topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-75.0, Neurosensory Disorder Aged from 18 to 75 years old(including 18 and 75 years old), males or females; 2. First onset, clinical diagnosis of hypertensive intracerebral hemorrhage, and CT confirmed that the amount of hemorrhage is between 15ml-50ml, the bleeding site is the basal ganglia, the bleeding has not penetrated into the lateral ventricle, and non-surgical patients； 3. Those with obvious neurological dysfunction after the onset, 5≤GCS≤15 or NIHSS≥6； 4. Admission within 72 hours after the onset of the disease, and no significant enlargement of the hematoma within 24 hours after admission (hematoma enlargement ≤ 5ml)； 5. The patient/family knows and signs the informed consent form voluntarily Cerebral hemorrhage caused by cerebral aneurysm, brain tumor, brain trauma, cerebral parasitic disease, cerebrovascular malformation, abnormal blood vessel network at the base of the brain, cerebral arteritis, blood disease, metabolic disorder and other diseases confirmed by examination; 2. Patients with enlarged hematoma found within 24 hours after admission (the volume of enlarged hematoma> 5ml); 3. Patients with simple transient ischemic attack, lacunar infarction, subarachnoid hemorrhage and ischemic cerebral infarction; 4. Patients who use anticoagulant drugs for a long time; 5. Patients with platelet count <100,000, INR>1.4 at admission and abnormal blood coagulation function; 6. The measured value of homocysteine at admission is higher than 15μmol/L; 7. Patients who need surgical treatment (including ventricular drainage); 8. Patients with severe primary diseases such as cardiovascular, liver (ALT or AST>1.5 times the upper limit of normal), kidneys (BUN>1.5 times the upper limit of normal and Cr>upper limit of normal), endocrine system and hematopoietic system; 9. Those who are allergic to protein and test drugs; 10. People who are dependent on drugs or alcohol; 11. Intended pregnancy or women of childbearing age with positive pregnancy test and lactating women; 12. Participated in other clinical trials within the past 3 months; 13. Patients considered by the investigator to be inappropriate to participate in clinical trials | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Bladder Dysfunction Neurogenic Bladder Dysfunction Urinary Incontinence Urinary Bladder, Overactive Urinary Incontinence, Urge Nocturia Urinary Frequency More Than Once at Night Lower Urinary Tract Symptoms Multiple Sclerosis Urinary Bladder, Neurogenic Self-reported diagnosis of any type of Multiple Sclerosis Male or female Aged ≥18 years old Ambulatory At least one bladder storage related symptom (e.g. urinary frequency, urinary urgency, nocturia with or without incontinence) People with an indwelling urethral catheter or indwelling suprapubic catheter Urologic disease including bladder malignancy Diabetic mellitus Pregnant women or planning to be pregnant during the study time Recent pelvic related surgery <1 year Pacemaker or other metallic internal devices Urinary tract infections (UTIs) during recruitment phase | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Refractory Non-Hodgkin Lymphoma Burkitt Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Lymphoplasmacytic Lymphoma Primary Mediastinal Large B Cell Lymphoma Diffuse Large B Cell Lymphoma Small Lymphocytic Lymphoma Transformed Lymphoma Patients must have a diagnosis of relapsed or refractory B-cell NHL DLBCL, Mantle Cell, Follicular Lymphoma, Lymphoplasmacytic lymphoma, Small Lymphocytic Lymphoma, Primary Mediastinal B-Cell Lymphoma, Burkitt Lymphoma, transformed lymphoma Subjects with small lymphocytic lymphoma (SLL) must have progressed after at least 2 prior therapies and prior treatment with or intolerance of both ibrutinib and venetoclax Subjects with DLBCL, primary mediastinal B Cell lymphoma, Burkitt lymphoma and transformed lymphoma must have relapsed or failed to respond to >= 2 prior lines of multiagent chemoimmunotherapy with prior exposure to both an anti-CD20 antibody agent and an anthracycline Subjects with indolent lymphomas (follicular lymphoma and lymphoplasmacytic lymphoma) must have relapsed after or been refractory to >=2 prior lines of multi-agent chemoimmunotherapy including prior exposure to rituximab and at least 2 other chemotherapy agents For subjects with Mantle cell lymphoma, previous lines of therapy may multiagent chemotherapy including alkylating agent or anthracycline and anti CD20 antibody therapy and Bruton's tyrosine kinase (BTK) inhibitor therapy Positron Emission Tomography (PET) -positive disease according to "Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification" At least one of the following Primary refractory or early relapse (first remission < 12 months) and not eligible for stem cell transplant Autologous transplant within 6 weeks of planned CAR-T cell infusion 2. Recipient of prior CAR-T cell therapy targeting CD19 outside of this protocol 3. Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast). 4. HIV seropositivity 5. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.) 6. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements. 7. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test. 8. Patients with history of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease. 9. History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months. 10. Body weight <40 kilograms(kg) for Infusion of Investigational Product: Subjects will undergo a second evaluation of on day -2 or -1 prior to infusion of antiCD19 CAR-T cell product. This criterion will the and required for enrollment with the following exceptions and additions exceptions: 1. Hematologic function parameters will not be included as a pre-infusion criterion (because lymphodepletive chemotherapy is expected to cause pancytopenia). 2. Laboratory result abnormalities that are considered not clinically significant by the principal investigator AND are not the result of a demonstrated active infection or an active central nervous system condition additions: 1. Use of corticosteroids within 7 days prior to infusion (with exception of agents used for prevention of emesis during lymphodepletive chemotherapy). 2. Neurologic symptoms suggestive of an active central nervous system condition. 3. Signs or laboratory markers of active infection or systemic inflammatory response | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethra Stenosis Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations (Appendix B) Age ≥ 18 years Male patient Fit for operation, based on the surgeon's expert opinion Isolated bulbar urethral stricture confirmed by imaging Preputium, penile shaft skin, buccal mucosa and lingual mucosa are allowed as free graft material in the executed dorsal onlay or ventral onlay FGU Patient is able and willing to attend the follow-up consultations Absence of signed written informed consent (Appendix B) Age < 18 years Female patients Transgender patients Patients unfit for operation Concomitant urethral strictures at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) A unique urethral stricture at other urethral locations (penile urethra, membranous urethra, prostatic urethra, bladder neck) Prior bulbar urethroplasty Lichen Sclerosus related strictures Strictures after failed hypospadias repair | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 15.0-60.0, Urinary Tract Infections Age 15 to 60 years with symptomatic acute urinary tract infection Willing to participate in the study Non-pregnant adult females Clinical signs and symptoms of a UTI (e.g., dysuria, frequency, urgency to urinate, Burning sensations during urination, Hematuria, suprapubic pain) with onset of symptoms < 72 hours prior to study entry One positive pre-treatment clean-catch midstream urine culture within 48 hours of enrollment in the study, defined as > 105 CFU/mL Patients having all socioeconomic classes including lower, middle and higher In-vitro susceptibility testing of the uropathogen to test and control drug • Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control. If an antimicrobial agent is to be studied for the treatment of UTI in pregnant women, this proposal should be justified, the risk/benefit expectations explained, and the issue presented to the division Three or more episodes of acute uncomplicated UTI in the past 12 months Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder Patients with onset of symptoms 96 hours or more prior to entry Patients with a temperature > 1010 F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection Patients with known or suspected hypersensitivity to the test or control drug Patients who received treatment with other antimicrobials within 48 hours prior to entry Patient suffering in chronic illness Diabetes mellitus, chronic liver diseases | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, D007239 Site and Five-hundred patients at each participating site will be enrolled into the trial with a series of and across nine service lines including two surgeons per service line. Site All medical centers with an operating room are eligible. Surgeons performing orthopedic total joint, orthopedic spine, oncologic gynecological, thoracic, general, colorectal, open vascular, plastic, and/or open urological procedures with uniform, baseline infection control practices will be recruited (i.e. similar decolonization and dressing change practices for orthopedic spine surgeons between sites) as done previously. medical centers actively enrolling patients in a bacterial transmission or infection prevention trial will be excluded. We currently have 12 sites enrolled that have met the and with engaged surgeons. Patient all elective patients undergoing surgery with the surgeons and procedures and uniform basic practices as described above, at least one incision (including laparotomy), placement of a peripheral intravenous catheter, and acquiring informed, written consent. no requirement for anesthesia and/or placement of a peripheral intravenous catheter, lack of incision or informed, written consent, an allergy to chlorhexidine, povidone iodine or isopropyl alcohol, and ASA health classification status>5 | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Diffuse Large B-cell Lymphoma Written informed consent according to ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures Histologically confirmed, treatment-naïve DLBCL, NOS that fulfill all the following Patient eligible for 6 cycles of R-CHOP Ann Arbor stage I-IV Metabolically active measurable disease by 18FDG PET-CT No previous treatment with systemic chemotherapy or radiotherapy (a pre-phase treatment with steroids for 10 days is allowed after PET/CT and baseline liquid biopsy have been collected) At least 1 measurable site of disease according to Revised Response for Malignant Lymphoma. The site of disease must be greater than 1.5 cm in the long axis regardless of short axis measurement or greater than 1.0 cm in the short axis regardless of long axis measurement, and clearly measurable in 2 perpendicular dimensions Quantifiable and qualifiable circulating tumor DNA Patients with a prior malignancy and treated with curative intention are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and/or no late recurrence Age ≥ 18 years CNS lymphoma involvement Stage I disease that has been completely surgically excised (not measurable) Specific diagnostic categories of large B-cell lymphoma such as high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, primary central nervous system lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, intravascular large B-cell lymphoma, plasmablastic lymphoma, lymphomatoid granulomatosis, primary effusion lymphoma etc Concomitant treatment with any other experimental drug Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV; unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of asymptomatic or rate controlled atrial fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation, uncontrolled hypertension Uncontrolled systemic infection History of cerebrovascular accident or intracranial hemorrhage within 6 months prior to registration History of bleeding diathesis (eg, haemophilia, von Willebrand disease) Major surgery in the preceding 4 weeks of first dose of study drug. If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction or gastric restrictions and bariatric surgery, such as gastric bypass | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-75.0, Coronary Artery Disease Intestinal Disease Coronary heart disease verified by coronary angiography Current infection requiring intravenous antibiotics Inflammatory bowel disease Renal failure with creatinine > 200µmol/L Hepatic impairment Pregnancy Previous bariatric surgery Colostomy Active malignant disease | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 45.0-85.0, Patient Satisfaction Bladder Cancer patients with bladder cancer eligible for surgery Patients who refuse to contribute in this study patients who are unfit for surgery patients refusing cystectomy patients with metastatic or inoperable cancer bladder | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Lymphoma Nonhodgkin Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma N/A | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-99.0, Urogenital Cancer Cohort-Specific • Bladder cohort: Histopathologically confirmed carcinoma of the urothelium (T1 high grade -T4a) in the bladder with mixed or rare histological subtypes such as squamous cell or adenocarcinoma. Patients with mixed histologies are required to have a dominant non transitional cell pattern. • UTUC cohort: Histopathologically confirmed,high grade or high risk upper urinary tract urothelial carcinoma (renal pelvis and ureter). This cohort includes all patients with upper tract malignancy who in the opinion of the investigators qualify for radical surgery (nephroureterectomy or distal ureter resection). Urothelial carcinoma of the upper urinary tract qualifies as high-risk disease if any of the below factors are present Hydronephrosis Tumour size >2cm on cross sectional imaging High grade cytology High grade biopsy Multifocal disease Variant histology Previous radical cystectomy for urothelial cancer of the bladder All patients undergoing radical surgery with curative intent in the opinion of the investigator are eligible. Radical surgical interventions nephroureterectomy or distal ureteral resection. General 1. Willing and able to provide written informed consent 2. Ability to comply with the protocol 3. Age ≥ 18 years 4. Residual disease after TURBT or URS (surgical opinion, endoscopy or radiological presence). 