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A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Vaginosis, Bacterial Premature Birth Birth Weight Chorioamnionitis African American, Hispanic, Asian/Pacific Islander, Native American, and white women Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 6.0-17.0, Crohn Disease Between the ages of 6 and 17 years Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX) Disease complications for which surgery might be indicated Surgery for bowel diversion with placement of a stoma within 3 months prior to screening Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | 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 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-55.0, Healthy Healthy male subjects Caucasian origin Age: between 18 and 55 years (inclusive) Body mass index (BMI) within 18-30 kg/m² Body weight at least 50 kg, at most 100 kg Non-smoker (or ex-smoker ≥1 year), proven by urine cotinine <500 ng/ml Clinically acceptable supine blood pressure and pulse rate, i.e. BP 100-145 mmHg systolic, 60-90 mmHg diastolic and pulse rate 50-100 bpm Normal ECG Participants must perform an adequate contraception during the study and until 6 months after the last dose of the present trial Ability to communicate well with the investigator and comply with the requirements of the entire study Subjects with contraindications for budesonide Subjects with contraindications for metronidazole History or current clinical evidence of any cardiac, cardio-vascular, pulmonary, gastrointestinal, (cholangio-)hepatic, renal, endocrine, neurological, musculoskeletal, ophthalmological, infectious, haematological, oncological, psychiatric, or other acute or chronic diseases and/or pathological findings which might interfere with the drugs' safety, tolerability, absorption and/or pharmacokinetics History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables Current smoker or ex-smoker ≤ 1 year Excessive alcohol consumption (³ 35 g/day in males) Abuse of drugs Positive drug screening Positive anti-HIV-test, HBsAg-test or anti-HCV-test | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 2.0-5.0, Helminthiasis Criteria:The are age of the child is 2-5 years old he/she has not been suffering from serious chronic illness the child stool test must be positive for STH he/she had not been taken any antehelminthic drug in the previous six months parents/guardian are agree for their child participation in the study. e - age of the child less than 2 years old and more than 5 years old his/her stool test negative for any intestinal helminth he/she has been suffering from serious chronic illness parents/guardian are not willing to give consent for their child's participation in the study if he/she receives any antehelminthic drug after survey but before the study interventions | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 0.75-3.0, Cryptosporidiosis Male and female children aged 9-36 months at the time of enrollment Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; >14 days duration for persistent diarrhea) Child's parent/guardian speaks English or Luganda Parent/guardian provides full and free informed consent for child to participate in study Unknown age Known cardiac, CNS, metabolic or endocrine disorders Moribund children Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | 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 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-50.0, Bacterial Vaginosis All women of between 18-50 years of age Confirmed current diagnosis of BV using Amsel's criteria Women with at least total 2 confirmed episodes of BV including most recent episode (by Amsel's criteria) within a six month period or at least total three or more in the past twelve months Patient who received antibiotic therapy within the past two weeks Patients who had co-existing gonorrhea or Chlamydia infection Any contraindications or sensitivity to taking the vaginal gel Allergy to metronidazole Alcoholics or those unable to abstain from alcohol consumption Pregnancy | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-45.0, Travelers' Diarrhea Male or female between 18 and 45 years of age, inclusive General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator (PI) or PI in consultation with the medical monitor and Sponsor Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade ≥ 70%) Willing to participate after informed consent obtained Available for entire inpatient portion of study and all outpatient study visits Negative serum pregnancy test at screening (initial visit and day -7 to and a negative urine pregnancy test on the day of admission to the inpatient phase for female subjects of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Alternatively, abstinence alone is acceptable. Female subjects who are unable to bear children must provide supporting documentation (e.g., prior tubal ligation or hysterectomy) Presence of a significant medical condition, (e.g., psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study Immunosuppressive illness or IgA deficiency (below the normal limits) Positive serology results for HIV, HBsAg, or HCV antibodies Significant abnormalities in screening laboratory hematology, serum chemistry, urinalysis, as determined by PI or PI in consultation with the medical monitor and Sponsor Allergy to fluoroquinolones, cotrimoxazole, or ampicillin/penicillin (excluded if allergic to two of three) Fewer than 3 stools per week or more than 3 stools per day as the usual frequency; loose or liquid stools other than on an occasional basis History of diarrhea in the 