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70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-100.0, Coronavirus Infections Pneumonia, Viral Positive nasopharyngeal swab for COVID-19, asymptomatic or paucisymptomatic, aged ≥70 years and/or with clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) or symptomatic with respiratory or systemic symptoms, however clinically stable (MEWS<3) with CT imaging showing viral pneumonia and positive or pending pharyngo-nasal swab for COVID-19: Temperature 38°C and/or intensive cough, Respiratory rate < 25 /min, oxygen saturation (pulse oximetry) >95% Positive swab for COVID-19 with respiratory and/or systemic symptoms and initial mild respiratory failure e with objective signs of lung involvement; the patient is in stable conditions (MEWS < 3) Temperature>38°C and or intensive cough, Respiratory rate ≥25 /min, or oxygen saturation 94 in room air Pregnant or breast feeding MEWS >=3 Hepatic failure Child-Pugh C Enrollment in other pharmacological studies Ongoing treatment with colchicine Ongoing treatment with antiviral drugs that ritonavir or cobicistat Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Snoring older than 18 years patients complaining of snoring and obstructive sleep panea chronic pulmonary disease ( COPD, Asthma ,IPF) Pregnancy sever cardiovascular disease ( unstable angina , sever arrhythmia , MI) chronic renal failure (CRF) neurological disorders | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Chronic Hypercapnic Respiratory Failure Obesity Hypoventilation Syndrome Obesity Hypoventilation Syndrome defined by obesity (IMC≥30) and Hypercapnic respiratory failure (PCO 2> 45 mm Hg) in stable phase (PH≥7.35 without clinical signs of worsening in at least one previous month). 2. Age between 18-80 years. 3. Absence of other diseases causing hypercapnia as moderate or severe chronic obstructive pulmonary disease (FEV1> 70% predicted if FEV1 / FVC <70), neuromuscular, thoracic wall or metabolic disease; d) Absence of narcolepsy or restless legs syndrome. 4. Overcome correctly a 30 minutes test of treatment with VNI in wakefulness Psychophysical disability for questionnaires. 2. Patients who cannot be evaluated by quality of life questionnaires because they present debilitating chronic disease. 3. Chronic nasal obstruction that prevents the use of NIV. 4. Pregnancy. 5. No informed consent obtained | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COVID-19 Age ≥ 18 years old (Sub-studies 2 and 3) Competent and capable to provide informed consent Have access to a smart device such as a cell phone, tablet, laptop computer with necessary data/internet accessibility Subjects meeting the following by Sub-Study Sub-Study 1 Age ≥40 years since the risk of prolonged disease that progresses to severe COVID-19 disease increases with age PCR-positive for the SARS-CoV2 virus (Fever, and cough, or Fever and shortness of breath ≤4 days since the first symptoms of COVID-19 and date of testing Not taking azithromycin Not requiring hospitalization and is sent home for quarantine <18 years of age Prisoners or other detained persons Allergy to hydroxychloroquine Pregnant or lactating or positive pregnancy test Receiving any treatment drug for 2019-ncov within 14 days prior to screening evaluation (off label, compassionate use or trial related) Co-enrollment onto another COVID-19 study is not allowed unless there is approval by the Medical Monitor in consultation with the PI and EM and ID sub-I leaders Known history of retinal disease including but not limited to age related macular degeneration Taking any of the following medications that prolong Qtc: Chlorpromazine.Haloperidol, Droperidol, Quetiapine, Olanzapine. Amisulpride. Thioridazine History of interstitial lung disease or chronic pneumonitis unrelated COVID-19 Due to risk of disease exacerbation patients with porphyria or psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations Patients with serious intercurrent illness that requires active infusional therapy, intense monitoring, or frequent dose adjustments for medication including but not limited to infectious disease, cancer, autoimmune disease, cardiovascular disease | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Obstructive Sleep Apnea Alzheimer Disease Vascular Dementia Mild Cognitive Impairment Parkinsons Disease With Dementia Dementia With Lewy Bodies Mixed Dementia Evidence of cognitive impairment by any one of: (i) Montreal Cognitive Assessment (MoCA) score of 13-28, or (ii) Mini Mental State Examination (MMSE) score of 18-30, or (iii) Toronto Cognitive Assessment (TorCA) score ≤281 A diagnosis of: (i) Single-domain amnestic or multiple cognitive domain (with one feature being amnestic) Mild Cognitive Impairment due to Alzheimer's disease (AD); or (ii) Probable AD dementia; or (iii) Possible AD dementia due to limited concomitant cerebrovascular disease; or (iv) Probable Vascular dementia or Vascular Mild Cognitive Impairment, as per the 2011 American Heart Association Scientific Statement; or (v) Patients with a suspected neurodegenerative condition known to be associated with non-OSA sleep disorders (e.g. Parkinson's disease-related dementia and dementia with Lewy Bodies); and/or (vi) Mixed disease Have the competency to provide informed consent, or the availability of a substitute decision maker/caregiver who can provide consent (if needed) The availability of a caregiver to assist in the completion of HSAT or iPSG, if needed Prior diagnosis of OSA within the last 2 years Patients already using CPAP or a dental appliance for previously diagnosed OSA A known contraindication for the use of the HSAT that will be used in this study: (a) Moderate to severe pulmonary disease or congestive heart failure that could compromise the validity of the HSAT results (in users of the ApneaLink); (b) Permanent pacemaker or history of sustained non-sinus cardiac arrhythmia (in users of the WatchPAT) Any medical device that would interfere with the placement of the HSAT Significant physical impairment or language barrier that would restrict the ability to use the HSAT or complete the study assessments | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COVID-19 Subjects enrolled in the trial must meet all of the following criteria Confirmed COVID-19 pneumonia Hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement Presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin ≥500ug/l, b) LDH ≥250U/L, c) d-dimer ≥1ug/L, or d) lymphopenia as defined by absolute lymphocyte count <1,000/uL Age ≥ 18 years Completed informed consent Subjects who meet ANY of the following are not eligible for enrollment as study participants Known allergy or hypersensitivity to sirolimus Inability or refusal to provide informed consent Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation) Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed Pregnant women Breast feeding On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4 Any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to) History of liver cirrhosis | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COVID-19 Patient with respiratory failure due to primary pulmonary pathology Patient who is selected for BiPAP or CPAP by the health care provider Age <18 years Respiratory failure due to non-pulmonary pathology Impaired consciousness (Glasgow coma scale <10) Patients with contraindications of NIV Severe upper gastrointestinal bleeding Chest trauma Agitated or violent patient | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COVID Study subjects will be inpatients with confirmed SARS-CoV-2 testing. Testing is performed at the discretion of the treating physician. Only Veterans will be enrolled. 1. Positive testing for novel coronavirus SARS-CoV-2019 2. Patients with moderate COVID-19 disease as defined clinically: 1. Score of 1-3 (out of 3) on a modified Brescia COVID respiratory severity score (BCRSS), elements of which wheezing or inability to speak complete sentences without effort, respiratory rate ≥22, O2 saturation ≤ 94% with or without supplemental oxygen, or requiring ≥2L supplemental oxygen to maintain O2 Sat >94% in patients without previously documented hypoxia or baseline oxygenation requirement; either is equal to one point on the score) all within a 24-hour period prior to enrollment, and/or any worsening of chest X-ray (CXR) findings after COVID-19 diagnosis 2. Worsening of baseline oxygenation by at least 3%, or increase in oxygen requirement by at least 2L, in patients with pre-existing hypoxemia or receiving supplemental oxygen chronically. 3. The BCRSS risk calculation score is available at: https://www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm Critical disease, defined by need for mechanical ventilation 2. Expected death within 48 hours 3. Patients taking any of the following for chronic inflammatory diseases: glucocorticoids equivalent to prednisone > 10 mg/day (methylprednisolone > 8 mg/day, dexamethasone > 2 mg/day), a JAK inhibitor (tofacitinib, baricitinib, upadacitinib), or a biologic 1. Use of chronic inhaled steroids is NOT an 2. Current or recent short-term use of glucocorticoids for chronic conditions such as COPD or gout is NOT an exclusion. 3. Current use of glucocorticoids for COVID-19 is NOT an 4. Use of biologics for non-inflammatory diseases is NOT an 4. Receipt of any IL-6 inhibitor within 3 months prior to enrollment in the trial 5. Pregnancy, due to lack of fetal monitoring capabilities 6. Patients enrolled in other interventional clinical trials, including for COVID-19. Patients enrolled in non-interventional studies or receiving non-FDA-approved drugs for compassionate use are not excluded. 7. Patients whose goal of care is comfort measures only 8. Inability to provide informed consent, or absence of a legally authorized representative to provide informed consent. 9. Severe psychiatric disease that prevents compliance with typical medical care. 10. Initial positive test for active infection with novel coronavirus SARS-CoV-2019 was >4 weeks prior to current admission | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 35.0-999.0, COPD Hypoxia Closed-Loop Communication Dyspnea Anxiety Depression COPD veryfied by Forced Expiratory Volume in 1 sec (Fev1) divided by forced Vital Capacity (FVC)< 0,70 Admission due to exercabation in COPD COPD exacerbation and pneumonia can be included Expeted duration of admission >48 hours Need for oxygen supplementation (SpO2<= 88% in room air) Cognitive able to participate in the study Willing to participate and give informed consent Need or anticipated need for mechanical ventilation ( Intermittent continuous Positive Airway Pressure (CPAP) is allowed) Major comorbidities causing hypoxemia (cancer, heart disease, pulmonary embolia) Asthma or other respiratory conditions requiring higher SpO2 than normal for COPD Pregnancy Cognitive barrierers for participation | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, Copd Chronic Respiratory Disease • Diagnosed COPD according to GOLD-guidelines Physical or intellectual impairment precluding informed consent or protocol adherence Non-German speaking Acute or recent (within the last 6 weeks) exacerbation of COPD Attending a pulmonary rehabilitation program within the last 3 months Pregnant patients | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Cardiac Disease diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, SARS-CoV-2 Pneumonia COVID-19 Age > 18 years of age 2. SARS-CoV-2 positive per FDA approved RT-PCR (reverse transcription-polymerase chain reaction) 3. Acute hypoxia (O2 sat < 90 % or paO2 < 60 on room air), or above baseline chronic O2 requirement 4. Inpatient admission Requires supplemental O2 >10 litres per minute or mechanical ventilation on admission 2. Pregnancy 3. AST/ALT > 5 times the upper limit normal 4. Baseline prolonged QT 5. Child-Pugh Score B or greater 6. ESRD(end-stage renal disease) requiring dialysis 7. Known allergy to medication component, 8. History of severe G6PD (glucose-6-phosphate dehydrogenase) 9. Myasthenia gravis 10. Porphyria 11. Ongoing treatment for epilepsy 12. Life expectancy < 6 months, 13. Patient lacks capacity to provide consent and does not have a surrogate decision maker. 14. Retinal Disease | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 55.0-999.0, Hypertension Cognitive Decline All participants will have established hypertension evidenced by awake ambulatory systolic blood pressure (ASBP)≥130 mmHg or awake ambulatory diastolic blood pressure (ADBP)≥80 or taking antihypertensive medication regardless of the awake ASBP and awake ADBP values. In addition, participants will have blood pressure (BP) within the safe range to exercise evidenced by awake ASBP<145 mmHg and awake ADBP<90 regardless of the use of BP medications For women only, participants need to be postmenopausal evidenced by having experienced >6 consecutive months without menstruation. This is because menstruation could potentially influence BP Participants will be free of Tai Chi practice in the past 12 months Participants will, at least, have graduated from high school or have obtained GED Participants will have intact cognitive function evidenced by scoring 25 or higher on the Mini Mental State Examination Participants will be physically inactive as did not exercise for 30 min or more per day at moderate intensity on 3 or more days per week in the past 12 weeks. Subjects will not have physically demanding occupations Participants will consume <2 alcoholic drinks daily because the effects of alcohol may obscure the BP response to exercise Participants will be non-smokers for at least 6 months prior to entry because the effects of tobacco may obscure the BP response to exercise Participants need to have sufficient access to internet and electronic equipment (e.g., laptop, desktop, tablet) to participate in virtual research visits and live online Tai Chi sessions, and email study personnel Participants will have no contradictions to fully participate in They will be excluded if they have: 1) signs or symptoms suggestive of cardiovascular, renal, and metabolic disease; 2) psychiatric and neurological disorders such as general anxiety and depression; 3) body mass index <18.5 kg.m^-2 or >35 Kg·m^-2) orthopedic problems likely to restrict Tai Chi exercise in standing position; 5) contradictions to MRI scans to the brain If the participants has been diagnosed with chronic diseases that require medical clearance to exercise that cardiovascular, renal, and metabolic disease, the PI and the study medical director will review the participants's medical history and determine if it is safe for him or her to participate in If determined unsafe to exercise, the participant will be excluded For participants who have been diagnosed with cancer, only those who have had cancer under remission for 6 months or longer will be considered for inclusion. Otherwise, the participant will be excluded Cancer survivors will be excluded if they: 1) had lung, abdominal surgery, or