eligible ages (years): 18.0-999.0,  All  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


A 33-year-old male athlete presented to the ER with acute abdominal pain. Family member says the patient fell off his bike a week earlier and suffered blunt trauma to the left hemi-abdomen, and he has had mild abdominal pain since that day. The patient's history is negative for smoking, drugs, and alcohol. BP: 60/30 mmHg, HR: 140/min. The patient is pale, the physical examination of the abdomen revealed muscle contraction and resistance. Emergency ultrasound and CT scan of the abdomen reveal extended intraperitoneal hemorrhage due to spleen rupture.

eligible ages (years): 14.0-999.0,  All  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


eligible ages (years): 18.0-65.0,  All  Liver Cirrhosis Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy  Liver function as Child-Pugh C Hemoglobin < 9 g/dL Ascites Abnormal coagulation


eligible ages (years): 18.0-85.0,  All  Incisional Hernia Umbilical Hernia Age > 18 Incisional or umbilical hernia over 2 cm and less than 6 cm in diameter  Patients with a complicated incisional (pain, occlusion, cutaneous necrosis), irreductible painless incisional or umbilical hernia will not be considered as a complication Patients with a recurrence of incisional hernia Patients with an incisional or umbilical hernia whose lateral edges are located so that fixation of the mesh (which must extend beyond the 4 to 5 cm) is not possible Pregnant women Patients with HIV therapy Patients with cirrhotic ascites or other signs of hepatic insufficiency (bilirubin> 35 micromol / l; TP < 55%) or significant thrombocytopenia (< 60 000 platelets) Patients with a contra indication for laparoscopy Patients with a life expectancy < one year, or whose mobility within two years of treatment will damage proper monitoring Patients unable to understand information about the protocol


eligible ages (years): 14.0-74.0,  All  Peritoneal Carcinomatosis Cytoreductive surgery and intraperitoneal chemotherapy Single-Photon Emission Computed Tomography (SPECT) before the second course of treatment


eligible ages (years): 18.0-999.0,  All  Tendon Injury All patients with traumatic rupture of FDP-tendon in zone II  < 18years Fracture crush injury; (partial) amputation CPPD


eligible ages (years): 18.0-999.0,  All  Acute Abdomen Signed informed consent form Age > 18 years old Nontraumatic acute abdomen Weight < 120kg Can keep apnoea for 15s Surgeon in charge considers patient fit for participation in study  Contraindications of MRI Suspicion of acute vascular disease Severe cardial or pulmonal insufficiency Pregnancy Untreated psychiatric illness


eligible ages (years): 0.0-999.0,  All  Ultrasonography Multiple Trauma Kidney Calculi Aortic Aneurysm, Abdominal Pregnancy Catheterization, Venous Activation of the Keller Fire Rescue Emergency Medical Service Meets disease process described earlier  Does not meet the disease process


eligible ages (years): 16.0-999.0,  All  Trauma Hospitalized for abdominal trauma diagnosis of splenic contusion confirmed by scanner or during surgery for hemodynamically unstable cases patient has signed a consent form patient is a beneficiary of or affiliated with a social security program  Refuses to participate Pregnant or breastfeeding Patient under guardianship


eligible ages (years): 18.0-65.0,  All  Head Injuries Subarachnoid Haemorrhage Intra-cerebral Haemorrhage Cerebral Thrombosis Infarction, Middle Cerebral Artery Patients over 18 years of age up to 65 years Patients receiving a decompressive craniectomy for : severe head injuries, Subarachnoid hemorrhage, intra-cerebral hemorrhage, cerebral dural sinus thrombosis, malignant middle cerebral artery stroke and undergoing to reconstructive cranioplasty Patients informed about the study and giving consent  Patients being not assisted by the French NHS Patients allergic to CT contrast products Pregnant and nursing women


eligible ages (years): 18.0-999.0,  All  Myelodysplastic Syndrome Males and females aged over 18 years, (no upper age limit) ECOG performance status 0-2 Life expectancy more than 6 months A confirmed diagnosis of MDS WHO type refractory anaemia (RA) hypoplastic RA ineligible for/or failed immunosuppressive therapy (ALG, cyclosporine) refractory anaemia with ring sideroblasts (RARS) refractory cytopenia with multilineage dysplasia myelodysplastic syndrome unclassifiable  MDS with bone marrow blasts greater or equal than 5% Myelodysplastic syndrome associated with del(5q)(q31-33) syndrome Chronic myelomonocytic leukaemia (monocytes greater than1.0x109/l) Therapy-related MDS Splenomegaly, with spleen greater or equal than 5 cm from left costal margin Platelets less than 30x109/l Uncorrected haematinic deficiency. Patient deplete to iron, B12 and folate according to local lab ranges Women who are pregnant or lactating Females of childbearing potential and all males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) for the duration of the study and for up to 3 months after the last dose of study medication. Note: Subjects are not considered of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal Females of childbearing potential must have a negative pregnancy test prior to starting the study


eligible ages (years): 18.0-999.0,  All  Microcirculation Achilles Tendon Rupture Acute rupture of the achilles tendon (on one or both sides) Older than 18 year of age Firmed letter of approval Patient speaks/understands German Planed surgical treatment No more than 48h after rupture  No-traumatic rupture of the achilles tendon More than 48h after rupture No planed surgical treatment History of surgery on the injured leg Condition of diabetes mellitus Condition of peripheral artery occlusive disease


eligible ages (years): 1.0-18.0,  All  Hereditary Spherocytosis Idiopathic Thrombocytopenic Purpura Need for splenectomy  Splenomegaly


eligible ages (years): 18.0-999.0,  All  Pregnancy Related Trauma Abruptio Placentae Singleton intrauterine pregnancy ≥20 weeks and ≤35 weeks gestational age Chief complaint of minor maternal trauma including motor vehicle accident, patient fall or assault with absence of maternal conditions outlined in  Maternal shock Unstable vital signs Altered sensorium Head injury resulting in coma signs or symptoms of intraperitoneal bleeding Emergency laparotomy for fetal or maternal indications Bone fractures History of previous abruptio placenta Known or suspected placenta previa Rupture of membranes


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  Distal Bicep Tendon Rupture Complete rupture of the Distal Bicep tendon Acute bicep tendon rupture (< 10 days since rupture)  Partial rupture of the Distal Bicep tendon Chronic bicep tendon Ruptures (>10 days since rupture) Under 18 years of age


eligible ages (years): 18.0-999.0,  All  Acute Appendicitis Patients who have been admitted and diagnosed as having acute appendicitis  Patients under the age of 18 years Pregnancy Uncooperative patients (senile dementia, mentally ill) Not speaking Danish Does not wish to participate


eligible ages (years): 0.0-999.0,  All  Splenic Artery Aneurysm Splenic artery aneurysm with diameter greater than 2 cm Splenic artery aneurysm with diameter smaller than 2 cm if risk factors for rupture are associated (child bearing age, pregnancy, blister or saccular shape, increasing diameter)  Complex aneurysm involving the celiac trunk American Society of Anesthesiologists (ASA) Score > 3


eligible ages (years): 18.0-80.0,  All  Tumor of Exocrine Pancreas Patients with solid or cystic neoplasms of the pancreas who are being considered for distal pancreatectomy/splenectomy to be performed in either an open, laparoscopic, of da Vinci assisted fashion No evidence of metastatic disease No evidence of local invasion into surrounding organs ECOG performance status <3 Age 18 years or greater Participants will provide written informed consent to be part of the study  Age less than 18 years old Women who are pregnant Known hereditary bleeding disorder with history of post-operative hemorrhage Patients maintained on chronic anticoagulation (eg Coumadin therapy) Known hematogenous disorder Previous gastric fundoplication procedure or any procedure which interrupts the short gastric blood supply to the spleen Known primary or secondary malignancy of the spleen Pancreatic tumors which invade surrounding structures Prisoners Patients with impaired decision-making skills


eligible ages (years): 18.0-999.0,  All  Pancreas Tumor Pancreatitis The subject has a surgical indication for distal pancreatectomy In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy At least 18 years of age The subject is willing to consent to randomization to the intraperitoneal drain vs. no drain group The subject is willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol  The subject does not have a surgical indication for distal pancreatectomy In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy Less than 18 years of age The subject is not willing to consent to randomization to the intraperitoneal drain vs. no drain group The subject is not willing to comply with 90-day follow-up and answer quality-of-life questionnaires per protocol


eligible ages (years): 18.0-75.0,  All  Urolithiasis men or women = or >18 but <76 years of age presenting with acute renal colic Emergency department physician highly suspects a primary diagnosis of kidney stones (renal colic) or the patient requires imaging to rule out kidney stones  children < 18 years old elderly patients > or = 76 years old pregnancy or planning pregnancy Morbid obesity (>285 pounds in men, >250 pounds in women) patients with an acute abdomen, signs of sepsis, signs of alternate diagnosis (ie appendicitis, abdominal aortic aneurysm, pyelonephritis, kidney stones not suspected) history of kidney problems (hemodialysis, kidney transplant, presence of only one kidney)


