1.
ClinicalTrials.gov; 23/08/2023; TrialID: NCT06020703
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06020703
ABSTRACT
Condition:
Critical Illness;COVID-19;PICS;Cognitive Impairment;Mental Health Impairment;Weakness, Muscle;DysbiosisIntervention:
Behavioral: Fermented Food DietPrimary outcome:
Feasibility of high fermented food diet among critical illness survivors;gut microbiome diversityCriteria:
Inclusion Criteria:
- patients who have survived critical illness, including severe COVID, and are at risk for
mental health morbidity/long COVID (spent >48 hours in the ICU or had COVID requiring ICU
stay) who have a smartphone, are enrolled into the Mayo PICS clinic, and have at least one
PICS-related impairment. Cognitive impairment, if present, has to be in the mild range to
ensure patient can provide consent and follow study instructions
Exclusion Criteria:
- History of dementia, mental retardation, psychotic disorders such as schizophrenia,
patients not expected to survive the hospital stay or non-English speaking, participants
not able to tolerate foods by mouth or those with potential contraindications to such diet
(chronically immunosuppressed including organ transplant recipients; those with neutropenia
or currently undergoing chemotherapy, those taking Monoamine oxidase inhibitors).
2.
ClinicalTrials.gov; 22/08/2023; TrialID: NCT06006884
Clinical Trial Register
| ICTRP | ID: ictrp-NCT06006884
ABSTRACT
Condition:
COVID-19Intervention:
Procedure: Bronchoscopies and Bronchoalveolar Lavages (BALs);Diagnostic Test: Chest Tomography (CT);Diagnostic Test: Electrocardiogram (ECG);Diagnostic Test: Pulmonary function tests (PFTs);Diagnostic Test: 6 minute walk test (6MWT)Primary outcome:
Decipher clinical, imaging, immune, molecular and/or viral traits underlying post-acute COVID-19 lung sequelaeCriteria:
Inclusion Criteria:
For the Sequelae Group
- Age =18 years at screening, PCR confirmed COVID19 illness (+PCR defines day 0 of
illness), hospitalization for COVID-19, absence of pre-existing history of
interstitial lung disease, or significant other lung disease.
- Severity of illness will be categorized as moderate disease (supplemental oxygen need
1-8L at any time during hospitalization), severe disease (need for high flow oxygen
delivery =8L at any time during hospitalization) and critical illness (need for ICU
admission or mechanical ventilation).
Control Recovery Group
- Age =18 years at screening
- PCR confirmed COVID-19 cases who had nonsymptomatic or mild acute infection that do
not require hospitalization 7,48,49
- Absence of pre-existing history of interstitial lung disease, or significant other
lung disease, absence of any ongoing respiratory and systemic symptoms.
Exclusion Criteria:
- Inability to provide informed consent, evidence of pre-existing interstitial lung
disease or chronic lung disease;
- Active cigarette smoking, vaping or other inhalation use.
- Immunocompromised host status due to ongoing therapy with methotrexate, CellCept,
azathioprine, rituximab, cyclophosphamide or other biologic agents;
- > 20 pack year smoking history.
- History of chemotherapy or radiation therapy in the last two years; and pregnancy.
3.
ClinicalTrials.gov; 24/07/2023; TrialID: NCT05969860
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05969860
ABSTRACT
Condition:
Advanced Malignant Solid Neoplasm;Advanced Anal Carcinoma;Advanced Biliary Tract Carcinoma;Advanced Bladder Carcinoma;Advanced Breast Carcinoma;Advanced Carcinoid Tumor;Advanced Cervical Carcinoma;Advanced Colorectal Carcinoma;Advanced Gastric Carcinoma;Advanced Glioblastoma;Advanced Head and Neck Carcinoma;Advanced HER2 Positive Breast Carcinoma;Advanced Lung Carcinoma;Advanced Lung Small Cell Carcinoma;Advanced Malignant Germ Cell Tumor;Advanced Neuroendocrine Carcinoma;Advanced Ovarian Carcinoma;Advanced Pancreatic Carcinoma;Prostate Small Cell Neuroendocrine Carcinoma;Advanced Prostate CarcinomaIntervention:
Procedure: Clinical Encounter;Other: Home Health Encounter;Other: Quality-of-Life Assessment;Other: Questionnaire AdministrationPrimary outcome:
Mean patient-reported rating of Cancer Connected Access and Remote ExpertiseCriteria:
Inclusion Criteria:
- Female or male patients with histologically confirmed malignancy who are currently
receiving treatment with one of the following eligible chemotherapy treatment
regimens:
- Cisplatin/gemcitabine for bladder, lung, biliary, or breast cancer
- Gemcitabine for pancreatic or ovarian cancer
- Cisplatin/etoposide for small cell lung cancer, germ cell carcinoma, small cell
prostate cancer, and neuroendocrine/carcinoid cancer
- Cisplatin for lung, bladder, head and neck, cervical, and breast cancer, and
glioblastoma
- Avastin for glioblastoma, breast, colorectal, and cervical cancer
- Cisplatin/fluorouracil (5-FU) +/- Avastin for anal cancer
- 5-FU/leucovorin +/- Avastin for colorectal or gastric cancer
- FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal cancer
- Paclitaxel for breast or bladder cancer
- Trastuzumab maintenance for Her-2 positive breast cancer
- Trastuzumab + paclitaxel for Her-2 positive breast cancer
- Leuprolide for prostate and breast cancer (monthly or every three month regimen
only)
- Goserelin acetate for breast cancer
- Patient has had adequate tolerability of their clinical standard of care chemotherapy
treatment in the opinion of their treating physician and no drug-related infusion
reactions prior to consent.
