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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Patients Aged ≥ 18 years Current or former smoker at least 10 packs-years At least one respiratory function test (EFR) with a FEV1/CVF ratio < 0.70 post-bronchodilator Acute exacerbation of COPD (greater degradation of respiratory symptoms than the usual daily variations and requiring a modification of therapeutic management) Need to implement NIV treatment (respiratory acidosis with pH<7.35) Ventilation frequency > 20min Affiliation to the French security system (or equivalent) Written informed consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency procedure will be allowed, with a mandatory delayed consent Patient already treated by NIV during admission (e. g. introduction in pre-hospital by SMUR) Sedative (barbiturates, benzodiazepines and related substances and other sedatives) or morphine treatment within 24 hours before Chronic alcoholism Contra-indication to NIV: disturbances of consciousness (Glasgow < 11) except moderate hypercapnic encephalopathy; indication of immediate intubation; risk of inhalation; sputum impossible; hemodynamic instability; inability to remove the mask; trauma, surgery or facial malformation; patients with pH < 7.25 can only be included in an intensive care environment NIV with palliative purpose from the outset with death expected within 24 hours of Patients with Alzheimer disease or psychiatric disorders Contra-indication to morphine without acute respiratory distress Pregnant or breastfeeding women Major mentioned in Articles L1121-6 and 1121-8 of French public health cod Patients in a period of from other research involving the human person type 1 or 2
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-100.0, COPD Exacerbation Stable COPD (40 years or older with baseline post-bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ≤0.70) will be recruited during their regular follow-up. 2. Control group: age and sex-matched volunteers without previous diagnosis of COPD or 6 other respiratory conditions, and with post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity [FVC]=0.70. 3. Exacerbated patients (patients 48h after being admited in Hospital due to severe COPD exacerbation Patients with renal failure or other severe chronic or acute conditions. 2. Patients with exacerbations in the previous 6 weeks
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-99.0, COPD Inhaled Corticosteroid Confirmed patients with COPD (at least one lung function test post bronchodilator FEV1/FVC <70% before the start of the study) Age ≥ 40 years old No acute attack record within half a year Triple therapy (dual long-acting inhaled bronchodilator and inhaled steroid) is stable for more than six months Eosinophil count in blood <300 cells/ul Clinical symptom assessment CAT score <20 Suspected or diagnosed with asthma Age <40 years Within half a year, there is a record of moderate to severe acute attacks Eosinophil count in blood ≥300 cells/ul Clinical symptom assessment CAT score ≥20
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-75.0, Chronic Obstructive Pulmonary Disease hospitalisation at Schoen Klinik Berchtesgadener Land or Klinikum Nuremberg Chronic obstructive pulmonary disease GOLD A-D sufficient german language and samrtphone skills to understand the mCST app sufficient good WLAN Connection in the domestic environment presence of comorbidities which could interfere the course of the trial (e.g. cognitive deficits, neurological or orthopedic diseases) significant mental illness, legal incapacity or limited legal capacity patients who are unable or unwilling to perform the study activities acording to the protocol
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Febrile Illness Documented fever (≥ 37.5°C axillary), hypothermia (< 35.5°C) and/or history of fever in the last 24 hours Willingness and ability to comply with study protocol for the study duration Written informed consent given to participate in the trial Currently enrolled in the study Accident or trauma is the cause for presentation Presentation ≤ 3 days after routine immunisations
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 65.0-999.0, COPD Arrhythmia Murmur, Heart Chronic Disease History of frequent admissions, defined as minimum of 2 during the last 6 months ICD diagnosis for COPD and/or hypertension and/or diabetes and/or cardiovascular diseases Patient has Smartphone or Tablet, as well as Internet connection in their homes (or 3G/4G/5G connection) Subjects with Pacemaker, ICD or Implanted Loop Recorder Subjects with no experience in using Smartphones and Apps Vulnerable Subjects (prisoners, elderly with decisional incapacity)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-65.0, Renal Insufficiency, Chronic History of primary glomerulonephritis eGFR between 60 ml/min and 30 ml/min age between 18-65 years old secondary GMN severe heart failure (NYHA IV) ongoing infectious diseases ongoing neoplasia hepatic diseases COPD inflammatory bowel disease history of stroke history of acute coronary disease less than 3 months pregnancy
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 55.0-999.0, Chronic Subdural Hematoma Must be 55 years of age or greater Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation Failure to obtain consent Vulnerable study population Any need for chronic anticoagulation Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma Glasgow Coma Scale (GCS) less than 8
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Bronchiectasis Adult Idiopathic bronchiectasis with FEV1/FVC < 70% With Asthma α-1 antitrypsin deficiency Turculosis Lung cancer Sarcoidosis Idiopathic pulmonary fibrosis Primary pulmonary hypertension Uncontrolled sleep apnea Bronchiectasis accepted long-term low dose macrolides Pulmonary surgery within 6 months
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Self-management Behaviors Age >40 years Chart-document severe or very severe COPD (FEV1<50% predicted) or COPD-related ED/hospitalization ≥ 1 visit within the past 12 months Prescribed any daily medication for COPD, English or Spanish speaking, Smoking history ≥ 10 pack-years Diagnosis in the clinical record of dementia, because the study focuses on patients with capacity to independently perform self-management tasks
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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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
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Prostatic Hyperplasia prostate volume less than 80 ml high IPSS more than 19 affecting quality of life recurrent urinary retention with failure of medical treatment recurrent urinary tract infection affection of upper urinary tract refractory hematuria bladder stones bladder diverticula patients with neurogenic bladder patients with previous prostate or urethral surgery associated urethral stricture prostate cancer diagnosed by TRUS biopsy prostate volume more than 80 ml
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Benign Prostatic Hyperplasia (BPH) Subject signed informed consent form (ICF) 2. Subject who had participated in the MT-03 study in the iTind arm 3. Subject able to comply with the study protocol Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study 2. Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, COVID-19 Healthcare workers with mild symptoms of COVID-19 tested with RT-PCR in nasopharyngeal swabs Cases : positive RT-PCR Controls : negative RT-PCR Informed consent obtained by e-mail no available e-mail address age < 18 no answer to the structured questionnaire
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-80.0, COPD Healthy Smoker Any adult (between 18 to 80 years old) who has been diagnosed with COPD guide GOLD (FEV1/FVC ratio post bronchodilator <0.70) Have a history of myocardial infarct Be unable to sit in an upright position for required period Have significant co-morbidities (i.e. Chest work or spinal deformity, OSA, AHI >30 secs Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participants' ability to participate in the study Height > 194 cm BMI >40
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-99.0, Smoking Total Joint Arthroplasty Primary elective total joint arthroplasty patients undergoing surgery with a Rothman Institute arthroplasty surgeon. 2. Participant is a current smoker. 3. Diagnosis of osteoarthritis, inflammatory arthritis, and post-traumatic arthritis. Exclusions 1. Age < 18 2. Revision surgery 3. Prior infection in hip or knee at the surgical site 4. BMI >40 (It is currently the standard of care in our practice to require patients to have a BMI < 40 due to an increased risk of infection. This will not represent a change in practice.) 5. Diabetics with Hgb A1C >8 (It is currently the standard of care in our practice to require patients to have a Hgb A1C <8 due to an increased risk of infection. This will not represent a change in practice.) 6. Patients using chewing tobacco, cigars, or other form of oral tobacco product 7. Patients using e-cigarettes or vaporizers
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-999.0, Coronary Heart Disease the presence of an established diagnosis in patients with coronary artery disease unstable angina pectoris (NS). When making a diagnosis, the recommendations of ESH / ESC (2015) and RCO / WHO (2014) were used stable exertional angina (SSN) I-III FC. When making the diagnosis, the IHD classification was used, adopted at the IV Congress of Cardiologists of the Republic of Uzbekistan (2000), as well as in accordance with the recommendations of ESH / ESC (2019) and RCO / WHO (2017) The patient's refusal to participate in the study Pregnancy and lactation Severe and unstable condition of the patient, making it difficult to conduct a questionnaire (for ethical reasons) Acute violation of cerebral circulation History of acute or chronic psychosis The presence of concomitant acute diseases or chronic diseases in the acute stage. Throughout the study, all patients were assigned the right to voluntarily withdraw from the study at their own request, notifying the researcher in writing or orally
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Relapsed or Refractory Diffuse Large B-Cell Lymphoma Participants greater than or equal to (≥) 18 years of age. 2. Pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). 3. Prior lines of systemic therapy for the treatment of DLBCL For Arms A, B, C, E, F, H: Participants must have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL For Arm D (S-R-GemOx) participants must have received at least 1 but not more than 2 lines of systemic therapy (Documentation to be provided) For Arm G (S-LT) participants must have received only 1 line of systemic therapy 4. Positron emission tomography (PET) positive measurable disease per the Lugano Classification 2014, having at least 1 node with longest diameter (LDi) greater than (>) 1.5 centimetres (cm) or 1 extranodal lesion with LDi >1 cm. 5. Adequate bone marrow function. 6. Circulating lymphocytes less than or equal to (≤) 50 * 109/L. 7. Adequate liver and kidney function. 8. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 9. An estimated life expectancy of >6 months at Screening. 10. Participants with primary refractory disease defined as no response or relapse within 6 months after ending first-line treatment will be allowed on study (up to 20 percentage [%] of enrolled participants in each Phase). 11. Male participants and female participants of childbearing potential must agree to use highly effective methods of contraception: Male participants must agree not to donate sperm. 12. Participants with active hepatitis B Virus (HBV) are eligible if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 international units per milliliter (IU/mL); participants with hepatitis C Virus (HCV) are eligible if viral load is negative; participants with human immunodeficiency virus (HIV) are eligible if cluster of differentiation 4 (CD4+) T-cell counts ≥350 cells per microliter (cells/μL), viral load is negative and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last year DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin lymphoma + NHL); Gray zone lymphoma; DLBCL transformed from Chronic Lymphocytic Leukemia (Richter Syndrome); Primary mediastinal large B-cell lymphoma (PMBCL); T-cell rich large B-cell lymphoma. 2. Participants with high grade lymphoma with c-MYC, B-cell lymphoma 2 (BCL-2) and/or BCL-6 rearrangements are excluded from the Phase 1 portion of the study only. 3. Previous treatment with selinexor or other XPO1 inhibitors. 4. Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to Cycle 1 Day 1 (C1D1). Low dose steroids <30 mg prednisone (or equivalent) are permitted; and palliative radiotherapy. 5. Received strong cytochrome P450 3A (CYP3A) inhibitors ≤7 days prior to Day 1 dosing or strong CYP3A inducers ≤14 days prior to Day 1 dosing. 6. Major surgery <14 days of C1D1. 7. Autologous stem cell transplant (SCT) <100 days or allogeneic SCT <180 days prior to C1D1 or active graft-versus-host disease after allogeneic SCT (or cannot discontinue graft versus host disease [GVHD] treatment or prophylaxis). 8. Prior chimeric antigen receptor T cell (CAR-T cell) infusion at any time (Phase 1 only); prior CAR-T cell infusion ≤120 days prior to C1D1 (Phase 2 only). The following are Arm Specific Arm B (S-PR): Serum total bilirubin >1.5 * ULN, Neuropathy Grade ≥2 (CTCAE, v5.0). 10. Arm C (S-PBR): Serum total bilirubin >1.5 * ULN, Neuropathy Grade ≥2 (CTCAE, v5.0). 11. Arm D (S-R-GemOx): Neuropathy Grade 2≥ (CTCAE, v5.0) interstitial lung disease or pulmonary fibrosis