ostomy within the past 6 months; 2) are currently experiencing ataxia, extreme fatigue, severe nutritional deficiencies, worsening/changing physical condition (i.e., lymphedema exacerbation), bone metastases. For other cancer survivors, the PI and the study medical director will review the participant's medical history and determine if it is safe for him or her to participate in If determined unsafe to exercise, the participant will be excluded Participants who have extensive experience with Tai Chi, defined as have practiced Tai Chi for ≥2 sessions/week for ≥3 months continuously, will be excluded Participants who have physically demanding occupations will be excluded Participants acknowledging illicit drug use within the past 5 years will not be recruited Participants taking any medications, except for corticosteroids and hypnotics, should: 1) have been taking the medications for ≥3 months prior to entry; and 2) maintain their routine of taking the medications throughout the study when possible. Otherwise, the participant will be excluded Participants who take corticosteroids and hypnotics as needed will not be recruited because these medications could potentially influence BP and brain blood flow and function Participants taking any nutritional supplements other than a 1-a-day vitamin, cold medications, and herbal supplements would be asked to discontinue these medications before entering the study or be excluded | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COVID Documented COVID-19 infection by nasal pharyngeal sampling COVID-19 disease falling into one of the following groups Critical disease: respiratory failure requiring mechanical ventilation, pressor support, or multiple organ dysfunction/failure Severe disease: tachypnea >/=30 per min, O2 sats </=93% at rest, PaO2/FiO2 index </=300mmHg High Risk: upper respiratory symptoms but no radiographic evidence of disease, immunocompromised, insulin-dependent diabetes, poorly controlled HIV disease, moderate to severe asthma history, severe COPD, morbid obesity (BMI >/=40, age >/=65 years Health Care Providers: health care providers at risk to exposure to COVID-19 infection or those with mild to non-severe disease History of IgA deficiency History of anaphylatic reaction to blood product transfusion including hypersensitivity to immunoglobulin therapy | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Pulmonary Disease, Chronic Obstructive Noninvasive Ventilation Admission for acute hypercapnic respiratory failure requiring mechanical ventilation or NIV 2. Resolution of acute respiratory failure reflected by normalization of pH and downgrade of clinical status to ward or floor status. 3. Severe COPD defined by GOLD stage 3 (FEV1 30-50%) or 4 (FEV1 < 30%) OR GOLD C or D. Pulmonary function tests (PFTs) done within 3 years preceding admission are acceptable to document an obstructive ventilatory defect and decrease diffusion capacity consistent with emphysema and COPD. If no PFTs are available, bedside spirometry will be performed to confirm COPD. 4. Chronic compensated respiratory acidosis based on PaCO2 >52 adjusted for pH 7.40, on pre-admission laboratory values or after resolution of acute respiratory failure. 5. Able to consent without surrogate and complete all required study visits Moderate or severe obstructive sleep apnea (OSA), apnea-hypopnea index (AHI) >15/h. Sleep testing done within the prior 3 years with no increase in body mass index (BMI) >2kg/m2 or major change in cardiopulmonary conditions (new reduced ejection heart failure [HFrEF], atrial fibrillation [AFib], opioid use with morphine dose equivalent (MDDE) >120mg, or cardiothoracic surgery for lung resection or coronary artery bypass grafting) will be accepted for AHI severity. 2. BMI>35 kg/m2 3. Congestive heart failure (HFrEF, EF< 45%) 4. Other cause of chronic respiratory failure: Obesity hypoventilation syndrome, spinal cord injury (cervical or thoracic) neuromuscular disease, diaphragmatic paralysis, chest wall restrictive ventilatory defect 5. Lack of stable housing, homelessness, or unreliable electricity source in home environment. 6. Use of NIV at home within past three months 7. Failure to tolerate NIV during initial hospitalization 8. Unable or unwilling to comply with the protocol 9. Age <18 years 10. Inability to consent due to limited cognitive capacity 11. Pregnancy | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Idiopathic Bronchiectasis *Patients Polynesian adult more than18 years dilatation of idiopathic bronchi confirmed to thoracic CTscan Negative etiological balance (including sweat test, research of Dyskinesia Ciliary Primitive and immunological check-up) Appearance of symptoms in childhood, or family history of chronic bronchial disease, or notion of inbreeding Signed consent Affiliated with a social security system Refusal to participate in the study *Relatives First-degree healthy relatives Polynesian adult more than 18 years Signed consent Affiliated with a social security system Refusal to participate in the study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-70.0, Obstructive Sleep Apnea Patients who are able to understand the nature of the study and to give free informed consent AHI ≥ 15 on screening/baseline PSG Any of the following conditions should be met: 1. Documented prior PSG within 1 year demonstrating AHI of 15 or higher 2. Documented Continuous Positive Airway Pressure (CPAP) intolerance or poor compliance (compliance is defined as self-reported use of CPAP 4 hours per night for 70% of nights) or CPAP-naïve. 3. Patients who have been using CPAP at least 4 hours nightly for at least 70% of the nights are eligible only if CPAP is not used for 2 weeks prior to the screening/study baseline PSG Epworth Sleepiness Scale (ESS) score ≥ 4 for patients not using CPAP Previous surgical treatment for OSA is allowed if ≥ 1 year prior to enrollment BMI between 18.5 and 40.0 kg/m2, inclusive History of narcolepsy Clinically significant craniofacial malformation Clinically significant cardiac disease or hypertension requiring more than 3 medications for control Clinically significant neurological disorder, including epilepsy/convulsions History of schizophrenia, schizoaffective disorder or bipolar disorder according to - Diagnostic and Statistical Manual of Mental Disorders-V (DSM V) or International Classification of Disease X edition criteria History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation Positive history for abuse of drugs or substance use disorder as defined in DSM-V within 12 months prior to Screening Visit A significant illness or infection requiring medical treatment in the past 30 days Clinically significant cognitive dysfunction Untreated narrow angle glaucoma | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-120.0, Alzheimer Disease Mild Memory Disturbance Mild Cognitive Impairment The patient Has Alzheimer's Disease (AD) or Amnestic Mild Cognitive Impairment (aMCI), is a Healthy Aging Brain Center, Eskenazi Health patient Community dwelling Has a legally authorized representative when they lack capacity to consent The caregiver or older No visual impairment Community dwelling Reports seeing patient most days of the week The patient History of mental illness (Schizoaffective disorder, schizophrenia, bipolar) Participating in another study The potential participant with a diagnosis of either aMCI or AD communicates observable dissent The caregiver History of mental illness (Schizoaffective disorder, schizophrenia, bipolar) Participating in another study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 20.0-999.0, Atrial Fibrillation, Persistent Cognitive Function Those who meet the diagnosis of persistent atrial fibrillation, meet one of the following conditions The twelve-lead electrocardiogram is used to diagnose atrial fibrillation, and to cooperate with clinical diagnosis hours ECG diagnosis 100% atrial fibrillation, with clinical diagnosis The seven-day ECG recorder diagnosed 100% atrial fibrillation. 2. Willing to accept treatment recommended by doctors, containing anticoagulant, and cooperate with examination and treatment in the coming year Unwilling to sign the clinical trial consent form. 2. Unable to complete the cognitive function questionnaire. 3. Unable to complete brain MRI examination due to various reasons | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-90.0, Covid 19 Male or non-pregnant female patients at least 18 years old 2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection, either Confirmed cases: prospective participants who test positive to a validated specific SARS-CoV-2 nucleic acid test or has the virus identified by electron microscopy or viral culture, as per local trust policy ≤ 7 days before randomisation Probable/Suspected case: prospective participants who may have been in contact with a confirmed case of COVID-19, AND have mild to severe COVID-19 clinical symptoms AND radio-graphic evidence* of pulmonary infiltrates consistent with COVID-19 disease 3. Moderate to severe COVID-19 requiring hospitalisation defined as: a) Clinical status category 3-5 (inclusive) on the 7-point clinical status category scale as proposed by the World Health Organisation (WHO) master protocol: I. Category 3: hospitalized, no oxygen therapy II. Category 4: hospitalized, oxygen by mask or nasal prongs III. Category 5: hospitalized, non-invasive ventilation or high-flow oxygen *where routinely available, no tests will be requested for research purpose Therapy Use of the following concomitant medications is prohibited at Screening Visit and throughout the duration of the trial: 1. Use of Oseltamivir for more than 48 hrs prior to the first treatment dose 2. Use of antiviral drugs (e.g. nucleoside analogue reverse-transcriptase inhibitors, protease inhibitors, etc.) 3. History of long-term or concurrent use of mycophenolate mofetil, methotrexate exceeding 17.5 mg weekly 4. Chloroquine or hydroxychloroquine 5. Any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad as well as uricosuric drugs such as probenecid 6. Treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafinib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib 7. Any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogues 8. Use of rosuvastatin at daily doses higher than 10 mg Medical History of Concomitant Disease Allergic or hypersensitivity to the IMU-838, Oseltamivir, or any of the ingredients Pregnant or breastfeeding or with intention to become pregnant during the study Participants who cannot take trial medication orally at presentation Undergoing active chemotherapy or radiotherapy If the attending clinician believes that there is a specific contra-indication to the IONIC intervention Patient has a medical or concomitant disease history preventing them from participating Critical patients whose expected survival time < 48-72 hours Evidence of pancytopenia or immunosuppression | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, COVID Acute Respiratory Distress Syndrome Endothelial Dysfunction SARS-CoV2 infection (PCR positive and/or TDM Imaging) None | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-70.0, Breast Neoplasms Hypothyroidism Radiation Toxicity Breast cancer patients at first diagnosis, patients who are treated with radiotherapy after breast conserving surgery or modified radical mastectomy, no medical history of hyperthyroidism, hypothyroidism or thyroiditis, have never taken thyroxine, no thyroid surgery Absence or ectopic thyroid gland, previous radiotherapy of the neck, diseases of thalamus or pituitary, previous radiotherapy of thalamus or pituitary | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obesity Hypoventilation Syndrome (OHS) Age ≥18 years BMI ≥ 30 kg/m² Indication for sleep lab admission or indication for BiLevel or non-invasive ventilation therapy initiation due to existing hypoventilation/OHS Age <18 years Pregnancy, Lactation Any medical, psychological or other condition impairing the patient's ability to provide informed consent Missing informed consent Participation in another clinical study | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Patients with mild to moderate obstructive sleep apnea syndrome Patients diagnosed with mild (AHI 5 to15) and moderate (AHI 16 to 30) OSAS with only retropalatal collapses Patients who are noncompliant with Continuous positive airway pressure (CPAP) Patients diagnosed with sever OSAS (AHI more than 30) The main site of obstruction at retrolingual level or multilevel obstruction Contraindication of surgery (e.g. cardiovascular problems and bleeding tendency) Patients with significant craniofacial anomalies affecting airway Patients with BMI>40 kg/m2 Patients unfit for general anesthesia History of previous velopharyngeal or lingual surgeries | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, COVID-19 Adult male and female patients, including women of childbearing potential, at least 18 years of age, inclusive 2. Participant (or legally authorized representative) capable of giving signed informed consent 3. Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection 4. Clinical findings and an imaging study consistent with ARDS; 5. PaO2 / FiO2 ratio < 300; 6. A requirement for mechanical ventilation ≤ 48 hours prior to enrollment. 7. Evidence of increased inflammation as assessed by hsCRP > ULN AND at least ONE of the following being > upper limit of normal (as available): 1. ferritin 2. procalcitonin 3. D-dimer 4. fibrinogen 5. LDH 6. PT/PTT Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection), or fungal infections 2. Active herpes zoster infection 3. Known active or latent tuberculosis (TB) or history of inadequately treated TB 4. Active hepatitis B or hepatitis C 5. Known history of human immunodeficiency virus (HIV) infection with a detectable viral load or CD4 count < 500 cells / mm3 (patients for whom documented viral load or CD4 counts are available will be excluded) 6. Active hematologic cancer 7. Metastatic or intractable cancer 8. Pre-existing neurodegenerative disease 9. Severe hepatic impairment defined as Child-Pugh Class B or Class C at baseline 10. Severe renal impairment with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 11. Severe anemia (Hb < 8.0 g/dL) 12. Any of the following abnormal laboratory values: 1. absolute lymphocyte count <250 cells/mm3 2. absolute neutrophil Count (ANC) <1000 cells/mm3 3. Platelet count <50,000 cells/mm3 4. ALT or AST > 5X ULN, or other evidence of hepatocellular synthetic dysfunction or total bilirubin > 2X ULN 13. Any other medical condition or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study 14. Prohibited concomitant therapy (see section 1.12.7.2) 15. Pregnancy (a negative urine or serum pregnancy test is required for inclusion) 16. Immunocompromised patients, patients with known immunodeficiencies or taking potent immunosuppressive agents (e.g., azathioprine, cyclosporine) 17. Anticipated survival < 72 hours as assessed by the Investigator. 