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NCT ID: NCT04008706 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients

ASSURE
Start date: September 17, 2019
Phase: Phase 3
Study type: Interventional

This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).

NCT ID: NCT04007770 Active, not recruiting - Gynecologic Cancer Clinical Trials

Acupuncture Pilot Study for Cancer-related Cognitive Function

Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.

NCT ID: NCT04007666 Active, not recruiting - Depression Clinical Trials

Leveraging Implementation Science to Increase Access to Trauma Treatment for Incarcerated Drug Users

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

The unmet need for effective addiction treatment within the criminal justice system "represents a significant opportunity to intervene with a high-risk population" according to NIDA's 2016-2020 strategic plan. The plan also encourages the development and evaluation of implementation strategies that address the needs of the criminal justice system. The proposed research will be conducted as part of Dr. Zielinski's Mentored Patient-Oriented Research Career Development Award (K23), which aims to: 1) advance knowledge on implementation of a gold-standard psychotherapy for trauma, Cognitive Processing Therapy (CPT), in the prison setting and 2) examine whether prison-delivered CPT reduces drug use, psychiatric symptoms, and recidivism compared to a control condition (a coping-focused therapy). These foci have been selected because severe trauma exposure, substance use, and justice-involvement overwhelmingly co-occur in prison populations. The three specific aims in this research are: 1) Use formative evaluation to identify factors that may influence implementation and uptake of CPT in prisons, 2) Adapt CPT for incarcerated drug users and develop a facilitation-based implementation guide to support its uptake, and 3) conduct a participant-randomized Hybrid II trial to assess effectiveness and implementation outcomes of CPT with incarcerated drug users. Participants will include people who have been incarcerated (pre- and post-release from incarceration) and prison stakeholders who will be purposively sampled based on their role in implementation of CPT and other programs. Anticipated enrollment across all three Aims is 244 adult men and women.

NCT ID: NCT04007393 Active, not recruiting - Adolescent Obesity Clinical Trials

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

SMART
Start date: November 21, 2019
Phase: Phase 2
Study type: Interventional

This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.

NCT ID: NCT04006457 Active, not recruiting - Alopecia Areata Clinical Trials

Long-Term PF-06651600 for the Treatment of Alopecia Areata

ALLEGRO-LT
Start date: July 18, 2019
Phase: Phase 3
Study type: Interventional

This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US, Australia and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.

NCT ID: NCT04006379 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Observational Study: Glycemic Control & CV Outcomes Among Patients With T2DM Newly Initiating GLP1-RAs vs Basal Insulin

Start date: May 1, 2019
Phase:
Study type: Observational

This study will compare HbA1c and CV outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.

NCT ID: NCT04006210 Active, not recruiting - Parkinson's Disease Clinical Trials

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

BouNDless
Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, double-dummy, active controlled clinical Study. Following a screening period, eligible subjects will be enrolled to an open-label oral IR-LD/CD adjustment period; then an open-label ND0612 conversion period; then after optimization periods subjects will be randomized to receive either ND0612 or its matching Placebo with IR-LD/CD. Subjects can continue to an optional open-label extension period.

NCT ID: NCT04005430 Active, not recruiting - Clinical trials for Refractory Diabetic Macular Edema

A Phase I Study of Episcleral Dexamethasone for Treatment of Macular Edema

Start date: April 3, 2019
Phase: Phase 1
Study type: Interventional

This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from refractory diabetic macular edema.

NCT ID: NCT04004936 Active, not recruiting - Aging Clinical Trials

Reducing Potentially Inappropriate Medication Prescribing for Older Patients in the ED

EQUIPPED
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This research is being conducted to learn which implementation strategy of EQUIPPED is most effective to improve prescribing practices of ED providers toward older Veterans and determine the factors influencing implementation of this program to reduce the prescribing of PIMs to older adults upon discharge from the ED. The study has three research aims. The procedures for these research aims are described below: - Aim 1 - Examining the Impact of Passive Provider Feedback vs. Active Provider Feedback Through a Randomized Trial - Aim 2 - Determination of Factors Affecting Organizational Adoption of EQUIPPED - Aim 3 - Micro-Costing the Active and Passive Feedback Versions of the EQUIPPED Intervention

NCT ID: NCT04004767 Active, not recruiting - Alzheimer Disease Clinical Trials

TRC-PAD Program: In-Clinic Trial-Ready Cohort

TRC-PAD
Start date: June 4, 2019
Phase:
Study type: Observational

The purpose of the TRC-PAD study is to develop a large, well-characterized, biomarker-confirmed, trial-ready cohort to facilitate rapid enrollment into AD prevention trials utilizing the APT Webstudy and subsequent referral to in-clinic evaluation and biomarker confirmation. Participants with known biomarker status may have direct referral to the Trial-Ready Cohort. If you are interested in being selected for the TRC-PAD study, you should first enroll in the APT Webstudy (https://www.aptwebstudy.org/welcome).