topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
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.
|
eligible ages (years): 18.0-75.0, Acute Pancreatitis Chronic Pancreatitis ALL All participants must sign an informed consent indicating that they are aware of the investigational nature of this study and willing to undergo study interventions, and authorizing the use of their protected health information for research purposes ALL Meet one set of group-specific listed below ALL All participants must be >= 18 years old and =< 75 years at the time of enrollment NO No personal history or symptoms of pancreatic disease NO No upper abdominal symptoms NO No family history of pancreatic disorders, celiac disease, cystic fibrosis NO No history of acute infectious or inflammatory conditions requiring medical treatment or evaluation in the preceding 6 months (per provider clinical judgment) NO No history of cancer, except for non-melanoma skin cancers NO No known pregnancy at the time of enrollment NO No solid organ transplant or history of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) ALL NO History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome ALL NO Primary pancreatic tumors pancreatic ductal adenocarcinoma, suspected cystic neoplasm (> 1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors ALL NO Pancreatic metastasis from other malignancies ALL NO History of solid organ transplant, HIV/AIDS ALL NO Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible criteria) ALL NO Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up ALL NO Patients with known abnormal creatinine (glomerular filtration rate [GFR] < 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP [yellow] subgroups) ALL NO Failure to agree for longitudinal follow-up ALL NO Known pregnancy. All participants of childbearing potential, except if post-menopausal [i.e. no menses for >= 2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum human chorionic gonadotropin (B-HCG) pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test
|
0
|
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.
|
eligible ages (years): 18.0-55.0, Vomiting Nausea Abdominal Pain Cannabis Use presenting to the emergency department with chief complaint of nausea or vomiting abnormal blood pressure (>200/100mmHg or <90/40mmHg) fever (>100.4F) acute trauma QT > 450ms on cardiac monitor altered mental status (GCS < 15) chest pain known allergy to haloperidol or ondansetron Parkinson's disease pregnancy or lactation use of any antiemetic in the previous 8 hours
|
0
|
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.
|
eligible ages (years): 18.0-75.0, Type 2 Diabetes Subjects who fully understand the test content and possible adverse reactions and voluntarily participate in the trial and sign the informed consent form Age: 18 to 75 years of age inclusive; no gender limitation Weight：body mass index (BMI) within the range of 18.5-35 kg/m2 (inclusive), BMI = weight (kg) / height 2 (m2) Patients have diagnosed with type 2 diabetes ≤ 3 years according to the World Health Organization (WHO1999) classification; and not on medication or without a history of regular medication for more than 1 week in the 3 months prior to screening (subjects with a history of medication only those with a history of oral medication and a history of short-term intensive insulin therapy (≤ 2 weeks)) 7.0% ≤ HbA1c ≤ 10.0% Subjects of childbearing potential must use reliable methods of contraception from the date of signing an informed consent to at least 3 months after the last dose The subject has the ability to communicate properly with the researcher and willing to fully comply with the research protocol Fasting plasma glucose ≥13.9mmol/L or a history of severe hypoglycemia (blood sugar below 2.2mmol/L) Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg during screening During the screening period, the white blood cell count fall outside the reference range by 10%, or hemoglobin<100g / L Have one or more positive tests in Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti Treponema pallidum-specific antibody Aspartate aminotransferase(AST) or Alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or triglyceride > 5.7mmol/L or eGFR<60 mL/（min*1.73 m2）during the screening period Hypercortisolism, polycystic ovary syndrome, abnormal thyroid function (those who need to be given medication or who have not reached clinical stability after treatment and whose medication still needs to be adjusted), etc. or other diseases that may affect blood glucose metabolism Have a personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary cancer; personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia, or other genetic diseases that are susceptible to medullary cancer Acute complications of diabetes (including diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, lactic acidosis and hypoglycemia coma) Proliferative diabetic retinopathy, foot ulcers/gangrene, and manifestations of peripheral neuropathy with obvious symptoms (e.g., gastroparesis, urinary retention, intestinal obstruction, urinary incontinence, and painful peripheral neuropathy)
|
0
|
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.
|
eligible ages (years): 18.0-65.0, Acute Pancreatitis Diagnosis of acute pancreatitis confirmed by revised Atlanta Admitted to the medical floor within 48 hours of emergency department arrival at Beth Israel Deaconess Medical Center (BIDMC) in Boston, Massachusetts Age 18-65 Active illicit drug use Discharged from the emergency department Direct admission to ICU from emergency department Known allergy to opioid medications Age <18 or >65 Known chronic pain syndrome or concurrent other medical condition with chronic pain Active encephalopathy/confusion/delirium/psychiatric illness or any other condition that limits capacity Known chronic opioid use Renal insufficiency (baseline Creatinine of >2 and/or acute kidney injury with Creatinine>3 on admission) Known allergy to acetaminophen or hepatic dysfunction otherwise limiting acetaminophen use
|
2
|
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.
|
eligible ages (years): 35.0-75.0, Inflammation Ambulatory, male or female, 35-75 years of age 2. Indicating "very mild," "mild, "or "moderate" for question #7 on the SF-36 Health Survey (How much bodily pain have you had during the past 4 weeks?) 3. Have had minor body discomfort, pain, or soreness occurring at least four times per week during the past 4 weeks including symptoms felt when arising in the morning, at the end of a day, during or after physical activity 4. Have personal access and able to operate a smartphone, tablet, or computer with enough memory to accommodate additional application(s) and have a reliable internet service 5. Able to print out and return documents by scan, email or by mail 6. Generally healthy and having no significant difficulty with digestion or absorption of food 7. Able to complete an Activity Log and Study Product Log daily 8. Has been generally weight stable for the past six months (+/ lbs.) 9. Willing and able to give written informed consent 10. Clearly understands the procedures and study requirements 11. Willing and able to comply with all study procedures, including following recommendations to maintain their usual diet and regular activity, as per protocol 12. Able to communicate, including reading, in English 13. Has not taken any nutritional supplements that may contain any of the components of the study products for a minimum of 14 days before Screening/baseline and for the duration of the study period - Not having basic skills needed to operate a smartphone, tablet, or computer 2. Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol (THC) in the past 30 days 3. Having donated blood within 30 days before Screening/baseline 4. Having been diagnosed with dysphagia or difficulty swallowing 5. Having participated in another study within 30 days prior to Screening/baseline 6. Being pregnant or planning on becoming pregnant during study participation; or breast feeding 7. History of allergy or sensitivity to any component of the study products 8. Having taken a lipid lowering medication (including statin medications) on a consistent basis for > 3 months and have muscle-related pain and/or anticipate a change in the medication during the study period 9. Currently taking a medication or dietary supplement specifically for pain or inflammation, including curcumin, and unwilling to washout (i.e., stop taking medication or supplement) for 14 days before Screening/baseline 10. Currently taking or having taken a fish oil, krill oil, omega-3 supplement and omega-3 prescription drugs within the past 3 months before Screening/baseline which, in the judgment of the Study Investigator/Sub-Investigator, would preclude participation in study 11. Currently taking or having taken pain medications or anti-inflammatory medication(s) (e.g., aspirin > 325 mg, non-steroidal anti-inflammatory drugs [NSAIDs], COX-2 (Cyclooxygenase-2) inhibitors, and corticosteroids) within 14 days before Screening/baseline which, in the judgment of the Study Investigator/Sub-Investigator would preclude participation in the study 12. Having been diagnosed, received medical treatment, or taking medication daily for the following medical condition(s) Acute or chronic inflammatory or autoimmune disease (including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic arthritis) Active infection Active periodontal disease 13. Having been in an accident or had surgery with resulting body discomfort, pain, or soreness 14. Having been diagnosed with a pain-related disorder or under the care of a pain specialist 15. Presence of active or recurring clinically significant conditions as follows Diabetes mellitus or other endocrine disease Eating disorder Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke, or heart valve problem Gastrointestinal disease including gallbladder problems, gallstones, or biliary tract obstruction Thyroid disease (unless on a stable dose of medication for ≥ 3 months before Screening/baseline and unlikely to change medication or dose during the study) Hypertension (unless on a stable dose of medication for ≥ 3 months before Screening/baseline and unlikely to change medication or dose during the study)
|
0
|
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.
|
eligible ages (years): 18.0-65.0, Gastric Emptying Endoscopic Sleeve Gastroplasty Gut Hormones Inflammatory Response Liver Function Insulin Resistance Obesity Diabetes Patient is 18-65 years old Has class I or II obesity (body mass index (BMI) of 30-34.9 and 35-39.9 kg/m2) Type 2 diabetes mellitus (HbA1c ≥ 6.5%) use of a weight loss medication within 6 months history of bariatric surgery or EBMT Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study Patient is unwilling or unable to sign and date the informed consent Patient is unwilling or unable to comply with the follow-up study schedule Patient for whom endoscopic procedures are contraindicated
|
0
|
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.
|
eligible ages (years): 18.0-75.0, Liver Cirrhosis Esophageal and Gastric Varices Patients with cirrhosis of gastroesophageal varices undergoing endoscopic therapy Endoscopic treatment of uncontrollable bleeding Accompanied with other endoscopic treatments that need to be fasting With obvious hepatic encephalopathy and liver failure Did not sign the informed consent form and refused to participate
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Spinal Cord Injuries Adult individual 18 years of age or older. 2. Cognitively intact and capable of giving informed consent. 3. Clinical diagnosis of Traumatic Spinal Cord Injury. 4. Subject has mesenchymal stem cells banked at Hope Biosciences. 5. The patient accepts to receive treatment and to comply with follow-up visits Clinically significant, uncontrolled cardiovascular, lung, renal, hepatic, or endocrine disease or any other acute or chronic medical condition that, in the opinion of the investigator may increase the risks associated with study participation. 2. Active Alcohol or Drug addiction. 3. Participation in concurrent interventional research studies during this study. 4. Severe organ failure (heart, kidney or liver), confirmed by additional tests or medical history. 5. Unwillingness to return for follow-up visits
|
0
|
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.
|
eligible ages (years): 18.0-90.0, Patient Engagement • Patients connected to a mechanical ventilator Patients who started enteral feeding with a nasogastric tube at least 24 hours ago Patients with no injuries to the extremity and abdominal area Patients without intestinal obstruction Patients who have not received abdominal radiotherapy and have not undergone abdominal surgery during the last six weeks Patients with Glasgow Coma Score (GCS) > 3 Patients with Acute Physiology and Chronic Health Evaluation (APACHE II)> 16 Patients given consent by their first-degree relative • Patients whose enteral feeding was discontinued during the study Patients who show signs of infection due to VAP or other infections during or before the study
|
0
|
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.
|
eligible ages (years): 18.0-75.0, Renal Disease, End Stage Healthy Subjects 1. Age 18 to 75 years of age at time of signing ICF. 2. Body mass index (BMI) between 18 and 38 kg/m2. 3. Must be willing and able to communicate and participate in the whole study. 4. Must provide written informed consent. 5. Must agree to use an adequate method of contraception 6. Healthy as defined by The absence of clinically significant illness and surgery within 4 weeks prior to dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. pre-dosing is at the discretion of the Principal Investigator The absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic (including cholecystectomy), and metabolic disease The absence of clinically significant history of lactic acidosis and severe hepatomegaly with steatosis The absence of history of suicidal tendency, disposition to seizures, state of confusion, or clinically relevant psychiatric diseases. 7. Normal renal function, i.e., eGFR or creatinine clearance ≥ 90 mL/min/1.73 m2 as calculated using the MDRD4 or Cockcroft-Gault equation; at the Principal Investigator's discretion, 24 hour creatinine clearance may be conducted to determine renal function. 8. Matched to subjects with severe renal impairment for gender, age (± 10 years), and BMI (± 15%) to the extent possible. Renal Impaired Subjects 1. Age 18 to 75 years of age at time of signing ICF. 2. Body mass index (BMI) between 18 and 38 kg/m2. 3. Must be willing and able to communicate and participate in the whole study. 4. Must provide written informed consent. 5. Must agree to use an adequate method of contraception 6. A diagnosis of renal impairment that has been stable, without significant change in overall disease status in the 3 months prior to screening as determined by the Principal Investigator, with no requirement for dialysis, and an eGFR at screening < 30 mL/min/1.73 m2 calculated using the MDRD4 equation Healthy Subjects 1. Subjects who have received any IMP in a clinical research study within the 30 days prior to IMP administration on this study. 2. Subjects who are study site, CRO or sponsor employees, or immediate family members of a study site, CRO or sponsor employee. 3. Subjects who have previously been enrolled in this study. 4. Women who are pregnant or breastfeeding. 5. Subjects who have received amisulpride for any indication within the 30 days prior to dosing. 6. Allergy to amisulpride or any of the excipients of amisulpride. 7. History of any drug or alcohol abuse in the 2 years prior to screening. 8. Regular alcohol consumption >21 units per week in the 6 months prior to screening. 9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening. 10. History of epilepsy in the 5years prior toscreening. 11. History of clinically significant syncope. 12. Family history of sudden death. 13. Family history of premature cardiovascular death. 14. Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome. 15. History of clinically significant arrhythmias or ischaemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm). 16. Conditions predisposing the volunteer to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa). 17. Clinically significant abnormal biochemistry,haematology or urinalysis at screening as judged by the investigator 18. Positive drugs of abuse test result 19. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening. 20. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening or menses) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing. 21. Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 2,000 mg per day acetaminophen) or herbal remedies in the 14 days before IMP administration 22. Administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration. 23. Failure to satisfy the investigator of fitness to participate for any other reason Renal Impaired Subjects 1. Subjects who have received any IMP in a clinical research study within the 30 days prior to IMP administration on this study. 2. Subjects who are study site, CRO or sponsor employees, or immediate family members of a study site, CRO or sponsor employee. 3. Subjects who have previously been enrolled in this study. 4. Women who are pregnant or breastfeeding. 5. Subjects who have received amisulpride for any indication within the 30 days prior to dosing. 6. Allergy to amisulpride or any of the excipients of amisulpride. 7. History of any drug or alcohol abuse in the 2 years prior to screening. 8. Regular alcohol consumption >21 units per week in the 6 months prior to screening. 9. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening. 10. History of epilepsy in the 5years prior to screening. 11. History of clinically significant syncope. 12. Family history of sudden death. 13. Family history of premature cardiovascular death. 14. Clinically significant history or family history of congenital long QT syndrome (e.g. Romano-Ward syndrome, Jervell and Lange-Nielson syndrome) or Brugada's syndrome. 15. History of clinically significant arrhythmias or unstable ischaemic heart disease (especially ventricular arrhythmias, atrial fibrillation (AF), recent conversion from AF or coronary spasm). 16. Positive drugs of abuse test result, unless caused by a documented prescription drug. 17. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results at screening. 18. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening or menses) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the dosing. 19. Administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration. 20. Failure to satisfy the investigator of fitness to participate for any other reason
|
0
|
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.
|
eligible ages (years): 0.0-999.0, Advanced Prostate Carcinoma born male diagnosed with advanced or metastatic prostate cancer able to read and speak English not born male not diagnosed with advanced or metastatic prostate cancer not able to read and speak English
|
0
|
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.
|
eligible ages (years): 55.0-80.0, Norovirus Infections To be eligible for this study, participants must meet all the following: Age 1. 55 to 80 years old inclusive at the time of signing the Informed Consent Form (ICF). Type of Participants 2. In stable and good general health, without significant medical illness, based on medical history, physical examination and vital signs at screening 3. Safety laboratory values within the following range at screening: 1. Laboratory value of < grade 1 elevation from normal or decrease from normal with no clinical significance (NCS) for alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin, 2. Laboratory value of < grade 1 from normal with no NCS for decreased: albumin, magnesium, total protein and phosphorous elevated: amylase, BUN, CPK and creatine and elevated or decreased: calcium, glucose, potassium and sodium; 4. Body mass index (BMI) between 17 and 35 kg/m2 at screening 5. Available for all planned visits and phone calls, and willing to complete all protocol defined procedures and assessments (including ability and willingness to swallow multiple small enteric-coated tablets per study dose). Gender and Reproductive Considerations 6. Male or female participants Female participants must provide a negative pregnancy test at screening and baseline or be at least one year post-menopausal or surgically sterile. Female participants of childbearing potential must be willing to use a reliable oral, implantable, transdermal or injectable contraceptive for 30 days prior to and until 60 days post last study drug administration. The form of contraception must be approved by the Investigator Contraception use by men should be consistent with local regulations regarding the methods of contraception for participants in clinical studies. Informed Consent 7. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol The participants must be excluded from participating in the study if they meet any of the following: Medical Conditions 1. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline 2. Cancer, or treatment for cancer treatment, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma) 3. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus 4. History of irritable bowel disease or other inflammatory digestive or gastrointestinal condition that could affect the distribution/safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine. Such conditions may but are not limited to: 1. Esophageal Motility Disorder 2. Malignancy 3. Malabsorption 4. Pancreaticobiliary disorders 5. Irritable bowel syndrome 6. Inflammatory Bowel Disease 7. Surgical Resection 8. GERD 9. Hiatal Hernia 10. Peptic Ulcer (History of cholecystectomy is not exclusionary) 5. History of any form of angioedema 6. History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain 7. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic 8. Any condition that resulted in the absence or removal of the spleen 9. Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam). (Assessment may be repeated during screening period.) 10. Presence of a fever ≥ 38oC measured orally at baseline (Assessment may be repeated during screening period) 11. Any significant hospitalization within the last year which in the opinion of the investigator or sponsor could interfere with study participation. 12. Any other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a participant taking in the study, would render the participant unable to comply with the protocol or would interfere with the evaluation of the study endpoints Diagnostic Assessments 13. Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) tests at the screening visit 14. Stool sample with occult blood at screening 15. Positive urine drug screen for drugs of abuse at screening 16. Positive breath or urine alcohol test at screening and baseline 17. Positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection by reverse transcription polymerase chain reaction (RT-PCR) at screening and by SARS- CoV-2 Rapid Antigen Test at baseline. If Rapid Antigen Test is positive, the test can be repeated using RT-PCR at baseline. If retest by PCR is also positive, the subject is ineligible. Prior/Concurrent Therapy 18. Receipt of a licensed vaccine within 14 days prior to baseline vaccination or planned administration during the study active period (Day 57) 19. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 7 days prior to study drug administration or planned use during the active study period (Day 57) 20. Use of medications known to affect the immune function (e.g., systemic corticosteroids and others) within 2 weeks before study drug administration or planned use during the active study period (Day 57) 21. Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the active study period (Day 57) 22. Administration of any investigational vaccine, drug or device within 8 weeks preceding study drug administration, or planned use within the duration of the study Other Exclusions 23. Donation or use of blood or blood products within 30 days prior to study drug administration or planned donation during the active study period (Day 57) 24. History of drug, alcohol or chemical abuse within 1 year of screening 25. History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin
|
0
|
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.
|
eligible ages (years): 18.0-999.0, Pulmonary Embolism Pulmonary Embolus/Emboli Pulmonary Disease Pulmonary Embolism and Thrombosis Pulmonary Embolism Subacute Massive Pulmonary Embolism Acute Massive Patient ≥ 18 years of age The patient must understand and sign informed consent form (ICF) Patients requiring intensive care unit (ICU) level care with a confirmed diagnosis of pulmonary embolism (PE) by computed tomography (CT) angiogram or endobronchial ultrasound (EBUS) prior to or within 4 hours of initiation of any PE therapy or intervention If a patient already has non-invasive hemodynamic monitoring by the Edwards system or by other systems, such as the Cheetah NICOM system, as part of their standard of care, this patient can still be enrolled. If the patient is already being followed by another system such as NICOM, the Edwards system would be added to it as long as the patient consents BMI < 20 or BMI > 35 Height less than 120 cm Diagnosis of atrial fibrillation, moderate to severe aortic or mitral valve insufficiency or stenosis, scleroderma, or end-stage renal disease Patients on extracorporeal membrane oxygenation (ECMO)
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-75.0, Diverticulitis, Colonic Acute Disease At least three of the following signs or symptoms of an acute attack of sigmoid diverticulitis must be present: *Fever (body temperature > 38°C, sublingual), *Abdominal tenderness, *Leukocytosis (leukocytes > 10,000/µl) and left shift of the differential blood count (>1% band forms), *Elevated CRP (> 20 mg/l) Evidence of sigmoid diverticulitis by contrast enema CT evidence of wall thickening in the sigmoid intestine Decision in favor of conservative therapy on the basis of the case history and diagnosis Contraindication for the use of the study medication or other beta-lactam antibiotics, e.g. patients with advanced renal impairment or patients requiring hemodialysis Antibiotic therapy in the two weeks prior to the start of the study Patients with an advanced incurable disease Patients with a hematologic/oncologic disease (leukemia, lymphoma) Patients on immunosuppressants Complications of sigmoid diverticulitis leading to an immediate indication for surgery Patients who have hypersensitivity to beta-lactam antibiotics Female patients who are pregnant or nursing or who could become pregnant during the study Participation in another clinical study or use of another study drug within the four weeks prior to enrollment in the study or use of another drug during the study Each patient can be enrolled only once in the study
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Appendicitis Before CT scanning Clinical suspicion of appendicitis Age more than 18 years Clinical signs of generalized peritonitis Previous take of antibiotics within the 5 days preceding the presentation Allergy or intolerance to lactamases and/or clavulanate potassium Corticosteroid or anticoagulant therapy Patient with a known inflammatory bowel disease (Crohn's disease or ulcerative colitis) Pregnant women Patient with iode allergy Renal insufficiency (creatinine > 200 ) CT scanning Appendix diameter > 6 mm Appendix non visualised
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-65.0, IBS-C and IBS With Mixed Bowel Habits women, outpatients, 18-65 years of age with IBS-C or IBS with mixed bowel habits In the 12 months preceding study entry, they had to have at least 12 weeks (not necessarily consecutive) of abdominal discomfort/pain with 2 out of 3 features: 1) relieved with defecation; 2) onset associated with a change in stool frequency; 3) onset associated with a change in form (appearance) of stool Had to fulfill the following (IBS questionnaire) during the last 3 months prior to study entry: abdominal discomfort or pain present during at least 3 weeks in the last 3 months, and at least two of the following: abdominal discomfort or pain gets better or stops after a bowel movement; change in bowel movement frequency when the abdominal discomfort or pain starts; change in bowel movement consistency when the abdominal discomfort or pain starts IBS-D not reporting any constipation and diarrhea evidence of structural abnormality of the gastrointestinal tract or diseases/conditions that affect bowel transit history of bowel obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or abdominal adhesions evidence of cathartic colon or history of laxative abuse Other protocol-defined inclusion/
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 16.0-999.0, Appendicitis Criteria:patients with appendicitis, not receiving operation - nil -
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours Fever plus other symptoms such as nausea, vomiting, abdominal pain Cancer Medicines that suppress the immune system Dialysis
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Clostridium Infections Diarrhea Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe abdominal pain or discomfort Subject has a positive Clostridium difficile stool toxin assay at screening Subject has had a previous episode of clinically diagnosed Clostridium difficile within the past 6 months Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel disease or diarrhea predominant irritable bowel syndrome [DIBS]) Subject has had any therapy with any agent administered for the treatment of Clostridium difficile prior to randomization
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, PAIN CHRONIC DISEASE Male and female subjects at least 18 years of age and of legal age of consent for the state in which they live Able to respond to a questionnaire written in English Report chronic pain (constant or recurring pain lasting more than 30 days and causing significant discomfort or limitation of activity) Provide informed consent to participate in the study Currently participating in another clinical trial Institutionalized person such as a prisoner or nursing home resident Questionnaire response suggests a medical or psychological condition that, in the opinion of the investigator, would compromise participation in the study, or suggests any other condition which, in the investigator's judgment, might increase the risk to the subject or decrease the chance of obtaining valid data Pain has resulted in a workman's compensation case Pain has resulted in litigation
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Constipation Fecal Incontinence Spinal Cord Injury Aged 18 or over Spinal cord lesion at any level at least 3 months from injury At least one or more of the following symptoms Spending ½ hour or more attempting to defecate each day or every second day Symptoms of autonomic dysreflexia before or during defecation Abdominal discomfort before or during defecation Episodes of faecal incontinence once or more per month The patient is able to understand the treatment and is willing to comply with the prescribed regimen The patient is able to perform transanal colonic irrigation seated on a toilet commode with or without assistance Signed informed consent has been obtained Co-existing major unsolved physical problems due to the injury Perform transanal retrograde irrigation on a regular basis Evidence of bowel obstruction Evidence of inflammatory bowel disease History of cerebral palsy or cerebral apoplexy Multiple sclerosis Diabetic polyneuropathy Previous abdominal or perianal surgery (not including minor surgery as appendectomy or haemorrhoidectomy) Pregnant or lactating Evidence of spinal chock
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Enterocolitis Pseudomembranous Colitis Antibiotic-associated Colitis Subjects will be identified based on the diagnosis of CDAD. This diagnosis is made bases on the presence of diarrhea, fever, abdominal pain and/or leukocytosis together with a positive fecal assay for Clostridium difficile toxin Patients who are unable to take oral medications and those with underlying gastrointestinal disease or colonostomy will be excluded Patients currently taking penicillins, cephalosporins, quinolones or tetracyclines will be excluded because these drugs are active against Lactobacillus
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Abdominal Pain Surgical Adhesions Must have history of prior surgery and documented adhesions during laparoscopy or open laparotomy within 5 years Must have undergone an evaluation to other causes of abdominal pain Abdominal pain must be present for greater than three months duration Patients that are pregnant or breast feeding Prior treatment with gabapentin, pregabalin or demonstrated sensitivity to these drugs Patients who are immunocompromised Patients with significant hepatic or renal insufficiency, or any significant hematologic disorder History of illicit alcohol or drug abuse within one year Documented serious or unstable medical or psychological condition Malignancy within the past 5 years other than in situ squamous cell carcinoma of the skin
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 10.0-999.0, Chronic Granulomatous Disease Crohn'S-like IBD Inflammatory Bowel Disease (IBD) Group One Must have a confirmed CGD diagnosis Must have IBD documented by medical history or documented IBD endoscopically Must not be pregnant or breastfeeding Must have a home physician Must be willing to submit samples for storage. Group Two Must have a confirmed CGD diagnosis Must have IBD documented by medical history or documented IBD endoscopically Must be symptomatic Must have negative results on stool examination for culture of enteric pathogens, such as Salmonella, Shigella, Yersinia, Campylobacter, E. coli O157/H7, Clostridium difficile toxin assay, enteric parasites and their ova such as Cryptosporidia, Cyclospora, Microsporidia and Giardia (by stool enzyme immunoassay [EIA]) prior to the start of receiving TNF? inhibitors Group One Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study. Group Two Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study Positive TB diagnosis Patients who are in the at-risk group for treatment such as history of tuberculosis, congestive cardiac failure or myocardial infarction within the last 12 months unstable angina, thrombocytopenia (platelet < 100, 000), uncontrolled hypertension Acute systemic or intestinal infection(s) Evidence of Hepatitis B or C infection Signs and symptoms of hepatotoxicity Pregnant or breastfeeding History of cancer within the last 10 years
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 5.0-18.0, Functional Abdominal Pain at least 3 episodes of abdominal pain over the previous 3 months normal complete blood count, sedimentation rate, urinalysis stable on current medications English speaking - unwillingness to participate chronic gastrointestinal disease cognitive-developmental delay major dissociative disorder -
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 20.0-65.0, Influenza Fever ≥ 380C The presence of at least one of the following respiratory symptoms: cough, sore throat, nasal congestion/ runny nose The presence of at least one of the following systemic symptoms: headache, fatigue, myalgia, chills/sweats, malaise Pregnant women or women who cannot pregnancy Patients with diabetes Immune-suppressed patients, including patients taking immunosuppressive drugs Patients with renal failure Patients who received the recent influenza vaccine
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Ileus Subject is scheduled for a partial small/large bowel resection of primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids Subject is scheduled for a total colectomy, colostomy, ileostomy Subject has complete bowel obstruction Subject is currently taking opioid analgesics or has taken opioid analgesics within 4 weeks prior to surgery
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Ileus Subject is scheduled for a partial small/large bowel resection of primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids Subject is scheduled for a total colectomy, colostomy, ileostomy Subject has complete bowel obstruction Subject is currently taking opioid analgesics or has taken opioid analgesics within the prior 2 weeks
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Ileus Subject is scheduled for a partial small/large bowel resection with primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids Subject is scheduled for a total colectomy, colostomy, ileostomy Subject has complete bowel obstruction Subject has recently been on an acute course (1-10 days) of opioid analgesics and has not been off all opioids for at least 1 week prior to surgery Subject has been on chronic (>10 days) opioid analgesics and has not been off all opioids for at least 2 weeks prior to surgery
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 15.0-45.0, Chronic or Recurrent Appendicitis Patients were eligible if they were between 15 and 45 years of age, and if they suffered from chronic or recurrent right lower abdominal quadrant pain for more than three months. They were to experience continuous pain, or should have endured at least one pain attack in the month prior to inclusion consisted of (a history of) chronic back pain, previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization), specific gastro-intestinal entities (such as inflammatory bowel disease) and gynaecological disease (all female patients consulted a gynaecologist). Routine laboratory investigations included hemoglobin rate, serum leukocyte count and differentiation, C-Reactive Protein concentration, Erythrocyte Sedimentation Rate, faeces cultures and urine sedimentation. Barium contrast studies of the colon were done in all patients, abdominal ultrasound or enteroclysis on discretion. Finally, was possible when diagnostic laparoscopy revealed abnormalities (see below)
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Dyspepsia Participants who are capable of providing informed consent, ages 18 years old and older. Partipants who are taking non-steroidal anti-inflammatory drugs on a daily basis must present with at least a 1 week history of dyspeptic symptoms including epigastric or upper abdominal discomfort or pain Participants presenting with only a complaint of heartburn will be excluded. Participants with alarm symptoms of vomiting, evidence of bleeding, inadvertent weight loss, or dysphagia will be excluded. Participants will be excluded if they have had upper endoscopy within 6 months prior to randomization. At the initial visit, participants will have a Helicobacter pylori IgG serology drawn and all participants with a positive serology will be excluded. Participants with a previous history of myocardial infarction, cerebrovascular infarction, gastric or duodenal ulcer disease, or carcinoma will be excluded. The study will not enroll participants who have received a H, K-ATPase inhibitor within the past 2 weeks. At the initial upper endoscopy, all participants with esophageal ulcer, esophageal cancer, gastric ulcer, gastric cancer, and duodenal ulcer will be excluded
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 5.0-18.0, Pain to 18 years of age Spoke English as a primary language Complained of an extremity injury with tenderness to palpation from the clavicle or femoral neck to the distal phalanges Scored 5 or greater on a 10-point ordinal or Varni-Ryan pain scale administered at triage Allergy or prior adverse reaction to acetaminophen, codeine or ibuprofen Administration of any analgesic within 6 hours of presentation Significant deformity or vascular insufficiency of the extremity requiring immediate treatment as determined by the treating physician Inability to use the study pain instrument Any laceration near the suspected injury Chronic hepatic or renal disease Pregnancy in the third trimester Concurrent use of contraindicated medications such as monoamine oxidase inhibitors; or Use of central nervous system depressants such as ethanol, benzodiazepines, barbiturates, antidepressants, or recreational drugs
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Abdominal Abscess Hospitalized male or female patients greater than or equal to 18 years of age Patients must be a candidate for or have had a laparotomy, or laparoscopy of an intra-abdominal abscess Patients with a complicated intra-abdominal infection such as an intra-abdominal abscess an intra-abdominal abscess (including liver and spleen) that develops in a post-operative patient after receiving > 48 hours and less than or equal to 5 days of a non-study antibiotic. An intra-abdominal culture must be obtained from the infected site appendicitis complicated by perforation (grossly visible) and abscess and/or periappendiceal abscess perforated diverticulitis complicated by abscess formation or fecal contamination complicated cholecystitis with evidence of perforation or empyema perforation of the large or small intestine with abscess, or fecal contamination purulent peritonitis or peritonitis associated with fecal contamination Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed Active or treated leukemia or systemic malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy or antineoplastic therapy within the past 3 months, or any metastatic malignancy to the abdomen with life expectancy less than 6 months Anticipated length of antibiotic therapy less than 5 days
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-75.0, Appendicitis Cholelithiasis Gallstones for transvaginal appendectomy: 1. Females between the ages of 18-75 2. Clinical diagnosis of appendicitis 3. Emergency room evaluation within 36 hours of the onset of pain 4. ASA Classification 1 5. Mentally competent to give informed consent 6. Scheduled to undergo a transvaginal NOTES appendectomy for transvaginal appendectomy: 1. Pregnant women (need to have negative icon in ER) 2. Morbidly obese patients (BMI >35) 3. Patients who are taking immunosuppressive medications or are immunocompromised 4. Patients with evidence of an abdominal abscess or mass 5. Patients who present with a clinical diagnosis of sepsis or peritonitis 6. Patients who have a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included. 7. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis 8. Patients with diffuse peritonitis on clinical exam 9. Patients on blood thinners or aspirin or abnormal blood coagulation tests for transvaginal cholecystectomy: 1. Females between the ages of 18 and 75 2. Diagnosis of gallstone disease which requires cholecystectomy 3. ASA class 1 4. Mentally competent to give informed consent 5. Scheduled to undergo a transvaginal NOTES cholecystectomy for transvaginal cholecystectomy: 1. Pregnant women 2. Morbidly obese patients (BMI > 35) 3. Patients who are taking immunosuppressive medications and/or immunocompromised 4. Patients with severe medical comorbidities will be excluded. 5. Patients with a presumed gallbladder polyps, mass or tumor 6. Patients with a history of prior transvaginal surgery. Patients with prior laparoscopic surgery will be included. 7. Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis 8. Patients with known common bile duct stones 9. Patients on blood thinners or aspirin or abnormal blood coagulation tests
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-75.0, Appendicitis Cholelithiasis for the Group #1 transgastric appendectomy: 1. Males and Females between the ages of 18-75 2. Clinical diagnosis of appendicitis Emergency room evaluation within 36 hours of the onset of pain 3. ASA classification I 4. Mentally competent to give informed consent. 5. Scheduled to undergo a transgastric NOTES appendectomy for group #1 transgastric appendectomy: 1. Pregnant women 2. Morbidly obese patients (Body mass index > 35) 3. Patients who are taking immunosuppressive medications or are immunocompromised 4. Patients who are on Proton Pump Inhibitors (PPI) 5. Patients with evidence of an abdominal abscess or mass on CT scan 6. Patients who present with a clinical diagnosis of sepsis 7. Patients who have a history of open abdominal surgery 8. Patients with diffuse peritonitis 9. Patients on blood thinners or aspirin for Group #2 transgastric cholecystectomy: 1. Males and Females between the ages of 18 -75 2. Diagnosis of gallstone disease that require cholecystectomy 3. ASA classification I 4. Mentally competent to give informed consent. 5. Scheduled to undergo a transgastric NOTES cholecystectomy for Group #2 transgastric cholecystectomy: 1. Pregnant women 2. Patients with a Body mass index > 35 3. Patients who are taking immunosuppressive medications or are immunocompromised 4. Patients who are on Proton Pump Inhibitors (PPI) 5. Patients with suspicion of gallbladder cancer 6. Patients with a history of open abdominal surgery 7. Patients with known common bile duct stones (gallstones are not limited to the gallbladder) 8. Patients on blood thinners or aspirin
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-60.0, Lateral Periorbital Wrinkles Main Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile Main Significant facial asymmetry
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-50.0, Gallbladder Diseases Appendicitis for group #1 Transvaginal cholecystectomy: 1. Females between the ages of 18 and 50 2. Diagnosis of gallstone disease which requires cholecystectomy 3. ASA class 1 for group #1 Transvaginal cholecystectomy: 1. Pregnant women 2. Morbidly obese patients (BMI > 35) 3. Patients who are taking immunosuppressive medications and/or immunocompromised 4. Patients with severe medical comorbidities will be excluded. 5. Patients with a presumed gallbladder polyps, mass or tumor 6. Patients with a history of prior open abdominal or transvaginal surgery. 7. Patients with a prior history of peritoneal or vaginal trauma 8. Patients with a history of ectopic pregnancy, pelvic inflammatory disease, or severe endometriosis 9. Patients with known common bile duct stones 10. Patients on blood thinners or aspirin or abnormal blood coagulation tests for group #2 Transvaginal appendectomy: 1. Clinical diagnosis of appendicitis 2. Emergency room evaluation within 36 hours of the onset of pain 3. ASA Classification for group #2 Transvaginal appendectomy: 1. pregnant women 2. Morbidly obese patients (BMI >35) 3. Patients who are taking immunosuppressive medications or are immunocompromised 4. Patients with evidence of an abdominal abscess or mass 5. Patients who present with a clinical diagnosis of sepsis or peritonitis 6. Patients who have a history of prior open abdominal surgery or prior transvaginal surgery. 7. Patients who endorse a history of ectopic pregnancy, pelvic inflammatory disease (PID), or severe endometriosis 8. Patients with diffuse peritonitis on clinical exam 9. Previous trauma to the perineal area 10. Patients on blood thinners or aspirin or abnormal blood coagulation tests
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-18.0, Appendicitis All children under the age of 18 years with diagnosed appendicitis Refusal of consent Primary language other than English or Spanish
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-70.0, Diabetic Neuropathy diagnosis of diabetic neuropathy must have some pain daily in the lower limbs due to diabetic polyneuropathy for at least 3 months prior to enrollment must be willing to comply with study directions, write information in a diary (such as pain medications taken), read and comprehend written instructions, complete questionnaires, and have the ability to apply the cream as directed uncontrolled pain that has persisted for > 12 months
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-120.0, Pancreatic Cancer Histologically confirmed adenocarcinoma of the pancreas Resectable, marginally resectable, or unresectable disease determined by one of the following Contrast-enhanced helical-CT scan Endoscopic ultrasound with biopsy (in patients who do not have metastatic or grossly unresectable disease) Dedicated pancreatic MRI Tumor must be locally advanced or potentially resectable, as determined by one of the following Abutment of the portal or superior mesenteric veins, hepatic or superior mesenteric artery Extension to the origin of gastroduodenal artery Occlusion of the superior mesenteric vein for < 2 cm Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint. Patients who suffered from a isolated rupture of the Anterior Cruciate Ligament with instability of the knee joint will be included in the study Patients with a meniscal tear that can be sutured will also be included. Partial meniscectomies are accepted Patients with chronic laxity (longer than 9 months), associated collateral laxity (grade III), subtotal or total meniscectomy, infection or inflammatory disease of the knee joint or large cartilage lesion will not be included in the study
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Pain Patients scheduled for OGD at the outpatient clinic of Telemark Hospital Age <18 Inability to give an informed concent Unsatisfactory norwegian language skills Patients not willing to participate COPD with dyspnoea NYHA 3-4
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Pain Adult ( more than 18 years old) patients with chronic pain after groin hernia surgery, and pain related impairment of everyday function. The pain should have occurred after previous open surgery The patient should be able to locate to a specific area with maximum pain. Patients should be able to understand and use pain scales, and the AAS-scale All that contradicts the above
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-45.0, Pelvic Pain Women with chronic diagnosis of pelvic pain; 2. Women in menacme; 3. Presence of the diagnostic for abdominal myofascial syndrome; 4. Agreement with the Term of Free and Clarified Assent Endometriosis, interstitial cystitis, syndrome of the irritable intestine or another illness that it justifies or it contributes for chronic pelvic pain; 2. Endometrioma or hernia evidenced to the ultrasound of the abdominal wall
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Abscess, Intra-Abdominal Patients who attained full age (18 years) with intra-abdominal abscesses documented by: A) Laparotomy revealing intra-abdominal abscess or macroscopic gastrointestinal perforation OR B) Suspected intra-abdominal abscess and scheduled for operation with at least three of the following fever leucocytosis symptoms referable to the abdominal cavity (nausea, pain) tenderness with or without rebound / abdominal wall rigidity radiological evidence for abscess or gastrointestinal perforation Patients with the following indwelling peritoneal catheter presumed spontaneous bacterial peritonits peripancreatic sepsis or infection secondary to pancreatitis peptic or traumatic perforation of gastrointestinal tract of < 24 h duration traumatic perforation of the small or large bowel of < 12h duration transmural necrosis of the intestine due to acute embolic, thrombotic or obstructive occlusions acute cholecystitis appendicitis without perforation or abscess required open abdomen techniques for management
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Colonic Neoplasms Consecutive adult patients (aged 18 or above) presenting with clinical features of left colonic obstruction were potential candidates In the absence of peritonitis, right lower quadrant tenderness or grossly distended caecum (10cm or above in maximal dimension) on plain abdominal radiograph, an urgent water-soluble single contrast enema was performed to determine the level of obstruction within 24 hours of admission Patients were recruited if the lower border of an obstructing tumour was found between the splenic flexure and rectosigmoid junction Informed consent was obtained from every patient recruited in the trial Patients who did not give informed consent Patients who were considered unfit for operative treatment Patients with previous laparotomy Patients with clinically palpable tumor on abdominal examination
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-75.0, Pain, Postoperative Must be a man or woman who is ≥ 18 and ≤ 75 years of age Has a body mass index (BMI) > 19 and < 40 kg/m2 Has a planned elective surgery that requires a vertical or transverse abdominal incision (including but not limited to abdominal aortic aneurysm repair, cholecystectomy and simple bowel resection) to be performed according to standard surgical technique under general anesthesia Has a risk classification of I, II or III according to the American Society of Anesthesiologists (ASA) If female, is nonpregnant (negative pregnancy test at Screening and Day 0 before surgery) and nonlactating If female, is either not of childbearing potential or practicing a defined medically acceptable method of birth control and agrees to continue with the regimen throughout the study Is free of other physical or mental conditions that, in the opinion of the Investigator, may confound quantification of postoperative pain resulting from the surgery Has the ability and willingness to comply with the study procedures and the use of the pain scales; is deemed capable of operating a PCA device; and is able to communicate meaningfully with the study staff Must voluntarily sign and date an informed consent form (ICF) that is approved by an IRB prior to the conduct of any study specific procedures Must be able to fluently speak and understand English and be able to provide meaningful written informed consent for the study Has known hypersensitivity to amide local anesthetics, opioids or bovine products, or to inactive ingredients of the test article Has 1 of the following surgical procedures planned: total abdominal hysterectomy, omentectomy or surgical procedure for staging cancer Requires the use of Seprafilm® or other absorbable adhesion barriers for the GI surgery. Requires any additional surgical procedures either related or unrelated to the GI surgery during the same hospitalization Is required to receive neuraxial (spinal or epidural) opioid analgesics during the study Has cardiac arrhythmia or atrioventricular (AV) conduction disorders Concomitantly uses antiarrhythmics (eg, amiodarone), propranolol or strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide antibiotics and grapefruit juice) Has used long acting analgesics within 24 hours of surgery. Short acting analgesics such as acetaminophen may be used on the day of surgery but are subject to preoperative restrictions for oral intake Has used aspirin or aspirin containing products within 7 days of surgery. Aspirin at a dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the patient has been on a stable dose regimen for ≥ 30 days prior to Screening Has undergone another major surgery within 3 months of the GI surgery Has known or suspected history of alcohol or drug abuse or misuse within 3 years of Screening or evidence of tolerance or physical dependency on opioid analgesics or sedative hypnotic medications
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-999.0, Abdominal Pain All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-999.0, Perforated Appendicitis Appendicitis and a preoperative laboratory workup with Leukocytes, C-reactive Protein, Bilirubin and liver transaminases GOT and GPT Alcoholism A history of viral hepatitis Gilbert's disease Dubin Johnson syndrome BRIC (benign recurrent intra-hepatic cholestasis) and other documented biliary Hemolytic or liver diseases associated with hyperbilirubinaemia
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 12.0-80.0, Perforated Appendicitis All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent Age less than 12 years older than 80 years perforated appendicitis was not revealed by pathologic investigation diverticulitis being diagnosed during surgery pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation the patient declining to enroll in this study
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 21.0-64.0, Pain Age greater than 21 years: Patients under the age of 21 are automatically triaged to the Children's Hospital at Montefiore Emergency Department, and hence cannot be enrolled in this study. 2. Age less than 65 years of age: Patients age 65 and over will be excluded in this study as the effects on opioids on the elderly may be different than in the non-elderly. 3. Pain with onset within 7 days: Pain within seven days is the definition of acute pain that has been used in ED literature. 4. ED attending physician's judgment that patient's pain warrants use of morphine: The factors that influence the decision to use parenteral opioids are complex and extensive. An approach that is commonly taken to address the issue of patient selection in drug trials is to use a specific condition (e.g., renal colic) or treatment (e.g., post-hysterectomy) that would generally be thought to be appropriately treated with an opioid analgesic, thereby eliminating individual judgment about for the study. However in order to assess the role of hydromorphone with the widest generalizability in the ED setting, we decided to enroll patients with a variety of diagnoses, all with a complaint of acute pain. Opioids are not an appropriate treatment for all patients who present with a complaint of pain (e.g., gastroenteritis, migraine). Therefore, unless there is a restriction to patients with a specific diagnosis, either a comprehensive list of diagnoses and situations in which opioids are indicated must be specified, or clinical judgment needs to be used. We have opted for the latter alternative. 5. The use of patients with a variety of diagnoses, and therefore heterogeneous painful stimuli, risks masking a treatment effect because of large inter-individual variability. There are several design and analytic factors (detailed below) that attenuate this risk: 1) a sufficiently large number of patients will be randomly assigned to each group so that the variety of painful stimuli will be equally distributed between treatment groups; 2) change in pain intensity and pain relief will be analyzed rather than absolute pain intensity or pain relief therefore reducing variability. 6. Normal mental status: In order to provide measures of pain experienced the patient needs to have a normal mental status. Orientation to person, place and time will be used as an indicator of sufficiently normal mental status to participate in the study Prior use of methadone: the effect of methadone use on the perception of acute pain is unknown and suspected to be altered. We feel that the needs of patients on methadone may exceed the dosage ceiling of 2mg that will be used for this study. Similar to sickle cell patients and chronic cancer patients, patients on methadone usually require significantly higher doses of opioids to control their pain. Thus, we feel that it would be unethical to restrict the dose that this subset of patients can receive. 2. Use of other opioids or tramadol within past seven days: to avoid introducing bias related to opioid tolerance that may alter the response to the study medication thereby masking the medication's effect. 3. Prior adverse reaction to hydromorphone. 4. Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months result in alteration in pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes sickle cell anemia, osteoarthritis, fibromyalgia, migraine, and peripheral neuropathies. 5. Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter perception, report, and treatment of pain. 6. Systolic Blood Pressure <90 mm Hg: Hydromorphone can produce peripheral vasodilation that may result in orthostatic hypotension or syncope. 7. Oxygen saturation <95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled. 8. Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAOs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma. 9. C02 measurement greater than 46: In accordance with a similar study (04-12-360), three subsets of patients will have their CO2 measured using a handheld capnometer prior to enrollment in the study. If the CO2 measurement is greater than 46, then the patient will be excluded from the study. The 3 subsets are as follows: 1. All patients who have a history of chronic obstructive pulmonary disease (COPD) 2. All patients who report a history of asthma together with greater than a 20 pack-year smoking history 3. All patients reporting less than a 20 pack-year smoking history who are having an asthma exacerbation 10. Pregnancy: this will be determined by asking the female of reproductive age about her pregnancy status and/or through the results of urine or serum pregnancy test
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 8.0-22.0, Abdominal Pain to 22 years old Diagnosed with RAP as verified by a physician, and having at least twice weekly episodes of abdominal pain which cause the patient to withdraw from normal activities At least one month trial on a high fiber diet without resolution of abdominal pain Ambulatory Focal abdominal pain by history or physical exam, unless a negative (including endoscopic) evaluation has been performed Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent), peptic ulcer disease, gastrointestinal infection (unresolved), or ongoing gastrointestinal inflammation Current or recent (within the past year) pregnancy and/or current breastfeeding Current diagnosis of nephropathy or genitourinary disease Blood in stools or emesis (EXCEPTION: blood in the stool secondary to hemorrhoids is not an criterion) Unintentional loss of over 10% body weight over the past 3 months or weight < 100% ideal body weight Recurrent fevers (T>100F) at least once a week or with abdominal pain episodes Recurrent dehydration with abdominal pain episodes requiring intravenous rehydration Current personal diagnosis of depression or report of suicidality, mania or bipolar disorder Family history of mania or bipolar disorder
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Appendicitis years and older who present to the York Hospital Emergency Department with signs and symptoms suggestive of acute appendicitis, but in whom the diagnosis remains unclear as determined by an attending emergency physician or consulting surgeon and in which a CT scan is needed to further assist in the diagnosis pregnant patients patients with known IV dye or oral contrast allergy patients in whom acute appendicitis is not the primary diagnosis patients with renal insufficiency that may have significant adverse effect from IV dye
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Pancreatic Cancer Pancreatic Adenocarcinoma Pathologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma, AJCC stage IV 2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as =/>20 mm with conventional techniques or as =/>10 mm with spiral CT scan. See Section 11 for the evaluation of measurable disease. Measurable disease must be present outside a previous radiation field or if inside, it must be a new lesion. 3. At least 6 months must have elapsed after completion of adjuvant therapy (if applicable). 4. Age =/>18 years. 5. ECOG Performance Status 0-1 (Karnofsky =/>60%). 6. Patients must have adequate organ and marrow function as defined below: 1) leukocytes =/>3,000 cells/mm^3; 2) absolute neutrophil count =/>1,500 cells/mm^3; 4) platelets =/>100,000 cells/mm^3; 5) total bilirubin <1.5mg/dl; 6) AST(SGOT)/ALT(SGPT) =/<2.5 X institutional upper limit of normal for patients without liver metastasis, =/< 5X institutional upper limit of normal for patients with liver metastasis; 7) creatinine within normal institutional limits OR creatinine clearance =/>60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal 7. Fasting blood glucose =/<160 mg/dl, prior to study enrollment. (For higher values, blood glucose may be controlled by dietary intervention, oral hypoglycemics and/ or insulin prior to enrollment). 8. Women of child-bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use adequate contraception for the duration of study participation. Acceptable contraception is defined as double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable contraception must be used for 90 days after last dose of study drugs. 9. (Continuation of # 8) Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 10. Ability to understand and the willingness to sign a written informed consent document. Signed informed consent form must be obtained prior to initiation of study evaluations and/or activities. 11. INR <1.5 (or =/<3 if on anticoagulation therapy) 12. Both men and women and members of all races and ethnic groups are eligible for this trial. 13. In phase II expansion cohort, which is primarily for predictive biomarker correlation, patients enrolled will be those with pre-existing core biopsies of primary tumor or metastatic site or must be willing to undergo a biopsy for correlative studies Prior systemic chemotherapy or biological therapy for metastatic disease 2. Prior exposure to IGF-1R inhibitors. 3. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Pregnant or nursing women are excluded from this study because there is an unknown but potential risk for adverse events in infants secondary to treatment of the mother the study agents. If a pregnancy test (serum or urine) is positive, patient will be excluded. 7. Patients who are known to be HIV-positive are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. 8. No other prior malignancy is allowed except for the following: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for two years. 9. Patients must not be currently enrolled in a therapeutic study for pancreatic cancer
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Periacetabular Osteotomy Pain Periacetabular osteotomy due to traditional dysplasia or retroverted acetabulum Informed consent Intolerance of local anaesthesia Habitual use of opioids
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 13.0-45.0, Obesity Stress Irritable Bowel Syndrome Women Abdominal Pain To be included, patients must meet all of the following Have a history of abdominal pain for greater than 6 months Males ages 13-45 years old or females ages 13-45 years old who have had their menses for at least 2 years Provide written informed consent, prior to entering the study or undergoing any study procedures Patients with any of the following will be excluded Have a history of an organic GI disease (e.g., inflammatory bowel disease, celiac disease, biliary disorders, bowel resection) cardiac, pulmonary, neurologic, renal, endocrine, or gynecological pathology Are currently taking medications for GI symptoms daily such as 5-HT3 antagonists/5-HT4 agonists, prokinetic drugs, laxatives (but not fiber supplements), anti-diarrheals or antispasmodics Are currently taking other medications daily that would alter serotonin (e.g., serotonin specific reuptake inhibitors [SSRI]), catecholamines (e.g., tricycle antidepressants but not inhaled beta-agonist for mild-moderate asthma), cortisol (excluding inhaled corticosteroids) Work during the late evening and night (as cortisol levels may be altered) Severe co-morbid pain or psychiatric conditions (e.g., fibromyalgia, bipolar or psychotic disorder) Take greater than 300 mg of caffeine containing beverages or food (e.g. chocolate) in the afternoon-evening or greater than 2 servings of alcohol containing beverages everyday (decaffeinated coffee is acceptable) Are unable to give informed consent Are unable to physically use the touch screen for the purpose of the study Are visually impaired or currently institutionalized
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-999.0, Fibromyalgia Criteria:1. Generalized musculoskeletal aching for over 3 months duration 2. Moderate-severe pain in 5 of 11 tender points 3. Age 7 4. Male or female Criteria:1. Diagnosed rheumatic or autoimmune condition contributing to pain 2. Abnormal laboratory results (Rf, ANA, ESR) 3. Use of opioid analgesics in the last 6 months 4. Severe depression and/or anxiety as evidenced by a diagnosis of either disorder, or by evidence based on a clinical interview with the patient and parent at the time of screening. 5. Current or previous psychiatric disorder requiring hospitalization 6. Inability to operate Palm OS® handheld device for self-reports 7. Inability to understand English 8. Inability to attend sessions at Stanford lab every 3 weeks 9. Pregnancy or planned pregnancy, or breastfeeding 10. Abnormal liver functioning tests
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-55.0, Chronic Low Back Pain Sustained or episodic non-specific low back pain lasting longer than 3 months Orthopaedic, neurological, circulatory or respiratory conditions History or family history of epilepsy Recent or current pregnancies Previous surgery to the abdomen or back Abdominal or back exercises in the preceding 12 months
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Acute Abdomen age > 18 abdominal pain > 2h and < 7 days pregnancy acute abdominal trauma allergy to iodinated contrast media severe renal insufficiency metformin medication combined with elevated plasma creatinin level lack of cooperation (if informed consent is not possible) abdominal pain combined with bleeding shock
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Breast Cancer Metastatic Cancer Diagnosis of breast cancer Unresectable disease or patient refused surgery Must have brain metastases WHO performance status 0-2 ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Liver transaminases ≤ 1.5 times upper limit of normal (ULN) Creatinine < 1.5 times ULN Not pregnant or nursing Fertile patients must use effective contraception
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Neoplasms Male or female patients aged at least 18 years old. 2. Histologically or cytologically confirmed diagnosis of a solid malignant tumour, known to express EGFR/HER2 that is either refractory to standard therapies, or for which no standard treatment is available (including patients with brain metastases). 3. At least one tumor lesion that can accurately be measured by computed tomography (CT) or magnetic resonance imaging (MRI) in at least one dimension with longest diameter to be recorded as greater than or equal to 20 mm using conventional techniques or greater than or equal to 10 mm with spiral CT scan. 4. Life expectancy of at least 3 months. 5. Written informed consent that is consistent with ICH-GCP guidelines. 6. Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2. 7. Patients must have recovered from any previous surgery. 8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of trial participation. Female patients with reproductive potential must have a negative serum pregnancy test within 7 days of trial enrolment. Breast feeding mothers will be excluded since these agents may be toxic to infants. For patients with Glioma and brain metastases the following additional should apply: 1. Histologically-confirmed WHO Grade IV malignant glioma at first episode of recurrence after prior combined chemo-radiotherapy. Patients with prior low-grade glioma are eligible if histological assessment demonstrates transformation to WHO Grade IV malignant glioma. 2. Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on Gd MRI performed within 14 days prior to first treatment (Day 1) Major 9. Radiotherapy within the past 2 weeks prior to treatment with the trial drug. 10. Chemo-, hormone (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks before first drug administration. 11. Patients not completely recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC < Grade 1. Prior chemotherapy is allowed if completed at least 4 weeks prior to first trial treatment (6 weeks for mitomycin C or nitrosoureas) and the patient has recovered from the acute toxicities of that therapy. 12. Prior treatment with EGFR targeting therapies or treatment with EGFR or HER2 inhibiting drugs within the past four weeks before start of therapy or concomitantly with this trial. 15. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3. 16. Cardiac left ventricular function with resting ejection fraction < 50% measured by multigated blood pool imaging of the heart (MUGA scan) or Echocardiogram. 17. QTcF interval > 470 ms at screening. 18. PR-interval > 230 ms at screening. 19. QRS-interval >120 ms at screening. 20. ST-segment and T/U-wave abnormalities at screening, as will be assessed by a cardiology specialist of a central lab. 21. Absolute neutrophil count (ANC) < 1,500/mm3. 22. Platelet count < 100,000 / mm3. 23. Bilirubin > 1.5 mg / dl (>26 micro mol / L, SI unit equivalent). Aspartate amino transferase (AST) or alanine amino transferase (ALT) > or equal to three times the upper limit of normal (if related to liver metastases > five times the upper limit of normal). 24. Serum creatinine > 1.5 times of the upper normal limit or calculated/measured creatinine clearance > or equal to 45 ml / min. 25. Patients with known Interstitial Lung Disease (ILD) For Patients with glioma and brain metastases additional apply; 1. Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least four (4) weeks, no history of cerebral oedema or bleeding in the past four (4) weeks. Steroids will be allowed. Anti-epileptic therapy will be allowed if no changes are anticipated within the initial 14 days of treatment (QTC-evaluation). 2. Less than 4 weeks between radiotherapy and start of study treatment, unless new enhancing lesion outside of radiation field or radiologically progressive on two consecutive MRI scans at least four weeks apart or biopsy-proven recurrence. 3. Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure. 4. Less than two weeks after previous chemotherapy (6 weeks from nitrosureas). 5. Less than four weeks from prior treatment with bevacizumab. 6. Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 21.0-80.0, Abdominal Drainage Laparoscopic Cholecystectomy Gall Stones patients with gallbladder stones and laparoscopic cholecystectomy patients above 80 years old patients with acute cholecystitis patients with history of upper laparotomy patients with a hemorrhagic tendency due to cirrhosis patients refused to give informed consent and patients who were converted to open cholecystectomy
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 15.0-999.0, Appendicitis age over 15 years suspected acute appendicitis suitability for laparoscopy patients refusal to participate lack of a laparoscopic surgeon
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 15.0-44.0, Appendicitis Suspected of having acute appendicitis Referred for abdomen CT from Emergency Department Body mass index < 18.5 kg/m2 (ultrasonography is favored) Intravenous contrast-enhancement is contraindicated
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Appendicitis Adult patient with acute appendicitis Children
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Complicated Intra-Abdominal Infection A recorded primary diagnosis of a complicated intra-abdominal. infection (cIAI) and a procedure involving a laparotomy, laparoscopy, or percutaneous drainage of an intra-abdominal abscess The study will be a prospective, multi-centre, epidemiological study of patients (aged > 18 years) diagnosed with a complicated intra-abdominal infection AND who received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess. cIAI's will the following conditions/ diagnoses Gastric ulcer with perforation Gastric ulcer with hemorrhage and perforation Duodenal ulcer with perforation Duodenal ulcer with hemorrhage and perforation Peptic ulcer with perforation Peptic ulcer with hemorrhage and perforation Gastrojejunal ulcer with perforation Gastrojejunal ulcer with hemorrhage and perforation Acute appendicitis with generalized peritonitis Patients not signing an informed consent form Patients participating in another interventional study
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-65.0, Pain Subjects who are in general good health, experiencing moderate to severe pain after surgical extraction of 2 or more third molars and who are willing to remain confined until the morning after surgery for study procedures Allergies to study medications History of multiple drug allergies Unable to stop excluded medications Clinically significant laboratory abnormalities at Screening Significant medical condition at Screening Women who are pregnant or breast feeding
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 14.0-999.0, Laparoscopic Cholecystectomy Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy Elective surgical procedure American Society of Anesthesiologists class I and II Patients refusing randomization Patients already on analgesics Patients with acute cholecystitis Patients requiring preoperative cholangiogram or common bile duct exploration Patients having bile or stone spillage during procedure Patients requiring conversion to open procedure Patients requiring re-exploration for any reason Patients with history of allergy to local anesthetic agents
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Abdominal Pain Patient with acute abdominal pain Patient under 18 Patient who cannot understand information in Swedish Patients previously operated in upper part of the abdomen
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Pain Recent cerebrovascular stroke Severe dementia, aphasia or psychosis Patients who cannot cooperate at time of Patients who do not understand Danish
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 10.0-999.0, Appendicitis patients from 10 years of age with <5 days of abdominal pain and suspicion of appendicitis pregnant women, children <10 years of age
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Appendicitis Suspected acute appendicitis on clinical and radiographic (CT) grounds Phlegmon, mass, peri-appendicecal abscess, or diffuse peritonitis 2. Prior open laparotomy with incision through the umbilicus 3. Body Mass Index > 35 4. Age <18 years 5. Mental illness, dementia, or inability to provide informed consent 6. Chronic pain requiring daily medication (including opiate and NSAIDs) 7. Pregnancy 8. Alternative diagnosis found by diagnostic laparoscopy (post-randomization)
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 7.0-75.0, Appendicitis Clinically diagnosed acute appendicitis Age less than 7 or more than 75 years old Gangrenous appendicitis Combined generalized peritonitis ASA score more than 3 point Pregnant women Cases requiring draining tube
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Acute Lithiasic Cholecystitis Grade I or II Symptoms Lasting for Less Than 5 Days Required Cholecystectomy Preoperative Amoxicillin Clavulanic Acid for at Most 5 Days Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder) Requiring early cholecystectomy (progression of symptoms <5 days In an adult patient (>18 years) For each patient included the consent form must have been read, understood and signed Severe acute cholecystitis (with organ dysfunction) Acalculous cholecystitis Biliary peritonitis Abscess perivesicular Cholangitis Acute Pancreatitis Septic shock Stone of bile duct Physical or mental state does not allow participation in the study Contraindication to surgery
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-999.0, Appendicitis Informed consent Patients who will undergo a diagnostic laparoscopy for suspicion of appendicitis No age or gender limits Elective scheduled appendectomy Unable to give informed consent
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-65.0, Irritable Bowel Syndrome Constipation Predominant Female aged 18-65 years old inclusive. 2. A previous diagnosis of IBS according to Rome III to those patients who have had recurrent abdominal pain or discomfort for the at least the six months prior to diagnosis and currently at least three days per month in the last three months associated with two or more of the following: 1. improvement with defecation 2. onset associated with a change in the frequency of stool 3. onset associated with a change in form (appearance) of stool. 3. Constipation predominant type IBS as defined by one or more of the following: 1. fewer than three spontaneous complete bowel movements per week 2. hard or lumpy stools more than 25% of the time 3. straining during a bowel movement more than 25% of the time. 4. A normal rectal exam result on file within the past two years or performed at screen to the possibility of an evacuation disorder. Examination must findings suggestive of an evacuation disorder such as high sphincter tone at rest, failure of perineal descent by more than one centimeter on straining and last, spasm, tenderness or paradoxical contraction of the puborectalis muscles. 5. Females of child bearing potential (those who have not experienced a bilateral tubal ligation, hysterectomy or menopause) must use an acceptable method of contraception during the study. Acceptable methods are surgical sterilization, hormonal methods such as oral contraceptives, Norplant and Depo-Provera, double barrier method such as a condom and spermicide, and an intrauterine device (IUD). Abstinent females may participate if they agree to use the double barrier method should they become sexually active during the study. 6. Able to provide written informed consent prior to any study procedures being performed Female patients who are pregnant or breast-feeding. 2. Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders other than C-IBS. 3. Unable to withdraw medications 48 hours prior to the study: any medication that alters GI transit including but not limited to laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants and serotonin-norepinephrine reuptake inhibitors (SNRIs); analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAIDs), and COX 2 inhibitors (Note: Tylenol is permitted), GABAergic agents and benzodiazepines. Note: All other concomitant medications will be reviewed on a case by case basis by the study physicians. 4. Clinical evidence (including but not limited to a clinically significant abnormal physical exam, ECG or laboratory result in the past medical record) or current clinically significant abnormal physical exam or laboratory test result that could indicate significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other diseases that interfere with the objectives of the study. If a laboratory test result is abnormal and clinically significant, it may be repeated once at the discretion of the PI. If the laboratory test result remains abnormal and clinically significant, the patient will be referred to a primary care physician for further evaluation. 5. Patients who are considered by the Investigator to be alcoholics not in remission or known substance abusers. 6. Patients who have participated in another clinical study within the past 30 days