5. Fit and planned for radical surgery with curative intent in the opinion of the investigator (according to local guidelines). 6. N0 or M0 disease CT or MRI (within 4 weeks of registration) 7. Representative formalin-fixed paraffin embedded (FFPE) tumour samples with an associated pathology report that are determined to be available and sufficient for central testing. 8. Patients who refuse neoadjuvant cisplatin-based chemotherapy or in whom neoadjuvant cisplatin-based therapy is not appropriate. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 10. Negative pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential. 11. For female patients of childbearing potential to use a highly effecting form(s) of contraception (i.e. one that results in a low failure rate [<1% per year] when used consistently and correctly) and to continue its use for 90 days after the last dose of atezolizumab. 12. Adequate hematologic and end-organ function within 4 weeks prior to the first study treatment defined by the following: 1. ANC ≥ 1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1) 2. WBC counts > 2500/μL 3. Lymphocyte count ≥ 500/μL 4. Platelet count ≥ 100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1) 5. Haemoglobin ≥ 9.0 g/dL (patients may be transfused or receive erythropoietic treatment to meet this criterion). 6. AST or ALT,and alkaline phosphatase ≤ 2.5 times the institutional upper limit of normal (ULN) (patients with known Gilbert disease who have serum bilirubin level ≤ 3 × the institutional ULN may be enrolled). 7. INR and aPTT ≤ 1.5 × the institutional ULN. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose. 8. Calculated creatinine clearance ≥ 20 mL/min (Cockcroft-Gault formula) Pregnant and lactating female patients. 2. Major surgical procedure within 4 weeks prior to enrolment or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis. 3. Previously intravenous chemotherapy for urothelial cancer. 4. Patients with prior allogeneic stem cell or solid organ transplantation. 5. Prior treatment with CD137 agonists,anti-CTLA-4,anti-programmed death-1 (PD-1),or anti-PD-L1 therapeutic antibody or pathway-targeting agents. 6. Patients must not have had oral or IV steroids for 14 days prior to study entry. The use of inhaled corticosteroids, physiologic replacement doses of glucocorticoids (i.e.,for adrenal insufficiency), and mineralocorticoids (e.g. fludrocortisone) is allowed. 7. Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to enrolment (Patients receiving prophylactic antibiotics (e.g.,for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible). 8. Administration of a live,attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live,attenuated vaccine will be required during the study. 9. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment. 10. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment. 11. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome). 12. Malignancies other than UC within 5 years prior to Cycle 1,Day 1,with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive). 13. Severe infections within 4 weeks prior to enrolment in the study including but not limited to hospitalization for complications of infection, bacteraemia,or severe pneumonia. 14. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3 months prior to enrolment, unstable arrhythmias, or unstable angina. 15. History of idiopathic pulmonary fibrosis (including pneumonitis),drug-induced pneumonitis, organizing pneumonia (i.e.,bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted). 16. Patients with uncontrolled Type 1 diabetes mellitus. Patients with Type 1 diabetes controlled on a stable insulin regimen are eligible. 17. Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. 18. Positive test for HIV 19. Patients with active tuberculosis 20. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug. 21. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or Ca > 12 mg/dL or corrected serum calcium > the institutional ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab. Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible. Patients who are receiving denosumab prior to enrollment must be willing and eligible to receive a bisphosphonate instead while on study. 22. History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. 23. Patients with a history of autoimmune-related hypothyroidism, unless on a stable dose of thyroid-replacement hormone. 24. History of severe allergic, anaphylactic,or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins 25. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma histologically confirmed diagnosis of CD20+ DLBCL primary central nervous system lymphoma "double-hit" lymphoma | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Non-Invasive Bladder Urothelial Carcinoma Non-Invasive Bladder Papillary Urothelial Carcinoma, Low Grade Non-Invasive Bladder Papillary Urothelial Carcinoma, High Grade Participant has a social security scheme Participant has signed a form of no objection to the use of the data Participant has had a transurethral resection of bladder tumor revealing non-invasive-muscle bladder tumor prior to within a maximum of 5 years from the date of diagnosis to the absence of recurrence since then Participant is seen for a follow-up cystoscopy on the day of the visit. Non-Inclusion Vulnerable persons (Article L 1121-6 of the Public Health Code) Adults subject to legal protection or unable to express their consent (Article 1121-8 of the Public Health Code) Persons with a bladder tumor other than a non-invasive bladder tumor (i.e., invasive bladder cancer) A person who has undergone bladder tumor resection or therapy with Calmette-Guerin bacilli or with Mitomycin C less than 6 weeks (42 days) prior to inclusion Participant no longer wishing to participate in the study, or in the course of the study with a refusal to use the data until exit from the study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urethral Stricture, Male men with urethral stricture above the age of eighteen were included in our trial. the length of the urethral stricture was less than 1.5 cm patient with complete urethral stricture with a suprapubic catheter in place patients whom internal urethrotomy is not applicable like multiple urethral strictures or balanitis xerotica obliterans | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Pyelonephritis Acute Suspicion of acute pyelonephritis by ED physician Suspicion of urinary tract infection by ED physician and systemic affection (e.g. fever, sepsis Unable to undergo an MRI Known allergy to US contrast If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit Admission within the last 14 days Verified COVID-19 disease within 14 days before admission Pregnant women Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days) | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Acute Pyelonephritis Suspicion of APN assessed by the receiving physician If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit Admission within the last 14 days Verified COVID-19 disease within 14 days before admission Pregnant women Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infection Bacterial Adults Diagnosis of UTI defined by at least two of the following symptoms :chills,temperature >38°C (fever), flank or pelvic pain, nausea or vomiting, dysuria, urinary frequency, or urinary urgency, costovertebral angle tenderness on physical examination Positive urine culture with ≥ 103 CFU/mL of a single strain of ESBL-E Confirmed ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems Multibacterial infection Opposition to data collection according to GDPR | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Painful Osteoarthritis of the Knee Participants must understand the nature of the study and must give signed and dated written informed consent prior to the initiation of any study procedures, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. For participants participating in the optional genetic research, a separate signed and dated optional genetic research ICF must be provided prior to collection of samples for optional genetic research that supports the Genomics Initiative. If a participant declines to participate in the genetic research, this will have no influence on the ability of a participant to participate in the study. 3. The participant should be willing and able to understand and comply with all protocol-specified restrictions and procedures and be able to use an electronic patient-reported outcome (ePRO) device as judged by the investigator. 4. The participant must be considered likely to comply with the study protocol and to have a high probability of completing the study, as judged by the investigator. 5. The participant must be willing and able to discontinue all analgesic therapy with NSAID or COX-2 inhibitors from the start of the washout period until the end of the FU period. This includes over-the-counter (OTC) pain medications and topical analgesics that contain an NSAID or COX-2 inhibitor. There are additional restrictions for medications use during the different periods of the clinical study Requires current treatment with another biologic therapeutic agent, DMARD, or other immunosuppressants 2. Previously received any form of anti-NGF, anti-TNF, or other biological DMARDs (including but not limited to golimumab, certolizumab, infliximab, adalimumab etanercept, rituximab, abatacept, tocilizumab, and tofacitinib) for 12 months prior to screening or received other immunosuppressants for 6 months prior to screening 3. Currently receiving strong opioids for any indication 4. Participation in another clinical study with an IP or device within 60 days or 5 half-lives, whichever is longer, prior to screening 5. Plasma donation within 28 days of screening or any blood donation or blood loss > 50 mL within 2 months of screening 6. Previous allogeneic bone marrow or stem cell transplant 7. Received nonleukocyte-depleted whole blood transfusion within 120 days of the genetic research sample collection, if participating in the optional genetic research 8. Involvement in the planning and/or conduct of the study | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 3.0-14.0, Acute Tonsillitis children from 3 to 14 years old children with sore throat children diagnosed with acute tonsillitis children diagnosed with acute respiratory infection (rhinitis, sinusitis, nasopharyngitis) children with the opportunity to visit the outpatient clinic children with the ability to receive inhalation therapy children from parents (or guardians) who have given written permission to conduct clinical and laboratory research children under 3 years old and over 14 years old children receiving hospital treatment children with acute respiratory tract diseases (bronchitis, pneumonia, pleurisy) children with сhronic respiratory tract diseases (bronchitis, pneumonia) children who are allergic to antibiotics children with cancer, immunological and hematological diseases children with severe psychological illnesses (schizophrenia, mental retardation, etc.) children with cancer, immunological and hematological diseases children with tuberculosis | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Acute Pyelonephritis Suspicion of APN assessed by the receiving physician at the ED If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit Admission within the last 14 days Verified COVID-19 disease within 14 days before admission Pregnant women Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Hemorrhagic Cystitis Males and females, at least 18 years Patients who provided signed written informed consent, which includes compliance with requirements listed in the consent form Patients with diagnosis of Hemorrhagic Cystitis Patients with diagnosis of bladder pain (pressure or pelvic discomfort) with at least one other urinary symptom (need to urinate right away (urgency), often (frequency), or both) Patients with Post-void residual (PVR) urine volume > 200ml Patients presently treated with intravesical treatment (replenishment therapy with glycosaminoglycans) Patients receiving HyperBaric Oxygen Therapy (HBOT) Patients with neurogenic bladder Patients treated with neuromodulation techniques within the last six months Patients undergoing or scheduled for radiation therapy, brachytherapy, chemotherapy or treatment with BCG or with Mitomycin-C Patients suffering from lower urinary infections (UTIs) Patients with unstable cardiovascular disease Patients with 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 trial, or may influence the result of the trial, or the participant's ability to participate in the trial | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Cancer, Lung Perfusion Computed Tomography Target Lesion Cancer Liver Metastatic Lung Cancer Metastatic Liver Cancer Patients suffering from primary malignant thoracic tumoral pathology or second line patients having had a therapy pause of at least 6 weeks; at least one tumoral lesion/component should have ≥15mm in diameter All patients willing to participate and to sign the informed consent All patients younger than 18-years-old Documented allergy for iodine Neutropenia (absolute White Blood Cell count ≤ 1.5 × 109/l) Thrombopenia (absolute platelet count ≤ 100 × 109/l) Renal insufficiency: serum creatinine ≥ 1.5× the upper limit of normal (ULN); 24-hours creatinine clearance ≤ 50ml/min) Serum bilirubine ≥ 1,5 x ULN, AST ≥ 2,5 x ULN, ALT ≥ 2,5x ULN Brain metastases | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 50.0-85.0, Urinary Tract Infections Female 2. Age 50 3. Have RUTIs (at least 2 UTIs within the past 6 months or 3 within the past year) - Being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy for urinary or non-urinary infections) 2. Neurogenic bladder condition 3. Using urinary catheters (including Foley catheter, intermittent catheterization, and suprapubic catheter) 4. Uncontrolled diabetes (HbA1c > 9) 5. Chronic renal failure defined as serum creatinine > 1.5 mg/dL 6. History of liver disease 7. Patients from out of town, in whom follow-up will not be possible 8. Pregnancy 9. Allergy to Hiprex 10. Inability to take Hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders 11. Non-English speakers - | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Kidney Stone Patients with planned PCNL and a preoperative CT scan Urologist obtained access and prone positioning during surgery Tract dilation performed either using balloon dilator or a single step mini-PCNL dilation Age: ≥18 years' old Stone size: 10-25mm Gender: Male and female patients Patients of all ethnic backgrounds Capable of giving informed consent Capable and willing to fulfill the requirements of the study Pre-existing indwelling nephrostomy tube or ureteral stent permitted Anticoagulated or history of coagulopathy (with the exception of daily 81 mg aspirin) Conversion to open procedure Multiple access tracts Inability to give informed consent or unable to meet requirements of the study for any reason | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-100.0, Neurogenic Bladder Post-operative Urinary Tract Infections Participants with neurogenic OAB, defined as OAB associated with a neurologic condition such as multiple sclerosis, Parkinson's disease, spinal cord injury, previous stroke, or any other neurologic condition the participant may have been told is a cause of their OAB symptoms 2. Age ≥ 18 3. Participants must be able to read, speak, and write in English 4. No contraindication to injection of Botox hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required. 