2 weeks prior to planned inpatient phase Regular use of laxatives or any agent that increases gastric pH (regular defined as at least weekly) Use of antibiotics during the 7 days before bacterial dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to dosing | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 0.75-1.0, Cholera Diarrhea Vibrio Infections Healthy male and female infants aged 9 months will be recruited from Vellore, India and Dhaka, Bangladesh All subjects must satisfy the following at study entry Male or female infants aged 9 months whose parents or primary caretaker have given the written informed consent prior to study entry Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection) Healthy subjects as determined by Medical history Physical examination Clinical judgment of the investigator Parents or primary caregiver are unwilling or unable to give written informed consent to participate in the study Ongoing serious chronic disease Immunocompromising condition or therapy Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours Intake of any anti-diarrheal medicine in the past week Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral) or axillary temperature ≥ 37.5ºC warrants deferral of the vaccination pending recovery of the subject Receipt of antibiotics in the past 2 weeks Receipt of live or killed enteric vaccine in the last 4 weeks Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 7.0-60.0, Exocrine Pancreatic Insufficiency Steatorrhea Malabsorption Syndromes Cystic Fibrosis Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces Have documentation of an abnormal COA-fat and a fecal elastase result of <100 micrograms fecal elastase/gram stool Must be on a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least the past 1 month No extreme physical wasting with loss of weight and muscle mass No severe, acute, or chronic pulmonary disease unrelated to complications of CF No worsening of pulmonary disease in past 30 days No use of drugs known to affect blood uric acid concentrations (e.g., aspirin, diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone, sulfinpyrazone) No known congenital (present at birth) abnormalities of the gastrointestinal tract, heart, or liver No distal intestinal obstruction syndrome (DIOS) | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-45.0, Cholera Vibrio Infections Diarrhea HIV-seropositive, non-pregnant adults, aged 18 years old who have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment or who have never started HAART regimen will be recruited in the study All subjects must satisfy the following at study entry Male and female HIV seropositive adults aged 18 to 45 years old who have given the written informed consent Will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection) CD4 T-lymphocyte count >500/mm3 for at least 6 months prior to Subjects that have never started HAART regimen must satisfy the following additional at study entry Asymptomatic HIV infection as determined by: Medical history, Physical examination, Laboratory tests, Clinical judgment of the investigator Subjects that have been on standard highly active antiretroviral therapy (HAART) for at least 6 months prior to enrollment must satisfy the following additional at study entry History of CD4 nadir >150/mm3 The following should be checked at the time of study entry, if any of the following is present then the subject will be excluded from the study Overt signs of immunodeficiency e.g. oral thrush, rapid weight loss, recurrent pneumonia (i.e. Stage 3 or 4 of the WHO clinical staging system for HIV infection and disease in adults and adolescents Ongoing serious chronic illness (e.g. with signs of cardiac or renal failure) Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours Presence of V. cholerae 01 or 0139, Shigella, or Cryptosporidium in stool at baseline Intake of any anti-diarrhoeal medicine in the past week Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral or otic) warrants deferral of the vaccination pending recovery of the subject Receipt of antibiotics in the past 2 weeks Receipt of live or killed enteric vaccine in the last 4 weeks Receipt of killed oral cholera vaccine in the past | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-40.0, Bacterial Vaginosis women 18-40 yrs old abnormal vaginal discharge or malodor positive QuickVue test positive KOH whiff test Positive finding of clue cells greater than or equal to 20% on wet mount Able to give informed consent willing to abstain from alcohol during the 5 day therapy and 1 day following immunocompromised women symptomatic VVC pregnancy or positive pregnancy test menstruating or breastfeeding women other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks women with MPC, PID | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 14.0-50.0, Clotrimazole Ovulen Vulvovaginal Candidiasis Non-pregnant females aged at least 14 years in Germany or at least 16 years in Russia and not older than 50 years Subjects presenting a symptomatic vulvovaginal yeast infection confirmed by microscopic evaluation (wet mount preparation) Subjects must be cooperative, able to understand the requirements of the trial participation, and willing to participate in the trial. For adolescents the informed consent has to be provided to a legal representative in addition Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception Negative saline smear for Trichomonas vaginalis Subjects with known hypersensitivity to imidazoles or triazoles and their analogues Subjects presenting a protozoan infection as confirmed by microscopic investigation