Search Results
Bone as Regulator of Energy Balance and Male Fertility after SCI: A Pilot Study (Osteocalcin Protocol)
This study will evaluate if there is a relationship between bone health, fertility, and metabolism to help develop future treatments for SCI. Both men with and without SCI will be participating in this trial to better understand how bone health, fertility, and metabolism are impacted by an injury to the spinal cord.
• Male age 18-50
• diagnosis of motor complete spinal cord injury (SCI)
• completed inpatient rehabilitation and living in the community
• use a wheelchair as primary mobility mode -English and non-English speakers
• For healthy volunteers: male age 18-50, able to walk independently, English and non-English speakers
• presence of other neurological condition
• use of chronic ventilator support
• metabolic bone disease
• thyroid disorder
• current use of medications potentially affecting bone health (including bisphosphonates (etidronate or didronel, clodronate or bonefos, tiludronate or skelid, pamidronate, or aredia, alendronate or fosamax, ibandronate or boniva, risedronate or actonel, zoledronate or reclast) parathyroid hormone (forteo, teriparatide, abaloparatide), denosumab (prolia), testosterone, estrogen, anti-epileptics (phenytoin or dilantin, phenobarbital, valproic acid or depakene) lithium, glucocorticoid use for more than 3 months, and those who have received inhaled glucocorticoids in the past year)
• study team will review additional exclusion criteria
• for Healthy Volunteers: presence of neurological condition, metabolic bone disease, thyroid disorder, current use of medications that potentially affect bone healthy, osteoporosis, diabetes, infertility, or other medical conditions (study staff will review)
COG AREN1921 - Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
This phase II trial studies how well combination chemotherapy works in treating patients (≤ 30 years old) with newly diagnosed stage II-IV diffuse anaplastic Wilms tumors (DAWT) or favorable histology Wilms tumors (FHWT) that have come back (relapsed).This trial may help doctors find out what effects, good and/or bad, regimen UH-3 (vincristine, doxorubicin, cyclophosphamide, carboplatin, etoposide, and irinotecan) has on patients with newly diagnosed DAWT and standard risk relapsed FHWT (those treated with only 2 drugs for the initial WT)and regimen ICE/Cyclo/Topo (ifosfamide, carboplatin, etoposide, cyclophosphamide, and topotecan) has on patients with high and very high risk relapsed FHWT (those treated with 3 or more drugs for the initial WT).
• patients must be =< 30 years old at study enrollment
• patients with newly diagnosed stages 2 - 4 diffuse anaplastic Wilms tumor and have received an initial risk assignment showing DAWT or patients with relapsed favorable histology Wilms tumor
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• patients with a history of bilateral Wilms tumor
• patients with any uncontrolled, intercurrent illness
• female patients who are pregnant or breastfeeding
Remote State Representation in Early Psychosis (Rem-STEP) (Rem-STEP)
The purpose of the current study is to test the effects of two forms of cognitive training: visual perception training or visual cognitive control training in individuals with early psychosis.
• people who have Schizophrenia, Schizoaffective disorder, Psychosis, Major depressive disorder with psychotic features, or Bipolar disorder with psychotic features
• between ages 18 and 30 except: Alabama & Nebraska 19 to 30 and Mississippi 21 to 30
• able to read and speak English,
• no hospitalizations for mental health issues in the past month
• have access to a computer with internet connection
• permanent resident of the United States
• history of substance abuse in the past month
• diagnosed with a neurological disorder
• cognitive training in the past 6 months
Natural History Study for DNA Repair Disorders
This research is being done to help us better understand the different DNA repair disorders. We will collect data and samples that we will use to develop new therapies and medicine to help treat the disease. We expect that participants will be in this research study for 3 years. Visits will occur every six months and alternate between in-person and remote. Remote visits should be expected to last 1-2 hours, and in-person visits should be expected to last 3-4 hours.
• at least 6 months old
• diagnosis of Cockayne syndrome (CS), xeroderma pigmentosum (XP), or trichothiodystrophy (TTD), based on genetic testing and/or key clinical characteristics
• have one or more of the neurodevelopmental or neurological complications such as gross motor delay, language delay, altered muscle tone (study staff will review)
• family member of an individual with the above condition
• prior history of systemic gene or cell-based therapy
• participation in a clinical trial for treatment
State Representation in Early Psychosis (STEP)
In the first phase of the study, participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews and questionnaires about their life experiences and mental health, and they will have an EEG and fMRI while completing computerized tasks. The second phase of the study is optional. In this phase, participants will test one of two forms of computerized cognitive training, or brain games. They will be asked to complete 10 hours of training over a 3-6 week period. After the training period is over, they will have two sets of follow up visits, one right after the training period and one five months later. At these appointments, participants will complete the same activities done in the first phase of this study, including the interviews, questionnaires, and imaging (fMRI and EEG) combined with computerized tasks. We are recruiting two groups of participants for this study. One group will include individuals who experience hallucinations, delusions, paranoia, or a psychosis disorder (i.e., schizophrenia), and the other group will be individuals who do not have a diagnosis or family history of schizophrenia, bipolar disorder, or autism spectrum disorder.
