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Natural History and Development of Spondyloarthritis
https://clinicaltrials.gov/ct2/show/NCT01422694

Sep 28th, 2022 - The purpose of this protocol is to study the natural history of spondyloarthritis (SpA) in children and adults. Spondyloarthritis encompasses a spectrum of immune-mediated inflammatory diseases that exhibit overlapping features, but differ from other types of inflammatory arthritis in genetic predisposition, pathogenesis, and outcome. Ankylosing spondylitis (AS), the most common form of SpA, fr...

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
https://clinicaltrials.gov/ct2/show/NCT03412565

Sep 9th, 2022 - The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected...

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents
https://clinicaltrials.gov/ct2/show/NCT03497676

Sep 30th, 2022 - This study will confirm the dose and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral cabotegravir (CAB), long-acting injectable cabotegravir (CAB LA), and long-acting injectable rilpivirine (RPV LA) in virologically suppressed HIV-1 infected children and adolescents aged 12 to less than 18 years. The study will include two cohorts of participants and two step...

Edinburgh and Lothian Virus Intervention Study in Kids
https://clinicaltrials.gov/ct2/show/NCT03463694

Sep 30th, 2022 - The study will run over ~30 months. Children are recruited prior to, or within 48 hours of developing URTI symptoms by advertising in areas such as local schools, nurseries, health centres and workplaces as well as social media. For the purposes of this study an URTI is defined as: at least two respiratory symptoms (nasal stuffiness, runny nose, cough, sore throat, or sneezing) OR one respirato...

Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer
https://clinicaltrials.gov/ct2/show/NCT03463460

Sep 30th, 2022 - PRIMARY OBJECTIVES: I. To evaluate the efficacy of pembrolizumab and sunitinib malate (sunitinib) for the treatment of patients with thymic carcinoma that have progressed on prior platinum based chemotherapy as measured by objective response rate. SECONDARY OBJECTIVES: I. To evaluate the safety profile and toxicity of combination pembrolizumab and sunitinib malate as per Common Terminology Crit...

Feeding Trial to Determine How Combinations of Different Dietary Bioactive Ingredients Influence High Density Lipoprotein (HDL) Metabolism
https://clinicaltrials.gov/ct2/show/NCT01803594

Sep 30th, 2022 - This study a partial randomized crossover study designed to determine how consumption of bioactive dietary ingredients in various combinations on three separate test days influences postprandial lipoprotein metabolism in participants with low circulating HDL-cholesterol. The dietary ingredients include: Dairy phospholipids(PC700); krill oil (K); lutein (L); and Niacin Eligible participants will...

Elucidation of Breast Milk Composition and Structure Over the First Year of Lactation: UC Davis Lactation Study
https://clinicaltrials.gov/ct2/show/NCT01817127

Sep 30th, 2022 - This study's objectives include: 1) develop a better understanding of the composition and structures of breast milk over the early stages of lactation with specific emphasis on the glycans and lipids; 2) how glycan diversity relates to maternal and infant gut microbiota with an emphasis on bifidobacteria species; 3)how milk composition and structure relate to maternal health and diet. These sam...

Determine How Consumption of Dairy Fat Fractions Rich in Phospholipids and Proteins Influence Inflammation in the Fed State-Phase 1
https://clinicaltrials.gov/ct2/show/NCT01811329

Sep 30th, 2022 - Phase 1 is a randomized crossover study designed to determine how inclusion of dairy fractions rich in milk fat globule membrane (MFGM) to shakes rich in dairy or palm fat influence postprandial inflammation. Participants who have 2 or more risk factors of metabolic syndrome or BMI ≥ 30 will consume four shakes on separate days. The four shakes are: high dairy fat, high dairy fat + MFGM, high p...

Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)
https://clinicaltrials.gov/ct2/show/NCT02631044

Sep 30th, 2022 - This is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics (PK), and antitumor activity of JCAR017 in adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma Grade 3B, and mantle cell lymphoma (MCL). This study will evaluate and refine the dose and schedule of JCAR017 to op...

A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma (POD1UM-201)
https://clinicaltrials.gov/ct2/show/NCT03599713

Sep 30th, 2022 - The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced/metastatic Merkel cell carcinoma (MCC).