- Patients have no documented reason to suspect they won't continue the treatment
regimen they are currently prescribed for at least 24 weeks of treatment
- Residing within 35 miles of clinic (hub) or within the area serviced by supplier and
paramedic network
- Residence has wireless fidelity (Wi-Fi) to enable a reliable connection with the
remote Command Center
- Age >= 18 years at time of registration
- Signed informed consent form by patient
- Willing and able to comply with the study protocol in the investigator's judgment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
- Ability to complete questionnaire(s)
- RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by
the CCBW Command Center that the patient has adequate tolerability to the standard of
care chemotherapy treatment and no drug-related infusion reactions since
pre-registration and prior to registration
Exclusion Criteria:
- Receiving any other investigational or standard of care agent which would be
considered as a treatment for the primary neoplasm and is not part of the eligible
treatment regimens (except hormone therapy for breast or prostate cancer)
- Requiring 24/7 assistance with activities of daily living (ADLs)
- Current inpatient hospitalization (excluding admission to the Advanced Care at Home
program)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Myocardial infarction =< 6 months
- Wound healing disorder
- Or psychiatric illness/social situations that would limit compliance with study
requirements
- Patients with any severe infection within 4 weeks prior to registration including, but
not limited to, hospitalization for complications of infections should not be enrolled
in the trial (in the current situation, this also applies to patients with suspected
or confirmed coronavirus disease 2019 [COVID-19] infection)
- Anticipation of the need for major surgery during the course of study treatment
4.
ClinicalTrials.gov; 21/12/2022; TrialID: NCT05674370
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05674370
ABSTRACT
Condition:
COVID-19;InfluenzaIntervention:
Device: GRIP Electronic Diagnostic Chip;Diagnostic Test: Laboratory-based nucleic acid amplification tests (NAATs)Primary outcome:
Positive Percent Agreement;Negative Percent AgreementCriteria:
Inclusion Criteria:
- Patients being tested for COVID 19 or Influenza
Exclusion Criteria:
- Patients < 18 years of age
5.
ClinicalTrials.gov; 08/07/2022; TrialID: NCT05456243
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05456243
ABSTRACT
Condition:
Kidney TransplantIntervention:
Biological: Low dose adipose tissue derived mesenchymal stromal cells (A-MSC);Biological: High dose adipose tissue derived mesenchymal stromal cells (A-MSC)Primary outcome:
Worsening kidney allograft rejection;Adverse EventsCriteria:
Inclusion Criteria:
- Able to understand and provide informed consent.
- Have received a renal transplant (first or repeat), and the most recent protocol
biopsy within 3 months of consent is diagnostic for ABMR or cellular rejection.
Clinical Inclusion Criteria:
- Stable renal function:
- Serum creatinine at the time of surveillance biopsy cannot be > 15% greater than the
serum creatine prior to the biopsy (must be within 3 months of the biopsy);
- Estimated eGFR > 30 ml/min by MDRD.
Histologic Criteria for Eligibility:
- ABMR: microvascular inflammation scores for glomerulitis (g) and peritubular
capillaritis (ptc) (g:1 or 2; ptc:1 or 2).
- Cellular rejection: tubulitis (t) (t:1or 2); interstitial inflammation (i) (i:1 or 2);
intimal arteritis (v) (v: 1 or 2).
- Mixed ABMR and cellular rejection.
Exclusion Criteria:
- Nephrotic range proteinuria (= 3.5g/24h), detected more than once in the year
preceding screening.
- History of post-transplant intervention for obstructive uropathy
- One or more of the following laboratory values:
o Hemoglobin (Hb} = 8 g/dL, Potassium (K) = 5.5 mEq/dL, Alanine aminotransferase (ALT)
= 60 U/L, Hemoglobin A1C (HbA1c) = 7%, International Normalized Ratio (INR) = 2.0,
Platelet count < 50 x 109/L (patients who receive a platelet transfusion to increase
their platelet count will not be excluded).
- One or more of the following parameters:
o Temperature = 38°C (100.4°F), Respiratory rate = 20/min, Oxygen saturation (SpO2) =
90%, Systemic systolic blood pressure >160mmHg or < 100 mmHg, Pulse < 45/min or >
140/min
- Patients with the following grades/classes of vascular diseases:
- NYHA Class 3-4 CHF
- Uncontrolled arrhythmia, defined as: atrial fibrillation with rapid ventricular
response, supraventricular tachycardia, Wolff-Parkinson-White syndrome,
ventricular fibrillation, or sick sinus syndrome. Subjects with rate-controlled
chronic atrial fibrillation will be allowed to participate.
- Cerebrovascular accident (CVA) within 90 days of screening
- Peripheral Arterial Disease (PAD), patients who have had prior vascular
interventions for PAD in the index lower extremity.
- Acute illness within 30 days of screening.
- History of allergy or intolerance to iodinated contrast agents
- Women of childbearing potential or male subjects with female partners of childbearing
potential unwilling to use an effective method of contraception during and for 12
months post-treatment.
- History of or current evidence of alcohol abuse, illicit drug use or dependence
- Active COVID 19 or positive test for the SARS-CoV-2 virus
- History of malignancy within 5 years of enrollment. History of adequately treated
in-situ cervical carcinoma and/or adequately treated skin cancer (basal or squamous
cell) will be permitted
- Serologic evidence of human immunodeficiency virus 1 or 2 infection
- Epstein Barr Virus (EBV) sero-negativity (EBV naïve)
- Cytomegalovirus (CMV) sero-negativity
- Active post-transplant opportunistic infections at the time of screening (CMV, BK
virus, polyoma virus, EBV)
- Active Hepatitis B or Hepatitis C infection (e.g. NAT positive), and/or HBV core
antibody positivity. Subjects with previously treated Hepatitis C (NAT negative, HCV
IgG positive), or those with HBV surface antibody positive but HBV core antibody
negative subjects will not be excluded from the study.
- Have received a kidney transplant from a Hepatitis C positive donor and plan to
receive anti-viral treatment after transplant
- Any chronic condition for which anti-coagulation cannot be safely interrupted for
kidney biopsy based on the CHA2DS2-VASc score of = 6 risk stratum. If subjects fall
into either the high or the moderate thrombotic risk, they will be deemed to be not
safe to interrupt anticoagulation:
- High thrombotic risk: Mechanical heart valve: Any mitral valve prosthesis, any
caged-ball or tilting disc aortic valve prosthesis, recent (within 6 months)
stroke or transient ischemic attack; Atrial Fibrillation: CHADS2 score 5-6,
CHA2DS2-VASc score 7-9, recent (within 3 months) stroke or transient ischemic
attack, rheumatic valvular heart disease; Venous thromboembolism: Recent (within
3 months) VTE, severe thrombophilia (e.g. deficiency of protein C, protein S, or
antithrombin; antiphospholipid antibodies; multiple abnormalities)
- Moderate thrombotic risk: Mechanical heart valve: Bileaflet aortic valve
prosthesis and 1 or more of the of following risk factors: atrial fibrillation,
prior stroke or transient ischemic attack, hypertension, diabetes, congestive
heart failure; Atrial Fibrillation: CHADS2 score 3-4, CHA2DS2-VASc score 4-6;
Venous thromboembolism: VTE within the past 3 to 12 months, non-severe
thrombophilia (e.g. heterozygous factor V Leiden or prothrombin gene mutation),
recurrent VTE
- For all other subjects, anticoagulation can be safely interrupted for 3 days
prior to infusion and resumed a day after the infusion.
- Positive pregnancy test
- Participation in any other studies that involved investigational drugs or regimens in
the preceding year
- Any other condition, in the investigator's judgment, that increases the risk of A-MSC
infusion or prevents safe trial participation
- Unwilling or unable to adhere to study requirements and procedures
- Per Banff criteria category 6: the presence of other changes not considered to be
caused by acute or chronic rejection, BK-Virus Nephropathy, Posttransplant
Lymphoproliferative Disorder, Calcineurin Inhibitor Toxicity, Acute Tubular Injury,
Recurrent Disease, De Novo Glomerulopathy (Other Than TG), Pyelonephritis or
Drug-Induced Interstitial Nephritis
6.
ClinicalTrials.gov; 01/07/2022; TrialID: NCT05445427
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05445427
ABSTRACT
Condition:
Post COVID Syndrome;Fatigue;HeadacheIntervention:
Device: vagal nerve stimulatorPrimary outcome:
Change in Post-COVID Functional Status ScoreCriteria:
Inclusion Criteria:
- Presence of fatigue and post exertional malaise.
- Presence of headache
- Clinical diagnosis of post COVID syndrome.
- They have consented to participate in the study
- They have the ability to participate in all aspects of the study.
Exclusion Criteria:
- Pregnant.
- Prior adverse reaction to 14FDG.
- Active implantable medical device e.g. pacemaker, hearing aid implant
- Metallic device e.g. stent, orthopedic hardware in neck
- Using another electronic device at the same time e.g. TENS, mobile phone.
- Any other condition deemed exclusionary by the study principal investigator
7.
ClinicalTrials.gov; 11/05/2022; TrialID: NCT05376319
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05376319
ABSTRACT
Condition:
Granulomatosis With Polyangiitis;Microscopic Polyangiitis;ANCA Associated VasculitisIntervention:
Drug: Obinutuzumab;Drug: RituximabPrimary outcome:
Number of patients to achieve both complete remission and seronegativity for ANCA.Criteria:
Inclusion Criteria:
- Fulfillment of the definitions of the Second Chapel Hill Consensus Conference for
ANCA-associated vasculitis (either granulomatosis with polyangiitis or microscopic
polyangiitis).
- Positivity for ANCA, directed against proteinase-3 (PR3)
- Severe newly-diagnosed disease or severe relapsing disease. Severe relapsing disease
is defined as at least one major BVAS/WG item or a score = 3 and the investigator
deems standard treatment for severe disease is necessary.
- Minimum BVAS/WG of 3
- Relapsing patients must have B cells detectable in the peripheral blood.
- Patients must have completed COVID19 vaccination (including booster if eligible) at
least 4 weeks prior to enrollment with a positive spike protein antibody test result.
Patients who have recovered from COVID19 prior to screening with a positive spike
protein antibody test result but have not been vaccinated are also eligible.
- Female subjects of childbearing potential who are not sterile must agree to use an
acceptable method of contraception for 18 months after the last dose of infusion
medication. Male subjects who are not sterile whose female partners are of
childbearing potential must agree to use an acceptable method of contraception for 180
days after the last dose of infusion medication.
- Females of childbearing potential include any female who has not undergone
successful surgical sterilization (hysterectomy, bilateral tubal ligation, or
bilateral oophorectomy) or is not postmenopausal (to be considered
postmenopausal, the patient must have had amenorrhea for >12 consecutive months).
- Acceptable methods of contraception include the use of at least two of the
following: 1) intrauterine device; 2) hormonal contraceptives for at least 30
days prior to first dose infusion (oral, injectable, implant or ring); 3) barrier
contraceptives (condom or diaphragm) with spermicide; or 4) abstinence.
Exclusion Criteria:
- Diagnosis with eosinophilic granulomatosis with polyangiitis (formerly Churg-Strauss
syndrome) as defined by the Chapel Hill Consensus Conference.
- Positive serum assays for ANCA directed against myeloperoxidase (MPO-ANCA)
- Non-severe AAV, defined as disease that does not justify treatment with both B cell
depletion and a four-month glucocorticoid taper.
- Any of the co-morbidities:
- Allergies: a history of severe allergic reactions to human or chimeric monoclonal
antibodies or murine protein.