18. Participation in other clinical trials of investigational treatments for COVID-19 19. Known history of nephrolithiasis | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 20.0-60.0, Carbon Dioxide Age: Adult Patients aged 20-60 years Sex: either male or female ASA physical status I or II Elective ERCP * Abnormal renal function test History of asthma or COPD patients with a history of hypertension and diabetes Cardiac patients | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Attention Deficit Hyperactivity Disorder Clinicians Currently providing care for children with ADHD as psychologists, general pediatricians, or developmental pediatricians > 18 years old Any race/ethnicity * Unable to read/speak either English or Spanish. 2. Family navigators Having experience working as family navigator and/or community health worker Latinx (Lx) or African American (AA) > 18 years old * Unable to read/speak either English or Spanish. 3. Caregivers Phase 1a: current or former caregiver of a child with ADHD, with and without experience with ADHD treatment Phases 1b and 2: current caregiver of a child (aged 7-11 years) with ADHD who is ADHD treatment-naïve at study enrollment Lx or AA > 18 years old * Unable to read/speak either English or Spanish | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 21.0-999.0, Covid19 Type 2 Diabetes T2DM according to the ADA criteria. Patients with long standing diabetes as well as patients with new onset diabetes will be recruited. Patients receiving glucocorticoids for treatment of COVID-19 and manifest plasma glucose levels consistent with diabetes diagnosis also will be included 2. Patients can be drug naïve, receiving oral antihyperglycemic therapy (except pioglitazone), GLP-1 RA or insulin therapy will be allowed to participate in the study 3. COVID-19 infection confirmed with PCR test 4. Age 21-85 years 5. Patients of both sexes will be included 6. In addition to diabetes and COVID-19 diagnoses, patients should manifest at least one of COVID-19 symptoms (Fever, Chills, Headache, Rhinorreah, Cough (dry or with sputum), Sore Throat, shortness of breath, Hemoptysis, Altered mentation, Fatigue/Malaise, Myalgia, Nausea/Vomiting, Diarrhea, Anosmia, Chest pain). 7. Patient receiving other anti-inflammatory therapy for their routine COVID-19 care (e.g. hydroxychloroquine), or antiviral therapy (e.g. remdesivire) will be included in the study and will be evenly randomized amongst the two treatment groups T1DM 2. Absence of confirmation of COVID-19 infection 3. Age <21 years 4. Presence of heart failure (LVEF<40%) or a history of hospitalization for heart failure 5. Use of diuretics (furosemide or aldactone) for heart disease usually for heart failure. Patients with hypertension receiving diuretic therapy (usually thiazide) will be included in the study 6. Patient on mechanical ventilation or patients whose clinical condition requires mechanical ventilation in the following 24 hours. 7. Patients not expected to survive > 48 hours 8. Patients receiving pioglitazone for the management of their diabetes 9. Patients participating in other research study will be excluded 10. Pregnant women will be excluded from the study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Chronic Respiratory Failure With Hypercapnia Chronic Obstructive Pulmonary Disease (COPD) Obesity Hypoventilation Syndrome (OHS) Patient with chronic respiratory failure for whom treatment with home NIV was prescribed at or two months earlier, and whose service provider is ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire Patient who meets all to participate in the program, namely Patient aged 18 and over Patient receiving NIV as part of an indication recognized by the Société de Pneumologie de Langue Française and the Haute Autorité de Santé Patient never before included in the program for the remote medical monitoring of their chronic respiratory failure Patient having agreed to participate in the program with the Chronic Care Connect Pneumology solution operated by the service providers ADEP Assistance, ADAIR Assistance, ARAIR Assistance or VitalAire, in the event that they are randomized to the Remote Medical Monitoring group Patient agreeing to the collection of data from their ventilator via remote transmission Patient fitted with a ventilator compatible with the Chronic Care Connect Pneumology solution Patient with health insurance cover Patient who has signed the consent form for the study Patient who has any of the non-eligibility for the program Physical or mental inability to use all components of the remote medical monitoring project, as determined by the doctor wishing to the patient in the remote medical monitoring project Patient with cancer with a life expectancy of less than 12 months estimated by the pulmonologist Patient with more than three COPD respiratory decompensations resulting in hospitalization within the previous 12 months Patient with diagnosed neuromuscular disease Estimated poor compliance or standard adherence to treatment according to the physician including the patient Patient's refusal of treatment support No permanent place of residence Patient participating in another intervention research program | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 8.0-16.0, Functional Abdominal Pain Syndrome Diagnosis of functional abdominal pain as defined by the Rome IV for childhood functional gastrointestinal disorders Diagnosis of inflammatory bowel disease or irritable bowel syndrome Lactose intolerance Abdominal surgery within the past year Contraindications for imaging Antibiotic use over the last 3 months | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Quality of Life For the patient Patient with a diagnostic of chronic obstructive pulmonary disease (COPD), sleep apnea or obesity hypoventilation syndrome Home respiratory equipment (NIV, CPAP or LTOT) since more than 3 months, patient and partner who shared the same household patient with medical stable condition patient who consents patient older than 18 years old patient followed at Rouen University Hospital For the partner patient who consents patient older than 18 years old For the patient Home respiratory equipment for neuromuscular disease Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship) patient not able to consent For the partner Patients who are institutionalized, deprived of their liberty or placed under judicial protection (guardianship or curatorship) patient not able to consent | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 8.0-14.0, Pediatric Obesity Executive Function Children who: 1. have a BMI ≥ 85th percentile; 2. are 8 and 14 years old at the beginning of treatment; 3. can read, write, and speak English, along with their caregiver; 4. plan to stay living in the local area during the study period; 5. have a consenting caregiver who can commit to all study procedures Children who: 1. have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function; 2. are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-90.0, Stroke Stroke, Acute Motor Function age 18-90 2. first-time clinical ischemic or hemorrhagic cerebrovascular accident as noted in the radiological (or physician's) report; 3. the ability to extend =20° at the wrist and 10° at the metacarpophalangeal and interphalangeal joints of all digits; 4. participants must demonstrate adequate balance while wearing the restraint; 5. the ability to stand from a sitting position and the ability to stand for at least 2 minutes with or without upper extremity support; 6. weakness, defined as score of 15-55 (out of 66) on arm motor Fugl-Meyer (FM) scale; and 7. stroke onset more then 6 months prior to study enrollment significant pre-stroke disability; 2. where applicable (a history of depression before the stroke); 3. any substantial decrease in alertness, language reception, or attention that might interfere with understanding the instructions for the motor testing; 4. excessive pain in any joint of the paretic extremity; 5. contraindications to single-pulse TMS (TMS will be used to measure cortical excitability) such as metal head implants; 6. advanced liver, kidney, cardiac, or pulmonary disease; 7. a terminal medical diagnosis consistent with survival 1 year; 8. coexistent major neurological or psychiatric disease (to decrease the number of confounders); 9. a history of significant drug abuse in the prior 6 months; 10. the use of certain neuropsychotropic drugs such as tricyclics, antidepressants, or 51 of 66 carbamazepine; 11. active enrollment in a separate intervention study targeting stroke recovery; ( 12. previously applied constraint-induced motor therapy and/or tDCS treatment for stroke; and 13. a history of epilepsy before stroke (or episodes of seizures within the last six months) | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-45.0, Obesity Weight Loss Eating Behavior overweight to obese (BMI 25-45 kg/m2) not currently engaged in exercise or weight loss activities free of any cardiac, pulmonary, or metabolic health conditions able to safely engage in exercise female participants must be premenopausal and not pregnant or nursing Lost or gained over 5% of their current bodyweight in the previous 12 months taking any medications or dietary supplements which may influence energy expenditure or intake have not been diagnosed with an eating disorder, clinical depression, or an anxiety disorder engage in less than 150 minutes of moderate to vigorous physical activity per week (assessed via accelerometry at baseline) | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-100.0, Cardiovascular Diseases Adults aged 50 and older Have access to internet Have access to a tablet (i.e., iPad or Android) or a computer Diagnostic of cardiovascular disease (stable chronic systolic or diastolic heart failure, atrial fibrillation, documented atherosclerotic disease) Able to do light to moderate aerobic exercice training With no contraindication to exercise training Non-cardiopulmonary limitation to exercise (e.g., arthritis) Severe exercise intolerance Respiratory disease (e.g., asthma, COPD, COVID-19) Mini Mental Scale Examination (MMSE) telephone version lower than 19/23 | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Pulmonary Disease Cardiomyopathies Heart Failure Restrictive Lung Disease Age > 18 years Patient who are willing to participate in follow-up survey 3 months after completion of pulmonary rehabilitation Patients who complete rehabilitation for at least 8 weeks • Not meeting | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Hypoxia Subjects 18 years old and up wearing masks as personal protective equipment (measure) Subjects younger than 18 years old Females who are pregnant or women of childbearing potential with a positive pregnancy test at the time of consenting. (If a pregnancy test has not been performed at the time of consenting, the individual will be automatically excluded since a confirmed negative pregnancy test is not available. We will not be able to provide the cost of pregnancy test and will only rely on verbal confirmation from the subject that they are not pregnant or have a -personally purchased standard of care negative pregnancy test.) Consent cannot be obtained from the subject Prisoners will be excluded Cognitively impaired subjects will be excluded | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-65.0, Flu-like Symptoms Healthy Volunteers Subjects with no symptoms of respiratory illness such as fever, rhinorrhea, mild cough, sore throat, headache, fatigue, muscle pain, and malaise but with no shortness of breath Male or non-pregnant female adult > 18 to 65 years of age at time of enrollment to all races and ethnic minorities Agree to the collection of blood specimens (for the pharmacokinetics study) Willingness of study participant to provide informed consent and accept randomization to any assigned treatment arm Must agree not to enroll in another study of an investigational agent prior to Day 28 of study, unless hospitalized Signs of any respiratory distress or pulmonary infection defined as the need for non-invasive or invasive mechanical ventilator support, ECMO or shock requiring vasopressor support Subjects with risk factors for severe disease (e.g. hypertension, diabetes, pulmonary, cardiovascular, renal, hepatic, neurologic disease or immune compromise, obesity, and pregnancy) Any previous history of clinically significant cardiovascular disease, including ventricular arrhythmias Current use of cardiac glycosides or a known allergic reaction to cardiac glycosides or compounds of similar chemical or biologic composition Any risk factors that can lead to severe COVID-19 including uncontrolled diabetes, hypertension, and systemic diseases including hepatic disease and renal insufficiency Pregnancy or breastfeeding Participation in any other clinical trial of an experimental treatment for COVID-19 | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Sleep Apnea, Obstructive Obesity Hypoventilation Syndrome (OHS) Sleep Apnea Syndromes Age ≥18 years old Sleep testing shows an apnea-hypopnea index or respiratory event index ≥5 Patient is PAP naïve Patient's diagnosis is obstructive sleep apnea, obesity hypoventilation syndrome, or central sleep apnea syndrome Prescribed therapy is CPAP, A-PAP, or BPAP in a spontaneous modality Patient is able to provide consent Patient is English speaking (limited to English for device) Prescribed therapy is BPAP ST or ASV Patient is not able to provide consent Patient is not able to speak or read English Nasal or facial trauma or surgery that leaves atypical facial features Protocol: Eligible patients will be randomized to Active or Usual Care using randomizer.com. This is the differentiating part of the study, with the prescription for a mask being decided by these two different processes Patients in the Active group will provide their inputs and have measurements obtained using MyMask™. The initial mask choice will be influenced by this interaction. If the patient is disinclined to accept the first recommendation offered by this application, the second, third, and so on will be offered to the patient. The initial prescription will then be issued for that particular mask Patients in the Usual Care group will engage in initial mask choice by viewing different options of mask styles using a standard online poster that demonstrates NM, NP, ONM, and Combination masks, and then choosing which type they would like ordered. An initial follow-up visit will be scheduled to occur either face to face or via video visit between day 31-90 of PAP use. This is a standard clinical visit, and the patient will be asked about their experience, the effects of therapy, and a download of their PAP machine will be obtained. Standard information will be gathered at this visit: Standard 31-90 day visit data Epworth Sleepiness Scale PAP satisfaction questionnaire (CPAP Questionnaire is a 12 item questionnaire, with items 1-6 a Likert like scale asking about various types of discomfort, and questions 7-12 using a 100 