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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 50.0-100.0, Alzheimer Disease Subject is between the ages of 50 Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26 Subject is willing to sign informed consent document If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent Subjects who do not have healthcare Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine) Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc Subjects with history of seizure or epilepsy within the past 24 months Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol Active treatment with one or more anti-epileptic agent Subjects who have had a stroke within the past 24 months Subjects diagnosed with migraine headache Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc)
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-80.0, Osteoarthritis, Knee Age between 40-80 History of symptomatic medial unicompartmental knee osteoarthritis > 6 months Willingness to wear the knee brace for a minimum of 4 hours per day during daily activities Understanding of the Chinese language Ethnic Chinese patients Symptomatic knee osteoarthritis affecting more than one compartment Clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint Significant knee effusion or soft tissue compromise preventing long-term knee brace use Obesity (BMI>30) Previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy Peripheral vascular disease of the lower limb
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Systemic Lupus Erythematosus (SLE) Screening Visit Subject has provided informed consent prior to initiation of any study-specific activities/procedures Age ≥ 18 years to ≤ 75 years at screening visit Fulfills classification for SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification for SLE (Aringer et al, 2019), with antinuclear antibody ≥ 1:80 by immunofluorescence on Hep-2 cells being present at screening Hybrid score ≥ 6 points with a "Clinical" hSLEDAI score ≥ 4 points. The "Clinical" hSLEDAI is the hSLEDAI assessment score without the of points attributable to laboratory results, including urine or immunologic parameters. Additional protocol-specific rules are applied at screening and throughout the study, as follows Arthritis: Arthritis (at least 3 tender and swollen joints) must involve joints in the hands or wrists for the hSLEDAI scoring Alopecia: Subjects should have hair loss without scarring; should neither have alopecia areata nor androgenic alopecia; and should have a CLASI activity score for alopecia ≥ 2 Oral ulcers: Ulcers location and appearance must be documented by the investigator Scleritis and Episcleritis: the presence of stable SLE-related scleritis and episcleritis must be documented by an ophthalmologist and other causes excluded Renal: subjects with urine protein/creatinine ratio < 3000 mg/g (or equivalent method) in a clear catch spot urine sample can enroll and be scored in the hSLEDAI, provided the subject has a clinical hSLEDAI ≥ 4 and did not receive induction treatment for nephritis within the last year Screening Visit Subjects are excluded from the study if any of the following apply: Disease Related Urine protein creatinine ratio ≥ 3000 mg/g (or equivalent) at screening or induction therapy for lupus nephritis within 1 year prior to screening visit Active CNS lupus within 1 year prior to screening including, but not limited to, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-60.0, Hand Injuries 1. Patients between 18-60 years of age 2. Patients Undergoing hand surgery in the Department of Plastics and Reconstructive Surgery, Dr. Ruth KM Pfau Civil Hospital Karachi, Dow University of Health Sciences 2 Pregnant women 2. Any patient presenting with the signs of Arrhythmia Myocardial ischemia Cognitive impairment Psychiatric disorders Drug abuse 3. Patients sensitive to any epileptic drug or taking any anti-epileptic drug 4. Having severe and multiple injuries
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Severe Acute Pancreatitis Clinical diagnosis of severe acute pancreatitis Admission time less than two days Malignant Tumor Positive confirmed pregnancy or urinary pregnancy test Acute liver failure Immunosuppressive state Hormone use Transplantation Death within seven days Blood transfusion over 1000ml in seven days Missing Visits Incomplete information
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-99.0, Metastatic Breast Cancer Parenting for patients Be a woman with metastatic (stage IV) breast cancer who has either: (1) estrogen (ER), progesterone (PR), or HER2 receptor-negative cancer and disease progression beyond first line of therapy, or (2) ER, PR, or HER2 -positive cancer and disease progression beyond two lines of therapy A mother of at least one dependent child, defined as a child <18 years of age who lives at least half-time in the home Be at least 18 years of age Adequate stamina to complete at least two study visits Able to provide informed consent Able to complete all study measures and visits in English Be willing to participate in study visits at the North Carolina Cancer Hospital (NCCH) if they live >75 miles away from NCCH Have an identified co-parent who is eligible and willing to participate in the study. for Co-parents Be an adult man or woman who is both a partners or spouse of the patient and who would serve as the child(ren)'s primary caregiver if the patient were to become unavailable for patients and co-parents Unable to participate in study visits due to illiteracy, inability to speak English or other causes Live more than 75-miles away from the North Carolina Cancer Hospital (NCCH) and unable to attend study visits at NCCH (participants who live more than 75-miles away and can attend study visits at NCCH remain eligible for participation) Unwilling to be audio-recorded during facilitated study visits and feedback interview
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 21.0-70.0, Chronic Pain Low Back Pain Heat Analgesia Chronic low back pain. By definition chronic low back pain is a condition that has been present for at least 6 months on more days than not. If there is a radiating component of the low back pain the radiating component must have a pain rating less than the non-radiating component of the low back pain. 2. Subjects must have pretreatment level of pain 4 or greater. 3. Ages 22 through 70 inclusive 4. Non pain medications are permitted as needed for conditions such as hypertension, diabetes, heart disease etc. 5. Medications such as tramadol, codeine, NSIADs, gabapentin and acetaminophen are not permitted during the trial but may be included under the discretion of the study physician. 6. Subjects must have a reliable method for clinic contact and follow-up. - Sciatica or radicular pain without non-radiating low back pain, cancer, radicular pain greater than the non-radiating component of low back pain, pregnancy, skin lesions such as open skin or sores, scar tissue, skins grafts, old burns over the treatment area. 2. Medications including oxycodone, hydromorphone, hydrocodone, fentanyl and methadone are excluded from the trial but may be included under the discretion of the study physician. Such decisions will be documented should they occur. -
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Postoperative Pain Meet the diagnostic of grade II-IV mixed hemorrhoids and meet the operation conditions; 2. Age 18~65; 3. External stripping and internal ligation of mixed hemorrhoids, general anesthesia or lumbar shu point anesthesia; 4. VAS score ≥3 points after the implementation of analgesia pump; 5. Improve clinical auxiliary examination and sign informed consent Combined with inflammatory hemorrhoids, thrombotic hemorrhoids, perianal eczema, perianal abscess and other perianal diseases that affect the evaluation of curative effect; 2. Combined with intestinal infectious diseases, intestinal polyps, rectal malignant tumors, etc; 3. Combined with severe cardiovascular disease, immune deficiency, mental disorder, or severe liver and kidney dysfunction; 4. Auricle skin lesions or auricle skin allergy to tape is difficult to tolerate treatment; 5. Combined cognitive impairment could not complete the efficacy; evaluation; 6. Pregnancy or planned pregnancy
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Pancreatitis, Chronic Subjects with abdominal pain secondary to chronic calcific pancreatitis and main pancreatic duct stones found on cross-sectional imaging, EUS, or ERP Subjects aged 18-80 Subjects must have failed at least one prior attempt of standard ERP to remove the PD stones Main PD stones in the head or body that are greater than 50% of the immediate downstream diameter of the pancreatic duct Stones ≥5 mm in diameter or impacted in the main PD on cross-sectional imaging or EUS. If multiple locations of stones are noted within the main PD, pancreatic tail stones cannot comprise more than one-third of the stone burden within the main PD Subjects who have previously received PPL or ESWL Patients with PD stones isolated in the tail or side branches of the main duct Inability to place a transpapillary pancreatic duct stent at index ERP Patients with prior pancreatic surgery Pancreas divisum or acquired pancreas divisum requiring minor papilla cannulation Pregnancy Significant cardiopulmonary co-morbidities precluding general anesthesia Patients with implanted cardiac pacemakers or defibrillators Patients with coagulation disorders that cannot be corrected to an INR below 2.0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Myofascial Pain Syndrome Age ≥ 18 years old No range of motion restriction Informed consent signed Diagnosis of myofascial pain of the upper trapezius muscle Myofascial pain of the upper trapezius muscle non-responsive to physioterapic treatments Age < 18 years Restricted range of motion Tumor in the area to be treated Wound in the area to be treated Coagulation disorders or anticoagulant therapy Local infection Pregnancy
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Leukemia, Myeloid, Acute De novo AML GB counts > 50 G/L Eligible for intensive chemotherapy no previous AML treatment secondary AML relapse of AML Acute promyelocytic leukemia Previous antiplatelet or anticoagulant treatment
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, C-Reactive Protein Anastomotic Leak Digestive System Neoplasm Surgical resection for digestive cancer Creation of anastomosis at least one measurement of CRP at the second and/or fourth postoperative day Surgical resection without anastomosis creation No measurement of CRP on the second or the fourth postoperative day
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Chronic Pancreatitis Pancreatic Duct Stone MPDS located in the head, neck, or neck/body junction of the pancreas MPDS > 5 mm in size Abdominal CT scan, Endoscopic ultrasound, or prior ERCP demonstrating MPDS Abdominal pain related to MPDS Previously failed ERCP performed with intent to clear MPDS, OR MPDS determined by treating physicians to not be amenable to clearance by standard ERCP techniques MPDS predominantly located in the body and tail of pancreas Any obstructing MPDS > 5 mm located in the body and tail of pancreas Known pancreatic head stricture precluding passage of the pancreatoscope with endoscopic stone extraction based on prior imaging or prior ERCP Pancreatic head mass Impacted MPDS located at the pancreatic duct orifice Prior attempts at ESWL or SOPIL for MPDS Walled off pancreatic necrosis Active alcohol use, defined as any alcohol use within 2 months Surgically altered anatomy (see text) Gastric outlet obstruction or obstruction precluding passage of the endoscope
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Spontaneous Bacterial Peritonitis Adult patients with cirrhosis and ascites and with low protein content in the ascitic fluid (≤1.5 g/dL) and with deteriorated liver function (Child-Pugh score ≥B9, serum bilirubin level ≥3 mg/dL) or impaired renal function (creatinine ≥1.2 mg/dL blood urea nitrogen level ≥25 mg/dL or hyponatremia ≤130 mEq/L) Age under 18 years Previous history of SBP Previous use of antibiotics within the previous two weeks Previous GIT bleeding within one month Resolving ascites for one month after diuretic therapy Liver malignancy, organic renal disease Human immunodeficiency virus infection Known hypersensitivity to planned drugs Refusal to provide informed consent