- Infection (systemic): an active systemic infection at screening visit
- Infection (deep space): have been diagnosed as having a deep-space infection,
such as osteomyelitis, septic arthritis, or pneumonia complicated by empyema or
lung abscesses, within 6 months prior to the screening visit
- Infection (blood borne): active hepatitis B or active hepatitis C or a documented
history of HIV, hepatitis B, or hepatitis C
- Infection (history): History of recurrent significant infection or history of
recurrent bacterial infections
- Liver disease: acute or chronic liver disease that is deemed sufficiently severe
to impair their ability to participate in the trial.
- Renal disease: a history of documented anti-glomerular basement membrane disease
(anti-GBM disease).
- Malignancy: Active or history of malignancy in the last 5 years. Individuals with
squamous cell or basal cell skin carcinomas and individuals with cervical
carcinoma in situ may be enrolled if they have received curative surgical
treatment.
- Active COVID-19 infection.
- Uncontrolled disease: evidence of glucocorticoid dependent disease (such as
asthma, COPD, psoriasis or IBD, etc.) requiring consistently greater than 10 mg
of prednisone for disease control which might affect endpoint assessment or,
- Other uncontrolled diseases, including any uncontrolled psychiatric disorders,
drug and alcohol abuse, that could interfere with participation in the trial
according to the protocol.
- Diagnosis of human anti-chimeric antibodies (HACA) formation.
- Subjects who are premenopausal and are:
- Pregnant on the basis of a serum pregnancy test,
- Breastfeeding, or
- Do not agree to use effective method(s) of contraception
- Use of prohibited medications: They have used any of the prohibited medication listed
in Section 5.9.1.
- Plasma exchange: They have been treated with plasma exchange within the 3 months
preceding the screening visit.
- History of intolerance to rituximab or other chimeric monoclonal antibodies (e.g.,
infliximab).
- Recent vaccination: They have had a live vaccine fewer than 4 weeks (28 days) before
or during randomization (vaccination with live vaccine through the end of study
participation is contraindicated).
- Daily use of non-steroidal anti-inflammatory drugs (NSAIDs)
- Exclusion criteria related to laboratory parameters:
- Bone marrow suppression as evidenced by a total white count < 4 x10 /l,
hemoglobin < 7 gm/dl or platelet count < 100,000/µl
- Aspartate aminotransferase or alanine aminotransferase or amylase > 2.5 times the
upper limit of normal, unless attributed to vasculitis
8.
National Technical Information Service; 2021.
Non-conventional
in English
| National Technical Information Service | ID: grc-753723
ABSTRACT
The present moment is not the first time that America has found itself at war with a pathogen during a time of international conflict. Between crowded barracks at home and trenches abroad, wartime conditions helped enable the spread of influenza in the fall of 1918 during World War I such that an estimated 2040% of U.S. military members were infected. While the coronavirus disease 2019 (COVID-19) pandemic is unparalleled for most of todays population, it is essential to not view it as unprecedented lest the lessons of past pandemics and their effect on the American military be forgotten. This article provides a historical perspective on the effect of the most notable antecedent pandemic, the Spanish Influenza epidemic, on American forces with the goal of understanding the interrelationship of global pandemics and the military, highlighting the unique challenges of the current pandemic, and examining how the American military has fought back against pandemics both at home and abroad, both 100 years ago and today.
9.
National Technical Information Service; 2020.
Non-conventional
in English
| National Technical Information Service | ID: grc-753521
ABSTRACT
In the current military and healthcare environment, it is essential to focus on rapid but safe development of functional skills with a goal of early discharge from rehabilitation to return to active duty or civilian life. Although the U.S. military has access to state-of-the-art treatment and devices, warfighters with lower extremity trauma still struggle to regain full functional capabilities. A key factor that limits the ability of these individuals to achieve maximum functional capabilities is falls. Falls have serious consequences including loss of confidence, fear of falling, and injury. Warfighters with lower extremity trauma need to face the risk of falling and overcome that fear. After standard rehabilitation for amputation or limb salvage, many warfighters still struggle with falls, which can exacerbate physical and emotional injury and delay healing. When individual strip or slip, they are likely to fall and injure themselves, in spite of advances in rehabilitation care. This project develops a secondary rehabilitation program, implemented after traditional therapy, and designed to reduce falls in warfighters with amputations or limb preservation procedures. The goals of this research effort are to augment existing rehabilitation with a novel, demonstrably successful fall-prevention training method to help warfighters return to full high-level functional capabilities and emotional wellness, and to decrease the time required to either return to active duty or to a productive, active civilian life. The training program utilizes a microprocessor-controlled treadmill designed to deliver task-specific training perturbations. The training consists of six, 30 minute sessions delivered over a 4-week period. In the current year, 35 subjects have completed training.
10.
ClinicalTrials.gov; 26/01/2022; TrialID: NCT05212077
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05212077
ABSTRACT
Condition:
The Trial Will Compare Two Care Delivery Models That Are Currently Being Used in Routine Practice Settings for Acute HospitalizationIntervention:
Other: Advanced Care at Home (ACH);Other: Traditional Brick-and-Mortar HospitalizationPrimary outcome:
The primary outcome is a composite outcome of all-cause mortality;30-day readmission.Criteria:
Inclusion Criteria:
- Adult patients, 18 years of age and older.
- Present to one of the participating hospitals.
- Have a chief complaint of one of the target diagnoses.
- Are within a certain geographical area (based on zip codes).
- Have a health insurance plan that covers ACH services.
- Have the capacity to consent or could assent with the consent of a health care proxy
who is physically present.
Exclusion Criteria:
- The patient is not suitable for ACH or inpatient hospital care based on:
- being a nursing home patient;
- on or requiring dialysis;
- positive for COVID-19;
- having discharge order;
- requiring intensive care unit (ICU) level of care;
- history of drug abuse.