• able to speak and write English
• 15 to 40 years old
• diagnosis of schizophrenia, schizoaffective disorder, psychosis, bipolar disorder with psychosis, or major depressive disorder with psychosis, with psychotic symptoms starting in the past 5 years
• no hospitalizations and on stable doses of medications for the past one month or more
• For healthy volunteers without a mental health diagnosis: will match on age, sex, etc. to people enrolled in the study.
• currently pregnant
• history of neurological disorder
• previous head injury with loss of consciousness
• currently suicidal or has attempted suicide in the past 6 months
Asymmetries in motor control and their impact on functional independence
We are trying to learn more about how the brain controls movement and how this affects function after stroke. We expect differences in the side of brain damage to result in distinct movements of each arm. We will collect information with standard clinical exams and movements during tasks completed on the Kinereach virtual reality system. We will compare results between people who have and have not had a stroke.
• right-handed
• stroke occurred at least 3 months ago
• stroke on only one side of brain
• weakness on one side of the body
• able to understand instructions
• history of more than 1 stroke
• pacemaker
• pregnant
• major psychiatric diagnosis (schizophrenia, major affective disorder, substance abuse requiring hospitalization)
• significant joint pain
• arthritis
• neurological disease other than stroke
• taking prescription drugs with sedative properties
• unable to have a MRI
Role of Oxidative Stress and Inflammation in Type 1 Gaucher Disease (GD1): Potential Use of Antioxidant/Anti-inflammatory Medications
The purpose of this study is to measure levels of blood and brain chemicals related to oxidative stress and inflammation in healthy volunteers and individuals with Type 1 Gaucher disease (GD1) to see if these levels are altered by GD1. We will also examine if there is a change in these blood and brain chemicals after participants begin taking oral N-acetylcysteine (NAC), which is available both as a prescription medication and a natural product that has antioxidant and anti-inflammatory effects.
• 18 years or older
• diagnosis of Type 1 Gaucher's Disease (GD1) who are medically stable
• on a stable medication therapy for 2 years, or if dosage or drug has been changed it has been at least 6 months and condition is stable
• women who are pregnant or breast feeding
• asthma that is currently being treated
• unable to have a MRI scan
Wearable monitor for FOG detection
Freezing of gait is a common problem in people with Parkinson's disease. Episodes of freezing can be overcome when a sensory cue is provided. This study will further develop and study the efficacy of a wireless shoe insole that can monitor walking and provide a cue (acoustic or vibrotactile) when a freezing event is detected. The experiment is designed to further test the ability of the device and algorithm to reliably detect freezing and release the episode with an external cue. This study has the potential to develop a tool that can help reduce the incidence and severity of freezing events in people with Parkinson's disease.
• Age: 21 to 75 years
• Able to walk independently without the assistance of a walking aid
• History of musculoskeletal disorders
• Other significant neurological disorders
• Hallucinations
• Unable to walk
• Legally Blind
• Symptomatic low blood pressure
• Additional exclusion criteria for young and healthy controls: diagnosis of Parkinson?s disease, or a family member with a diagnosis of Parkinson?s disease.
Cardiac Sarcoidosis Consortium
This is a registry study. The Cardiac Sarcoidosis Consortium (CSC) is an international, multicenter partnership among physicians and allied professionals at major medical centers with the unifying purpose to learn more about cardiac sarcoidosis through collaborative research.
• People who have been diagnosed with Cardiac sarcoidosis (CS)
• History of ventricular tachycardia or fibrillation
• Ventricular arrhythmias treated medically or with an implanted device
Quality of life in patients who have undergone different treatments for upper airway stenosis
The objective of the study is to define quality of life in patients with upper airway stenosis after bypassing the stenosis with either tracheotomy or t-tube stenting. Participants complete surveys over 2 years to collect quality of life information.
• diagnosis of upper airway stenosis treated with tracheotomy or t-tube.
• seen at the Lions Voice Clinic
• at least 18 years old
• able to complete questionnaires in English without help
• require mechanical ventilation
• neurological conditions such as stroke, cerebral palsy, neurodegenerative disease.
• new diagnosis (less than 1 year) of head and neck cancer as the indication for tracheotomy
Cortical Inhibitory Biomarkers of Acute Suicidal States in Adolescents
Risk for suicidal behavior in young people may include particular types of brain functions. The goal of this research is to learn more about the biology of the brain as it relates to suicidal thoughts and behaviors.
• ages 13-21
• current diagnosis of depression
• prior history of either thoughts about suicide, or suicidal behaviors (a suicide attempt or a planned attempt that was stopped before it began)
• must be able to communicate verbally and in writing in English
• parental permission is needed for participants aged 17 or younger
• must have reliable internet connection
• Active substance use in the past month
• Neurological disorders such as seizures, head injury
Transcatheter Replacement of Stenotic Aortic Valve through Implantation of ACURATE in Subjects InDicatEd for TAVR
Severe aortic valve stenosis can include stiffening and hardening of the heart valve leaflets (tissue that opens and closes in the heart valve) so that the valve cannot work properly. If left untreated, excessive strain put on the heart muscle will eventually cause it to fail or lead to other serious complications. This study is a research project to assess a way of replacing aortic valves without the need for open-heart surgery and without surgically opening the heart to remove the narrowed valve. The device under study is called the ACURATE Transfemoral Aortic Valve System. The study will compare the safety and effectiveness of the ACURATE Valve, along with other commercially available TAVR devices.
• severe symptomatic aortic stenosis
• able to return to the hospital for all required follow up visits
• additional requirements from cardiac evaluation/testing (study staff will review)
• acute myocardial infarction within 30 days
• cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months
• significant medical or mental health issues including specific abnormal lab values (study staff will review)
Neurofeedback and Neural Plasticity of Self-Processing and Affect Regulation Circuits in Suicide Attempting Adolescents
The purpose of this study is to examine a new, experimental treatment for adolescents at risk for suicide attempts called neurofeedback training. In neurofeedback training, you are trying to control your brain function on purpose. In this study, your child will see their brain activity (displayed like a thermometer). He/she will recall positive memories to try to change the levels of their brain activity shown on the visual thermometer inside a scanner.
• any gender identity
• 11-17 years old
• past suicide attempt and/or current suicide ideation
• Autism Spectrum Disorder
• Cognitive Developmental Delay (IQ < 75 i.e.intellectual disability)
• diagnosis of Schizophrenia
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
Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery: A Prospective Randomized Controlled Pilot Trial
This research is being done to determine if a procedure done by the anesthesiologist, known as a paravertebral block, can decrease the chance of developing atrial fibrillation after surgery. The block consists of using a numbing medication delivered over time through two small tubes to specific spots on the upper back. There is evidence that this helps reduce the chance of atrial fibrillation after similar procedures and the potential complications of that condition.
• undergoing one of the following elective or urgent (but not emergency) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG & surgical valve replacement
• history of atrial fibrillation or flutter
• Infective endocarditis
• Left ventricular ejection fraction (LVEF) < 30%
• redo surgery
• unable to have a block because of local anesthetic allergy, bleeding problem
• Body mass index > 35kg/m2
• woman who is pregnant
APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
This study is being done to improve outcomes after kidney donation and kidney transplantation. We will test kidney donors and kidney transplant recipients for apolipoprotein L1 gene (called APOL1) variants (or forms of the gene) and to see how these may affect them. Genes control the traits inherited from your family such as your eye color or blood type. Only a blood sample (and possibly urine) will be collected. Information routinely collected as part of surgery will also be used in the study. There will not be any changes to usual medical care.
• living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African)
• people who have received a kidney transplant from an eligible living or deceased donor with recent African ancestry
• people who have received multi-organ transplants including a kidney plus an additional organ (i.e. liver, heart, lung, pancreas, etc.) or pediatric en bloc and dual kidney transplants
Role of exogenous and endogenous sex hormones on tenofovir and emtricitabine disposition in female genital tract
This study aims to determine the role of menopause and exogenous hormone use in regulating antiretroviral disposition in the female genital tract.