eligible ages (years): 18.0-45.0,  All  Preterm Labor Preterm labor(pregnant between 28th and 37th week) Singleton pregnancy Amnion membranes were intact  Past history of preterm labor or premature delivery Urinary tract infections and any other infections Poly or oligohydramnios Fetal distress, fetal or uterine anomaly Membranes rupture and placenta pathology Preeclampsia or intrauterine growth retardation


eligible ages (years): 18.0-89.0,  All  Open Abdominal Wounds Abdominal Adhesions Wound Sizes Trauma Population Trauma patients undergoing DC/OA management for traumatic injury Age 18+ Life expectancy longer than 48 hours  Prisoners Pregnant patients Younger than 18 years of age


eligible ages (years): 16.0-999.0,  All  Aortic Rupture During the study period of 14 years (January 1990 to December 2003), all consecutive cases with traumatic rupture of the thoracic aorta being reported in the greater area of Zurich with about one million inhabitants were included in the present study  Non-traumatic aortic rupture Non-traumatic aortic dissection


eligible ages (years): 18.0-999.0,  All  Purpura, Thrombocytopenic, Idiopathic and Hepatitis C Subject is ≥18 years old Diagnosed with ITP for at least 12 months prior to screening, and have a platelet count of <30 X109/L on Day 1 (or within 48 hours prior to dosing on Day 1) Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have either not responded to one or more prior therapies (except splenectomy), or who have relapsed prior therapy Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) >450msec or QTc >480 for patients with a Bundle Branch Block No history of clotting disorder, other than ITP A complete blood count (CBC), within the reference range, with the following exceptions Platelets <30×109/L on Day 1 (or within 48hours of Day 1) is required for Hemoglobin: females and males 10.0 g/dl are eligible for  Patients with any prior history of arterial or venous thrombosis, AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, antiphospholipid syndrome, etc) Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study Female subjects who are nursing or pregnant at screening or pre-dose on Day 1 History of alcohol/drug abuse or dependence within 12 months of the study Treatment with thrombopoietin or an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for >3 consecutive days within 2 weeks of the study start and until the end of the study Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start History of platelet aggregation that prevents reliable measurement of platelet counts An abnormality in bone marrow examination result, other than ITP, identified on the screening examination, which in the opinion of the investigator makes the subject unsuitable for participation in the study (e.g. ≥MF-2 according to EU consensus scale [Thiele, 2005]) or suggests another primary diagnosis (e.g. Thrombocytopenia is secondary to another disease)


eligible ages (years): 0.0-999.0,  All  Trauma Injuries all patients admitted with the trauma team all patients admitted with Injury Severity Score >15  secondary admittance(transfers)>24 post injury


eligible ages (years): 0.0-999.0,  All  Myeloproliferative Neoplasms (MPN) Polycythemia Vera (PV) Essential Thrombocythemia (ET) Myelofibrosis (MF) One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) Palpable spleen length >5 cms below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET  Known history of portal vein thrombosis Known history of Budd-chairi syndrome Known history of oesophageal varices Known history of cirrhosis from any cause


eligible ages (years): 3.0-60.0,  All  Blunt Abdominal Trauma 3-60 years of age evaluated for blunt trauma with a GCS of >14 Order of CT abdomen and pelvis imaging  Patients requiring intubation or suspected neurological injury (defined above) Pregnant patients Intoxicated patients Patients with age defined hypotension Exploratory laparotomy or transfusion during the ED evaluation Non-verbal patients Positive FAST exam Patients with abdominal trauma or surgery in the last month Victims of sexual assault or non-accidental trauma (NAT) Patients with known or suspected fractures of the femur or pelvis prior to CT imaging


eligible ages (years): 18.0-999.0,  All  Blunt Injury Clinical diagnosis of blunt aortic injury (BAI)  Clinical diagnosis of penetrating aortic injury


eligible ages (years): 15.0-75.0,  All  Immune Thrombocytopenia adult ITP patients whose platelet counts remain less than 10 x 10^9/L patients whose platelet counts remain less than 30 x 10^9/L and who continue to experience excessive bleeding after 4 to 6 weeks of appropriate medical treatment patients who have experienced a transient response to primary treatment and have platelet counts less than 30 x 10^9/L after 3 months require continuous glucocorticoid therapy to maintain safe platelet counts Willing and able to sign written informed consent  Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit Current HIV infection or hepatitis B virus or hepatitis C virus infections Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are pregnant Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test Patients who are deemed unsuitable for the study by the investigator


eligible ages (years): 45.0-75.0,  All  Laparoscopic Hysteretctomy With Promontofixation Age 45-75 years old Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse Menopaused ASA class I or II  Absolute contraindications to laparoscopy Previous history of pelvic surgery, endometriosis and/or infection Pathological peritoneal tissue BMI more than 30 Height less than 150cm


eligible ages (years): 18.0-75.0,  All  Antibody-mediated Rejection Humoral Rejection Adult renal transplant recipients, men and women between 18 and 75 years of age Any patient with acute graft dysfunction (elevation of creatinine above post transplant nadir) AND, two out of three, of the following Presence of circulating anti HLA antibody (DSA) Histological findings compatible with Banff Class II or III AMR on transplant biopsy Peritubular capillary c4d positivity on transplant biopsy  Patients that have received eculizumab prior to enrolling in the study Patients with ongoing non-acute antibody mediated rejection Patients with predominantly chronic antibody mediated rejection or interstitial fibrosis/tubular atrophy History of severe cardiac disease (e.g., New York Heart Association [NYHA] Functional Class III or IV, myocardial infarction ≤ 6 months of randomization, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina or other significant cardiovascular diseases) Prior splenectomy Has a known bleeding disorder Has any active bacterial or other infection which is clinically significant in the opinion of the Investigator and is a contraindication to transplantation Has participated in any other investigational drug study or was exposed to an investigational drug or device within 30 days of screening Has received rituximab (Rituxan®) ≤ 3 months prior to screening Has received bortezomib (Velcade®) ≤ 3 months prior to screening


eligible ages (years): 18.0-999.0,  All  Acute Abdomen All patients with acute abdomen undergoing abdominal surgery under emergency and presenting on arrival in ICU at least a sign of bad perfusion  Patients with chronic renal failure already receiving dialysis treatment Acute Coronary Syndrome (ACS) <12 months and New York Hearth Classification (NHYA ) class > 3 Patients judged at the admission not subject to resuscitative measures for severity and comorbidity Patients with massive hemorrhage in operative room or in the immediate perioperative with the need for blood transfusions and abundant blood products > 5 units of Erytrocyte Concentrates (EC) Patients scheduled for Orthotopic Liver Transplantation (OLT) Patients younger than 18 years old


eligible ages (years): 30.0-999.0,  All  Atrial Fibrillation Heart Failure Stroke Myocardial Infarction Patients with a coded diagnosis for atrial fibrillation in their primary or secondary care record Patients in GPRD practices which are deemed "up to standard" by GPRD Patients whose records are deemed "acceptable" by GPRD and contain at least one year of data Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES  A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation


eligible ages (years): 18.0-80.0,  All  Wound Infection age ≥ 18 years patients with complicated intra-abdominal infections who needed open abdomen (OA) and vacuum-assisted wound closure and mesh-mediated fascial traction (VAWCM) Eligible patients were properly consented before enrollment. If the patient was incapable, the patient's legal representative was asked to provide consent on the patient's behalf Patients with grade 1b (contaminated OA without adherence between bowel and abdominal wall), 2b (contaminated OA developing adherence) open abdomen, as classified by Bjorck  < 18 years pre-existing large ventral hernia Frozen OA with adherent bowel (OA of grade 4) Clean wound (OA of grade 1a or 2a) chronic wound infection critical wound ischemia severe systemic infection end-stage renal disease severe liver disease uncontrolled diabetes mellitus


eligible ages (years): 0.0-999.0,  All  Traumatic Subarachnoid Haemorrhage All patients of traumatic subarachnoid haemorrhage  Metabolic disorder Altered coagulation profile Cardiac disease morbid illness


eligible ages (years): 0.0-24.0,  All  Meconium Ileus premature infants with a birthweight 1500 gram  major congenital malformations known gastrointestinal abnormalities


eligible ages (years): 18.0-999.0,  All  Postpartum Haemorrhage Pregnancy, gestation age > 24 weeks  Age < 18 Adults incapable of giving informed consent Gestational age < 24 weeks


eligible ages (years): 18.0-999.0,  All  Thoracoabdominal Trauma Focused Assessment With Sonography for Trauma (FAST) NanoMaxx Ultrasound System (SonoSite) RP-Xpress (InTouch Technologies) for FAST cohort Patient is 18 years of age or older Patient presenting with blunt or penetrating trauma to the thorax or abdomen Patient transported by MD Ambulance to Royal University Hospital Patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be used in connection with the RP-Xpress (InTouch Technologies) Patient will take longer than 10 minutes to transport to hospital Patient's care will not be compromised in completing a FAST exam opinion of paramedic Patient's care will not be compromised in completing a FAST exam opinion of ER physician  Patients under the age of 18 Patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a FAST exam Patients who are not being transported to Royal University Hospital Patients whose expected transport time from scene to hospital is less than 10 minutes