Medication Adherence in Children, Adolescents and Adults With Neurofibromatosis Type 1 (NF1) on Clinical Treatment Trials
https://clinicaltrials.gov/ct2/show/NCT03531814

Sep 30th, 2022 - Background: Neurofibromatosis type 1 (NF1) is a genetic disorder that affects approximately 1 in 3,500 individuals and is associated with a broad variety of symptoms and physical findings. Plexiform neurofibromas (PN) are histologically benign tumors which occur in 25-50% of patients with NF1 and can lead to significant morbidity. Oral therapeutic options for the treatment of plexiform neurofib...

Mechanism and Effects of Manipulating Chloride Homeostasis in Stable Heart Failure
https://clinicaltrials.gov/ct2/show/NCT03440970

Sep 30th, 2022 - The overarching goal of this study is to develop a comprehensive understanding of the biology and therapeutic potential of sodium-free chloride supplementation. While sodium homeostasis has been the focus of substantial investigation, very little research has been devoted to understanding chloride homeostasis. Thus, this proposal is designed to obtain the full spectrum of information pertaining...

Kilkari Impact Evaluation
https://clinicaltrials.gov/ct2/show/NCT03576157

Sep 30th, 2022 - The Johns Hopkins Global mHealth Initiative, Oxford Policy Management, and University of Cape Town proposes supporting BBC Media Action and the Ministry of Health and Family Welfare (MOHFW) to conduct an external evaluation of Mobile Academy (MA) and Kilkari. In the below text, we outline 6 proposed activities which comprise the evaluation, which are planned from mid 2018 to April 2020. These s...

Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
https://clinicaltrials.gov/ct2/show/NCT03576547

Sep 30th, 2022 - PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of venetoclax, ponatinib, and dexamethasone in patients with relapsed/refractory Philadelphia positive (Ph+) acute lymphoblastic leukemia (ALL) or lymphoid blastic phase (BP)-chronic myelogenous leukemia (CML). (Phase I) II. To determine the efficacy of the regimen, as defined by the rate of complete remission (CR) or CR with ...

Comparative Effectiveness of School-based Caries Prevention
https://clinicaltrials.gov/ct2/show/NCT03442309

Sep 30th, 2022 - Dental caries is the most prevalent childhood disease in the world and can lead to infection, pain, reduced quality of life, and negative educational outcomes. Multiple prevention agents are available to arrest and prevent dental caries, however little is known of the comparative effectiveness of combined treatments in pragmatic settings. The aim of the presented study is to compare the benefit...

Peri-Operative Ipilimumab+Nivolumab and Cryoablation in Women With Triple-negative Breast Cancer
https://clinicaltrials.gov/ct2/show/NCT03546686

Sep 30th, 2022 - The purpose of this study is to determine the impact of pre-operative cryoablation, ipilimumab and nivolumab on 3-year Event Free Survival (EFS), in women with triple negative breast cancer after taxane-based neoadjuvant chemotherapy. Our strategy combines two interventions: induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens v...

DISCOVER iCaReMe Global Registry
https://clinicaltrials.gov/ct2/show/NCT03549754

Sep 30th, 2022 - The registry intends to provide real world data on patient management and quality of care for patients with T2DM, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 di...

Abatacept, Ixazomib Citrate, and Dexamethasone in Treating Patients With Multiple Myeloma Resistant to Chemotherapy
https://clinicaltrials.gov/ct2/show/NCT03457142

Sep 30th, 2022 - PRIMARY OBJECTIVES: I. To determine the therapeutic efficacy (as measured by response rate) of abatacept + ixazomib citrate (ixazomib) + dexamethasone in multiple myeloma patients who have relapsed (or who are primary refractory) following treatment with their first proteasome inhibitor-containing regimen (excluding ixazomib), compared to historical controls of ixazomib + dexamethasone. SECONDA...

Achalasia Patient Reported Outcomes
https://clinicaltrials.gov/ct2/show/NCT02606578

Sep 30th, 2022 - This is a non-randomized, non-inferiority trial that has been created to compare results of achalasia procedures including but not limited to: POEM + Partial Fundoplication (PF), POEM and Laparoscopic Modified Heller Myotomy + PF and POEM + Peroral Plication of the esophagus. Using a set of consistent evaluation tools for patients undergoing treatment for achalasia allows a standardized evaluat...

Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma
https://clinicaltrials.gov/ct2/show/NCT03513952

Sep 30th, 2022 - PRIMARY OBJECTIVE: I. To determine the clinical efficacy of the investigational treatment combination. SECONDARY OBJECTIVES: I. To determine the clinical activity and toxicity of the investigational treatment combination. II. The clinical benefit rate (CBR), progression-free survival (PFS), duration of response (DOR), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and ...