mm VAS to answer questions related to PAP and sleep satisfaction). In addition, a video or telephone visit will be as soon after 90 days as possible to collect PAP compliance and leak rate data PAP satisfaction questionnaire data | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Heart Failure Patients being admitted with ADHF over 18 years old Known history of systolic or diastolic dysfunction of greater than 6 weeks NYHA Class II-IV Heart failure as defined in [Table 1]. One symptom must be present at time of screening and one sign must be present in the last 12 months Elevated pro-BNP >/= 360 pg/ml and not explained by any other etiology Willing to consent and comply with scheduled visits and phone calls Table 1. for Diagnosing Heart Failure (at least 1 must be present at time of screening) Paroxysmal nocturnal dyspnea Orthopnea Dyspnea on mild or moderate exertion SIGNS (at least 1 must be present in the last 12 months) Any rales post cough Systolic blood pressure <85 mmHg Signs of significant respiratory distress, according to the discretion of the investigator Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion Chronic dialysis Acute renal failure defined as creatinine > 2 x baseline Severe systemic illness with life expectancy judged less than three years Chronic pulmonary disease requiring home O2, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator Primary hemodynamically significant uncorrected valvular heart disease, obstructive, or regurgitant, or any valvular disease expected to lead to surgery during the trial Atrial fibrillation with resting heart rate >90 bpm Myocardial infarction in past 90 days | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Death, Sudden Ventricular Tachycardia Implantable Defibrillator User Myocardial Infarction Myocardial Dysfunction AMI patients over 18 years old LVEF equal or lower than 40% determined by a transthoracic echocardiography 4 days after the onset of the AMI Revascularization during hospitalization according to the clinical practice guidelines Signed informed consent Non-ischemic etiology of left ventricular dysfunction by cMRI Patient already implanted with a cardiac device (pacemaker, ICD or ICD-TRC) Indication of pacemaker, ICD or ICD-TRC implantation during hospitalization Allergy or hypersensitivity to any implatable device component Contraindication for cMRI performance Life expectancy under 1 year due to a non-cardiac cause Concomitant valvulopathy with indication for surgery High functional class (NYHA IV) No possibility to connect to the remote monitoring | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Hypothyroidism Male or female aged ≥18, ≤75 years old clear diagnosis of primary hypothyroidism Use the same dose of levothyroxine for ≥3 months The levels of thyroid function (TSH, TT4, FT4, TT3, FT3) in hospital laboratory blood tests no more than 6 weeks before participation were within the normal range regnancy or lactation women affect blood sugar, blood lipid metabolism drugs serious heart disease thyroid malignant tumor history of mental illness | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Atrial Fibrillation Obstructive Sleep Apnea Experimental group: (15 patients) 75-year-old, AND With mild to severe OSA (mild: Apnea Hypopnea Index: AHI between 5-15, Moderate AHI= 15-30, severe AHI>30), diagnosed by polysomnography Patient with a creatinine measurement within the last 6 months Control group (5 patients): patients with no lung or heart disease, matched by age and BMI History of chronic heart failure (Left Ventricle Ejection fraction (LVEF) < 50%), AF, myocardial infarction, valvular disease Prior cardiac or chest surgery Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate <30 ml/min, etc.) BMI > 35 kg/m2 (affects DE-MRI quality) Pregnancy Contraindications to device (peripheral neuropathy) Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the use of Inability to give informed consent No access to proper smartphone technology and/or internet | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Metabolic Syndrome Obesity Hypoventilation Syndrome Capnography BMI>30 kg/m2 no treatment with CPAP nor NIV obstructive respiratory disease non-treated cardiac dysfunction | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Endometrial Carcinoma Obesity EIN Endometrial Intraepithelial Neoplasia Endometrial Cancer Stage I Female adults at least 18 years of age A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities --including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40 Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN Younger than 18 years old BMI < 35 Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis Pregnant participants will be excluded from this study Patients with contraindications to bariatric surgery will also be excluded. --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness inability to read an English informed consent form, and unwillingness to provide informed consent | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Vertigo Dizziness The patient suffering from vertigo and dizziness for at least 1 month and The ability to walk independently or do their routine tasks will be included in the study Patients should be capable to complete the questionnaire without any help Patients suffering from blindness musculoskeletal abnormalities neurologic disorder, or paralysis in ENT or neurologic evaluation by ENT and neurologist will be excluded from the study Also, if the patients are unable to cooperate then, they will also be excluded | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Ventricular Tachycardia Ischemic Cardiomyopathy Ventricular tachycardia ablation between October 2014 and April 2021 Patient for whom electroanatomical data are available Ischemic cardiomyopathy / previous myocardial infarction At least 30 points of pace-mapping during the VT procedure Incomplete data Poor quality ECG recordings Absence of ventricular tachycardia isthmus identified during the procedure | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Age 40 years or older Diagnosis of COPD Discharged within the past 3 months after hospitalization for COPD exacerbation, congestive heart failure exacerbation and/or pneumonia Active prescription for supplemental oxygen within 48 hours of discharge that remains active No inpatient or outpatient exacerbations of COPD within the last 30 days Smoked at least 10 pack-years of cigarettes Room air resting saturation >88% on room air Spirometry consistent with COPD (FEV1/FVC < 0.70) and/or evidence of emphysema on CT scan Willingness on the part of the participant to stop oxygen if randomized to the intervention Ability and willingness to participate in virtual video visits with study staff using VA approved software Desaturation during 6MWT <80% for one minute or more Non-COPD lung disease that affects oxygenation or survival (including pulmonary hypertension) Prescription of oxygen for alternative condition (e.g. bleed-in with positive airway pressure therapy for obstructive sleep apnea) Diagnosis expected to result in death in six months or enrollment in hospice Participation in another intervention trial Cognitive issues that would preclude participation (dementia, stroke, etc.) Residence in skilled nursing facility Inability to speak, read, or understand English Any safety concerns | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Hypothyroidism Thyroid Neoplasms Patients greater than or equal to 18 years of age, with well-differentiated, non-medullary thyroid cancer, including papillary (including follicular-variant), follicular, and Hurthle cell. Patients who recently have undergone a total or near-total thyroidectomy and are scheduled to undergo initial 131I diagnostic studies and ablation. Patients must have evidence of residual thyroid tissue after thyroid surgery confirmed by ultrasound or other imaging technique (e.g., a technetium [Tc 99] pertechnetate or thallium scan). Patients who have undergone thyroidectomy or other thyroid surgery at least 6 weeks prior to enrollment. All patients who have been sustained on maintenance THST for at least 4 weeks, but not longer than 12 weeks after thyroidectomy. All patients who have confirmed serum TSH levels less than or equal to 0.5 mU per liter within 7 days prior to the first Thyrogen dose, and prior to randomization. Female patients of childbearing age must have a negative serum human chorionic gonadotropin (HCG) pregnancy test prior to entering the study and within 5 days of any 131I administration and must be following an approved method of contraception. Patients who are committed to following the protocol requirements as evidenced by providing written informed consent. Patients for whom a 131I scan is currently contraindicated because withdrawal from THST is not an option due to pituitary dysfunction or other compelling medical reasons are excluded. Patients should not have a concurrent major medical disorder (e.g., documented cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease or advanced pulmonary disease) who may be too ill to adequately comply with the requirements of this study. Patients with non-thyroidal conditions known to effect 131I uptake (e.g., congestive heart failure, renal failure) are excluded. Patients should not have undergone any intravenous water soluble radiographic contrast administration within the previous 4 weeks. Patients should not have received intrathecal or cholecystographic iodinated contrast agent administration within 3 months prior to enrollment. Patients should not be taking drugs that affect thyroid or renal function (e.g., renal drugs, lithium, or corticosteroids). Patients should not be participating in another investigational drug study or in such a study within 30 days of their enrollment in this study. No patients with a recent history of alcoholism or drug abuse, severe emotional behavioral or psychiatric problems who, in the opinion of the investigator, would not be able to comply with the requirements of this study | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-120.0, Pancreatic Cancer Histologically or cytologically proven adenocarcinoma of the exocrine pancreas excluding periampullary cancer Resectable malignancy must be located in a region that can be encompassed by a radiation port of 20 x 20 cm No evidence of extranodal metastatic disease Age and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC at least 3500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Not specified Renal Bilateral renal function as demonstrated by excretory urogram (IVP) or abdominal CT scan with contrast OR | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Esophageal Cancer Patients with histologically documented untreated squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastro-esophageal junction and with less than 2 cm distal spread into the gastric cardia were eligible. 2. No evidence of distant metastatic disease by history and physical examination 3. Upper endoscopy with biopsy, computed tomography (CT) of the chest and upper abdomen, and pulmonary function studies are required. 4. Bone scan is required for alkaline phosphatase more than 3X the institutional normal value. 5. Bronchoscopy is required if the primary tumor was adjacent to the trachea or left main stem bronchus. 6. Patients are required to have granulocyte counts ≥1,800/mL platelet count ≥ 100,000/mL creatinine clearance ≥ 50 mL/min 7. Esophageal ultrasound (EUS) and preresection staging by thoracoscopy (ts) and laparoscopy/minilaparotomy (ls), including biopsy of celiac axis and lesser curvature are recommended 8. Tumors must be considered surgically resectable (T1-3, NX), including regional thoracic lymph node (N1) metastases. 9. Patients with supraclavicular lymph nodes measuring ≤ 1.5 cm by CT (not palpable) are eligible. 10. Patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) ≤1.5 cm by CT. 11. Patients may not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. 12. Patients with previous malignancies are eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence. 13. There can be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent. Patients with uncontrolled or severe cardio vascular disease,pulmonary disease, oractive infections are excluded. 14. Pregnant patients are excluded. 15. Informed consent is required for all patients | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Major Depression Major depression assessed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID; First et al, 1995) Minimum score greater than or equal to 20 on the 17-item Hamilton Depression (HAM-D) Scale at screen and at baseline GAF of 60 or less (moderate symptoms) at screen and at baseline HAM-D cannot decrease by 25% or more between screening and baseline Capacity to give informed consent and to follow study procedures Abstinence or effective method of contraception throughout the study Scores greater than 2 on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months Current suicidal or homicidal risk, as determined by the investigator Women of childbearing age who are pregnant, planning pregnancy in the next 6 months, breast-feeding, or not using medically acceptable means of birth control (hormonal treatment such as birth control pill, injection or implant, IUD, or double barrier of condom and diaphragm together is acceptable; primary use of condom, sponge or diaphragm alone (single barrier) is not acceptable because these may carry a higher rate of failure when used alone Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal; asymptomatic Gilbert's syndrome is not an exclusion). 4. Serious or unstable medical illness. 