eligible ages (years): 18.0-65.0,  All  Ovarian Adenocarcinoma Fallopian Tube Adenocarcinoma Primary Peritoneal Carcinoma Stage IIIC unresectable ovarian, tubes or peritoneal primitive adenocarcinoma according to FIGO classification previously treated with 6 cycles of carboplatin-cisplatin neoadjuvant chemotherapy with a response allowing complete surgery after the 6 cycles Time frame between the sixth platin injection and the CRS + HCIP < 10 weeks No disease progression during the neoadjuvant chemotherapy 18 </= âge </= 65 ans Performance Status OMS < 2 Hematological function : PNN >/= 1.5x10^9/L, platelets >/= 150x10^9/L, hemoglobin > 9 g /dl (transfusion allowed) Hepatic function : Bilirubin </= 1,5 x LSN, ASAT (SGOT) and ALAT (SGPT) </= 3 x LSN, Phosphatases alkaline </= 3 x LSN No kidney related pathology, plasmatic creatinine < 140 µmol/l, creatinine clearance > 60 ml/min (Cockcroft formula) and urinary strip <2 (If urinary strip >/= 2, proteinuria < 1g/24h) Plasmatic albumine > 25 g/l HIV negative status  Incomplete cell kill surgery Non-epithelial ovarian cancer Borderline tumors Non in complete remission previous cancer for more than 5 five years before Uncontrolled high blood pressure (blood pressure > 150/100 mm Hg despite antihypertensive treatment) Previous abdominal or pelvic radiotherapy Previous pathology of the central nervous system, except for well controlled pathology like epilepsy Previous stroke, transient ischemic attacks or subarachnoid hemorrhage Previous pulmonary embolism Pregnant or breastfeeding women (Women in age must have a blood negative pregnancy test at least 15 days before going under surgery)


eligible ages (years): 18.0-90.0,  All  Intra Abdominal Hypertension Abdominal Compartment Syndrome Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique  Patients that according to the surgeon estimates will not survive 24 hours


eligible ages (years): 18.0-65.0,  All  Asplenia Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury  Ages less than 18 and greater than 65 Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study


eligible ages (years): 18.0-999.0,  All  Hernia, Abdominal Hernia,Ventral Informed Consent Form (ICF) signed by the patient or his/her legal representative primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair recurrence after former abdominal hernia repair WITH MESH recurrence after suture abdominal hernia repair CAN be included  no written informed consent patient under 18 years old emergency surgery (incarcerated hernia) patients with expected life time shorter than one year for example due to generalised malignancy BMI exceeding 40.0kg/m² contaminated surgical fields patients on immunosuppression, steroid therapy, constant pain therapy


eligible ages (years): 18.0-999.0,  All  Malignant Pleural Mesothelioma Patients with histologically confirmed Malignant Pleural Mesothelioma Age of 18 years or more first-line chemotherapy with platinum-Based agents  history of prior malignancy pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5* Upper Limit of Normal or Serum bilirubin more than 1.5* Upper Limit of Normal)


eligible ages (years): 18.0-70.0,  All  Achilles Tendon Rupture Patient is willing and able to give informed consent for participation in the study Aged 18 years Diagnosed with acute Achilles tendon rupture Presenting within and receiving study treatment within 7 days post injury Patients in whom the decision has been made for non-operative treatment Able (in the Investigators opinion) and willing to comply with all study requirements Able to attend a PATH-2 study hospital site for the 24-week follow-up  The patient may not enter the study if ANY of the following apply Previous major tendon or ankle injury or deformity to either lower leg History of diabetes mellitus Known platelet abnormality or haematological disorder Current use of systemic cortisone or an anticoagulant Evidence of lower limb gangrene/ulcers or peripheral vascular disease History of hepatic or renal impairment or dialysis Female patients who are pregnant or breast feeding Is currently receiving or has received radiation or chemotherapy within the last 3 months Has inadequate venous access for drawing blood


eligible ages (years): 18.0-30.0,  All  Anterior Cruciate Ligament Injury Sportive, active patient (Tegner score =/>5) Age above 18 untill 30 years at time of Primary rupture of the anterior cruciate ligament, evidence by history (acute trauma, clicking sensation, swelling within a few hours, instability) and physical examination (positive Lachman, anterior drawer test and/or Pivot shift) Primary rupture indicated by MRI No associated ligamentuous disorde of the knee, evidenced by history, physical examination, x-ray or MRI) Time span between anterior cruciate ligament rupture and operation no longer than 21 days Willingness to comply to advised rehabilitation protocol supervised by (NFVS registrated) sports physiotherapist  Infection Known hypersensitive response for materials used (Cobalt, chroom, nickel) Serieus pre-existing malaligment of leg indicated for surgery Tendency for excessive scar tisseu formation, such as arthrofibrosis History of previous surgery on leg indicated for surgery History of removal of tendon on leg indicated for surgery Muscular, neurological or vascular disorders negatively affecting healing or rehabilitation Cartilage injury requiring (some kind of) cartilage repair surgery (such as microfracture or cell therapy) Arthrosis more dan ICRS grade 2 evidenced by x-ray Long(er) term use of relevant medication, such as prednisolon or cytostatica


eligible ages (years): 18.0-999.0,  All  Malignant Melanoma Head and Neck Cancer Biopsy proven incurable melanoma or incurable HNSCC amenable to have biopsy and/or surgical resection of either the primary and/or locoregional metastatic site, at the University of Colorado Hospital Age ≥ 18 years old Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Adequate bone marrow, hepatic and renal function Absolute neutrophil count ≥ 1,500/µL Platelets ≥ 100,000/µL Hemoglobin ≥ 9.0 g/dL Creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min Total bilirubin ≤ 1.5x ULN Aspartate Aminotransferase (AST)/Alanine Aminotransferase ( ALT) ≤ 2x ULN  Contraindication (absolute or relative) to granulocyte colony-stimulating factor (G-CSF) filgrastim usage known hypersensitivity to E coli-derived proteins' filgrastim, or any other component of the product Sickle cell disorders Clinically significant and active lung hemorrhagic or inflammatory disease, including but not limited to chronic obstructive pulmonary disease (COPD), autoimmune disease, and alveolar hemorrhage; or hypoxemia of any etiology requiring oxygen Clinically significant splenomegaly or splenic metastases; history of splenic rupture, recent splenic trauma or other clinically significant splenic disease that increases the risk of splenic rupture Clinically significant and active malignancy other than incurable melanoma or head and neck squamous cell cancer Known hepatitis B or C, or HIV


eligible ages (years): 18.0-45.0,  All  Pregnancy American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I Healthy, ASA II mild and controlled systemic disease) Singleton pregnancies 42 weeks gestation Non-labouring Scheduled cesarean delivery English speaking Age 18-45 years  Cardiovascular disease Hypertensive disease of pregnancy (i.e. mild & severe preeclampsia) Allergy to phenylephrine, or any other standardized medication Obesity (BMI > 35 kg/m2) Diabetes Mellitus type 1 Smoker Coffee/Caffeine intake within 6 hours of SDF measurement


eligible ages (years): 0.0-15.0,  All  Injuries Trauma Wounds and Injuries Children Child Children 0-15 years inclusive Presenting to either of the study hospitals for assessment or treatment Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) Due to an incident involving any non-motorized bicycle, tricycle or kick scooter  Incidents where the injured child was involved in a motor vehicle collision Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) Incidents involving a bicycle fitted with 'bull bars' Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted


eligible ages (years): 18.0-999.0,  All  Acute Abdominal Pain Presentation at ED with acute abdominal pain, aged at least 18 years  No informed consent, pregnancy, homeless, no social assurance


eligible ages (years): 18.0-999.0,  All  Thoracic Injuries, Glasgow Coma Scale (GCS) of 15 stable vital signs admitted within the first 6 hours after injury  urgent and urgent triage category


eligible ages (years): 18.0-65.0,  All  Biceps Tendon Rupture male subjects between 18 and 65 years of age patient has had a DBTR amenable to surgical repair surgeon must be able to obtain a tension-free repair using an endobutton participants must have been working prior to the injury patient must be expected to return to work post-injury  females outside of the specified age range patient with an identified congenital abnormality at the insertion of the distal biceps tendon those who have previously ruptured the tendon or those with tendon ruptures resulting from a multi-trauma patients with psychiatric illness, cognitive impairment, or health conditions that preclude informed consent patients with life expectancy of less than 2 years patients who do not speak/read/understand English patients with no fixed address or contact information patients who are unwilling to complete follow-ups


eligible ages (years): 18.0-999.0,  All  Stroke Atrial Fibrillation (AF) Intracerebral Haemorrhage (ICH) Study I: (AF) Adult (≥18y; no upper limit) patients with a clinical diagnosis of non-valvular AF (verified by ECG) with intention to treat with best practice oral anticoagulants (e.g. warfarin) Previous ischaemic stroke or TIA diagnosed by treating clinician All patients must be able to have GRE MRI before (or within 1 week) of starting best practice oral anticoagulant  Any MRI contraindications Previous use of oral anticoagulation Definite contra-indication to oral anticoagulation Serious head injury (resulting to loss of consciousness) Study II: (ICH) • Adult (>18y) patients treated at participating centres with confirmed ICH (confirmed on CT or MRI scans) with or without a history of anticoagulant use at the time of the ICH Known underlying structural cause for ICH (e.g arteriovenous malformation, tumour, cavernoma, intracranial aneurysm, haemorrhagic transformation of an infarct) Major head trauma (causing loss of consciousness and though to be sufficient to have caused the ICH) in previous 24 hours


