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NCT ID: NCT03398148 Recruiting - Clinical trials for Ulcerative Colitis (UC)

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Start date: March 7, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

NCT ID: NCT03398135 Recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

Start date: August 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC. This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.

NCT ID: NCT03345849 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional Therapies But Have Not Failed Biologic Therapy

Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345836 Recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

Start date: November 29, 2017
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).

NCT ID: NCT03345823 Enrolling by invitation - Crohn's Disease Clinical Trials

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.

NCT ID: NCT02441283 Active, not recruiting - Hepatitis C Clinical Trials

A Study to Assess Resistance and Durability of Response to ABT-493 and/or ABT-530

Start date: June 22, 2015
Phase: Phase 2
Study type: Interventional

This is a rollover study to assess resistance and durability of response to ABT-493 and/or ABT-530 in subjects who have participated in Phase 2 or 3 clinical studies with these agents for the treatment of chronic HCV.

NCT ID: NCT01848561 Recruiting - Clinical trials for Ulcerative Colitis (UC)

A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Start date: April 29, 2013
Phase:
Study type: Observational

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

NCT ID: NCT00961675 Completed - Clinical trials for Acute Otitis Externa

FST-201 in the Treatment of Acute Otitis Externa

Start date: August 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This study will be conducted at one site, the LBJ Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

NCT ID: NCT00850824 Completed - Clinical trials for Type 2 Diabetes Mellitus

Community Health Workers in Diabetes Care in American Samoa

DCAS
Start date: October 2007
Phase: N/A
Study type: Interventional

As type 2 diabetes prevalence increases in the United States, the burden of diabetes falls more on groups with greater barriers to care, such as language and cultural differences, and lower economic resources. Healthy People 2010 targeted diabetes as one of six diseases for the elimination of racial and ethnic health disparities. These disparities extend to the US Territory of American Samoa, where the proportion of adults >18 years with diabetes was 19.6% in 2002, compared to 6.4% of US adults. There have been no reported diabetes interventions in Samoans in the US. The overall purpose of this application is to translate recent advances in diabetes care into clinical practice for the American Samoan community by improving methods of health care delivery and methods of diabetes self management. We will conduct a randomized clinical trial to test the effectiveness of a community health worker (CHW) and primary-care coordinated intervention to provide outreach, education and support to 352 type 2 diabetes patients and their families in American Samoa. The CHW intervention will utilize evidence-based algorithms and protocols to prompt risk behavior interventions, communication with health care team, and visit schedule. The individual treatment action plans are also guided by the Precede-Proceed Model. The outcomes at a one-year follow-up will include glycosolated hemoglobin (HbA1c), cardiovascular disease risk factors, diet and exercise behaviors, and adherence to diabetes care guidelines. The study hypothesis is that diabetes patients in the CHW trial arm will have lower HbA1c levels, lower cardiovascular disease risk factor levels, increased exercise behaviors and healthy dietary intakes and greater adherence to diabetes care such as adherence to prescribed medications, keeping medical appointments for diabetes care and specialty referrals. The intervention builds upon best clinical practices for CHWs in diabetes care by translating effective strategies to American Samoans, while also extending prior CHW research, by using a model that is potentially replicable in other ethnic minority populations suffering the burden of diabetes.

NCT ID: NCT00377169 Completed - HIV Infections Clinical Trials

Collection of Blood Samples From SMART Study Participants for Future Genetic Studies

Start date: n/a
Phase: N/A
Study type: Observational

The purpose of this study is to collect blood samples from SMART study participants to use in future genetic studies.