Pregnant, breast feeding or lactating subjects Subjects with suspected bacterial vaginal infection Subjects with abdominal pain, fever, or foul smelling vaginal discharge Subjects who had a vaginal infection, or who had used an intravaginal or systemic antimycotic treatment within 60 days prior to visit 1 Subjects using or wishing to use intra-vaginal or systemic anti-infectives or systemic antifungal therapy during the trial Subjects wishing to use contraceptive foams, creams, jellies, sponges, therapeutic ointments, condoms, diaphragms, and OTC vaginal products during treatment and 3 days thereafter (i.e. until day 4) Subjects unable to refrain from the use of vaginal tampons during treatment and for 3 days thereafter (i.e. until day 4) Subjects unable to refrain from the use of feminine hygiene products (e.g. douches, feminine deodorant products) for 2 weeks (i.e. from visit 1 until visit 2) | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 65.0-999.0, Aged Subject (male or female) is at least 65 years of age Subject has a Geriatric Nutritional Risk Index (GNRI)of 92 or over Subject has Body Mass Index (BMI) > 20.0 but <30.0 Subject is ambulatory Subject agrees to maintain current activity level Subject has undergone major surgery, less than 4 weeks prior to enrollment in the study Subject has current active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix Subject has stated immunodeficiency disorder Subject has stated history of diabetes Subject has stated presence of partial or full artificial limb Subject has stated kidney disease Subject has stated history of uncontrollable hypertension Subject had myocardial infarction within the last 3 months Subject had recent antibiotic use (within 1 week prior to screening) Subject has a history of allergy to any of the ingredients in the study products | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-40.0, Healthy Males Only healthy male volunteers in the 18-40 age range will be included At the selection visit allowed normal range for vital signs will be: Blood pressure (with the subject sitting down) 90-130mm Hg systolic and 60-90 The volunteers' health condition will be determined from their complete clinical history by doctors at the clinical research site and lab test results by certified clinical laboratories mm Hg diastolic, heart rate 55-100 bpm , respiratory rate 14-20 respirations per minute Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening Treatment with a PDE-5 inhibitor within the 4 days preceding the first dose of study medication History of hypersensitivity to sildenafil citrate or any components of its formulations | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-55.0, Healthy Volunteers Healthy subjects Weight: BMI from 17.5 to 30.5 Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) A positive urine drug screen | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-55.0, Healthy Volunteers Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight >50 kg (110 lbs) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) A positive urine drug screen | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Traveler's Diarrhea Male and female patients 18 years of age or older Female and male patients of child-bearing potential must agree to use an effective method of birth control (this method must be approved by the investigator and may total abstinence from sexual intercourse) during the treatment and follow-up study periods; female patients of child-bearing potential must have a negative pregnancy test in the 72 hours before randomization; female patients who abstain totally from sexual intercourse are not required to take the pregnancy test Recent travel (i.e., must be within 30 days of randomization) from an industrialized country Experiencing signs or symptoms indicative of acute bacterial diarrhea (travelers' diarrhea), defined as at least three unformed, watery or soft, stools within the 24 hours preceding randomization and the duration of illness ≤ 72 hours before randomization, and able to provide an unformed stool sample during Screening (the latter can be the third unformed stool passed by the patient within the 24 hours preceding randomization); the bacterial cause of diarrhea will be confirmed by microbiology analysis of the stool sample Experiencing one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, or defecation urgency) Capable of and willing to give informed consent Fever (> 100.4ºF or 38ºC) or presence of signs and symptoms of systemic infection Note: antipyretic medication should not be administered in the 6 hours before this assessment Known or suspected infection with non-bacterial pathogen before randomization Presence of diarrhea for >72 hours duration Presence of grossly bloody stool Presence of moderate to severe dehydration (i.e., presence of orthostatic hypotension and/or dehydration requiring treatment with intravenous fluids) History of ulcerative colitis, diarrhea-predominant irritable bowel syndrome, Crohn's disease, celiac sprue (gluten-enteropathy), chronic pancreatitis, malabsorption, or any other gastrointestinal disease associated with diarrhea. Note: lactose intolerance treated with lactase supplements or a lactose-free diet are not excluded if these regimens are maintained during the study Receiving more than two doses of an antidiarrheal medication (e.g., antimotility, absorbent, adsorbent, antisecretory, or probiotics) within 24 hours before randomization Receiving one or more of the following antibiotics within 7 days before randomization, which are active against gram negative bacteria trimethoprim/sulfamethoxazole, fluoroquinolone, azithromycin