- Patients will also need to meet the clinical stability criteria.
- Do not have the capacity to consent or assent with the assistance of a health care
proxy.
11.
ClinicalTrials.gov; 18/01/2022; TrialID: NCT05199233
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05199233
ABSTRACT
Condition:
COVID-19;Post Acute Sequelae of SARS-CoV-2Intervention:
Device: Muse S™ Headband systemPrimary outcome:
Reducing Stress;Reducing AnxietyCriteria:
Inclusion Criteria:
- Identified with one of 3 Post-Covid Syndrome (PASC) phenotypes at Mayo Clinic
Rochester.
- Not pregnant by subject self-report at time of consent.
- Have the ability to provide informed consent.
- Have the ability to complete all aspects of this trial.
- Have access to an iPhone, iPad, or Android device.
- Have no contraindicating comorbid health condition which would interfere with the
proper use of the Muse-SÔ system, as determined by the clinical investigators.
Exclusion Criteria:
- Used an investigational drug within the past 30 days.
- Anyone that is not on a stable dose of medication for anxiety, depression or sleep.
- Currently (within the past 3 weeks) been practicing mindfulness training on a
weekly/regular basis.
- Currently (within 3 weeks) has been enrolled in another clinical or research program
which intervenes on the patients' QOL, or stress.
- An unstable medical or mental health condition as determined by the physician
investigator.
12.
ClinicalTrials.gov; 10/01/2022; TrialID: NCT05220514
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05220514
ABSTRACT
Condition:
COVID-19;SAR-CoV-2Intervention:
Drug: (R)-1-(2-chlorophenyl)- N-[11C] ([11C] PK11195);Drug: 2-(4-[11C]methylamino phenyl)-6-hydroxybenzothiazole (11C]6-OH-BTA-1 or [11C]PIB)Primary outcome:
Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19;Change in neurological, cognitive, and functional trajectories in participants who are status post hospitalization for COVID-19 and participants receiving intensive care for diagnosis other than COVID-19Criteria:
Inclusion Criteria:
- Control Participants: Males and females over the age of 18 years hospitalized and
receiving intensive care for diagnosis's other than COVID-19 or an acute neurological
disease and who were not diagnosed (clinically or with PCR testing) with COVID-19.
- Case Participants: Males and females over the age of 18 years who had been
hospitalized at Mayo Clinic Hospital for treatment of COVID-19 confirmed by PCR test.
- We acknowledge that some participants may be unable to consent due to underlying
medical conditions; an eligible proxy may provide the informed consent and provide a
signature on the designated line.
- Women of childbearing age, between the ages of 18 to 55, must complete a negative
pregnancy test.
- Minority individuals over the age of 18 years will be eligible to enroll.
Exclusion Criteria:
- Males and females, under the age of 18 years.
- Participants with PET/MRI non-compatible devices.
- Claustrophobia.
- Allergies to study related procedures.
- Pregnant , incarcerated, or institutionalized subjects will not be included in the
study.
13.
ClinicalTrials.gov; 03/11/2021; TrialID: NCT05120934
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05120934
ABSTRACT
Condition:
Interstitial Lung DiseaseIntervention:
Drug: Amitriptyline 25 MG;Drug: Amitriptyline 50 MG;Drug: Duloxetine 30 MG;Drug: Duloxetine 60 MG;Drug: Placebo 30 MG;Drug: Placebo 60 MGPrimary outcome:
Change in awake objective cough frequency (at 4 & 8 weeks)Criteria:
Inclusion Criteria
- Have a diagnosis of interstitial lung disease according to the American Thoracic
Society Guidelines
- Have a chronic cough for at least 3 months prior to the screening visit
- Patients should be on a stable dose of ILD-directed therapies for 3 months prior to
enrollment and will be allowed to continue their ILD-directed therapies. These include
-but are not limited to- corticosteroids, immunosuppressing agents such as
azathioprine and mycophenolate, as well as antifibrotic medications including
nintedanib and pirfenidone. Additional corticosteroids and adjustment of ILD-directed
therapy doses is permitted if deemed appropriate by the treating physician
- Have a score of = 40mm on the Cough Severity VAS at Screening.
- Women of child-bearing potential must agree to use 2 forms of acceptable birth control
and make no donation of eggs from Screening through the end of the 8-week study
period. Acceptable birth control methods include established use of oral, injected, or
implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine
system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm
for female subject and condom for male partner with spermicidal) satisfies the
requirement for 2 forms of acceptable birth control. When concordant with the
preferred lifestyle of the subject, true and complete abstinence (not periodic
abstinence) is acceptable.
- Male subjects and their partners of child-bearing potential must use 2 methods of
acceptable birth control, 1 of which must be a barrier method, and make no donation of
sperm from Screening until 3 months after the last dose of study drug at the end of 8
weeks.
- Have provided written informed consent.
- Are willing and able to comply with all aspects of the protocol.
Exclusion Criteria
- Current smoker (cigarettes, e-cigarettes or marijuana) or former smokers who have
smoked within the past 12 months.
- Former smokers with > 20 pack-year history of smoking
- Ongoing treatment with an ACE-inhibitor that is considered as the potential cause of a
subject's cough or requiring treatment with an ACE-inhibitor during the study or
within 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
- History of upper or lower respiratory tract infection or recent significant change in
pulmonary status within 4 weeks of the Screening/Baseline Visit (Day -14 to Day 0)
- History of opioid use specifically prescribed for chronic cough within 2 weeks of the
Screening/Baseline Visit (Day -14 to Day 0). Use of opioids for other indications (for
example, to treat pain) is permitted.
- History of baclofen use specifically prescribed for chronic cough within 2 weeks of
the Screening/Baseline Visit (Day -14 to Day 0). Use of baclofen for other indications
(for example, to treat spasticity) is permitted.