• at least 18 years old
• female, or transgender female with a cervix
• HIV- positive
• on a stable antiretroviral regimen containing tenofovir or emtricitabine for at least 2 weeks before starting the study
• currently pregnant, or previous pregnancy in the past 3 months, or breast feeding
• vaginal infection within 2 weeks before starting the study
• abnormal bleeding per vagina, bleeding per vagina during or following vaginal intercourse, or gynecologic surgery within 90 days prior starting the study
• use of oral and/or vaginal preparations of antibiotic or antifungal medications within 30 days prior to starting the study
Neurobiological and Psychological Maintenance Mechanisms Associated with Anticipatory Rewards in Bulimia Nervosa
The purpose of this investigation is to identify the potentially crucial role of anticipatory reward mechanisms maintaining bulimic behavior (i.e., binge eating and purging) in bulimia nervosa (BN).
• ages 18 to 55 years
• right handed
• able to read and speak English
• at least one bulimic episode and one self-induced vomiting episode per week for at least three months
• stable dose (for at least 6 weeks) in medication that affects mood, appetite, or weight
• For Healthy Participants: right handed, speak and read English, no history of eating disorder
• history of gastric bypass
• current medical or psychiatric illness instability (e.g. hospitalization in past 3 months
• history of psychosis or bipolar disorder
• current substance use disorder
• neurological disease
• BMI less than 19 kg/m^2
COCOA (COCOA-PAD II)
Few medical treatments are available to improve walking ability in patients with PAD. This research study will help determine the effects of cocoa flavanols on walking ability in people with blockages in their leg arteries. Cocoa flavanols are a type of plant nutrient found in cocoa beans. These supplements are available over-the-counter at drugstores.
• Age 55 and older
• Presence of peripheral artery disease (PAD). PAD will be defined as either an ABI <= 0.90 at baseline or vascular lab evidence of PAD or angiographic evidence of PAD.
• Unable to tolerate study pills
• Inability to walk or requiring a walker
Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients
Balance and walking problems in patients with Parkinson’s Disease do not respond well to the typical medication or surgical treatments. This research study uses five small wearable devices that attach to clothing and can measure the body’s location while performing walking tests, balance tests, and normal daily activities. By comparing patients with Parkinson’s Disease to people of similar age without Parkinson’s Disease, we hope to learn important differences relevant to the walking and balance problems in Parkinson’s Disease
• Anyone who has been diagnosed with parkinsonism including Parkinsons disease, Normal Pressure Hydrocephalus, or atypical parkinsonism
• Healthy adults of similar age as study participants
• people who have dementia of sufficient severity to impair their ability to make health-care decisions for themselves
Efficacy and Mechanisms of Combined Aerobic Exercise and Cognitive Training in MCI (The ACT Trial)
The purpose of the study is to see how aerobic exercise and cognitive training alone or together affect cognition, brain structure and function, and physical fitness over the course of 18 months.
• diagnosis of Mild Cognitive Impairment
• live in the community
• English speaking
• adequate vision
• physician confirms that exercise is safe
• stable on drugs affecting cognitive and psychological status
• able to have a MRI
• resting heart rate less than 50 or greater than 100
• additional medical or mental health diagnosis (study staff will review)
• enrolled in another intervention study related to cognitive improvement
A Clinical Trial of Cognitive Multisensory Rehabilitation for Sensory and Motor Recovery in Adults with Spinal Cord Injury
Almost 300,000 Americans with a spinal cord injury or disorder (SCI/D) suffer from reduced or complete loss of sensory and motor function, which can compromise functional independence and quality of life. The purpose of this study is to find better treatment options for improving sensation and movement after SCI/D.
• 18 to 75 years old
• incomplete or complete SCI/D of more than 3months
• medically stable.
• MRI contra-indications (stabilizing hardware is typically MRI safe)
• uncontrolled seizure disorder
• cognitive impairment and/or communicative disability (e.g., due to brain injury) that prevents following directions or learning
• ventilator dependent
• other major medical complications
• pregnant women
Autonomic regulation of blood pressure in premature and early menopausal women
The goal of this study is to learn more about the effects of menopause on women's blood pressure and heart health. We are looking for women between the ages of 35 and 70 years to participate in the study. Participants may be pre- or postmenopausal; we are specifically interested in evaluating the influence of premature (< age 40 years) and early (< age 46 years) menopause.
• 35 to 70 years old
• experienced premature (less than 40 years old) or early (45 or younger) menopause OR
• premenopausal 35-49 years of age OR
• typical-age menopause who are between 50-70 years old
• menopause will be confirmed by report of amenorrhea for 12 months
• nicotine or tobacco use within the past six months
• have diabetes or asthma
• diagnosed significant carotid stenosis
• additional medical diagnosis (study staff will review)
• women who are pregnant or breastfeeding
Surgical Timing and Rehabilitation for Multiple Ligament Knee Injuries: A Multicenter Integrated Clinical Trial (Protocol # PRO16090503)
This study is being conducted to determine when is the best time to do surgery is and when to start rehabilitation after surgery for the treatment of a multiple ligament knee injury. The study will randomize (i.e. a coin toss) when you have surgery and when you begin rehabilitation (early or delayed surgery and early or delayed rehabilitation). The type of surgery is decided between you and your surgeon. Rehabilitation is tailored to the type of surgery you have. You will fill out some questionnaires and have your knee examined at your normal postsurgery appointments with your surgeon.