5. No contraindication to oral Ciprofloxacin hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine. 6. No active antibiotic therapy for any indication at the time of Botox injection 7. Not pregnant and/or breastfeeding Botox is contraindicated in pregnancy (screen serum pregnancy test 72 hrs prior to the procedure is standard of care). 8. No active symptomatic UTI the day of the procedure wherein the participant presents the day of their Botox procedure with new or worsening urinary frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills, will be ground for from the study bladder Botox is contraindicated in patients with active symptomatic UTI Participants with idiopathic OAB 2. Age < 18 3. Patients who cannot read, speak, and write in English 4. Any contraindication to injection of Botox hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required. 5. Any contraindication to oral Ciprofloxacin hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine. 6. Active antibiotic therapy for any indication at the time of Botox injection 7. Pregnant (as indicated by pre-operative serum quantitative B-hCG for patients aged 18 to 51 without previous hysterectomy) and/or breastfeeding 8. Active symptomatic UTI the day of the procedure wherein the participant presents with new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills, will be ground for from the study | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 60.0-90.0, Recurrent Urinary Tract Infection Vaginal Atrophy Postmenopausal Disorder 90 yo Female Postmenopausal Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months) English Proficiency Unable or unwilling to use topical estrogen Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study Patient on oral estrogen therapy may be included Patient with slings, prior vaginal surgery or pessary may be included Current UTI/ Dipstick and culture positive (> trace leukocytes or nitrites) Antibiotic (vaginal or oral) use in the last 4 weeks Current sexually transmitted infection Chronic Foley catheter use or chronic ureteral stent placement Vaginal probiotic use in the last 4 weeks Patient currently using vaginal estrogen Post-void Residual Volume >150 mL or current diagnosis of urinary retention Non-evaluated hematuria (> trace on dipstick, microscopic, gross) Unable to complete study tasks or comply with follow up | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 5.0-18.0, Neurogenic Bladder Neurogenic Bowel Spina Bifida Fecal Incontinence Fecal Impaction Urinary Incontinence Between the ages, 5 to 18, and are diagnosed with neurogenic bladder Use CIC (CIC: Clean Intermittent Catheterization) daily to empty the bladder A recent history of fecal incontinence within the last 3 months More than two episodes of urinary tract infection and/ or pyuria within the last 6 months An anatomical abnormality of the bladder neck Known intractable origin of bacteriuria such as urolithiasis (kidney stone) or nonfunctional renal segment Received bladder augmentation surgery Patient without completion of toilet training Either received following treatment diagnosed according to Peristeen® product safety guideline: 1. Anorectal malformation 2. Colorectal cancer 3. Endoscopic polyp removal surgery in 3 months 4. Ischemic colitis 5. Acute inflammatory bowel disease 6. Acute intestinal diverticulum. 7. Radiotherapy to the colon 8. Long-term corticosteroid usage | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-999.0, Urinary Tract Infections Nursing Home Inclusion/ Facility is either a SNF, Long term care setting, assisted living Must be certified by Medicare and Medicaid and can either be nonprofit or for-profit freestanding facility Minimum bed size 50 (beds size= staffed beds and not occupied beds) with no more than 35% of total beds in the home dedicated to short-stay (acute care) residents OR a minimum of 60 beds dedicated for long-term stay Independent Living Facilities enrolled in NHSN LTCF and willing/able to complete UTI and CDI components and add study sponsor as NHSN user for the facility Must be enrolled into NHSN LTCF UTI and CDI component and add study sponsor as NHSN Successful completion of a 30-day training period followed by a 30-day testing period before randomization and 12 months of prospective data collection Trained staff (data capture, result interpretation etc.,) present at all times Must be willing/able to capture 100% of UTI events on each Monthly Reporting Plan for LTCF NHSN UTI and C. diff module The facility may not participate in another UTI trial during the course of the study that will affect the method of care in which the assigned testing methods in this protocol are delivered | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Inclusion/ Subject is male or female >18 years of age at date of injection Subject receiving BoNT injection for symptoms of OAB (including urgency, urinary incontinence, and detrusor overactivity) refractory to first-line therapies | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Bladder Neoplasms Patients will be enrolled in this Phase I study only if they meet all of the following Male or non-pregnant, non-breastfeeding female, age 18 years or older at date of consent Any of the following histologically confirmed non-muscle invasive urothelial carcinoma of the bladder: High-risk tumors according to EAU guidelines pT1 G3 HG tumors CIS Multiple, recurrent and large (>3cm) pTa G1-G2 LG tumors (all features must be present) Patients of the subgroup of highest risk tumours (T1G3/HG associated with concurrent bladder CIS, multiple and/or large T1G3/HG and/or recurrent T1G3/HG, T1G3/HG with CIS in the prostatic urethra, some forms of variant histology of urothelial carcinoma, lymphovascular invasion) will be only enrolled if they have already failed BCG-treatment or they cannot tolerate it and are ineligible or refuse cystectomy. In the Part II of the study a minimal expression of EpCAM in the tumor tissue may be required, based on preliminary evidence from the Part I of the study Previous therapies must be discontinued at least 2 weeks prior to administration of Catumaxomab and all treatment related toxicities must have resolved or decreased to common toxicity (CTCAE) grade 1 Patients will not be enrolled in this Phase I study if they meet any of the following The female patient is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period Low risk or intermediate risk tumors according to EAU guidelines History or signs (obstruction of upper urinary tract or cross hematuria in the ureteral orifice) of urethral or upper tract transitional cell carcinoma (TCC). Patients with T1 disease of the bladder must have no evidence of upper or lower tract disease or a more advanced stage of disease by either computed tomography (CT) urography or magnetic resonance imaging (MRI) urography of the abdomen and pelvis performed within 8 weeks before the first application of study treatment. If intravenous contrast medium for CT and MRI is contraindicated, retrograde ureteropyelography, or CT or MRI without intravenous contras tmedia may be performed Patients with hydronephrosis Any intravesicular or other chemotherapy treatment within 2 weeks or any investigational agent within 4 weeks or 5 half-lives of the agent whatever is longer prior to the initial dose of study drug History of recurrent severe urinary tract infections (UTIs) per investigator judgment Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose the patient to the development of complications from the administration of intravesical therapy A diagnosis of another malignancy within 2 years before the first dose of study treatment, except for superficial skin cancer or localized solid tumors deemed cured by surgery and not treated with systemic anticancer therapy and not expected to require anticancer therapy within the next 2 years i.e., while the patient may be taking study treatment or is in the follow up period of this study Patients with a history of cancer who have completed treatment and are free from disease since at least 5 years can be enrolled | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Intracranial Hemorrhage Patient is between 18 and 80 years of old Patients with ICH rupture into the ventricle in the primary basal ganglia region or non-aneurysmal subarachnoid hemorrhage confirmed by skull imaging examination Patient is admitted to hospital within 72 hours after onset Informed consent of the patients or their family members, and signed informed consent for CSF replacement treatment Non-spontaneous intracranial hemorrhage Time from onset to admission is longer than 72 hours The patient who needs surgical treatment Contraindication of lumbar puncture, such as: cerebral hernia, severe intracranial hypertension, puncture site inflammation, blood system diseases, etc Patient has other serious diseases, such as heart failure, kidney failure, liver failure, etc Patient or his/her relatives refuse to accept the above research plan | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 20.0-999.0, Bladder Pain Syndrome Interstitial Cystitis The subject is aged over 20 years old. 2. The subject was diagnosed as bladder pain syndrome/interstitial cystitis subject with lower urinary tract symptoms, such as frequent urination, urgent urination, bladder pain, etc The subject is aged under 20 years old. 2. Pregnant women. 3. The subject with congenital disorders of the urinary tract. 4. The subject with a urinary tract infection or tumor | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Urinary Tract Infections Catheter Infection Catheter-Related Infections Infection Patient under age of 80 years old who need prolonged urethral catheterization (more than 2 weeks) as a method of bladder drainage Patients with current or recent symptomatic urinary tract infection Antibiotic use currently or within 7 days prior to inclusion Known hypersensitivity to latex, silver salts or hydrogel Patients with recent surgical intervention in the urinary tract Patients with anatomic or functional upper urinary tract issues (e.g reflux, stones, etc.) Uncontrolled DM. Patients on corticosteroid treatment. Immunosuppressed patients. Patients received pelvic irradiation | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-90.0, Recurrent Urinary Tract Infections Diagnosed with recurrent cystitis including 2 times of rUTI within the last 6 months or 3 times in the last 12 months, where at least 2 cultures show the same bacteria Normal investigation for lower urinary tract diseases (LUTD) including voiding diary, symptom scores, flexible cystoscopy, voiding diagram and test for residual urine Failed previously treatments Patients with native bladder with both spontaneous voiding, the need for clean intermittent catheter (CIC) or indwelling catheter Patients with neurogenic and non-neurogenic bladder dysfunction Patients with urostomy, kidney transplantation or another complicated genesis Written consent Malignancy in the urinary tract, kidney-, ureteral or bladder stones, age < 18 years, pregnancy, breastfeeding. Patients in ongoing orally antibiotic treatment. Not able to speak or understand Danish | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Diffuse Large B-Cell Lymphoma Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma Patients must have histologically confirmed DLBCL, irrespective of cell-of-origin. Patients with previously diagnosed indolent lymphoma (follicular lymphoma and marginal zone lymphoma but not small lymphocytic lymphoma) who have transformed to DLBCL are eligible only if they have not previously been treated for indolent lymphoma except for local radiation for early-stage disease Patients may have received brief treatment with glucocorticoids (up to 250 mg/day prednisone or equivalent for a maximum of 10 days) and/or 1 cycle of chemotherapy such as R-CHOP (or some component[s] thereof) for the diagnosis of B-cell lymphoma provided they had staging computed tomography (CT) and/or positron emission tomography (PET)/CT scans prior to glucocorticoids and/or chemotherapy. Treatment must occur within 28 days prior to enrollment Age >= 18 years. Because no dosing or adverse event data are currently available on the use of zanubrutinib in combination with R-CHOP in patients <18 years of age, children are excluded from this study Eastern Cooperative Oncology Group (ECOG) performance status =< 2. Performance status of 3 will be accepted if the impairment is caused by DLBCL complications and improvement is expected once therapy is initiated Measurable disease (defined as >= 1.5cm in diameter) or at least one PET fludeoxyglucose F-18 (FDG) avid area of disease Patients must have adequate hematologic, hepatic, and renal function as defined below Hemoglobin >= 7.0 g/dL Absolute neutrophil count (ANC) > 1,000/mcL Platelet count > 75,000/mcL Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease) Major surgery