- Presence of an untreated or undertreated cause (other than ILD) for the patient's
chronic cough (as determined by the treating/referring physician per ACCP guidelines).
e.g. uncontrolled asthma, GERD or post-nasal drainage that could potentially explain
the patient's chronic cough.
- Requiring concomitant therapy with prohibited medications (listed below).
- Treatment with any pharmaceutical or biological investigational therapy (excluding
coronavirus disease of 2019 (COVID) vaccination and COVID related monoclonal antibody
therapy)
- Participation in another clinical trial that does not allow co-enrollment within 4
weeks prior to the Screening/Baseline Visit (Day -14 to Day 0)
- Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >
3x the upper limit of normal (ULN) during screening.
- Serum creatinine < 30 mL/min, hemodialysis or peritoneal dialysis
- Advanced liver disease as defined by the presence of cirrhosis and/or signs of portal
hypertension
- History of previous hypersensitivity or intolerance to Duloxetine & Amitriptyline
(patients who have previously been on either amitriptyline or duloxetine for chronic
cough or other reasons and have tolerated the medication will be offered participation
regardless of previous response to therapy).
- Currently pregnant or breastfeeding female subject.
- Presence of any medical condition or disability that the investigators believe could
interfere with the assessment of safety or efficacy in this trial or compromise the
safety of the subject.
- Planned or anticipated major surgical procedure or other activity that would interfere
with the subject's ability to comply with protocol-mandated assessments (e.g.,
extended travel) during the subject's participation in the study.
- Currently taking either another SSRI, SNRI or MAO inhibitor which the patient cannot
safely discontinue at least 2 weeks prior to the screening period.
Therapies that are prohibited during the 8-week blinded phase of the study:
The following therapies are prohibited from 2 week prior to the Screening/Baseline Visit
(Day -14 to Day 0) through the end of the 8-week blinded treatment period.
- Opioids (of any kind including tramadol & codeine) specifically prescribed for
treatment of cough
- Dextromethorphan
- Guaifenesin
- Chlorpheniramine
- Benzonatate
- Trazodone
- Pregabalin or gabapentin prescribed for chronic cough
- 1% tetracaine lollipops prescribed for chronic cough
- 4% nebulized lidocaine solution prescribed for chronic cough
- Any SSRI (selective serotonin reuptake inhibitor) e.g. bupropion, citalopram,
escitalopram, fluoxetine, fluvoxamine, paroxetine.
- Any SNRI (serotonin-norepinephrine reuptake inhibitor) e.g. venlafaxine,
desvenlafaxine, milnacipran, levomilnacipran
- Any Tricyclic antidepressant e.g. doxepin, clomipramine, nortriptyline, imipramine,
protriptyline, amoxapine, trimipramine
- Any MAO (Monoamine oxidase) inhibitor. e.g. phenelzine, selegiline, isocarboxacid or
tranylcypromine
- Patients who were previously prescribed either amitriptyline or duloxetine for chronic
cough will be eligible for the study as long as they had discontinued the medication
at least 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
The following therapies are prohibited from 4 week prior to the Screening/Baseline Visit
(Day -14 to Day 0) through the end of the 8-week blinded treatment period.
14.
ClinicalTrials.gov; 03/11/2021; TrialID: NCT05110144
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05110144
ABSTRACT
Condition:
Refractory Chronic CoughIntervention:
Drug: Duloxetine 30 MG;Drug: Duloxetine 60 MG;Drug: Amitriptyline 25 MG;Drug: Amitriptyline 50 MG;Drug: Placebo 30 MG;Drug: Placebo 60 MGPrimary outcome:
Change in awake objective cough frequency (at 4 & 8 weeks)Criteria:
Inclusion Criteria
- Chest radiograph or computed tomography (CT) of the thorax within the last 1 year not
demonstrating any abnormality considered to be significantly contributing to the
refractory chronic cough in the opinion of the Principal Investigator
- Have a diagnosis of refractory chronic cough or unexplained cough for at least one
year according to the American College of Chest Physicians guidelines
- Have a score of = 40mm on the Cough Severity VAS at Screening.
- Women of child-bearing potential must agree to use 2 forms of acceptable birth control
and make no donation of eggs from Screening through the end of the 8-week study
period. Acceptable birth control methods include established use of oral, injected, or
implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine
system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm
for female subject and condom for male partner with spermicidal) satisfies the
requirement for 2 forms of acceptable birth control. When concordant with the
preferred lifestyle of the subject, true and complete abstinence (not periodic
abstinence) is acceptable.
- Male subjects and their partners of child-bearing potential must use 2 methods of
acceptable birth control, 1 of which must be a barrier method, and make no donation of
sperm from Screening until 3 months after the last dose of study drug at the end of 8
weeks.
- Have provided written informed consent.
- Are willing and able to comply with all aspects of the protocol.
Exclusion Criteria
- Current smoker (cigarettes, e-cigarettes or marijuana) or former smokers who have
smoked within the past 12 months.
- Former smokers with > 20 pack-year history of smoking
- Ongoing treatment with an ACE-inhibitor that is considered as the potential cause of a
subject's cough or requiring treatment with an ACE-inhibitor during the study or
within 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
- FEV1/FVC < 60%.
- History of upper or lower respiratory tract infection or recent significant change in
pulmonary status within 4 weeks of the Screening/Baseline Visit (Day -14 to Day 0)
- History of opioid use specifically prescribed for chronic cough within 2 weeks of the
Screening/Baseline Visit (Day -14 to Day 0). Use of opioids for other indications (for
example, to treat pain) is permitted.
- History of baclofen use specifically prescribed for chronic cough within 2 weeks of
the Screening/Baseline Visit (Day -14 to Day 0). Use of baclofen for other indications
(for example, to treat spasticity) is permitted.
