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NCT ID: NCT04710537 Completed - Clinical trials for Acellular Dermal Matrix in Breast Reconstruction

Comparing AlloDerm and DermACELL in Breast Reconstruction

Start date: October 21, 2021
Phase: N/A
Study type: Interventional

This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.

NCT ID: NCT04710407 Completed - Healthy Volunteers Clinical Trials

Study to Assess the Intrapulmonary Pharmacokinetics of SPR859 by Comparing the Plasma, Epithelial Lining Fluid (ELF), and Alveolar Macrophages (AM) Concentrations Following the Oral Administration of Five Doses of SPR994 in Healthy, Nonsmoking Volunteers

Start date: December 7, 2020
Phase: Phase 1
Study type: Interventional

To evaluate the intrapulmonary pharmacokinetics (PK), including ELF and AM concentrations, of SPR859 (tebipenem) compared to plasma concentrations of SPR859 (tebipenem) (the active moiety in plasma of the prodrug SPR994) in nonsmoking healthy adult volunteers.

NCT ID: NCT04710394 Completed - Covid19 Clinical Trials

Visual-OLfactory Training in Participants With COVID-19 Resultant Loss of Smell

VOLT
Start date: January 11, 2021
Phase: N/A
Study type: Interventional

Olfactory dysfunction is a defining symptom of COVID-19 infection. As the number of total, confirmed COVID-19 cases approached 19 million in the United States, it is estimated that there will be 250,000 to 500,000 new cases of chronically diminished smell (hyposmia) and loss of smell (anosmia) this year. Olfactory dysfunction is proposed to worsen numerous common co-morbidities in patients and has been shown to lead to a decreased quality of life. There are very few effective treatments for hyposmia or anosmia, and there is no gold standard of treatment. One proposed treatment option is smell training, which has shown promising yet variable results in a multitude of studies. It garners its theoretical basis from the high degree of neuroplasticity within the olfactory system, both peripherally and centrally. However, due to a relative inadequacy of proper studies on olfactory training, it is unknown what the most efficacious method in which to undergo the training is. This study proposes two novel procedural modifications to smell training in an attempt to enhance its efficacy. The investigators propose using a bimodal visual-olfactory approach, rather than relying on olfaction alone, during smell training, as well as using patient-preferred scents in the training that are identified as important by the study participant, rather than pre-determined scents with inadequate scientific backing. The investigators hypothesize that by utilizing bimodal visual-olfactory training and patient-selected scents, the olfactory training will be more efficacious and more motivating for participants.

NCT ID: NCT04710368 Completed - Clinical trials for Coronary Artery Disease

Effect of Evolocumab on Coronary Plaque Characteristics

YELLOW III
Start date: May 4, 2021
Phase: Phase 4
Study type: Interventional

The aim of the study is to assess the effect of evolocumab on coronary plaque morphology using intravascular imaging and gene expression analysis of peripheral blood mononuclear cells (PBMC) in patients with stable CAD on maximally tolerated statin therapy. The study combines multi-modality intravascular imaging approaches and transcriptomic based machine learning algorithms to uncover molecular mechanisms responsible for the beneficial changes in atherosclerotic lesions of patients treated with evolocumab. The primary end-points are the changes from baseline to follow-up in (1) the minimal fibrous cap thickness (FCT) assessed by optical coherence tomography (OCT) and (2) maxLCBI4mm assessed by near-infrared spectroscopy (NIRS) after 26 weeks of evolocumab. The secondary endpoints are the changes in (1) the maximal lipid arc, lipid length, lipid volume index, macrophage accumulation and calcification by OCT; (2) PAV and TAV defined by intravascular ultrasound (IVUS) and (3) Changes in PBMC gene expression.

NCT ID: NCT04710277 Completed - Postoperative Pain Clinical Trials

Novel Multimodal Pain Control Protocol for Minimally Invasive Gynecologic Surgery

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

The study is a randomized controlled trial investigating a multimodal postoperative pain management protocol which will include use of ice therapy and scheduled opioid-sparing medications for pain control after minimally invasive gynecologic surgery.

