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NCT ID: NCT05243628 Completed - Type 1 Diabetes Clinical Trials

Afrezza With Basal Combination

ABC
Start date: March 31, 2022
Phase: Phase 4
Study type: Interventional

MKC-TI-192 is a Phase 4, 90-day, randomized, three-arm, multicenter clinical trial evaluating the treatment paradigm and efficacy of Afrezza in controlling postprandial glucose in adult subjects (≥18 years of age) with Type 1 Diabetes Mellitus (T1DM). Subjects will be randomized to one of three treatment groups (two Afrezza groups and one control group): - Afrezza + AID: Subjects in this group will use Afrezza for their bolus (mealtime) insulin and a continuous subcutaneous insulin infusion (CSII) pump with an automatic insulin delivery (AID) algorithm using rapid acting analogs (RAA) for their basal and correction insulin coverage. - Afrezza + Insulin Degludec: Subjects in this group will use Afrezza for their bolus (mealtime and correction) insulin and insulin degludec for basal insulin coverage. - AID Control: Subjects in this group will use a CSII pump with an AID algorithm using RAA for all bolus (mealtime and correction) and basal insulin coverage (control group). The study is composed of up to 5 clinic visits (screening, 3 treatment visits, and an end-of-treatment visit) and 9 telephone visits.

NCT ID: NCT05243511 Completed - Fibromyalgia Clinical Trials

Prospective Study to Evaluate a Digital Regimen for Fibromyalgia Management

PROSPER-FM
Start date: February 8, 2022
Phase: Phase 3
Study type: Interventional

PROSPER-FM is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. Eligible participants are randomized (1:1) to either the Digital Acceptance and Commitment Therapy (Digital ACT) group or the Digital Symptom Tracker group and receive assigned therapy for 12 weeks.

NCT ID: NCT05243264 Completed - Depression Clinical Trials

Empower@Home: A Feasibility Pilot

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

This is an open pilot feasibility study of a novel internet-based cognitive behavioral therapy program for older adults with elevated depressive symptoms. This study will enroll approximately 15 older adults throughout the state of Michigan to better understand the feasibility of the intervention and to probe preliminary effects. The intervention will take approximately 10 weeks to complete. Participants will have lower levels of depression after completing the intervention than before enrollment. Participants will be able to use the internet-based platform with minimal support.

NCT ID: NCT05242770 Completed - Gynecologic Cancer Clinical Trials

Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

Start date: March 28, 2022
Phase: N/A
Study type: Interventional

The purpose of this research study is to investigate the use of pelvic physical therapy for gynecologic cancer survivors who report sexual dysfunction. Physical therapy experts believe that a full 10-week regimen is necessary for true improvement of symptoms. Investigators aim to see if this tense regimen is feasible for survivors. Investigators also aim to see if patients have an improvement in their sexual function and quality of life.

NCT ID: NCT05242575 Completed - Clinical trials for Developmental Language Disorder

The Influence of Immersive Virtual Field Trips on Academic Vocabulary

Start date: October 7, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate an immersive virtual field trip (iVFT) on topic specific academic vocabulary for students with developmental language disorder (DLD). DLD is the most common childhood learning disorder with a prevalence of 7.4%(1) and occurs in the absence of a known biomedical condition (e.g., hearing loss, autism, stroke, intellectual disability). DLD affects a person's academic and social function due to difficulty with using and understanding language.(2,3) Approximately half of students with DLD have a deficit in vocabulary that persists through highschool.(4) Once children fall behind in their language and vocabulary development, it is very difficult to catch up generally resulting in a wider gap as they progress through their school years. This deficit can have cascading social, mental health, occupational and financial consequences.(5) There is preliminary evidence that a virtual reality experience such as an immersive virtual field trip (iVFT) was beneficial for facilitating vocabulary and comprehension in general education(6-8) and within targeted populations of students including second language learners(9) and those with learning differences (e.g., autism,(10) attention deficit hyperactivity,(11,12) and dyslexia(13). The term "immersive" refers to a state of heightened sensation when viewing a simulated environment that is superimposed onto a screen with embedded multisensory input (e.g., visual, auditory, proprioceptive).(14) The viewer looks through 3D goggles to block out the present environment resulting in a feeling of presence. These simulated experiences or destinations (e.g., space) are a type of VR referred to as an immersive virtual field trip (iVFT). To date, there is a lack of empirical evidence, explicitly targeting academic vocabulary growth for early grade school students with DLD. In addition, no study has reported on learning outcomes of students with DLD following a VR condition. Therefore, the primary study objective was to compare gains in academic vocabulary measures between a traditional book condition and an iVFT learning condition for young students with DLD.

NCT ID: NCT05242523 Completed - Stress Clinical Trials

Automated Stress Detection and Restoration in Office Workers

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

This study aims at establishing a laboratory experiment that mimics office work stressors, examining the feasibility of automated stress detection, and identifying the most significant physiological and/or behavioral features that can be used to differentiate between positive stress (eustress) and negative stress (distress). Additionally, we will investigate if triggering the olfactory (exposing participants to pleasant smells) senses would help reduce stress.

NCT ID: NCT05242458 Completed - Crohn's Disease Clinical Trials

A Study of Ustekinumab Treatment in Children With Crohn's Disease

REALITI
Start date: March 21, 2022
Phase:
Study type: Observational

The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving clinical remission in pediatric participants (greater than or equal to [>=] 2 to less than [<] 18 years and weight >= 40 kilograms [kg] at baseline).

NCT ID: NCT05241808 Completed - Physical Inactivity Clinical Trials

Girls Can...Move! Testing the Feasibility of a Community-based Physical Activity Intervention for Adolescent Girls

Start date: December 2, 2021
Phase: N/A
Study type: Interventional

The purpose of this research is to learn about how to promote physical activity among adolescent girls by testing the feasibility and initial effectiveness of the Girls Can...Move! intervention. Girls Can...Move! will target each component of physical literacy by providing opportunities for adolescent girls to gain knowledge about their own physical activity level, to explore and practice different types of physical activities, and to learn from active female role models. Female participants (n = 30) from one middle school will be randomly assigned to the Girls Can...Move! intervention group or a control group at a 1:1 ratio. The primary outcome variables, physical activity and physical literacy, will be assessed before and after the 8-week Girls Can...Move! intervention using accelerometers and online surveys.

NCT ID: NCT05241535 Completed - Healthy Subjects Clinical Trials

Study to Evaluate the Effect of a Single Oral Dose of MT-7117 on the QT/QTc Interval in Healthy Subjects

Start date: January 12, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effect of a single oral dose of MT-7117 on the QT/QTc interval in healthy subjects.

NCT ID: NCT05241470 Completed - Dry Eye Disease Clinical Trials

Study of ST-100 as Treatment for Dry Eye Disease

Start date: May 17, 2021
Phase: Phase 2
Study type: Interventional

The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.