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-65.0, Musculoskeletal Injury Patients aged 18-65 with operative fractures of the femur and tibia (to distal femur (33A, B), plateau (41A, B), pilon (43A, B), and selected ankle injuries (44A, B)) presenting to the Orthopaedic Surgeon for either acute care or for the follow-up of care performed elsewhere (within 14 days of the injury) All patients must be English or Spanish competent and able to be followed at the sites for at least 12 months following injury Patients with Injury Severity Score (ISS)>18 Bilateral lower-extremity injuries that preclude crutch ambulation Associated spine, pelvic, and/or acetabular fractures that otherwise alter weightbearing plan Type III B/C open fractures Glasgow Coma Scale <15 at time of discharge Major peripheral nerve injury Planned admission to a skilled nursing facility or inpatient rehabilitation facility Pregnant women Patients diagnosed with a Traumatic Brain Injury (TBI) will be excluded from the study
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Heart Failure Patients included in PRADO Patient whose age is ≥ 18 years Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018 Patients included in the PRADO program Patients not included in PRADO Patient whose age is ≥ 18 years Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018 Patients not included in the PRADO program Patient under guardianship or guardianship Patient living in EHPAD Patient transferred to another establishment on discharge from hospital (surgery, follow-up care, EPHAD, etc.) Patient who died during hospitalization Patient objecting to the use of their data
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Chronic Pain Have a complex, prolonged axial neck pain or lower back pain Have been followed by a pain management specialist for at least 3 months or have a history of chronic pain for at least 3 months as recorded by physician Be >18 years of age Have a goal and motivation that is adequate in relation to the program offered Be medically prepared Have no major change in interventional treatment or be a surgical candidate Own a smart phone, tablet or computer or have the knowledge to use one Chronic pain requiring imminent surgical intervention Reported severe or acute psychiatric illness, severe anxiety or depression Current history of substance abuse Serious health risks or scheduled major health interventions for other medical reasons Pain related to malignancy Pain duration <3 months Other areas of pain exceeding the amount of back or neck pain Not currently involved in lawsuit or pending litigation
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Covid19 Ards Respiratory Failure Hospitalized patients with confirmed or suspected COVID-19 pneumonia requiring more than 3 liters per minute of supplemental oxygen or a Fraction of Inspired Oxygen (FIO2) over 35% to keep Pulse Oximetry Saturation (SpO2) over 90% Treating physician indicated prone position as instructed by the institutional protocol Patient capable of changing position with minimal help from the personnel Patient requiring immediate intubation Patient requiring non-invasive mechanical ventilation Respiratory Rate > 40, signs of respiratory fatigue or unconsciousness with inability to protect the airway PaCO2 > 50mmHg Hemodynamic instability (defined by Heart Rate > 120, Systolic Pressure < 90mmHg, Mean Arterial Pressure < 60mmHg or requiring vasopressor support) Obesity with BMI > 40 (Body Mass Index: weight in kilograms and height in meters will be combined to attain BMI in kg/m2) Persistent vomiting Facial or thoracic trauma or recent surgery contraindicating the prone position Pregnancy > 20 weeks
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 45.0-90.0, Sleep Apnea, Obstructive Pulmonary Disease, Chronic Obstructive Respiration Disorders Male or female, age >=45 and <=90 at the time of informed consent 2. Voluntary agreement and ability to provide written informed consent 3. Body mass index (BMI) <40 Kilogram per meter square (kg/m^2) 4. Reports habitually sleeping for at least 5.5 hours per night 5. Reports habitual bedtime between 21:00 and midnight 6. Agrees to stay in bed for 7 hours per night for the duration of the study 7. At Screening Visit 2: Has completed the sleep diary for at least 5 consecutive nights 8. At Screening Visit 2: Confirmation of mean habitual bedtime (MHB) between 21:00 and midnight (sleep diary) Additional (OSA Cohort) 9. Moderate to severe OSA diagnosed according to the of the ICSD, confirmed by PSG (home sleep testing by portable monitor is acceptable) within the previous 5 years or a repeated PSG during screening 10. On screening PSG: moderate OSA (defined as 15 <=AHI <30) or severe OSA (defined as AHI >=30 per hour) 11. SpO2 >=94% assessed as part of vital signs at Screening Visit 1 Additional (COPD Cohort) 12. Screening spirometry performed as per the Global Initiative for Obstructive Lung Disease (GOLD) recommendations 13. On screening spirometry, based on post-bronchodilator Forced Expiratory Volume in 1 second (FEV1): • FEV1/Forced Vital Capacity (FVC) <0.70 and one of the following <=FEV1 <80% predicted (GOLD 2 Classification for moderate COPD) or <=FEV1 <50% predicted (GOLD 3 Classification for severe COPD) 14. Moderate to severe COPD according to medical history and screening spirometry as per the GOLD (GOLD 2019) 15. On screening PSG AHI <15 SpO2 during wakefulness >90% (both supine and sitting) SpO2 during sleep >=80% for at least 75% of the recording period with no more than five continuous minutes <80% and with no SpO2 readings <70% Females of childbearing potential 2. A current diagnosis of restless legs syndrome, periodic limb movement disorder, circadian rhythm sleep disorder, or narcolepsy 3. Reports symptoms potentially related to narcolepsy, that in the clinical opinion of the investigator indicate the need for referral for a diagnostic evaluation for the presence of narcolepsy 4. A history of symptoms of rapid eye movement (REM) Behavior Disorder, sleep-related violent behavior, sleep-driving, or sleep-eating, or symptoms of another parasomnia that in the investigator's opinion make the participant unsuitable for the study 5. Periodic Limb Movement with Arousal Index (PLMAI) as measured on the screening PSG Age 18 to <65 years: PLMAI >=10 Age >65 years: PLMAI >15 6. A prolonged QT interval by Fredericia (QTcF) (QTcF >450 milliseconds [ms]) as demonstrated by a repeated electrocardiogram (ECG) at Screening 7. Any suicidal ideation with intent with or without a plan at Screening or within 6 months of Screening (that is, answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS]) 8. Any lifetime suicidal behavior (per the Suicidal Behavior section of the C-SSRS) within 10 years of Screening 9. Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments 10. Hypersensitivity to the study drug or any of the excipients 11. Used any prohibited prescription or over-the-counter medications within 1 week or 5 half-lives, whichever is longer, before the screening PSG 12. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study 13. Scheduled for surgery during the study that requires general anesthesia or administration of prohibited medications 14. Psychotic disorder(s) or unstable recurrent affective disorder(s) evident by use of antipsychotics or prior suicide attempt(s) within approximately the last 2 years 15. History of drug or alcohol dependency or abuse within approximately the last 2 years 16. Use of illegal recreational drugs (includes marijuana, regardless of whether prescribed for medicinal use) 17. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5*the half-life, whichever is longer preceding informed consent 18. Previously participated in other clinical trial of lemborexant 19. Exposure within the last 14 days to an individual with confirmed or probable corona virus disease 2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention (CDC) list of COVID symptoms or any other reason to consider the participant at potential risk for an acute COVID-19 infection Additional (OSA Cohort) 20. SpO2 <80% for >=5% of TST during the screening PSG 21. Use of a continuous positive airway pressure (CPAP) device or dental appliance within 2 weeks of the screening PSG, and does not agree to abstain from the use of a CPAP device or dental appliance from the 22. Current evidence of a clinically significant, active respiratory disorder other than OSA. This includes bronchiectasis, emphysema, asthma, COPD or any other pulmonary disorder identified by review of medical history, physical examination, and which in the opinion of the investigator, could compromise the participant's safety or interfere with study assessments 23. Current evidence of other clinically significant disease (example, psychiatric disorders, disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, cardiovascular system, or a congenital abnormality), malignancy within the past 5 years (other than adequately treated basal cell carcinoma or in situ carcinoma of the cervix), or chronic pain that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments. Screening Visit through the last study visit Additional (COPD Cohort) 24. Use of continuous (>16 hours/day) oxygen therapy 25. Use of oxygen therapy during PSG 26. Determination that, in the opinion of the investigator, removal of oxygen therapy could affect the participant's safety or interfere with the study assessments 27. Recent changes to COPD medications or recent acute exacerbation of COPD (that is, needing hospitalization or treatment with oral corticosteroids and/or antibiotics) within 3 months of enrollment 28. On screening spirometry (COPD only) FEV1/FVC >=0.70 FEV1 >=80% predicted (GOLD 1 Classification for mild COPD) FEV1 <30% predicted (GOLD 4 Classification for very severe COPD) 29. On screening PSG (COPD only) Moderate to severe OSA (AHI >=15) SpO2 <90% during wakefulness (supine and sitting)
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Churg-Strauss Syndrome Eosinophilic Asthma Eosinophilic Esophagitis Eosinophilic Pneumonia Severe Eosinophilic Asthma (with multi-disciplinary diagnosis as per ERS/ATS <20 pack year smoking history, blood eosinophils ≥ 0.3 x109/L on inhaled corticosteroids); or EGPA (as per American College of Rheumatology (ACR) Criteria); or Eosinophilic COPD (post-bronchodilator FEV1/FVC < 70% predicted, absence of bronchodilator reversibility, > 20 pack year smoking history, no history of asthma, blood eosinophils ≥ 0.3 x109/L); or Eosinophilic oesophagitis (with diagnostic histology); or Granulomatosis with Polyangiitis (GPA, formerly called Wegener's) (as per American College of Rheumatology (ACR) Criteria) Known Pregnancy Anaemia Hepatitis B Virus, Hepatitis C Virus or HIV infection Donation of more than 240mls blood in the last sixteen weeks (four months) to any other research study or as a donation to the National Blood Transfusion Service Rituximab, plasmapharesis or polyclonal immunoglobulin infusion (ever)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive With capability of communicating via oral conversation or written documents and signing informed consent With capability of receiving and participating in study related auxiliary examinations Age: 40-80 yrs, both male and female, with or without smoking history, receiving treatment in community hospitals or outpatient department in general hospitals GOLD Stage II-III COPD: FEV1/FVC<70% and FEV1 45-80% predicted (about 1/3 subjects in 45%-50%), measured 20min after 400μg salbutamol inhalation With stable COPD (no COPD exacerbation during the latest 4 weeks prior to the recruitment) and irregular use of inhalation therapy, or regular use of inhalation therapy but no more than 2 weeks. Subject is willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol Subjects are participating in other clinical research or have completed another clinical research within 3 months prior to screening Significant diseases or conditions other than COPD. A significant disease or condition is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study Patients with clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, or other single restricted ventilation Severe cardiovascular, neural, hepatic, renal and hematologic diseases or malignancies that may interfere with the operation of the study Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms, or narrow angle glaucoma Patients have a current and history diagnosis of asthma, or who have a blood eosinophil count ≥600/mm3 (0.6×109/L) Patients with active pulmonary tuberculosis Patients with life-threatening pulmonary embolism, α1-antitrypsin deficiency, or cystic fibrosis History of pneumonectomy COPD exacerbation in 4 weeks prior to the first visit (V1), or hospitalization and/or antibiotic application and/or oral or intravenous glucocorticosteroids application is required during screening stage