eligible ages (years): 18.0-65.0,  All  Cardiac Arrest Sudden Death -Eligible patients have the following combination of Adults over 18 years of age and under 65 years of age And Refractory cardiac arrest (defined by the failure of professionals to resuscitate at the 20th minute of cardiac arrest with a minimum of 3 Automatic External Defibrillator (AED) or equivalent analyze And Beginning of external cardiac massage within the first 5 minutes after cardiac arrest (no flow < 5 min.) with shockable rhythm or the presence of signs of life during resuscitation (any rhythm): spontaneous movement, absence of mydriasis and/or pupillary response, respiration And Medical cause of the cardiac arrest And End-Tidal CO2 (ETCO2) above 10 mm Hg at the time of And Absence of major co-morbidity. And Extra-corporeal Membrane Oxygenation (ECMO) team available  Children under 18 years of age Adults over 65 years of age Period of more than 5 minutes without cardiac massage after collapsing Known co-morbidity that compromises the prognosis for short or medium-term survival Cardiac arrest during transportation times


eligible ages (years): 18.0-999.0,  All  Primary Myelofibrosis Intermediate-1, intermediate-2, or high-risk PMF, PPV-MF or PET-MF as based on The Dynamic International Prognostic Scoring System (DIPSS) Palpable splenomegaly ≥5 cm below the LCM in midclavicular line by physical examination TSS ≥13 on the MPN-SAF TSS 2.0, not including the inactivity question, based on a single assessment during screening visit Age ≥18 years old at the time of screening (or minimum age of legal consent consistent with local regulations, if minimum is >18 years of age) ECOG performance status 0 to 3 Peripheral blast count <10% Absolute neutrophil count >500/μL Participants who are platelet or RBC transfusion dependent are eligible Adequate liver and renal function, defined by liver transaminases (AST/serum glutamic oxaloacetic transaminase [SOOT] and alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]) ≤3 × upper limit of normal ([ULN], AST/ALT ≤5 × ULN if transaminase elevation is related to MF), direct bilirubin ≤4 × ULN, and creatinine ≤2.5 mg/dL At least 6 months from prior splenic irradiation  Any GI or metabolic condition that could interfere with absorption of oral medication Life expectancy <6 months Prior treatment with a JAK2 inhibitor Completed ASCT, or are eligible for and willing to complete ASCT History of splenectomy or planning to undergo splenectomy Uncontrolled intercurrent illness, including but not limited to ongoing active infection, or psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with study requirements Other malignancy within the last 3 years, other than curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, organ confined, or treated non-metastatic prostate cancer with negative prostate specific antigen, in situ breast carcinoma after complete surgical resection, or superficial transitional cell bladder carcinoma Inflammatory or chronic functional bowel disorder, such as Crohn's disease, inflammatory bowel disease, chronic diarrhea, or constipation Clinically symptomatic and uncontrolled cardiovascular disease History of any of the following within 6 months prior to first dose of pacritinib: myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure


eligible ages (years): 7.0-18.0,  All  Appendicitis Children and adolescents aged 7-18 years old ASA Score I (American Society of Anesthesiologists classification) [Appendix 1]: a normal healthy patient ASA Score II (American Society of Anesthesiologists classification): A patient with mild systemic disease Patients scheduled for laparoscopic appendectomy surgery Uncomplicated appendicitis Hemodynamically stable patient No evidence of appendiceal perforation based on preoperative clinical and imaging assessment Diagnosed to have simple acute appendicitis by intraoperative laparoscopy Patients who have provided a written informed assent Caregivers who have provided a written informed consent  ASA Score III (American Society of Anesthesiologists classification): A patient with severe systemic disease ASA Score IV (American Society of Anesthesiologists classification): A patient with severe systemic disease that is a constant threat to life ASA Score V (American Society of Anesthesiologists classification): A moribund patient who is not expected to survive without the operation Hemodynamically unstable patient Evidence of appendiceal perforation on based on preoperative clinical and imaging assessment Perforated or gangrenous appendicitis diagnosed during laparoscopic surgery Postoperative admission in an intensive care unit with sedation or ventilatory assistance Cognitive impairment or mental retardation Progressive degenerative diseases of the CNS Seizures or chronic therapy with antiepileptic drugs


An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment.

eligible ages (years): 6.0-16.0,  All  Brain Injuries Moderate to severe traumatic brain injury


eligible ages (years): 16.0-45.0,  All  Brain Injuries Hypothermia FOR EARLY TO 35°C GCS 3-8 on initial evaluation or deteriorates during transport Mechanism of injury consistent with blunt, non-penetrating trauma to head Systolic blood pressure > 110 mm Hg Diastolic blood pressure> 60 mm Hg Heart rate (pulse) < 120 beats per minute Estimated or known age 16-45 No suspicion of pregnancy Esophageal/rectal probe temperature > 35.5°C (Pre-hospital cooling only) Injured < 2 hours prior to arrival of pre-hospital providers  Following commands upon EMS arrival without deterioration to coma or follows command after an initial period of coma Mechanism of injury GSW or no indication of head injury Systolic blood pressure < 120 mm Hg Diastolic blood pressure < 60 mm Hg Heart rate (pulse) > 120 beats per minute Estimated or know age > 45 or < 16 Suspected pregnancy Forehead scan temp < 35.5°C (Pre-hospital cooling only) Injured >2 hours prior to arrival of pre-hospital providers Evidence of major chest trauma (unilaterally absent breath sounds with tracheal deviation or distended neck veins or requiring thoracentesis


eligible ages (years): 9.0-18.0,  All  Traumatic Brain Injury English speaker Minimum birth weight of 2500 grams (5.5 lbs) and 37 weeks' gestation Additional for Children with Traumatic Brain Injury Head injury resulting in a post-resuscitation Glasgow Coma Scale score of either 13 to 15 or 3 to 8 No evidence of hypoxic injury  History of epilepsy, mental retardation, or documented evidence of developmental dysfunction Previous hospitalization for head injury involving loss of consciousness or post-concussional symptoms History of autism, major psychiatric disorder, or pervasive developmental delay History of meningitis or encephalitis History of child abuse History of chronic or uncontrolled serious physical disorders (cancer, uncontrolled diabetes, cystic fibrosis, etc.) Note: siblings of participants with TBI or orthopedically-injured comparison children will not be enrolled to maintain the independence of the groups


eligible ages (years): 17.0-70.0,  All  Traumatic Brain Injury Traumatic Brain Injury with a Glascow Coma Score < 9 (ie: severe head injury) Traumatic Brain Injury with a Glascow Coma Score > 8 with an intracranial pressure monitor in situ and CTscan evidence of one or more of the following: Cerebral oedema (Marshall grades III & IV), midline shift >5 mm cerebral contusion >3cm, evacuated subdural haematoma Enrolled within the first 48 hours after trauma Aged 17 ears  Has had a cardiac arrest at or post the trauma scene Pupils are fixed bilaterally and dilated >4mm,GCS=3 Coagulopathy sufficient to contraindicate surgery No chance of survival after consideration of CT and clinical findings Patients with lower limb/pelvic trauma excluded from Innercool monitoring only


eligible ages (years): 18.0-70.0,  All  Traumatic Brain Injury severe closed head injury patients or GCS 3-9 patients who receive brain oxygen monitoring ventriculostomy/ICP monitor at least one reactive pupil no known life threatening disease prior to trauma age 18-70 years old consent for microdialysis/brain 02 monitoring legal family representative present that can give informed consent for perfluorocarbon administration  no motor response both pupils fixed and dilated no consent available allergy to egg proteins coagulopathy major liver injury major pulmonary injury


eligible ages (years): 16.0-45.0,  All  Traumatic Brain Injury Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5) Estimated or known age > 16 and < 45 years old Time of Injury within 2.5hrs of arrival at hospital  GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post randomization GCS = 3 AND bilaterally non-reactive pupils Abbreviated Injury Score (AIS) > 4 for any body area except head Positive abdominal ultrasound or CT scan Persistent hypotension (systolic blood pressure < 110mmHGg) Persistent hypoxia (O2 Saturation < 94%) Positive pregnancy test Injured greater than 2.5 hours from hospital arrival Pre-existing medical conditions, if known


eligible ages (years): 0.0-17.0,  All  Traumatic Brain Injury Patients with a GCS </= 8 Glasgow Motor Score < 6 Closed head injury Age 0 < 18 y  Unavailable to initiate cooling within 6 hours of injury Glasgow Coma Scale (GCS) score = 3 and abnormal brainstem function Normal initial CT scan (No blood, fracture, swelling, and/or shift) Penetrating brain injury No known mechanism of injury Unknown time of injury Uncorrectable coagulopathy (PT/PTT > 16/40 sec, INR > 1.7) Hypotensive episode (Systolic Blood Pressure <5th percentile for age>10 min) Documented Hypoxic episode (O2 saturation < 94% for > 30 min) Pregnancy


eligible ages (years): 1.0-16.0,  All  Traumatic Brain Injury have a severe traumatic brain injury as defined by either a GCS ≤ 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score ≤ 3 and normal CT scan are aged between 1 and 16 years are mechanically ventilated  are not randomized by 6 hours after injury have penetrating brain injuries have fixed dilated pupils and GCS = 3 have proven cervical spinal cord injury have more than mild neurodevelopmental disability prior to injury have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal have had a post-traumatic seizure with a normal CT scan have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation


eligible ages (years): 0.0-999.0,  All  Minor Head Injury Intracranial Bleeding Traumatic Brain Injury Minor head injury, dizziness, nausea, vomiting  no injury to the head


eligible ages (years): 2.0-16.0,  All  Fractures Healthy pediatric emergency patients with isolated extremity injury requiring reduction  Active respiratory illness Seizure disorder Craniofacial abnormalities Allergy to soy, ketamine, or propofol Hypertension Significant renal, cardiovascular or neurologic disease


eligible ages (years): 0.0-17.0,  All  Cardiac Arrest Informed consent by parent or legal guardian Age ≥ 38 weeks gestation up to and including 17 years Patient admitted with a diagnosis of a cardiac arrest requiring compressions ≥3 minutes Remain comatose i.e. have Glasgow Coma Score less than or equal to 10 assessed at the tertiary level pediatric hospital at least 1 hour post cardiac arrest Invasive mechanical ventilation  Cardiac arrest lasting ≥45 minutes, irregardless of commencement of ECMO Refractory hemorrhagic shock Dysrhythmia leading to cardiac arrest, where cooling would be part of standard therapy Suspected diagnosis of brain death as defined as fixed and dilated pupils, Glasgow Coma Score of 3 and no evidence of brain function on neurological examination Patients who have had a prolonged cardiac arrest at the scene of a trauma Decision to withhold (DNR) or withdraw life sustaining therapies Acute Birth asphyxia Terminal illness, not expected to survive 12 months Cardiac arrest caused by septic shock Severe neurodevelopmental disability or persistent vegetative state prior to cardiac arrest


eligible ages (years): 16.0-70.0,  All  Severe Head Trauma Diagnosis TBI GCS 4-8 Age 16-70  Multiple trauma resulting in shock Bilateral absent pupil response Time from injury > 6 hours Brain tumor or mass effect secondary to hemorrhage or brain surgery Pregnancy Confounding condition or injury Spinal cord injury Sustained high blood pressure or arterial oxygen saturation


eligible ages (years): 18.0-70.0,  All  Traumatic Brain Injury Male or female 18 years of age (inclusive) at the time of study entry Weight ≥45 kg Able to begin the infusion of study drug within 12 hours of injury Evidence of severe non-penetrating traumatic brain injury by clinical evaluation, clinical indication for intracranial pressure (ICP) monitoring, Glasgow Coma Scale (GCS) assessment (4-8 prior to randomization, obtained any time prior to dosing and including patients who deteriorate to severe TBI after arrival in the hospital, not including times when the patient is pharmacologically paralyzed for management or treatment) and with definite anatomic signs of injury on head CT scan (e.g., Marshall Grade II-VI or equivalent) At least one reactive pupil at screening. Just prior to study drug administration pupil reactivity must be confirmed again. If the patient is in the peri-postoperative period at that time and reactivity is difficult to assess due to small pupil size, the Investigator will determine if the patient is eligible based on clinical presentation If a patient, due to his or her injuries is unable to provide written informed consent, then written consent may be obtained by an appropriate surrogate decision maker in accordance with preapproved procedures in compliance with local regulations  Patients who meet any of the following will not be included in the study Physical Assessment Not expected to survive the next 24 hours Morbidly obese (BMI >40) Absence of a motor response (not including times when the patient is pharmacologically paralyzed for management or treatment) Severe unexpected hyperthermia on admission (e.g. >39°C) Bilaterally fixed and dilated pupils Penetrating traumatic brain injury Major liver, kidney, or cardiac injury requiring operative intervention Major pulmonary injury, including lung contusion, severe atelectasis, acute respiratory distress syndrome, or acute aspiration pneumonitis


eligible ages (years): 18.0-999.0,  All  Hematoma, Subdural, Chronic Patients with chronic subdural hematoma that needs surgical evacuation Age > 18 year  Lack of compliance Kidney artery stenosis Stenosis of the aorta Severely decreased kidney function Allergy or intolerance/contraindications toward ACE inhibitors Already in ACE inhibitor treatment Coagulopathies Malignant disorders Fertile women Other neurological disorders


eligible ages (years): 3.0-9.0,  All  Traumatic Brain Injury Moderate to severe TBI that occurred within the last 24 months Overnight hospital stay English-speaking Parent must be willing to provide informed consent  Child does not live with parents or guardian Child or parent has history of hospitalization for psychiatric problem Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability


eligible ages (years): 8.0-18.0,  All  Type 1 Diabetes Mellitus 18 years old Have a diagnosis of type 1 diabetes mellitus  < 8 years or > 18 years old Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)


eligible ages (years): 6.0-18.0,  All  PTSD Traumatic Brain Injury Post Concussive Syndrome For the whole sample Children age 6 to 18 Language spoken: Hebrew, Arabic DSM IV R diagnosis: PTSD Car accident event within past 3 years For the m-TBI group Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain] Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI Glasgow coma scale; GCS<15  Children presenting with psychotic symptoms Children presenting with mental retardation


eligible ages (years): 18.0-89.0,  All  Subarachnoid Hemorrhage Intracranial Hemorrhage Ischemic Strokes Subdural Hematoma Patients aged between 18 and 89 years old Patients with critical illness including ischemic or hemorrhagic stroke, epidural/subdural bleeds and subarachnoid hemorrhage Patients who are expected to stay in the ICU for at least 5 days Hyperglycemia is not an  Patients who have received or will be treated with systemic corticosteroids Patients who will be receiving high doses of propofol (>40 cc/hr) Patients with type 1 Diabetes Patients with sepsis or acute trauma Patients with an expected stay in the ICU of less than 4 days Patients who are unable to receive enteral nutrition or who have medical conditions precluding nutrition by the enteral route including allergies to formula components Pregnant and lactating patients Patients with prior history of gastroparesis Patients with acute kidney failure (creatinine > 2.5mg/dl) Patients with acute liver failure (bilirubin > 2.0 mg/dl)


eligible ages (years): 18.0-30.0,  All  Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent  inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein


eligible ages (years): 21.0-28.0,  All  Physiological Strain healthy civilian volunteers aged 21-28 without known medical illnesses or medication use  the existence of or suspicion of existing cardiac or respiratory disease hypertension diabetes any hormonal disease or any other chronic illness that may inhibit participation in the experiment infectious disease 3 days prior to the experiment


eligible ages (years): 18.0-999.0,  All  Cerebral Ischemia Subarachnoid Hemorrhage for Admission to one of the participating study centres Age 18 years or over SAH with an aneurysmatic bleeding pattern  for Evidence of DCI after the SAH, defined as any decrease in the level of consciousness or the development of new focal neurological deficits after the onset of the SAH that is not due to increasing hydrocephalus, rebleeding of the aneurysm, epileptic seizure, septic or metabolic encephalopathy, unless symptoms of DCI started within 3 hours Co-existing severe head injury Perimesencephalic haemorrhage (perimesencephalic bleeding pattern and no aneurysm on CT-angiography) A history of a ventricular cardiac rhythm disorder, necessitating medical treatment A history of a left ventricular heart failure, necessitating medical treatment Likely transfer to another hospital, not participating in the trial, soon after treatment for the aneurysm Moribund Pregnancy


eligible ages (years): 10.0-999.0,  All  Minor Head Injury Patient with acute MHI was defined as a patient having a blunt trauma to the head within 24 hours with a Glasgow Coma Scale (GCS) of 13 to 15 and at least 1 of the following risk factors: history of loss of consciousness, short-term memory deficit, amnesia for the traumatic event, post-traumatic seizure, vomiting, headache, external evidence of injury above the clavicles, confusion, and neurologic deficit  Patients are excluded from the study if they are younger than 10 years, had GCS score of less than 13 or instable vital signs, came to the ED more than 24 hours after head trauma, were pregnant, were taking warfarin or had bleeding disorder, had an obvious penetrating skull injury or had contraindications for CT


eligible ages (years): 7.0-7.417,  All  Heart Defects, Congenital Critical Illness Mental Processes Child Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=<1year)  Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment IQ < 70 Lack of baseline neurocognitive measurements during first follow-up Date of birth before February 2005


eligible ages (years): 1.0-17.0,  All  Trauma Pediatric trauma patients with Injury Severity Score greater than 12 Age 1-17 years Trauma within 8 hours  Injury Severity Score less than 12 Pre-existing renal disease On medication that affects serum sodium (i.e diuretic therapy) Blood transfusion within first 24 hours Operation within first 24 hours Oral intake of fluid or solids in first 24 hours


eligible ages (years): 18.0-999.0,  All  Traumatic Brain Injury Ages 18 Years or older Males or Females Primary diagnosis of TBI, subarachnoid hemmorhage (SAH), intracranial hemmorhage (ICH), stroke Requires mechanical ventilation Requires or is receiving continuous IV sedation  Glascow Coma Score (GCS) of 3 persisting from the scene with bilaterally fixed dilated pupils with no appreciable chance of survival The inability to identify a next of kin or guardian to give consent if patient unable to consent Pregnant Allergy or contraindication to propofol Allergy to contraindication to midalozam Status epilepticus Current neuromuscular blockade Patient with a known hypersensitivity to propofol or midalozam Allergies to eggs, egg products, soybeans or soy products Acute narrow-angle glaucoma


eligible ages (years): 10.0-16.0,  All  Diabetes Diabetic Ketoacidosis To be eligible for the study, all subjects must meet the following Healthy control OR Clinical new onset or established diagnosis of diabetes with diabetes ketoacidosis as defined by the Pediatric Endocrine Society Consensus Statement guidelines Age 10 years to less than 17 years Parent/guardian understand the study protocol and agrees to comply with it Primary care giver (i.e parent/guardian) comprehends written English. This is due to the fact that questionnaires and neurocognitive testing tools used as outcome measures do not have validated versions in Spanish or other language. Subject comprehends and speaks English  Subjects who meet any of the following are not eligible for the study History of head trauma with any loss of consciousness History of premature birth (less than 30 weeks of gestation) History of significant developmental delay (lack of single word speech or ability to walk independently by 18 months of age History of neurologic disease independent of diabetes (seizure disorder)


eligible ages (years): 0.0-15.0,  All  Traumatic Brain Injury TBI patients admitted to the pediatric intensive care service (PICU)or pediatric progressive care unit Range in age from birth to 15 years TBI with a Glasgow Coma Scale of 3-15 Acoustic window for adequate transcranial doppler (TCD) ultrasound English or Spanish speaking or understanding parent/legal guardian to consent Access for a buccal swab for genotyping  Non-English or Spanish speaking parents/legal guardian Children with a previously diagnosed neurodevelopmental delay


eligible ages (years): 60.0-999.0,  All  Chronic Subdural Hematoma Subdural Drain Patients diagnosed to have symptomatic chronic subdural haematoma confirmed by a computed tomography or magnetic resonance imaging brain scan Ethnic Chinese Age >/= 60 years-old Reasonable expectation of completion of outcome measures at follow-up Written informed consent  Unsalvageable patients: fixed and dilated pupils after resuscitation or signs of brainstem herniation that precludes definitive therapy When the operating surgeon judges that drain placement may be hazardous or to be of limited benefit e.g. readily expanded brain in young patients History of previous cranial neurosurgical procedure On concurrent glucocorticoid therapy Suspected intracranial hypotension syndrome Blood dyscrasia Use of antiplatelet medication e.g. aspirin or warfarin without adequate reversal or observation for drug effect to wear off (at least 5-7 days) Thrombocytopenia: platelet level <100 x 109/l Coagulopathy: prothrombin time PT >12sec or, activated partial thromboplastin time (APTT) >37.4 sec End-stage renal/ hepatic failure


eligible ages (years): 18.0-999.0,  All  Brain-damaged Patients male or feminine Subjects of 18 or more years old Patients cérébro hurt presenting disorders(confusions) of the consciousness (Score of Glasgow < 9) and justifying an hourly pupillary surveillance(supervision) in the middle of neurosurgical resuscitation. (Definition of the Score of Glasgow in appendix) acute(sharp) intellectual Aggression bound(connected) to a cranial trauma, a meningeal bleeding by break of anévrysme, a cerebral vascular accident, an intra-cranial expansive process, a post-operative neurosurgical complication, an intra-cranial high blood pressure of medical origin (méningo-encephalitis, hypertensive encephalopathy) Admission in resuscitation within first 48 hours of the aggression  Subject having a direct eye trauma, as well as any history which can affect(allocate) the relevance of the pupillary examination (anophthalmia, cataract(waterfall) opalescente, surgery irienne, blindness, reached(affected) by III prerequisite, that the character of these affections is bilateral or unilateral) presenting Subject of the signs of irreversible coma in the admission minor Subject, pregnant or breast-feeding woman, subject deprived of freedom, subject not being affiliated to the national insurance scheme


eligible ages (years): 30.0-80.0,  All  Intracranial Arterial Stenosis Intracranial Atherosclerosis Ischemic Stroke Cerebral Angiogenesis TIA or non-severe stroke within 30 days of enrollment attributed to 70% to 99% stenosis* of a major intracranial artery (carotid artery or MCA) *May be diagnosed by TCD, MRA, or CTA to qualify, but must be confirmed by catheter angiography as per usual clinical practice Modified Rankin scale score of ≤3 Target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm Target area of stenosis is ≤14 mm in length Age ≥30 years and ≤80 years * Patients 30 to 49 years of age are required to meet at least 1 additional (i-vi) provided below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in patients 30 to 49 years is atherosclerotic: i. Insulin-dependent diabetes for at least 15 years ii. At least 2 of the following atherosclerotic risk factors: hypertension (BP ≥ 140/90 mm Hg or on antihypertensive therapy); dyslipidemia (LDL ≥130 mg/dL or HDL ≤40 mg/dL or fasting triglycerides ≥150 mg/dL or on lipid lowering therapy); smoking; non-insulin-dependent diabetes or insulin-dependent diabetes of <15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, and peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event iii. History of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease iv. Any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by noninvasive vascular imaging or catheter angiography and is considered atherosclerotic v. Aortic arch atheroma documented by noninvasive vascular imaging or catheter angiography vi. Any aortic aneurysm documented by noninvasive vascular imaging or catheter angiography that is considered atherosclerotic Negative pregnancy test in a female who has had any menses in the last 18 months Patient is willing and able to return for all follow-up visits required by the protocol  Tandem extracranial or intracranial stenosis (70-99%) or occlusion that is proximal or distal to the target intracranial lesion Bilateral intracranial vertebral artery stenosis of 70% to 99% and uncertainty about which artery is symptomatic (e.g., if patient has pontine, midbrain, or temporal occipital symptoms) Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days before the expected enrollment date Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis Presence of intraluminal thrombus proximal to or at the target lesion Any aneurysm proximal to or distal to the stenotic intracranial artery Intracranial tumor (including meningioma) or any intracranial vascular malformation Computed tomographic or angiographic evidence of severe calcification at target lesion Thrombolytic therapy within 24 hours before enrollment


eligible ages (years): 18.0-999.0,  All  Chronic Subdural Hematoma Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma Chronic subdural hematoma verified on cranial CT or MRI  A subdural drainage cannot be placed due to intraoperative circumstances (e.g. brain unfolds) The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy) Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt) no informed consent


eligible ages (years): 6.0-17.0,  All  Traumatic Brain Injury TBI ADHD Between ages of 6-17 Sustained Moderate to Severe TBI TBI occurred at least 6 months prior to beginning the study TBI occurred no earlier than 5 years of age Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or hyperactivity scale  History of developmental disability or mental retardation Current active participation in ADHD-related behavioral intervention History of psychiatric condition requiring an inpatient admission in past 12 months Actively taking medications with a contraindication to Concerta that cannot be discontinued Current use of stimulant medication or ADHD specific medications that cannot be discontinued Non-blunt head injury Family history of arrhythmia Pregnancy


eligible ages (years): 18.0-999.0,  All  Head Injury Traumatic Brain Injury (TBI) Photosensitivity Photophobia years old reports a previous head injury that occurred at least 6 months ago score of 2 or 3 (mild TBI) on OSU-TBI ID Survey best-corrected visual acuity of at least 20/30 in both eyes reliable visual field  pregnancy significant afferent pupillary defect previous history of neurodegenerative disease intraocular pressure more than 21 mm Hg significant visual field defect active corneal pathology history of retinal or optic nerve disease strabismus (eye turn)


eligible ages (years): 15.0-999.0,  All  Traumatic Brain Injury Blunt or penetrating traumatic mechanism consistent with traumatic brain injury Prehospital Glasgow Coma Score (GCS) score ≤ 12 at any time prior to randomization and administration of sedative and/or paralytic agents Prehospital systolic blood pressure (SBP) ≥ 90 mmHg prior to randomization Prehospital intravenous (IV) or intraosseous (IO) access Estimated Age ≥ 15 (or estimated weight > 50 kg if age is unknown) Emergency Medicine System (EMS) transport to a participating trauma center  Prehospital GCS=3 with no reactive pupil Estimated time from injury to hospital arrival > 2 hours Unknown time of injury no known reference times to support estimation Clinical suspicion by EMS of seizure activity or known history of seizures, acute myocardial infarction (MI) or stroke Cardio-pulmonary resuscitation (CPR) by EMS prior to randomization Burns > 20% total body surface area (TBSA) Suspected or known prisoners Suspected or known pregnancy Prehospital TXA given prior to randomization


eligible ages (years): 18.0-90.0,  All  Chronic Subdural Hematoma Age ≥ 18 and ＜90 years old, male or female CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult) Markwalder's Grading Scale and Glasgow Coma Scale (MGS-GCS)＜Grade 3 Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted Patients have never undergo surgery on the hematoma Patient fully understood the nature of the study, and voluntarily participates and signs informed consent  Allergic to the statin or its ingredients Cerebral herniation might occur at any time Hematoma leads to herniation and warrants surgical operation Hematoma caused by tumors, blood and other known comorbidities Abnormal liver function Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study Patients have been on oral Statin treatment for a long time Patients have been on oral Steroids treatment for a long time Participate in clinical trials in the past four weeks Pregnant or breastfeeding