within 4 weeks before Day 1, Cycle 1 of treatment Prior anthracycline use >= 150 mg/m^2 Known central nervous system (CNS) involvement. Patients at high risk for secondary CNS involvement but without neurologic symptoms suspected to be due to lymphoma are allowed to be enrolled and receive intrathecal chemotherapy with methotrexate, cytarabine, and/or glucocorticoids. CNS prophylaxis with IV methotrexate is NOT permitted in this study. Patients who are enrolled and subsequently identified to have pathologic confirmation of CNS involvement by lymphoma may be continued on the study at the discretion of the principal investigator Active systemic bacterial, fungal or viral infection except for localized fungal infections of skin or nails. Patients with resolving infections such as urinary tract, respiratory, or skin infections may be enrolled if clinically improving. NOTE: patients may be receiving prophylactic antiviral or antibacterial therapies at the investigator's discretion Evidence of current uncontrolled or symptomatic cardiovascular conditions, including, uncontrolled cardiac arrhythmias, history of or symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or greater), unstable angina, or myocardial infarction within the past 6 months. Poorly controlled or clinically significant atherosclerotic vascular disease including angioplasty, cardiac or vascular stenting within 6 months of enrollment History of cerebrovascular accident or transient ischemic attack within the 6 months before Day 1, Cycle 1 of treatment Any prior history of intracranial hemorrhage Known bleeding diatheses or platelet dysfunction disorders Known gastrointestinal (GI) disease or gastrointestinal procedure that will significantly interfere with the oral absorption or tolerance of zanubrutinib including the inability to swallow pills/capsules Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-80.0, Bone Metastases From Solid Tumors The subject or his/her guardian and/or impartial witness voluntarily signed the written informed consent form（ICF） Aged 18 to 80 Years old (Female or male subjects to the date of signing the informed consent form) Subjects with solid tumor confirmed by histological or cytological examination. At least one documented bone metastasis confirmed by computed tomography[CT], magnetic resonance imaging[MRI]) or pathology (bone biopsy) Eastern Cooperative Oncology Group（ECOG）performance status≤2 Adequate organ function at baseline Prior treatment with denosumab or other RANKL-targeted therapeutic drugs Subjects who previously received any bone-modifying agents (including intravenous or oral bisphosphonates, etc.) for advanced tumor disease Orthopedic surgery or bone-related radiation therapy within 1 month prior to first dose. Bone radioisotope therapy within 6 months prior to first dose, or planned radiation therapy or surgery for bone during the study Past or ongoing osteomyelitis or osteonecrosis of the jaws （ONJ）, an active dental or jaw condition requiring oral surgery, non-healed dental or oral surgery, or any planned invasive dental procedure during the study period Primary central nervous system malignancy. Subjects with central nervous system metastases who have failed local therapy. Subjects with asymptomatic brain metastases or clinically stable brain metastases who do not require steroids and other therapy for brain metastases for ≥ 28 days may be enrolled | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Sepsis Respiratory Distress Syndrome Respiratory Distress Syndrome, Adult ENTRY --Disease Characteristics-- Diagnosis of adult respiratory distress syndrome (ARDS) with sepsis ARDS characterized by: hypoxemia refractory to supplemental oxygen therapy, diffuse pulmonary infiltrates, no cardiogenic cause of pulmonary edema, and reduced pulmonary compliance Sepsis characterized by: Two or more of the following: Fever or hypothermia; Tachycardia; Tachypnea; WBC greater than 12,000/mm3 or less than 4,000/mm3 or immature neutrophils; Hypotension; Clinical suspicion of infection; Inadequate organ perfusion or organ dysfunction as demonstrated by: Acute deterioration in mental acuity (excluding sedatives or other nonsepsis causes) OR Unexplained metabolic acidosis OR Oliguria for greater than 2 hours OR Unexplained coagulopathy (elevated PT or PTT or platelet count decreased to less than 50% of baseline within 24 hours or less than 100,000/mm3) OR Acute elevation of bilirubin to greater than 2.0 mg/dL AND elevation of alkaline phosphatase, SGOT, or SGPT No sepsis with unstable BP --Prior/Concurrent Therapy-- At least 30 days since prior enrollment in investigational trial; No other concurrent enrollment in investigational trial --Patient Characteristics-- Hematopoietic: See Disease Characteristics; No uncontrolled hemorrhage (transfusion of 4 or more units required within past 24 hours); No chemotherapy induced neutropenia (granulocyte count less than 1000/mm3) Hepatic: No severe liver disease with portal hypertension Renal: No anuria (urine output less than 50 mL/day) Cardiovascular: No cardiogenic shock Neurologic: No recent stroke, head trauma, or increased intracranial pressure; No other serious neurologic disorder Other: Not pregnant; No acquired immune deficiency syndrome; No immunosuppressed transplant patients; No severe burns; No irreversible underlying condition with rapidly fatal course; No marked obesity; No recent history of diarrhea | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 55.0-999.0, Dementia Alzheimer Disease, Pain Behavior, Agitation Patients must be: 55 years old and older, nursing home residents, a diagnosed painful that would respond to tylenol, documented agitated behavior, a dementia diagnosis or a functional impairment severe enough to rate a 7 on the Global Deterioration Scale, be unable to report pain. Patients must have been residents in the nursing home for at least 1 month with a plan to stay at least 2 months | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Leukemia B-cell acute lymphoblastic leukemia Disease involving at least 30% of bone marrow or circulating blasts In first relapse with at least 1 of the following high-risk features Age under 1 year at diagnosis Age over 18 years at diagnosis t(9;22) Occurrence of first relapse less than 18 months after diagnosis In second relapse or beyond Refractory disease Successful generation of adequate CD40 ligand-activated autologous tumor cell vaccine Concurrent treatment as part of another therapeutic research protocol Pregnancy or nursing mothers Clinically significant pulmonary or cardiac disease Clinically significant autoimmune disease Documented infection that is active and/or not responding to therapy Evidence of HIV infection or known positive HIV serology Lansky performance scale (if <18yo) <60%, Karnofsky performance scale (if >18yo) >60% Once vaccination course has started: patients may not receive chemotherapy, radiotherapy, immunotherapy or immunosuppressive treatment, hematopoetic growth factors. However between tumor cell collection and vaccine administration, patients may receive non-protocol chemotherapy. ********************************************NOTE******************************************* ******** It is anticipated that there will be a number of patients at first relapse who are eligible for tumor cell collection and vaccine preparation but who are not eligible to receive the vaccination course. These patients will be evaluable for Objective 3.1.1 (feasibility of vaccine preparation). Patients at first relapse who are eligible for vaccine preparation but not administration should instead be treated with standard salvage regimens which may allogeneic bone marrow transplantation according to the judgement of their primary oncologist. However, these patients represent a population at extremely high risk for progression of their disease following salvage therapy. Many of these patients will therefore be likely to fulfill for vaccination in the future (i.e. should they relapse again, or fail to enter 2nd complete remission). The majority of those patients who relapse for a second time will do so within 1 year. Those patients who become eligible for vaccination because of 2nd relapse within 1 year of tumor cell collection will receive the original vaccine and will not have further vaccine made from tumor cells collected at the time of 2nd relapse. Given the proliferative thrust of the disease in many patients, it will be advantageous to have vaccines already prepared for these patients to reduce the amount of time from 2nd relapse to vaccination.*** | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Patients with chronic obstructive pulmonary disease | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Breast Neoplasms Signed consent Diagnosis made by core biopsy or incisional biopsy Histologic confirmation of invasive breast cancer Clinical staging as IIB (cT3N0 only), IIIA (cT3N1 or cT0-3N2), or IIIB (cT4N0-2) ECOG performance 0 or 1 At the time of entry: *Absolute neutrophil count (ANC) must be greater than or equal to 1200/mm3; *platelet count must be greater than or equal to 100,000/mm3; *hemoglobin must be greater than or equal to 10 g/dl; *serum creatinine must be less than or equal to ULN for the lab The following for evidence of adequate hepatic function must be met: *Total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (> ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and *alkaline phosphatase must be < 2.5 x ULN for the lab; and *AST must be less than or equal to 1.5 x ULN for the lab MUGA scan or echocardiogram within 3 months prior to entry if: *age greater than or equal to 60, or *history of hypertension, or *plan to receive trastuzumab. For any patient who has a MUGA scan or echocardiogram performed for any reason, the baseline LVEF must be greater than or equal to LLN for the facility performing the procedure and there must be no regional wall abnormalities Clinical stage IIB disease that is cT2N1 Definitive evidence of metastatic disease (M1 by AJCC criteria) Prior history of invasive breast cancer in either breast or ductal carcinoma in situ (DCIS) in the ipsilateral breast treated with radiation therapy (patients with a history of lobular carcinoma in situ [LCIS] are eligible) Any treatment for the currently diagnosed breast cancer prior to study entry including radiation therapy, chemotherapy, and/or hormonal therapy Pregnancy or lactation at the time of study entry Prior anthracycline or taxane-containing chemotherapy for any malignancy Nonmalignant systemic disease (cardiovascular, renal, hepatic, diabetes, etc.) that would preclude the patient from receiving study treatment or would prevent required follow-up Grade 2 or greater peripheral polyneuropathy at the time of entry Cardiac disease that would preclude the use of anthracyclines or trastuzumab. This includes: *myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; *angina pectoris that requires the use of anti-anginal medication; *any history of documented congestive heart failure; *serious cardiac arrhythmia requiring medication; *severe conduction abnormality; *valvular disease with documented cardiac function compromise; or *uncontrolled hypertension defined as blood pressure > 160/100 mm/Hg Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible if this therapy is discontinued prior to randomization.) Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 45.0-999.0, Chronic Obstructive Pulmonary Disease All patients must have a clinical diagnosis of chronic obstructive pulmonary disease according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines Patients must have a cigarette smoking history of more than 10 pack-years Patients must be clinically stable and at least 4 weeks from last acute exacerbation (and return to baseline level of symptoms) Patients must have an FEV1 of less than 80% of predicted values with FEV1 to FVC ratio of less than 0.70 (post-bronchodilator values) Men or women ≥ 45 years of age | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Tachycardia, Ventricular Ventricular Fibrillation ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease [CAD] or non-CAD in primary or secondary ICD prevention) Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF Patient's life expectancy less than 1 year due to a non-cardiac chronic disease Patient on heart transplant list which is expected in < 1 year Patient's age less than 18 years ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD) Unwillingness or inability to provide written informed consent Enrollment in, or intention to participate in, another clinical study during the course of this study Inaccessibility for follow-up at the study center Ventricular tachyarrhythmias associated with reversible causes Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients Other electrical implantable devices (neurostimulators, etc.) | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Tachycardia, Ventricular Ventricular Fibrillation CRT + ICD indications (Class I-IIA) according to the guidelines Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD Patient's life expectancy less than 1 year due to a non cardiac chronic disease Patient on heart transplant list which is expected in < 1 year Patient's age less than 18 years Replacements and upgrades Epicardial lead Mechanical tricuspid valve Ventricular Tachyarrhythmias associated with reversible causes Unwillingness or inability to provide written informed consent Enrollment in, or intention to participate in, another clinical study during the course of this study Inaccessibility for follow-up at the study center | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-60.0, Malaria, Falciparum Ages 18-60 years 2. P. falciparum parasitemia (1,000-100,000 parasites/ul). 