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-999.0, COPD Adults (men or women) aged more than 40 years old Diagnostic code in Andalusian clinical records (Diraya) in accordance with ICD-9 (Diagnostic codes 496, 492.8, 494.0, 491.20, 493.2) Current of former smokers of at least 10 pack years Patient with a minimum follow up of 1 year, who have been assisted in a scheduled primary care appointment at date Patients with a diagnostic code for COPD attended at primary care office, but without information related with COPD in the previous year Patients currently involved in any clinical trial or research study related with COPD Those patients excluded will be collected in an causes chart for each centre. These patients will not affect overall number of patients targeted for each centre
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Telerehabilitation COPD Being diagnosed with COPD (FEV1 / FVC <70% in the stable phase of the disease) Age > 18 years old Have the ability to use a smartphone Musculoskeletal disorders that limit exercise Dizziness, significant sensory or motor impairments, dementia or terminal illnesses that prevent education Serious comorbidities such as unstable heart disease, irregular diabetes, known malignant disease, any other disease that makes the patient unsuitable for participation in the study Incompatible patient Severe vision or hearing impairment Unwillingness or inability to follow the protocol Have had a COPD exacerbation in the previous 6 weeks
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-60.0, TB - Tuberculosis HIV/AIDS 60 years old Agree to undergo CXR and/or CT scan Has unilateral TB disease defined as one lung with extensive evidence of TB disease (non-applicable to healthy controls; sick controls will require an alternative diagnosis) No evidence of prior TB treatment and/or CXR/CT does not have obvious evidence of prior TB Willing to undergo a research bronchoscopy at baseline, 6 months and 18 months and likely to remain in the area for the study period If HIV-positive, must be stable on antiretroviral therapy (ART) for ≥1 year Able and willing to return for follow-up visits, with no plans to move in the near future Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment Less than 18 years or older than 60 years of age Has already initiated TB treatment Rifampicin resistant Has a previous history of TB Bilateral TB disease defined as both lungs with extensive TB disease Has received probiotics, antibiotics or inhaled steroids within three months prior to enrolment (not applicable to sick controls) Has diabetes mellitus, which affects TB disease, treatment response, and the microbiome Has a contraindication for bronchoscopy (e.g., FEV1 <70%), as determined by bronchoscopists according to best practice guidelines Has a daily alcohol intake of more than 6 beers or 4 mixed drinks Is pregnant (a commercial human chorionic gonadotropin determination assay will be performed in accordance with manufacturer's guidance on urine) or pregnancy planned for follow-up period
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Swallowing Disorders Dysphagia Disorders of Consciousness Assessment Tool Speech Therapy Age above 18-year-old Perfect knowledge of French language before the injury Previous event of coma phase caused by a severe acquired brain injury Medical stability (absence of mechanical ventilation and sedation, no acute medical pathology such as infection or respiratory distress) No neurological or otorhinolaryngological disease which can impact swallowing prior to the brain injury Minimum of 28 days since the acquired brain injury at Diagnosis of UWS, MCS-, MCS+ or EMCS based on the CRS-R or Informed consent from legal representative of the patient Affiliated patient or beneficiary of a health insurance plan (for French participants only)
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-70.0, Nasal Obstruction Copd COPD- Other pulmonary diseases pregnancy
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2
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-75.0, Hypertension Between 18 and 75 years old with HTN (ICD-10 code I10) 2. Has had at least one office visit at Penn Family Care (PFC) within the past 12 months (at time of chart review), with the last visit having a BP reading exceeding HTN guidelines (150/90 if >60 or, 140/90 if ages 21-59 yrs or has CKD or diabetes). 3. Must have a cellular phone with texting capabilities 4. Must be prescribed at least one medication for hypertension Has metastatic (Stage IV) cancer 2. Has end stage renal disease 3. Has congestive heart failure 4. Has dementia 5. BMI >= 50 6. Is Non-English speaking requiring a translator
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-70.0, Type 2 Diabetes Mellitus Healthy volunteers Age [18 -30], [50-59] and [60-70] years Male and female healthy volunteers, except with skin types 5 and 6 Body weight ≥ 50 kg and BMI between [18.0 -28.0] kg/m^2 inclusive Non or ex-smokers (defined as someone who completely stopped smoking for at least 1 month before the beginning of this study) No clinically relevant findings in the medical history and physical examination, especially with regards to cardiovascular system, lung, liver and renal function Normal blood and urine laboratory tests Patients with type 2 diabetes (T2D) mellitus Male and female patients, except with skin types 5 and 6 Age [50 years
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 3.0-70.0, Cystic Fibrosis Asthma COPD Interstitial Lung Disease Patients with chronic lung disease and clinical examination, pulmonary function test, and CT acquired during a routine follow-up In the Clinical Validation group, patients with exacerbation or part of the other groups
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1
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 0.0-18.0, Sepsis Children, Only Age of 29d to 18 years old Children diagnosed with sepsis requiring blood purification with a history of a duration of PICU stay <24 h active bleeding, including cerebral hemorrhage
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Spinal Cord Injuries Adult individual 18 years of age or older. 2. Cognitively intact and capable of giving informed consent. 3. Clinical diagnosis of Traumatic Spinal Cord Injury. 4. Subject has mesenchymal stem cells banked at Hope Biosciences. 5. The patient accepts to receive treatment and to comply with follow-up visits Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator may increase the risks associated with study participation. 2. Active Alcohol or Drug addiction. 3. Participation in concurrent interventional research studies during this study. 4. Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history. 5. Unwillingness to return for follow-up visits
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 18.0-999.0, Immunosuppression Cancer COVID-19 Other Complication of Kidney Transplant Chemotherapy Renal Disease Diabetes Mellitus Cardiovascular Diseases Chronic Obstructive Pulmonary Disease Adults 18 years of age or older; 2. Diagnosis of SARS-CoV-2 infection confirmed by RT-PCR or antigen test no more than 5 days ago; 3. Onset of clinical signs and symptoms of COVID-19 no more than 5 days manifested as: 1. Presenting sudden onset of anosmia and/or ageusia without any other reasonable explanation and/or; 2. Thoracic image by radiography, tomography or ultrasonography compatible with acute clinical symptoms findings of COVID-19 and/or; 3. Acute onset of cough accompanied by fever and/or 4. Acute onset of three or more of the following symptoms: fever, cough, fatigue or general weakness, headache, myalgia, sore throat, runny nose, dyspnea, anorexia or nausea or vomit, diarrhea and mental status change. 4. Oxygen saturation by pulse oximetry ≥92% 5. Agree to periodic contacts by phone, electronic means and home visits; 6. Demonstrate intention to participate in the study, documented by Informed Consent Form signature on the part of the participant. For the very high risk group: 7. Being on continuous drug immunosuppressant more than two weeks due to a basic medical condition (e.g. transplant or cancer); For the high risk group: 8. To present at least two risk factors for developing serious COVID-19 (Over 60 years of age; diabetes mellitus; chronic obstructive pulmonary disease; kidney disease; cardiovascular diseases and body mass index ≥ 35) Presenting COVID-9 in need of oxygen therapy on the moment of study in other words, score 5 or higher in WHO COVID-19 progression scale; 2. Behavioral, cognitive or psychiatric disease that, in principal investigator opinion or his/her medical representative, affect the participant capacity in understanding and collaborating with study protocol requirements; 3. Any use considered alcohol or drugs abuse in the last 12 months prior to study that caused medical, professional or family problems, as indicated by clinical history; 4. Severe allergic reaction history or anaphylaxis to heterologous serum or product components of the study; 5. To have received heterologous serum or convalescent plasma in the last three months before of study or planned administration of hemoderivatives or immunoglobulin on the next 28 days of study inclusion; 6. The participant is a team member who is conducting the study or is in a dependent relationship with one of the study team members. Dependency relationships close relatives (in other words, sons, partner/spouse, brothers, parents), as well as Researcher staff or staff from the location conducting the study; 7. Any other condition that, in the principal investigator opinion or his/her medical representative, could threaten the safety or rights of a potential participant or which prevents him from fulfilling with this protocol. For female: 8. Pregnancy (confirmed by positive β-hCG test), breastfeeding and/or expressing an intention to have sexual practices with reproductive potential without using a contraceptive method within four weeks of the product administration; For stages A and B: 9. Previous immunization with vaccine against COVID-19
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0
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The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
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eligible ages (years): 40.0-80.0, Fecal Microbiota Transplantation Clinical diagnosis of COPD 2. Tobacco use: current or former smokers with a continuous smoking history of more than 1 year. 3. Subjects are willing and able to complete the follow-up according to the plan. 4. Subjects can cooperate to complete relevant examination items. 5. Compliance: Subjects must be willing to return to the hospital and complete all visits and evaluations according to the protocol Having a significant disease or condition other than COPD that, in the Investigator's judgment, would put the subject at risk for participating in the study or affect the study outcome and the subject's ability to participate in the study. 2. Women who are pregnant or breastfeeding or who plan to become pregnant during the study period. 3. Digestive system: ① patients with known gastrointestinal organic diseases. ② Complicated with intestinal double infection, such as Clostridium difficile infection, EHEC, Salmonella, Shigella, Campylobacter, plague and cytomegalovirus; ③ patients with various acute infections, tumors, severe arrhythmias, mental disorders, drug or alcohol addiction; (4) pregnant or lactating women; (5) Use of antibiotics or probiotics within the last 4 weeks; (6) There are taboo witnesses for this study; (7) Clinical investigators who were conducting other related COPD studies at the time of enrollment or within 3 months before enrollment; 4. Complicated with serious primary diseases of heart, liver, kidney, hematopoietic system and other important organs or systems. 5. Patients with lower back, chest and abdomen injuries or after surgery. 6. People with mental disorder or cognitive impairment. 7. Non-compliance: Subjects did not follow the study procedures, including non-compliance to complete the journal. 8. Informed consent validity is in doubt: Subjects with a history of psychosis, mental retardation, poor motivation, substance abuse (including drugs and alcohol), or other medical conditions that limit the effectiveness of informed consent in this study. 9. Obesity (BMI≥28) Hyperlipidemia (1.5 times the upper limit of normal value of plasma total cholesterol > or 1.5 times the upper limit of normal value of triglyceride BBB>; Confirmed diabetic patients; Diagnosed cancer patients; Have used any antibiotics or antibiotics in the last 2 weeks
