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NCT ID: NCT04629508 Completed - Myelofibrosis Clinical Trials

To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)

Start date: July 12, 2021
Phase: Phase 2
Study type: Interventional

This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.

NCT ID: NCT04629443 Completed - Clinical trials for Acute Myeloid Leukaemia

Phase I/II Trial of S64315 Plus Azacitidine in Acute Myeloid Leukaemia

Start date: February 17, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.

NCT ID: NCT04629430 Completed - Multiple Myeloma Clinical Trials

Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

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Start date: February 19, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to see whether hematopoietic stem cell transplant (HSCT) patients can consistently eat a diet rich in prebiotics. This type of diet may be helpful in maintaining diversity in the gastrointestinal (GI) system and therefore potentially decreasing risk of other GI problems.

NCT ID: NCT04629170 Completed - Healthy Clinical Trials

Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria

Start date: November 4, 2020
Phase: Phase 1
Study type: Interventional

This Phase 1a/b, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB8802 in healthy volunteers (HV) and subjects diagnosed with enteric hyperoxaluria (EH). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration. In Part 2, all evaluations and assessments throughout this study may be conducted either at the clinical site or by a home healthcare professional at an alternative location (e.g., EH patient's home, hotel).

NCT ID: NCT04629066 Completed - Heart Failure Clinical Trials

Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION

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Start date: April 27, 2021
Phase: N/A
Study type: Interventional

This single center randomized controlled trial will involve 50 medically stable outpatients with HF, reduced ejection fraction, and previously implanted ICD or CRT-D devices followed longitudinally on the Abbott Medical Merlin remote patient monitoring network. Patients will be randomized in a 1:1 fashion to usual care plus a remotely administered home based weekly prescription for aerobic exercise (intervention) or usual care alone (control). Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team. The exercise prescription will be created by an exercise physiologist after incorporating remotely collected data from a patient directed smartphone app assessing HF symptom severity, vital signs, weight, and blood sugar, implantable device measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity.

NCT ID: NCT04628988 Completed - Prostatic Neoplasms Clinical Trials

A Study of CC-90011 and Comparators in Participants With Prostate Cancer

Start date: July 28, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, positron emission tomography (PET) imaging Proof of Biology (POB) study to determine whether CC -90011 reverses, by the induction of androgen receptor (AR) expression, the castration resistance, due to lineage switch, in participants with mCRPC that have failed enzalutamide as last prior therapy. This study aims to assess whether CC-90011 can induce AR expression and, consequently, re-sensitize tumors to anti-hormonal therapy.

NCT ID: NCT04628949 Completed - Clinical trials for Endoscopic Retrograde Cholangiopancreatography (ERCP)

A Single-Use Duodenoscope in a Real-World Setting

Start date: January 25, 2021
Phase: N/A
Study type: Interventional

This study will assess how the aScopeā„¢ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.

NCT ID: NCT04628936 Completed - Dermatomyositis Clinical Trials

Open-label Extension to the Phase 2 Crossover Study (PRESIDIO) Evaluating KZR-616 in Patients With PM and DM.

Start date: November 4, 2020
Phase: Phase 2
Study type: Interventional

This was an open-label study to evaluate the long-term efficacy and safety of KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM) who completed the double-blind treatment period of Study KZR-616-003, up to and including the Week 32 Visit, prior to the first dose of open-label KZR-616.

NCT ID: NCT04628832 Completed - Opioid Use Clinical Trials

Nudging Providers to Curtail Dangerous Opioid Prescribing: A Trial to Investigate Mechanisms

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

Despite an enormous policy response, opioid prescribing remains well above historical levels and harms from opioids continue to mount. Nearly all states have Prescription Monitoring Programs (PMPs) to facilitate safer prescribing of opioids and other drugs, but research suggests these systems only deliver benefits when health care professionals are required to use them. Even with PMP mandates in place, providers may be unaware of the dangers of co-prescribing opioids with benzodiazepines or gabapentinoids, which include increased risk of overdose and death. Working with the Minnesota state government, the investigators will mail letters to guideline-discordant opioid prescribers that either highlight an upcoming legally mandated requirement to check the PMP before prescribing an opioid, inform and educate providers about patients filling concurrent prescriptions and the dangers of such co-prescribing, or both. Study participants will be randomized to receive no intervention or one of the three treatment letters. Using administrative data, the investigators will track effects of the letters on not only prescribing but also PMP usage and queries. Findings form the multiplicity of treatment messages and outcomes will shed light on the mechanisms driving overprescribing. Results will inform future work by state and local policymakers to make opioid prescribing safer.

NCT ID: NCT04628793 Completed - Clinical trials for Healthy Participants

A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants

Start date: March 16, 2021
Phase: Phase 1
Study type: Interventional

This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants.