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A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 0.417-1.417, Malaria Healthy infant/child aged 5-17 months at the time of first study vaccination Informed consent of parent/guardian Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness Weight-for-age Z score of less than -3 or other clinical signs of malnutrition History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator Serum Creatinine concentration greater than 70 µmol/L, where judged to be clinically significant in the opinion of the investigator Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator Blood transfusion within one month of enrolment Previous vaccination with experimental malaria vaccines Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-70.0, Spinal Cord Injury Muscle Spasticity Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months) Moderate to severe lower-limb spasticity Able to give informed consent and willing to comply with protocol Pregnancy History of seizures Existing or history of frequent Urinary Tract Infections History of drug or alcohol abuse Allergy to pyridine-containing substances Received a botox injection 4 months prior to study Received an investigational drug within 30 days Previously treated with 4-aminopyridine (4-AP) Not on stable medication dosing in 3 weeks prior to study Abnormal ECG or laboratory value at screening | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 20.0-75.0, Stroke first episode of unilateral stroke time since stroke less than 3 months, i.e., acute or subacute stage initial motor part of upper limb of FMA score ranging from 10 to 40, indicating severe to moderate movement impairment no serious cognitive impairment (i.e., Mini Mental State Exam score > 23) pregnant or breastfeeding women aphasia that might interfere with understanding instructions major health problems or poor physical conditions that might limit participation currently participation in any other research. Potential participants will be also excluded if they have any contraindication to fMRI scanning including claustrophobia, seizures, the presence of pacemaker, mental elements (e.g., steel nails) inside the body or in the eyes, and excessive obesity | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 0.0-999.0, Rabies Vaccine Allergy Parent/legal acceptable representatives of children or the adult participants are willing and able to understand the protocol requirements and provide informed consent signed Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months before injured The man-killer could found and detect whether it carries the virus Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Apply passive immunity preparation | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 2.0-17.0, Rabies Aged 2 to 17 years on the day of Informed consent form has been signed and dated by the parent(s) (and subject, if applicable by local regulations), or another legally acceptable representative and by an independent witness, as applicable, and the assent form has been signed and dated by the subject (if applicable by the local Ethics Committee or country regulations) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination Any previous vaccination against rabies (in pre or post-exposure regimen) with either the trial vaccine or another vaccine Bite by a potentially rabid animal in the previous 6 months without post-exposure prophylaxis Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Self-reported seropositivity for Human Immunodeficiency Virus (HIV) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-80.0, Tremor Essential Tremor Men and women, between 18 and 80 years, inclusive Patients who are able and willing to give consent and able to attend all study visits A diagnosis of ET as confirmed from clinical history and examination by a movement disorder neurologist Tremor refractory to adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated Vim nucleus of thalamus can be target by the ExAblate device. The Vim region of the thalamus must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain Able to communicate sensations during the ExAblate MRgFUS treatment Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale Stable doses of all medications for 30 days prior to study entry and for the duration of the study May have bilateral appendicular tremor Significant disability due to essential tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities]) have been agreed upon by two members of the medical team Patients with unstable cardiac status including Unstable angina pectoris on medication Patients with documented myocardial infarction within six months of protocol entry Congestive heart failure requiring medication (other than diuretic) Patients on anti-arrhythmic drugs Alcohol or drug abuse within the past 6 months Severe hypertension (diastolic BP > 100 on medication) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 45.0-80.0, Stroke a history of acute phase of stroke (less than 12 months post onset) first stroke episode no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity no contracture of the affected wrist or fingers (Modified Ashworth<3) no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study for P-ROM patients, the absence of active hand movements for the A-ROM patients, the presence of active hand movements unstable medical disorders active Complex Regional Pain Syndrome (CRPS) severe spatial neglect aphasia cognitive problems | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-45.0, Malaria Phase Ia Healthy volunteers aged 18-45 years General good health based on history and clinical examination Written informed consent obtained before any study procedure Female volunteers practicing contraception before and up to 13 weeks after the last immunisation Available to participate in follow-up for the duration of study (34 weeks) Reachable by phone during the whole study period Phase Ib Healthy male volunteers aged 18-45 years General good health based on history and clinical examination Phase Ia Positive pregnancy test for females Actively breast feeding females Previous participation in any malaria vaccine trial Symptoms, physical signs or 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 trial results or compromise the health of the volunteers Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site Enrolment in any other clinical trial during the whole trial period Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the 13 weeks preceding the screening visit or during the trial period except topical and inhaled steroids Volunteers unable to be closely followed for social, geographic or psychological reasons Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-65.0, Hyperhidrosis Muscle Spasticity Glabellar Lines Patients treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice for primary axillary hyperhidrosis, focal spasticity or moderate to severe glabellar lines | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-65.0, Upper Limb Spasticity Unilaterally in Adults With History of Stroke Increased Muscle Tone in Elbow, Wrist, Finger, and Thumb Flexors. Adults with history of stroke that resulted in a unilateral, upper-limb focal spasticity Wrist flexor tone of more than 2 and finger flexor tone of more than 2 as measured by the Ashworth Scale Ability to understand and follow verbal directions At least 1 functional disability item (hygiene, dressing, pain, or limb posture) with a rating of more than 2 on the Disability Assessment Scale (DAS) At least 1 functional task score at Day 0 that met the following nail filing less than 6, hand cleaning less than 6, holding a water bottle less than 4, brushing teeth less than 4, holding fruit (small, medium, or large equals no Stroke within 6 months of the study enrollment visit Females who are pregnant, nursing, or planning a pregnancy during the study period or who are not using a reliable means of contraception Previous or current Botox therapy of any type in the study limb Any medical condition that may put the patient at increased risk with Botox exposure or any other disorder that might have interfered with neuromuscular function Presence of fixed contracture of the study limb Limited use of the wrist and fingers | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 40.0-999.0, Myopic Macular Degeneration Adult male or female over 40 years of age Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment Axial myopia of equal to or greater than -8 diopters and/or axial length equal to or greater than 28 mm Clinical findings consistent with MMD with evidence of one or more areas of >250microns of geographic atrophy (as defined in the Age-Related eye Disease Study [AREDS] study) involving the central fovea GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA No evidence of current or prior choroidal neovascularization The visual acuity of the eye to receive the transplant will be no better than 20/80 The visual acuity of the eye that is NOT to receive the transplant will be no worse than 20/400 The eye with the more advanced disease and worse vision will be the study eye Electrophysiological findings consistent with macula-involving geographic atrophy Negative urine screen for drugs of abuse Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serologies No history of malignancy (with the exception of successfully treated (excised) basal cell carcinoma[skin cancer] or successfully treated squamous cell carcinoma of the skin) Negative cancer screening within previous 6 months complete history & physical examination dermatological screening exam for malignant lesions negative fecal occult blood test & negative colonoscopy within previous 7 years negative chest roentgenogram (CXR) normal CBC & manual differential negative urinalysis (U/A) | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 1.0-999.0, Rabies Infection Healthy males and females ≥ 1 years of age Individuals/ individual's parents or legal guardians who have given written consent Individuals in good health Individuals who can comply with study procedures Behavioral or cognitive impairment or psychiatric disease Unable to comprehend and to follow all required study procedures for the whole period of the study History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable) Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50 Female of childbearing potential, with a positive pregnancy test prior to enrollment Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 16.0-999.0, Cerebral Palsy Spasticity Aged sixteen or older Spastic Cerebral Palsy with stable condition Motor disability unilateral or predominantly unilateral Troubles of speech clinically evident Normal or Slightly sub-normal I.Q No psychiatric disorders Severe cardiac or respiratory troubles Fixed abnormal postures (except if previously corrected by orthopedic surgery) Chronic recurrent bronchial or pulmonary infections Chronic recurrent urinary infections Severe osteoporosis on affected limbs Chronic skin ulcerations | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-40.0, Rabies Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial Physical examination and laboratory results without clinically significant findings Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 Subjects must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during treatment and the 4-week F/U period after the last treatment Use of any investigational or non-registered product (adjuvant, drug) other than CV8102 within 4 weeks preceding the administration of the CV8102, or planned use of any such agent during the trial period Subject has received any licensed or non-licensed vaccines within 4 weeks prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine or planned vaccinations during the trial period Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of CV8102 alone or in combination with the licensed rabies vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted Any medically diagnosed or suspected immune deficient condition based on medical history and physical examination History of autoimmune disease or suspected autoimmune disease based on medical history and physical examination that cannot be ruled out based on further examinations Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of CV8102 or licensed rabies vaccine Acute disease at the time of enrolment. Acute disease is defined as the presence of any acute condition including but not limited to non-febrile or febrile common colds, urinary tract infections, inflammatory, allergic or traumatic conditions that may interfere with safety assessment of the investigational products Presence or evidence of significant acute or chronic disease, in particular heart disease including coronary artery disease and chronic pulmonary diseases (e.g., chronic obstructive pulmonary disease [COPD]); uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥ 3 months e.g., mild hypertension well-controlled with medication, may be enrolled provided the condition and its therapy are known not to be associated with an immunocompromised state or an autoimmune disease) Major congenital defects | 1 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-40.0, Rabies Healthy male and female volunteers aged 18 to 40 years inclusive Compliant with protocol procedures and available for clinical follow-up through the last planned visit (V9) Physical examination and laboratory results without clinically significant findings Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 Females: Negative human chorionic gonadotropin (HCG) pregnancy test (serum) for women presumed to be of reproductive potential on the day of enrolment Females of childbearing potential must use acceptable methods of birth control during the trial and Follow-up period (from 6 weeks before the first administration of the test vaccine for the duration of the trial i.e., until the last planned visit (V9)). The following methods of birth control are acceptable when used consistently and correctly: established use of oral, injected or implanted hormonal methods of contraception; intrauterine devices (IUDs) or intrauterine systems (IUSs) with the exception of steel or copper wire; barrier methods of contraception (condom or occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository); true abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal and postovulation methods] and withdrawal are not acceptable) Males must use reliable forms of contraception (barrier method with spermicidal agent or true abstinence) and must refrain from sperm donation during the trial and Follow-up period i.e., until the last planned visit (V9) Use of any investigational or non-registered product (drug or vaccine) other than the trial vaccine within 4 weeks preceding the administration of the trial vaccine, or planned use during the trial period Subject has received any other licensed vaccines within 4 weeks prior to the administration of the trial vaccine Subject has received any investigational or licensed rabies vaccine previously Intending to travel to regions/countries for which rabies vaccinations are recommended or where high risk of infections exists according to travel recommendations by the German Society of Tropical Medicine and International Health (DTG) during the trial and up to V9 (Day 91/120) Follow-up Any treatment with immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the trial vaccine. The use of inhaled and nasal steroids, as well as topical steroids outside the vaccination area, will be permitted Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination History of autoimmune disease Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the trial vaccine Subject is taking chloroquine for malaria treatment or prophylaxis Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness or fever ≥ 38 °C measured orally | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 1.0-15.0, Dog Bite they are 1-15 years healthy children give signed informed consent from their parents willing to participate in this study and be able to receive the vaccination and collect blood sample as the study plan they have prior history of rabies vaccination or any equine/human serum administration such as snake antivenom and tetanus antiserum or vaccine allergy Persons who have immunosuppressive conditions such as known HIV infection, transplantation, chronic renal failure, receiving of steroid or immunosuppressive drugs person received anti-malarial drugs within the previous two months or any blood products within previous three months were excluded Urine pregnancy test must be done in all female adolescents to the pregnancy in first visit | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-85.0, Stroke First focal unilateral lesion, ischemic or hemorrhagic Had a stroke less than a month prior to enrollment Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand Apraxia Subjects who have other unrelated or musculoskeletal injuries | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-85.0, Stroke • First focal unilateral lesion, ischemic or hemorrhagic Had a stroke less than a month prior to enrollment Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand • Apraxia Subjects who have other unrelated or musculoskeletal injuries | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-60.0, Rabies Male and non-pregnant females aged ≥ 18 to ≤ 60 years on the day of Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Previous history of receiving the rabies vaccine Previous history of receiving rabies immune globulin Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that is well controlled is not an criteria Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block, SVT, PAC, VF, VT, or any other conduction abnormalities Use of any immunosuppressive drug , including topical steroids of potency groups I, II or III within 30 days of the study period Any immunosuppressive disorder, such as HIV, common variable, active cancers or chemotherapy History of renal insufficiency or requiring dialysis | 1 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-85.0, Essential Tremor Essential Tremor diagnosed by listed in the Consensus statement of the Movement Disorders Society on Tremor Age 18 years of age Motor skills allowing for capability to complete evaluations Medically cleared for undergoing anesthesia and DBS surgery Dementia per DSM-V Medical or other condition precluding MRI History of supraspinal CNS disease other than Essential Tremor Alcohol use of more than 4 drinks per day Pregnancy History of suicide attempt Currently uncontrolled clinically significant depression (BDI>20) History of schizophrenia, delusions, or currently uncontrolled visual hallucinations | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 2.0-999.0, Cervical Dystonia clinical diagnosis of cervical dystonia or spasmodic torticollis ages 2-100 no clinical diagnosis of cervical dystonia or spasmodic torticollis symptoms beginning over the age of 40 pregnant women are excluded from Aim 2 | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 0.0-999.0, Complication of Labor and Delivery all midwives and physicians working on labor ward in the participating hospitals all women giving birth in the participating hospitals both genders are included in the staff, and among the newborns the study aim is the education of the staff, and hospitals are compared as units | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 10.0-60.0, Rabies Aged from 10 to 60 years old Subjects or legal guardians can and will comply with the requirements of the protocol Subjects or legal guardians are able to understand and sign the informed consent Healthy subjects judged from medical history after investigator's inquiry Subjects with temperature <=37.0°C on axillary setting Female in lactation or pregnancy, or plan to be pregnant during the study period Subject who has allergic history to any vaccine or other medicines Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain Subject with congenital malformation, developmental disorder or serious chronic disease Subject with autoimmune diseases or immunodeficiency Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids Subject with diabetes (Type I or II) excluding gestational diabetes Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease Subject with severe angioedema in the past 3 years or require treatment in the past 2 years | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-60.0, Rabies HIV infected patients Age 18 years Received primary rabies immunization Have any active opportunistic infections Received blood or blood product within 3 months Allergy to vaccine or any vaccine components Received anti-malarial drugs | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-70.0, Neck Pain No current history or past history of neck pain; able to lie on back or stomach without difficulty 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc History of neck whiplash injury Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck) Prior surgery to your neck or upper back A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency) Diagnosis from your physician of fibromyalgia syndrome Currently pregnant, or could be pregnant | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-60.0, Rabies Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female, aged ≥ 18 to ≤ 60 years on day of inclusion In good general health based on medical history and physical exam Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Previous history of receiving the rabies vaccine Previous history of receiving rabies immune globulin Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not criteria Use of any immunosuppressive drug at the time of the study or 30 days previously. Topical steroids will not be considered an immunosuppressive drug and their use will not be considered an Any immunosuppressive disorder, such as HIV infection, common variable immunodeficiency, active cancers or chemotherapy History of renal insufficiency or requiring dialysis Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator | 0 |
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized. | eligible ages (years): 18.0-999.0, Lateral Epicondylosis Lateral Epicondylitis Tennis Elbow Aged > 18 years old Lateral elbow pain lasting > 3 months Pain induced by direct compression on the lateral epicondyle or common extensor tendon, resistant wrist extension and pronation in the elbow extension position, or static stretching of common extensor tendon through the palmer flexion in wrist pronation and elbow extension position Generalized inflammatory arthritis (e.g., rheumatic arthritis) Pain at the proximal part of involved arm (e.g., shoulder pain, neck pain) Pain other than elbow pain at the involved arm Abnormal neurogenic symptom over the involved arm (e.g., radicular pain, hands numbness, hemiplegia) Wound or skin lesion at the elbow of the involved arm Pregnancy Severe local or systemic infection Malignancy Coagulopathy Cardiac pacemaker | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.0-999.0, Immunologic Deficiency Syndrome Patients with a clinical history or signs and symptoms suggestive of a primary immune deficiency syndrome and their family members are eligible for in this study and they may be referred by their physician or self-referred. If possible, a local physician/clinical immunologist will be identified for self-referred patients to serve as primary reference. If screening of the patients, either by phone interview or review of their medical records indicates that the patient may have a primary immunodeficiency syndrome and is HIV-negative, the patient will be invited to come to the NIH and sign an informed consent. If family history is positive for immunodeficiency, the patients or family members may be asked to invite other relatives to contact the PI to participate in the study Adult patient who are unable to provide informed consent are eligible to participate with permission obtained from their legal guardian or durable power of attorney Inability of the subject or the subject s parent/guardian to provide informed consent Patients infected with the Human Immunodeficiency Virus before enrollment | 2 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 5.0-999.0, E. Granulosus Cystic Hydatid d Living in study area (Cooperative Tupac Amaru) Older than five-years old Pregnant woman (only for chest X-ray procedure) | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-75.0, Common Variable Immunodeficiency A subject is eligible for the study if all of the following are met Has given written informed consent prior to screening Is male or female aged 18 through 75 years Has CVID diagnosed definitively prior to screening (based on the IUIS criteria) Has a documented, unintended loss of greater than 5% of their body weight over the last year or requires nutritional supplements to maintain his/her body weight OR has chronic diarrhea defined as a complaint of liquid stools for at least 4 consecutive weeks (and an output of greater than 200 g stool/24hr on a diet of at least 1600 calories with 60 g fat.) If taking oral antibiotics chronically, must have used a stable dose of the antibiotic continuously for at least 2 weeks prior to start of screening period Not taking any potential CYP3A4 inhibitors/inducers (e.g., macrolide antibiotics, HIV protease inhibitors, antifungals, grapefruit juice, St. John's Wort) A subject is excluded from the study if any of the following are met General Has any clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrinologic, psychiatric, hematologic, urologic, or other acute or chronic illness) that in the opinion of the investigator would make the subject an unsuitable candidate for this trial Is a woman who has a positive serum pregnancy test or who is breast-feeding Is a woman of childbearing potential or a man who does not agree to use two forms of contraception during the course of the study and follow-up period Has hypersensitivity to any of the components of STA 5326 mesylate drug product Has any of the following clinical chemistry values AST greater than 2.5 x upper limit of normal (ULN) ALT greater than 2.5 x ULN Serum bilirubin greater than 1.5 x ULN | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.0-999.0, Hyper-IgM Syndrome Ectodermal Dysplasia All patients must have a known or suspected immune defect with hyper-IgM syndrome and/or disorders of immunoglobulin production. There will be no limit on age, sex, race, or disability. Normal volunteers must be healthy adults between the age of 18 and 70 years. All study participants enrolled on to this study must agree to allow PI to store research samples. Refusal to let PI store samples may lead to withdrawal fro this specific study The presence of an acquired abnormality, which leads to immune defects, such as HIV, chemotherapy, and malignancy are general Refusal to let us store samples may lead to withdrawal from this specific study. Other factors, which are in the judgment of the Principal Investigator PI that may interfere with patient evaluation or determine to pose an added risk for study participants are also for exclusion | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-90.0, Abscess Cysts Female or male, aged between 18 and 90 years Written informed consent Abscess formation or abdominal cyst scheduled to drainage Plasma creatinine <1.5 mg/dL Pregnancy or lactation Hemodialysis or hemofiltration Allergy or hypersensitivity against study drugs Massive edemata or hypernatremia Reduced liver function (Child-Pugh A, B, C) Relevant prolongation of QT-interval CNS-diseases which predispose for cramps | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer Diagnosis of cancer of the biliary tract by 1 of the following methods Histologic confirmation Stenosis of the biliary tract by MRI, CT scan, or ECHO Unresectable disease Amenable to radiotherapy No visceral metastases by imaging Hepatic adenopathies that can be included in a radiation field allowed No known ampulla of Vater or pancreatic cancer involving the biliary tract WHO performance status 0-2 Creatinine < 1.5 mg/dL | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.0-18.0, Ruptured Appendicitis Clinical diagnosis of ruptured appendicitis Inability to have usual follow up care (e.g. transient to area) | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 1.0-70.0, Common Variable Immunodeficiency Agammaglobulinemia Key Written informed consent, age-adapted Male or female aged 1 to 70 years Diagnosis of primary humoral immunodeficiency No prior immunoglobulin substitution therapy IgG level of <5 g/L at screening Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening Key Evidence of serious infection between screening and first treatment Bleeding disorders that require medical treatments Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-75.0, Known or Suspected Focal Liver Lesions Patients between 18 and 75 years of age inclusive Patients (men or women) with at least one focal liver lesion, either identified or suspected by ultrasound (US), Computed Tomography (CT)/spiral-CT, conventional angiography, CT-angiography (CTA), CT-arterioportography (CTAP) or unenhanced / contrast-enhanced MRI* within 2 months before entering the study For reference, the following pathologies will meet the definition of 'focal liver lesions' Hepatocellular carcinoma Cholangiole carcinoma Metastasis Focal lymphoma Adenoma Focal nodular hyperplasia Hemangioma Patients who have previously entered this study Patients who have received any contrast material within 24 hours before injection with study drug, or who are scheduled to receive any contrast material within 24 hours after injection Patients who are, or suspected to be, nursing Patients who require emergency treatment Patients with severely impaired hepatic or renal functions (e.g. serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of reference range, acute renal failure) Patients who are clinically unstable and whose clinical course during the observation period is unpredictable (e.g. due to previous surgery, acute myocardial infarction) Patients with any physical or mental status that interferes with the signing of informed consent Patients with known anaphylactoid or anaphylactic reaction to any contrast media or hypersensitivity to any allergen including drugs Patients with a contraindication for MRI Patients who are scheduled for liver biopsy/surgery or other surgeries within 24 hours after injection with contrast media, or who would have a biopsy within 24 hours before planned injection with contrast media | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Intra-Abdominal Infection Adult patients ( > 18 years) requiring surgical intervention within 24 hours of diagnosis, for localized IAI infections (i.e extending beyond the organ wall but confined near the hollow viscus, mild to moderate in severity) Acute appendicitis: Ruptured or perforated with abscess Acute diverticulitis with perforation and/or abscess Acute cholecystitis (including gangrenous) with either rupture or perforation Acute gastric and duodenal ( > 24 hours) perforation Traumatic (> 12 hours) perforation of the intestines Secondary peritonitis due to perforated viscus Intra-abdominal abscess (including of liver and spleen) Traumatic bowel perforation requiring surgery within 12 hours Perforation of gastroduodenal ulcers requiring surgery within 24 hours other intra-abdominal processes in which the primary etiology was unlikely to be infectious Patients lactating or pregnant Patients with a history of allergy, hypersensitivity, or any severe reaction to the study antibiotics Patients with rapidly progressive or terminal illness Patients with a history or presence of severe hepatic or renal disease (e.g. creatinine clearance < 0.5 ml/min/1.73 m2) Patients with a concomitant infection that would interfere with evaluation of response to the study antibiotics | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 16.0-80.0, Amebic Liver Abscess Clinical, ultrasonographic and serologic diagnosis (ELISA) of amebic liver abscess Both genders Older 15 years Clinically suspected piogenous liver abscess Positive hemoculture Negative ELISA for amoebic antigens Immunosupresion (HIV) Abdominal or biliary surgery antecedents Abdominal neoplasia antecedents | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.0-999.0, Abdominal Pain All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 12.0-80.0, Perforated Appendicitis All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent Age less than 12 years older than 80 years perforated appendicitis was not revealed by pathologic investigation diverticulitis being diagnosed during surgery pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation the patient declining to enroll in this study | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Colon Surgery Consecutive patients undergoing open colonic resection at MSC under the ERAS program Known sensitivity to the local anaesthetic agents Patients who prefer not to participate (no consent gained) ASA greater or equal to 4 Rectal resection Formation of stoma Current use of systemic steroids | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 21.0-80.0, Abdominal Drainage Laparoscopic Cholecystectomy Gall Stones patients with gallbladder stones and laparoscopic cholecystectomy patients above 80 years old patients with acute cholecystitis patients with history of upper laparotomy patients with a hemorrhagic tendency due to cirrhosis patients refused to give informed consent and patients who were converted to open cholecystectomy | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Stomach Neoplasm patients with operable local gastric adenocarcinoma previous abdominal surgery previous open or blunt abdominal trauma history of inflammatory bowel disease or Typhoid Fever, Gallstone disease, chemotherapy or radiotherapy, or any other abdominal condition that could alter peritoneal integrity All other gastric malignancies such as lymphomas, GIST, carcinoids | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 15.0-80.0, Gall Bladder Stone in Cirrhotics patients with liver cirrhosis with symptomatic gall bladder stone patients above 80 years old patients with history of upper laparotomy patients with common bile duct stones and pregnant females | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 21.0-999.0, Dengue Fever Age ≥ 21years Probable or confirmed dengue a) Confirmed dengue: laboratory confirmation of acute dengue by either i) positive polymerase chain reaction (PCR) for viral ribonucleic acid (RNA), or ii)positive NS1 antigen test with a compatible clinical syndrome b) Probable dengue: Positive acute dengue serology and clinical presentation fulfilling either WHO 1997 or 2009 for probable dengue i) 1997 Acute febrile illness and two or more of the following headache retro-orbital pain myalgia arthralgia rash hemorrhagic manifestations | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 2.0-18.0, Appendicitis All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon Consent to participate Uncertainty about the diagnosis The need for laparotomy for another reason Free intraperitoneal air on imaging Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-90.0, Complicated Intra-abdominal Infection Male or female, from 18 to 90 years of age, inclusive One of the following diagnoses (in which there is evidence of intraperitoneal infection) including:(a) Cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or progression of the infection beyond the gallbladder wall;(b)Diverticular disease with perforation or abscess; (c) Appendiceal perforation or periappendiceal abscess; (d) Acute gastric or duodenal perforation, only if operated on >24 hours after perforation occurs; (e) Traumatic perforation of the intestine, only if operated on > 12 hours after perforation occurs; (f) Peritonitis due to perforated viscus, postoperative or spread from other focus of infection (but not spontaneous [primary] bacterial peritonitis or peritonitis associated with cirrhosis and chronic ascites).Subjects with inflammatory bowel disease or ischemic bowel disease are eligible provided there is bowel perforation; or (g) Intraabdominal abscess (including liver and spleen) Subject requires surgical intervention (e.g. laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug If subject is to be enrolled preoperatively, the subject must have radiographic evidence of bowel perforation or intraabdominal abscess Subjects who failed prior antibacterial treatment for the current cIAI can be enrolled but must: (a) have a positive culture (from an intraabdominal site) and (b) require surgical intervention. Such subjects can be enrolled before the results of the culture are known; however, if the culture is negative, study drug administration must be discontinued Willing and able to comply with all study procedures and restrictions Willing and able to provide written informed consent Women who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control (e.g. condom, oral contraceptive, indwelling intrauterine device, or sexual abstinence) Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours; perforation of gastroduodenal ulcer with surgery within 24 hours (these are considered situations of peritoneal soiling before infection has become established); another intraabdominal process in which the primary etiology is not likely to be infectious Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected, necrotizing pancreatitis, or pancreatic abscess cIAI managed by staged abdominal repair (STAR), open abdomen technique or any situation where infection source control is not likely to be achieved Known prior to randomization to have an IAI or postoperative infection caused by pathogen(s) resistant to meropenem Considered unlikely to survive the 4 to 5-week study period Any rapidly-progressing disease or immediately life-threatening illness (including acute hepatic failure, respiratory failure and septic shock) | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Incidence of Symptomatic Lymphocele After Kidney Transplantation Prevalence of Perirenal Fluid Collections at One, Five and Ten Weeks Adult recipients of kidney transplants from deceased donors Former extensive abdominal surgery Participation in other studies | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-70.0, Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases, or Tumour Rupture in the Abdominal Cavity A) Patients presenting with the following history Histologically-proven colorectal adenocarcinoma Presenting at the time of resection of the primary with one of the following 4 (criteria indicating a high risk of developing PC) Minimal PC, resected at the same time as the primary Ovarian metastases Rupture of the primary tumour inside the peritoneal cavity Iatrogenic rupture of the primary tumour during surgery B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified…) Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons…) Cancers of non colorectal origin, particularly, appendiceal cancers are excluded Patients presenting with a detectable recurrent tumour Grade ≥ 3 Peripheral neuropathy History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 14.0-999.0, Endometritis Wound Infection Abscess Surgical Site Infection Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of ≥1cm dilatation or ≥50% effacement), or Membrane rupture (standardized to duration of at least 4 hours prior to randomization) Patient unwilling or unable to provide consent Multiple pregnancy Known azithromycin (or other macrolide) allergy Vaginal delivery Elective or scheduled cesarean prior to labor or membrane rupture Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient) Fetal demise or major congenital anomaly Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 6.0-15.0, Streptococcal Sore Throat Age of 6 to 15 years old The in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered No antibiotic was used during the week before -Performing throat culture before the initiation of drug administration Positive throat culture indication GABHS No previous history of allergy to penicillin Age of below 6 years old or above 15 years old No signs of pharyngitis in the clinical examination Antibiotic use during the week before Throat culture was not performed before the initiation of drug administration Negative throat culture or the culture indicates a microorganism other than GABHS History of allergy to penicillin Not using drugs or not following the treatment in the field of having the second culture performed | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Polycystic Liver Disease Liver volume ≥ 4 liter ≥ 20 liver cysts Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity Abdominal distention perceived as uncomfortable Frequent abdominal pain Early satiety Nausea (with the of dyspeptic complaints) Dyspnea Diagnosed with ADPKD or ADPLD Male and female patients of 18 years and older Creatinine clearance < 20 ml/min Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year Hormonal replacement therapy Hormonal contraception Pregnant or lactating Presenting with an uncontrolled disease (other than ADPKD/ADPLD) Planned to undergo any surgery of the liver during study participation Planned to undergo any surgery of the during study participation (ADPKD patients only) Patients with known allergies to somatostatin or its analogues or any of its components Patients who received somatostatin analogues in the 6 months preceding study | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Focal Nodular Hyperplasia of Liver Toxic Liver Disease With Focal Nodular Hyperplasia Liver Metastases patients diagnosed with de novo FLL at standard ultrasound age > 18 years, male and female gender informed consent for the contrast enhanced study patients with contraindication for contrast enhanced study: subjects with acute cardiac infarction, with class III/IV cardiac insufficiency, with rhythm disorders and pregnant women Patients diagnosed with simple cysts at standard ultrasound (biliary of hydatid) Patients with known FLL, for example after percutaneous treatment, in which the contrast study is used for the follow up of the patient | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Abdominal Sepsis Patient > 18 years old 30 patients with severe abdominal sepsis in order to form the study group and 30 patients without sepsis undergoing major elective surgery (middle line incision >15cm) to form the control group Patient or relatives signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures Patient's Manheim Peritonitis Score < 29 Patient's pre-operative SOFA score < 6 The use of other temporary abdominal closure system Decease before the first VAC dressing change Patient is participating in another clinical trial which may affect this study's outcomes Patients with immune deficiency Documented seropositivity for human immunodeficiency virus (AIDS) Patient receiving steroids treatment for other medical condition Patient receiving chronic anti-inflammatory treatment Patient receiving anti | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-75.0, End Stage Liver Disease Age >18 years Clinically diagnosed liver cirrhosis by any of the following: ultrasound/MRI/ CT/ + tissue biopsy MELD score ≥ 18 and <35 Ability to sign an informed consent Refused by liver transplant program or labeled as not a liver transplant candidate, decided by at least 3 transplant physicians On a liver transplantation waiting list Questionable diagnosis of cirrhosis Prior history of organ transplantation Past history of malignancy within the 2 years prior to Probable or diagnosis of hepatocellular carcinoma Major hepatic vascular thrombosis (hepatic artery, or portal or hepatic veins) Serious cardiovascular or respiratory disease, or other medical condition with a high anticipated mortality within twelve months Current or recent (within the past 4 weeks) use of vasoactive drugs (Epinephrine, Norepinephrine, Vasopressin, Dopamine, terlipressin) Type-1 (acute) hepatorenal syndrome Levels of serum creatinine >150 µmol/ml and/or creatinine clearance <30 ml/min (as calculated by MDRD system) | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-65.0, Acute Appendicitis Without Peritonitis patients between 18 and 65 years old first episode of suspected AA diagnosed by Andersson's score or combination with abdominal ultrasound patients with any potential immunodeficiency status assumption of antibiotics for different infectious disease or surgery in the last 30 days allergy to antibiotics established in the study protocol no acceptance of study protocol pregnancy or delivery in the last 6 months ASA IV or V, no Italian or English fluently speakers | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Polycystic Ovary Syndrome Normal Volunteers All Female patients undergoing controlled ovarian hyperstimulation (COH), transvaginal oocyte aspiration (TVA), and Saline Infused Sonography (SIS) with UL collection Age <35 y/o at time of in vitro fertilization (IVF) cycle Normal ovarian function defined Day 3 Follicular Stimulating Hormone (FSH) <8 pg/ml or Anti-Mullerian Hormone (≥ 1.0 ng/ml) Controls Female patients undergoing COH and TVA donating her oocytes Female patients undergoing COH and TVA for male factor infertility only (i.e. no female causes of infertility) Normal menstrual cycles Lean PCOS Diagnosis of PCOS by Rotterdam Age ≥ 35 y/o Female partners with infertility associated diagnosis (i.e. tubal factor, cervical factor, endometriosis) Unexplained infertility | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-30.0, 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 | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 25.0-90.0, Gastric Cancer Gastric cancer patients who are elegible for curative surgery Age 25-90 Gastric cancer patients who are not elegible for curative surgery | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Liver Transplant Rejection Patients of both sexes aged ≥ 18 years Standard analytical parameters, defined by Leukocytes ≥ 3000 Neutrophils ≥ 1500 Platelets ≥ 100,000 Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) ≤ 1.5 standard range institution creatinine ≤ 1.5 mg / dl Patients with liver space occupying lesion (LOE) that require extended hepatic resection Patient selection should be cautious, covering basically 5 types of liver damage which must be submitted prior to liver volumetry Metastatic Disease subsidiary right hepatectomy extended to segment IV Different tumor records current disease or any disease hematologic Patients with uncontrolled hypertension Severe heart failure (NYHA IV) Patients with malignant ventricular arrhythmias or unstable angina Diagnosis of deep vein thrombosis in the previous 3 months Adjunctive therapy including hyperbaric oxygen, vasoactive substances, agents or angiogenesis inhibitors against Cox-II BMI> 40 kg/m2 Patients with alcoholic with active alcoholism Proliferative retinopathy Concomitant disease that reduces life expectancy to less than a year | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.0-50.0, Endometriosis Endometriosis Adnexal finding Laparoscopic sterilization Pregnancy Acute infection Hemoperitoneum Suspicion of a malignancy | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-75.0, Chronic Granulomatous Disease (CGD) A patient will be included if he or she meets all of the following Has documented chronic granulomatous disease Age 18 Has a liver abscess infected with Staphylococcus aureus, but is not an optimal candidate for curative surgical resection either due to location of disease, multiplicity of disease, or previous surgery or other comorbidities, such as pulmonary insufficiency, or has other contraindications to general anesthesia or perioperative management or refuses surgery Is willing to return to NIH for imaging scans Is willing to undergo testing or procedures associated with this protocol Has failed long term antibiotic treatment and abscess drainage if applicable A patient will be excluded if he or she satisfies 1 or more of the following Positive results for toxin-producing bacteria obtained from liver biopsy in the pertinent abscess Is a good candidate for liver-curative open surgical resection and does not refuse the surgery Is not a candidate for RFA therapy due to lesion size, location, and/or infection with a non staphylococcal bacteria Has a prothrombin time (PT) or partial thromboplastin time (PTT) > 1.5 times normal (except in patients who have a known lupus anticoagulant or other condition which a hematologist deems will not cause excessive bleeding despite the abnormal coagulation parameters) Has a platelet count < 50,000/mm(3) which cannot be maintained despite platelet transfusions If you are pregnant Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study Please Note: Co-morbidities in critically ill patients will not themselves constitute because the cause of their illness/condition may require the use of RFA as a less invasive treatment than surgery | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.0-999.0, Acute Cholecystitis Empyema of Gallbladder Abscess of Gallbladder acutely inflamed gallbladder chronic cholecystitis gallbladder polyp or gallbladder cancer the patient who underwent reduced port surgery the patient who underwent common bile duct exploration during the operation the patient who underwent concurrent operation the patient who had past history of upper abdominal surgery the patient who had a immunodeficiency state the case which had a suspicion of delayed bile leakage the case which had a incomplete cystic duct ligation the patient who underwent open conversion surgery during the operation | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Cryptogenic Pyogenic Liver Abscess Pyogenic liver abscess radiologically and bacteriologically diagnosed Amebic liver abscess Other causes of pyogenic liver abscess such as cholangitis, liver cancer, complication of transarterial chemoembolization or radiofrequency ablation to hepatocellular carcinoma Refusal to colonoscopic examination Inadequate general patient status to perform the colonoscopic examination Patient who has had the screening colonoscopic examination within 1 year and showed normal finding or had 1 or 2 colon polyp in adequate exam | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-70.0, Symptomatic Dominant Liver Cyst All patients who are diagnosed with a dominant liver cyst with an indication for aspiration and sclerotherapy are suitable for in this study In order to be eligible to participate in this study, a subject must meet all of the following Age 18 years Indication for aspiration and sclerotherapy Providing informed consent A potential subject who meets any of the following will be excluded from participation in this study Signs of cyst bleeding on ultrasound Signs of cyst infection (elevated CRP and/or leukocytes or temperature exceeding 38 degrees with the of a different focus) Cyst < 5 cm Coagulopathy (INR > 2 or platelets < 80 x 10^9) Severe co-morbidity contraindicating anesthesia (i.e. ASA 4 classification) Patients with a known hypersensitivity to SST analogues or any component of the pasireotide LAR or SQ formulations Pregnant or nursing women Symptomatic cholecystolithiasis QT interval related | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Gastroesophageal-junction Cancer patients with biopsy verified GEJ-cancer referred to the department of surgical gastroenterology, Rigshospitalet, which is considered resectable at MDT-conference >18 years old informed consent < 18 years old Not informed consent | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 21.0-80.0, Gastric Cancer Patients who have T3 (subserosal) or T4 (serosal) disease based on CT scan and intra-operative inspection with any N staging and M0 gastric cancer Patients planned for open or laparoscopic gastrectomy Patients undergoing gastrectomy with curative intent Lower age limit of research subjects 21 years old and upper age limit of 80 years old Ability to provide informed consent Patients who undergo a palliative gastrectomy Patients who undergo a gastrectomy as emergency Vulnerable persons under age of 21 Patients receiving neoadjuvant therapy Patients presented with life-threatening bleeding from tumour ASA score of 4 & 5 Patients with another primary cancer within last 5 years Patients with gross peritoneal and liver metastasis at surgery | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-75.0, Hypersplenism Liver Cirrhosis Hypersplenism Patients with bad performance scale Patients with hepatic encephalopathy and tense ascites Patient with active esophageal variceal bleeding Patients with hypocellular bone marrow (BM) Patients with renal failure | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Open Abdomen After Damage Control Laparotomy All admissions of trauma patients who sustain trauma necessitating damage control laparotomy Male and female patients 18 years or older Children (<18 years old), prisoners, or pregnant patients Patients who have more than 1/3 loss of abdominal wall due to trauma Patients with baseline serum sodium of <120 mEq/L or >155 mEq/L | 2 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Breast Neoplasms Bone Neoplasms Be willing and able to provide written informed consent/assent for the trial Be 18 years of age on day of signing informed consent Have histologically or cytologically confirmed breast cancer. Oligometastatic lesions do not need to be biopsied but they must be strongly suspected to represent metastatic disease CT scan (Chest, Abdo + Pelvis), Whole Body Bone scan, and FDG-PET scan evidence of 1 to 5 metastases within 8 weeks of study registration Note: At least 1 of the 5 metastases must be deemed suitable for SABR treatment Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the study P.I's Have a performance status of 0-2 on the ECOG Performance Scale Demonstrate adequate organ function Life expectancy > 12 months Be willing and able to comply with all study requirements, including treatment, attending assessments and follow-up Previous high dose radiotherapy (biological equivalent of 20 Gy in 5 fractions to the area to be treated) Evidence of visceral metastases in liver or brain Treatment with any chemotherapy agent within +/ weeks of SABR. Targeted therapy or endocrine therapy is permitted at any stage during the conduct of this study, however is not to be changed during the study period unless due to progression Evidence of Spinal Cord Compression Spinal Instability Neoplastic Score greater than or equal to 7 unless lesion reviewed by a neurosurgical service and considered stable Surgical fixation of lesion required for stability Lytic metastases in a long bone (femur or humerus) that which erodes the cortex Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Single once of doses are acceptable | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.25-0.5, Hernia of Abdominal Wall Incisional Hernia animal model: New Zeeland female rabbits of 3000 gr of body weight - any kind of illness in rabbit subjects | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-40.0, Fetal Membranes, Premature Rupture singleton pregnancy with a definite history of current PPROM for the study group Suspected fetal growth restriction (IUGR) Any gross fetal anomalies Abnormalities of placentation Uterine structural abnormalities Fetal jeopardy or intrauterine fetal death (IUFD) Women presenting with chorioamniointis with fever over 38 c abdominal tenderness, foul vaginal discharge and/or fetal tachycardia Diabetics, immunocompromized and cardiac patients Women with cervical cerclage Women with drained liquor | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Intracranial Aneurysm Subject ≥ 18 years old Subjects with non-ruptured or ruptured intracranial aneurysm that is referred for endovascular treatment Parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm Subject understands the nature of the procedure and provides voluntary written informed consent in accordance with the requirements of this study protocol Subject is willing to participate in the telephone follow-ups and to return to the investigational site for the post-procedure follow-up evaluations Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e.: severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy) Mycotic or traumatic aneurysm Arteriovenous malformation (AVM) in the territory of the target aneurysm Two or more aneurysms (>2mm) in associated distribution Hunt and Hess Scale (HHS) of IV or V at for subject with ruptured aneurysms Life expectancy of less than 6 months as determined by the treating physician A planned staged procedure (i.e. a procedure where entire treatment with the devices (e.g. coils/stents) is completed over separate sessions) Previous neuro-interventional or neuro-surgical procedure of any kind within 30 days prior to the study procedure Intracranial mass (tumor, abscess, or other infection), or undergoing radiation therapy for carcinoma or sarcoma of the head or neck region Unsuitable for the antithrombotic and/or anticoagulant therapies | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 12.0-999.0, Cystic Fibrosis Immunologic Deficiency Syndrome Turner Syndrome Congenital Hepatic Fibrosis Idiopathic Non-Cirrhotic Portal Hypertension Age 12 years or above, male or female Known diagnosis of NCPH, or to be at the risk for NCPH by virtue of underlying disease processes such as but not limited to; CGD, SCD, Mastocytosis, CVID, CF, and CHF seen at the NIH clinical center or via referral from outside institutions Evidence of other forms of liver disease that typically result in cirrhosis Evidence of active chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (> 10,000 IU/mL) Hepatitis C as defined by the presence of hepatitis C RNA in serum Primary sclerosing cholangitis as defined by liver histology Primary biliary cirrhosis as defined by cholestasis, +/ antimitochondrial antibody positivity and liver histology Wilson s disease as defined by ceruloplasmin below the limits of normal and liver histology and urinary copper consistent with Wilson disease Autoimmune hepatitis as defined by antinuclear antibody (ANA) of 3 EU or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy for autoimmune hepatitis Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y. Patients with iron saturation indices of > 45% and serum ferritin levels of > 300 ng/ml for men and > 250 ng/ml for women will undergo genetic testing for hemochromatosis Bile duct obstruction as suggested by imaging studies done within the previous six months | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Cancer Aged > 18 years old Capable of providing informed consent Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases Evidence of low-volume peritoneal disease defined by a PCI < 10 based on cross-sectional imaging / and / or diagnostic laparoscopy findings ECOG Eastern Cooperative Oncology Group (Zubrod) performance status of 0-2 Patients who are medically fit for surgery defined as the following No parenchymal hepatic metastases No evidence of clinical (jaundice), biochemical (abnormally elevated serum bilirubin and/or alkaline phosphatase) or radiological (ultrasound, CT, or MR) biliary obstruction No cross sectional imaging findings indicative of multi-segmental (>1 site) small bowel obstruction, or small bowel loops matted together, or gross disease of the small bowel mesentery characterized by distortion, thickening or loss of mesenteric vascular clarity Peritoneal carcinomatosis index (PCI) > 10 Systemic (extraperitoneal) disease, pregnant, incarcerated Pregnant and lactating women. Women of reproductive age must be willing to use contraception during study therapy | 0 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 0.0-999.0, Immune Deficiency and Early BMF in Childhood Immune Deficiency and early BMF in childhood Common Variable Immunodeficiency (CVID) Genetic patients Refusal to consent | 1 |
A 48-year-old white male with history of common variable immunodeficiency (CVID) with acute abdominal pain, fever, dehydration, HR of 132 bpm, BP 80/40. The physical examination is remarkable for tenderness and positive Murphy sign. Abdominal ultrasound shows hepatomegaly and abundant free intraperitoneal fluid. Exploratory laparotomy reveals a ruptured liver abscess, which is then surgically drained. After surgery, the patient is taken to the ICU. | eligible ages (years): 18.0-999.0, Anal Fistulas ≥18 yrs old Perianal abscess (without spontaneous rupture) Abscess larger than 2 cm in diameter Signed informed consent Malignancy within 5 yrs Previous radiotherapy of the abdomen and pelvis Recurrent abscess within 6 months Immune suppressed patients Pregnant and lactating women Abscess with horseshoe formation Allergy to Clindamycin | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-999.0, Glomerulonephritis Lupus Nephritis Systemic Lupus Erythematosus Patients must be 18 years of age or older and able to provide informed consent Patients must have at least 4 for SLE as defined by the American Rheumatism Association (ARA) Active glomerulonephritis with Renal biopsy within 1 year with class III or class IV active lupus nephritis, AND Abnormal urine analysis Greater than 10 RBC/hpf and cellular (RBC, WBC or mixed) casts, OR Greater than 10 RBC/hpf and proteinuria greater than 2 g/day, OR Proteinuria greater than 3.5 g/day No patients with severe proliferative lupus nephritis: a. very active renal histology with crescents or necrosis in more than 25% of glomeruli; or b. rapidly progressive glomerulonephritis (doubling of serum creatinine in less than or equal to 3 months); or c. severe impairment of renal function Cr greater than 2.5 mg/dL or GFR less than 50 mL/min measured by inulin clearance Patient has not had previous immunosuppressive therapy | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-80.0, Acute Renal Failure ENTRY --Disease Characteristics-- Group 1: Patients on chronic hemodialysis Group 2: Patients at high risk of developing acute renal failure (ARF) after cadaveric renal transplantation Received high risk allograft Cadaveric kidneys with greater than 24 hours of cold ischemia time Donor had rising creatinine before organ procurement Donor over 60 years Group 3: Patients with ischemic ARF due to hypotension, surgery, or trauma ARF severity index 20-60% Creatinine clearance 12-14 mL/min Rising creatinine of at least 0.5 mg/dL per day for 2 days without evidence of recovery despite standard supportive care No drug or contrast induced renal failure No oliguric renal failure (creatinine clearance 3-4 mL/min) No prior chronic renal failure Baseline creatinine greater than 2.5 mg/dL (males) or 2.0 mg/dL (females) No ARF due to bacterial or fungal sepsis, nephrotoxins, acute tubulointerstitial nephritis, cyclosporine toxicity, bilateral renal vascular disease, or systemic diseases (hepatorenal syndrome, glomerulonephritis, renal vasculitis, etc.) --Prior/Concurrent Therapy-- Group 1: No recent immunosuppressive therapy Group 2 and 3: No prior renal transplantation No prior alpha-MSH Group 3: No prior dialysis for this episode of ARF No anticipated need for dialysis for at least 24 hours At least 12 hours since prior diuretics, mannitol, or dopamine At least 14 days since prior immunosuppressive drugs --Patient Characteristics-- No recent infection No known reaction to Terumo T175 dialyzer Not a prisoner Not pregnant or nursing No allergy to drugs used in study Not mentally impaired Group 3: No severe nonrenal medical condition that would interfere with the study (e.g., terminal cancer) | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-1.0, Infant, Newborn, Diseases Pain ENTRY --Disease Characteristics-- Infants scheduled for surgery with postoperative inpatient care Must be born after 35 weeks or more gestational age No prenatal opiate exposure Part I patients Less than 12 months of age undergoing surgeries involving major thoracic, abdominal, or cardiac procedures No pneumonectomy, tracheal or bronchial stenosis reconstruction, diaphragmatic hernia repair, or surgeries resulting in high intraabdominal pressure (closure of large gastroschisis or omphalocele defects) No hepatic or renal transplantation Part II patients | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 13.0-60.0, IGA Glomerulonephritis Histologically confirmed IgA nephropathy, diagnosed within the past 3 years Clinical presentation of either isolated hematuria/proteinuria for less than 3 years OR Acute nephritic or nephrotic syndrome No secondary forms of IgA nephropathy associated with chronic inflammatory disease of the bowel and liver No end stage renal failure as defined by the following: Glomerular filtration rate less than 15 mL/min AND Extensive glomerulosclerosis and tubulointerstitial damage No systemic lupus erythematosus or systemic (extrarenal) vasculitis (Henoch-Schonlein syndrome) Healthy volunteers will be accrued as a control group No other concurrent medical or psychiatric illness that would preclude study | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-2.0, Heart Defects, Congenital Diagnosis of one of the following Ventricular septal defect (VSD) Infant coarctation of the aorta Transposition of the great arteries Tetralogy of Fallot Complete atrioventricular canal defect Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia Patient must be scheduled for surgery Certain additional defects and/or requirement for additional surgery | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.123, Congenital Heart Defects Criteria:1) scheduled cardiac surgery with hypothermic CPB to repair either D-transposition of the great arteries (D-TGA) with intact ventricular septum (IVS) or ventricular septal defect (VSD), VSD with or without aortic arch obstruction (AAO), tetralogy of Fallot (TOF) with or without pulmonary atresia (PA), truncus arteriosus, total anomalous pulmonary venous return (TAPVR), or double outlet right ventricle (DORV), or to palliate hypoplastic left heart syndrome (HLHS) or other forms of single ventricle (SV) with AAO using the stage I (Norwood) operation, 2) age 1-45 days at surgery, 3) birth weight > 2.3 kg, and 4) a cranial ultrasound < 1 week prior to enrollment showing at most grade II hemorrhage in high risk patients - included the following: 1) need for urgent cardiac surgery, 2) cardiac arrest ≤ 1 week before surgery, 3) prior procedure with hypothermic CPB, 4) acute or chronic infection, 5) major noncardiac congenital anomalies or chromosomal abnormalities, 6) preoperative arterial pH ≤ 7.0, 7) any significant noncardiac organ dysfunction such as renal failure, respiratory failure, seizures, or necrotizing enterocolitis, and 8) use of another investigational drug | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 8.0-12.0, Hematuria Hydronephrosis children aged 8-12 years All children presenting with macro-haematuria or severe pathology detected by ultrasonography (large masses, pseudo-polyps or hydronephrosis/hydroureter) at the 6 months follow-up examination will be treated with praziquantel and excluded in the data analysis | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-3.0, Healthy Healthy children, free of medication History of urinary diseases | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Renal Failure Critically Ill cessation of hemofiltration mechanical ventilation written informed consent pre-existent renal failure glomerulonephritis | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Contrast Nephropathy Renal Failure Greater then 18 years of age Referral for coronary angiography Type 1 or type 2 diabetic requiring insulin or oral hypoglycemic agents Stable serum creatinine concentration (140 to 300 μmol per liter for men or 125 to 300 μmol per liter for women or a creatinine clearance not greater than 60 ml/min (as calculated by Cockcroft-Gault equation) Non diabetic subjects with a stable serum creatinine concentration of 160 to 300 µmol per liter for men and 140 to 300 µmol per liter for women Stable renal function defined as no documented rise or fall in serum creatinine by more then 44 umol/L in the preceding 2 weeks Refusal or inability to give consent Pregnant Non-elective coronary angiography Recent administration (within 21 days) of iodinated intravenous contrast dye Recent administration (within 21 days) of non-steroidal anti-inflammatory drugs (excluding aspirin), aminoglycoside antibiotics or chemotherapeutic agents Severe/unstable diabetics requiring emergency room or inpatient therapy in the previous 21 days Compensated or decompensated hepatic failure Renal transplant | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-40.0, Escherichia Coli Infections Sign an Institutional Review Board-approved consent prior to any study-related activities Initiate screening 21± 7 days prior to admission or enrollment Must accomplish all laboratory and diagnostic examinations at 21± 7 days prior to admission or enrollment Be at least 18 years of age but not older than 40 years of age at the time of enrollment Be otherwise healthy with a stable address and telephone where the volunteer can be contacted Be able to read and write English Possess a social security number in order to receive compensation Female participants must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the morning of the challenge and use effective birth control during the entire study period. Methods of effective birth control complete abstinence, the use of a licensed hormonal method, intrauterine device, barrier method plus spermicide, or having sexual relations exclusively with a vasectomized partner. Appropriate barrier methods condoms, cervical sponge, and diaphragm. Females who are not of childbearing potential are defined as those who are physiologically incapable of becoming pregnant, including any female with tubal ligation or who is postmenopausal. For purposes of this study, postmenopausal status will be defined as absence of menses for at least 1 year Be seronegative for antibodies to dispersin Have normal laboratory screening values including a white blood cell (WBC) count, hemoglobin, hematocrit, platelets, blood urea nitrogen, glucose, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), quantitative immunoglobulins, T cell subsets (CD4 and CD8), urinalysis Has acute or chronic medical illness (i.e., renal or hepatic disease, hypertension, diabetes mellitus, coronary artery disease, malnutrition, obesity (body mass index >30 kg/m2), HIV, corticosteroid use, cancer or receiving chemotherapy, chronic debilitating illness, syphilis) Has used antibiotics within 7 days of challenge Has used medications or drugs, including over-the-counter medications such as decongestants, antacids (calcium carbonate or aluminum-based antacids, H2 blockers), anti-diarrheal medications (such as bismuth subsalicylate or loperamide), antihistamines within 7 days of challenge Has a history of chronic gastrointestinal illness, intra-abdominal surgery, chronic functional dyspepsia, chronic gastroesophageal reflux, documented peptic ulcer disease, gastrointestinal hemorrhage, gallbladder disease, inflammatory bowel disease (Crohn's and ulcerative colitis), diverticulitis, irritable bowel syndrome or frequent diarrhea Has a history any of the following psychiatric illness(es) Depression not controlled with current drug therapy or involving institutionalization Schizophrenia or psychosis Suicide attempt Has a history of or current alcohol or illicit drug abuse Is unable to remain as an inpatient in the University Clinical Research Unit for up to 8 days | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.082, Gastroschisis Diagnosis of Gastroschisis Birth Weight ≥ 1500 grams Gestational Age ≥ 34 weeks Birth Weight < 1500 grams Gestational Age < 34 weeks Presence of Bowel Ischemia or Necrosis Abdominal wall defect too small Major associated anomalies or medical condition Presence of Intracranial Hemorrhage (grade IV) Parent Refusal for Randomization | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-1.0, Low Cardiac Output Syndrome Age younger than one year corrective open heart surgery with biventricular repair, except tetralogy of fallot Missing written consent of parents Weight less than 3 kg preoperative LCOS gestational age less than 36 weeks preexisting renal failure preexisting thrombopenia preoperative cardiopulmonary resuscitation preoperative use of milrinone or levosimendan | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-70.0, Immunosuppression in Solid Organ Transplant First time recipient of deceased donor liver transplant Age 18-70 Hepatitis C virus (HCV) positive recipients For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52) Target Disease Exclusions Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age < 12 or > 65 years d) Non heart-beating donors e) Anticipated cold ischemia time > 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative Medical History and Concurrent Diseases Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio > 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR < 40 ml/min/1.73 m^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease [MDRD]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-90.0, Kidney Failure, Acute Acute Kidney Insufficiency Age over 18 years planned CABG or valvular surgery with cardiopulmonary bypass Serum creatinine available (within 30 days) Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4) Emergent or urgent surgery (to be performed within the next 36 hours) End stage renal disease, or GFR < 15ml/min (CKD stage 5) Estimated GFR>90ml/min (CKD stage 1 or no CKD) Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR Allergy to minocycline or tetracyclines inability to take oral medications use of preoperative vasopressor agents at therapeutic doses Pregnant or lactating females Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice) Rising creatinine meeting the definition of acute kidney injury prior to surgery | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 18.0-999.0, Acute Renal Failure cardiac surgery at least one risk factor for acute renal failure oliguria < 0.5 ml/kg/hour for over 3 hours despite adequate blood volume and furosemide intravenously at least 60 mg furosemide/12 hours iv to maintain diuresis > 1 ml/kg/hour refused or none consent chronic renal failure with chronic renal replacement therapy chronic increase of serum creatinine > 2 mg/dl | 2 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-999.0, Acute Kidney Injury Families of infants (birthweight >1500g) be asked to participate in the study Infants with prenatal renal ultrasound diagnosis of severe hydronephrosis or other known renal abnormalities will be excluded | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 1.0-16.0, NEPHROSIS, LIPOID proteinuria over 0.25 g/mmol of creatinine with hypoalbuminemia below 30g/L for the case No history of renal disease Normal C3 and negativity for hepatitis B and C no medical insurance in another study | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.5-3.0, Distress Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery Neurological impairment Eczema or other skin disorders Nut allergy | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-999.0, Ileostomy Presence of ileostomy due to any disease or condition (i.e., necrotizing enterocolitis, intestinal atresias, gastroschisis, or intestinal perforations) Minimum birth weight of 500g Likely to survive Dysmotility of the gastrointestinal system Major congenital anomalies, including heart disease Meconium ileus Not expected to survive for at least 2 weeks | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-48.0, Preterm and Term Infants Infants born at >28 weeks gestation will be eligible for enrollment in this study Infants with fetal malformations, chromosomal anomalies, clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia), or no urine output for the first 48 hours will be excluded | 1 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-0.5, Congenital Heart Disease Patient selection will be determined by an assessment of the risk of systemic ventricular dysfunction following open cardiac repair in a population of infants undergoing stage I palliation (Norwood procedure) for the diagnosis of either hypoplastic left heart syndrome or similar left-sided obstructive lesions in the setting of single-ventricle physiology. Eligible neonates and infants those aged 0 days to 6 months. These patients will be evaluated on an individual basis and the decision to give phenoxybenzamine would be determined by the attending surgeon, anesthesiologist, and cardiologist | 0 |
A 6-month-old male infant has a urine output of less than 0.2 mL/kg/hr shortly after undergoing major surgery. On examination, he has generalized edema. His blood pressure is 115/80 mm Hg, his pulse is 141/min, and his respirations are 18/min. His blood urea nitrogen is 33 mg/dL, and his serum creatinine is 1.3 mg/dL. Initial urinalysis shows specific gravity of 1.017. Microscopic examination of the urine sample reveals 1 WBC per high-power field (HPF), 18 RBCs per HPF, and 5 granular casts per HPF. His fractional excretion of sodium is 3.3%. | eligible ages (years): 0.0-999.0, Kidney Failure, Acute Renal Insufficiency for Adults: (must have at least one of the following) Emergent surgery Pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dL) Ejection fraction less than 35% At least 70 years old Diabetes mellitus Combined CABG and valve surgery Repeat CABG or valve surgery for Adults Pre-operative acute kidney injury Enrolled in a conflicting research study Prior kidney transplantation Baseline serum creatinine level greater than 4.5 mg/dL Nephrotoxic drugs administered pre-operatively Surgery for only left ventricular assist device for Children Undergoing open heart surgery for Children | 1 |
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