or rifaximin Females pregnant or breast feeding or not using adequate birth control | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-65.0, Proctitis Adults, male and female, 18 to 65 years of age 2. Active, mild to moderate UP, with disease activity not to exceed 15 cm beyond the anal verge: the upper disease boundary will be confirmed by flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 3. Newly diagnosed or newly relapsed UP, where newly relapsed UP is defined as UP that has relapsed within less than and equal to 6 weeks prior to the Baseline Visit 4. A Disease Activity Index (DAI) score greater than or equal to 4 and less than or equal to 10 at the Baseline Visit; the DAI must a Physician's Global Assessment (PGA) sub-score of less than or equal to 2, a rectal bleeding sub-score of greater than or equal to 1 and a mucosal appearance sub-score of greater than or equal to 1 5. Histological confirmation of UP with a Histological Disease Activity Score > or equal to 1 for the biopsy taken from the most severe area of disease during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 6. For female patients of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit; all female patients will be considered of child-bearing potential unless they are post-menopausal for at least one year or have been surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) 7. Female patients of childbearing potential must be practicing one of the following methods of birth control and must agree to continue with regimen throughout the study: hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of one full cycle (based on the patient's usual menstrual cycle period) before investigational product administration; total abstinence from sexual intercourse (since the last menses before investigational product administration); intrauterine device; double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream); Male patients must also agree to use acceptable methods of birth control with their female partners, and this may use of a male condom plus spermicide. 8. Ability to give written informed consent 9. Ability and willingness to comply with study requirements, including dosing procedures, diary completion, and study visits Known history of allergic reaction or clinically significant intolerance to aspirin or salicylate derivatives (including mesalamine) or non-active ingredients of the investigational product 2. Onset of UP relapse >6 weeks prior to the Baseline Visit for patients experiencing a relapse of their UP (i.e., patients who are not newly diagnosed) 3. Severe UP as defined by a DAI score of greater than or equal to 11 or a PGA sub-score of 3 4. Histological Disease Activity Score > or equal to 1 for the biopsy taken from the normal tissue above the disease margin during the flexible sigmoidoscopy/colonoscopy performed within 14 days of the Baseline Visit 5. UP with disease involvement greater than 15 cm beyond the anal verge as confirmed on flexible sigmoidoscopy/colonoscopy 6. Prior unsuccessful treatment of active UP or active ulcerative colitis with rectally administered mesalamine preparations of any strength 7. Any prior treatment of UP or ulcerative colitis with any oral 5-aminosalicylic acid product if used at >2 g/day, regardless of treatment outcome 8. Use of local, rectally administered therapies for UP or ulcerative colitis (e.g., suppositories or enemas containing mesalamine, etc.) within 30 days of the Baseline Visit 9. Use of any of the following medications Biological therapies (e.g., infliximab) within 90 days of the Baseline Visit Immunosuppressive/immunomodulating (e.g., azathioprine) medications within 90 days of the Baseline Visit Oral, intravenous, intramuscular, or rectally administered corticosteroids within 30 days of the Baseline Visit; the use of intranasal and/or inhaled corticosteroids is permitted Oral 5-aminosalicylic acid products within 7 days of the Baseline Visit, if used at & less than or equal to 2 g/day Oral, intravenous, or intramuscular antibiotics within 7 days of the Baseline Visit Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) within 7 days of the Baseline Visit; low-dose aspirin (less than or equal to 325 mg/day) taken for cardio-protective reasons is permitted Antidiarrheals, antispasmodics, and iron therapy within 7 days of the Baseline Visit Transdermal nicotine products within 7 days of the Baseline Visit 10. A change in regimen (i.e., dosage or frequency of use) of permitted medications within 30 days of the Baseline Visit, or any plans to change the regimen during the course of this study 11. Use or treatment with an investigational drug, therapy, or device within 30 days of the Baseline Visit 12. A planned change in tobacco usage (e.g., smoking, oral tobacco) during the study 13. Female patients who are pregnant, planning a pregnancy, or who are breastfeeding 14. Diseases interfering with the DAI assessment, including but not limited to, hemorrhoids and anal fissures 15. History of Crohn Disease, short bowel syndrome, or bowel surgery (except appendectomy), or active peptic ulcer 16. A positive stool culture for enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, Vibrio, E. coli O157/H7), detection of Clostridium difficile toxin through immunoassay, or enteric parasites and their ova (including Giardia, Cryptosporidium, and Entamoeba histolytica) on routine microscopy at the Screening Visit 17. Significant impairment of renal or hepatic function, as defined by any of the following Creatinine >1.5 x Upper Limit Normal (ULN) | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-55.0, Healthy Volunteers Healthy male and/or female literate subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) Body Mass Index (BMI) of 17.5 to 26.4 kg/m2; and a total body weight >50 kg (110 lbs) Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) A positive urine drug screen | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-65.0, Functional Dyspepsia Gastric Emptying Gastric Accommodation All adult male or non-pregnant female patients who are diagnosed as functional dyspepsia and fulfilling Rome III (1) will be considered Patients should be negative for H. pylori on gastric biopsy and Urea Breath Test duodenal biopsy in these patients should be negative for giardiasis or celiac disease or any other established organic pathology A normal upper abdominal ultrasound Willing to participate and give consent for participation in the study Age <18 years Helicobacter Pylori positive on gastric biopsy and / or UBT Taking other medications that alter gastric motility like macrolide anti-emetics and antibiotics Pregnant or breast-feeding females | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 1.0-999.0, Cholera Diarrhoea Vibrio Infection Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 will be recruited in Kolkata Males or non-pregnant females aged 18 years and above and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection) Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 years Healthy subjects as determined by Medical history Physical examination Clinical judgment of the investigator Ongoing serious chronic disease For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening) Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day) Diarrhea (3 or more loose/watery stools within a 24-hour period) 6 weeks prior to enrollment One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months Intake of any anti-diarrhea medicine in the past week Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC warrants deferral of the vaccination pending recovery of the subject Receipt of immunoglobulin or any blood product during the past 3 months | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Peritonsillar Abscess referring doctor suspects peritonsillar abscess patient is voluntary patient has daily access to his/her e-mail patient speaks and understands Finnish of Swedish female patients have adequate birth-control method patient has peritonsillar abscess allergy to penicillin allergy to metronidazole use of metronidazole in preceding one month pregnancy breast-feeding renal insufficiency liver insufficiency alcoholism (drunk at least once a week) participant in another clinical trial at the moment treatment of peritonsillar abscess requires in-patient care | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | 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 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 0.0-99.0, Cystic Fibrosis Exocrine Pancreatic Insufficiency Pancreatic Diseases Digestive System Diseases Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis Patients with a history of hypersensitivity to the ingredient of LipaCreon Patients with a history of hypersensitivity to porcine protein | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-50.0, Healthy Provision of signed and dated, written informed consent prior to any study-specific procedures Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture; female subjects must be post menopausal or surgically sterile Male subjects should be willing to use barrier contraception ie, condoms, from the first day of the investigational product administration until 3 months after the last administration of the investigational product Have a body mass index (BMI) between 19 and 30 kg/m2 Be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the Investigator History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs Known history of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to carbapenem or cephalosporin antibiotics or other beta-actam antibiotics or any other investigational product to be administered as part of the study Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks prior to the first administration of investigational product Any clinically significant abnormalities in physical examination, ECG, clinical chemistry, haematology, or urinalysis results, as judged by the Investigator | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Clostridium Difficile Associated Diarrhea Male and female patients 18 years of age or older Mild to moderate C.difficile associated diarrhea (CDAD) with a positive stool C.difficile toxin (by ELISA) Either a first episode of CDAD or a first recurrence (patients with more than 1 recurrence are not eligible) Greater than 3 watery or unformed bowel movements in the prior 24 hours Females of child bearing potential having a negative pregnancy test and taking adequate birth control measures Patients should not consume alcohol at least 12 hours prior to dosing (i.e. in-house monitoring) and until 48 hours after the last dose of drug administration (until Day 14) Able to comprehend and give informed consent for the study and able to adhere to study schedules and protocol requirements Known prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives Life expectancy ≤ 60 days Sepsis, severe sepsis, or septic shock Signs or symptoms of peritonitis, megacolon or ileus History of ulcerative colitis or Crohn's disease Oral or parenteral antibiotic therapy with metronidazole or vancomycin or other drugs effective in treating DCAD (e.g., bacitracin, fusidic acid) within the 1 week prior to enrollment Recent history of significant drug or alcohol abuse within 1 year Any findings on physical examination, medical history, 12-lead ECG or clinical laboratory tests which, in the judgment of the Principal Investigator, would patients from participating in the study Patients with history of blood dyscrasias, porphyria and active non-infectious disease of the central nervous system Patients with history of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption | 1 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 0.0-63.0, Malnutrition Diarrhea Child Development (1) Infants (target child) will be eligible to participate in the study if they are They are in utero at the baseline survey Their parents/guardians are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still be a candidate for enrollment) (2) Children < 36 months old at baseline that are living in the compound of a target child will be eligible to participate in diarrhea measurement if They are < 36 months old at the baseline survey Their parents/guardians are planning to stay in the study village for the next 12 months (3) Children 18 months old at baseline that are living in the compound of a target child will be eligible to participate in intestinal parasite specimen collection if They are 18 months old at the baseline survey | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-70.0, Acute Bacterial Infections Acute Viral Infections current acute infection age 18-70 male or female any race currently active symptoms | 2 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 0.0-999.0, Malnutrition Diarrhea Child Development Study Population Description The subject population will be young children and their mothers/guardians living in several contiguous districts of Western Province, in the rural areas outside the towns of Bungoma and Kakamega. Communities must meet the following Located in a rural area (defined as villages with <25% residents living in rental houses, <2 gas/petrol stations and <10 shops) Not enrolled in ongoing WASH or nutrition programs No chlorine dispensers at water sources installed by programs separate from the present study Majority (>80%) of households do not have access to piped water into the home At least six eligible pregnant women in the cluster at baseline From enrolled communities, household compounds will be enrolled if they meet the following criteria One or more women who self-identify as pregnant at the time of the baseline survey The woman plans to stay in the community for the next 12 months (1) The study excludes households who do not own their home to help mitigate attrition during follow-up | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Newly Diagnosed High-Grade Glioma Patients must have histologically confirmed newly diagnosed high-grade glioma(WHO Grade III or IV) Age ≥18 years Karnofsky Performance Score (KPS) ≥ 60% Life expectancy greater than 12 weeks Patients must have adequate organ and marrow function Completed >80% of the prescribed radiation therapy and concurrent temozolomide according to the Stupp regimen without grade 3 or 4 hematologic toxicity Patients may have received Gliadel during surgery Ability to swallow pills and keep medication record women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation Ability to understand and willingness to sign a written informed consent document Patients must not have received prior therapy other than standard chemoradiation according to Stupp et al and Gliadel Patients may not be receiving any other investigational agents while on study Patients who have known allergy to mebendazole or benzimidazole Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy Patients who have taken any benzimidazole (ABZ, flubendazole, thiabendazole, fenbendazole, triclabendazole, etc.) within the last 3 months Patients who are taking any anti-convulsant medication that interferes with the cytochrome P450 pathway (e.g. phenytoin, phenobarbital, carbamazepine, etc.) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, chronic hepatitis, acute hepatitis, or psychiatric illness/social situation that would limit compliance with study requirements Pregnant women are excluded Patients with human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C positive; or with a history of chronic active hepatitis or cirrhosis | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Fecal Incontinence age ≥18 years living in the community (not a nursing home or assisted living facility) self-report of usually having FI of loose or liquid consistency at least twice in a 2-wk period toilets independently ability to read and write in English Persons that regularly performed pelvic floor muscle exercises and/or biofeedback on a maintenance regimen for at least 20 wks or who took a steady dose of anti-motility medications on a regular schedule that still met the FI were also eligible difficulty swallowing a gastrointestinal (GI) tract altered by surgery a malabsorption disorder inflammatory bowel disease gastrointestinal cancer or active cancer treatment allergy to the fibers regularly used a laxative or enema, were tube-fed, or unwilling to discontinue taking periodic self-prescribed fiber supplements or anti-diarrheal medications a score ≤24 on the Mini Mental State Examination having/reporting fewer than two episodes of FI or being incapable of performing study procedures during the run-in baseline period | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | 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 | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-75.0, Glomerulonephritis, Membranous Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent Histological diagnosis: Have clinical diagnosis of IMN, as verified by biopsy (either by light microscope with immuno-fluorescence, or by electron microscope) in the last 3 years (biopsy results [and slides where possible] should be available for independent evaluation). For patients with relapsed disease, a biopsy should be available within the preceding 7 years Proteinuria: Have clinically active disease (nephrotic range proteinuria) for at least 3 months prior to screening and no improvement (<30% reduction), despite supportive therapy (which must maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may statins, diuretics, dietary salt restriction). During screening proteinuria must be >400 mg/mmol by uPCR (or >4.0 g per 24 hrs) as measured from a 24 hrs urine collection and/or spot urine sample (early morning where possible) on 2 occasions at least 7 days apart Proteinuria in patients with relapsed disease: Patients who previously achieved proteinuria <2 g per 24h for at least 6 months and have subsequently relapsed with proteinuria levels as documented above, may be eligible providing recurrence has been within the previous 3 years and patient is known to be anti-PLA2R positive Female Subject is eligible to participate if she is not pregnant or nursing; is non-childbearing potential. Females of child-bearing potential must agree to use one of the approved contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose French subjects: In France, a subject will be eligible for in this study only if either affiliated to or a beneficiary of a social security category for Long Term Follow-up: Subjects who have signed informed consent for the Long Term Follow-up and have completed 2 years study treatment and the 16 week follow-up visit, or who have withdrawn early from study treatment but completed the Week 104 Withdrawn visit Non-Idiopathic MN or other condition affecting the kidney: If the diagnosis of MN is secondary to other conditions, or the subject has renal impairment from a condition that is not MN. Causes of secondary MN (but are not limited to) Immune diseases (Systemic lupus erythematosus, diabetes mellitus; rheumatoid arthritis, Hashimoto's disease, Grave's disease, mixed connective tissue disease, Sjogren's syndrome, primary biliary cirrhosis, bullous pemphigoid, small bowel enteropathy syndrome, dermatitis herpetiformis, ankylosing spondylitis, graft-versus-host-disease, Guillain-Barre syndrome); or Infectious or parasitic diseases (Hepatitis B; Hepatitis C, syphilis, filariasis, hydatid disease, schistosomiasis, malaria, leprosy); or Drugs and toxins (Gold, penicillamine, non-steroidal anti-inflammatory agents, mercury, captopril, formaldehyde, hydrocarbons, bucillamine); or Miscellaneous(Tumors excluded with reasonable diligence, renal transplantation, sarcoidosis, sickle cell disease, Kimura disease, angiofollicular lymph node hyperplasia) Anti-PLA2R autoantibody: Patients known to be negative for anti-PLA2R autoantibody Severely reduced or deteriorating kidney function: An eGFR at screening <40 mL/min/1.73m^2 (as determined by 4 variable version MDRD equation) or kidney function not stable (as defined by >15% decrease in eGFR in 3 months before screening unless due to medication change) Blood Pressure: Uncontrolled hypertension defined as blood pressure (BP) >150/90 mmHg (treatment target <=140/80) Prior Therapy: Have received treatment with the following therapies at the times specified prior to Day 0: Therapy B-cell targeted therapy except rituximab (e.g., other anti CD20 agents, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS-receptor fusion protein [BR3], TACI Fc, or belimumab), Time period: anytime; Therapy: Rituximab (subjects with rituximab treatment between 1 and 2 years prior to Day 0 are eligible if there is documented evidence of B-cell repopulation to >50% of pre-treatment levels), Period: 2 years; Therapy: Abatacept and any other biologic investigational agent other than B cell targeted therapy (i.e. not approved for sale in the country in which it is being used), Time Period: 364 days; Therapy: Cyclophosphamide or chlorambucil 3 or more courses of systemic corticosteroids for concomitant conditions (e.g., asthma, atopic dermatitis). (Topical or inhaled steroids are permitted.), Time Period: 180 days; Therapy: Anti-tumour necrosis factor (TNF) or anti-IL-6 therapy (e.g. adalimumab, etanercept, infliximab, tocilizumab). Interleukin-1 receptor antagonists (e.g. anakinra). Other immunosuppressive/immunomodulatory agents (e.g azathioprine, 6-mercaptopurine, mycophenolate mofetil (PO)/ mycophenolate mofetil hydrochloride (IV), mycophenolate sodium (PO), methotrexate, tacrolimus, sirolimus, thalidomide, leflunomide, mizoribine, ciclosporin). Intravenous immunoglobulin (IVIG). Plasmapheresis, leukapheresis, Time Period: 90 days; Therapy: A non-biologic investigational agent (i.e. not approved for sale in the country in which it is being used). Intravenous corticosteroid, Adrenocorticotropic hormone (ACTH). Aliskiren. A change in dose of >50% for angiotensin pathway antihypertensive (e.g., ACE inhibitor, angiotensin receptor blocker), Time Period: 60 days; Therapy: A live vaccine. Greater than 30mg/day corticosteroid, Time Period: 30 days; Therapy: Greater than 10mg/day corticosteroid. A change in dose of a corticosteroid. Note: Changes to inhaled steroids and new topical immunosuppressive agents (e.g., eye drops, topical creams) are allowed, Time Period: 14 days Transplantation: Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix Acute or chronic infection: Have required