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Lymphoma, B-Cell Lymphoma, Non-hodgkins Chronic Lymphocytic Leukemia B-Cell Chronic Lymphocytic Leukemia Patients must have any B-cell lymphoma, or CLL/SLL, Gray-zone lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma, or classical Hodgkin lymphoma with any CD19 or CD20 expression on Reed-Sternberg cells. Lower grade lymphomas or CLL transformed to DLBCL are potentially eligible as is primary mediastinal B-cell lymphoma and all other subtypes of DLBCL. Burkitt and mantle cell lymphoma are potentially eligible For classical Hodgkin lymphoma only, a biopsy from any time from any institution that shows any CD19 or CD20 expression on Reed-Sternberg cells is adequate for eligibility. CD19 or CD20 expression on the Reed-Sternberg cells that is weak or only present on some Reed-Sternberg cells by immunohistochemistry is compatible with protocol eligibility For all lymphoma types except for classical Hodgkin lymphoma, either CD19 or CD20 expression must be uniform . Uniform CD19 or CD20 expression is defined as no obvious lymphoma population lacking antigen expression is present. Antigen expression can be assessed by either immunohistochemistry or flow cytometry Only when insufficient biopsy material is available to allow CD19 and CD20 expression assessment at the NIH, CD19 and/or CD20 staining performed at another institution can be used DLBCL patients must have received at least two prior chemotherapy-containing regimens at least one of which must have contained doxorubicin and a monoclonal antibody. Follicular lymphoma patients must have received at least 2 prior regimens including at least 1 regimen with chemotherapy. All other B-cell lymphoma and leukemia patients must have had at least 1 prior chemotherapy-containing regimen. All patients with CLL or small lymphocytic lymphoma must have had prior treatment with ibrutinib or another signal transduction inhibitor.and venetoclax Hodgkin lymphoma patients must have had at least 3 prior lines of therapy documented progression of lymphoma while on checkpoint inhibitor therapy or failure to respond to checkpoint inhibitor therapy, or intolerance to checkpoint inhibitor therapy had at least 1 prior cytotoxic chemotherapy-containing regimen had prior exposure to brentuximab vedotin Patients that require urgent therapy due to tumor mass effects or spinal cord compression Patients must not have received any anti-CD20 or anti-CD19 antibody products in the past 30 days prior to CAR T-cell infusion Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with infusion of CAR-T cells within 8 weeks of enrollment Patients that have active hemolytic anemia HIV-positive patients are excluded because HIV causes complicated immune deficiency and study treatment can pose more risks for these patients Patients with second malignancies in addition to their B-cell malignancy are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 3 years or is not in complete remission. There are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinoma Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Pregnant women are excluded from this study because study therapy can cause fetal harm. Because there is potential risk for adverse events in nursing infants secondary to treatment of the mother with study therapy, breastfeeding should be discontinued if the mother is treated with study drugs Active uncontrolled systemic infections (defined as infections causing fevers and infections requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours), active coagulation disorders or other major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of ventricular tachycardia or ventricular fibrillation, active cardiac arrhythmias (active atrial fibrillation is not allowed, resolved atrial fibrillation not requiring current treatment is allowed (anticoagulants count as current treatment) ), active obstructive or restrictive pulmonary disease, active autoimmune diseases such as rheumatoid arthritis Hospitalization within the 7 days prior to enrollment Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Cardiovascular Risk Factor one or more of the following modifiable risk factors for cardiovascular disease [as defined by the American Heart Association]: 1. cigarette smoking 2. high blood pressure 3. high cholesterol 4. abnormal blood sugar 5. sedentary lifestyle 6. overweight/obese must be an employee of the Heart Hospital at North Shore University Hospital prior history of heart attack or stroke pregnancy
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-60.0, Shift Work Current night shift worker (defined as a period of work between 11pm and 6am) working regular blocks of 3 night shifts Body mass index between 18.5 and 35 kg/m2 Weight stable (no weight change by more than 3 kg in the last 2 months) Not a regular smoker (1 or more cigarettes per day) and would be willing not to smoke for the duration of the study Not pregnant or breastfeeding Not diagnosed with heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer Not currently taking medication to stabilize blood glucose (e.g. acarbose, metformin or sulfonylureas) Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones Do not take medication for blood pressure e.g. diuretics, (beta-blockers, Ca-channel, ACE inhibitors, Angiotensin Receptor blockers) Do not have diagnosed hypertension (high blood pressure, systolic blood pressure that is higher than 180 mmHg and or diastolic blood pressure that is higher than 110 mmHg)
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 19.0-999.0, Pancreatitis, Acute >=19 years of age 2. Patient with acute pancreatitis with organ failure which has been determined as severe acute pancreatitis prior to assignment(randomization) (1) Organ failure: 2 points of Modified Marshall Score in one or more of the respiratory system, renal system and cardiovascular system (2) Acute pancreatitis: at least 2 of the following 3 conditions are met 1. Typical abdominal pain indicating acute pancreatitis 2. Increased blood level of pancreatic enzyme (amylase or lipase >= three times of upper limit of normal) 3. Finding acute pancreatitis in imaging test (contrast enhanced computerized tomography, abdominal magnetic resonance imaging, or abdominal sonography) (3) Severe: at least 1 of following organ failures lasting for > 48 hours according to the 2012 Atlanta Classification Respiratory system: PaO2/FiO2 =< 300 Renal system: Creatinine >= 1.9 mg/dL Cardiovascular system: low systolic blood pressure persists despite fluid replacement (SBP < 90 mmHg. off inotropic support) 3. Patient who or whose representative voluntarily agrees to participate in this study and has given a written informed consent Patient with allergic or hypersensitivity reaction to investigational product, drug of similar class or ingredients (bovine serum, dimethyl sulfoxide) 2. Patient who cannot undergo contrast-enhanced computerized tomography due to allergic reaction to contrast medium 3. Patient past >72 hours after the onset of organ failure at assignment (randomization) 4. Patient with condition that may develop acute abdominal pain 5. Patient with pancreatitis resulting from trauma, surgery, or neoplasm 6. Patient with unstable ventilation due to underlying disease other than pancreatitis 7. Patient with active infection such as non-pancreatic infection, septicemia, or pneumonia resulting from other disease 8. Patient requiring urgent surgery within 7 days 9. Patient with severe comorbidity (chronic renal disease, hepatic cirrhosis, chronic obstructive lung disease, bronchial asthma, congestive heart failure) 10. Patient with evidence of chronic pancreatitis (recurrent, obstructive and chronic; autoimmune and chronic; marked pancreatic insufficiency such as steatorrhea) 11. Pregnant woman, breastfeeding woman, or woman and man of reproductive potential not willing to use contraceptive measures during the study period 12. Patient who received other investigational product/device within 30 days prior to screening 13. Patient not eligible for study participation in the opinion of the investigator 14. Patient with current or past malignancy
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 45.0-75.0, Colorectal Adenoma Colorectal Polyp Colorectal Adenocarcinoma Colorectal SSA Primary Criteria. 1. Average risk asymptomatic subjects undergoing a first colonoscopy (screening) or screening colonoscopy at least 10 years after prior colonoscopy. 2. Aged 45 years to aged 75 years at the time of enrollment. 3. Capable of providing written informed consent and willing and able to adhere to all protocol requirements, and/or the subject's legally acceptable representative(s) capable of providing written informed consent. Primary 1. History of any colorectal cancer or colon adenomas. 2. History of inflammatory bowel disease, including Crohn's disease or ulcerative colitis. 3. Family history of colon cancer or precancerous colon polyp in a first degree relative before age 50. 4. Polyposis syndromes including Familial Adenomatous Polyposis, Cowden syndrome, Lynch syndrome, Peutz-Jeghers syndrome, MUTYH Associated Polyposis, Familial Colorectal Cancer Type X. 5. Surveillance, therapeutic, preoperative, or diagnostic colonoscopy. 6. Colonoscopy for work-up of abdominal or pelvic symptoms including abdominal pain, flank pain, pelvic pain, subject report of altered stool, subject report of anemia within the past 12 months, subject report of gastrointestinal bleeding including bright red blood per rectum or tarry stools, constipation, diarrhea, subject reported history of abdominal or pelvic mass, subject report of unintentional weight loss. 7. Workup or referral to diagnose or evaluate abnormal imaging of the abdomen or pelvis. 8. Positive Fecal Immunochemical Test history. 9. Severe co-mobordity, including end-stage cardiovascular, pulmonary, liver, or renal disease. 10. History of colon resection, not including the appendix. 11. Currently receiving a therapy not permitted during the trial, as defined in Section 8.3. 12. Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the trial. Enrolled subjects will be eligible for Post-procedure Periods if their colonoscopy meets the following 1. Adequate bowel preparation score per the Boston Bowel Preparation Scoring System (BBPS) > or equal to 2 in all colonic segments. 2. Colonoscopies with successful cecal intubation. 3. Colonoscopies with withdrawal times of at least 6 minutes
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Acute Pancreatitis all patients with acute pancreatitis aged more than 18 yrs admitted to Al-raghy ICU of all etiologies patients less that 18 years patients above 80 years patients with known cardiac disease patients with pre-existing diabetes, chronic renal failure or malignancy patients with underlying chronic pancreatitis
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 16.0-60.0, Irritable Bowel Syndrome Male and female subjects of Caucasian race 2. Age between 16 and 60 years (inclusive) 3. Good physical, medical and mental status estimated on the basis of the medical history and a general clinical examination. 4. Results of laboratory tests (hematology, clinical chemistry, serology, and urinalysis) within the normal range of the local laboratory or considered non-clinically significant by the investigator. 5. Subjects who have provided freely their own written informed consent. 6. Subjects available for the whole study period. 7. Diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) according to Rome III i.e. symptoms of recurrent abdominal pain or discomfort* and a marked change in bowel habit with symptoms experienced on at least three days a week of at least three months within last year. Pain/discomfort is related to a change in the appearance of stool, frequency of stool and improves with defecation. * "Discomfort" means an uncomfortable sensation not described as pain. 8. The following subjects will be enrolled in the study: 1. with diarrhea-predominant irritable bowel syndrome, i.e., persons, who have at least one stool of type 6 or type 7 in Bristol stool score (BSS) over at least 2 days a week 2. with at least moderate form assessed using IBS-SSS (5 questions, maximum number of points 500); enrolled subjects with score >175 points Mild <175 points, Moderate 175-300 points, Severe >300 points. 9. Subjects who are able to follow strictly the instructions of the investigational team regarding the study procedures and to fulfil the requirements of the protocol. 10. The following medications are permitted during the course of the study, as long as they are used at a constant dosage and are commenced at least 1 month prior to study start: 1. birth control pill, or depot intramuscular contraceptive preparation, 2. estrogen-progesterone replacement therapy, 3. L-thyroxine, 4. low-dose antidepressants (up to 25 mg day of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor) 5. low-dose antihypertensives in the diuretic, angiotensin-converting enzyme inhibitor or angiotensin II inhibitor classes Patients with cardiovascular disorders: uncontrolled hypertension (blood pressure > 170/100 mmHg), cerebrovascular diseases. 2. Patients with respiratory disorders (asthma, chronic obstructive pulmonary disease [COPD]). 3. Patients with hepatic disorders (including condition following cholecystectomy procedure) and renal disorders as well as abnormal results of biochemical blood tests without diagnosis: serum creatinine > 2 x upper limit of normal, AST or ALT > 2 x upper limit of normal. 4. Patients with gastrointestinal disorders other than IBS, including clinically or endoscopic-confirmed gastroenteritis. 5. Patients with endocrinological disorders, including patients with diabetes mellitus (fasting blood glucose concentration > 11 mmol/L), and TSH > normal. 6. Patients with serious neurological disorders, psychosis. 7. Patients with malignancies. 8. Pregnant or lactating women. 9. Soy hypersensitivity. 10. The subject has been diagnosed with lactose intolerance and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet). 11. Use of motility drugs or dietary fiber supplements within 2 weeks before study start. 12. Patients, taking anti-coagulant medication. 13. Plan to have surgery during the time of the study. 14. Currently consuming probiotics and refuse to have a three months washout period. 15. Recent antibiotic therapy within the last 3 month. 16. Patients, who receive antibiotics during the study, will be excluded. 17. Patients, enrolled in another clinical trial in the past 3 months. 18. The subject has a history of alcohol or substance abuse
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Lateral Epicondylitis Pain in elbow for at least two weeks Nonsteroidal antiinflammatory drug usage during last week Rheumatic diseases (Rheumatoid arthritis, systemic lupus erythematosus, reactive arthritis, etc.) Malignancy Extracorporeal shock wave therapy in last six months Lateral epicondylitis injection in last six months or any treatment Lateral epicondylitis brace usage
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Cholelithiasis All healthy patients without cholecystitis Acute cholecystits, mucocoele, empyema, carcinoma, peritonitis, ASA 3 and 4
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Age ≥ 18 years Presented to ER with Acute severe pain for < 48 hours before presentation Laboratory values of Lipase and/or amylase > 3X normal History of recent penetrating or blunt abdominal trauma Patients transferred to MDMC for upper abdominal pain consistent with pancreatic etiology