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Diabetes Mellitus Type 1 diabetes for > 5 years AND Hypoglycemia unawareness, not felt adequately by patient (glucose < 54mg/dL) in last 1.6 years, not otherwise explained, requiring outside help OR Metabolic lability/instability, characterized by hypoglycemia or ketoacidosis (>2 hospital < 12 mo), chaotic glucose profile (MAGE > 120mg/dL), disruption in lifestyle or danger to life, to self, to others OR Failure of intensive insulin management, as judged by an independent endocrinologist
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 10.0-19.0, Diabetes Mellitus for screening will be patients who have one of the following: 1. 120% of ideal body weight or BMI> 27 2. Weight greater than 75th percentile 3. Family history of type 2 diabetes in first or second degree relative 4. Acanthosis nigricans or skin tags as signs of insulin resistance 5. Symptoms of hyperglycemia (polyuria, polydipsia, polyphagia, or recurrent infections). 6. Symptoms or signs of PCOS (hyperandrogenism, hirsutism, irregular menses)
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hepatitis Age at entry at least 18 years. 2. Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 3. Evidence of steatohepatitis on liver biopsy done within the previous 12 months with a NASH activity score of at least 4 (of a total possible score of 16) including a score of at least 1 each for steatosis, hepatocellular injury and parenchymal inflammation. Histological of steatohepatitis (1) macrovesicular steatosis, (2) acinar zone 3 hepatocellular injury (ballooning degeneration), (3) parenchymal and (4) portal inflammation. Additionally helpful, but not required, features the presence of (5) Mallory's hyaline and (6) pericellular and/or sinusoidal fibrosis that predominantly involves zone 3. 4. Written informed consent Evidence of another form of liver disease. 1. Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg). 2. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA in serum. 3. Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy. 4. Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis. 5. Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease. 6. Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency. 7. Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D. 8. Drug-induced liver disease as defined on the basis of typical exposure and history. 9. Bile duct obstruction as shown by imaging studies. 2. History of excess alcohol ingestion, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1drink per day: 7 drinks per week) in the previous one year. 3. Contraindications to liver biopsy: platelet counts less than 75,000/mm(3) or prothrombin time greater than 16 seconds. 4. Decompensated liver disease, Child-Pugh score greater than or equal to 7 points. 5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months. 6. Presence of diabetes mellitus as defined by: fasting plasma glucose of greater than or equal to 126 mg/dl on two separate occasion, or diabetic symptoms with a random plasma glucose of greater than or equal to 200 mg/dl (34). 7. Use of anti-diabetic drugs, including insulin, biguanides, sulfonylureas, or thiazolidinediones in the previous 6 months. 8. Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease with hypoxia, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator would preclude treatment with metformin and adequate follow up. 9. Positive test for anti-HIV. 10. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year. 11. Pregnancy or inability to practice adequate contraception in women of childbearing potential. 12. Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study that is suggestive of liver cancer. 13. Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study. 14. History of hypersensitivity reactions to metformin. 15. Serum creatinine greater than 1.5 mg/dl in men and greater than 1.4 mg/dl in women
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetic Retinopathy AND Age greater than or equal to 18 years. 2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: 1. Current regular use of insulin for the treatment of diabetes. 2. Current regular use of oral antihyperglycemia agents for the treatment of diabetes. 3. Documented diabetes by ADA guidelines. 3. No history of renal failure requiring dialysis or renal transplant. 4. No condition that in the opinion of the investigator would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). Patients in poor glycemic control who recently initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 3 months should not be enrolled. 5. Ability and willingness to provide informed consent. 6. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months. AND STUDY EYE: At least one eye must meet all of the following 1. Best corrected ETDRS visual acuity score greater than or equal to 19 letters (approximately 20/400 or better). 2. Definite retinal thickening due to diabetic macular edema based on clinical exam at or within 500 microns of the macular center for which the investigator believes laser photocoagulation is indicated. 3. A thickness of 250 microns or more in the central subfield OR a thickness of 300 microns or more in any one of the four subfields directly adjacent to the central subfield on OCT. 4. No prior focal/grid laser photocoagulation in the macula. 5. No prior medical treatment for DME (e.g., intravitreal/peribulbar steroids). 6. No panretinal scatter photocoagulation (PRP) within prior 4 months. 7. No anticipated need for PRP within next 4 months. 8. No major ocular surgery (including cataract extraction, any other intraocular surgery, scleral buckle, glaucoma filter, cornea transplant, etc.) within prior 6 months. 9. No Nd:YAG laser capsulotomy within prior 2 months. 10. Macular edema is not considered to be due to a cause other than diabetic macular edema. An eye should not be considered eligible (1) if the macular edema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggests that vitreoretinal interface disease (eg. vitreo-retinal traction or epriretinal membrane) is the primary cause of the macular edema. 11. Media clarity, papillary dilation, and patient cooperation sufficient for adequate fundus photos. 12. No ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the first 12 months of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome). Glaucoma per se is not an exclusion. A patient may have two "study eyes" only if both are eligible at the time of randomization. An eye that becomes eligible after randomization will not be considered a study eye for purposes of data analyses or treatment decisions although information is being gathered on all eyes
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 1 Type 1 diabetes for at least 12 months Current treatment with basal-bolus insulin regimen for more than or equal to 3 months HbA1c less than or equal to 11.0% Proliferative retinopathy or maculopathy Recurrent major hypoglycaemia Impaired hepatic or renal function Cardiac problems or uncontrolled hypertension
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 2 Type 2 Diabetes for more than 12 months Currently treated with glucose lowering tablets or insulin HbA1c: 7.0-12.0%
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 4.0-17.0, Diabetes Mellitus, Insulin-Dependent Girls/boys, 4-17 years, inclusive Girls not yet of childbearing potential or, if sexually active, agree to use reliable medically accepted contraceptive measure during study Type 1 diabetes mellitus established in medical history: for example, but not limited to, clear signs of insulinopenia (polyuria, polydipsia, polyphagia, weight loss, ketonuria, ketoacidosis); or glutamic acid decarboxylase (GAD) antibody indicative of type 1 diabetes measured at any time before study; or requiring continuous insulin therapy from time of diagnosis Onset of diabetes at least 1 year prior to visit 1 (V1) of study Uninterrupted insulin therapy for at least 1 year before V1 of study At V1, on stable insulin regimen of either NPH or insulin glargine as basal insulin and willing to have multiple daily injections of insulin Glycated hemoglobin at V1 between ≥ 6.0 and ≤11.0 % Ability/willingness to do blood glucose monitoring using sponsor-provided glucometer and subject diary Active proliferative diabetic retinopathy, defined by application of focal or panretinal photocoagulation or vitrectomy, 6 months before V1, or any other unstable/rapidly progressing retinopathy requiring surgical treatment (including laser photocoagulation) during study Diabetes other than type 1 diabetes mellitus Pregnancy (positive pregnancy blood test at V1) or breastfeeding Pancreatectomized subjects Subjects who have had pancreas and/or islet cell transplants Treatment with any anti-diabetic oral agent at any time from diabetes diagnosis Treatment with systemic corticosteroids in last month before V1 Subjects on pump therapy during last 2 months before V1 Subjects requiring excessively high doses of insulin ("resistant" patients), for example, but not limited to, subjects receiving over 150 IU per day Likelihood of needing treatment during study period with drugs not permitted by protocol
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Diabetes Mellitus, Type 1 Type 1 diabetes mellitus diagnosed > 5 years previously Body mass index less than or equal to 26 to 65 years of age Compliance with an optimized diabetic management plan as assessed by an Emory University endocrinologist Checking and recording blood sugars at least 3 times per day Intensive insulin therapy (injecting insulin at least 3 times a day or using an insulin pump) Severe hypoglycemia and/or hyperglycemia. Severe hypoglycemia is defined by: episodes requiring assistance by others and/or hypoglycemic unawareness (the inability to recognize blood glucose < 54 mg/dL). Severe hyperglycemia is defined by: two episodes of ketoacidosis requiring hospitalization within the past year Renal dysfunction Severe co-existing cardiac disease, characterized by any one of these conditions: recent myocardial infarction (within past six months); angiographic evidence of non-correctable coronary artery disease; or evidence of ischemia on a dobutamine stress echocardiogram Current bacterial or fungal infection Macroproteinuria Baseline hemoglobin < 11.4 gm/dL in women; < 12.9 gm/dL in men Hyperlipidemia Positive tests for human immunodeficiency virus (HIV), or hepatitis B or C Negative antibody test for varicella zoster virus (subjects may be reconsidered if they receive the vaccination and convert to a positive antibody) History of malignancy (except squamous or basal cell skin carcinoma) Previous/concurrent organ transplantation
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 1 Type 1 diabetes for > 5 years Use of multiple daily injections of a basal insulin and a rapid acting component Regular consumption of modest amounts of alcohol Type 2 diabetes Type I diabetes < 5 years Excessive alcohol consumption Unstable diabetes
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.0-0.077, Type 1 Diabetes HLA genotypes that increase risk of type 1 diabetes: heterozygous for DRB1*03, DQA1*0501, DQB1*0201 / DRB1*04, DQA1*03011, DQB1*0302 (DRB1*04 ≠ *0403 or related alleles), or homozygous for DRB1*03, DQA1*0501, DQB1*0201, or homozygous for DRB1*04, DQA1*03011, DQB1*0302 (DRB1*04 ≠ *0403 or related alleles) Premature, low birthweight, or major congenital malformations or serious chronic disease
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Coagulation Bleeding Thrombosis Currently receiving warfarin with a target INR of 2.0 to 3.5 INR value > 4.49 and drawn within last 24 hrs Elective discontinuation of warfarin Age < 18 years Life expectancy of less than 10 days Indication for the acute normalization of INR i.e. active major bleeding (bleeding into central nervous system, retroperitoneum or other critical area or any bleeding requiring transfusion), need for surgery, major non-orthopedic surgery within the last seven days, invasive diagnostic procedure, head injury or termination of warfarin Known Severe liver disease AST or ALT > 5 x normal, bilirubin > 50 umol/litre, known coagulopathy due to liver disease Recent (<1 month) history of major bleeding episode i.e. Hemorrhagic stroke, gastrointestinal bleed or other bleed requiring transfusion or admission to hospital Known bleeding disorder or thrombolytic therapy within 48 Hrs i.e. Hemophilia, disseminated intravascular coagulation Known allergy to vitamin K Inability to take oral medications Known significant thrombocytopenia i.e. Platelet count of < 50 x 10 9/litre