eligible ages (years): 18.0-85.0,  All  Intracerebral Hemorrhage Spontaneous intracranial or intraparenchymal hemorrhage 85 years of age Hemorrhage occurred in a supratentorial location  Inability to obtain consent within 3 days of hemorrhage onset Known pregnancy Therapeutic anticoagulation with Lovenox, Coumadin or Heparin Prior history of therapeutic radiation to any area Brain tumor Hemorrhage related to trauma, aneurysm, arteriovenous malformation or other vascular malformation Central nervous system infection Subdural hematoma Subarachnoid hemorrhage Chronic immunosuppression, including steroids or chemotherapy agents


eligible ages (years): 22.0-65.0,  All  Subdural Hematoma, Traumatic Non-penetrating traumatic brain injury GCS motor score ≤5 (not following commands) Estimated or known age 22-65 years Acute subdural hematoma requiring emergent craniotomy within 6 hours of initial injury Estimated time of injury to time to reach temp of 35°C<6 hrs  Total GCS = 3 and bilateral fixed and dilated pupils Following commands after an initial period of coma (GSC motor score of 6) Known pre-existing neurological deficit (e.g., previous TBI, stroke) Concomitant spinal cord injury Arrival temperature is <35°C Hemodynamic instability (i.e., MAP<60mmHg for 30 minutes) Active cardiac dysrhythmia resulting in hemodynamic instability Pregnancy Duret hemorrhage Prisoner or Ward of the State


eligible ages (years): 5.0-999.0,  All  Concussion Stress Disorders, Post-Traumatic All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following Any period of loss of consciousness (LOC) Any loss of memory for events immediately before or after the accident Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused) Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following Loss of consciousness of approximately 30 minutes or less After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15 Posttraumatic amnesia (PTA) not greater than 24 hours  Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2 Pregnant individuals and prisoners will also be excluded from the study


eligible ages (years): 18.0-89.0,  All  Chronic Subdural Hematoma Age ≥18 and＜90years old, both gender Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI scan is warranted if diagnosis is difficult) The midline shift to less than 1 cm Attending physician makes a judgment that cerebral hernia would not occur and surgical operation might not be performed in a short time. Conservative treatment is adopted Patients have never undergo surgery on the hematoma Patient fully understood the nature of the study, and voluntarily participates and signs informed consent  Allergic to the statin and dexamethasone or its ingredients Hematoma caused by tumors, blood and other known comorbidities Abnormal liver function Uncontrolled hepatitis and other liver diseases, as well as suffering from other disease may interfere the study Patients have been on oral Statin treatment in the past four weeks Patients have been on oral Steroids treatment for a long time Diagnosed Diabetes patients with poorly controlled blood glucose Participate in clinical trials in the past four weeks Pregnant or breastfeeding Failure of completing the trial by poor compliance


eligible ages (years): 18.0-999.0,  All  Trauma Injury Bleeding Haemorrhage Coagulopathy Injured trauma (penetrating or blunt) patients who are at risk of significant bleeding, defined as: i. Systolic blood pressure (SBP) ≤ 100mmHg at any time from the injury scene until 30min after hospital admission AND ii. Red blood cell transfusion has been ordered by the trauma team leader (or delegate)  Patients in shock which the etiology is purely not related to bleeding i. Cardiogenic (myocardial or valvular dysfunction); ii. Distributive (septic, anaphylactic, acute adrenal insufficiency and neurogenic) and iii. Obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli) Severe head injury, defined as any of the following i. Glasgow coma scale (GCS) of 3 due to severe traumatic brain injury (TBI); ii. TBI with clear indication of immediate neurosurgical intervention based on clinical findings (mechanism of trauma associated with focal signs such as anisocoria with fixed pupil) or on CT results (bleeding causing mass effect); iii. Unsalvageable head injury such as through-through gunshot wound to the head, open skull fracture with exposure/loss of brain tissue; as per the trauma team or neurosurgery initial clinical assessment or as per initial CT of the head findings Known complete or incomplete spinal cord injury Known hereditary or acquired coagulopathies unrelated to the trauma resuscitation (e.g. known hepatic dysfunction) Use of anticoagulant medications such as warfarin, low-molecular weight heparin, and direct thrombin and factor Xa inhibitors Moribund with evidence of unsalvageable injuries and withdrawal of care, as per the trauma team Received blood products prior to admission Patients with estimated body weight under 50Kg


eligible ages (years): 18.0-999.0,  All  Chronic Subdural Hematoma Healthy Volunteers Patient admitted for surgery of chronic subdural hematoma A CT scan of the patient has been performed, within the latest 96 hours The patient should be able to have a normal conversation and understand the information about the study, corresponding to Glasgow Coma Scale (Verbal Response) of 5 Patient/healthy volunteer should be ≥ 18 years of age The patient/healthy volunteer has signed a written informed consent  Females who are pregnant or breast feeding women Patient/healthy volunteer has a shunt or other foreign object implanted in the brain Patient/healthy volunteer participating in any other clinical study that could interfere with the result in the ongoing study


eligible ages (years): 18.0-999.0,  All  Subarachnoid Hemorrhage Written informed consent of the patient or consent of patient's next of kin Spontaneous SAH Age: ≥18 Glasgow coma scale (GCS) ≤ 12. In intubated patients the GCS assessment will be performed after cessation of sedation or if not possible the last GCS score before intubation will be used  SAH due to any other cause or structural abnormality of the brain (trauma, dissection, arterio-venous malformation, dural arterio-venous fistula) Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad)


eligible ages (years): 7.0-25.0,  All  Sarcoma, Soft Tissue Osteosarcoma Tumor Survivors of paediatric bone or soft tissue sarcomas, who were treated from 1992 onwards in the paediatric haematooncology department of UZLeuven according to one of the following treatment protocols *For soft tissue sarcomas: MMT 95, MMT 98, RMS2005 or NRST2005 *For Ewing sarcoma: 92, Euro-Ewing 99 or Euro-Ewing 2008 *For osteosarcoma: EORTC 80931 or Euramos1 protocols There will be variability in treatment regimens, but the patient group will be clustered into four subgroups Cisplatin and anthracyclines Cisplatin, anthracyclines and methotrexate Alkylating agents Alkylating agents and anthracyclines  Mental retardation documented before treatment Inability to perform the tests because of motor or sensory deficits Epilepsy Other cognitive disorders Depression Relapse Parameningeal or intracranial sarcomas Syndrome (e.g. Down) Autologous stemcell transplantation Head/neck/spinal radiotherapy or psychopharmaca


eligible ages (years): 18.0-999.0,  All  Substance Withdrawal Syndrome intermittent use or continuous infusion opioids for at least 96 hours  Patient and/or relatives unable to communicate in French or English Patients unable to communicate (consent form and evaluation) Patient deaf without appropriate hearing aid Patients unable to communicate (consent form and evaluation) Imminent and predictable death according to medical team Severe brain injury, defined as Glasgow Coma Scale (GCS) score of 8 or less at ICU admission Moderate brain injury, defined as GCS between 9 and 12, with elevated intracranial pressure (ICP > 20 mm Hg) who requires ICP monitoring and osmotherapy Major confounding factors for withdrawal syndrome by causing shivering, sympathetic drive and autonomic disorders Underlying active neurological condition (status epilepticus, encephalopathy, hypoxia) Neurological problems are covariates, which would make the assessment of sedation or IWS difficult Patient previously included in the study at any of the two hospitals (readmission to the ICU at a later date during the period of recruitment for the study, limiting to 1 weaning episode per patient)


eligible ages (years): 18.0-999.0,  All  Hematoma, Subdural, Chronic years and older evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging) classified between 0 and 2 using the Markwalder grading scale  contraindications or intolerance to corticosteroid therapy patients already undergoing steroid treatment for any other indication previous neurological surgery up to one year prior to being considered for the study concomitant cerebral pathology of neoplastic or presumed infectious origin anticoagulant therapy that could not be stopped for 6 months refusal to participate in the study


eligible ages (years): 0.0-15.0,  All  Injuries Trauma Wounds and Injuries Children Child Children 0-15 years inclusive Presenting to either of the study hospitals for assessment or treatment Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) Due to an incident involving any non-motorized bicycle, tricycle or kick scooter  Incidents where the injured child was involved in a motor vehicle collision Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) Incidents involving a bicycle fitted with 'bull bars' Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted


eligible ages (years): 0.0-6.0,  All  TBI (Traumatic Brain Injury) Children <72 months old in whom a head CT is ordered/obtained with concerns for TBI Present to the Children's Hospital Colorado (CHCO) Emergency Department (ED) or inpatient wards  Contraindication to MR (e.g. pacemaker, implanted metallic object incompatible with MR) Prior diagnosis of TBI, structural brain lesion or prior brain surgery including shunted hydrocephalus Prior participation in this study Clinically unstable in the opinion of the patient's attending physician Wards of the State TBI not included in the differential diagnosis of the patient's attending physician (e.g. the indication for imaging is concern for infections, tumor, autoimmune or inflammatory disease) or if imaging has already identified a non-traumatic source for symptoms