- Diagnosis of COPD, bronchiectasis, interstitial lung disease or cystic fibrosis
- Presence of an untreated or undertreated cause for the patient's chronic cough (as
determined by the treating/referring physician per ACCP guidelines). e.g. uncontrolled
asthma, GERD or post-nasal drainage that could potentially explain the patient's
chronic cough.
- Requiring concomitant therapy with prohibited medications (outlined below)
- Treatment with any pharmaceutical or biological investigational therapy (excluding
coronavirus disease of 2019 (COVID) vaccination and COVID related monoclonal antibody
therapy)
- Participation in another clinical trial that does not allow co-enrollment within 4
weeks prior to the Screening/Baseline Visit (Day -14 to Day 0)
- Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >
3x the upper limit of normal (ULN) during screening.
- Serum creatinine < 30 mL/min, hemodialysis or peritoneal dialysis
- Advanced liver disease as defined by the presence of cirrhosis and/or signs of portal
hypertension
- History of previous hypersensitivity or intolerance to Duloxetine & Amitriptyline
(patients who have previously been on either amitriptyline or duloxetine for chronic
cough or other reasons and have tolerated the medication will be offered participation
regardless of previous response to therapy).
- Currently pregnant or breastfeeding female subject.
- Presence of any medical condition or disability that the investigators believe could
interfere with the assessment of safety or efficacy in this trial or compromise the
safety of the subject.
- Planned or anticipated major surgical procedure or other activity that would interfere
with the subject's ability to comply with protocol-mandated assessments (e.g.,
extended travel) during the subject's participation in the study.
- Currently taking either another SSRI, SNRI or MAO inhibitor which the patient cannot
safely discontinue at least 2 weeks prior to the screening period.
- The following therapies are prohibited from 2 week prior to the Screening/Baseline
Visit (Day -14 to Day 0) through the end of the 8-week blinded treatment period.
- Opioids (of any kind including tramadol & codeine) specifically prescribed for
treatment of cough
- Dextromethorphan
- Guaifenesin
- Chlorpheniramine
- Benzonatate
- Trazodone
- Pregabalin or gabapentin prescribed for chronic cough
- 1% tetracaine lollipops prescribed for chronic cough
- 4% nebulized lidocaine solution prescribed for chronic cough
- Any SSRI (selective serotonin reuptake inhibitor) e.g. bupropion, citalopram,
escitalopram, fluoxetine, fluvoxamine, paroxetine.
- Any SNRI (serotonin-norepinephrine reuptake inhibitor) e.g. venlafaxine,
desvenlafaxine, milnacipran, levomilnacipran
- Any Tricyclic antidepressant e.g. doxepin, clomipramine, nortriptyline,
imipramine, protriptyline, amoxapine, trimipramine
- Any MAO (Monoamine oxidase) inhibitor. e.g. phenelzine, selegiline, isocarboxacid
or tranylcypromine
- Patients who were previously prescribed either amitriptyline or duloxetine for
chronic cough will be eligible for the study as long as they had discontinued the
medication at least 12 weeks prior to the Screening/Baseline Visit (Day -14 to
Day 0).
- The following therapies are prohibited from 4 week prior to the Screening/Baseline
Visit (Day -14 to Day 0) through the end of the 8-week blinded treatment period.
• Investigational biologic or pharmaceutical therapies (excluding COVID vaccination
and COVID related monoclonal antibody ther
15.
ClinicalTrials.gov; 08/10/2021; TrialID: NCT05118867
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05118867
ABSTRACT
Condition:
DeliriumIntervention:
Behavioral: iPREPAREDPrimary outcome:
Feasibility of study recruitment to intervention study;Usability and acceptability of digital technology;Delirium incidenceCriteria:
Patient Inclusion Criteria:
- 60 years of age or older
- Have 1 risk factor for delirium (pre-existing cognitive impairment, vision/hearing
impairment, identified as high risk for falls, illness rated as severe)
- Estimated length of stay of 24 hours or more in hospital
- Have an informal caregiver (18 years of age or older, family member or friend) willing
to participate
Patient Exclusion Criteria:
- Patient lacks capacity to consent
- Unable to communicate or participate in study due to language barriers or sensory
deficits
- Prisoners
- Documented history of dementia in the medical record
- Patient admitted to hospice service or actively dying
- Delirium present upon admission to hospital
- COVID-19 positive test
Caregiver Inclusion Criteria:
- 18 years of age or older
- Family member, friend, or neighbor of the patient willing to participate in the study
and support the patient during the study period (support can be in-person or virtual)
Caregiver Exclusion Criteria:
- Unable or unwilling to participate due to language barriers, availability, or other
communication barriers
16.