5. History of seizure disorder (other than febrile) Any of the following DSM-IV diagnoses by SCID: current (within past 6 months) alcohol or other substance abuse disorder; schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent) Clinical or laboratory evidence of untreated or unstable thyroid disorder Failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent Have taken sertraline or any form of hypericum during this current episode of depression at any dose level, daily, for at least one month, within the past 6 months Current (within past 6 months) use of other prescription or non-prescription drugs, including anticonvulsants and other medications with significant psychotropic properties, antiretroviral medications, cyclosporine, digoxin, coumadin, dietary supplements, natural remedies, and botanical preparations (eg, hypericum, kava, valerian) Have had other investigational drugs within 30 days or other psychotropic medication within 21 days of baseline (6 weeks for fluoxetine) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-100.0, Cardiovascular Diseases Heart Diseases Hypertension for probands: Onset of hypertension by age 60 years and the presence of at least one additional hypertensive sibling who was willing to participate. Hypertension was defined according to systolic BP ≥140 or diastolic BP ≥90 in at least two different evaluations, or treatment for hypertension. Volunteers with type 1 diabetes or renal failure were excluded. for subsequent recruits: as indicated in Study Population Description (i.e., based on familial relationships, hypertension and antihypertensive medication status) | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Pancreatic Cancer Pancreatic Neoplasm Patients must have regionally confined histologically or cytologically proven adenocarcinoma of the pancreas or Ampulla of Vater. Tumors must overexpress HER2 as demonstrated by greater than or equal to 2+ immunohistochemical staining of the biopsy specimen. Patients must sign an informed consent. Patients must have an ECOG performance status of less than or equal to 2. Patients should have a serum creatinine less than 1.5 mg/dl or creatinine clearance greater than 60 ml/hr; SGOT and SGPT less than 4 times the upper limit of normal. Patients must have an ANC greater than 2000/mm(3) and platelets greater than 100,000/mm(3). Patients must be at least 18 years of age. Patients of all racial and gender groups will be included. Patients must not have received any prior gemcitabine, radiotherapy, or Herceptin therapy for pancreatic cancer. Patients cannot receive concurrent hormonal or immunotherapy treatment for pancreatic cancer. Patients cannot receive any anti-tumor therapy within 30 days of protocol and must have recovered from any prior treatment related toxicity. Patients must not have evidence of distant metastases (e.g., peritoneal, carcinomatosis, liver metastases). No concurrent second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ. Must not have medical conditions that preclude undergoing surgery or receiving therapy or follow up, or have psychiatric disease which would prevent adequate informed consent or render receiving this therapy unsafe. No patients with an LV ejection fraction less than the lower limit of normal as determined at the Clinical Center, NIH. Women must not be pregnant or nursing due to the unknown effects of this therapy on the unborn or nursing child. Must not have received prior abdominal or pelvic radiation. Must not have recent myocardial infarction (less than 6 months prior), unstable angina, or congestive heart failure (NYHA class III or IV). Must not have active diseases which make the patient more susceptible to infection, including but not limited to AIDS, hepatitis, history of autoimmune disorders, because the experimental treatment being evaluated in this protocol may be unsafe in the absence of an intact immune system | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-120.0, Pancreatic Cancer Thromboembolism Histologically or cytologically confirmed pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection Age and over Performance status Eastern Cooperative Oncology Group 0-2 Life expectancy Not specified Hematopoietic White Blood Cell count greater than 3,500/mm^3 Platelet count greater than 100,000/mm^3 No clinically significant bleeding disorder No prior heparin-induced thrombocytopenia Hepatic Bilirubin less than 2.0 mg/dL aspartate aminotransferase less than 3 times normal Renal | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Lung Neoplasms Carcinoma, Non-Small-Cell Lung Brain Neoplasms Metastases, Neoplasm Patients will be eligible for the study if they Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study) Have an ECOG performance status of Zero or One Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain Have signed an informed consent form Patients will not be eligible for this study if they Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed Are taking or have taken part in any investigational study within 30 days of start of study Have received an indium agent within 30 days of start of study Are not able to remain immobile during scanning time Have taken drugs that may damage the kidneys within 2 weeks of start of study Have abnormal laboratory test results: hemoglobin<9.5 gms/dl, serum creatinine>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration Have undergone a PET scan within 7 days prior to study drug administration | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Gastrointestinal Neoplasm The patient must have histologically or cytologically proven peritoneal carcinomatosis from low-grade mucinous adenocarcinoma of the gastrointestinal tract. Patients with no tissue for examination may undergo percutaneous needle aspiration under computed tomography (CT) or ultrasound guidance as clinically indicated or a laparotomy with biopsy if a tumor grade cannot be determined on other available material. 2. Radiologic workup must demonstrate that there is no imageable disease outside of the peritoneal cavity. 3. Radiologic workup or prior abdominal exploration must show abnormalities consistent with disease which can be debulked to a residual size of less than 1 cm in diameter per tumor deposit in the judgement of the investigators. 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 on study entry and on the day prior to planned treatment. 5. Patients must have a minimum expected duration of survival of greater than 16 weeks. 6. Patients must have recovered from any severe toxicity from all prior chemotherapy, immunotherapy or radiotherapy except as outlined in appendix 1 of the protocol and be at least 30 days past the date of their last treatment. 7. Patients must have a serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) within 5 times the upper limit of normal and a total serum bilirubin of less than 3 times the upper limit of normal, both of which define the upper limit of grade 2 treatment related toxicities.. 8. Patients must have a absolute neutrophil count (ANC) greater than 1,500/microliter. 9. Patients must be age greater than or equal to 18 years Patients will be excluded if they have concomitant medical problems that would place them at unacceptable risk for a major surgical procedure. 1. Patients at increased risk for coronary artery disease or cardiac dysfunction (e.g. age greater than 65, and a history of hypertension, first degree relative with atherosclerotic coronary artery evaluation and will not be eligible if they demonstrate significant irreversible ischemia on a stress thallium study or an ejection fraction of less than 40%. 2. Patients who have shortness of breath with minimal exertion or who are at risk for pulmonary disease (e.g., chronic smokers) will undergo pulmonary function testing and will not be eligible if their forced expiratory volume 1 (FEV1) is less than 1.2 liters or their maximum voluntary ventilation is less than 50% of expected. 2. Patients who have a neurological toxicity of Grade 3 or greater will be excluded because of the potential neurotoxicity associated with platinum and paclitaxel therapy. 3. Patients will be ineligible if they have a serum creatinine of greater than 1.5 mg/dL unless the measured creatinine clearance is greater than 60mL/min/1.73m^2. 4. Patients will be ineligible if platelets are less than 75, 000/mm^3. 5. Patients who have failed previous intraperitoneal chemotherapy will be ineligible. 6. Pregnant women or women who are breast-feeding will be ineligible. 7. Patients less than 30 kg will be ineligible. 8. Patients who have undergone two or more operative procedures to debulk disease, have received 2 or more regimens of systemic chemotherapy, or any previous continuous hyperthermic peritoneal perfusion (CHPP) therapy will be excluded from study | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Patient must be > 18 years of age. 2. Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration. 3. Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system NOTE: The pathology report must be submitted to on the Pathology Report Shuttle CRF. 4. Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to on the Operative Report Shuttle CRF. 5. Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration WBC > 3,000 mm^3 ANC > 1,500 mm^3 hemoglobin > 9.5 mg/dl platelet count > 100,000 mm^3 total bilirubin < 3 mg/dl AST (SGOT) < 2.0 times institutional upper limit of normal (ULN) ALT (SGPT) < 2.0 times institutional ULN alkaline phosphatase < 2.0 times institutional ULN Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma. 2. Patient is pregnant or lactating. 3. Patient has recurrent pancreatic cancer. 4. Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer. 5. Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis. 6. Patient has received any biologic/ immunologic therapies. 7. Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality. 8. Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis, Acute Necrotizing Pancreatic necrosis or peripancreatic fluid collection following acute pancreatitis noted on CT scan Infected pancreatic necrosis or pancreatic abscess and determined by + FNA (gram stain or culture), as defined by the Atlanta Symposium Not neutropenic or pregnant No prior necrosectomy No pancreatic pseudocyst, either sterile or infected | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Biopsy proven completely resected (R0 or R1) pancreatic adenocarcinoma of the pancreatic head or uncinate process [American Joint Committee on Cancer (AJCC) Stage I-III]. Surgery (pancreaticoduodenectomy) may be performed at M. D. Anderson Cancer Center or prior to referral to M. D. Anderson Cancer Center. Protocol treatment must begin within 12 weeks of surgery. 2. Postoperative (pre-treatment) computed tomography (CT) scan without evidence of radiographically defineable residual primary/metastatic disease or clinically significant post-surgical changes. 3. Staging studies completed within three weeks +/ days of protocol registration. 4. Hemoglobin (Hb) >9.0 g/%, White Blood Count (WBC) >3,000 cells/mm3 (Absolute neutrophil count (ANC)>1,500 cells/mm3), platelets >75,000 cells/mm3. 5. Postoperative serum calcium (CA) 19-9 < 100. 6. Performance status: Zubrod 0 or 1. 7. Creatinine £1.5 mg/dL and calculated or measured creatinine clearance (CrCl) of 60 ml/min or greater by the following formula: Creatinine clearance rate (CrCl) = (140 - age) * Weight (kg) * 0.85 (female) OR * 1.00 (male) 72 * serum creatinine 8. Patients should have bilateral renal function, as determined on excretory urogram (IVP) or abdominal CT, or ³ 2/3 of one functioning kidney must be able to be shielded from the radiation beam. 9. No acute infections at the time of therapy initiation. 10. Women of childbearing potential must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent. 11. Patients must sign a study-specific consent form, which is attached to this protocol. 12. Patients with a prior history of non-pancreatic malignancy who are free of disease from their primary cancer may be eligible at the discretion of the study chair Residual (clinical or CT definable) metastatic or incompletely resected local disease. 2. Patients with positive peritoneal cytology (for adenocarcinoma) detected at laparotomy for pancreaticoduodenectomy or as part of prior laparoscopic assessment of peritoneal cytology. 3. Patients with a history of hypersensitivity to interferon alfa-2b. 4. Patients with significant cardiovascular disease, such as unstable angina or congestive heart failure. 5. Pregnancy or breastfeeding. 6. Patients with severe pulmonary disease. 7. Children under the age of 18 are excluded (as the disease is rare and toxicity profile of this regimen untested in pediatric patients). 8. Presence or history of severe depression | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 25.0-999.0, Breast Cancer At high risk for breast cancer, as defined by at least 1 of the following Known BRCA1 or BRCA2 mutation Personal history of breast cancer with conserved breast analyzed separately Prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, or atypical papilloma and not receiving chemoprevention (i.e., not on tamoxifen, raloxifene, anastrazole, or any other aromatase inhibitor) OR any of these atypical lesions (including phyllodes tumors) AND first-degree relative diagnosed with breast cancer under age 50 Prior biopsy showing lobular carcinoma in situ Age 30 and under and received prior chest and/or mediastinal and/or axillary irradiation ≥ 8 years ago Risk of breast cancer meeting one of the following Gail or Claus lifetime cancer risk ≥ 25% Gail 5-year cancer risk ≥ 2.5% Gail 5-year cancer risk ≥ 1.7% AND known to have extremely dense breasts (≥ 75% dense) by most recent mammogram | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Atherosclerosis Cardiovascular Diseases Hypertension, Renovascular Renal Artery Obstruction Either 1. Documented history of hypertension on two or more anti-hypertensive medications OR 2. Renal dysfunction, defined as Stage 3 or greater chronic kidney disease (CKD) based on the new National Kidney Foundation (NKF) classifications (estimated glomerular filtration rate [GFR] less than 60 mL per minute per 1.73 m^2, calculated by the modified Modification of Diet in Renal Disease [MDRD] formula) 2. One or more severe renal artery stenoses by any of the following pathways: a. Angiographic: greater than or equal to 60% and less than 100% by renal angiogram OR b. Duplex: systolic velocity of greater than 300 cm/sec OR c. Core Lab approved Magnetic Resonance Angiogram (MRA) (refer to the protocol for specific criteria) demonstrating stenosis greater than 80% OR stenosis greater than 70% with spin dephasing on 3D phase contrast MRA OR stenosis greater than 70% and two of the following: i. Ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Ischemic kidney enhances less on arterial phase iii. Ischemic kidney has delayed Gd excretion iv. Ischemic kidney hyper-concentrates the urine v. 2-D phase contrast flow waveform shows delayed systolic peak vi. Post-stenotic dilatation d. Clinical index of suspicion combined with a Core Lab approved Computed Tomography Angiography (CTA) demonstrating Stenosis is greater than 80% by visual assessment on high quality CTA Stenosis is greater than 70% on CTA by visual assessment and there are two of the following i. The length of the ischemic kidney is greater than 1 cm. smaller than contralateral kidney ii. Reduced cortical thickness of ischemic kidney iii. Less cortical enhancement of ischemic kidney on arterial phase iv. Post-stenotic dilatation Unable to provide informed consent 2. Unable or willing to comply with study protocol or procedures 3. Must be greater than 18 years of age 4. Fibromuscular dysplasia or other non-atherosclerotic renal artery stenosis known to be present prior to randomization 5. Pregnancy or unknown pregnancy status in female of childbearing potential 6. Participation in any drug or device trial during the study period, unless approved by the Steering Committee 7. Prior enrollment in the CORAL study 8. History of stroke within 6 months, if associated with a residual neurologic deficit* 9. Any major surgery, major trauma, revascularization procedure, unstable angina, or myocardial infarction 30 days prior to study entry* 10. Any planned major surgery or revascularization procedure, outside of the randomly allocated renal stenting indicated by the protocol, after randomization* 11. Hospitalization for heart failure within 30 days* 12. Comorbid condition causing life expectancy of less than or equal to 3 years* 13. Allergic reaction to intravascular contrast, not amenable to pre-treatment 14. Allergy to stainless steel 15. Allergy to all of the following: aspirin, clopidogrel, ticlopidine 16. Known untreated aneurysm of the abdominal aorta greater than 5.0 cm.