eligible ages (years): 18.0-999.0,  All  Vestibular Schwannoma Vestibular schwannoma advised to surgical treatment No measurable remaining vestibular function  impaired decision making neurofibromatosis signs for central dysfunction remaining vestibular function Patients are advised not to participate in the gentamicin arm if hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70% the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss


eligible ages (years): 21.0-80.0,  All  Pain Head and Neck Disorder Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia  previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation


eligible ages (years): 18.0-999.0,  All  Brain Injuries Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay  Patients admitted less than 24 hour


eligible ages (years): 2.0-17.0,  All  Pain Long-bone Fractures children aged 2 through 17 years (17 years included) accompanied by at least one of their parents in the emergency department accompanied by at least one of their parents in the emergency department suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the inclusion) within the first 12 hours after the injury at least one signed parental informed consent affiliated to health insurance  analgesic treatment within the 6 hours before contraindication to one of the study drug cognitive impairment multiple injuries resuscitation manœuvres open fracture non affiliated to social security parental refusal


eligible ages (years): 18.0-999.0,  All  Atrial Fibrillation (Prevention of Stroke) Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window Diagnosis of NVAF on start date of study or anytime during 365 days before this date Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date) Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window  Patients with valvular AF Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort


eligible ages (years): 18.0-999.0,  All  Chronic Subdural Hematoma CT scan demonstrating the existence of a subdural hematoma containing a chronic component Diagnosis within the last 14 days  Acute subdural hematoma with no chronic component Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency Atrial fibrillation (unless under successful rhythm control therapy) Metallic heart valve Vascular stenting procedure within the last year Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty Ongoing investigation for suspected malignancy Confirmed active malignancy


A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy.

eligible ages (years): 18.0-60.0,  All  Malaria, Falciparum Healthy adult: male or female Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 000 parasites/Î¼L Age 18 years to 60 years Willingness to sign and ability to understand consent form Willingness and ability to return for scheduled follow up visits  Mixed malaria infection by Giemsa smear History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin) Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting) Inability to swallow oral medication Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality Any situation which could prevent the patient from returning to follow up visits Pregnancy or breast feeding Any other concurrent illness that may confound the result Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study


eligible ages (years): 15.0-49.0,  All  Malaria in Pregnancy HIV Infections Pregnant women 24 weeks gestation Consent Presenting for ANC at study hospitals/centres Agree to have an HIV test and to be examined for viral load  Severe systemic disease AIDS-related disease At-risk pregnancy


eligible ages (years): 0.115-4.917,  All  Malaria Ages 6 weeks to 59 months Residence in the study area Informed consent  Known allergy to study drugs Serious underlying illness


eligible ages (years): 10.0-999.0,  All  Malaria Written informed consent Available for 4 x monthly follow ups or more individuals in household  Allergy to repellents / plants Malaria positive at baseline


eligible ages (years): 1.0-999.0,  All  Malaria Falciparum Age > 1 year Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old) Willingness to come to the health facility for the following 28 days  Signs or symptoms of severe malaria Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition) History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines


eligible ages (years): 18.0-999.0,  All  Acute Uncomplicated P. Falciparum Malaria Patients were eligible for if they met all of the following Male or female aged 18 or older (prior to Amendment 1: more than 2 years old) Non-immune patients suffering from acute uncomplicated P. falciparum malaria, or mixed infection including P. falciparum, with parasitemia of less than or equal to 2% asexual P.falciparum parasites, confirmed by microscopy using Giemsa-stained thick film Non-immune patients were regarded as those who had not spent the first five years of their life, nor the last five years in a malaria endemic area, and did not have acute P. falciparum malaria diagnosed during those past five years Non-immune patients who had received prophylaxis with anti-malarials (excluding halofantrine) were included only if clear progression of acute P. falciparum infection was documented Female patients were eligible to participate in the study if they were of non-childbearing potential or had a negative pregnancy test (urine or serum) at screening, and using an acceptable contraceptive method Patients, who had been informed of the study procedures and medication, and had given written informed consent and were willing to comply with the study protocol  Patients were to be excluded from participation if they met any of the following Known hypersensitivity to artemether or lumefantrine Signs/symptoms indicative of severe/complicated malaria according to the WHO classification (e.g. cerebral malaria, see Post-text supplement 1) Treatment with artemisinin derivatives within the previous 7 days Concurrent administration of other treatment / prophylaxis for malaria Concurrent administration of medications with potential hemolytic effects Patients taking any drug metabolized by cytochrome isoenzymes CYP3A4 or CYP2D6 Received any other investigational drugs in the last 4 weeks before entry into the study Severe cardiac impairment (i.e. evidence of existing cardiac conduction defect or overt symptoms of cardiac dysfunction or abnormalities of baseline ECG not associated with acute malaria); clinically relevant bradycardia or congestive cardiac failure with reduced left ventricular ejection fraction; pre-existing prolongation of the QT interval; history of symptomatic cardiac arrhythmias Having received halofantrine or any other drug known to influence cardiac function within 4 weeks prior to Screening visit or taking other drugs that are known to prolong the QT interval, including class IA and III antiarrhythmics, neuroleptics, antidepressive agents, certain antibiotics (including some macrolides, fluoroquinolones, imidazole, and triazole antifungal agents), certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride


eligible ages (years): 14.0-45.0,  All  Anaemia Malaria Primigravida Secundigravida Permanent resident Hemoglobin (Hb) > 7 g/dl  Hb < 7 g/dl Allergy to sulpha Multiple pregnancy Chronic diseases


eligible ages (years): 0.25-4.917,  All  Malaria For original trial: Children aged 3-59 months present in participating villages For follow-up: Children who were in original trial for at least 1 year  For original trial: None For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests


eligible ages (years): 18.0-50.0,  All  HIV Infections Permanent residents of the Luanshya district Males and non pregnant adults between 18 and 50 years old Having a CD4 cell count of least 350 perµL at enrolment HIV sero-status determined at the VCT of the health center No obvious underlying disease at time of enrolment Signed informed consent  HIV stage III or IV following the WHO classification (see attached documents regarding policy in Zambia) Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition, TB) Intent to move out of the study catchment area during the study period History of allergy to MQ (or related drugs) or sulfa drugs Chorionic gonadotrophic hormone in urine or obvious pregnancy


eligible ages (years): 5.0-60.0,  All  Malaria Age: 5 years old Fever (axillary temperature equal or higher than 37,5 °C) or history of fever in the previous 24 hours Monoinfection with P. falciparum, with parasitic density between 1,000 and 200,000 par/µl Informed consent provided by patient or parent or legal tutor  Mixed malaria infection Pregnancy or breastfeeding to child ≤ 6 months of age One or more danger signs or any sign of severe or complicated malaria A concomitant severe disease History of treatment with mefloquine in the last 60 days or chloroquine, primaquine or quinine within the 14 days before the present episode History of neuropsychiatric disease History of hypersensitivity reactions to artemisinins or mefloquine History of splenectomy


eligible ages (years): 18.0-45.0,  All  Falciparum Malaria Age > 18 and < 45 years healthy volunteers (males or females) General good health based on history and clinical examination All volunteers have to sign the informed consent form Negative pregnancy test Use of adequate contraception for females Reachable by phone during the whole study period Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the trial  History of malaria or residence in malaria endemic areas within the past six months Positive serology for P. falciparum Previously participated in any malaria vaccine study Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers Cardiovascular risk >10% according to European guidelines, taking into account sex, age, cholesterol, weight, smoking habits, blood pressure, diabetes Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests Volunteers should not be enrolled in any other clinical trial during the whole trial period Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period Pregnant or lactating women Volunteers unable to give written informed consent


eligible ages (years): 15.0-45.0,  All  Malaria Parasitaemia Birth Weight Anaemia Pregnant women of all parities Second trimester  Severely ill pregnant women Pregnant women in first trimester


eligible ages (years): 0.0-0.003,  All  Malaria Anemia Born in San Francis Designated District Hospital of Ifakara  Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus Twins Birth weight < 1,5 kg Clinical signs of cerebral asphyxia Clinical signs of neonatal or congenital infection Mother unreliable (deaf, mentally handicapped)


eligible ages (years): 18.0-40.0,  All  Length of Pregnancy Prolongation in Hours All patients admitted with the diagnosis of preterm labor between 24 0/7 and 33 6/7 weeks gestation. Preterm labor will be defined by regular contractions and/or cervical change from last documented exam Cervical exam 4 cm or greater Intact membranes  Multiple gestation (>2) Clinical evidence of chorioamnionitis, such as maternal fever, uterine tenderness, fetal tachycardia Lethal fetal anomaly Persistent vaginal bleeding, abruption, or placenta previa Rupture of membranes Maternal illness or fetal indication requiring delivery Inability to give informed consent Serious allergy to study medications. GI discomfort will not be considered a drug allergy


eligible ages (years): 18.0-85.0,  All  Orthopedic Disorders Unwillingness to sign informed consent  Pregnancy


eligible ages (years): 0.0-999.0,  All  Malaria in Pregnancy Female First or second trimester of pregnancy First or second pregnancy Resident in the study area  Refuse to give informed consent