQ) score.
NCT05579730
To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual components and vehicle in a population of subjects with allergic conjunctivitis:
NCT06087406
The purpose of this study is to determine the safety and tolerability of imvotamab in patients with moderate to severe rheumatoid arthritis who have failed prior therapies. Participants will be given imvotamab or placebo through a vein (i.e., intravenously). A placebo is a look-alike substance that contains no active drug
NCT06719544
Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder. Researchers want to learn about lithium when taken at the same time with enlicitide. They want to: * Measure a person's blood to find out if the amount of lithium in the blood is the same when lithium is taken alone or with enlicitide * Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it
NCT02043678
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
NCT03277989
Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 150 with 9 sites
NCT06640933
In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release BIIB091 slowly and consistently, helping to keep steady drug levels in the body for longer. The other new form is a "gastro-retentive" tablet, also known as "GR." This form has a special coating that swells and allows BIIB091 to stay in the stomach longer. For both GR and ER tablets, there are also "slow" and "fast" forms that change how quickly BIIB091 is released into the body. But, eating food with these tablets may affect how much BIIB091 is in the body. The main objective of this study is to learn how 2 new forms of BIIB091, which are released into the body at different rates, are processed in the body. Researchers also want to learn how these new forms compare to the "immediate release" tablet, also known as "IR". This form delivers BIIB091 immediately into the body. The main question researchers want to answer in this study is: * How does the body process different tablet forms of BIIB091 with or without food? Researchers will also learn more about: * How the body processes the 2 new tablet forms of BIIB091 with food compared to the IR tablet form with food * How the body processes the ER tablet form of BIIB091 with food compared to without food * Any medical problems the participants have during the study * Any changes in the participants' overall health during the study This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 22 days, after which eligible participants will check into their study research center. * Participants will be randomly assigned to 1 of 6 groups. In each group, the participants will take the below tablet forms, but in different orders: * Immediate-Release (IR) * Gastro-Retentive slow (GR-slow) * Gastro-Retentive fast (GR-fast) * Extended-Release slow (ER-slow) * Extended-Release fast (ER-fast) * ER-slow, without food * Each period includes the participant taking a single dose of what they were assigned to on the first day. There will be 3 days of no dosing in each period. The participant will then move to the next tablet form assigned. This will continue until each participant has taken a single dose of each of the 6 tablet forms. * Participants will remain at their study research center for 25 days for the treatment periods. Afterwards, there will be follow-up visit 11 to 14 days after each participant's last dose. Each participant will be in the study for up to 57 days.
NCT04714320
The purpose of this study was to evaluate the effect of IONIS-AGT-LRx compared to placebo on seated automated office systolic blood pressure (SBP) from baseline to Study Day 85 in uncontrolled hypertensive participants on ≥ 3 antihypertensive medications and to evaluate the effect of IONIS-AGT-LRx on ambulatory blood pressure, seated automated office SBP, seated automated office diastolic blood pressure (DBP), and plasma angiotensinogen (AGT) at each scheduled visit in uncontrolled hypertensive participants on ≥ 3 antihypertensive medications.
NCT05909995
The purpose of this study is to characterize the safety, tolerability, PK, and efficacy of INCB 99280 in combination with ipilimumab in participants with select solid tumors.
NCT04249947
An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC and SGC.
NCT05862324
TAC01-CLDN18.2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes Claudin 18.2. TAC directs T-cells to the targeted antigen (CLDN 18.2), and once engaged with the target, activates them via the endogenous T cell receptor. This is an open-label, multicenter Phase ½ study that aims to establish safety, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-CLDN18.2.
NCT03400150
The BioProtect Balloon Implant™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the balloon to reduce the radiation dose delivered to the anterior rectum. The balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
NCT04718675
Part 1: Dose Escalation. The primary objective of Part 1 of this study is to evaluate the safety and tolerability of KB-0742 in participants with relapsed or refractory (R/R) solid tumors or non-Hodgkin lymphoma (NHL). Part 2: Cohort Expansion. The primary objective of Part 2 of this study is to further evaluate the safety and tolerability of KB-0742 in defined participant cohorts including Platinum Resistant High Grade Serous Ovarian Cancer (HGSOC).
NCT02868268
This proposal sets forth the platform for a Precision Medicine clinical trial through the New Approaches to Neuroblastoma Therapy (NANT) consortium. The plan is to utilize NANT's established multi-institutional infrastructure and Translational Genomics Research Institute GEM sequencing platform for acquisition and gene panel sequencing of relapsed biological specimens in relapsed/refractory neuroblastoma (rNB) including those obtained from the bone, bone marrow or soft tissue. Our primary aim is to identify subgroups of rNB patients who have potentially targetable genetic (ALK, MAPK pathway, Metabolic-related genes) and/or immunologic (tumor-associated macrophage infiltration and/or programmed death ligand \[PD-L1\] expression) biomarkers in rNB. Additional potential novel biomarkers will also be evaluated and reported in this cohort of patients.
NCT03452111
The long term objective is to develop a gel to be used as a male contraceptive.
NCT05714059
The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting.
NCT04728295
Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).
NCT04973657
Subjects will be administered multiple doses of VK0214 in a cohort dose escalation process. A total of up to 36 subjects will be enrolled in the study, into one of three dose cohorts. For each cohort, up to 12 subjects will be randomized to receive VK0214 or placebo in a 3:1 ratio so that there will be a total of up to 9 subjects for each of the active doses and up to 3 subjects dosed with placebo in each cohort.
NCT03426059
The protocol aims to comprehensively define the phenotype of Phelan-McDermid Syndrome and to identify potential genetic factors, which may play a role in the variability of the disease's outcomes. The first aim involves a physical exam, a neurological exam, collection of medical history information, a clinical genetic evaluation, blood work and neuropsychological assessments. If clinically indicated, the protocol collects information from medical tests. These medical tests may include electrocardiography, echocardiography, renal ultrasonography, and renal ultrasound.
NCT02731612
This is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study to assess the cognitive effects of lurasidone in bipolar I and II patients (manic depression) who are in remission from an episode. Participants who show cognitive impairment at the screening visit will be enrolled into the study and randomized at the baseline visit to receive either lurasidone or placebo adjunctive therapy in a 1:1 ratio for 6 weeks.