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Systolic Heart Failure Stage D (Disorder) Mitral Regurgitation aged 18 years or older acute decompensated heart failure due to severe left ventricular systolic dysfunction combined with hemodynamically significant mitral regurgitation. Severe systolic dysfunction and hemodynamically significant mitral regurgitation are defined as left ventricular ejection fraction less than 35% and mitral regurgitant volume more than 45 ml (more than moderate degree), respectively cancer or other significant co-morbid diseases with expected life span less than 3 years adverse effects of hydralazine surgical interventions of mitral regurgitation will be done in follow-up period which change the course of native condition other valvular conditions other than mitral regurgitation with severity more than or equal to moderate degree, particularly mitral stenosis, and aortic regurgitation/stenosis lack of written informed consent
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, IBS - Irritable Bowel Syndrome • Age ≥ 18 years Man and Women, Negative pregnancy test and effective contraception IBS defined by the Rome IV During the previous seven days the visit, average numeric rating scale (NRS) pain ≥ 4 IBS Treatment stable for 1 month • Breastfeeding Diabetic patients Significant liver function abnormalities (transaminases> 3N, cholestasis) and moderate renal disease (MDRD <60 ml / min) Addiction to alcohol and / or drugs Antiepileptic drugs taken (epilepsy or chronic pain) Chronic pain of greater intensity than that related to IBS Known Allergyto succinimides (ethosuximide, methsuximide, phensuximide) and pentoxifylline History or current severe depression (hospitalization, long-term antidepressant treatment) Psychotic disorders
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Acute Pancreatitis Quality of Life Acute pancreatitis Must be able to response an online survey • N/A
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Helminthiasis Helminth Infection The included volunteer is a researcher within parasitology with focus on Trichuris trichiura and Trichiura suis. He planned to infect himself under medical supervision. This was his third self-infection with Trichuris. The only clinical criterion for his in the study was that he was healthy N/A
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-60.0, Diabetic Nerve Problems Diabetic Neuropathy Diabetic Complications Neurological Males aged 40 Type 2 diabetes of >10 years duration Symptoms of peripheral neuropathic painpresent by scoring on Diabetic neuropathic score (minimum score 1) Diabetic foot ulcer Deformed or contracted foot Neurological complications Presence of neurological disease Presence of cardiovascular or peripheral vascular disease Usage of topical analgesics or implanted medical device six weeks prior to the study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 12.0-18.0, Functional Gastrointestinal Disorders Vagus Nerve Autonomic Disorder Irritable Bowel Syndrome Nausea Dyspepsia Female patients 12-18 years old with chronic idiopathic nausea, function abdominal pain, dyspepsia and/or irritable bowel syndrome English Speaking Patients who are unable to stand upright during the heart rate variability recording Patients with a known bleeding disorder Gastric or cardiac pacer or defibrillator Poor circulation in lower limbs Swollen or inflamed outer ear Epilepsy Abdominal or inguinal hernia Any unstable medical condition, such as renal disease, uncontrolled diabetes, etc Requires new medication during the 8 weeks of the study that may affect gastrointestinal symptoms, vagal modulation or immune response Inability to answer questionnaires or repoty pain in a 0-10 visual analog scale
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Solid Tumor Metastatic Cancer Advanced Cancer Unresectable Solid Neoplasm The study population consists of adult patients with advanced solid tumors that meet all of the following to be enrolled into this study: 1. Age ≥ 18 years. 2. Patients with histologically confirmed solid tumors with a likelihood of expression of GNX102 targeted antigens, which are limited to colorectal hepatocellular non-small cell lung gastric breast bladder pancreatic melanoma (cutaneous, acral, or mucosal) esophageal Patients who meet any of the following will be excluded from participation in this study: 1. Has any other malignancy not listed in # 2. 2. Has a positive PCR test for active COVID-19 infection or has signs or symptoms consistent with COVID-19 in the absence of a negative PCR test. 3. Has New York Heart Association Class III or IV heart disease. 4. History of myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, within the past 6 months. 5. History of cerebral vascular accident or transient ischemic attack within the past 6 months. 6. History of primary CNS tumor. 7. History of CNS metastases, unless previously treated and stable for at least 4 weeks in the absence of steroids. Patients with meningeal carcinomatosis are excluded regardless of treatment. 8. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 72 hours of start of therapy. 9. Active, nonmalignant GI disease requiring treatment (such as inflammatory bowel disease, Crohn's disease, colitis) that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study. 10. Clinical symptoms of pancreatitis within the past 28 days. 11. Known active infection with HIV, hepatitis B (HBV), or hepatitis C (HCV) Patients with a history of HBV or HCV are allowed if HBV DNA or HCV RNA are undetectable. Patients with hepatocellular cancer on anti-viral therapy must have DNA levels ≤ 500 IU/ml Patients with a history of HBV or HCV will be monitored for reactivation while on study. 12. Pregnant or nursing women. 13. Treatment with radiation therapy within 14 days prior to dosing with GNX102. 14. Major surgery within 14 days prior to dosing with GNX102. 15. History of autoimmune hemolytic anemia or autoimmune thrombocytopenia. 16. No second malignancy which is considered active or requires concurrent treatment. 17. For patients with hepatocellular carcinoma Ascites requiring more than 1 paracentesis per month History of hepatic encephalopathy within 12 months of study entry. 18. History of bleeding esophageal or gastric varices within 6 months of study entry. 19. Prior or ongoing cancer treatment, including investigational treatment within 5 half-lives or 21 days whichever is less, prior to dosing with GNX102 and 6 weeks for nitrosoureas or mitomycin C. 20. Allergies to any excipients in GNX102 (i.e., L-histidine, sucrose, Polysorbate 80). 21. Severe acute or chronic medical or psychiatric conditions or other laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the patient inappropriate for entry into this study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-99.0, Stroke, Ischemic Stroke Hemorrhagic For ischemic stroke Age > 18-year-old Ischemic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging) inferior to 6 hours from stroke onset Initial NIHSS score > 0 at the time of clinical examination Patients with multimodal imaging either through MRI or CT perfusion and supra-aortic vessels and intra-cerebral vessels (Willis circle) imaging <0 Procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present For hemorragic stroke Age > 18 year-old Hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (CT or MRI imaging) Not affiliated to social security Patient under legal protection or deprived of liberty by a judicial or administrative decision Patient whose follow-up will be impossible Prior stroke GROUP FOR Patients with TIA and a negative cerebral CT or MRI GROUP FOR Cerebral hemorrhage related to subarachnoid hemorrhage Post-traumatic hemorrhage Hemorrhagic transformation in patients with ischemic stroke GROUP FOR Contraindication MRI
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 19.0-999.0, Abdominal Pain Patient presenting to the MGH Emergency Department with abdominal pain English-speaking Known to be pregnant Patients with altered mental status Patients who are critically ill or unstable
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Postoperative Pain Medically cleared to undergo elective surgery (including associated anesthesia) at UW Transformations Surgery Center Pregnant or breast-feeding women Incarcerated women or men Individuals unable to give consent due to another condition such as impaired decision-making capacity Men or women who take opioid pain medications on a regular basis prior to surgery Men or women with a history of opioid abuse and/or dependence Participants with a history of bleeding disorders precluding safe abdominoplasty Participants on anticoagulation therapy who have not held their anticoagulation as recommended by their surgeon or anesthesiologist Participants not medically cleared for surgery at Transformations Surgery Center. This would participants with sepsis/bacteremia, significant valvular disorders or heart conditions
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Chronic Back Pain Willingness to and ability to participate in study procedures Chronic back pain (pain above the gluteal cleft of at least 3 months duration) Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis) Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Heart Failure Symptoms and Signs Quality of Life Being at least primary school graduates Being over 18 years old Being diagnosed Stage III-IV with heart failure Not using any other complementary or integrative therapy during the study period Having an additional disease such as advanced stage chronic obstructive pulmonary disease, asthma, cancer Stage I-II diagnosed with heart failure Having an active thrombosis Having a coagulation problem Not volunteering to participate in the research Patients who have been hospitalized for 5 days or less and discharged before five days after the start of the application
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Effectiveness and Safety of the Seldinger Wire Technique Using a 145 cm Guidewire With the Modified Seldinger Technique Using a 70 cm Guidewire female, male adults ≥ 18 years medical indication for Power-PICC-Line catheter implantation because of chemotherapy or parenertal nutrition and outpatients age < 18 years systemic infection local infection of the interventional location known allergy to used material general contraindication of Power-PICC-Line catheter implantation
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 19.0-87.0, Blood Pressure Mean screening systolic blood pressure of 110 to < 160 mm Hg at most recent visit Mean screening diastolic blood pressure of 70 to <100 mm Hg at most recent visit Currently taking antihypertensive medications Known to be currently pregnant History of sleep apnea History of heart attack, stroke, or any cardiovascular disease History of arrhythmia (e.g atrial fibrillation or ventricular tachycardia) Completed ambulatory blood pressure monitoring in the past year Second shift, overnight, or jobs that will not allow ambulatory blood pressure device to measure every 30 minutes for 24 hours
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-55.0, Leukocytosis Triglycerides Cognitive Function Inflammatory Response Must be over the age of 18 Must drink between 1-4 cups of coffee per day (on average) Must be able to tolerate lactose and dairy products Have not been sick for the past 3 weeks (immune function) Non smoker Must be able to fast for 10-12 hours If you are required to take corticosteroids (immune function) Cannot understand or speak English Individual has an auto-immune disease and requires medication Individual is following a ketogenic diet Individual has allergy or sensitivity to dairy, coffee or caffeine or coconut oil Individual has hypertension
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-70.0, Neuromuscular Blockade Reversal Agent Sugammadex Neostigmine Quality of Recovery Laparoscopic Cholecystectomy patients who underwent laparoscopic cholecystectomy aged 20-70 neuromuscular disease allergy to rocuronium, sugammadex, neostigmine cognitive impairment ( disable to answer the questionnaire ) refuse to participate
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 55.0-999.0, Cognitive Decline Patients Man or woman 55 years and over Patient received for the first time in Memory Consultation and not aware of his diagnosis Patient with a Mini-Mental State Assessment score (MMSE) ≥ 20 Patient accompanied by a primary caregiver Patient able to provide consent to participate in research Caregiver The caregiver accompanies the patient and is considered as the main caregiver during the consultation is able to provide consent to participate in research Patient living in a care homes Patient protected by law (under legal protection, guardianship or trusteeship) Patient with a hearing or visual impairment that does not allow to carry out assessments in Memory Consultation Patient opposing research
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Pancreatitis Alcohol Drinking Aged 18-75 years at the time of assessment History of at least one AP per Revised Atlanta Classification (20) within past 3 years from screening, which requires two of the following evidence of pancreatitis Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back) Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal Characteristic findings of AP on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI) or transabdominal ultrasonography Access to a mobile or portable device that has the capability to sync to the BACtrack sensor and internet connection for syncing purposes Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors Episode of acute pancreatitis requiring hospitalization in the past 4 weeks Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures Currently incarcerated Known pregnancy
