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Use of High-resolution Manometry to Detect Upper Airway Obstruction During Sleep

Obstructive sleep apnea (OSA) is a major public health issue in both children and adults, present in 1-5% of children and 10-30% of adults. It is characterized by repeated episodes of airway obstruction during sleep, leading to brain arousal, sympathetic activation, oxygen desaturation, sleep fragmentation, and non-restorative sleep. Patients report daytime tiredness, insomnia, and morning headaches. Children with OSA experience daytime somnolence, difficulties at school, behavioral problems, enuresis, and reduced quality of life. If left untreated, OSA can lead to numerous complications including hypertension, cardiovascular disease, stroke, and insulin resistance. Sleep partners are also affected, with patients viewing their disorder as a burden and sleeping in separate rooms. Further, disease prevalence is increasing as obesity increases. Continuous positive airway pressure (CPAP) is the current gold standard treatment for OSA. If used effectively and consistently, it can improve patient symptoms. However, adherence is generally poor, with patients experiencing physical discomfort, chest discomfort, and dry mouth. For those patients that cannot tolerate CPAP, surgical intervention is an option. In children, this typically starts with adenotonsillectomy. However, 20-75% of children will have persistent symptoms after adenotonsillectomy. In adults, anatomic factors including tonsil hypertrophy and redundant pharyngeal tissue can contribute to upper airway obstruction and may also necessitate higher pressures for effective CPAP treatment. Even if surgical intervention does not cure the OSA, it may make CPAP more tolerable and improve CPAP adherence. Sleep-related airway obstruction is a complex phenomenon potentially involving multiple anatomic levels. For patients with persistent symptoms despite initial therapy or intolerance to CPAP, further evaluation of the upper airway is clinically valuable. Polysomnography (PSG) is the gold standard for diagnosing OSA, but it does not provide information on the location(s) of upper airway obstruction. Knowledge of the precise sites of obstruction is critical to planning effective sleep surgery. Currently, this is accomplished with drug-induced sleep endoscopy (DISE). DISE was originally proposed in 1991 and involves administering anesthetic to a patient to simulate a sleep state, and then visualizing the upper airway using transnasal flexible endoscopy. Sites of obstruction at key locations including the adenoids, soft palate, lateral oropharynx, tongue base, and epiglottis can be identified. Though DISE offers valuable clinical information, it has notable limitations. First, it cannot evaluate the entire upper airway simultaneously, as any obstruction occurring superiorly precludes visualization of any obstruction occurring more inferiorly. Second, interpretation of DISE is subjective and there is no universally accepted system for analysis. Rating systems are qualitative, using grades such as complete, partial, or no obstruction as opposed to quantitative measurements. The optimal sleep assessment would be quantitative, reliable, and provide information on the entire upper airway simultaneously. A potential alternative to DISE which could meet these criteria is sleep manometry. Measurement of upper airway pressures captures the effects of obstruction along the entire upper airway, from the nasopharynx to larynx. Prior studies have attempted to employ manometry, but have been limited primarily by inadequate equipment and suboptimal methods of data analysis. Woodson et al. used a solid-state manometer with diameter of 2.3 mm and 5 sensors to detect palatal obstruction and tongue base obstruction in patients with OSA. They also used the same approach to detect persistent tongue base obstruction following uvulopalatopharyngoplasty. While these studies help demonstrate that manometry can be a useful adjunct to OSA assessment, they are severely limited both by the type of manometer used as well as the lack of a clear, detailed description of the method of data analysis. High-resolution manometry (HRM) uses pressure censors spaced 1 cm apart to allow for pressure measurement along the entire upper airway. The investigators have previously applied HRM to assessment of swallow physiology. Sophisticated methods of automated data analysis have been developed that have been shown to be reliable for both expert and novice users . Further, pattern recognition techniques have been applied to identify dysphagia and specific swallowing abnormalities. Application of this technology and modification of existing data analysis platforms will allow for a quantitative, reliable, and comprehensive assessment of upper airway obstruction during sleep in both children and adults, with potential for development of algorithms to predict effects of targeted surgical therapy at all levels of the upper airway.
Timothy Mcculloch
All
5 Years to 90 Years old
NA
This study is also accepting healthy volunteers
NCT04139499
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Inclusion Criteria:
ADULTS
• Age 18-90
• Any participant undergoing sleep endoscopy as part of standard clinical care would be eligible. This entails physician concern for sleep-disordered breathing and corresponding questionnaire and/or polysomnogram results supporting a diagnosis of obstructive sleep apnea.
• Participants without apnea are eligible, provided they are undergoing tonsillectomy or bronchoscopy for either chronic tonsillitis or airway assessment without concern for history of sleep apnea.
• Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential. CHILDREN
• Age 5-17
• Any patients undergoing sleep endoscopy as part of standard clinical care would be eligible.
• Participants undergoing either tonsillectomy for chronic tonsillitis or bronchoscopy for airway assessment.
• Women with childbearing potential will not be excluded, as the proposed experiment would have no potential ramifications on childbearing potential.
Exclusion Criteria:

• Participant desire to avoid added anesthesia time.
• Inability to safely tolerate the added anesthesia time (about 5-10 minutes) for the experiment (as judged by either otolaryngologist or anesthesiologist).
• Pregnant women
• Vulnerable groups (i.e., prisoners, individuals lacking consent capacity, individuals unable to read the consent form).
Acute obstructive laryngitis [croup] and epiglottitis, Obstructive Sleep Apnea
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E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease

This study is designed to enhance the understanding of the possible health effects of e-cigarette use by relating the acute and long-term use of e-cigarettes and conventional cigarettes ("products") to well-validated cardiovascular and pulmonary disease biomarkers. Participants will be enrolled in 3 groups: exclusive e-cigarette users, exclusive cigarette smokers, and a control group of never-users. Participants can expect up to 4 weeks of study participation.
James Stein
All
18 Years and over
NA
This study is also accepting healthy volunteers
NCT03863509
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Inclusion Criteria:

• able to read and write English
• no plans to quit smoking and/or e-cig use in the next month
• not using cigars/smokeless/snus tobacco >/= 1 time per week
• having a stable pattern of current product use
• able to walk at least 2 blocks without assistance or stopping
• Specific to Exclusive Smokers:
• smokes daily
• >/= 5 cigs/day for last 6 months
• < 3 uses E-cigs in lifetime
• >/= 5 ppm carbon monoxide (CO)
• Cotinine > 100 ng/ml
• Specific to Exclusive E-cig users:
• >/= 5 days per week E-cig use for last 3 months
• Cotinine > 100 ng/ml
• Specific to Never-users
• < 100 cigarettes in a lifetime, none for > 5 years
• < 3 E-cig uses in a lifetime
• Continine < 100 ng/ml
Exclusion Criteria:

• current use of a smoking cessation medication
• women who are pregnant or plan to get pregnant in the coming month
• women who might be pregnant
• incarcerated individuals
• history of sarcoidosis in past 5 years, or active interstitial lung/pulmonary fibrosis
• history of positive COVID-19 test
Tobacco Use, E-Cigarette Use, Cardiovascular Diseases, Pulmonary Disease, Nicotine dependence, Secondary hypertension, Atherosclerosis, Tobacco use, Prevention & Screening, Heart & Vascular, Lung & Respiratory
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Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
Mai Elezaby, MD
Female
45 Years to 74 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03233191
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Inclusion Criteria:

• Women of childbearing potential must not be known to be pregnant or lactating
• Patients must be scheduled for, or have intent to schedule, a screening mammogram
• Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility
• Patients must be willing and able to provide a written informed consent
• Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
• Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
• Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
• Patients must not have breast enhancements (e.g., implants or injections)
• ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
• To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:
• Patients are pre-menopausal; OR
• Post-menopausal aged 45-69 with any of the following three risks factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
• Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
• Currently on hormone therapy; OR
• Post-menopausal ages 70-74 with either of the following two risk factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
• Currently on hormone therapy
• Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
• All other postmenopausal women are eligible for inclusion in the biennial screening regimen
• For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND have not had a prior mammogram, breast density will be determined by the radiologist?s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic DM portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
• Breast density will be determined by prior mammography reports, when available; all other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report
Breast Screening, Malignant neoplasms of breast
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Safety, Tolerability, and Pharmacokinetics of MK-1654 in Infants (MK-1654-002)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of MK-1654 in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.
Ellen Wald, MD
All
up to 8 Months old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT03524118
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Inclusion Criteria:

• is healthy, based on screening safety laboratory, medical history, and physical examination results
• is a pre-term infant (born at 29 weeks to 35 weeks gestational age [inclusive]) or a full-term infant (born at over 35 weeks gestational age), as confirmed in medical records
• weighs ≥2 kg at screening
Exclusion Criteria:

• has been recommended to receive palivizumab per local standard of care
• has ≥1 documented out-of-range safety laboratory results (adjusted for age) at the time of screening
• has a known hypersensitivity to any component of the respiratory syncytial virus (RSV) monoclonal antibody
• has a history of congenital or acquired immunodeficiency (e.g., splenomegaly)
• has documented human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive), or hepatitis C (HCV ribonucleic acid [RNA] positive)
• has known history of functional or anatomic asplenia
• has a diagnosis of failure to thrive within 14 days of screening
• has known or history of a coagulation disorder contraindicating intramuscular injection
• has received or is expected to receive blood products (except irradiated platelets) within 3 months prior to enrollment
• has prior known documented RSV infection
• has hemodynamically significant congenital heart disease
• has chronic lung disease of prematurity requiring ongoing medical therapy
• has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that, in the opinion of the investigator, might expose the participant to undue risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study
• has any history of malignancy prior to randomization
• if any of the following apply, the Day 1 visit may be rescheduled for a time when these criteria are not met:
• has had a recent febrile illness (rectal temperature 38.1°C [100.5°F] or higher or axillary temperature 37.8°C [100.0°F] or higher) within 72 hours pre-dose
• is not up-to-date on required vaccinations per local pediatric vaccine schedule at time of screening
• has received inactivated or component vaccines (eg, influenza, hepatitis B) less than 14 days pre-dose
• has received live, attenuated, non-study licensed pediatric vaccines (e.g., Bacillus Calmette-Guerin vaccine) less than 30 days pre-dose
• has received any prior vaccine or monoclonal antibody (mAb) for the prevention of RSV
• is currently participating in or has participated in an interventional clinical study with an investigational compound or device at any time prior to first dose administration or while participating in this current study (participants enrolled in observational studies may be included and will be reviewed on a case-by-case basis for approval by the Sponsor)
• has enrolled previously in this study and been discontinued
• participant's mother participated in a RSV vaccine clinical study while pregnant and participant is ≤3 months of chronological age
• is unable to provide blood sample at screening
• cannot be adequately followed for safety according to the protocol plan
• has a parent/legally acceptable representative who is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study
• is, or has, an immediate family member (eg, spouse, parent/guardian, sibling, or child) who is directly involved with the study at the site or with the Sponsor
Respiratory Tract Infection, Respiratory Syncytial Virus, Healthy Volunteers, Lung & Respiratory, Children's & Adolescent Health, Prevention & Screening
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Stroke Prevention in the Wisconsin Native American Population

This project will develop a "Stroke Awareness Team" including training of Oneida Health Service Coaches working in partnership with the UW team for a population-based health awareness program. This team will develop a series of Oneida Nation Healthy Living and Stroke Awareness Events (from now on health events) to provide education as to the severity of the problem as well as our standard therapies for lifestyle change and risk factor avoidance. This will include education of the healthy members of the tribe including the children to identify signs of stroke and TIA in their elders as well as to develop healthy lifestyles at the earliest of ages to influence the elders to modify their risks.
Robert Dempsey, MD
All
55 Years to 80 Years old
N/A
This study is also accepting healthy volunteers
NCT04382963
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Inclusion Criteria:

• Participants receiving health care through the Oneida Health Council Program
• Participants deemed to be at high risk for stroke by modified Framingham assessment of medical history, including cerebral cardiovascular symptomatology, hypertension, diabetes, smoking, BMI
• Willingness to participate in the study, including two-year follow-up
• Controls will be selected using the same criteria with the exception that upon screening, they are not deemed to be at high risk for stroke.
Exclusion Criteria:

• Presence of established dementia
• Inability to participate in physical and exercise programs due to preexisting disability
• Illiteracy
• Prior carotid procedure altering ultrasound finding
• Presence of medical condition precluding participation or follow-up over a two-year period of time.
Stroke, Atherosclerosis, Cerebral infarction, Brain & Neurological, Prevention & Screening
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