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 4.0-15.0, Appendicitis male and female children, between 4 and 15 years-old, with more than 37,5°C of body temperature during the 3 days before hospital admission, and with abdominal pain located in right or median lower quadrant children coming from another hospital, children with septic choc, children with co-morbidity in interaction with algorithm (antibiotics allergy, mellitus diabetes, haemostasis disturbance, …)
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 2.0-18.0, Appendicitis All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon Consent to participate Uncertainty about the diagnosis The need for laparotomy for another reason Free intraperitoneal air on imaging Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Abdominal Pain acute right side abdominal pain willing participate study acute disease malignancy other disease which might cause discomfort
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Low Back Pain Understand and voluntarily sign the informed consent and HIPAA forms Age >18 years at the time of signing the informed consent Scheduled for epiduroscopy assisted epidural neurolysis A diagnosis of low back pain with or without radiculopathy Not scheduled for epiduroscopy assisted epidural neurolysis In the opinion of the investigator, the patient's overall condition is not suitable for
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 14.0-999.0, Lower Abdominal Pain Right Iliac Fossa Pain Acute Appendicitis Age >14 years 2. Lower / RIF Abdominal Pain 3. Clinical Suspicion of Acute Appendicitis: i.e Alvarado Score 5-6 (equivocal for acute appendicitis) Alvarado Score 7-8 (probably appendicitis) Alvarado Score 9-10 (highly likely appendicitis) 4. Informed consent (patient or legal representative) Diffuse peritonitis 2. Antibiotic (Penicillin) documented allergy 3. Ongoing previously started antibiotic therapy 4. Previous appendectomy 5. Positive pregnancy test 6. IBD history or suspicion of IBD recrudescence
|
2
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 20.0-80.0, Shoulder Pain Laparoscopic Surgery Patients receive benign gynaecological laparoscopic surgery American Society of Anesthesiologists (ASA) physical status of patient: classification I-II The procedure will be required to conversion to laparotomy Any cardio-vascular diseases
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-50.0, Scapulocostal Syndrome Male or female 2. Age between 18 years old 3. The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition. 4. The participants will be able to follow instructions. 5. Good communication and cooperation A history of the following diseases or disorders Rotator cuff disease Cervical radiculopathy Degenerative shoulder joint disease Shoulder stiffness 2. Contraindications of traditional Thai massage Contagious skin disease Injury or inflammation of muscle Bone fracture and/or joint dislocation Open wound Uncontrolled hypertension
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-80.0, Gallstones Symptomatic gallstone disease (SGBS): Episodes of pain in the right subcostal or midline epigastric area lasting more than 30 min, with ultrasonography signs of gallstones Ultrasonographic: echo with an acoustic shadow in a visible gallbladder, or an echo with positional change and size <3 mm or, alternatively no demonstrable gallbladder but a strong echo with an acoustic shadow in the position of the gallbladder SGBS Infrequent and/or minimal pain that need only very occasional medication Age below 18 or above 80 Not willing to participate acute cholecystitis (AC) Acute abdominal pain Duration of more than 8-12 h Tenderness on clinical examination in the upper right quadrant Presence of gallbladder stones and signs of inflammation on ultrasonography and in clinical biochemistry data, including an elevated temperature AC Severe concomitant disease
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-50.0, Scapulocostal Syndrome Age between 18 years old 2. The participants have experienced spontaneous scapular pain (VAS ≥ 3) for longer than 12 weeks (chronic) and that at least one trigger point will be present in the scapular region (serratus posterior superior, rhomboid groups, levator scapulae and trapezius muscles). Trigger points will be diagnosed as the presence of focal tenderness in a taut band and with pain recognition. 3. The participants will be able to follow instructions. 4. Good communication and cooperation A history of the following diseases or disorders Rotator cuff disease Cervical radiculopathy Degenerative shoulder joint disease Shoulder stiffness 2. Contraindications of traditional Thai massage Contagious skin disease Injury or inflammation of muscle Bone fracture and/or joint dislocation Open wound Uncontrolled hypertension
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-75.0, Appendicitis History of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant Fever ≥ 38°C and/or WCC > 10 X 103 cells per mL Right lower quadrant guarding, and tenderness on physical examination All patients included were 18-75 years old Patients are excluded if the diagnosis of appendicitis is not clinically established (symptoms attributable to urinary or gynaecological problems) History of symptoms > 5 days and/or a palpable mass in the right lower quadrant, suggesting an appendiceal abscess treated with antibiotics and possible percutaneous drainage Patients with the following conditions are also excluded: history of cirrhosis and coagulation disorders, generalized peritonitis, shock on admission, previous abdominal surgery, ascites, suspected or proven malignancy, contraindication to general anesthesia (severe cardiac and/or pulmonary disease), inability to give informed consent due to mental disability, and pregnancy
|
1
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Cesarean Section Cicatrix Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started Woman who speak and understand Danish Woman who can give informed consent Level I or II caesarean section (ordered less than 30 min. before surgery is started) Diabetics (this does not gestational diabetes) Infection Regular treatment with immunosuppressives Alcohol or drug abuse Age under 18 Chronic pain disease eg fibromyalgia, rheumatoid arthritis BMI over 35 Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time)
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Bacterial Infection Postoperative Infection Abdominal Infection Suspected infection in the GI tract or after abdominal surgery Age < 18 years
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-24.0, Transient Tachypnea of the Newborn gestational age ≥ 35 weeks diagnosis of TTN, defined as respiratory rate >60, presence of subcostal and /or intercostal retractions, nasal flaring, grunting, oxygen saturations 70-93% on room air, and radiological evidence of perihilar streaking and patchy infiltrates admission to the NICU at Mount Sinai hospital within first 24 hours of life gestational age < 35 weeks history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome diagnosis of major congenital pulmonary or cardiac anomalies initial CXR demonstrating air leak respiratory distress first occurring after 24 hours of life presumptive diagnosis of RDS as indicated by the need for FiO2 > 40%, severe retractions and grunting with poor air entry, and diffuse alveolar consolidation on chest radiograph
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-99.0, Anesthesia Main OR patients at UIHC who require arterial catheter placement for surgery The patients who will be excluded from the study those who have had arterial cannulation in the previous month, infections at site of insertion, and AV shunts in upper extremity
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-999.0, Diverticulitis All consecutive patients with left sided acute diverticulitis diagnosed clinically by the presence of abdominal pain leukocytosis (>11x109) fever >38°C and confirmed by imaging (CT scan, ultrasonography, water soluble contrast enema) The CT for the diagnosis included at least one of a localized thickening (≥4 mm) of the colonic wall signs of inflammation of the pericolic fat abscess extraluminal air extraluminal contrast The ultrasound included at least two of bowel wall thickening (>4 mm) inflammatory bowel disease irritable bowel syndrome colorectal cancer diseases precluding adequate follow up
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-80.0, Appendicitis Abdominal Abscess Periappendicular abscess at least 2 cm in size Missing written informed consent Antimicrobial therapy lasted over 24 hours before randomization Attempt of drainage before randomization Age over 80 years or under 18 years old Pregnancy Allergy to either Cefuroxime or Metronidazole Severe chronic disease, that substantially increases the risk for operative mortality Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions Carrier of a resistant bacterial strain Being institutionalized or hospitalized for at least 2 weeks before randomization
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Cesarean Section Woman having caesarean section for the first time Woman, who have had no previous lower abdominal surgery Woman who speak and understand Danish Woman who can give informed consent Diabetes Mellitus (This does not gestational diabetes) Infection Regular treatment with immunosuppressives Alcohol or drug abuse Age under 18 years old Chronic pain disease eg. fibromyalgia, rheumatoid arthritis BMI over 35
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 0.0-999.0, Influenza Male or Female, of all ages (assuming appropriate consent is obtained). 2. Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI). For example: 1. Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days. 2. Nasal congestion 3. Rhinorrhea 4. Sore throat 5. Cough 6. Headache 7. Myalgia 8. Malaise Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes. 2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. 3. Unable to understand and consent to participation; for minors this includes parent or legal guardian
|
0
|
The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
|
eligible ages (years): 18.0-999.0, Regional Anesthesia all patients scheduled for neuraxial anesthesia previous spine surgery contraindication for neuraxial anesthesia refusing to sign the consent form
|
0
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.