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 30.0-75.0, Type 2 Diabetes Coronary Heart Disease -English speaking people with newly diagnosed Type 2 diabetes (within 3-12 months of diagnosis) who are attending the Alfred Hospital, Diabetes Education Outpatient Clinic age <30 years or > 75 years body mass index (BMI) < 25 kg/m2 or >37 kg/m2 on corticosteroid or insulin therapy presence of established renal and/or liver disease (serum creatinine more than 0.12 mmol/L/albumin excretion rate greater than 300 µg per minute or ALT more than twice the upper limit of normal respectively)
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-999.0, Diabetes Erectile Dysfunction diabetic male age above 20 men using any form of erectile dysfunction treatment-
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 6.0-18.0, Diabetic Ketoacidosis Ages 6-18 y.o. presenting to Vanderbilt Children's Hospital (VCH) Emergency Room with Established history of insulin dependent diabetes AND Chief c/o hyperglycemia or vomiting Venous pH < 7.24 Serum Bicarbonate < 18 Blood glucose > 150 Urinary Ketones Age < 6y.o New onset diabetes Received IV insulin bolus prior to arrival to VCH Emergency Room (ER) Venous pH > 7.24 Serum Bicarbonate > 18 Pregnancy Received glargine within 12 hours prior to arrival to VCH Emergency Room/Pediatric Critical Care Unit
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Metabolic Syndrome Diabetes Inpatients and outpatients diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Treated either with typical or atypical antipsychotics Illegal drug use/abuse/dependence Alcoholism Pregnancy Clinical diagnosis of type I or type II diabetes before the onset of schizophrenia or treatment of schizophrenia (via chart review)
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, HIV Infections AIDS Lactic Acidosis Lipodystrophy Participants at least 18 years of age or older either HIV negative, or HIV positive, not on antiretroviral therapy (for at least 6 months) or HIV positive, on D4T/ddC/ddI/AZT containing HAART or HIV positive, on D4T/ddC/ddI/AZT containing HAART, with hepatic steatosis/liver disease No evidence of acute illness on physical or laboratory examination Patients who have voluntarily consented to the study and signed the appropriate consent have not been supplementing with multi-vitamins, thiamine, riboflavin for at least 2 months prior to Active AIDS defining illness Treatment with growth hormone Known poor adherence with therapy End stage renal disease Pregnancy
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-60.0, Schizophrenia Type 2 Diabetes Mellitus Patient meets DSM-IV for Schizophrenia 60 years of age or older Able to give informed consent Treated with olanzapine, quetiapine, risperidone or ziprasidone for greater than or equal to 3 months prior to enrollment pregnant or breastfeeding women will be excluded Meets DSM-IV for substance abuse or dependence within past 6 months involuntary legal status (as per Missouri law) any serious medical disorder that may confound assessment of symptoms subjects taking prescription medications except psychotropic meds meets DSM-IV for Mental Retardation (mild or worse) Subjects taking tricyclic antidepressants or mood stabilizers
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemia Valid physician order of the protocol. - No valid phycician order for the protocol -
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Type 1 Diabetes Type 1 diabetes mellitus (American Diabetes Association definition) HbA1c greater than or equal to 7.5% Intensive insulin treatment for at least 3 months Physical and intellectual ability to operate MIP system Subject has been under the routine care of the investigator for at least two months prior to enrollment Subject has a reliable support person (defined as a person who has daily contact with the subject and knows whom to contact in the event of an emergency) Capability and willingness to perform self-monitoring of blood glucose at least four times daily for 9 months of the study and 7 times daily for 3 months of the study Physical and intellectual ability to operate the MIP system and to comply with the data reporting requirements of the study Subject is willing to sign the informed consent form (approved by local Institutional Review Board and Medtronic MiniMed) The subject's insulin usage exceeds 66 units per day Severe complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months Reside at or plan to travel to elevations above 8000 feet during the study period (commercial airline travel is acceptable) Subject who is pregnant, of childbearing potential or lactating and is neither surgically sterile, using contraceptives (devices, oral or implanted) nor other physician approved contraceptive The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data The subject has previously enrolled in or participated in an investigational drug or device study within the preceding 4 weeks The subject has any condition that precludes him/her from completing the study requirements Has plans for activities which require them to go 25 feet below sea level
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemia Critical Illness Patients are eligible for in the study if ALL the following are met: 1. At time of the patient's admission to the ICU the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission. 2. Patient has an arterial line in situ or placement of an arterial line is imminent (within the next hour) as part of routine ICU management Patients will be from the study if ONE or MORE of the following are present: 1. Age < 18 years. 2. Imminent death (cardiac standstill or brain death anticipated in less than 24 hours) and the treating clinicians are not committed to full supportive care. This should be confirmed by a documented treatment-limitation order that exceeds a "not-for-resuscitation" order. 3. Patients admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state. 4. Patient is expected to be eating before the end of the day following admission 5. Patients who have suffered hypoglycaemia without documented full neurological recovery. 6. Patient thought to be at abnormally high risk of suffering hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or fulminant hepatic failure) 7. If a patient has previously been enrolled in the NICE-SUGAR Study (patients cannot be enrolled in the NICE-SUGAR Study more than once). 8. If the patient can not provide prior informed consent, there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent 9. The patient has been in the study ICU or another ICU for longer than 24 hours for this admission. There is no upper age limit for into the study unless any of the specific are present. -
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 12.0-999.0, Cystic Fibrosis Related Diabetes 1. CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl) 1. . The diagnosis must be made at a time when the patient is in his/her basal state of health with no evidence of acute exacerbation in the preceding two months. a). Acute exacerbation is defined on page 9. 2. . For patients with onset of diabetes in the preceding 6 months, the hemoglobin A1c must be stable for 3 months prior to study entrance within 5% (0.3% A1c increment). 2. Age ≥18, post-pubertal (done growing, since change in weight is a study endpoint) 3. Weight stable within 5% during the previous 3 months as measured in CF clinic 4. Willingness to attend all study visits and to engage in regular phone or e-mail contact with the study diabetes nurse 5. Glucocorticoids can have a profound effect on weight, and thus we wish to minimize the occurrence of changing steroid doses during the study period. Patients receiving glucocorticoid therapy will be included in the protocol only if: 1. . They have been on the same steroid dose for the preceding six months, 2. . There are no plans to change their steroid dose in the next eight months. 2 Pregnancy or plans to become pregnant in the next eight months (because of the changes pregnancy would cause in our study endpoints), 2. Unwillingness / inability to take multiple injections or to count carbohydrates, 3. A history of hypoglycemia unawareness (rare in CF), 4. Plans to start any medication in the next 8 months that might affect weight, such as testosterone or Megace. Patients chronically taking these medications may be included if: 1. . They have been on the same dose for the preceding six months 2. . There are no plans to change their dose in the next eight months
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 21.0-85.0, Diabetes Mellitus The researchers will up to 200 patients both male and female between the ages of 21 and 85 diagnosed with type 1 or type 2 diabetes mellitus Self reporting or diagnosed with significant complications resulting from diabetes Taking oral agents and/or insulin for diabetic control Under an Endocrinologists supervision for their diabetes management. Endocrinologist must assess and approve patient for participation in this study Ability to swallow without difficulty Ability to commit to the weekly time requirements associated with the study Other causes of complications not related to diabetes Inability to respond to 44 item questionnaire Lack of intravenous access Pregnancy Alcohol abuse, drug addiction or the use of illegal drugs Positive HIV Inability to breathe into machine for respiratory quotients
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 20.0-90.0, Diabetes Mellitus, With Complications The researchers will up to 500 patients both male and female between the ages of 20 and 90 diagnosed with type 1 or type 2 diabetes mellitus All patients were diagnosed by their endocrinologists as having diabetic neuropathy All patients had failed conventional treatment for diabetic neuropathy Taking oral agents and/or insulin for diabetic control Under an Endocrinologists supervision for their diabetes management. Endocrinologist must assess and approve patient for participation in this study Ability to swallow without difficulty Ability to commit to the weekly time requirements associated with the study Other causes of complications not related to diabetes Lack of intravenous access Pregnancy Alcohol abuse, drug addiction or the use of illegal drugs Positive HIV Inability to breathe into machine for respiratory quotients
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-60.0, Diabetes Mellitus, Type 1 Subjects with type 1 diabetes mellitus for more than three years Subjects on multiple daily injection insulin therapy, basal-bolus scheme therapy HbA1c <= 9 % (measured by central Lab, with DCCT aligned standard method) Fasting C-Peptide <= 0,1nmol/L with FBG >126 mg/dl Body Mass Index (BMI) < 30 kg/m2 Willingness to accept intensive insulin therapy Ability and willingness to perform SMBG using plasma glucose meter Female subjects must be postmenopausal or under adequate contraception as judged by the investigator (it may be oral contraceptives, intra-uterine device or surgical treatment) and must have a negative serum pregnancy test Diabetes other than type 1 diabetic mellitus Type 1 diabetic patients with total insulin dose >= 1 IU/kg/day Serum creatinine > 1.5 mg/dl, or history of renal transplantation or current renal dialysis Congestive heart failure NYHA class II Acute or chronic metabolic acidosis, including diabetic ketoacidosis Clinical evidence of active liver disease, or serum ALT/AST 2 times the upper limit of the normal range Hypoglycemia unawareness Pregnancy or lactation Concomitant use of β-blockers, thiazides or systemic corticosteroids More than one episode of severe hypoglycemia with seizure or coma during the past year
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-80.0, Type 1 Diabetes Type 1 diabetes, HbA1c < 7.8%, who have had prior instruction in a complex insulin program, and presently using a MDI insulin program with basal insulin preparations of Glargine or Ultralente and Humalog as the short acting insulin, should be free of hepatorenal abnormalities and hypoglycemia unawareness; non-pregnant, and should be able to perform frequent self monitoring of blood glucose (SMBG) and accept the use of continuous glucose monitoring system (CGMS). They should also possess the skill and understanding of insulin dose adjustments and supplementation