3. Clinical syndrome consistent with malaria associated with documented fever (axillary temperature > 38℃) or self-reported history of fever in the last 48 hours with no other cause present 4. Commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine 5. An indication for hospital admission (eg relative cannot look after/supervise treatment at home but not having any warning signs or severe malaria in " " below) 6. Informed consent obtained Pregnancy or lactation 2. Mixed infection with P. falciparum and P. vivax 3. Warning signs of altered mental state and inability to sit unaided 4. Features of severe/complicated malaria 5. Diabetes 6. Systolic blood pressure (BP) < 100 mmHg 7. Serious underlying disease (cardiac, hepatic, kidney) 8. Initial iSTAT test showing any of the following values glucose < 4 mmol/L K+ ≥ 4.2 meq/L > 106 meq/L HCO3 < 20 meq/L. 9. Known allergy to L-arginine 10. Concurrent therapy with any of the following medications spironolactone oral nitrates phosphodiesterase inhibitor (eg sildenafil [Viagra]) | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 14.0-60.0, Schizophrenia Obesity Diagnosis of schizophrenia or schizoaffective disorder Body mass index (BMI) greater than 27 Stable on antipsychotic drug regimen for at least 1 month prior to study entry Parent or guardian willing to provide informed consent, if applicable Positive and negative syndrome scale score less than 90 Willing to use acceptable methods of contraception during the study Medical contraindication for participating in a weight reduction/exercise program Mental retardation Current enrollment in another weight management program Current use of weight reduction medication Unstable cardiovascular or thyroid disease Active or end-stage renal disease Psychiatric hospitalization within 1 month prior to study entry Current use of more than one anti-psychotic medication Pregnancy or breastfeeding | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Aspirin therapy Cardiac Pacemaker - | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 15.0-999.0, Tuberculosis Adults 18 years of age or older; 2. Have sputum smear positive or sputum smear negative pulmonary or extrapulmonary TB, using the standard NTP definitions for these diagnoses; 3. Have never received more that one month of anti-tuberculosis treatment in the past (that is, only new cases of TB will be included). 4. Agree to continue treatment at the clinic of diagnosis for the full eight month course of treatment. 5. Not pregnant. 6. Agree to enrol in the study Children less than 18 years of age, 2. TB patients who have previously received treatment for TB for more than one month, 3. Not willing to continue treatment at the clinic for the full course. 4. TB Patient who are currently pregnant, 5. TB patients who are not willing to enrol in the study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 55.0-999.0, Heart Failure Chronic Obstructive Lung Disease diagnosis of Chronic Heart Failure diagnosis of Chronic Obstructive Pulmonary Disease living in a nursing home inability to give informed consent involved in other studies of CHF or COPD | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Gastroesophageal Reflux Adults (> 18 years old) with mild to moderate OSA (as defined by an apnea-hypopnea index between 5 and 30) currently on no therapy. 2. GERD as documented by 24 pH probe (> 6% of the time with pH < 4). 3. Agreeable to participating in the study Those not meeting the 2. Prisoners, minors, incompetent subjects, unconscious subjects, house staff and students, pregnant women 3. Oxygen dependent, requiring supplemental oxygen during sleep, or significant hypoxia during the initial PSG (O2 sats < 85% for > 5 minutes of sleep) 4. Severe cardiac or pulmonary disease (CHF with EF < 40%, active coronary ischemia or unstable angina, uncontrolled arrythmias,COPD or other lung condition requiring supplemental oxygen or documented hypercapnia of a pCO2 > 45). 5. Neuromuscular disease with hypercapnia (pCO2 > 45) 6. Any cancer with a prognosis of < 1 year survival 7. Use of H2 blocker therapy or PPI therapy within 14 days of the initial PSG. 8. Individuals requiring routine use of sleep aids (i.e. benzodiazepines or other sedatives) 9. Individuals with active alcohol or substance abuse 10. Night shift workers or those working rotating shifts 11. Disabling sleepiness (Epworth Sleepiness Scale > 17 or history of accidents related to sleepiness) that places individual at risk for accidents. 12. Inability to complete study questionnaires 13. Allergy to lansoprazole | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-999.0, COPD -History of COPD and cigarette smoking Clinical diagnosis of asthma Chest X-ray that is diagnostic of a significant pulmonary disease other than COPD Disease of other major organ systems | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, COPD Medical diagnosis of COPD Current or prior history of cigarette smoking Medical diagnosis of asthma Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD Significant condition or disease other than COPD | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-65.0, Chronic Headache Analgesic Rebound Headache Chronic Daily Headache Headache, Intractable Adult subjects (18-65 years) with CDH by the of Silberstein and Lipton.41 i.e. on the basis of pre-randomization history suffer chronic headaches lasting more than 4 hours a day for more than 15 days a month Previously investigated to serious treatable pathology On the basis of the pre-randomization headache diary: the average pain intensity during each episode should be at least 5 /10 on the Numerical Rating Scale (NRS) on 4 days out of 7 Quality of life and function should be impaired as evidenced by a (pre-randomization) Headache Disability Index (HDI) of at least 40 History of the following Known or suspected allergy to propofol, intralipid or midazolam In emergency or life-threatening situations Those having language barriers (e.g. illiterate, not English-speaking, dysphasic) Known or suspected difficult airway or sleep apnea Severe respiratory disease Neuromuscular disease Seizure disorder Severe cardiac disease Severe gastroesophageal reflux disease | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 65.0-999.0, Respiratory Tract Infection Age 65 years of age and older current season influenza immunization available for follow-up visits willing and able to sign written informed consent HIV infection malignancy (under active observation or treatment) unstable cardiovascular diseases renal abnormalities (serum creatine >200umol/l) pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids prednisone >10mg/day, other chronic respiratory illness) acute or active chronic liver disease neurologic or psychiatric disease (progressive or currently under treatment active tuberculosis multiple sclerosis | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease and an acute exacerbation After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease Diagnosis/history of asthma Oxygen uptake (saturation) is <92% after the initial acute treatment A requirement for regular use of oxygen therapy Regular treatment with any inhaled steroid >1 000 µg/day at study entry Additional and will be evaluated by the investigator | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-60.0, HIV Associate Weight Loss HIV positive men, 18-60 years of age, with objective evidence of HIV-infection with low to low-normal testosterone levels (<400 ng/dL). In boys before the age of 18, the hormonal and body composition changes of puberty can confound the data. We will men over 60 because of age-related changes in testosterone levels and body composition, and increased risk of prostate disease Documented weight loss within the previous 6 months of between 5-15% of body weight, or an actual body mass index (BMI) at screening of between 17 and 20 (= 85-95% of the lower limit of ideal weight) An energy intake of at least 80% of the estimated requirements. On stable and potent antiretroviral therapy for at least 12 weeks, and in whom, in the opinion of the primary care provider, a change in antiretroviral therapy is unlikely in the next 4 months. Stable therapy may those not on any antiretroviral therapies and whom, in the opinion of the primary care provider, will not be starting antiretroviral therapy in the next 4 months CD4 cell count >50 /mm3, and HIV-copy number less than 10,000 copies/ml Testosterone levels <400ng/dL Able and willing to provide informed consent and comply with the protocol Concurrent severe lipodystrophy* according to the patient and the investigator, defined as "the new appearance of thin extremities due to loss of subcutaneous fat (especially the medial compartment of the thigh) along with the new appearance of prominent veins. Loss of tissue in the buccal fat pad and subgluteal region provides further evidence that thin extremities may be in large part due to loss of fat and not just muscles." History of prostatic or mammary cancer Significant diarrhea defined as 6 or more stools per day with recent change in bowel habits towards more frequent stools, especially if associated with weight loss and fever Use of any androgen, growth hormone, or other anabolic or orexigenic agents within the past 6 months Use of systemic corticosteroids, except for topical application Significant cardiac, renal, hepatic or other diseases that, in the opinion of the Investigator, may put the subject at risk if entered onto the trial or prevent successful completion of the trial AIDS defining illness (CDC HIV Classification, 1993: Clinical Category C) within the previous 3 months (except HIV wasting syndrome) Malignancy, other than Kaposi's Sarcoma localized to the skin Involvement in (vigorous) resistance exercise training programs (body building) in the past 3 months Diabetes mellitus Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological defect that would preclude measurements of muscle strength or physical function | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-50.0, Obesity Chronic Sleep Deprivation to 50 year old obese men and premenopausal women BMI between 29-55 Chronically (for more than 6 months) sleep-deprived, defined as sleeping on a regular basis less than or equal to approximately 6-1/2 hours/night by history and objective devices (wrist activity monitors and sleep logs). External comparison subjects for extension of Effectiveness Study must meet the above Diagnosed sleep disorders including Chronic insomnia Untreated sleep disordered breathing (sleep apnea at a level of severity [using standardized for measurement], or diagnosed UARS [upper airway resistance syndrome] that would impair the ability to increase sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable) Restless leg syndrome or periodic limb movement disorder Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence) Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night Narcolepsy Central apnea. Unstable weight (voluntary losses in BMI greater than 5% over the past 6 months); currently being enrolled in a weight loss program Untreated or uncontrolled diabetes Severe uncontrolled hypertension Other chronic organ disease diagnosis including COPD Chronic cardiac arrhythmia requiring treatments | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea Stroke Ischemic stroke within 7 days of planned polysomnography/sleep screening study Modified Rankin Scale score >1 If of child-bearing potential, has a negative urine or serum pregnancy test Decompensated heart failure Cardiac or respiratory arrest within the past 3 months Myocardial infarction within the past 3 months Severe pneumonia Hypertension refractory to treatment Any other unstable medical condition which is thought to interfere with participation Known preexisting OSA already on CPAP or previously failed CPAP or used CPAP Previous pneumothorax Bullous emphysema Chronic obstructive pulmonary disease (COPD), obesity-hypoventilation, or another condition warranting the use of nasal bilevel positive airway pressure instead of CPAP | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Patients admitted with will be recruited for the study. will be defined when a patient with background COPD has at least two of the major symptoms (increased dyspnoea, increased sputum purulence, increased sputum amount) or one major and one minor symptom (nasal discharge/congestion, wheeze, sore throat, cough) for at least two consecutive days patients who are ambulatory (no major joint problem and no Class III or IV angina) patients agree to join exercise programme if offered, the forced expiratory volume in 1 second (FEV1) <70% predicted normal and an age of over 40 years old Patients who have had PRP within the past 1 year will not be recruited for this study Patient who are unable or refuse to consent for the study will also be excluded | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-95.0, Obstructive Sleep Apnea Syndrome Glaucoma OSAS planned begin of a nCPAP treatment Current malignancy Oral steroids | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease Admission for chronic obstructive pulmonary disease Other severe acute or chronic diseases | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Sleep Apnea Syndrome Obese patient scheduled to undergo bariatric surgery Age less than 18 Active smoking Psychotropic medication Angiotensin-converting enzyme inhibitor or angiotensin II receptor antagonist medication Pregnancy Anesthesia or endotracheal intubation during the previous month Allergic rhinitis Upper airway or bronchopulmonary infection during the previous month Chronic cough Chronic respiratory disease | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Cancer Pregnancy Patients do not need to participate in both; however, preferentially both study parts should be performed. **************Part I: Pregnancy, delivery and maternal health************** Patients must meet the following Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy) > 18 years of age, premenopausal Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II) Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent **************Part II: Follow-up of children************** Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease 80 years stable COPD FEV1 < 60 % predicted severe chronic breathlessness (Baseline Dyspnea Index < 6) SpO2 at rest < 90% or a a sustained decrease of > 4% in arterial O2 saturation during the ergometer test, as determined by pulse oximetry a body mass index (BMI) < 19 or > 30 chronic oral steroid therapy other medical conditions which could cause or contribute to breathlessness, i.e., heart disease or other respiratory diseases other problem which could interfere with carrying out of exercise testing, i.e., neuromuscular diseases, orthopedic diseases, etc | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Sleep Apnea Syndromes Inflammation Moderate to severe OSA (as defined by an apnea-hypopnea index [AHI] score greater than 15 events per hour) Body mass index greater than 30 kg/m Baseline CRP greater than 1.0 mg/dL Predominant central sleep apnea Type 1 Diabetes Type 2 Diabetes associated with either: (a) unstable anti-diabetic therapy (anti-diabetic medication changes within past 3 months); (b) Hemoglobin A1C levels > 7%; (c) Inability to perform home blood glucose monitoring (fingerstick checks) Requires use of supplemental oxygen Acute coronary syndrome or stroke in the 3 months prior to study entry A high-risk occupation or motor vehicle driving record, as defined by a score of 10 points or higher on an occupational and driving habits questionnaire Blood pressure greater than 160/95 mm Hg (may be re-screened after blood pressure control is obtained) Active infection, cancer, or chronic inflammatory disorder Use of systemic steroids Currently on an unstable dose of statin therapy (participants taking statins must be on a stable dose for at least 8 weeks prior to study entry) | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Pulmonary Hypertension Summarized 1. 