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Patients age greater or equal to 18 presenting to one of the collaborating centers Diagnosis of acute pancreatitis according to the revised Atlanta classification which requires 2 of the following 3 A) Typical abdominal pain; B) Increase in serum amylase or lipase levels higher than 3 times the upper limit of normality; and C) Signs of AP in imaging Uncontrolled arterial hypertension (systolic blood pressure >180 and/or diastolic blood pressure 100 mmHg) New York Heart Association Class II hear failure (slight limitation of physical activity; fatigue, palpitations or dyspnea with ordinal physical activity) or worse, or ejection fraction<50% in the last echocardiography Decompensated cirrhosis (Child's Class B or C) Hyper or hyponatremia (<135 or >145 mEq/l) Hyperkalemia (>5 mEq/l) Hypercalcemia (albumin or protein-corrected calcium>10.5 mg/dl) Chronic kidney failure (basal glomerular filtration rate <60 mL/min/1.73m2) Clinical signs or symptoms of volume overload or heart failure at recruitment (dyspnea, peripheral edema, pulmonary rales, or evident increased jugular ingurgitation at 45º) Shock or respiratory failure according to the revised Atlanta classification at recruitment (non-fluid responding systolic blood pressure< 90 mmHg, PaO2/FIO2≤300 mmHg) Time from pain onset to arrival to emergency room >24h
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Heart Failure Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no prespecified criterion with respect to heart failure etiology and/or ejection fraction Other etiologies of fluid overload different from heart failure. 2. Hyponatremia: Sodium level below 125mmol/l 3. Unstable patients: acute coronary syndrome, cardiogenic shock . 4. Patients requiring inotropic agents or renal dialysis. 5. Pregnancy or breastfeeding period. 6. sever hepatic disease 7. GFR is less than 45 mL/min/1.73 m² . 8. Patient with diabetic ketoacidosis or non ketotic hyperosmolar
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-40.0, Bioequivalence Healthy Caucasian male subjects aged between 20 and 40 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period, 3. Negative Covid-19 Rapid Test results and two Negative Covid-19 PCR test results, 4. Negative alcohol breath test results, 5. Normal physical examination at screening visit, 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age, 7. Ability to communicate adequately with the investigator himself or his representatives, 8. Ability and agreement to comply with the study requirements, 9. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm, 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 11. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate), 12. Understanding of the study and agreement to give a written informed consent according to section 20.3. 13. Volunteer's compliance with isolation rules defined at study protocol Who have atopic constitution or asthma or known allergy for lopinavir and ritonavir or any other ingredients of the products. 2. Any history or presence of clinical relevance of cardiovascular (myocardial infarction/ ischaemia and/or QT prolongation etc.), neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 3. Baseline ECG should be performed at screening. subjects having a QTc > 440 ms 4. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator), 5. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 6. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 7. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 8. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 10. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 11. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 13. History of allergic response to heparin. 14. History of drug abuse. 15. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 16. Positive blood test for HBV, HCV and HIV. 17. Who have relationship to the investigator. 18. Who are not suitable to any of criteria. 19. History of difficulty of swallowing. 20. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 22. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Locally Advanced Pancreatic Carcinoma Metastatic Pancreatic Carcinoma Recurrent Pancreatic Carcinoma Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 PRE-REGISTRATION Histological confirmation of a pancreatic malignancy as confirmed by the local pathology lab Patients whose disease has progressed on (or who were intolerant of) at least one line of therapy for metastatic disease Patients whose disease has recurred with metastatic disease =< 12 weeks of completion of neoadjuvant or adjuvant systemic chemotherapy; or patients with locally advanced disease whose disease progressed to metastatic disease on, or =< 12 weeks after completion of systemic chemotherapy would also be eligible Provide informed written consent =< 28 days prior to pre-registration Central electronic/paper confirmation of the presence of a BRAF V600E mutation. This review is mandatory prior to pre-registration to confirm eligibility. Results from a Clinical Laboratory Improvement Act (CLIA)/College of American Pathologists (CAP) certified testing lab (commercial or institutional) that confirm the presence of a BRAF V600E mutation in the patient's tumor must be submitted for central review NOTE: Registration must occur =< 30 days after pre-registration Confirmation of the presence of BRAF V600E mutation in the patient's tumor Measurable disease Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United [ACCRU] web site) Patients whose tumor harbors a BRAF non-V600E mutation or a BRAF fusion Prior therapy with BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib) and/or a MEK inhibitor (e.g., binimetinib, trametinib, cobimetinib) Known hypersensitivity or contraindication to any component of binimetinib or encorafenib or their excipients Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown Pregnant women Nursing women Men or women of childbearing potential who are unwilling to employ adequate contraception NOTE: Female participants of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, and to not donate ova from screening until 30 days after the last dose of study drug NOTE: Male participants must agree to use methods of contraception that are highly effective or acceptable, and to not donate sperm from screening until 90 days after the last dose of study drug Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Delirium Confusion Mental Status Change Back Pain Hip Pain Chronic Chest Pain Asthma COPD Cellulitis Soft Tissue Infections Cough Deep Vein Thrombosis Pulmonary Embolism Venous Thromboembolism Dyspnea Electrolyte Metabolism Abnormal Fever Failure to Thrive Weakness Protein-Calorie Malnutrition Headache Neck Pain Hypoxia Pneumonia Sepsis Syncope Vomiting Diarrhea Leg Pain Abdominal Pain Age 18 or older Adult patients admitted to General Medicine Services at Brigham and Women's Hospital during the 21-months study data collection period English speakers Patients who were diagnosed with any of the following conditions and symptoms upon admission Abdominal pain Altered mental status/ delirium / confusion Asthma / chronic obstructive pulmonary disease (COPD) Cellulitis / soft tissue infection Chest pain Cough Not pregnant women, prisoners and institutionalized individuals
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-40.0, Bioequivalence Healthy Caucasian male subjects aged between 20 and 40 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period, 3. Two Negative Covid-19 PCR test results. 4. Negative alcohol breath test results, 5. Normal physical examination at screening visit, 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age, 7. Ability to communicate adequately with the investigator himself or his representatives, 8. Ability and agreement to comply with the study requirements, 9. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm, 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 11. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate), 12. Understanding of the study and agreement to give a written informed consent according to section 20.3. 13. Understanding of that he and his partner will use a practice adequate contraception during the study and at least 7 days after the study. 14. Volunteer's compliance with isolation rules defined at study protocol Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products. 2. Who have positive Covid-19 PCR test result. 3. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 4. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator), 5. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 6. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 7. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 8. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 10. History of allergic response to heparin. 11. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 12. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 13. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 14. History of drug abuse. 15. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 16. Positive blood test for HBV, HCV and HIV. 17. Who have relationship to the investigator. 18. Who are not suitable to any of criteria. 19. History of difficulty of swallowing. 20. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 22. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-40.0, Bioequivalence Healthy Caucasian male subjects aged between 20 and 40 years 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period 3. Two Negative Covid-19 PCR test results 4. Negative alcohol breath test results 5. Normal physical examination at screening visit 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age 7. Ability to communicate adequately with the investigator himself or his representatives 8. Ability and agreement to comply with the study requirements 9. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest 11. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate) 12. Understanding of the study and agreement to give a written informed consent according to section 20.3 13. Understanding of that he and his partner will use a practice adequate contraception during the study and at least 7 days after the study 14. Volunteer's compliance with isolation rules defined at study protocol Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products. 2. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 3. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator), 4. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 5. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 6. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 7. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 8. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 9. History of allergic response to heparin. 10. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 11. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 13. History of drug abuse. 14. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 15. Positive blood test for HBV, HCV and HIV. 16. Who have relationship to the investigator. 17. Who are not suitable to any of criteria. 18. History of difficulty of swallowing. 19. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 20. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 21. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Postoperative Nausea acute pancreatitis systemic disease as hypertension or diabetes
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-40.0, Bioequivalence Healthy Caucasian male subjects aged between 20 and 40 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period, 3. Two Negative Covid-19 PCR test results. 4. Negative alcohol breath test results, 5. Normal physical examination at screening visit, 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age, 7. Ability to communicate adequately with the investigator himself or his representatives, 8. Ability and agreement to comply with the study requirements, 9. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm, 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 11. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate), 12. Understanding of the study and agreement to give a written informed consent according to section 20.3. 13. Understanding of that he and his partner will use a practice adequate contraception during the study and at least 7 days after the study. 14. Volunteer's compliance with isolation rules defined at study protocol Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products. 2. Who have positive Covid-19 PCR test result. 3. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 4. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator), 5. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 6. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 7. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 8. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 10. History of allergic response to heparin. 11. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 12. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 13. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 14. History of drug abuse. 15. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 16. Positive blood test for HBV, HCV and HIV. 17. Who have relationship to the investigator. 18. Who are not suitable to any of criteria. 19. History of difficulty of swallowing. 20. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 22. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 15.0-65.0, Multiple Trauma Pain, Acute patients with acute limb trauma, aged 15-65 years, with moderate to severe pain (45 mm; visual analog scale (VAS)), with a GCS score of 15, with the systolic blood pressure of lower than 180 mmHg, diastolic blood pressure of higher than 90 mmHg lack of pregnancy no history of allergy to ketamine, fentanyl (or opioids), or acetaminophen no history of liver diseases no acute or chronic structural or functional nasal obstruction diseases no history of drug or psychiatric addiction no pain medication within the past four hours no history of heart disease and the presentation of the written consent to participate in the study a decrease in GCS score to less than or equal to 14 an elevated systolic blood pressure to higher than 180 mmHg a decreased diastolic blood pressure to less than 80 mmHg inability to understand the VAS pain rating system symptoms of acute heart disease and respiratory depression (respiratory rate <8 / min) and the patient's dissatisfaction to continue the cooperation in study