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Diabetes Mellitus, Type 1 Type 1 diabetes mellitus Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week renal function impairment: creatinin ≥ 150 micromol/L or a creatinin clearance < 50 ml/min Cardiac problems: decompensated heart failure (NYHA III and IV); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months Known or suspected allergy against insulin or any component of the composition Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past Severe untreated proliferative retinopathy Insufficient knowledge of the Dutch language to understand the requirements of the study Current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year Substance abuse, other than nicotine A history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma Participation in other trials, involving investigational products within 30 days prior to trial entry
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 1 have type 1 diabetes mellitus hemoglobin A1C between 6 and 10% have evidence of early diabetic renal disease as determined by creatinine clearance more than 80 ml/minute, urine albumin to creatinine ratio of more than 3.0 and urinary albumin levels consistent with the diagnosis of diabetic nephropathy (more than 20 mg/mmol for men and more than 28 mg/mmol for women) are without language barrier, cooperative, expected to return for all follow-up visits, and who give informed consent before entering the study's randomization phase and after being informed of the study medications and procedures Have poorly controlled diabetes, chronic liver disease, clinical jaundice, and/or elevation of liver-related laboratory results, have chronic renal failure on dialysis, have received a kidney transplant or have a moderate to severe kidney disease, have previous history of myocardial infarction, stroke, claudication or amputation, have cancer and are currently receiving chemotherapy or plan to receive chemotherapy in the next 6 months and woman of childbearing potential despite actively practicing birth control by using a medically accepted device or therapy are being treated or intending to start treatment during the trial with excluded drugs: topical or oral carbonic anhydrase inhibitors and require more than 2 weeks of treatment with drugs known to strongly inhibit cytochrome P450 3A4 (CYP3A4), including but not limited to, delavirdine, fluconazole, itraconazole, indinavir, ketoconazole mibefradil, nelfinavir, ritonavir, and saquinavir consume alcohol, tobacco and nicotine products within 48 hours before the study and have any condition that, in the investigator's opinion, would preclude meaningful participation in the study, including, but not limited to, abnormal laboratory values the investigator considers clinically significant, patients who are poor medical or psychiatric risks for treatment with an investigational drug, patients who are unlikely to complete the study suspected or proven to have a kidney disease other than diabetic related albuminuria and/or renal insufficiency
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 0.0-999.0, Diabetes Hyperglycemia All patients admitted to the internal medicine ward with hyperglycemia Patients admitted due to hypoglycemia, hyperosmolar state, and ketoacidosis
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 1.0-999.0, Type 1 Diabetes Mellitus Must have a diagnosis of T1D and have stored umbilical cord blood in an AABB and/or FACT accredited cord bank. 2. TID diagnosis will be defined as having a clear history of polydipsia, polyphagia, polyuria, and weight loss consistent with a clinical diagnosis, diagnosis will mot be based solely upon the presence of autoantibodies. 3. Cord blood meets all selection and testing (see below). 4. Able to complete mixed meal tolerance / glucagon stimulation test. 5. Normal screening values for CBC, Renal function and electrolytes (BMP). 6. Willing to comply with intensive diabetes management Complicating medical issues that would interfere with blood drawing or monitoring. 2. Chronic use of steroids or other immunosuppressive agents for other conditions. 3. Positive infectious disease markers from mothers' blood or cord at time of collection (See below for details). 4. Any evidence of illness on planned infusion date (i.e. fever >38.5 C, vomiting, diarrhea, wheezing, or crackles)
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 65.0-999.0, Type 2 Diabetes Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit Patients with type 1 diabetes History of ketoacidosis or requires insulin use Alanine aminotransferase / aspartate aminotransferase > 2.5 X ULN, triglycerides > 600 mg/dL, creatinine clearance < 35 mL/min Fasting plasma glucose consistently > 260 mg/dL Poorly controlled hypertension
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 1 Type 1 Diabetes Current basal-bolus insulin therapy HbA1c < 10% BMI < 32 kg/m2 Proliferative Retinopathy / Maculopathy Recurrent major hypoglycaemias Impaired hepatic or renal function Cardiac Problems Uncontrolled hypertension
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Type 1 Diabetes Mellitus Potential candidates must have type 1 diabetes mellitus and fulfill one or more of the following: 1. Manifest signs and symptoms that are severe enough to be incapacitating. Incapacitating signs and symptoms hypoglycemic episodes requiring assistance by others and hypoglycemia unawareness (the inability to recognize low blood glucoses; glucoses < 54 mg/dl). These patients are at high risk for involvement in accidents (they can lose consciousness or act irrationally), thus causing harm to themselves and/or others. 2. Patients with poor diabetes control (HbA1c > 8.0% but < 12%), despite intensive insulin therapy, as defined by: self monitoring of blood glucose ≥ 4 times/day, multiple insulin injections (≥ 3/day) or insulin pump, and close monitoring of blood glucose control by an endocrinologist. These patients can experience acute, rapid hyperglycemia secondary to several stress factors, that can lead to dehydration, disorientation, and in some instances, ketoacidosis. 3. Progressive diabetic complications. These patients with chronically poor glycemic control are at higher risk for the development of a wide variety of complications (retinopathy, neuropathy, nephropathy, and cardiovascular disease) associated with diabetes Potential candidates will be excluded as per the following 1. Age < 18 or > 65 years 2. Duration of diabetes < 5 years 3. Do not have a physician that is monitoring diabetes for > 6 months 4. Body mass index > 26 5. Weight > 80 kg 6. Insulin requirement > 1.0 u/kg/d 7. HbA1c > 12% 8. Stimulated or basal C-peptide > 0.3 ng/ml 9. Corrected creatinine clearance < 60 ml/min 10. Serum creatinine consistently above 1.6 mg/dl 11. Macroalbuminuria (> 300 mg/24 hours) 12. Anemia (hemoglobin < 12.0 g/dl for males; < 11 g/dl for females) 13. Hyperlipidemia (fasting low-density lipoprotein [LDL] cholesterol > 130 mg/dl and/or fasting triglycerides > 200 mg/dl) 14. Abnormal liver function tests (consistently > 1.5 x normal range) 15. Serological evidence of HIV, HBsAg and/or HBcAb, HBsAb without history of vaccination, human t cell lymphotropic virus 1 (HTLV-1), or hepatitis C virus (HCV) 16. Negative serology for Epstein-Barr virus (EBV) or evidence of acute or chronic infection (IgM ≥ IgG) 17. Lack of updated immunizations per current Centers for Disease Control (CDC) guidelines (including lack of immunization against hepatitis B, pneumococcus and influenza - during season) 18. Presence of panel reactive antibodies > 20% 19. Prostate-specific antigen (PSA) > 4 ng/ml unless malignancy is ruled out 20. Positive tuberculin test (unless proof of adequate treatment for latent tuberculosis can be provided) 21. X-ray evidence of pulmonary infection or other significant pathology 22. Gall stones and/or portal hypertension and/or hemangioma on liver ultrasound 23. Abnormal abdominal or pelvic ultrasound (evidence of masses that are considered suspicious for malignancy or adenopathy) 24. Active peptic ulcer disease 25. Active infections 26. Unstable cardiovascular status (including positive stress echocardiography if age > 35) 27. Untreated or unstable proliferative diabetic retinopathy 28. Previous/concurrent organ transplantation (except for failed islet cell or pancreas transplantation) 29. Malignancy or previous malignancy 30. Any medical condition requiring chronic use of steroids 31. Active alcohol or substance abuse; smoking in the last 6 months. 32. Sexually active females who are not post-menopausal surgically sterile, or not using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices with spermicide are acceptable; condoms used alone are not acceptable) 33. Positive pregnancy test or intent for future pregnancy, or male subject's intent to procreate 34. Any condition or any circumstances that make it unsafe to undergo an islet cell transplant 35. Psychogenically unable to comply 36. Failed psychological evaluation 37. Persistent leukopenia (white blood cell count < 3,000/uL on more than 3 occasions)
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hypertension Diabetes Mellitus Type 2 Diabetes with baseline A1c > 8.0 % on diet or medical therapy with no history of diabetic ketoacidosis Patients must be greater than or equal to 18 years of age Written informed consent must be obtained prior to admission to this study Hypoglycemic therapy and A1c<8.0% New York Heart Association Stage III-IV congestive heart failure. This will eliminate approximately 2% of people with diabetes based on the Strong Heart Study Data Suspected secondary hypertension due to any cause (e.g. pheochromocytoma,coarction of the aorta or renal insufficiency.) Unstable angina, myocardial infarction, or revascularization within the last 3 months Angioedema Cerebrovascular event, including stroke or transient ischemic attack, within the last six months Creatinine >250 umol/L Cerebral Vascular event, including strike or transient ischemic attack, within the last six months Connective tissue disorders (e.g.lupus, rheumatoid arthritis) Active hepatic disease as indicated by AST and ALT >2X the upper limit of normal; serum bilirubin >1.5X upper limit of normal, or serum albumin <3.0 gm/dl
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-80.0, Hyperglycemia Diabetes Fasting glucose > 100 mg/dl Patients on surgical services or in intensive care units receiving intravenous insulin Inability to obtain informed consent from patient or next-of-kin Allergy to insulin Participation in another research study Patients for whom there are "do-not-resuscitate" orders
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Hyperglycemias all patients with hyperglycaemia (≥ 8.0 mmol/l) admitted to the medical emergency room patients with presumed hospitalisation in ER or medical ward of more than 48 h duration patients in shock (defined as hypotension or shock index > 1 with oliguria, changed mental status and metabolic acidosis) patients with a terminal illness on palliative care patients with type 1 diabetes patients with insulin pump therapy patients with need for hospitalisation in the intensive or coronary care unit patients with presumed hospitalisation shorter than 48 hours known pregnancy (in women with childbearing potential pregnancy test for mandatory) no informed consent
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-75.0, Diabetes Mellitus Type 2 Subjects with type 2 diabetes mellitus (no history of ketoacidosis)and stable treatment with NPH insulin(once or twice daily)and mealtime insulin for at least 3 months HbA1c values smaller/equal 8.0%(measured at screening visit, Visit 1) Ability and willingness to perform continuous and self monitoring blood glucose profiles, using a self monitoring blood glucose meter as well as carrying the continuous blood glucose meter at least two times for 72 hours throughout the study at home All forms of diabetes other than type 2 diabetes mellitus Oral antidiabetic drugs(OADs)and/or insulins other than NPH and mealtime insulins, except metformin(stable dose for a minimum of 3 months, no dose adjustments during the study) Pregnant(as determined by urine pregnancy test at Visit 1)or breast-feeding Women of childbearing potential who did not take adequate contraceptive protection such as systemic hormones or who planned to become pregnant during the study Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (e.g. systemic corticosteroids) History of hypersensitivity to the study medication or to drugs with similar chemical structures Treatment with any investigational drugs in the last month before study entry History of drug or alcohol abuse Diabetic retinopathy with surgical treatment (laser photocoagulation or vitrectomy) in the 3 months prior to study entry or which required surgical treatment within the study Clinically relevant cardiovascular, gastrointestinal, hepatic, neurological, endocrine, hematological or other major systemic diseases making implementation of the protocol or interpretation of the study results difficult