NCT ID: NCT04710212 Completed - Clinical trials for Hematologic Malignancy

Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies

SCENE
Start date: March 12, 2021
Phase:
Study type: Observational

This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization.

NCT ID: NCT04710108 Completed - Nutrition Clinical Trials

Testing Message Modality of Culturally Appropriate Nutrition Communication for Mexican American Women

Start date: December 2, 2020
Phase: N/A
Study type: Interventional

A randomized controlled trial to test the effects of culturally appropriate nutrition communication delivered via different modalities for Mexican American women.

NCT ID: NCT04710069 Completed - Postoperative Pain Clinical Trials

Postoperative Opt-In Narcotic Treatment Study

POINT
Start date: June 26, 2020
Phase: N/A
Study type: Interventional

pills go unused, generating waste and leaving an opportunity for misuse and abuse. In a recent study, researchers let patients choose what medications to go home with after surgery. After their thyroid or parathyroid surgery, 96% of patients declined narcotic pain medication. They preferred to manage their pain with acetaminophen instead. Giving patients counseling and empowering them to choose significantly reduces the amount of opioids prescribed and wasted. The aim of our study is to compare a similar "opt-in" protocol for narcotics to usual care (where patients are routinely discharged with opioids). We would elaborate upon the aforementioned study by studying patient pain scores on a more granular level once they return home. Our study will be designed as a randomized, controlled trial. When adult patients consent for a thyroid or parathyroid surgery, they will be asked to participate in the study. Patients who are currently using narcotics would be excluded. We would then randomize participants to the "opt-in" protocol versus being provided with a standard opioid prescription after surgery. Patients in the opt-in protocol will be recommended a pain treatment regimen with over-the-counter medications, such as acetaminophen or ibuprofen. These patients will be reassured that if their pain is uncontrolled after discharge, a narcotic prescription will be called in to their pharmacy if requested. We will assess patient pain scores and medication use in the recovery area using the electronic medical record. We will collect data on patient pain scores and medication use after discharge on a daily basis via phone call or electronically transmitted survey. We will also evaluate patients at the time of their follow-up visits. Any patient phone calls will be routed to study personnel who will fill narcotic prescription requests if requested. Finally, among patients who do receive an opioid prescription, we will track their opioid consumption.

NCT ID: NCT04709978 Completed - Pneumonia Clinical Trials

Community Acquired Pneumonia in Older Adults

Start date: February 24, 2021
Phase:
Study type: Observational

This study will utilize diagnostic imaging and salivary biomarkers to estimate the prevalence of aspiration in older adults with suspected community-acquired bacterial pneumonia (CABP). 150 participants over the age of 60 diagnosed with pneumonia will be recruited into this study. 62 of these participants will be enrolled in a supplemental study.

NCT ID: NCT04709939 Completed - Clinical trials for Outpatient Parenteral Antibiotic Therapy

Mobile-health Approach to Gather Clinical Information From Patients Following Hospital Discharge

Start date: August 27, 2021
Phase:
Study type: Observational

The purpose of this study is to assess the feasibility of using a mobile-health approach to gather clinical data from patients following discharge from the hospital on outpatient parenteral antibiotic therapy (OPAT). The study population will consist of adult participants who have a smartphone that is capable of both text messaging and pairing with a Bluetooth thermometer that will be provided. Following discharge, patients will be asked to respond to two daily text messages. They will also be reminded to take and send in photos of any skin rashes that may develop as well as their PICC-line site during dressing changes. Text messages will be sent for up to 30 days, but will be stopped sooner if the patient is readmitted to the hospital or if OPAT is discontinued. At the end of the 30 days, all patients will be sent a text message survey about usability, the time it took to complete the study tasks, suggestions for future improvements, and whether they would be willing to be interviewed via phone. A subset of the participants will be interviewed via phone to obtain more detailed feasibility data. Information from the patient's medical record will be collected at the time of hospital discharge as well as at the end of the study period. Additionally, a focus group (via conference call) will be conducted with all research team members and infectious disease physicians involved in OPAT who did not use the system to gauge their needs and to get ideas for future applications of our tools.