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Stroke, Ischemic Informed consent signed by patient Ischaemic stroke with determination of infarct size by imaging (MRI) NIHSS 1-24 CRP increase ≥ 5 mg/l within 24 hours after stroke and/or CRP value > 20 mg/l Legal capacity Withdrawal of consent Participation in other interventional studies Severe dysphagia (danger of aspiration pneumonia) Clinical or laboratory evidence of a systemic infection Contraindications against apheresis therapy Modified Rankin Scale (mRS) before index event ≥ 3 Intracranial hemorrhage Epileptic seizure in the context of the acute event Pregnancy, lactation
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pancreatitis Patients with amylase and lipase levels measured during covid-19 disease with or without pneumonia Patients with pregnancy Patients whose amylase and lipase levels were not measured during covid 19 disease Patients with known solid organ malignacy Patients with known hematologic malignacy
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Histiocytosis Histologically proven histiocytosis Informed consent form signed by patients (or parents/legal tutors of children) to participate"Gene Histio" or "HISTIO target 2020" Patient refusal
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-40.0, Bioequivalence Healthy Caucasian male subjects aged between 20 and 40 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period, 3. Two Negative Covid-19 PCR test results. 4. Negative alcohol breath test results, 5. Normal physical examination at screening visit, 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age, 7. Ability to communicate adequately with the investigator himself or his representatives, 8. Ability and agreement to comply with the study requirements, 9. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm, 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 11. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate), 12. Understanding of the study and agreement to give a written informed consent according to section 20.3. 13. Understanding of that he and his partner will use a practice adequate contraception during the study and at least 7 days after the study Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products. 2. Who have positive Covid-19 PCR test result. 3. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 4. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator), 5. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 6. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 7. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 8. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 10. History of allergic response to heparin. 11. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 12. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 13. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 14. History of drug abuse. 15. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 16. Positive blood test for HBV, HCV and HIV. 17. Who have relationship to the investigator. 18. Who are not suitable to any of criteria. 19. History of difficulty of swallowing. 20. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 22. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 21.0-70.0, Cardiovascular Risk Factor Nicotine Dependence Heart rate < 105 beats per minute (BPM)* Systolic Blood pressure <160 and > 90* Diastolic Blood Pressure <100 and > 50* Body Mass Index (BMI) < 38.0 (at investigator's discretion for higher BMI if no other concurrent health issues) *considered out of range if both machine and manual readings are above/below these thresholds Use e-cigarettes on at least 15 days in the past 30 for at least 3 months Smoke 10 or fewer cigarettes/tobacco products per day in the last 30 days Willing to use mod e-cigarette Willing to abstain from tobacco product use for night before study Age: > 21 years old and < 70 years old Using e-liquid > 0mg/ml nicotine Seizures Cancer Hepatitis B or C or Liver Disease Oral Thrush Heart disease Glaucoma Kidney disease or urinary retention Diabetes High Blood Pressure (taking sympatholytic medications such as alpha and beta blockers) History of stroke
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Colorectal Surgery Adult patients >18years (homme et femme de plus de 18 ans) Elective Patients undergoing colorectal surgery with intestinal anastomosis (Colectomy, Anterior Resection, intestinal resection or stoma closure) without protective stoma creation in an Enhanced Recovery After Surgery Program Able to give the consent Affiliated to Social Security Mental disorders Cutaneous infection on the abdomen Pregrancy and breast feeding Patients unable to give their free consent (incarcerated, legal protection measures)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Potential Therapeutic Role Patients with severe acute aluminum phosphide poisoning systolic blood pressure (SBP) ≤90 mmHg PH ≤ 7.2 HCO3 ≤15 meq/L during the first six hours of admission Pregnant and lactating women Asymptomatic patients with history of acute aluminum phosphide exposure Patients with co-ingestion to other substances in addition to aluminum phosphide Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure) Patients with previous medical intervention (fluid therapy and vasopressors)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Back Pain Clinical diagnosis of chronic low back pain with a disease duration of more than 3 months (further diagnostic results were not required) Aged 18-75 Scored at least 4/10 in pain scale (VAS or Numerical) Written consent Acute back pain Protrusion or prolapse of 1 or more intervertebral discs with concurrent neurological symptoms Radicular pain Prior vertebral column surgery Infectious spondylopathy Low back pain caused by inflammatory, malignant, or autoimmune disease Congenital deformation of the spine (except for slight lordosis or scoliosis) Compression fracture caused by osteoporosis Spinal stenosis Spondylolysis or spondylolisthesis
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-75.0, Stroke Patients Being over 40 years old Stroke diagnosis The Mini-mental test score is above 23 Other neurological or orthopedic problems that affect functionality and balance, other than stroke High blood pressure, heart disease which may prevent rehabilitation Patients with pulmonary disease (COPD) Have undergone thoracic or cardiovascular surgery Agnosia or a person with visual impairment Patients with epilepsy The medical condition is not stable Patients with reluctance towards treatment Patients with communication problem An area under 23 points from the Minimental Test
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-40.0, Bioequivalence Healthy Caucasian male subjects aged between 20 and 40 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period, 3. Two Negative Covid-19 PCR test results. 4. Negative alcohol breath test results, 5. Normal physical examination at screening visit, 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age, 7. Ability to communicate adequately with the investigator himself or his representatives, 8. Ability and agreement to comply with the study requirements, 9. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm, 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 11. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate), 12. Understanding of the study and agreement to give a written informed consent Who have atopic constitution or asthma or known allergy for umifenovir and/or any other ingredients of the products. 2. Who have positive Covid-19 PCR test result. 3. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 4. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator), 5. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 6. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 7. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 8. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 10. History of allergic response to heparin. 11. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 12. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 13. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 14. History of drug abuse. 15. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 16. Positive blood test for HBV, HCV and HIV. 17. Who have relationship to the investigator. 18. Who are not suitable to any of criteria. 19. History of difficulty of swallowing. 20. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 22. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Hypertension Diagnosed with hypertension Proficient in English
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Endocrine System Diseases )Ist episode of acute pancreatitis. 2) Non diabetic or non pre diabetic as per American Diabetes Association . 3) Age >18yrs Acute pancreatitis cases who die within 1 month of hospitalization. 2. Recurrent acute pancreatitis 3. Chronic pancreatitis. 4. Previous diagnosed diabetes or prediabetes 5. Any malignancy 6. Age <18yrs 7. Pregnant females or lactating women. 8. Chronic diarrhea, intestinal tuberculosis or Crohns disease
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-100.0, His Bundle Pacing Heart Failure, Systolic AV block II or III with high expected pacing need Left ventricular ejection fraction between 40% and 55% (inclusive) Willing to participate and sign informed consent Under 18 years old Pregnant Hypertrophic cardiomyopathy Cardiac sarcoidosis Cardiac amyloidosis Previous myocardial infarction within last 3 months Ventricular septum defect or other other left ventricular corrective surgery Congenital heart disease surgically corrected Atrial fibrillation with uncontrolled rate (if not planned for AV node ablation)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Metastatic or Locally Advanced Malignancies Provision of written informed consent Ability of patient to understand and comply with the protocol for the duration of the study, including treatment and scheduled visits and examinations Diagnosis of a metastatic or locally advanced malignancy Progressive disease At least one measurable lesion that can be accurately assessed at baseline by computed tomography or magnetic resonance imaging and is suitable for repeated assessment Prior administration of at least one standard chemotherapy for primary and/or relapsed malignancy according to current guidelines ECOG Performance Status ≤2 Age ≥18 years, no upper age limit Postmenopausal or evidence of non-childbearing status Female patients of childbearing potential and male patients with partners of childbearing potential who are sexually active must agree to the use of two highly effective forms of contraception. These should be started immediately after signing the informed consent form and continued throughout the period of study treatment plus three months for female and for male patients thereafter (general) Other malignancy except for study indication within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or other malignancies curatively treated with no evidence of disease for ≥5 years Concurrent or previous treatment within 30 days prior to C1D1 in another interventional clinical trial with an investigational anticancer therapy Persistent toxicity (≥Grade 2 according to Common Terminology for Adverse Events (CTCAE) version 5.0) caused by previous cancer therapy, excluding alopecia Clinical signs of active infection (>Grade 2 according to CTCAE version 5.0) History of human immunodeficiency virus (HIV) infection and immunocompromised patients Active Hepatitis A virus infection Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at baseline patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at baseline , are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at baseline confirmed by a polymerase chain reaction (PCR) positive for HCV RNA Dementia or significant impairment of cognitive state Epilepsy requiring pharmacologic treatment
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Complication Patients diagnosed with acute pancreatitis with clinical, radiological or laboratory criteria All genders Acute pancreatitis of any aetiology Over 18 years old Lung diseases Heart failure Cholangitis Acute cholecystitis Pregnancy Refuse to participate
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Healthy Be at least 18 years old Be able to walk and/or lift heavy objects without pain/discomfort Have prior back/neck injuries or chronic pain in the last 6 months Have a pacemakers Have breast implants Have removed the axillary lymph nodes Pregnant women Using blood thinning medications Participants must consult a physician prior to participating this study if any of the following occurred before or during use: Inguinal hernia, hernia, knee injury hip/knee prosthesis, hyperextended knee, recent surgery, skin disease/injury, scars, inflammation, skin reddening
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pancreatitis, Acute Adult patients (age >18 years) with acute pancreatitis according to the revised Atlanta criteria;12 Informed consent Known time of debut of symptoms Chronic pancreatitis Pregnancy Known malignant disease More than 72 hours from debut of symptoms to inclusion
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-100.0, Burns Pain Burn patients of legal age Estimated hospitalization of > 8 days at the time of signing the informed consent Patients with known psychiatric disorders Patients with cognitive disabilities Mechanically ventilated and sedated patients