• Ages 16-55
• Has a multiple ligament knee injury (MLKI is defined as a complete grade III injury of two or more ligaments)
• Prior knee ligament surgery of the involved knee
• Torn or avulsed patellar or quadriceps tendon
• Periarticular or long bone fracture that is anticipated to preclude weight-bearing after surgery
• Require use of an external fixator for greater than 10 days
• Planned staged surgical treatment
• Unable to weight bear on the contralateral uninjured leg
• Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care
• Surgical procedures that precludes early weight-bearing or range of motion
Characterization of spleen motion and anatomy using imaging and sensors
This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).
• at least 18 years old
• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
Stress Response and Opioid Dysfunction in Nicotine Dependence
This study includes healthy adults between 18-70 years old who are either non-smokers or cigarette smokers interested in quitting. The purpose of this study is to learn more about how people respond to stress and to taking one dose of a widely and safely used drug called naltrexone as well as to learn about how these responses relate to whether or not someone smokes, smoking cessation, and smoking relapse.
• Between 18-70 years old
• generally healthy
• want to quit using tobacco and nicotine
• willing to attend study visits over a period of approximately 4 months (though you may be asked to complete the last visits over a period of up to 1 year)
• have access to an internet-enabled device
• current, uncontrolled hypertension (high blood pressure)
• current cardiac or other chronic diseases
• current opiate dependence, recent daily opiate use, or use of any narcotic medication
• women who are pregnant
• currently taking Naltrexone
Prospective quantitative kinematic assessment of patients with normal pressure hydrocephalus
The purpose of this research is to better understand balance and walking in patients with normal pressure hydrocephalus. Balance and walking problems in patients with normal pressure hydrocephalus do not respond well to the typical medication treatments. This research study uses small wearable devices that attach to your clothing and can measure your body’s location while performing walking and balance tests.
• People who have dementia of sufficient severity to impair their ability to make health-care decisions
• People who have other types of Parkinson's Disease
• People who are unable to stand without help
Determinants of Renal Structural Responses to Enzyme Replacement Therapy (ERT) in Fabry Disease Study (LDN6702)
The effect of enzyme replacement therapy on how well your kidneys are responding to enzyme replacement therapy (ERT) is not clear from blood and urine tests alone, but may be more clear in comparisons of kidney biopsies performed before and some time after ERT has been initiated, and this is what we are focusing our study efforts on. The purpose of this study is to obtain your permission to allow us to study the kidney biopsy tissues (collected for medical reasons) after the regular routine studies have been completed. Through our special research measurements and additional study, we hope to be able to see and measure very specific changes in the kidney tissues from Fabry patients taking ERT. We also hope that through these studies of what happens within the kidney before and after starting ERT, we are able to reveal valuable information about the importance of factors like your age that you started ERT, the amount or dosage of ERT, and any differences seen between males and females.
• diagnosed with Fabry disease and a clinical decision has been made to obtain a kidney biopsy, a GFR, and urinary albumin studies
• have previously completed clinical trials which included measures of renal function and renal biopsies
• serum creatinine more than 2.5 mg/dL
• known to have a renal disease other than Fabry
Minnesota Neurogenetics Repository
This research study is for participants who have an inherited neuromuscular disorder or neurogenetic disorder, or family members are unaffected by such disorders.
• any one with a genetic neurological or muscle disease
• family member with a genetic neurological or muscle disease
• none
A person-centered employment preparation program for adolescents and young adults with autism spectrum disorder and their families
This study includes the development and evaluation of a person-centered employment preparation program for families of transition-aged youth with autism.
• between the ages of 15-25
• have a medical diagnosis of Autism Spectrum Disorder (ASD) or educational eligibility for special education services under the category of autism
• verbally fluent (can speak in complete sentences and have basic conversation) and speak and understand English
• have access to WiFi and two devices with webcams
• at least one caregiver are able to commit to attending 8 90-minute virtual intervention sessions
• do not live in MN
• medical, behavioral, or mental health concerns that make it too difficult to participate in the study or that necessitates a higher level of care