18 years of age or older 2. Current diagnosis of PH associated with an acceptable etiology as outlined in the protocol, including: PH due to the following etiologies: 1) PAH including idiopathic and familial PAH and PAH associated with collagen vascular disease, congenital systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1); 2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing, and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO Group 5). 3. Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium channel blocker, or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor therapy 4. Right heart catheterization completed prior to screening must meet pre-specified 5. Female participants of childbearing potential must have a negative serum pregnancy test and must agree to use a reliable double method of contraception until study completion and for at least four weeks following their final study visit. 6. Male participants must be informed of the potential risks of testicular tubular atrophy and infertility associated with taking ambrisentan and queried regarding his understanding of the potential risks as described in the Informed Consent Form. Summarized Participation in a previous clinical study with ambrisentan 2. Bosentan or sitaxsentan use within four weeks prior to the screening visit 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is greater than 3 times the upper limit of normal at the screening visit 4. Pulmonary function tests not meeting the following pre-specified 1) mean pulmonary arterial pressure (PAP) >= 25 mm Hg; 2) PVR > 3 mm Hg/L/min; 3) pulmonary capillary wedge pressure (PCWP) or left ventricle end diastolic pressure (LVEDP) < 15 mm Hg; 4) total lung capacity (TLC) >= 70% of predicted normal for participants without ILD or >= 60% of predicted normal in participants with ILD; forced expiratory volume in 1 second (FEV1) >= 65% of predicted normal in participants without COPD or >= 50% of predicted normal in participants with COPD 5. Contraindication to treatment with endothelin receptor antagonist (ERA) 6. History of malignancies other than basal cell carcinoma of the skin or in situ carcinoma of the cervix within the past five years 7. Female participant who is pregnant or breastfeeding | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease Exertional dyspnea Activity limitation COPD Recent exacerbation (< 4 wks) Supplemental O2 Significant cardiovascular/musculoskeletal abnormalities | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 21.0-85.0, Sleep Critical Illness Patients requiring mechanical ventilation with a diagnosis of Acute Respiratory Distress Syndrome Cardiogenic Pulmonary Edema Pneumonia Chronic obstructive pulmonary disease Patients who are considered too unstable to undergo this investigation by their primary physician Comatose patients, or patients with severe debilitating neurological disease Renal insufficiency (Sr. Creatinine > 2 mg/dL) Heart block (second or third degree heart block) or sinus bradycardia (heart rate < 60 beats per minute) Pregnancy | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Total Knee Arthroplasty undergoing primary, unilateral knee replacement 2. age 18 years 3. postoperative analgesic plan includes perineural local anesthetic infusion and 4. the availability of a "caretaker" who will remain with the patient from home discharge until catheter removal morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2) 2. renal insufficiency (preoperative creatinine > 1.5 mg/dL) 3. chronic opioid use (use within the 2 weeks prior to surgery and duration of use > 4 weeks) 4. history of opioid abuse and 5. any comorbidity which results in moderate or severe functional limitation | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 2.0-16.0, Obstructive Sleep Apnea Males or females aged 2 to 16 years. 2. OSAS diagnosed on polysomnography. 3. Positive airway pressure therapy indicated by patient's physician because surgery was either contraindicated or ineffective. 4. No plans for upper airway surgery in the next 3 months Age less than 2 years, as infants and toddlers have different pulmonary mechanics from older children, and may require intense behavioral modification programs prior to CPAP use. 2. Age greater or equal to 16 years, as results may be similar to adult studies in these older patients. 3. Previous use of CPAP / bilevel ventilation. 4. Unable to read / understand English. - | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Acromegaly Growth Hormone Deficiency for acromegaly Clinical and biochemical diagnosis of acromegaly. Thyroid and glucocorticoid replacement if necessary stable for at least 4 weeks before the study. Gonadotrophin status will be recorded and whenever possible patients will be studied in the same status Males and females aged 18-70 years willing to give informed consent At least 6 months after the onset of symptoms of acromegaly and on stable medication for heart failure treatment (if any) for at least 4 weeks prior to into the study Systolic blood pressure < 180 mmHg, diastolic blood pressure < 110 mmHg. for GHD Clinical and biochemical diagnosis of GHD. All hormones replaced (if clinically necessary) except GH. Thyroid and glucocorticoid replacement if necessary stable for at least 4 weeks before the study. Gonadotrophin status will be recorded and whenever possible patients will be studied in the same status Males and females aged 18-70 years willing to give informed consent At least 6 months after the onset of symptoms of acromegaly and on stable medication for heart failure treatment (if any) for at least 4 weeks prior to into the study Systolic blood pressure < 180 mmHg, diastolic blood pressure < 110 mmHg for acromegaly Change in medication in the preceding 4 weeks Patients on subcutaneous insulin therapy Hyperthyroidism Not being in sinus rhythm Unstable angina pectoris and decompensated heart failure (define as NYHA 3-4) Clinically significant valvular disease, clinically significant chronic obstructive pulmonary disease History of myocardial infarction or stroke within the last 6 months, major cardiac surgery within the last 6 months Significant history of drug or alcohol abuse or unable to give informed consent | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 2.0-10.0, Obstructive Sleep Apnea ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and without adenoidectomy diagnosis of anxiety disorder or chronic pain syndrome chronic disabilities or developmental delays are currently on psychotherapeutic or sedating medication are on chronic pain medication or opiate any known adverse effect to the study drug any known cardiac abnormalities | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-75.0, Breast Cancer Obesity Weight Changes At increased risk for developing breast cancer due to any of the following lifestyle risk factors Lack of physical activity Excess weight Obesity Weight gain over lifetime Body mass index > 25.0 Physically able to undertake a moderate exercise or calorie reduction program No history of invasive or in situ breast cancer Postmenopausal, defined by the absence of periods for the past 12 months Able to attend study clinic visits and classes, and undergo study measurements | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-999.0, Osteoporosis Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/ apply. All must be answered "yes" for a subject to be enrolled in the trial. 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject female and at or above the age of 50? 3. Has the subject been postmenopausal for more than 5 years in the judgement of the investigator? 4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia? 6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for evaluation? [*] 7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper? [*] Note that no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also and note [**] All must be answered "no" for a subject to be enrolled in the trial. Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: 5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted. 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? according to the investigator's opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**] 17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**] 18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**] 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**] 20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**] 21. have severe impaired liver function ? [**] 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? according to the investigator's opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed. [**] no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Delirium Agitation Ventilator Weaning Respiration, Artificial Intensive Care Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible Patients who could not be extubated even if delirium or agitation were corrected. This will Patients receiving high dose opioid analgesia (>20 m/morphine/day) Patients shortly to return to the operating theatre Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity) Known allergy to haloperidol or alpha2 agonists | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Lung Cancer Precancerous Condition Meets 1 of the following Current smoker, defined as ≥ a 20 pack year smoking history and/or 20 year duration of smoking Ex-smoker who has quit smoking within the past 8 years AND has ≥ a 20 pack year smoking history and/or 20 year duration of smoking Mild to moderate chronic obstructive pulmonary disease (COPD) as defined by the GOLD Mild COPD: FEV_1/forced vital capacity (FVC) < 70%; FEV_1 ≥ 80% of predicted* Moderate COPD: FEV_1/FVC < 70%; FEV_1 50-80% of predicted* NOTE: *Spirometric values will be obtained post bronchodilator according to the recommendations in the GOLD Inadequate lung function (FEV_1 < 50% of predicted after bronchodilator) Life expectancy must be at least 5 years History of malignant disease within the past 5 years except non-melanomatous skin cancers Other serious co-morbidity Evidence of severe or uncontrolled systemic diseases that, in the view of the investigator, makes it undesirable for the patient to participate in this trial Any disorder making reliable informed consent impossible Unlikely to co-operate with a 5 year follow-up PRIOR Patients may receive all concurrent therapy deemed to provide adequate care as decided by their medical doctors | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Type 2 Diabetes Mellitus Diagnosed with type 2 diabetes Treated with metformin and/or a thiazolidinedione HbA1c between 6.5% and 9.5%, inclusive Body Mass Index (BMI) > 25 kg/m^2 and < 40 kg/m^2 Have previously received exenatide or glucagon-like peptide-1 analogs Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry Receiving beta blockers Receiving treatment with a drug directly affecting gastrointestinal motility, including but not limited to Reglan® (metoclopramide), Propulsid® (cisapride), and chronic macrolide antibiotics Have received treatment with systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route within 6 weeks of screening, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption or bronchodilators Have been treated with drugs that promote weight loss (for example, Adipex® [phentermine], Acomplia® [rimonabant], Xenical® [orlistat], Meridia® [sibutramine], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening: *Insulin; *Alpha-glucosidase inhibitors (for example, Glyset® [miglitol] or Precose® [acarbose]); *Meglitinides (for example, Prandin® [repaglinide] or Starlix® [nateglinide]); *Sulfonylureas (for example, Glucotrol® [glipizide] or Micronase® [glyburide]); *Dipeptidyl peptidase IV (DPP-IV) inhibitors (for example, Januvia™ [sitagliptin]) Have donated blood within 60 days of screening | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Coronary Artery Disease Obstructive Sleep Apnea Patients with angiographically-verified CAD who have newly undergone PCI or CABG treatment Written, informed study consent OSA (AHI>=15 per hour) or non-OSA (AHI<5 per hour) diagnosis on the unattended sleep recording at home Patients with already treated OSAS Patients presenting mainly central apneas (Cheynes-Stokes breathing) Patients with borderline OSA (AHI <15 and >=5 per hour) upon the unattended sleep recording at home | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease Adult males or females with a diagnosis of COPD screened for nocturnal desaturation as indicated above Clinical stability defined by absence of treatment change or need for acute care within the last two months Weight stable, within 5%, in the previous three months as measured during office visits Willingness to participate in a clinical study Acute illness within the preceding 2 months Patients who received systemic glucocorticoid therapy within the past month Clinical and/or overnight pulse oximetry evidence of obstructive sleep apnea (OSA). The Multivariate Apnea Prediction Questionnaire (MAP) will be given to all patients to assess the likelihood of OSA based on common symptoms of this disorder. While we recognize that this screening instrument was not evaluated specifically in COPD patients, it assesses common signs and symptoms of OSA. This tool has been shown to identify OSA