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 40.0-75.0, Hepatic Impairment for all subjects (Groups A, B, C, D) Each subject must satisfy all of the following to be enrolled in the study. 1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted. 2. Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions. 4. 4. Male, or non-pregnant and non-nursing female between ≥ 40 and ≤ 75 years of age the time of signing the ICF.. 5. Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening. 6. Supine systolic blood pressure (BP): 90 to 160 mmHg, supine diastolic BP:50 to 100 mmHg, and pulse rate: 40 to 100 bpm. 7. Subject is afebrile. 8. Female subjects NOT of childbearing potential must: a. Have been surgically sterilized at least 6 months before screening, or be naturally postmenopausal. 9. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline Visits. While receiving IP and for at least 2 months after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options. 10. Male subjects must: 1. Practice true abstinence or 2. agree to use a barrier method of birth control during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions, and for at least 2 months after the last dose of IP, even if he has undergone a successful vasectomy. for Subjects with mild, moderate, or severe hepatic impairment (Groups A-C) Each subject with mild, moderate, or severe hepatic impairment must also meet all the applicable listed below for study entry: 11. Subject has moderate or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use. 12. Subject has mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score. 1. Group A subjects must have mild hepatic impairment and are required to have documentary confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy, or imaging study with a Child-Pugh score of < 7, at screening. 2. Group B subjects must have moderate hepatic impairment and are required to have documentary confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy, or imaging study with a Child-Pugh score of ≥ 7 to ≤ 9, at screening. 3. Group C subjects must have severe hepatic impairment. If biopsy or laparoscopy is not performed prior to screening, subject can be included only if they have chronic liver disease and objective evidence of portal hypertension (ascites diagnosis by imaging or varices), or current medication for consequences of portal hypertension. In either case a Child-Pugh score of ≥ 10 to ≤ 14 at screening is required. Subjects should be enrolled into the group corresponding to the Child-Pugh classification score that most accurately reflects the most severe hepatic disease classification within the past 6 months (based on past medical history or physical examination observation). 13. Must be medically stable for at least 1 month before screening with clinically acceptable medical history, PE, clinical laboratory tests, vital signs, and 12-lead ECGs consistent with the underlying stable mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment condition, as judged by the Investigator. 14. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: • Subject (male or female) has a QTcF value ≤ 500 msec at screening. 15. Must be stable on a concomitant medication regimen before dosing with study drug). 16. Subjects may be treated with diuretics for ascites; however, subjects with severe ascites at time of enrollment may only be included at the discretion of the investigator with agreement of the Sponsor. 17. Subjects may have a history of encephalopathy; however, they must be on stable treatment for at least 1 month prior to screening, and must not have had an acute encephalopathic episode in the 1 months prior to screening. for a Matched Healthy Subject (Group D) Each matched healthy subject must also meet all applicable listed below for study entry: 18. Subject must be free of any clinically significant disease that would interfere with the study evaluations. 19. Subject must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the Investigator. 20. Subject in Group D must match at least one subject in Groups A-C, as needed with respect to sex, age (± 10 years), and weight (± 30 pounds). 21. Subject must be in good health as determined by past medical history, PE, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (ie, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the Investigator. 22. Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition: 23. If male, subject has a QTcF value ≤ 450 msec at screening; 24. If female, subject has a QTcF value ≤ 470 msec at screening for all Subjects (Group A, B, C, and D) The presence of any of the following will a subject from enrollment. 1. Subject has any condition or circumstance that prevents the subject from understanding and signing the ICF. 2. Subject has any condition that places the subject at an unacceptable risk from participating in the study or would confound the ability to interpret data from the study. 3. Subject has any significant medical condition or psychiatric illness that would prevent the subject from participating in the study at Investigator discretion. 4. Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included. a. Subject has an estimated creatinine clearance < 60 mL/min as calculated using the Cockcroft-Gault formula at screening and baseline (Day -1). 5. Subject is pregnant or is breastfeeding. 6. Subject participated in Study CC-90007-CP-003. 7. Subject donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center. 8. Subject has a history of alcohol abuse within 6 months before the first dose administration, or positive alcohol screen. 9. Subject has a history of drug abuse within 6 months before the first dose administration, or positive drug screen that is not consistent with the patient's prescribed medication and or/medical history. 10. Subject is known to have active serum hepatitis, or have a positive result to the test for Human immunodeficiency virus (HIV) antibodies at screening. • Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, Vasculitis, clinically significant cryoglobulinemia, etc. are unacceptable.) 11. Subject was exposed to an investigational drug within 30 days before dosing, or 5 half-lives of that investigational drug, if known (whichever is longer). 12. Subject used approved medications or herbal medicines that are moderate or strong cytochrome P450 (CYP)1A2, CYP2B6 CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 inducers and/or inhibitors (including St. John's wort) within 14 days or 5 half-lives of screening, whichever is longer. 13. Subject will have consumed Seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, or grapefruit hybrids within 14 days or 5 half-lives of dosing, whichever is longer. 14. Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported). 15. Subject has a history of multiple drug allergies or drug-related anaphylaxis. 16. Subject has received live vaccination (excluding seasonal flu vaccination) within 90 days of dosing. 17. Subject is part of the staff personnel or a family member of the investigational study staff. 18. Subject is, for any reason, deemed by the investigator to be inappropriate for this study, including a subject who is unable to communicate or to cooperate with the investigator or the clinical staff. 19. Subject has had a Transjugular intrahepatic portosystemic shunt (TIPS) procedure. 20. Positive SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test or signs/symptoms of COVID-19 (Coronavirus Disease 2019) infection. 21. Participants currently in other interventional trials, including those for COVID-19, may not participate in BMS clinical trials until the protocol specific washout period is achieved. If a study participant has received an investigational COVID-19 vaccine or other investigational product designed to treat or prevent COVID-19 prior to screening, enrollment must be delayed until the biologic impact of the vaccine or investigational product is stabilized, as determined by discussion between the Investigator and the Medical Monitor for Subjects with Hepatic Impairment (Group A, B, and C) The presence of any of the following will a hepatically impaired subject from enrollment. 22. Subject has any unstable medical condition occurring within 3 months prior to signing the ICF (excluding hepatic impairment and associated comorbidities per Investigator discretion). 23. Subject has any serious medical condition (excluding hepatic impairment and related complications), clinically significant laboratory abnormality not related to hepatic impairment and related complications, or psychiatric illness that would prevent the subject from signing the ICF and participating in the study per Investigator discretion. 24. Subject has hepatic encephalopathy with time or place disorientation, somnolence, stupor, rigidity, coma, no personality/behavior, rigidity, or hyperactive reflexes - or has had such within 1 month of screening. 25. Subject has a history of incipient/planned liver transplantation within 6 months of screening or has received a liver transplant. 26. Subject has a history of hepatorenal syndrome or hemolysis for a Matched Healthy Subject (Group D) The presence of any of the following will a healthy match subject from enrollment. 27. Subject has any clinically significant laboratory abnormality that in the opinion of the Investigator, is considered to prevent the subject from safely completing the study. 28. Subject has any unstable clinically significant illness within 3 months prior to the study. 29. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 30. Positive testing for any active hepatitis, or history of Hepatitis B or C
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Hyponatremia Inappropriate ADH Syndrome Age ≥18 years Attended ≥1 visit at a University of Pittsburgh Medical Center (UPMC) outpatient clinic within the prior 12 months Chronic hyponatremia with a history of ≥ 2 sequential plasma sodium concentration (PNa) between 125 mmol/L and 132 mmol/L performed ≥ 30 days apart within the last 12 months with most recent PNa ≤ 132 mmol/L prior to screening Patients are ambulatory without the need for any assist device (e.g., cane, walker) Mini-mental state examination (MMSE) score ≥ 27 Diagnosis of SIADH established by the Bartter and Schwartz as follows: 1. Hyponatremia with a PNa between 125 mmol/L and 132 mmol/L 2. Plasma osmolality < 275 mOsm/kg 3. Clinical euvolemia 4. Urine osmolality > 100 mosm/kg 5. Urine Na > 30 mmol/L 6. Intact adrenal function (i.e., morning plasma cortisol value ≥15 μg/dL, or negative corticotropin stimulation test) 7. Normal thyroid stimulating hormone (TSH) level (i.e., TSH between 0.3 to 5 μIU/mL) 8. Normal kidney function (i.e., eGFR > 60 ml/min/1.73 m2) Cirrhosis and/or end-stage liver disease Heart failure on diuretics and/or with recorded left ventricular ejection fraction <40 percent Chronic kidney disease with most recent estimated glomerular filtration rate <60 ml/min/1.73m2 Adrenal insufficiency Untreated hypothyroidism Urinary tract obstruction within the prior 2 months Uncontrolled hyperglycemia (most recent random plasma glucose ≥ 200 mg/dL) Ongoing drug treatment for hyponatremia with vaptans or combination of loop diuretics and salt tablets Active malignancy Active infection
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Irritable Bowel Syndrome Patient must be willing and able to give informed assent/ consent for participation in the study Patient must be willing and able (in the PI's opinion) to comply with all study requirements Patient must be a premenopausal female or male aged 18 and older Patient must have a documented history of IBS that is not completely controlled by current IBS drugs Patient must have a score of ≥150 on the IBS-SSS at screening Patient must have no clinically relevant (in the judgment of the PI) abnormal blood laboratory levels at screening or randomization The clinician will assess as per the Rome IV (Recurrent abdominal pain or discomfort at least 1 day/week in the last 3 months associated with two or more of the following: Improvement with defecation. Onset associated with a change in frequency of stool). Critieria Patient has clinically significant unstable medical conditions other than IBS Patient has had clinically relevant symptoms or a clinically significant illness in the four weeks prior to screening or randomization Patient has clinically significant laboratory values (in the PI's opinion)
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Coronary Heart Disease the presence of an established diagnosis in patients with coronary artery disease unstable angina pectoris (NS). When making a diagnosis, the recommendations of ESH / ESC (2015) and RCO / WHO (2014) were used stable exertional angina (SSN) I-III FC. When making the diagnosis, the IHD classification was used, adopted at the IV Congress of Cardiologists of the Republic of Uzbekistan (2000), as well as in accordance with the recommendations of ESH / ESC (2019) and RCO / WHO (2017) The patient's refusal to participate in the study Pregnancy and lactation Severe and unstable condition of the patient, making it difficult to conduct a questionnaire (for ethical reasons) Acute violation of cerebral circulation History of acute or chronic psychosis The presence of concomitant acute diseases or chronic diseases in the acute stage. Throughout the study, all patients were assigned the right to voluntarily withdraw from the study at their own request, notifying the researcher in writing or orally
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Heart Failure Patients included in PRADO Patient whose age is ≥ 18 years Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018 Patients included in the PRADO program Patients not included in PRADO Patient whose age is ≥ 18 years Patient hospitalized for global heart failure or left ventricular failure in the Cardiology department of the GHPSJ between January 2016 and September 2018 Patients not included in the PRADO program Patient under guardianship or guardianship Patient living in EHPAD Patient transferred to another establishment on discharge from hospital (surgery, follow-up care, EPHAD, etc.) Patient who died during hospitalization Patient objecting to the use of their data
