Search Results Within Category "Breathing, Lung & Sleep Health"
ABATE-IP-18: A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are Colonized with Nontuberculous Mycobacteria (The ABATE Study) (ABATE)
The purpose of this research study is to test the safety of giving two separate 5-day infusions (starting on Day 1 and again around Day 15) through a vein with a drug called gallium nitrate. Laboratory tests suggest that this drug may be able to fight Nontuberculous Mycobacteria (NTM) infections
• diagnosis of cystic fibrosis
• persistent Nontuberculous Mycobacterium lung infection (NTM)
• able to expectorate sputum
• enrolled in the CFF Patient Registry
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of solid organ or hematological transplantation
• current diagnosis of osteoporosis
• women who are pregnant or breast feeding
• men and women who are unwilling to practice a medically acceptable form of contraception
Vibrotactile stimulation of the larynx to treat unexplained chronic cough
This is a study of adults with unexplained chronic cough between 18-80 years old. This study is trying to determine whether a noninvasive vibrotactile stimulation device can help reduce cough symptoms.
• adults aged 18-80
• more than 8 weeks of non-productive cough
• chest x-ray or chest CT negative (collected as part of routine clinical care); no time limit on imaging (if available)
• clinical impression that untreated or inadequately treated gastroesophageal, pulmonary, and/or sinus or nasal issue is not the reason for the cough
• able to read and speak English
• current smoker or quit less than 3 months ago
• infectious cause for cough (e.g., TB, pertussis, COVID)
• history of known or suspected aspiration pneumonia
• recent intubation/neck surgery (within 8 weeks)
• neuromuscular impairment that may affect cough/laryngeal sensation and/or function (e.g., multiple system atrophy, Parkinson, CVA)
• untreated carotid artery disease
• electronic implants (e.g., pacemaker)
• specific medications (study staff will discuss)
• anticipate use of new medications to treat the cough during the period of the study
• currently having speech therapy for cough
• BMI > 40 (for transmission of VTS through soft tissue)
• allergy to adhesives
• drug/alcohol dependency or abuse
• pregnant
• without regular access to wifi and internet
VX21-522-001: A Phase 1 Multiple Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
This is a clinical research study exploring the safety and tolerability of a single dose of VX-522 for people with cystic fibrosis (CF) who are not expected to benefit from CFTR modulators.
• 18 to 65 years old
• Stable cystic fibrosis disease
• FEV1 at least 40%
• Specific CFTR gene mutations
• Uncontrolled asthma in the last year
• Oxygen saturation without oxygen therapy is >94%
• Severe liver disease
Non-Invasive Sleep and Circadian Rhythm Assessment Pre- and Post-surgery in Cushing Disease
The goal of this study is to see if using in-home sleep activity monitoring may help understand sleep problems that occur before and after surgical treatment for Cushing Disease.
• Aged 18 years or older
• Their own legal guardian
• Confirmed Cushing's Disease (CD) by biochemical test and brain MRI imaging
• Scheduled for surgery to treat CD
• Receiving care through an Endocrinology or Neurosurgery clinic
• Able to complete the self-report their health/wellbeing and sleep diary information
• Biochemical and/or brain MRI imaging test with inconclusive results
• Patients not electing for surgical intervention for CD
A double-blind, randomized, placebo-controlled study to assess the safety and efficacy of nebulized PC945 when added to systemic antifungal therapy for the treatment of refractory invasive pulmonary aspergillosis
The purpose of this study is to learn about the safety and efficacy of PC945 when given in combination with the antifungal therapy that is normally given for this condition, also known as the standard of care (SoC). This study will also assess how PC945 is processed in the body (e.g., distributed, transformed, and removed) by measuring the levels of PC945 in your blood and lungs; this is called pharmacokinetics (PK).
• diagnosis of invasive pulmonary aspergillosis that hasn't responded to treatment
• surgical or medical condition that makes participation difficult or potentially unsafe
• require care in an intensive care unit
A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations
XTMAB-16 is a new, experimental drug and is part of a group of drugs known as tumor necrosis factor alpha (TNF α) inhibitors. TNF is a protein in your body that causes inflammation. TNF α inhibitors work by suppressing part of the immune response along with reducing inflammation. We are conducting this research study to see if XTMAB-16 will help in the treatment of pulmonary sarcoidosis.
• Diagnosis of pulmonary sarcoidosis with some respiratory symptoms
• Must be taking 7.5 to 25 mg of prednisone daily and will to taper down dose
• Must be on an additional medication for the treatment of sarcoidosis
• Please contact umnsarc@umn.edu if you have any questions
• Pregnancy or breast-feeding
MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
People planning to undergo a bone marrow transplant and are at risk for developing problems with the lungs related to this planned therapy. The types and seriousness of lung problems that may develop after transplant can be very different and currently, we don’t exactly know what risk factors influence who develops them or how they may respond to therapy. Also, we do not know what the best test is to monitor lung function after transplant, especially in children and young adults. The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what is the best method for diagnosing lung problems and following how well the lungs are working. In this study, clinical information, laboratory results and imaging findings will be collected from medical records to assist researchers in learning more about lung complications after bone marrow transplant.
• up to 24 years old
• undergoing allogeneic or autologous HSCT
NAPS2: North American Prodromal Synucleinopathy Consortium Stage 2
We are recruiting only healthy participants who do not have REM sleep behavior disorder. The information gained from this study will help the investigators understand more about REM sleep behavior disorder (RBD), and the possible underlying neurologic disorders that can cause RBD.
• male
• 54 to 75 years old
• Caucasian
• history of dream enactment
• diagnosis of Parkinson's Disease, dementia, MCI, or MSA
• blood relative with REM Sleep Behavior Disorder