* 17. Previous kidney transplant 18. a. Stenosis of greater than 50% of a previously treated revascularized renal artery OR b. Treatment of any renal artery stenosis within the past 9 months (roll-in patients can have prior treatment on the contralateral side) 19. Kidney size less than 7 cm. supplied by target vessel 20. Hydronephrosis, nephritis or other known cause of renal insufficiency, not due to large vessel renal artery stenosis 21. Visualized stenosis of only an accessory renal artery supplying greater than 1/2 of the ipsilateral renal parenchyma, without stenosis in a dominant renal artery 22. Local lab serum Cr greater than 4.0 mg/dl on the day of randomization* 23. Presence of a renal artery stenosis not amenable for treatment with a stent, known to be present prior to randomization 1. The index lesion cannot be treated with a single stent (i.e. greater than 18 mm. in length) 2. The placement of a stent will necessitate covering a renal artery branch renal artery with a stent 3. The stenosis is in an artery less than 3.5 mm. in diameter 4. The stenosis involves a segmental renal artery branch 24. Abrupt vessel closure or dissection after diagnostic angiography [NOTE: Patients with abrupt vessel closure or dissection as a result of diagnostic angiography will not be randomized but will undergo stent revascularization, receive optimal medical therapy and will be followed for the full study period] *Roll-in patients do not need to meet these inclusion/ | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Diverticulitis, Colonic Acute Disease At least three of the following signs or symptoms of an acute attack of sigmoid diverticulitis must be present: *Fever (body temperature > 38°C, sublingual), *Abdominal tenderness, *Leukocytosis (leukocytes > 10,000/µl) and left shift of the differential blood count (>1% band forms), *Elevated CRP (> 20 mg/l) Evidence of sigmoid diverticulitis by contrast enema CT evidence of wall thickening in the sigmoid intestine Decision in favor of conservative therapy on the basis of the case history and diagnosis Contraindication for the use of the study medication or other beta-lactam antibiotics, e.g. patients with advanced renal impairment or patients requiring hemodialysis Antibiotic therapy in the two weeks prior to the start of the study Patients with an advanced incurable disease Patients with a hematologic/oncologic disease (leukemia, lymphoma) Patients on immunosuppressants Complications of sigmoid diverticulitis leading to an immediate indication for surgery Patients who have hypersensitivity to beta-lactam antibiotics Female patients who are pregnant or nursing or who could become pregnant during the study Participation in another clinical study or use of another study drug within the four weeks prior to enrollment in the study or use of another drug during the study Each patient can be enrolled only once in the study | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Hidradenitis Suppurativa Subjects must be able to give informed consent Severe hidradenitis suppurativa clinically confirmed by the investigator and defined as recurrent abscesses, with 4 or more lesions (e.g. nodules or abscesses) with sinus track and scar formation (e.g. Stage II or III disease) that has not responded to previous standard therapies such as topical or oral antibiotics, or intralesional injections of steroids Age 18 or older Willingness to use at least one form of effective contraception during the study period and for one month after discontinuation of etanercept if female and of child bearing capacity or if male. If the patient elects to use a hormonal form of contraception then the patient must be on the same form of hormonal contraception for 90 days prior to the start of Etanercept and must plan to continue using the same form of hormonal contraception for the duration of the study (e.g. until week 18) Use of oral or topical antibiotics, isotretinoin, or intralesional steroids within 30 days prior to day 0 or at any time during the study treatment period Use of systemic immunosuppressants within 90 days prior to day 0 of this study Use of an investigational medication 90 days prior to day 0 of this study Use of a live vaccine 90 days prior to day 0 of this study Any previous use of TNF α inhibitors If using a hormonal form of contraception, the patient will be excluded if they have not used the same form of hormonal contraception for 90 days prior to the start of the etanercept (e.g. day 0) or are not willing to continue the use of the same form of hormonal contraception for the duration of the study Active infection within 30 days of day 0 of the study that is moderate (discomfort sufficient to reduce or affect normal daily activity) or severe (incapacitating with inability to work or perform normal daily activities) or requires treatment with antibiotics History of tuberculosis or other mycobacterial disease or positive screening visit purified protein derivative (PPD) (≥ 5 mm) Known history of an immuno-suppressing disease (e.g. HIV) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Breast Neoplasms Signed consent Diagnosis made by core biopsy or incisional biopsy Histologic confirmation of invasive breast cancer Clinical staging as IIB (cT3N0 only), IIIA (cT3N1 or cT0-3N2), or IIIB (cT4N0-2) ECOG performance 0 or 1 At the time of entry: *Absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; *platelet count must be greater than or equal to 100,000/mm3; *hemoglobin must be greater than or equal to 10 g/dl; *serum creatinine must be less than or equal to ULN for the lab The following for evidence of adequate hepatic function must be met: *Total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and *alkaline phosphatase must be < 2.5 x ULN for the lab; and *AST must be less than or equal to 1.5 x ULN for the lab MUGA scan or echocardiogram within 3 months prior to entry if: *age greater than or equal to 60, or *history of hypertension, or *plan to receive trastuzumab. For any patient who has a MUGA scan or echocardiogram performed for any reason, the baseline LVEF must be greater than or equal to LLN for the facility performing the procedure and there must be no regional wall abnormalities Clinical stage IIB disease that is cT2N1 Definitive evidence of metastatic disease (M1 by AJCC criteria) Prior history of invasive breast cancer in either breast or ductal carcinoma in situ (DCIS) in the ipsilateral breast treated with radiation therapy (patients with a history of lobular carcinoma in situ [LCIS] are eligible) Any treatment for the currently diagnosed breast cancer prior to study entry including radiation therapy, chemotherapy, and/or hormonal therapy Pregnancy or lactation at the time of study entry Prior anthracycline or taxane-containing chemotherapy for any malignancy Nonmalignant systemic disease (cardiovascular, renal, hepatic, diabetes, etc.) that would preclude the patient from receiving study treatment or would prevent required follow-up Grade 2 or greater peripheral polyneuropathy at the time of entry Cardiac disease that would preclude the use of anthracyclines or trastuzumab. This includes: *myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; *angina pectoris that requires the use of anti-anginal medication; *any history of documented congestive heart failure; *serious cardiac arrhythmia requiring medication; *severe conduction abnormality; *valvular disease with documented cardiac function compromise; or *uncontrolled hypertension defined as blood pressure > 160/100 mm/Hg Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.) Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 21.0-999.0, Coronary Artery Disease Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory) De novo lesions with at least 50% stenosis Myocardial ischemia (stable, unstable, silent) Prior PCI or CABG Acute myocardial infarction (with creatinine kinase >2x upper limit of normal) Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement) Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed Inability to give informed consent due to mental condition, mental retardation, or language barrier | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 0.0-999.0, Urinary Tract Infection Parturients planned for vaginal delivery Parturients receiving antibiotic treatment during delivery or in the week before | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis All patients (men and women) more than 18 years old who are going to have an ERCP procedure performed at the different centers from September 1, 2004 to about January 31, 2005 will be included Before the study: active acute pancreatitis (defined as: acute upper abdominal pain and S-amylases x 3 upper normal limit OR upper abdominal pain + radiological findings [CAT-/MR-scan] consistent with acute pancreatitis OR pathoanatomical findings consistent with acute pancreatitis by surgery) Known previous sphincterotomy Chronic pancreatitis with known calcifications Hypotension (definition: systolic blood pressure < 100 mmHg) Anemia, men/women (hemoglobin < 6 mmol/l or <9.7 g/dl) Constrictive pericarditis Pericardial tamponade Hypertrophic obstructive cardiomyopathy, aortic stenosis Mitral stenosis sildenafil within 24 hours before the ERCP procedure and 24 hours after the procedure Hypersensibility to nitroglycerine | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 35.0-999.0, Cerebral Infarction Atherosclerosis Cerebral infarction within 2 weeks from the onset or TIA with corresponding acute ischemic brain lesions on MRI within 2 weeks from the onset Age: more than 35 years of age Patient with significant focal stenosis in the M1 segment of middle cerebral artery (MCA) or basilar artery (BA) with acute ischemic lesions on magnetic resonance imaging (MRI) within the vascular territory of the stenosed artery Patients with any contraindications to the treatment with antiplatelet therapy Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks) Patients with more than 50% stenosis in the parent artery of symptomatic stenosis Bleeding diathesis Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl) Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3) Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated angiopathy, and other vasculitis Severe stroke: NIH stroke scale : more than 16 Pregnant or lactating patients Chronic user of NSAIDs | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatitis Painful chronic pancreatitis (>1 abdominal pain attack during the preceding 12 months) At least 1 calcified stone greater than 4 mm in one of its axes in the cephalic or corporeal portion of the main pancreatic duct (MPD) with upstream duct dilation Written informed consent obtained from the patient History of treatment of the pancreas using ESWL, endoscopy, or surgery Pancreatic collection greater than 2 cm in diameter at magnetic resonance or CT scan Alkaline phosphatase levels greater than twice the upper limit of normal values or signs of cholangitis Age below 18 years Pregnancy or lactation | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Appendicitis Before CT scanning Clinical suspicion of appendicitis Age more than 18 years Clinical signs of generalized peritonitis Previous take of antibiotics within the 5 days preceding the presentation Allergy or intolerance to lactamases and/or clavulanate potassium Corticosteroid or anticoagulant therapy Patient with a known inflammatory bowel disease (Crohn's disease or ulcerative colitis) Pregnant women Patient with iode allergy Renal insufficiency (creatinine > 200 ) CT scanning Appendix diameter > 6 mm Appendix non visualised | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Coronary Disease Coronary Artery Disease Coronary Restenosis all of the following Subject is ≥ 18 years old Subject is eligible for percutaneous coronary intervention (PCI) and has a single lesion requiring treatment Subject is an acceptable candidate for CABG Clinical evidence of ischemic heart disease or a positive functional study Documented stable angina pectoris The target lesion is a single de novo coronary artery lesion with ≥50 and <100% stenosis by visual estimate all of the following Female of childbearing potential. Female subjects must be medically or surgically sterile or diagnosed as post-menopausal (i.e. one year since final menstrual cycle Evidence of an acute myocardial infarction and/or CK-MB>2x upper limit of normal within 72 hours of the intended treatment Known allergies to the following: aspirin, clopidogrel (Plavix) or ticlopidine (Ticlid), heparin, stainless steel, tantalum, contrast agent (that cannot be adequately premedicated), paclitaxel or drugs similar to zotarolimus (ABT-578) (i.e. tacrolimus, sirolimus, everolimus) A platelet count <100,000 cells/mm3or >700,000 cells/mm3; a WBC <3,000 cells/mm3; or hemoglobin <10.0g/dL Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150µmol/L) Subject has had any previous or planned brachytherapy in the target vessel | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 15.0-90.0, Ovarian Cancer Patients with ovarian carcinoma who undergo hysterectomy, bilateral salpingo-oophorectomy, omentectomy, and appendectomy will be enrolled and the clinical data will be obtained from our hospital. All of the patients received four to six courses of adjuvant platinum-containing chemotherapy.Histologic grading was according to International Union against Cancer (28). The stage of disease was classified according to the International Federation of Gynecology and Obstetrics (FIGO, 1987). Pelvic and paraaortic lymph node samplings will be performed, if the disease will be confined to within the ovary or will be without a ruptured capsule. The histopathologic data, including histologic type and histologic grade, will be evaluated by a certified pathologist. The maximal diameter of the residual tumor after surgery will be also recorded. All patients will be followed up at 3-month intervals. Patients with ovarian endometrioma, other benign ovarian tumors receiving surgical intervention, or healthy patients without surgical intervention will be presented as normal controls | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-75.0, Post Polio Syndrome, PPS Male or female subjects ≥18 to ≤75 years of age. 2. Post-polio syndrome according to Halstead and Gawne History of polio virus infection Restitution or improvement regarding motor function and disabilities after initial infection Confirmed polio by EMG Subjectively increased muscular weakness after a period of at least 15 years functional stability No other explanation but post-polio syndrome to the symptoms 3. Confirmed polio by EMG in the lower extremities in at least two of the following major muscle groups; musculi quadriceps, gastrocnemicus and tibialis anterior. (Two affected muscle groups in the same extremity were accepted). 