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Low Back Pain Acute Pain patients aged>18 years old initiation of acute low back pain in the 10 days prior to study entry and functionally impairing low back pain, which we defined as a score of > 5 on the Roland-Morris Disability Questionnaire (RMDQ) aged>65 years old history of trauma radicular pain, which we defined as pain radiating below the gluteal folds history of vertebral tumor or metastasis patients who were pregnant or lactating unavailable for follow-up with allergy or contraindication to the investigational medications chronic analgesic use autoimmune diseases or inflammatory rheumatic disorders cardiopulmonary restrictions
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Chronic Pain Have a complex, prolonged axial neck pain or lower back pain Have been followed by a pain management specialist for at least 3 months or have a history of chronic pain for at least 3 months as recorded by physician Be >18 years of age Have a goal and motivation that is adequate in relation to the program offered Be medically prepared Have no major change in interventional treatment or be a surgical candidate Own a smart phone, tablet or computer or have the knowledge to use one Chronic pain requiring imminent surgical intervention Reported severe or acute psychiatric illness, severe anxiety or depression Current history of substance abuse Serious health risks or scheduled major health interventions for other medical reasons Pain related to malignancy Pain duration <3 months Other areas of pain exceeding the amount of back or neck pain Not currently involved in lawsuit or pending litigation
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-55.0, Bioequivalence Only volunteers fulfilling all of the following should be enrolled in the present trial: 1. Healthy Caucasian male subjects aged between 18 and 55 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during each study period, 3. Negative alcohol breath test results, 4. Normal physical examination at screening visit, 5. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age, 6. Ability to communicate adequately with the investigator himself or his/her representatives, 7. Ability and agreement to comply with the study requirements, 8. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm, 9. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 10. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate), 11. Understanding of the study and agreement to give a written informed consent according to section 20.3 Volunteers presenting any of the following will not be included in the trial: 1. Who have atopic constitution or asthma and/or known allergy for phenyramidol HCl or any other ingredients of the products. 2. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic, gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 3. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator). 4. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 5. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 6. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 7. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 8. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 9. History of allergic response to heparin. 10. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 11. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 12. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study, or during the washout periods. 13. History of drug abuse. 14. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 15. Positive blood test for HBV, HCV and HIV. 16. Who have relationship to the investigator. 17. Who are not suitable to any of criteria. 18. History of difficulty of swallowing. 19. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 20. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 21. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Acute Pancreatitis Recurrent Acute Pancreatitis Patient hospitalized with alcohol-induced AP Regular consumption of at least 40g (women)/ 50g (men) alcohol daily or 280g (women)/ 350g (men) alcohol during the preceding week of onset of abdominal pain Every day smoker (an adult who has smoked at least 100 cigarettes in his or her lifetime, and who now smokes every day; CDC definition), with at least 1-year history of smoking individuals between 18-65 years of age completed the standard intervention provided written informed consent Other possible etiologies for AP (eg. gallstones, hypertriglyceridemia above 11.5 mM , hypercalcemia, viral infection) and cases with more than one identified etiological factors will be excluded Major psychiatric illnesses (schizophrenia, bipolar disorder, dementia) currently receiving therapy for alcohol use disorder currently taking part in a smoking cessation program at least 3 documented episodes of AP or diagnosed chronic pancreatitis undergoing active or palliative treatment for malignancy pregnancy chronic pancreatitis life expectancy is less than two years
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-55.0, Bioequivalence Healthy Caucasian male subjects aged between 20 and 40 years, 2. Non smokers or smoking maximum 5 cigarettes a day, those who won't smoke or drink coffee during the study period, 3. Two Negative Covid-19 PCR test results. 4. Negative alcohol breath test results, 5. Normal physical examination at screening visit, 6. Having the Body Mass Index ranged between 18.5-30 kg/m2 (see Appendix I) which is in the desirable range according to the age, 7. Ability to communicate adequately with the investigator himself or his representatives, 8. Ability and agreement to comply with the study requirements, 9. Normal blood pressure and heart rate measured under stabilised conditions at the screening visit after at least 5 minutes of rest under supine position: SBP within 100 to 140 mmHg, DBP within 60 to 90 mmHg and HR within 50 to 90 bpm, 10. Normal/ acceptable 12-lead electrocardiographic results at least after 5 minutes of rest, 11. Laboratory results within normal range or clinically non-significant (CBC, glucose, urea, uric acid, creatinine, estimated GFR (eGFR), total bilirubin, sodium, potassium, calcium, chloride, SGOT (AST), SGPT (ALT), GGT, alkaline phosphatase, total protein and urinalysis), drug addiction scanning in urine results in negative (amphetamine, barbiturate, benzodiazepine, cannabinoid, cocaine, opiate), 12. Understanding of the study and agreement to give a written informed consent according to section 20.3. 13. Understanding of that he and his partner will use a practice adequate contraception during the study and at least 7 days after the study. 14. Volunteer's compliance with isolation rules defined at study protocol Who have atopic constitution or asthma or known allergy for favipiravir and/or any other ingredients of the products. 2. Who have positive Covid-19 PCR test result. 3. Any history or presence of clinical relevance of cardiovascular, neurological, musculoskeletal, haematological, hepatic,gastrointestinal, renal, pulmonary, endocrinological, metabolism or psychiatric disease, any type of porphyria. 4. Symptomatic or asymptomatic orthostatic hypotension at screening or before the first drug administration defined by a decrease of SBP more than 20 mmHg or DBD more than 10 mmHg occurs between sitting/supine to standing position subject will be excluded (if it deemed necessary by the investigator), 5. Presence or history of malabsorption or any gastrointestinal surgery except appendectomy or except herniotomy. 6. Subjects who have given more than 400 mL blood within the last two months before the first drug administration and subjects who have participated to any drug research within the last two months before the first drug administration. 7. Subjects suspected to have a high probability of non-compliance to the study procedure and/or completion of the study according to the investigator's judgement. 8. Subjects who used any of prescribed systemic or topical medication (including OTC medication) within 2 weeks (or six elimination half lives of this medication, whichever is longer) before the initiation of the study (except single doses of analgesics which have no drug interaction with study product). 9. Use of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. 10. History of allergic response to heparin. 11. Subjects who have any chronic disease which might interfere with absorption, distribution, metabolism or excretion of the drug. 12. Subjects who regular consumed of beverages or food containing methylxanthines (e.g. coffee, tea, cola, caffeine, chocolate, sodas,) equivalent to more than 500 mg methylxanthines per day. 13. Subjects who has taken any grapefruit or grapefruit juice during 7 days prior to drug administration, during the study. 14. History of drug abuse. 15. History of alcohol abuse and/or regular use of more than 2 units of alcohol per day or 10 units per week and/or positive alcohol breath test results (Note: one unit of alcohol equals 250 mL beer, 125 mL wine or 25 mL spirits). 16. Positive blood test for HBV, HCV and HIV. 17. Who have relationship to the investigator. 18. Who are not suitable to any of criteria. 19. History of difficulty of swallowing. 20. Intake of depot injectable solutions (including study medications) within 6 months before start of the study. 21. Intake of enzyme-inducing, organotoxic or long half-life drugs within 4 weeks before start of the study. 22. Special diet due to any reason, e.g. vegetarian
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Histiocytosis Histiocytosis, Langerhans-Cell Histiocytosis Pulmonary Age >= 18 years Diagnosis of PLCH was either histologically confirmed on a biopsy of an involved tissue, or based on the combination of the following 1) an appropriate clinical picture; 2) a typical nodulo-cystic pattern on lung high-resolution computed tomography (HRCT) and 3) of alternative diagnoses
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Adenocarcinoma Pancreatic Cancer Metastatic Pain Patient ≥ 18 years old Patient with histologically or cytologically proven locally advanced and/or metastatic adenocarcinoma of the pancreas Patient undergoing or failing medical treatment and comfort care only Patient with EVA ≥ 4 and/or requiring analgesics level 3 Performans Status (ECOG) < 3 Informing the patient and obtaining free, informed and written consent signed by the patient and the investigator Patient affiliated or beneficiary of the social security system Patient does not have a smartphone, tablet or computer Patient with no personal internet access at home (WIFI, wired), or via his smartphone Patient does not feel able to fill out an electronic questionnaire Patient cannot read or write French Patient does not speak and understand French Persons deprived of liberty or under guardianship or trusteeship Dementia, mental alteration or psychiatric pathology that could compromise the patient's informed consent and/or compliance with the protocol and follow-up of the trial Inability to submit to trial protocol follow-up for geographical, social, or other reasons Patient participating in another interventional study evaluating treatment and pain management
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Acute Pancreatitis Systemic Inflammatory Response Syndrome All of the following must be met for a patient to be randomized into the study: 1. The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 1. Serum lipase > 3 times the upper limit of normal (ULN); 2. Characteristic findings of acute pancreatitis on abdominal imaging; 2. The diagnosis of SIRS has been established by the presence of at least two of the following four 1. Temperature < 36°C or > 38°C; 2. Heart rate > 90 beats/minute; 3. Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg; 4. White blood cell count (WBC) >12,000 mm3, or <4,000 mm3, or > 10% immature (band) forms; 3. At least one of the following is also present: 1. A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 12 hours before Consent or after Consent and before Randomization; 2. Abdominal examination documenting either abdominal guarding or rebound tenderness; 3. Hematocrit ≥44% for men or ≥40% for women; 4. The patient is ≥ 18 years of age; 5. Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 12 hours before Consent or after Consent and before Randomization; 6. A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days; 7. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days; 8. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol Patients with any of the following conditions or characteristics must be excluded from randomizing: 1. Expected survival <6 months; 2. Suspected presence of cholangitis in the judgment of the treating physician; 3. The patient has a known history of: 1. Organ or hematologic transplant; 2. HIV, hepatitis B, or hepatitis C infection; 3. Chronic pancreatitis; 4. Current treatment with: 1. Chemotherapy; 2. Immunosuppressive medications or immunotherapy 3. Pancreatic enzyme replacement therapy; 4. Hemodialysis or Peritoneal Dialysis; 5. The patient is known to be pregnant or is nursing; 6. The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization; 7. Allergy to eggs or known hypersensitivity to any components of study drug
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-65.0, Acute Gastroenteritis Abdominal Pain Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain Peritonitis Hemodynamic instability Pregnancy Inability to give consent Medication given in the emergency room before being included in the study Taking pain medication within 4 hours Diabetes Mellitus and other neuropathic diseases
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 0.0-999.0, Fournier Gangrene Clinical diagnosis of Fournier's Gangrene Insulin dependent diabetes (type 2) n/a
