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NCT ID: NCT04009798 Active, not recruiting - Heart Failure Clinical Trials

Predicted Prognosis in Heart Failure

Intuition
Start date: May 18, 2018
Phase:
Study type: Observational

The purpose of the project is to conduct a physician-initiated Canadian multicentre observational research study that compares physician judgement and model prediction to estimate one-year survival in ambulatory heart failure (HF) patients and evaluate the use of resources according to physician intuitive risk. This study will evaluate the accuracy and impact of physician intuition and predictive models in the assessment of prognosis in ambulatory HF patients by: comparing 1-year physician predicted survival and 1-year observed survival to 1-year model predicted survival; evaluating whether model performance could be enhanced by incorporating physician intuition; evaluating the accuracy of physician intuition according to level of confidence in physician intuition (very low, low, moderate, high or very high); evaluating whether physician expertise impacts accuracy of physician intuition; and evaluating patient management and use of resources according to physician estimated survival.

NCT ID: NCT04009499 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

BE VITAL
Start date: August 13, 2019
Phase: Phase 3
Study type: Interventional

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

NCT ID: NCT04009291 Active, not recruiting - Clinical trials for Endocrine System Diseases

A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism

PaTH Forward
Start date: August 27, 2019
Phase: Phase 2
Study type: Interventional

During the first four weeks of the trial, participants will be randomly assigned to one of four groups: three groups will receive fixed doses of TransCon PTH and one group will receive placebo. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the four weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, Denmark, and Norway.

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: 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: NCT04005183 Active, not recruiting - Clinical trials for Renal Cell Carcinoma

Renal Cell Carcinoma Microenvironment Discovery Project

REMEDY
Start date: May 6, 2019
Phase:
Study type: Observational

This study will obtain tumor samples from nephrectomy specimens in a multi-regional fashion and subject them to integrated genomics, proteomics, pathological, and radiological assessment. The goal is to better understand the the molecular basis for how various cells within the tumor microenvironment act in a coordinated manner to facilitate tumor progression and therapy resistance. Our ultimate aim is to leverage this data resource to identify novel therapeutic targets and biomarkers to improve the clinical management of this disease.

NCT ID: NCT04004156 Active, not recruiting - Clinical trials for Degenerative Disc Disease

Safety Study for An Artificial Disc Replacement to Treat Chronic Low Back Pain

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

This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.

NCT ID: NCT04004065 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

Two-Part Study for Dose Determination of Vesleteplirsen (SRP-5051) (Part A), Then Dose Efficacy (Part B) in Participants With Duchenne Muscular Dystrophy Amenable to Exon 51-Skipping Treatment

MOMENTUM
Start date: June 26, 2019
Phase: Phase 2
Study type: Interventional

This study will be comprised of 2 parts: 1) Part A (Multiple Ascending Dose [MAD]) will be conducted to evaluate the safety and tolerability of vesleteplirsen at MAD levels to determine the maximum tolerated dose (MTD), and 2) Part B will be conducted to further evaluate the vesleteplirsen doses selected in Part A. Participants enrolling in Part B will be those who completed Part A or Study 5051-102 (NCT03675126) and meet applicable eligibility criteria for Part B, as well as additional participants who meet applicable eligibility criteria for enrollment at the beginning of Part B.

NCT ID: NCT04003636 Active, not recruiting - Clinical trials for Biliary Tract Carcinoma

Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)

KEYNOTE-966
Start date: September 24, 2019
Phase: Phase 3
Study type: Interventional

This is a study of pembrolizumab plus gemcitabine/cisplatin versus placebo plus gemcitabine/cisplatin as first-line therapy in participants with advanced and/or unresectable biliary tract carcinoma. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).

NCT ID: NCT03998501 Active, not recruiting - Clinical trials for Stress Disorders, Post-Traumatic

fMRI to Examine the Effect of CBTm to Increase Resiliency for PTSD

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

A substantial proportion of public safety personnel (PSP) develop service-related posttraumatic stress disorder (PTSD). PTSD is associated with a range of negative outcomes and its exact underlying neurophysiological mechanism is still not well understood. Cognitive behavioral therapy (CBT) is commonly prescribed to treat PTSD, and recent studies suggest that it may be effective in preventing the condition. We have developed a 5-session class focused on teaching introductory CBT skills to prevent and manage psychological distress, and we are currently in the process of launching a clinical trial to demonstrate its effectiveness in preventing PTSD and related conditions in PSP. In the proposed adjunctive study to this trial, we will quantitate the brain connectivity signature that is specific to the PTSD-resilience, and examine whether the classes increase this resilience-related brain mechanism.