with 95% sensitivity (63). In addition, the ODI 4% will be determined from the overnight pulse oximetry recording. Patients will be excluded if the MAP score is > 0.4 or if the ODI 4% is >15/hour, which is suggestive of the concomitant presence of obstructive sleep apnea Hypercapnia defined as PaCO2 > 50 mmHg on resting arterial blood gas Previous diagnosis of erythrocytosis, pulmonary vascular disease, pleural effusions, ischemic heart disease or congestive heart failure No chronic illnesses known to affect the inflammatory response such as infection, collagen vascular disease, liver disease, thyroid disease or diabetes Primary care or pulmonary physician refusal Patient refusal for any reason Lack of capacity to participate in the informed consent process | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-90.0, COPD All patients admitted to King's College Hospital with a clinical diagnosis of acute exacerbation of COPD. Patients with radiological and microbiological evidence of pneumonia with co-existing COPD will also be included Significant co-morbidity that could limit exercise training & testing: Patients unable to walk due to a comorbid neuromuscular or rheumatological condition; patients with severe sensory and cognitive impairment; patients with unstable angina or aortic valve disease in which exercise could be dangerous Attendance at a pulmonary rehabilitation programme in the preceding year | 2 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 45.0-70.0, COPD Age 45-70 yrs of age, incl, women as described above as far as child-bearing potential and subjects who if they have coexisting disease, the disease is stable and does not place an untoward risk or result in compromise of data Non smokers will be lifelong and have not worked in a chronic dusty environment Smokers will require a minimum of 10 pkyr history and currently smoking at least a pack per day. The smokers without symptoms of COPD must demonstrate a pulmonary function with an FEV1 > 80%. The FEV1/FVC ratio may be less than .7 however they can not demonstrate symptoms of chronic bronchitis by medical history. Smokers with symptoms must demonstrate an FEV1 < 80% and FEV1/FVC <.7 Any female subject who is pregnant or breast-feeding or a female subject who is of child-bearing potential who is unwilling to sue two acceptable methods of birth control Any condition that would place the subject at risk for endobronchial brushings(such as bleeding diathesis) or subjects who are currently taking anticoagulants Any subject who has had an exacerbation of COPD within the last six months of screening or who has been hospitalized for any reason within the last three months Illicit substances indicated by positive urine drug screen | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-90.0, Osteoporosis 18 years old or greater 2. agree to at least one bone biopsy 3. agree to BMD, blood and urine tests 4. receiving at least 10 mg/day of prednisone for at least three months 5. either be a candidate for alendronate or be taking alendronate (70 mg/week for at least three months) any metabolic bone disorder such as Paget's disease, renal osteodystrophy, parathyroid disease or osteomalacia 2. obesity enough to make a biopsy difficult 3. concurrent use of any tetracycline 4. hypercalcemia 5. kidney stones in the last two years 6. home O2 7. gastric surgery, stapling or bypass 8. inflammatory bowel disease 9. untreated thyroid disease 10. organ transplants 11. malabsorption 12. anticoagulation 13. current infection 14. serious illness 15. allergy to Demerol, Valium, iodine, tetracycline, tape 16. use of anticonvulsant drugs, heparin, Forteo, calcitonin or high-dose fluoride within the past six months | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-80.0, Restless Legs Syndrome Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist . 2. Patients must report some degree of pain which occurs on a regular basis. 3. Age 18 years to 80 years. 4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study. 5. Stable doses of all medications for 30 days prior to study entry and for the duration of the study. 6. Willing and able to provide informed consent. 7. Willing to comply with protocol. - Any illness that in the investigator's opinion preclude participation in this study. 2. Pregnancy or lactation. 3. Concurrent participation in another clinical study. 4. Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline). 5. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24). 6. Legal incapacity or limited legal capacity. 7. Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP. 8. Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34). 9. Presence of severe daytime sleepiness. 10. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities. 11. Patients taking dopamine agonists for any condition other than RLS. - | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Males or females at least 18 years old. 2. Patient has not been previously enrolled in the genebank registry. 3. Patient able to give informed consent. 4. Patient to undergo cardiac catheterization or had a left heart cath at The Cleveland Clinic or at The University of North Carolina at Chapel Hill, or at MetroHealth Medical Center within 1 year. 5. Patients > or = to 50 y/o with normal cardiac catheterizations (< 30% in all coronary vessels per angio). (If subjects enrolled as normal controls are later deemed to have significant CAD, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 6. Any patient with history of myocardial infarction. (If a subject reports history of MI at another facility, outside records will be obtained to confirm the diagnosis. If MI cannot be confirmed by data in the record, the subject's blood and data will still be useful in the Genebank under the broader scope of the study). 7. Non-caucasian patients or of Hispanic Ethnicity (UNC and MetroHealth Medical; Center only). 8. All Patients undergoing Cardiac CT or had Cardiac CT within 1 year (CCF only). (Cleveland Clinic will follow 1-7, 9, UNC and MetroHealth Medical Center will follow criteria1-8). 9. Any patients coming to the Heart and Vascular Institute for outpatient scheduled appointments. 10. Any patients that have had or are going to have an implanted cardioverter defibrillator (ICD) or Cardiac Resynchronization Defibrillator (CRT-D). 11. Any patients with cardiac arrhythmias or a family history of cardiac arrhythmias None except as noted in the | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer Brain Metastasis Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded 2. Extracerebral lesions show stable disease after first line chemotherapy. Patient has recovered from CTCAE grade 3/4 toxicity. Patients who had never received EGFR-TKI or EGFR monoclonal antibody. 3. Patients must be at least 18 years. 4. ECOG Performance Status 0, 1 or 2. 5. Life expectancy of at least 12 weeks. 6. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI. 7. Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. 8. Total bilirubin £ 1.5 x upper limit of normal (ULN) 9. ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. 10. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).11. PT-INR/PTT < 1.2 x ULN. 12. Written informed consent.13. Able to comply with study and follow-up procedures Mixed small cell and non-small cell lung cancer histology. 2. Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy. 3. Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry. 4. Other concurrent anticancer therapy. 5. Patients with exposure to investigational drug therapy outside of this trial. 6. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. 7. Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication). 8. Significant cardiovascular event: congestive heart failure >NYHA class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrhythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension. 9. Brain metastases or spinal cord compression, if treated before the start of study treatment, and have any symptoms. Symptoms signs of increased intracranial pressure ,headache,nausea and vomiting,cognitive or affective disturbances,seizures,and focal neurologic symptoms. 10. History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis & T1]. 11. Pregnant or breast-feeding women. 12. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 13. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, COPD Pulmonary Hypertension Diagnosis of COPD Prior admittance to hospital with exacerbation in COPD Informed consent Exacerbation in COPD less than 6 weeks before examination | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 25.0-75.0, Heart Failure previous history of symptomatic heart failure caused by left ventricular systolic dysfunction inspiratory muscle weakness (PImax < 70% of the predicted) clinical stability, including no change in medications for the past three months unstable angina myocardial infarction, or cardiac surgery within the previous three months chronic metabolic, orthopedic, or infectious diseases treatments with steroids, hormones, or cancer chemotherapy history of exercise-induced asthma, chronic obstructive pulmonary disease smokers | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Central Alveolar Hypoventilation Syndrome Members of familiar congenital central hypoventilation syndrome Refuse to participate study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-80.0, Lung Diseases, Obstructive Chronic Heart Failure Chronic Hypoxemia Age 40 > 80 years Confirmed COPD (GOLD criteria) Moderate and stable hypoxemia (55< PaO2 <65 mmHg) Clinical signs of CHF (ESC criteria) Ex-smokers (> 20 pack/years) since at least 3 months Clinical instability and/or exacerbation Congenital heart diseases Lung cancer Thoracic restrictive disorders Other coexisting diseases influencing 3-yr survival | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-999.0, Alzheimer's Disease Male or female subjects with a clinical diagnosis of probable Alzheimer's disease The subject has an MMSE score at screening of 12 to 26 for Part A and 16-26 for Part B Age ≥ 50 and above If female, the subject must be post-menopausal (i.e. 12 months without menstrual period) or surgically sterile Male subjects must be willing to abstain from sexual intercourse with pregnant or lactating women; or be willing to use a condom/spermicide in addition to having their female partner use another form of contraception if the woman could become pregnant, from the time of the first dose of GSK239512 until 84 days following completion of the study The subject has the ability to comply with the study procedures The subject has a permanent caregiver and is willing to attend all study visits for Parts A and B The subject has provided full written informed consent prior to the performance of any protocol specific procedure, or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative The caregiver has provided his / her written consent prior to the performance of any protocol specific procedure In the opinion of the investigator, following review of CT/MRI scans in the past 12 months and completion of neurological review there could be other probable causes of dementia History of significant psychiatric illness such as schizophrenia or bipolar affective disorder that in the opinion of the Investigator would interfere with participation in the study, or current depression (a score of ≥8 on the Cornell Scale for Depression in Dementia), or subjects with other psychiatric features in their AD which would in the opinion of the investigator, would increase risk to safety History of significant sleep disturbance, for example, when it is associated with nocturnal wandering, nocturnal confusion / disorientation / agitation, which in the opinion of the investigator, may increase safety risk History or presence of known or suspected seizures, unexplained significant loss of consciousness within last 6 months. Subjects who had febrile seizures in childhood may be included if these ceased by age 10 and they have had no other type of seizure in their medical history and have not been on anti-epileptic medications History or presence of significant cardiovascular, gastro-intestinal, hepatic, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs, or any other clinically relevant abnormality, medical or psychiatric condition, which, in the opinion of the Investigator, makes the subject unsuitable for in the study History of alcohol or other substance abuse, according to the Diagnostic and Statistical Manual of Mental Disorders Substance related disorders (DSM-IV) criteria Clinically significant abnormalities in laboratory tests, including subjects with active liver disease or uncontrolled thyroid disease Uncontrolled hypertension with systolic BP ≥160 and/or diastolic ≥95 mmHg. Subjects with controlled hypertension with systolic BP < 160 mmHg and diastolic <95 mmHg for at least 4 weeks are acceptable Systolic BP <100 mmHg and/or diastolic <60 mmHg | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Cardiac failure Renal failure Liver failure Diabetes mellitus Systemic inflammatory diseases eg Rheumatoid arthritis, SLE Warfarin, coagulation problems | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 2.0-99.0, WAGR Syndrome Wilm's Tumor Aniridia Urogenital Abnormalities Mental Retardation For WAGR/11p deletion subjects: 1. Diagnosis of WAGR/11p deletion confirmed by prior genetic testing or clinical history consistent with WAGR syndrome (Wilms Tumor and/or genitourinary anomalies plus aniridia). Genetic diagnosis will be confirmed at the NIH, if not done previously 2. Age greater than or equal to 2 years old (Subjects age 2-6y will only have an outpatient evaluation, one 60 mL (or 5 mL/kg if weight <12 kg) blood draw, eye examination, and cognitive, behavioral, and psychiatric assessment performed; subjects age 6y and older will participate in full protocol) 3. Medically stable (so that the patient can safely undergo planned testing); if history of Wilms tumor, must be >6 months since completion of chemotherapy and must be considered in remission by primary oncologist caring for the patient For parents of WAGR/11p deletion subjects: a)Biological parent of child with WAGR/11p deletion able to give consent for self participation For healthy control subjects: 1. Age greater than or eqaul to 2 years old (Subjects age 2-6y will only have an outpatient evaluation, one 60 mL (or 5 mL/kg if weight <12 kg) blood draw, and cognitive, behavioral, and psychiatric assessment performed; subjects age 6y and older will participate in full protocol) 2. No chronic medications. Use of as-needed and over-the-counter medications will be reviewed on a case-by-case basis by the Principal Investigator 3. No chronic medical or psychiatric conditions anticipated to affect results or impede study participation For aniridia subjects: 1. Diagnosis of aniridia confirmed by ophthalmologist 2. Age greater than or eqaul to 2 years old (Subjects age 2-6y will only have an outpatient evaluation, one 60 mL (or 5 mL/kg if weight <12 kg) blood draw, eye examination, and cognitive, behavioral, and psychiatric assessment performed; subjects age 6y and older will participate in full protocol) 3. Medically stable, with no chronic medical or psychiatric conditions anticipated to affect results or impede study participation For WAGR/11p deletion subjects: 1. Anorexiant use in preceding 6 months 2. Greater than 2% body weight loss in preceding 6 months 3. Pregnancy 4. Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study For parents of WAGR/11p deletion subjects: a) No exclusions other than lack of ability to give consent for participation For healthy control subjects: 1. Anorexiant use in preceding 6 months 2. Greater than 2% body weight loss in preceding 6 months 3. Pregnancy 4. Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study For aniridia subjects: 1. Anorexiant use in preceding 6 months 2. Greater than 2% body weight loss in preceding 6 months 3. Pregnancy 4. Individuals who have, or whose parent or guardians have, current substance abuse or a psychiatric disorder or other condition which, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Ventricular Fibrillation Tachycardia, Ventricular Ventricular Flutter ICD Patient Population Indication for 1-/2 chamber ICD implantation, including replacement indication Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent ICD Patient Population Patients with contraindication to ICD implantation Patients with indication for cardiac resynchronization (CRT) Minors and pregnant women Patients participating in another study CRT-D Patient Population Patients with indication for de novo CRT-D implantation according to current guidelines Patient is willing and able to comply with the clinical investigation plan and has provided written informed consent CRT-D Patient Population Patients who had a cardiac device implanted before (upgrade, device replacement) Life expectancy less than 12 months Planned heart transplantation NYHA IV | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-90.0, Latent Autoimmune Diabetes in Adults LADA Male, non-fertile female (i.e., post menopausal, post hysterectomy, or sterilized by tubal ligation) or female of childbearing potential using a medically approved birth control method. 2. The patient has a diagnosis of diabetes mellitus according to WHO classification. 3. The patient has a positive GAD antibody test of 101 WHO units or more on two separate occasions. 4. Age 18 + 5. The patient did not start on insulin within 1 month of diagnosis 6. Written informed consent to participate in the study. 7. Ability to comply with all study requirements Pregnant or breast-feeding females and females who plan pregnancy or breast-feeding during the course of the study. 2. A history of: Diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly. Acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months 3. Acute infections, which may affect blood glucose control within 4 weeks prior to visit 1. 4. Malignancy including leukaemia and lymphoma (not including basal cell skin cancer) within the last 5 years. 5. The patient has a known immune deficiency from any disease, or a condition associated with an immune deficiency. 6. The patient is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy, or any medication that, in the opinion of the site investigator, might interfere with the study. 7. Any of the following significant laboratory abnormalities Patients with severe renal failure as defined previous renal transplant or currently having renal dialysis or GFR <30 Clinically significant laboratory abnormalities, confirmed by repeat measurement, that may interfere with the assessment of safety and/or efficacy of the study drug, other than hyperglycemia and glycosuria at visit 1 Severe ketonuria (+++ on urine sticks testing; ++ on repeated urine sticks testing). 8. The patient is a known or suspected drug abuser. 9. The patient has chronic hepatitis or liver cirrhosis, or any other chronic liver disease. 10. The patient is known to test positive for hepatitis B antigens or hepatitis C antibodies 11. The patient is known to test positive for HIV antibodies. 12. The patient has any significant diseases or conditions, including psychiatric disorders and substance abuse that, in the opinion of the site investigator, are likely to affect the patient's response to treatment or their ability to complete the study. 13. The patient has chronic haematological disease. 14. The patient has had a severe blood loss (>400 mL, e.g., blood donation) within 2 months before the first dosing of the study medication. 15. The patient has known proliferative retinopathy. 16. Patient has had stage 3-4 heart failure. 17. The patient is participating in another research study which may affect the results of this trial | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 35.0-999.0, COPD Exacerbation Both inpatients and outpatients with acute COPD exacerbation will be selected for randomization. Patients will be considered to fulfill the diagnosis of if they meet the following 5 1. Patients must have had a previous diagnosis of chronic bronchitis, emphysema or COPD established by a physician. 2. Patients must have evidence of airflow obstruction on presentation, defined as an forced expiratory volume at one second (FEV1) equal to or less than 70% of predicted and a FEV1 / forced vital capacity (FVC) ratio less 70%. 3. Patients must be > 35 years old. 4. Patients must have a minimum history of 10 pack years smoking. 5. Patients must be experiencing an acute exacerbation of COPD and must meet at least two of the following three clinical for acute COPD exacerbation as defined by Anthonisen increased chronic baseline dyspnea increased sputum volume or increased sputum purulence The above complaints had to have necessitated the emergency department or physician visit Respiratory failure necessitating admission to an intensive care unit or necessitating use of mechanical invasive or non-invasive (BIPAP) mechanical ventilation. 2. Physician diagnosed asthma. 3. Any patient who has used oral or injectable corticosteroids during the month preceding trial entry will be excluded,except for patients who have received a single dose of oral or injectable steroids (up to the equivalent of 125 mg of methylprednisolone) in the emergency department prior to randomization. (Note that standard clinical practice in emergency departments is to treat these patients with oral or intravenous steroids on presentation to the ED. Since it will be functionally impossible to randomize patients prior to initial ED treatment we will allow randomization of patients who have been given a single dose of steroid in the ED). 4. History of chronic lung disease other than COPD. Patients with a history of bronchiectasis, cystic fibrosis, lung cancer and interstitial lung disease. 5. Pneumonia or congestive heart failure or suspected malignancy on chest x-ray (CXR) prior to randomization. 6. Patients with a history of infection, or suspected current infection, with mycobacteria tuberculosis, non-tuberculous mycobacteria, or fungal infection. 7. Patients not able to perform an FEV1 assessment. 8. Patients with known adverse reaction or intolerance to systemic steroids or TNF-alpha antagonists. 9. Patients with a history of multiple sclerosis or demyelinating disease (etanercept is contraindicated in these patients). 10. Inability to provide informed consent or comply with the study protocol due to cognitive impairment, language barrier, or distance > 100 kilometres from the study centre. 11. Patients with a history of HIV or other immuno-compromising diseases. 12. Patients with a known malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that was treated with no evidence of recurrence). 13. Patients who have serum white blood cell count (WBC) < 3,000 or platelet count < 100,000 at time of randomization. 14. Patients who are pregnant or nursing will be excluded. Females of child-bearing age will be required to have a negative serum or urine pregnancy test before randomization. 15. Patients with suspected sepsis ie. those with temperature > 38.5 degrees or serum WBC> 20 000 will be excluded. 16. Patients who have a history or active infection with viral Hepatitis B or Hepatitis C | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Cramps Amyotrophic Lateral Sclerosis Patients must be at least 18 years of age and have full legal capacity Patients must voluntarily give written informed consent Patients diagnosed with possible, probable laboratory supported, probable or definite ALS according to the revised El Escorial (Brooks 2000) Patients must score severity of cramps on the VAS 5 or more Patients must be able to communicate and report adverse events by phone Patients must have laboratory parameters within the following limits: Creatinine, Bilirubin,Transaminases less than 3x upper limit of normal Patients may take any medication for the treatment of ALS (ALS -specific and -symptomatic) but may not change this medication during the study period Patients must not have cannabis or cannabinoids for at least one month prior to the study and agree not to use it at all during the study. They have to have a negative urinary test for cannabinoids at baseline Pre-menopausal females must provide negative pregnancy test within fourteen days before beginning of study participation and have to apply adequate (barrier) birth-control methods Patients must agree not to drive a vehicle or use dangerous machines during the entire study period Patients who are not willing or able to sign the consent form. Doubt of investigator concerning compliance of the patient Patients who have a history of failure to respond to, or had significant adverse effects from or hypersensitivity to THC or any cannabinoid Patients who have significant concomitant illness(-es), or acute, uncontrolled infections, which might make evaluation of treatment and side effects difficult Patients with a history of significant psychiatric disorder, explicitly of schizophrenia Patients who are current drug abusers, including alcohol abusers Patients with severe coronary artery disease or hemodynamically relevant ECG-documented arrhythmia Pregnancy or breast feeding | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-75.0, Cachexia Chronic Obstructive Pulmonary Disease Chronic Heart Failure diagnosis of CHF or COPD current body weight less than 6 months ago BMI >=20 and <=30 kg/m2 CHF: LVEF >=45% measured within the past 6 months symptom status equivalent to NYHA class II to IV biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP on standard therapy of CHF including ACE inhibitors and beta blockers COPD: symptom status equivalent to GOLD standard class II to IV FEV1 < 80% FEV1/FEV < 70% significant oedema in the time of screening and randomisation concomitant inflammatory diseases active infections including HIV and AIDS liver failure chronic renal failure (sCr>1.5mg/dL) or cardiac pacemaker acute or chronic infections insulin treated diabetes mellitus patient with established diagnosis of cachexia life expectancy of less than 6 months in the opinion of the investigator medications that impair sex hormone synthesis, secretion or function | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 18.0-999.0, Thyroid Function Obesity Patients who underwent bariatric surgery between 1998 and 2007 age >18 years | 0 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 40.0-75.0, Chronic Obstructive Pulmonary Disease COPD patients on necessity of long-term oxygen therapy Patients treated by LTOT, with or without clinically fulfilled for LTOT, with PaO2<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56% Patient clinically stable Patient with oxygen device of network Oral and written consent Patient with obstructive sleep apnea or overlap syndrome Patient with non invasive ventilation Patient with evolutive cancer Inability to complete questionnaires Inability to attend outpatient clinic | 1 |
70 y/o with COPD on 2.5-3.5L O2 at baseline, OSA and obesity hypoventilation syndrome, dCHF, discharged [**2132-8-24**] now presents with agitation and altered mental status with hypoxia and O2 sats 70s on BipAp with 5L. Pt agitated then somnolent at initial presentation. Daughter reported increased agitation and altered mental status x 2-3 days with O2 sats 60s-70s at home. Daughter has also noted increased LE edema and weight gain which prompted a phone call to her PCP and increased lasix dose from 80daily to 100mg daily with some mild improvement in edema. She has had decreased appetite, PO intake, energy level at home with difficulty with ADLs. No recent history of fever, cough, chills, sputum production, CP, abd pain, or other complaints other than chronic right thigh pain last 1-2 months. Daughter also reports med compliance and compliance with BiPap at night. Past Medical History: - CAD; s/p 4 vessel CABG in [**2119**] - CHF; EF 55%, mild AS - obesity hypoventilation syndrome - obstructive sleep apnea - DM2 - ventricular tachycardia; s/p ICD in [**2127**] - hypothyroidism - schizophrenia - COPD - Pneumona treated in [**4-7**] at [**Hospital1 **] | eligible ages (years): 50.0-999.0, Alzheimer's Disease adult patients, >/=50 years of age probable Alzheimer's disease MMSE score at screening of 13-22 under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for >=4 months prior to baseline not requiring nursing home care, but looked after by a caregiver/carer dementia due to condition other than Alzheimer's disease other significant neurological disorder untreated/non-stabilized major depressive disorder bipolar disorder, schizophrenia, or any other serious psychiatric condition | 0 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.