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 12.0-90.0, Scoliosis Spinal Deformity Acute Pain Chronic Pain Postoperative Pain Anesthesia Regional Anesthesia Morbidity Anesthesia, Local Anesthesia Complication Hyperalgesia Intraoperative Complications Intraoperative Hypotension Intraoperative Blood Loss Intraoperative Bleeding Intraoperative Neurological Injury Intraoperative Injury Coagulation Disorder Postoperative Nausea and Vomiting Postoperative Cognitive Dysfunction Neuropathic Pain Nutrient Deficiency Nutrition Disorders Ventilator-Induced Lung Injury Informed consent of the patient or his legal representatives to participate the study. 2. Spinal deformity that requires surgical correction. 3. No known allergies to local anaesthetics. 4. Negative intradermal test for sensitivity to local anaesthetics Refusal of the patient or his legal representatives to participate the study 2. Diabetes mellitus, known allergy to local anaesthetics 3. Acute spinal cord injury 4. Physical status according to classification ASA III and more 5. A positive intradermal test for sensitivity to a local anaesthetic
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Abdominal Aortic Aneurysm Willing and able to comply with all study procedures and visits Written informed consent to participate in the study Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively • Medical, social or psychological problems that, in the opinion of the investigator, preclude patient from receiving treatment with the TREO Abdominal Stent-Graft System
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Pseudocyst Walled Off Cavity patients with post-pancreatitis PCF endoscopically drained refuse to sign the informed consent
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-99.0, Acute Pancreatitis Criteria:All patients aged 18-99 who were admitted to the intensive care unit in Meir medical hospital between years 2010-2020, whose cause of admission was hypertriglyceridemia-induced acute pancreatitis, defined as abdominal pain, elevated levels of amylase and lipase and blood triglyceride level above 1000 mg/dl, without any other apparent etiology of pancreatitis. - None -
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Intestinal Complications Cancer Age ≥18 years old; 2. Diagnosed as malignant tumor; 3. Patients who underwent cancer-related treatment suffering from gastrointestinal symptoms(e.g., abdominal pain, diarrhea, abdominal distension, and difficulty defecating) occurred after standard tumor therapy (such as chemotherapy, radiation, immunotherapy, surgical treatment, etc.); 4. Estimated time of survival ≥ 3 months, and vital signs were stable); 5. Physically qualified and intended to undergo FMT Patients who were pregnant or nursing; 2. Patients who were unable or unwilling to undergo a gastroscopy or colonoscopy; 3. Patients with cardiopulmonary failure; 4. Antibiotics, PPI, probiotics, and other drugs that alter gut microbiota were used in the previous week; 5. history of inflammatory bowel disease and intestinal symptoms unrelated to tumor treatment; 6.Serious uncontrolled diseases and acute infectious diseases；
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-60.0, Kidney Stone to 60 years of age High risk for recurrence (1 or more of) Bilateral or complex stones, Recurrent stones, Family history (1st degree relative), Non-calcium stones, Solitary kidney or anatomical abnormality, Nephrocalcinosis, Systemic disease with risk of stones (tubular acidosis, cystinuria, etc.) Diuresis < 1.8 L/24 hours despite recommendations from physicians and/or nutritionist at the kidney stone clinic (as documented in the previous 6 months) Patient does not meet 1 of the 3 Pregnancy or breastfeeding Lack of understanding about the protocol and effects of Ure-Na Expected inability to adequately increase fluid intake on Ure-Na
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-100.0, Acute Pancreatitis Patients with acute pancreatitis diagnosis who admitted to ER within 24 hours after the beginning of abdominal pain Patients who sign a treatment rejection form immediately after admission to the hospital and leave the hospital Patients with uncompleted data Psychiatric patients Patients with very poor general conditions
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-75.0, Pancreatitis, Acute Alcohol Drinking Health Behavior Aged 18-75 years at the time of assessment Currently hospitalized with Acute Pancreatitis (AP) per Revised Atlanta Classification, which requires two of the following evidence of pancreatitis: 1. Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back) 2. Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal 3. Characteristic findings of AP on computed tomography (CT), magnetic resonance imaging (MRI) or transabdominal ultrasonography Alcohol Use Disorders Identification Test Consumption (AUDIT-C) alcohol consumption score of ≥3 Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors Chronic pancreatitis with calcification(s) Pancreatic cancer or pancreatic metastasis from other malignancies History of pancreas transplant or pancreatectomy Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures or participate in longitudinal follow up Currently incarcerated Known current pregnancy
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2
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-70.0, Type 2 Diabetes Mellitus Healthy volunteers Age [18 -30], [50-59] and [60-70] years Male and female healthy volunteers, except with skin types 5 and 6 Body weight ≥ 50 kg and BMI between [18.0 -28.0] kg/m^2 inclusive Non or ex-smokers (defined as someone who completely stopped smoking for at least 1 month before the beginning of this study) No clinically relevant findings in the medical history and physical examination, especially with regards to cardiovascular system, lung, liver and renal function Normal blood and urine laboratory tests Patients with type 2 diabetes (T2D) mellitus Male and female patients, except with skin types 5 and 6 Age [50 years
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-999.0, Critical Limb Ischemia Peripheral Arterial Disease - PAD Ischemic Ulcer Ischemic Feet Diabetic Foot Scleroderma, Systemic Thrombo Angiitis Obliterans Ischemic Leg Age > 18 Established diagnosis of CLI according to TransAtlantic InterSociety Consensus (TASC II) guidelines Ankle oxygen partial pressure < 40 mmHg with no ischaemic lesions or < 60 mmHg with ischaemic lesions Tibial injections site free from ulcers Absence of comorbidities responsible for life expectancy < 6 months Non suitability for surgery (comorbidities or angiographic results) Informed consent taken Age < 18 years Inability of understanding and signing informed consent Tibial injections sites involved by ulcers Life expectancy < 6 months Unwillingness to attend follow up Any of the following: women who are or may be pregnant or women hoping to become pregnant; women who are breastfeeding; men whose partners hope to become pregnant during the treatment period
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 20.0-80.0, Post-ERCP Pancreatitis Patients aged 20 to 80 2. As patients who developed pancreatitis after receiving ERCP, the following must be satisfied at the same time. 1. increased serum amylase or lipase 3 times higher than the normal range, at 4 hours after ERCP or the morning of the following day, 2. New or worsening abdominal pain compatible with pancreatitis, arising 4 hours after ERCP or the next morning If the intended procedure is not completed 2. If complications such as abdominal perforation or bleeding have occurred or are suspected 3. If it is judged as severe acute pancreatitis with multi-organ failure la. 4. When PEP has occurred, but additional imaging tests and endoscopy for diagnosis of the underlying disease or treatment of complications of the patient are required, and fasting is necessary regardless of this study 5. Patients with a history of chronic pancreatitis 6. Patients with malignant tumors 7. Pregnant women, lactating women
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0
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The patient is a 57-year-old man with abdominal pain and vomiting. The pain started gradually about 20 hours ago in the epigastric and periumbilical regions, radiating to his back. He drinks around 60 units of alcohol per week and smokes 22 cigarettes per day. He is healthy with no history of allergies or using any medications. His family history is positive for type 2 diabetes (his father and sister). He lives alone and has no children. The abdomen is tender and soft. His bowel sounds are normal. His heart rate is 115/min and blood pressure 110/75 mmHg. The lab results are remarkable for leukocytosis (19.5), urea of 8.5, high CRP (145), high amylase (1200) and Glc level of 15. Cross-sectional imaging was negative for obstructive pancreatitis.
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eligible ages (years): 18.0-80.0, Head and Neck Squamous Cell Carcinoma Patients aged 18-80 years. 2. Histologically confirmed malignancies involving the oral cavity, oropharynx, hypopharynx and larynx (including non-squamous cell histologies, salivary gland carcinomas and unknown primary tumors). 3. Undergoing a course of either definitive radiation (dose of at least 50 Gy to the head and neck region) +/-chemotherapy or adjuvant radiation (at least 50 Gy to the head and neck region) +/ chemotherapy (Patients with a history of prior definitive course of radiation will be allowed). 4. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2 5. Concurrent enrollment on interventional trial is allowed. 6. English speaking and literate 7. Patients will be allowed to take radiotherapy mix, viscous lidocaine or magic mouthwash like agents that do not contain opioids. Tylenol allowed for fever and mild pain before starting drug regimen. 8. Adequate organ function: Minor dose adjustments for tramadol is required in severe liver and renal impairment so we would only patients with adequate organ function outlined in below. No dose adjustment for renal or hepatic impairment is required for TD buprenorphine. Some other parameters like hemoglobin, platelets and white blood count (WBC) are required for administration of standard of care chemotherapy like cisplatin along with radiation in treatment of head and neck squamous cell carcinoma (HNSCC). They are not required for administration of buprenorphine or tramadol. 1. total bilirubin < 2 mg/dL 2. aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 5 times institutional upper limit 3. creatinine clearance > 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal" 9. Pregnancy: It is known that standard of care treatments of HNSCC radiation therapy and chemotherapy have detrimental effects on human pregnancy or development of the embryo or fetus. Therefore, female patients participating in this study should avoid becoming pregnant, and male patients should avoid impregnating a female partner. Non-sterilized female patients of reproductive age and male patients should use effective methods of contraception through defined periods during and after study treatment as specified below. Female patients must meet one of the following Postmenopausal for at least one year before the screening visit, or Surgically sterile, or If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through three months after the last dose of study drug, AND Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable contraception methods.) Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose, OR Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods] and withdrawal are not acceptable methods of contraception.) 10. Ability to understand a written informed consent document, and the willingness to sign it. 11. Possession of a smart phone (android or apple-based platforms) and ability to operate a smart phone application. Patients who do not have smart phones will be provide wireless devices that have OM pain app installed on them Physical exam demonstrating preexisting mucositis. 2. Preexisting oral infection or ongoing toxicity from prior radiotherapy. 3. History of substance abuse, positive urine drug screen in last six months. 4. Patients with multiple distant metastasis (subjects with resectable oligometastasis will be allowed) 5. Current or recent use (within four weeks of screening) of mixed opioid agonists/antagonists or other opioid antagonists. Methadone use within four weeks of screening. 6. History of prolonged QTc>greater than 450 milliseconds in males and greater than 470 milliseconds in females. 7. Patients on systemic therapy (chemotherapy or immunotherapy) for another cancer subtype. 8. Patients receiving induction chemotherapy prior to or after radiation/chemoradiation like patients with nasopharyngeal carcinoma 9. Patients with history of abdominal surgery within 60 days of registration, acute gastrointestinal conditions like colitis and appendicitis within four weeks of screening. 10. Patients with conditions that may compromise blood-brain barrier permeability. The blood-brain barrier may become leaky in select neurological diseases, such as amyotrophic lateral sclerosis, epilepsy, brain trauma and edema 11. Patients with a history of myocardial infarction ≤ 6 months prior to registration. 12. Patients with h/o significant respiratory depression; acute or severe bronchial asthma; known or suspected gastrointestinal obstruction, including paralytic ileus. 13. History of serious or severe hypersensitivity reaction to buprenorphine or tramadol or any of its excipients. 14. Patients on anti-depressant and anti-psychotic therapy 15. Pregnant and lactating women are excluded from this study because chemotherapy and radiation given for treatment of HNSCC has a potential for teratogenic or abortifacient effects. Additionally, Buprenorphine is classified as category C for use during pregnancy, which means that the risk of adverse effects on the fetus cannot be ruled out. Buprenorphine does cross the placenta, and the use of opioids during pregnancy may result in neonatal withdrawals soon after birth. Symptoms of this may irritability, apnea, increased tone, tremor, convulsions, or respiratory depression in the neonate. The onset of withdrawal in a neonate whose mother has taken buprenorphine during the pregnancy could be anywhere from the first day of life to the eighth day of life. 16. Patients with history of seizure disorder as oral tramadol may reduce seizure threshold
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