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NCT ID: NCT04605549 Active, not recruiting - Clinical trials for Primary Aldosteronism

A Study of CIN-107 in Adults With Primary Aldosteronism

Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label study in adult patients with PA to evaluate the effectiveness and safety of CIN-107 after up to 12 weeks of treatment (Part 1), and then for eligible, consenting patients follow patients in Part 2 for up to 74 weeks for evidence of long-term safety and tolerability.

NCT ID: NCT04604314 Active, not recruiting - Clinical trials for Endodontically Treated Teeth

Alternative EndoCrowns Designs for Chairside CAD/CAM

Start date: December 10, 2020
Phase: N/A
Study type: Interventional

This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.

NCT ID: NCT04604301 Active, not recruiting - Fractured Tooth Clinical Trials

Celtra Quatro Crown Study

Start date: September 24, 2020
Phase: N/A
Study type: Interventional

This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

NCT ID: NCT04603911 Active, not recruiting - Breast Cancer Clinical Trials

RCT Comparing ESPB Solutions in Breast Surgery

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

The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. This will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.

NCT ID: NCT04603495 Active, not recruiting - Myelofibrosis Clinical Trials

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

MANIFEST-2
Start date: April 9, 2021
Phase: Phase 3
Study type: Interventional

A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

NCT ID: NCT04603482 Active, not recruiting - Dementia Clinical Trials

Dementia Caregiver Career Study

Start date: January 8, 2021
Phase: N/A
Study type: Interventional

How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).

NCT ID: NCT04603352 Active, not recruiting - Down Syndrome Clinical Trials

Impact of an Orthotic Garment on Gross Motor Skills for Infants With Down Syndrome

Start date: May 5, 2021
Phase: N/A
Study type: Interventional

Infants with Down syndrome (DS) develop slower than their typically developing peers. Physical therapist (PT) supervised home programs have the potential to optimize gross motor development in a financially feasible way. An inexpensive orthotic garment (Hip Helpers®) is commonly employed by PTs as a home program supplement, but its effectiveness has not yet been investigated. The garment is worn as pliable shorts over a child's lower extremities to keep upper legs together, promoting a narrow base of support. This encourages activation of upright postural muscles to improve gross motor skill development. The purpose of this randomized controlled study is to investigate the impact of a home program using the Hip Helpers® orthotic garment on gross motor skill acquisition in infants with DS. We hypothesize that the addition of a structured home program using Hip Helpers®, supervised by a PT and implemented by parents, will increase the rate at which infants with DS acquire gross motor skills. Thirty-four participants, consisting of children who are at least three-months-old and are not yet able maintain sitting independently, will be randomly assigned to a control (n=17) or intervention group (n=17). PTs at pediatric therapy agencies will initiate the home program and administer the Gross Motor Function Measure-88 (GMFM-88) at regular intervals to monitor gross motor skill acquisition until the child is able to take three independent steps. Groups will be compared on the length of time elapsed between the acquisition of identified gross motor skills using independent t-tests. GMFM-88 scores will be compared between the two groups at different ages to identify trends using independent t-tests. The contribution of this project will be significant by informing physical therapists about the effectiveness of an inexpensive orthotic garment used in a supervised home program on gross motor outcomes in infants with DS.

NCT ID: NCT04603001 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

Start date: December 1, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

NCT ID: NCT04602988 Active, not recruiting - Delirium Clinical Trials

Study to Assess and Monitor Brain Activity

SAMBA
Start date: August 10, 2020
Phase:
Study type: Observational

A mainstay in the diagnosis and care of hospitalized patients is the assessment of mental status. Changes in mental status can have broad clinical significance, and while some patients are admitted with mental status changes, nearly half of the patients who experience delirium in the hospital develop it after admission in a manner that is hard to predict on the level of individual patients. Patients with altered mental status such as delirium have worse clinical outcomes, suggesting that early monitoring of mental status can identify important clinical populations who may benefit from targeted delirium prevention and intervention. Delirium remains under-recognized in the hospital, in part due to its fluctuating nature. Typically, mental status is assessed sporadically, perhaps once a day, through intermittent and subjective clinical interactions. As such, there is a clear clinical need for objective, continuous methods to monitor mental status. Such methods could potentially improve detection of delirium, potentially even predicting it prior to clinical recognition, and therefore direct multimodal delirium prevention and intervention strategies when most effective-before delirium becomes fully manifest. In this proposal we plan on testing noninvasive, continuous monitors of mental status in the inpatient setting, primarily through the use of EEG.

NCT ID: NCT04602728 Active, not recruiting - Sickle Cell Disease Clinical Trials

Building Adaptive Coping and Knowledge to Improve Daily Life

Back2Life
Start date: January 27, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to find out how teenagers with chronic pain and sickle cell disease respond to a new training program called Back2Life and get their feedback about how to modify the program to best fit their needs. The Back2Life training program focuses on teaching pain coping skills (also known as cognitive-behavioral therapy). The program teaches skills and strategies that may help teens improve chronic pain management and get back into their everyday activities.