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NCT ID: NCT03801928 Completed - Clinical trials for Ulcerative Colitis (UC)

Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease

ONWARD
Start date: February 23, 2018
Phase:
Study type: Observational

This is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (UC) or Crohn's disease (CD). The study plans to recruit 300 subjects in the United States and Canada in which the participating physician has decided to treat with INFLECTRA. The study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. Patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with INFLECTRA.

NCT ID: NCT03801889 Withdrawn - Iron Overload Clinical Trials

SP-420 in Subjects With Transfusion-dependent Beta-Thalassemia or Other Rare Anemias

Start date: August 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the safety and tolerability of SP-420 and it's efficacy in terms of lowering iron in subjects with Beta-thalassemia or other rare anemias who need regular blood transfusions.

NCT ID: NCT03801759 Completed - Clinical trials for Drug Interaction Potentiation

Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide

Start date: July 20, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, 3-arm, fixed sequence, study to evaluate vadadustat as a perpetrator of drug-drug interactions (DDIs) with digoxin, adefovir and furosemide in healthy male and female subjects.

NCT ID: NCT03801746 Completed - Clinical trials for Drug Interaction Potentiation

Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin

Start date: July 20, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine, probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female subjects.

NCT ID: NCT03801733 Completed - Clinical trials for Drug Interaction Potentiation

Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

Start date: June 17, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, three-part, open-label study to evaluate vadadustat as a perpetrator in drug-drug interactions with rosuvastatin, sulfasalazine, pravastatin, atorvastatin and simvastatin in healthy male and female subjects.

NCT ID: NCT03801460 Recruiting - Frailty Clinical Trials

Physiological Reconditioning Program Administered Remotely in Patients Undergoing Transcatheter Aortic Valve Replacement: A Pilot Study

PREPARE-TAVR
Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The PREPARE TAVR pilot study will examine the effects of remotely administered physiological reconditioning program (RAPR) on quality of life (QOL) and clinical outcomes at one year post TAVR in frail older adults.

NCT ID: NCT03800875 Completed - Clinical trials for Diabetes Mellitus, Type 1

Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting

Dual
Start date: February 8, 2019
Phase: Phase 2
Study type: Interventional

Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, closed-loop system that delivers insulin and pramlintide that controls postprandial glucose levels without any input from the user.

NCT ID: NCT03800277 Completed - Metabolic Syndrome Clinical Trials

Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health

Phenulin
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem. Recent studies have clearly established that the gut microbiota plays a key role in the investigator's propensity to develop obesity and associated metabolic health disorders. The gut microbiota compositions plays a decisive role in glucose metabolism and the chronic inflammatory state associated with insulin resistance. Consuming prebiotic rich diet, including polyphenol and inulin rich food could help modulate favorably the gut microbiota which could lead to a reduction of endotoxemia and beneficial metabolic health effects.

NCT ID: NCT03800238 Completed - Caregivers Clinical Trials

Telehealth Powerful Tools for Caregivers Effectiveness Study

TPTC
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

The purpose of this research is to examine the efficacy of telehealth as a delivery format for an education-based caregiver wellness program focusing on self-care. The study will examine two research questions. 1) Are outcomes equivalent for caregivers in an education based-wellness program delivered via telehealth and one delivered in person as measured by a general rating of health, the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R), self-care behaviors (health self-care neglect, frequency of stress management and relaxation activities, and exercise frequency), self-efficacy, use of community resources, and the Bakas Caregiving Outcomes Scale (BCOS)? 2) Is class attendance equivalent for classes delivered via telehealth and in person? This research involves a specific education-based caregiver wellness program called Powerful Tools for Caregivers (PTC). PTC is an evidence-based six-week program that addresses caregiver health by promoting self-care. Collaborating community organizations offer the program at little to no cost. This study will employ a quasi-experimental nonequivalent pretest-posttest design to compare outcomes from in-person to telehealth delivered PTC classes. PTC classes are conducted by a pair of class leaders who model concepts. Each pair of class leaders will conduct both a telehealth and in-person PTC class. Collaborating community organizations will recruit 105 caregivers to attend PTC classes delivered by 7 pairs of class leaders. Telehealth classes will use VSee software to allow caregivers to participate in the PTC program synchronously via secure videoconferencing from their own home. VSee is a free software program designed to deliver secure telehealth services. Class leaders will guide participants in installation of the software on their home computer. Participants will undergo assessment one week before and one week after the PTC program, and at six-month follow up. Outcome measures replicate previous PTC research and add additional outcomes meaningful to caregiver wellness. Statistical analysis will include descriptive statistics and a mixed design analysis of variance including repeated measures to examine differences in the variables of interest over time.

NCT ID: NCT03800134 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

AEGEAN
Start date: December 6, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.