4. Subjectively increased muscular difficulties or pain after a period of at least 15 years functional stability. 5. A muscle that had deteriorated within the last five years, and had 20-75 % of the muscle strength compared to age matched normal population when measured by a dynamometer or an electronic grip force sensor (GRIPPIT). 6. Stable weight (defined as weight change <7 kg) during the last five years. 7. Body Mass Index (BMI) £ 29 kg/m2. 8. Subjects capable to understand given information and had signed the Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits Known or suspected intolerance to trial product or related products (e.g. sorbitol, glucose and fructose). 2. Selective IgA deficiency. 3. Inability to walk with walking aids. 4. Any active malignancy, history of active malignancy or treatment for malignancy during the last three years. 5. Disabling pain from extremities or skeletal system due to previous fracture(s), arthritis or other reasons not related to PPS. 6. Subjects who received or who within 12 weeks prior to enrolment received any immunosuppressive/ systemic corticosteroid treatment (topical corticosteroids excluded). 7. Treatment with intravenous human immunoglobulin for the Post-polio syndrome within six months prior to the first screening visit. 8. Participation in any other study during this study and the receipt of any investigational drug within three months prior to the screening visit. 9. Pregnancy or lactation or females of childbearing potential taking inadequate measures to prevent pregnancy. 10. Hepatitis or HIV disease. 11. Increased liver enzymes (ASAT, ALAT, γGT) above twice the upper normal value. 12. Creatine kinase >10 mkat/l. 13. Any disease or treatment that according to the discretion of the Investigator could pose a medical threat to the subject in combination with study drug, i.e. clinical manifested severe cardiovascular disease or severe arteriosclerosis or severe psychiatric disorder or other treatment that affected the immunological system such as prednisone and methotrexate. 14. Any disease or condition that according to the discretion of the Investigator would obstruct the subject from performing the tests in the protocol (e.g. fill in the questionnaires). 15. Conditions associated with a risk of poor protocol compliance (e.g. known drug or alcohol abuse). 16. Previous participation in the study | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Clostridium Difficile-associated Diarrhea (CDAD) Males and female greater than 18 years of age 2. Positive stool C. difficile cytotoxin assay and/or biopsy evidence of Pseudomembranous Colitis (PMC) at onset of illness 3. Current history of severe, relapsing CDAD or Current history of severe, refractory CDAD 4. A score of 6 or 7 on the C.Diff Severity and Prognosis Score (CDSPS) scale27,28,29,30 OR failure to respond (as identified by a score of 4 or more on the CDSPS scale below) to any of the following: a 4-day or more course of oral or IV metronidazole 500 mg po TID or QID; or to a 4-day course of oral vancomycin 125-500 mg po Q6 hours; or to a 4-day course of vancomycin enemas; or failure to respond to a 4-day course of combination therapy of oral vancomycin 125-500 mg po Q6 hours and IV metronidazole 500mg IV Q8 or Q6 hours and/or vancomycin enemas. CDSPS SCALE (each item is scored as one point for a 7 point maximum total) 1. underlying immunosuppression/chronic medical condition 2. altered or depressed mental status as defined by medical chart documentation 3. abdominal pain and/or distention 4. WBC > 20,000 or < 1,500 and/or bandemia > 10% 5. hypoalbuminemia (<3 mg/dL) 6. ascites (clinically or per CT scan findings per medical chart) 7. abnormal CT scan findings per medical chart - Pregnant or lactating women 2. Selective IgA deficiency 3. Hypersensitivity to immune globulin, human albumin, or thimerosal - | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 19.0-999.0, HER2/Neu Positive HLA-A2 Positive Cells Present Stage IV Breast Cancer Stage IV Ovarian Cancer Subjects must have either stage IV breast or ovarian cancer in remission or with stable disease on trastuzumab monotherapy HER2 overexpression by immunohistocytochemistry (IHC) of 2+ or 3+, in the primary tumor or metastasis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by fluorescence in situ hybridization (FISH) Subjects must be HLA-A2 positive Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and any immunosuppressive agents such as systemic steroids for at least 30 days prior to enrollment; patients should continue trastuzumab monotherapy throughout the course of this protocol; concurrent hormonal and biphosphonate therapies are allowed Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status score = 0 or 1 Male subjects must agree to contraceptive use during the study period (7 months) and non-menopausal female subjects must agree to contraception for the remainder of their childbearing years Hematocrit >= 30 performed within 60 days of enrollment Platelet count >= 100,000 performed within 60 days of enrollment White blood cells (WBC) >= 3000/ul performed within 60 days of enrollment Stable creatinine =< 2.0 mg/dL or creatinine clearance >= 60 ml/min performed within 60 days of enrollment Subjects cannot be simultaneously enrolled on other treatment studies Any contraindication to receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) based vaccine products Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion Active autoimmune disease Subjects cannot have an active immunodeficiency disorder, e.g. human immunodeficiency virus (HIV) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Appendicitis Cholecystitis Cross Infection Diverticulitis Peritonitis Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain Cancer Medicines that suppress the immune system Dialysis | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Colonic Neoplasms Clinical diagnosis of a single adenocarcinoma of the ascending, descending, or sigmoid colon years of age or older Able to give informed consent Must be able to participate in follow-up examinations Must not have prohibitive scars or adhesions from previous abdominal surgery Advanced local disease, defined as >8cm in diameter or extensive infiltration Any previous or current malignant tumour with the previous 5 years (except superficial squamous or basal cell skin carcinoma or in situ cervical cancer) ASA 4 ASA 5 Associated gastrointestinal disease Dukes D disease Emergency presentation Massive bleeding Morbid obesity Pregnancy | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction Experience regurgitation origination from the central two-thirds of the valve Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass Ejection fraction < 30% Endocarditis Rheumatic heart disease Renal insufficiency | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Planned Abdominal Hysterectomy Planned abdominal hysterectomy with or without BSO Age above 18 years Written informed consent American Society of Anesthesiologists (ASA) class I-III Planned vaginal or laparoscopic hysterectomy Hysterectomy as part of other surgery Allergy to part of the treatment regimen Previous reactions to opioids (nausea, cognition) Previous inability to place correct epidural catheter Severe state anxiety according to the OCAP or STAI ASA class IV Dependency on alcohol, opioids or central stimulants Chronic pain condition Hemorrhagic diathesis | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer Histologic or cytologic evidence of Stage IIIA (N2) OR Stage IIIB NSCLC Unresectable Stage IIIA will be defined by the following N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan such that in the opinion of the treating investigator, the patient is not a candidate for surgical resection N2 disease must be documented by biopsy, FDG-PET scan imaging, or by CT if nodes are > 2 cm on CT scan Stage IIIb patients must have N3 or T4 status. N3 status must be documented by one of the following Contralateral (to the primary tumor) mediastinal lymph node, supraclavicular or scalene lymph nodes proven by biopsy, FDG-PET scan imaging, or by CT if nodes are > 2 cm on CT scan Patients with positive supraclavicular or scalene lymph nodes must not have disease extending up into the cervical region All patients must have measurable or evaluable disease documented by CT, MRI, X-ray or physical exam within 28 days prior to study treatment Negative pregnancy test for Consolidation Therapy Following completion of induction chemoradiotherapy patients without local progression of disease or distant metastases will then be randomized to receive consolidation therapy with docetaxel or observation. Patients will be stratified and randomized based on stage IIIa vs IIIb disease at baseline, CR vs. non-CR following induction chemoradiation, and ECOG PS 0 or 1 vs. 2 No prior chemotherapy or radiotherapy for lung cancer No unintended weight loss > 5% body weight in the preceding 3 months prior to study treatment will not be eligible for this trial No symptomatic peripheral neuropathy prior to entry onto the study. Peripheral neuropathy must be < Grade 1 to be eligible No prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years No history of allergic reactions to drugs utilizing the vehicle polysorbate 80 (docetaxel) and polysorbate 80 + polyethylene glycol (etoposide) If the patient has hearing loss at pre-study, performance of an audiogram is recommended (not mandatory) to document baseline hearing status in the event of possible further hearing loss due to cisplatin administration No current breastfeeding | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Colon Mucinous Adenocarcinoma Colon Signet Ring Cell Adenocarcinoma Lynch Syndrome Stage IIA Colon Cancer AJCC v7 Stage IIB Colon Cancer AJCC v7 Stage IIC Colon Cancer AJCC v7 STEP 1 The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination; colonoscopy should be performed postoperatively for those unable to have a preoperative colonoscopy to guarantee there are no synchronous lesions; (if tumor is located beyond sigmoid colon and centimeter distance unavailable, anatomic region of colon, e.g. right colon, transverse colon, hepatic flexure descending colon, cecum etc.) Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk High-risk patients will be randomized to treatment Arms A or B Low-risk patients will be registered to Arm C for observation NOTE: Every effort should be made to submit blocks (tumor and normal mucosa) to the Principal Coordinates Analysis (PCO) immediately; blocks be accepted after day 50 (post surgery) in order to allow for molecular assessment Specific laboratory requirements for Step 2 must be obtained within 2 weeks prior to Step 2 randomization Patients must not have synchronous tumors Patients must not have appendiceal tumors Patients must not have a history of inflammatory bowel disease (IBD) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Anemia, Iron-Deficiency Kidney Failure, Chronic Moderate to severe anemia Iron deficiency Moderate to severe chronic kidney disease Receiving therapy with erythropoietic agent Receiving dialysis Known sensitivity to Ferrlecit® or any of its components Clinically unstable | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Anemia, Iron-Deficiency Kidney Failure, Chronic Moderate to severe anemia Iron deficiency Moderate to severe chronic kidney disease Receiving dialysis Known sensitivity to Ferrlecit® or any of its components Receiving therapy with erythropoietic agent Clinically unstable | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours Fever plus other symptoms such as nausea, vomiting, abdominal pain Cancer Medicines that suppress the immune system Dialysis | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 20.0-80.0, Cerebral Infarction Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction 2. Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI 3. Patients aged 20 to 80 years (inclusive) at time of consent 4. Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale 5. Patients without asymptomatic cerebral infarction 6. Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction 7. Patients without severe disturbances/impairments following occurrence of cerebral Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body) 2. Pregnant, possibly pregnant, or nursing women 3. Patients with ischemic heart failure 4. Patients with peptic ulcer 5. Patients with severer blood disorders 6. Patients with severe hepatic or renal 7. Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study 8. Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets 9. Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma 10. Patients who are being treated with ticlopidine hydrochloride 11. Patients who are participating in another study for an investigational drug 12. Patients who are otherwise judged inappropriate for in the study by the investigators | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-89.0, Coronary Artery Disease This is a study only of Chinese Subjects will be allowed to participate if they self-identify as Chinese The age range of the participants will be between 18 and 89 years The study group will consist of consecutive patients who are undergoing coronary angiography for suspected coronary artery disease | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 20.0-80.0, Coronary Artery Disease (CAD) Age 20 to 80 years English Proficiency Internet Access (home or work) Documented CAD (most recent cardiac diagnosis); documented Myocardial Infarction (MI), successful PCI procedure Patient intends to enroll in structured cardiac rehabilitation Hospitalization for Coronary Artery Bypass (CABG) Hospitalization for diagnostic procedure not associated with previously documented MI Patient coming back to hospital for planned staged PCI within 6 months Cardiac transplantation Presence of, or hospitalization for defibrillator implant Hospitalization for pacemaker implantation Unresolved unstable angina &/or hospitalization for angina (without MI or PCI) Uncontrolled arrhythmias causing symptoms or hemodynamic compromise Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise | 2 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-71.0, Coronary Artery Disease Patient eligible for surgical myocardial revascularization 2. Age 70 years or less 3. Triple vessel coronary disease with significant coronary artery stenosis defined as a stenosis of at least 50% in luminal diameter 4. Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Classification 1b, 2b, 3b) or proven silent myocardial ischemia No informed consent 2. Age > 65 years 3. Participation in another study with any investigational drug or coronary revascularization procedure 4. When follow up over a period of five years is difficult or unlikely 5. Concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer) 6. One or two vessel coronary disease and isolated left main stenosis 7. Estimated left ventricular ejection fraction < 25% 8. Myocardial infarction within seven days 9. Need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.) 10. Redo-cardiac surgery 11. Presence of the combination of insulin dependent diabetes mellitus and chronic obstructive pulmonary disease requiring therapy 12. Renal insufficiency requiring dialysis 13. Presence of the combination of severe adiposity and insulin dependent diabetes mellitus 14. Presence of the combination of severe adiposity and chronic obstructive pulmonary disease requiring therapy 15. Severe hepatic disease 16. Emergent operation for coronary artery disease with signs of ischemia (e.g. failed PTCA, ongoing myocardial infarction) 17. Unstable angina pectoris Class A and C according to Braunwald classification (i.e. secondary unstable angina and postinfarction unstable angina within one week after acute MI) 18. Inadequate quality of saphenous vein material 19. Inadequate quality or number of arterial conduits to achieve complete revascularization likely (e.g. chest irradiation, major abdominal surgery) 20. Recent (< 2weeks) cerebrovascular event (TIA, RIND, stroke) | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 70.0-999.0, Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Mixed Tumor, Mesodermal Age 70 or older Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus Life expectancy greater than 6 months Baseline laboratory values as described in protocol Active infection requiring antibiotics at the time of starting chemotherapy Prior pelvic radiotherapy > 25% of bone marrow Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs Past history of bone marrow transplantation or stem cell support Known history of central nervous system (CNS) metastasis History of prior malignancy that required prior systemic therapy Clinically significant cardiac disease Uncontrolled diabetes mellitus Any signs of intestinal obstruction Participation in an investigational drug study within three weeks prior to study entry | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Cancer Histologically or cytologically confirmed adenocarcinoma of the pancreatic head No tumors of the body or tail, as defined by a tumor lying between the left border of the superior mesenteric vein and the left border of the aorta and/or the left border of the aorta and the hilum of the spleen Locally resectable disease by CT scan Major vessels (e.g., portal vein, confluence of mesenteric and splenic vein, superior mesenteric artery, celiac trunk, splenic artery, hepatic artery, or superior mesenteric vein) maximally enclosed ≤ 180° by the tumor No infiltration of extrapancreatic organs except the duodenum No carcinoma of the ampulla of Vater No metastasis No peritoneal carcinoma Karnofsky performance status 70-100% Creatinine clearance > 70 mL/min | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Pancreatic Neoplasms Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process is required prior to treatment. Islet cell tumors are not eligible. 2. Patients must be staged with a physical exam, CXR, and contrast-enhanced CT. Only potentially resectable patients are eligible. Potentially resectable defined as: a) no extra pancreatic disease, b) no evidence (on CT) of tumor extension to the celiac axis or SMA, and c) no evidence (CT or angiogram) of occlusion of the SMV or SMPV confluence. Visceral angiography is optional. Laparoscopic staging is not part of the pretreatment evaluation for this study. Laparoscopy may be performed prior to planned laparotomy at surgeon's discretion. Staging needs to be done within 28 days of enrollment. 3. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, or laparotomy prior to chemoradiation. 4. There will be no upper age restriction; patients with Karnofsky performance status greater than 70 are eligible. 5. Adequate renal, and bone marrow function: Leukocytes greater than or equal to 3,000/uL; Absolute neutrophil count greater than or equal to 1,500/uL; Platelets greater than or equal to 100,000/U1; Serum creatinine less than or equal to 2.0-mg/dL and urine protein: creatinine ratio less than or equal to 1.0 at screening 6. Hepatic function (endoscopic or percutaneous drainage as needed) Total bilirubin less than or equal to 2 X institutional upper limits of normal (ULN); AST (SGOT)/ALT (SGPT) less than or equal to 5 X institutional ULN 7. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy. 8. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding, as specified in the informed consent. 9. Patients must sign a study-specific consent form Tumors in the body or tail of the pancreas (to the left of the portal -SMV confluence) are not eligible. 2. Patients with uncontrolled hypertension, baseline blood pressure of greater than 150/100 mmHg 3. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure. 4. History of myocardial infarction, stroke, DVT, or pulmonary embolism within 6 months of the study 5. Clinically significant peripheral vascular disease. 6. Known history of bleeding diathesis coagulopathy. If patient has prior documented PT, INR then INR should be less than 2.0 (patients on anticoagulation for atrial fibrillation, other cardiac disorders, and for remote history of thrombosis are not excluded). Lab results should be within 2 weeks of patient enrollment. 7. Known presence of central nervous system or brain metastases. 8. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study 9. Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0 10. Urine protein: creatinine ratio greater than 1.0 at screening; a 24 hour urine protein should be obtained and the level must be less than 1gm/24 hours in order for the patient to be eligible. 11. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 12. Serious, non-healing wound, ulcer, or bone fracture 13. Evidence of duodenal invasion 14. Inability to comply with study and/or follow-up procedures 15. Patients less than 18 years of age | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Cough Lower Respiratory Tract Infection (LRTI) Chest Infection Aged 18 years and over With acute or worsened cough with a duration of up to and including 28 days, or a clinical presentation that suggests a lower respiratory tract infection Consulting for the first time within this illness episode Seen within normal consulting hours Able to fill out study materials Who have provided written, informed consent to participate Previous study participants Immunocompromised | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Low Back Pain Positive for facet joint pain with comparative local anesthetic blocks Candidates are over 18 years of age Subjects with a history of chronic, function limiting neck pain of at least six months in duration Subjects who are able to give voluntary, written informed consent to participate in this investigation Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the center for all the required post-operative follow-ups The subject has not had recent surgical procedures within the last three months. - Negative or false-positive response to controlled comparative local anesthetic blocks Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 mg, or dose equivalent Uncontrolled major Depression or uncontrolled psychiatric disorders Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intercranial pressure, pseudotumor cerebri, intercranial tumors, unstable angina, and severe chronic obstructive pulmonary disease. Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function Women who are pregnant or lactating Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study due to the overlap of pain complaints. Inability to achieve appropriate positioning and inability to understand informed consent and protocol History of adverse reaction to local anesthetic or anti-inflammatory drugs | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 12.0-999.0, Infection Male or female subjects aged greater or equal to 12 years Intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening Presence of at least three of the following five indicators consistent with intra-abdominal infections (Fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation) Written informed consent obtained Rapidly progressive illness or critically ill subjects Pregnant or lactating women, or women of childbearing potential not using an effective method of contraception Treatment with a presumably effective systemic antimicrobial agent for >24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator) | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-85.0, Stroke New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS >/= 6) Age >/= 18 ≤ 85 Clot retrieval procedure can be initiated within 8 hours from onset Large vessel proximal anterior circulation occlusion on MR or CT angiography (internal carotid, M1 or M2 MCA) Pretreatment MRI performed according to MR protocol Signed informed consent obtained from the patient or patient's legally authorized representative Premorbid modified Rankin score of 0-2 Allowed but not required: patients treated with IV tPA (tissue plasminogen activator) up to 4.5 hours from symptom onset with persistent target occlusion on post-treatment MR MR or CT protocol performed at the completion of drug infusion (Note: Rapidly improving neurological signs prior to randomization is an exclusion) NIHSS >/= 30 Contraindication to MRI (pacemaker etc) Acute intracranial hemorrhage Coma Rapidly improving neurological signs prior to randomization Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations Pregnancy Known allergy to iodine previously refractory to pretreatment medications Current participation in another experimental treatment protocol Contrast-Enhanced Neck MRA (magnetic resonance angiography) or CTA (computed tomography angiography) suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-70.0, Anaemia Renal Transplantation Kidney Failure Adults male or female of 18 years male or female sex to 70 years Patients having profited from one 1st or one the 2nd transplantation Patients transplanted since more than 1 year and less than 20 years Patients having a CDG defined by a clearance of creatinin, lower than 50 ml/mn/1,73 m2 (according to Gault and Cockcroft) and whose renal function is stable over the last 3 months (variation of Scr of less than 20% over the last 3 months) Patients presenting an anaemia: Hb lower than 11.5 g/dl No deficiency out of iron: Saturation of the transferrin > 20% and ironnemia > 50 mg/l at the time of the screening visit Patients having given their written consent Major forms of drepanocytosis or thalassaemia Iron Deficit (CST < 20% or ferritin < 50 mg/l) Haemolysis (haptoglobin < 0,30 g/l) Severe renal insufficiency: Clcr < 20 ml/min/1,73 m2 Severe Hyperparathyroidy (serum PTH > 800 pg/ml) Evolutionary chronic inflammatory Disease (CRP > 15 mg/l) Acute or chronic infectious disease Evolutionary neoplasic Disease Infection by the HIV and viral cirrhosis Recent Antecedents of MI or AIT (< 3 months) | 0 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 18.0-999.0, Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer Histologic or cytologic documentation of pancreatic adenocarcinoma with evidence of disease progression following first-line therapy is required No brain metastases Patients with measurable disease Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded as >= 20 mm with conventional techniques or as>= 10 mm with spiral computed tomography (CT) scan; of particular note, the primary pancreatic tumor does not constitute measurable disease; therefore, patients with locally advanced pancreatic cancer as the sole site of disease are not eligible Patients must have received one of the following prior therapies containing gemcitabine One and only one prior therapy for metastatic disease with gemcitabine, or a gemcitabine-containing cytotoxic combination, or One prior chemoradiation therapy containing gemcitabine for inoperable locally advanced pancreatic cancer, as long as the patient has subsequently progressed and has measurable disease outside a radiation port, or One prior adjuvant chemotherapy regimen or chemoradiation therapy containing gemcitabine if the patient subsequently progressed within 3 months of completion of adjuvant therapy; patients who have received chemoradiation in the adjuvant setting must have measurable disease outside the radiation port No prior therapy with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.) At least 4 weeks must have elapsed prior to initiation of treatment since the completion of chemotherapy and/or radiation therapy | 1 |
70 year-old woman with a history of CAD recently noted abdominal mass who presents with fevers/rigors and bandemia. Over the last few weeks leading up to admission, she has been experiencing mid-abdominal pain, radiating to the left flank. It lasts throughout the day is not increased by eating though there is associated vomiting and is worsened with coughing. CT abdomen without contrast was then performed on [**4-20**] showing a large 9.5 x 7.5 x 6.0-cm heterogeneous left upper abdominal mass. Patient underwent a EUS with biopsy. The results of the biopsy were consistent with pancreatic adenocarcinoma at the head of pancreas. Splenic flecture/pancreatic tail mass was also seen on CT, likely diverticular abscess given the patients recent likely history of diverticulitis this was thought to be an infected fluid collection or abscess. She was treated with IV antibiotics (Zosyn, then ceftriaxone and flagyl) and will continue on them until seen by ID as an outpatient. Past Medical History: 1. Coronary artery disease with history of angioplasty in [**State 108**] one year ago 2. Mitral valve prolapse 3. Atrial fibrillation 4. Hyperlipemia 5. Hypertension 6. Chronic kidney disease (SCr 2.1 in [**3-17**]) 7. Hypothyroidism? (TSH 10 in [**3-17**]) 8. Anemia (HCT | eligible ages (years): 1.0-30.0, T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434 Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory T-NHL For T-NHL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of T-NHL defined by the submitting institution will be accepted Prior therapy restrictions Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine IT chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC); steroid pretreatment may alter the risk group assessment; if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above; patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to Induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years Pregnant or lactating females are ineligible Patients with Down syndrome are ineligible to enroll onto this study For T-NHL patients the following additional apply B-precursor lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma CNS3-positive or testicular involvement | 0 |
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