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Diabetes Hyperglycemia Males or females between the ages of 18 and 70 years admitted to a general medicine service. 2. A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones). 3. Subjects must have an admission blood glucose > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones) Subjects with increased blood glucose concentration, but without a known history of diabetes. 2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [57]. 3. Patients with known HIV, acute critical or surgical illness and/or expected to require admission to a critical care unit (ICU, CCU), corticosteroid therapy, or to undergo surgery during the hospitalization course. 4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥3.0. 5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 6. Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism. 7. Female subjects are pregnant or breast feeding at time of enrollment into the study
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Diabetes or With New Hyperglycemia Males or females between the ages of 18 and 70 years admitted to a medical ICU 2. A known history of diabetes mellitus or with new hyperglycemia untreated or treated by diet, insulin therapy or with any combination of antidiabetic agents (sulfonylureas, metformin, thiazolidinediones) Blood glucose greater than 120 mg/dl on ≥ 2 occasions for known, treated diabetics or greater than 140 mg/dl on ≥ 2 occasions for those with new hyperglycemia. 3. Subjects must have an admission blood glucose < 400 mg/dL, without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 milliequivalents/L or positive serum or urinary ketones) Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state [38]. 2. Patients with known HIV, severely impaired renal function (serum creatinine ≥3.0 mg/dl). 3. Patients with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 4. Female subjects who are pregnant or breast feeding at time of enrollment into the study
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Cystic Fibrosis Phlebitis Diagnosis of cystic fibrosis, made accordingly to the Cystic Fibrosis Foundation Guideline (Rosenstein BJ. J Pediatr 1998;132: 589-595) age of 18 years or more and ability to consciously express owns informed consent have a prescription done by one of the CF Centre specialist Physicians of an IV antibiotic course of the expected duration of 2 weeks, due to a pulmonary exacerbation, with the association of ceftazidime 3 times daily and tobramycin once daily diluted in Normal Saline absence of clinical conditions that contraindicate the administration of 350ml of Normal Saline in 30 minutes 3 times daily and of 400ml of Normal Saline in 40 minutes no simultaneous anti-inflammatory therapy administered orally, IM or IV days have passed from the end of the previous course The IV course will be given to the subject as an inpatient, and he or she will be admitted to our hospital
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 3.0-45.0, Diabetes Mellitus, Type 1 Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of diagnosis. Probands considered to have type 1 diabetes by their physician who do not meet this definition will be referred to the TrialNet Committee. 2. If the proband is a parent, sibling or a child, the study participant must be 3 -45 years of age. If the proband is a second or third degree relative (i.e. niece, nephew, aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20 years of age. 3. Willing to sign Informed Consent Form. 4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in which fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and hour plasma glucose < 140 mg/dL (7.8 mmol/l) 5. mIAA confirmed positive within the previous six months. 6. Two samples with at least one autoantibody other than mIAA positive within the previous six months Does not satisfy the above criteria. Subjects with mIAA positive but no other autoantibodies positive are not eligible for randomization. 2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary, renal, hepatic, immune deficiency and/or disease that is likely to limit life expectancy or lead to therapies such as immunosuppression during the time of the study. 3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin, immunosuppressive drugs. 4. History of treatment with insulin or oral hypoglycemic agent. 5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two years for a period of more than three months. 6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta adrenergic blockers, niacin. Subjects on such medications should be changed to a suitable alternative, if available, and will become eligible one month after medication is discontinued. 7. Pregnant or intends to become pregnant while on study or lactating. 8. Deemed unlikely or unable to comply with the protocol. 9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting Glucose (IFG). Diabetes is defined by fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR hour plasma glucose ³ 200 mg/dL (11.1 mmol/l) IGT is defined by fasting plasma glucose < 126 mg/dL (7 mmol/l), and hour plasma glucose 140-199 mg/dL (7.8 mol/l), IFG is defined by fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND hour plasma glucose < 140 mg/dL (7.8 mmol/l) 10. Subject has HLA DQA1*0102, DQB1*0602 haplotype
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 19.0-65.0, Ketosis Prone Diabetes Diabetic Ketoacidosis Severe Hyperglycemia Obese AA subjects with DKA or severe hyperglycemia and 8 obese nondiabetic subjects, age 19-65. All studies will be performed in the GCRC at Grady Memorial Hospital Subjects with a BMI ≥ 28 kg/m2 will be included Diagnostic for DKA will a plasma glucose > 250 mg/dl a venous pH < 7.30 a serum bicarbonate < 18 mEq/l, and high serum ketones Obese hyperglycemic patients will have a blood glucose on admission > 400 mg/dl a serum bicarbonate > 18 mEq/l, and Patients with significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes Patients with recognized endocrine disorders, such as hypercortisolism, acromegaly, or hyperthyroidism Bleeding disorders, or abnormalities in coagulation studies Pregnancy
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Chronic Kidney Failure Male or female subjects on active haemodialysis, aged 18 years or over who are able to comply with study procedures Written informed consent given On a stable haemodialysis regimen (three times per week) for at least 3 months and be unlikely to change their dialysis prescription during the study period On a stable dose of phosphate binder for at least 1 month prior to screening Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium or iron-containing products and preparations, other than the study medication Willing to avoid any intentional changes in diet such as fasting, dieting or overeating On a dialysate magnesium ion concentration of ≤1.0 mmol/L for at least 1 month prior to screening Received a cardiac transplant Heart failure according to New York Heart Association (NYHA) Functional IV Classification Participation in any other clinical trial using an investigational product or device within the previous 4 weeks A significant history of alcohol, drug or solvent abuse in the opinion of the investigator Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn Clinically significant laboratory findings (at screening for this subject population) in the opinion of the investigator Any history of recent clinically significant malignancy A significant illness (excluding renal disease) in the 4 weeks before screening A history of poorly controlled epilepsy Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-60.0, Type 1 Diabetes Patients with established type 1 diabetes mellitus who meet all are eligible for enrollment in the study All patients enrolled must be on insulin replacement therapy Written informed consent conforming to the institutional guidelines obtained from the patient Documented evidence of insulin-requiring type 1 diabetes of >5 years duration Adequate immune competence, as indicated by positive reaction to one or more of the common DTH skin tests that are part of the Multitest CMITM test system (Pasteur-Merieux Connaught) and as indicated by the manufacturer. Also, proof of vaccination for tetanus (no more than 10 years must have elapsed between tetanus vaccination and the onset of this study) Age 18-35 Adequate hematologic function Absolute neutrophil count > 1,000/mm3 Absolute lymphocyte count > 1,000/mm3 Hemoglobin > 9 gm/dl One or more of the are not met A significant history or current evidence of cardiac disease including, but not limited to, congestive heart failure, coronary artery disease, angina pectoris, uncontrolled hypertension, serious arrhythmias; or myocardial infarction within the previous six months Evidence of active infection requiring antibiotic therapy History of other concurrent diseases Pregnant or lactating women Patients requiring systemic corticosteroids Any other immune disorder including but not limited to other autoimmune diseases like rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis Pregnancy History of radiation therapy, immunotherapy, or chemotherapy Breastfeeding
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 12.0-45.0, Diabetes Mellitus, Type 1 Adults 12 to 45 years old who are in good general health Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control Measurable C-peptide levels Females must not be pregnant or lactating and willing to practice contraception No prior malignancy, other than non-melanoma skin cancer Body Mass Index (BMI) > 32 at screening
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 40.0-75.0, Diabetes Mellitus Hypertension Men or women of any racial background Age >= 40 years and <= 75 years SBP>= 130 mmHg and < 140 mmHg or DBP >= 85 mmHg and < 90 mmHg, average of screening and randomisation visits (in absence of any antihypertensive medication) FG >=100 mg/dl (5.6 mmol/l) and < 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication) Waist circumference >= 102 cm in men and >= 88 cm in women SBP >= 140 mmHg or DBP >= 90 mmHg Any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation Any current or previous cardiovascular or renal disease requiring continuous administration of Ds, ßBs, ACEIs, ARBs, CAs, and any other antihypertensive medication Any medical condition preventing adherence to lifestyle measures included in the protocol Hepatic disease as AST (SGOT) or ALT (SGPT) values equal or greater than two times the upper limit of normal Chronic renal dysfunction as serum creatinine > 2.0 mg/dl Any gastrointestinal disorder interfering with drug absorption Known allergy or contraindications to ACEIs or ARBs Pregnant or lactating women; women in reproductive age not using recognized contraceptive methods Malignancy within the last 5 years
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Type 1 Diabetes Mellitus Mentally stable and able to comply with study procedures Clinical history compatible with type 1 diabetes with onset at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28 Absent stimulated C-peptide (less than 0.3 ng/mL) 60 and 90 minutes post-mixed-meal tolerance test Involvement of intensive diabetes management, defined as: 1. Self-monitoring of glucose values no less than a mean of three times each day averaged over each week 2. Administration of three or more insulin injections each day or insulin pump therapy 3. Under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least three evaluations during the 12 months prior to study enrollment At least one episode of severe hypoglycemia in the past 12 months prior to study enrollment Reduced awareness of hypoglycemia. More information about this criterion, including specific definition of hypoglycemia unawareness, is in the protocol Body mass index (BMI) greater than 30 kg/m^2 or weight less than or equal to 50 kg Insulin requirement of more than 1.0 IU/kg/day or less than 15 U/day Hemoglobin A1C (HbA1c) greater than 10% Untreated proliferative diabetic retinopathy Systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg Measured glomerular filtration rate (GFR) using iohexol of less than 80 mL/min/1.73m2. More information about this criterion is in the protocol Presence/history of macroalbuminuria (greater than 300 mg/g creatinine) Presence/history of panel-reactive anti-HLA antibodies above background by flow cytometry. More information about this criterion is in the protocol Pregnant, breastfeeding, or unwilling to use effective contraception throughout the study and 4 months after study completion Presence of history of active infection, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or tuberculosis (TB). More information about this criterion is in the protocol
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus Patients presenting with a diabetic emergency aged 18 and above Patients who do not speak English and need a translator Patients under the age of 18 years Patients who are unable to give their consent and who do not have a relative present wiling to give assent