ClinicalTrials.gov; 20/09/2021; TrialID: NCT05075980
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05075980
ABSTRACT
Condition:
Head and Neck Carcinoma;Head and Neck Carcinoma of Unknown Primary;Hypopharyngeal Carcinoma;Laryngeal Carcinoma;Metastatic Malignant Neoplasm in the Lymph Nodes;Nasal Cavity Carcinoma;Oral Cavity Carcinoma;Oropharyngeal Carcinoma;Paranasal Sinus Carcinoma;Salivary Gland Carcinoma;Skin CarcinomaIntervention:
Drug: Cisplatin;Procedure: Intensity-Modulated Proton Therapy;Other: Quality-of-Life Assessment;Other: Questionnaire AdministrationPrimary outcome:
Rate of local/regional control (LRF)Criteria:
Inclusion Criteria:
- Age >= 18 years
- Histological confirmation of a newly diagnosed non-human papillomavirus (HPV)
associated malignant epithelial cancer in the head and/or neck. Diagnosis requires
confirmation of p16 and/or HPV DNA negativity for oropharyngeal and unknown primary
sites. p16 positivity in skin cancers is allowed
- Primary lesion located in the nasal cavity, paranasal sinuses, oral cavity,
oropharynx, larynx, hypopharynx, salivary glands, lymph nodes (unknown primary or
metastasis from head and neck [HN]-skin primary) or skin cancer where lymph node
radiation is recommended
- NOTE: Patients with primary lesions in the larynx must have a T3 primary, bulky
T2 primary (> 6 cc), and/or at least 1 regional lymph node
- Confirmation of American Joint Committee on Cancer (AJCC) 8th edition defined M0
established by positron emission tomography (PET)/computed tomography (CT) or
PET/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status (0-1 prior to initial
treatment)
- Able to provide written informed consent
- Able to complete questionnaires independently or with assistance
- Willing to return to enrolling institution for follow up during the observation phase
- Hemoglobin >= 8.0 g/dl (within 8 weeks of registration)
- Platelets >= 75,000 cells/mm^3 (within 8 weeks of registration)
- Absolute neutrophil count > 1500 cells/mm^3 (within 8 weeks of registration)
- Coronavirus disease 2019 (Covid-19) testing per institutional standard. If
pre-treatment testing, patients should be negative prior to starting treatment or
symptom free for at least 14 days from documented positive test. Vaccination status
should be documented
Exclusion Criteria:
- Pregnant women (serum pregnancy test required before treatment per department policy)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV)
positive and currently receiving antiretroviral therapy
- NOTE: Patients known to be HIV positive, but without clinical evidence of
immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements
- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm
- Other active malignancy =< 2 years prior to registration
- EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix and
prostate cancer with a Gleason score of 6 or less
- NOTE: If there is a history or prior malignancy, they must not be receiving
ongoing anticancer treatment
- History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Prior radiation therapy that would have a clinically significant overlap with the
intended head/neck radiation
- Unable to receive proton therapy because of extensive metallic hardware in close
proximity to treatment site, logistical circumstances, or any other reason
- Any of the following diagnoses: HPV-associated squamous cell carcinoma, germ cell
tumors, hematologic malignancies, neuroendocrine malignancies, adenoid cystic
carcinoma, sarcomas of bone, benign tumors
17.
ClinicalTrials.gov; 25/08/2021; TrialID: NCT05038891
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05038891
ABSTRACT
Condition:
Cervical DilationIntervention:
Diagnostic Test: Digital Cervical Exam;Diagnostic Test: Transperineal Ultrasound;Diagnostic Test: Transvaginal UltrasoundPrimary outcome:
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.Criteria:
Inclusion Criteria:
- Pregnant females age 18 years or older
- Third trimester of pregnancy with a singleton fetus (gestational age >28 weeks)
- Pre-gestational body mass index <40
- Scheduled for induction of labor
- Eligible for induction of labor based on current birth center guidelines
- Intact membranes when presenting for induction of labor
Exclusion Criteria:
- History of prior cervical loop electrosurgical excisional procedure or cold knife
conization
- Cerclage placement during current pregnancy
- Positive COVID-19 test within 7 days of admission for induction of labor
- Fever > 38.0 C at time of admission for induction of labor
18.
ClinicalTrials.gov; 02/07/2021; TrialID: NCT04952389
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04952389
ABSTRACT
Condition:
Olfactory Dysfunction;COVID-19Intervention:
Device: Acupuncture Therapy;Drug: Budesonide;Other: Olfactory TrainingPrimary outcome:
Change in UPSIT scoresCriteria:
Inclusion Criteria:
- 18 years or older.
- Patients with post-viral olfactory dysfunction > 4 weeks.
- History of positive COVID-19 PCR.
Exclusion Criteria:
- Less than 18 years of age.
- Active sinus infection.
- New diagnosis of untreated CRS.
- Prior diagnosis of dementia or Parkinson's disease.
- Prior head trauma or neurosurgical procedure resulting in olfactory loss.
- Patients who do not speak or read English.
- Patients unable to understand and sign the study consent.
19.
ClinicalTrials.gov; 30/06/2021; TrialID: NCT04950725
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04950725
ABSTRACT
Condition:
Covid19Intervention:
Behavioral: Strength RMT;Behavioral: Strength RMT and nasal breathing;Behavioral: Endurance RMT;Behavioral: Endurance RMT and nasal breathing;Behavioral: Low dose RMTPrimary outcome:
Change in Phonation time;Change in Sit to stand executions;Change in number of reported COVID symptoms;Change in breathing difficulty;Change in reported affect of health on physical activity;Change in reported cognitionCriteria:
Inclusion criteria:
- Positive test for SARS-CoV2 within the last 3 months.
- Smartphone user.
- English speaker.
- Age 18 or above.
- US resident.
Exclusion criteria:
- Hemodynamic instability.
- Contraindications or inability to perform RMT.
- Inability to navigate study questionnaires or tasks.
- History of kidney disease, arteriosclerosis obliterans, and high calcium levels.
20.
ClinicalTrials.gov; 30/06/2021; TrialID: NCT04954222
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04954222
ABSTRACT
Condition:
Covid19Primary outcome:
Change in diffusion capacity of the lungs;Change in airway morphology;change basic spirometry;Change in peak aerobic capacity;Presence of post-exertional malaise;Change in symptoms;change in quality of lifeCriteria:
Inclusion Criteria:
- Have a documented positive qRT-PCR for SARS-CoV-2 confirming prior COVID-19 diagnosis
- At least 18 years of age.
- Female subjects must not be pregnant or trying to become pregnant during the duration
of study participation.
- No known plans to move out of the state, or become unable to return to one of the Mayo
Clinic sites for follow-up testing.
- Must be able to provide clear informed written consent.
Exclusion Criteria:
- Individuals with pacemakers or other implantable devices that will make interpreting a
CT scan challenging.
- Individuals with major limitations to exercise.