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Diabetes Mellitus Type 1 or type 2 diabetic patients Measure HbA1c 6.5% to 11.0% at visit 1 More than 3 months of continuous insulin treatment immediately prior to study entry Pregnant women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-65.0, Type 1 Diabetes Mellitus Mentally stable and able to comply with study procedures Clinical history compatible with type 1 diabetes with onset of disease at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28 Absent stimulated C-peptide (less than 0.3 ng/mL) 60 and 90 minutes post-mixed-meal tolerance test Involvement of intensive diabetes management, defined as: 1. Self-monitoring of glucose no less than a mean of three times each day averaged over each week 2. Three or more insulin injections each day or insulin pump therapy 3. Under the care of an endocrinologist, diabetologist, or diabetes specialist with at least three clinical evaluations during the past 12 months prior to study enrollment At least one episode of severe hypoglycemia, defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable behavior; irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms, in which the participant was unable to treat him/herself and which was associated with either a blood glucose level less than 54 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagons in the 12 months prior to study enrollment Reduced awareness of hypoglycemia. More information about this criterion is in the protocol Body mass index (BMI) greater than 30 kg/m^2 or weight less than or equal to 50 kg (110 lbs) Insulin requirement of more than 1.0 IU/kg/day or less than 15 U/day HbA1c greater than 10% Untreated proliferative diabetic retinopathy Systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg Measured glomerular filtration rate using iohexol of less than 80 mL/min/1.73m^2 Presence or history of macroalbuminuria (greater than 300 mg/g creatinine) Presence or history of panel-reactive anti-Histocompatibility Antigen (HLA) antibody levels greater than background by flow cytometry. More information about this criterion is in the protocol Pregnant, breastfeeding, or unwilling to use effective contraception throughout the study and 4 months after study completion All women more than 35 years and women of any age who have first degree relatives with a history of breast carcinoma or who have other risk factors of breast carcinoma. More information about this criterion is in the study protocol
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Microalbuminuria Diabetic Nephropathy Patients with type 2 diabetes mellitus (according to World Health Organization criteria) attending the Endocrine Division's outpatient clinic at Hospital de Clínicas de Porto Alegre, Brazil. Patients were selected according to the following age <75 years, A1c <10%, 24-hour UAER 20 mcg/min and 199 mcg/min confirmed at least twice in a 6-month period, serum triglycerides <400 mg/dl and normal liver and thyroid function tests Patients were excluded from the study if they had BMI >34 kg/m2, serum creatinine >1.5 mg/dl, repeated episodes of urinary tract infection, other renal diseases, symptomatic autonomic neuropathy, heart failure, and acute myocardial infarction, coronary artery revascularization procedures or stroke within the last 6 months
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 14.0-70.0, Type 1 Diabetes Type 2 Diabetes Male and female subjects, 14-70 years of age, with type 1 and type 2 diabetes mellitus for a minimum of six (6) months Subjects must be utilizing a regimen of at least two (2)injections daily of either Novolin®, Humulin®, NovoLog®, Humalog® or Apidra® and no more than one (1) injection of Lantus® daily using a standard syringe or insulin pen Current regimen of intensified insulin therapy (defined as separate injections of basal and prandial insulin with at least three (3) insulin injections per day) for a minimum of three (3) months Body Mass Index <35 kg/m2 HbA1c ≤ 10 % If medications (other than oral anti-diabetic agents) in addition to insulin are taken at screening, the subject must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least three (3) months prior to study enrollment Subjects must be willing to provide written informed consent Use of Continuous Subcutaneous Insulin Infusion (CSII) at any time within the preceding three (3) months History or current diagnosis of chronic diseases which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study Use of short term or chronic steroids within two (2) months of entry into the study or likelihood that same might be required during the conduct of the study Use of hydrochlorthiazide at doses >25 mg daily Use of beta-blocker drugs Regular pre-prandial doses of SC insulin >30 IU per meal Intake of any drug or herbal preparation which, in the evaluation of the PI, may interfere with the interpretation of clinical study results or that is known to cause clinically relevant interference with insulin action, glucose utilization or ability to detect or recover from hypoglycemia (e.g., systemic steroids) History of known hypersensitivity to plastics or polymers Treatment with any investigational drug within two (2) months prior to enrollment or during this study Progressive fatal disease
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-95.0, Hyperglycemia Patients scheduled for non emergent surgery under either general or regional anesthesia deemed to have moderate to high physiologic stress Male and female subjects over the age of 18 with or without a diagnosis of diabetes mellitus Patients must be able to provide informed consent Cognitively impaired Non-English or Spanish speaking with no relative present who is fluent in reading and comprehending English or Spanish Female patients of child bearing age who have a positive pregnancy test on admission
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 30.0-80.0, Type 2 Diabetes Newly diagnosed type 2 diabetic patients. 2. Hospitalization due to hyperglycemia hyperosmolality syndrome. 3. Those who age between 30 and 80 years old and can inject insulin by themselves Pregnant women. 2. Impaired liver function (ALT > 120 U/L) 3. Impaired renal function (Serum creatinine >3.0 mg/dL) 4. Recently suffered from MI or CVA. 5. Patients are acute intercurrent illness. 6. 2-hour C-peptide level < 1.8 ng/mL
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Type 2 Diabetes Diagnosis of Type 2 diabetes for ≥ 3 months treated with metformin, thiazolidinedione, or sulfonylurea (either monotherapy or combination) or diet alone (drug naïve) Fasting plasma glucose: 126 mg/dL Hemoglobin A1c: 6 Estimated CrCl ≥ 60 mL/min ALT ≤ 1.5 x ULN and total bilirubin ≤ 2 x ULN Stable and well controlled hypertension and/or dyslipidemia Concomitant medications used for hypertension and/or dyslipidemia, thyroid hormone replacement therapy and low dose aspirin will be allowed if stable for at least 6 weeks Women of childbearing potential Symptomatic diabetes with polyuria and/or polydipsia History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome History of renal disease including diabetic nephropathy
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO for at least 3 months 2. Age ≥ 18 years 3. BMI ≥ 25.0 kg/m2 4. HbA1c ≥ 7.0 % 5. Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days Prior or current use of any PPAR-γ agonist 2. Recent use (< 3 months) of an investigational drug 3. Pre-existing medical condition judged to preclude safe participation in the study 4. Contraindication/intolerance to study medication 5. Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids) 6. Diagnosed or receiving medication for heart failure, NYHA I to IV 7. Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention 8. Uncontrolled treated/untreated systolic blood pressure >180 mmHg and/or diastolic blood pressure > 95 mmHg 9. Known diabetic macular oedema 10. Hematuria 11. Serum creatinine >130 μmol/l 12. ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal 13. Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay 14. Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives) 15. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation 16. Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols 17. Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-999.0, Diabetes Type 2 lists of and Patients with type 2diabetes inadequately controlled on a combination of OAD + NPH insulin for more than three months Stable OAD therapy for at least three months, according to the following specified daily dose: glibenclamide> 3, 5 mg, glipizid >5 mg, glimeperid >2mg, metformin>1000 mg, acarbose >150 mg HbA1c > 7,0% Ability to perform QoL assessment Body Mass Indes: women <30 and men <32 Exlusion Autoimmune diabetes, as defined by WHO Ongoing treatment with tiasolidindion drug Retinopathy with surgical treatment during preceding three months of study entry or requiring treatment within three months after study entry Drug abuse Hypersensitivity to insulin glagine excipients The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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0
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 10.0-16.0, Type 1 Diabetes a current hemoglobin A1c(HbA1c) of >8.0% an average HbA1c of >8.0% during the past year diagnosed with Type 1 diabetes for at least one year reside in the metro Detroit tri-county area severe mental impairment/thought disorder non-English speaking patient/parent co-morbid major medical condition such as cystic fibrosis
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 16.0-75.0, Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Patients who have been diagnosed with Type 1 or Type 2 diabetes for at least 1 year, based on the diagnostic for diabetes Patients who have smoked during the 6 months prior to screening (smoking shall be prohibited during the term of this study, as well) Patients exhibiting pulmonary function test (spirometry) abnormalities (FVC or FEV1 < 70% of predicted) ) at Week -4
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 21.0-85.0, Diabetes Mellitus, With Complications The researchers will up to 750 pts between male and female between -the ages of 21 and 85 diagnosed with diabetes mellitus Self reporting or diagnosed with significant complications resulting from diabetes Taking oral agents and/or insulin for diabetic control Under an Endocrinologist supervision for their diabetes management, Endocrinologist must assess and approve pt for participation in this study Ability to swallow without difficulty Ability to perform Respiratory Quotient requirements by breathing into a mask for 3 minutes at a time Lack of Intravenous access Pregnancy Alcohol abuse, drug addiction or the use of illegal drugs Active liver disease Active chemotherapy Positive HIV Inability to breathe into a respiratory quotient machine
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-40.0, Type 1 Diabetes Pregnancy Signed informed consent Females with Type 1 diabetes for at least 5 years Diabetes onset < 21 years Lean at diabetes onset Insulin required from diagnosis Willing to undergo intravenous arginine tolerance tests Inability to provide informed consent Any medical condition that would preclude safe conduct of the intravenous arginine A family history which includes three generations of family members with the diagnosis of diabetes mellitus Women with elevated serum creatinine as arginine is excreted by the kidneys
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1
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 18.0-70.0, Type 1 Diabetes Hypoglycemia Type 1 Diabetes Mellitus confirmed by C-peptide <0.10 nmol/L age 18 yrs HYPO score >423 normal TSH, serum cortisol and anti-transglutaminase (ATTG) current diagnosis of cancer planning a pregnancy Inability to give informed consent
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2
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The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion
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eligible ages (years): 6.0-18.0, Type 1 Diabetes Newly diagnosed type 1 diabetes within 1 week of diagnosis Age 6 years Care provided at Children's Medical Center, Dallas Actual treatment with oral drugs influencing beta cell function or blood glucose levels (e.g. oral hypoglycemic agents) Actual treatment with drugs influencing insulin sensitivity (e.g. Metformin, or systemic steroids) Significant concomitant disease likely to interfere with glucose metabolism (children with active bacterial infections at the time of diagnosis must be cured prior to entry) Expected poor compliance Pregnancy Any other condition that by the judgement of the investigator may be potentially harmful to the patients
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1
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