management of acute or chronic infections such as currently on any suppressive therapy for a chronic infection such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); or hospitalisation for treatment of infection within 60 days prior to Day 0; or use of parenteral (IV or IM) antibiotics (anti-bacterials, anti-virals, anti-fungals, or anti-parasitic agents) within 60 days prior to Day 0 | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-35.0, Concentration-Time Profiles in Stomach & Intestine. Healthy volunteers age: 20-35 year Diseases Acute/chronic gastrointestinal disorders Medication use Possible pregnancy Frequent exposure to x-ray radiation during the past year HIV positive | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-55.0, Healthy Apparently healthy; no medical conditions that might affect the study measurements Male or female Age between 18 and 55 years of age Body mass index (BMI) between 18.5 and 24.9 kg m-2 Suitable for MRI scanning (eg absence of metal implants, infusion pumps and pacemakers as assessed by the MRI safety questionnaire Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy) Known gastrointestinal disease Smoking History of alcohol or drug abuse Taking medication that is likely to affect gastrointestinal function Participation in night shift work the week prior to the study day. (Night work is defined as working between midnight and 6 am) Strenuous exercise greater than 10 hours per week Consumption of more than 21 units of alcohol in a typical week | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 5.0-39.0, Diarrhea Healthy male or female adults from 18-39 years old, inclusive General good health as determined by the screening evaluation no greater than 30 days before admission Properly informed about the study, able to understand it and sign the informed consent form Normal bowel habits (< 3 grade 1 or2 stools each day; ≥ 1 grade 1 or 2 stools every 2 days) Free of obvious health problems as established by medical history and clinical examination before entering into the study Available for the entire period of the study and reachable by study staff throughout the entire follow-up period Females of childbearing potential who are willing to take a serum pregnancy test at screening and urine pregnancy tests before each vaccination. Pregnancy tests must be negative before each vaccination. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is also acceptable Signed Informed Consent Presence of a significant medical or psychiatric condition that in the opinion of the Investigator precludes participation in the study Known infection with Hep C or HIV History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder Participation in research involving another investigational product (defined as receipt of investigational product) 30 days before planned date of first vaccination or concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational product Clinically significant abnormalities on physical examination Clinically significant abnormalities in screening hematology, serum chemistry, or urinalysis as determined by the PI or the PI in consultation with the Study Physician History of febrile illness within 48 hours prior to vaccination Known or suspected impairment of immunological function based on medical history and physical examination Prior receipt of any Shigella vaccine Fever at the time of immunization. Fever is defined as a temperature ≥ 37.5C (99.5F) on axillary, oral, or tympanic measurement | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 1.0-21.0, Pilomyxoid Astrocytoma Pilocytic Astrocytoma Glioma, Astrocytic Optic Nerve Glioma Pleomorphic Xanthoastrocytoma Glioblastoma Multiforme Anaplastic Astrocytoma Gliosarcoma Diffuse Intrinsic Pontine Glioma DIPG Low-grade Glioma Brainstem Glioma Age > 1 year of age and ≤ 21 years of age Diagnosis 1. Group A Low-grade Glioma Group Histology: Biopsy-proven Pilocytic Astrocytoma Fibrillary Astrocytoma Pilomyxoid Astrocytoma Pleomorphic Xanthoastrocytoma Other low grade astrocytomas Age < 1 year or > 21 years Patients who have known allergy to mebendazole or benzimidazole class drugs Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than 7 days prior to starting mebendazole therapy Pregnant female patients are not eligible for this study. Pregnancy tests with a negative result must be obtained in all post-menarchal females Lactating females must agree they will not breastfeed a child while on this study Males and females of reproductive potential may not participate unless they agree to use an effective contraceptive method and continue to do so for at least 6 months after the completion of therapy Patients who are unable to take oral medications because of significant vomiting will be excluded Group A Low-grade Glioma Group ONLY | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Chronic Diarrhea Renal transplant recipient (RTR) with proven diagnosis of chronic norovirus infection, whereas chronic virus shedding is defined as more than two polymerase chain reaction (PCR) positive samples in an interval of at least one month (case group) or chronic diarrhoea defined as more than three bowel movements per day since more than four weeks (control group) Missing informed consent Primary lactose intolerance Concomitant intestinal infection (other than norovirus) Subjects with galactosemia or patients requiring a low galactose diet Age < 18 years | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 21.0-70.0, Chronic Periodontitis diagnosis of chronic periodontitis presence of at least 6 periodontal pockets with a clinical attachment loss of ≥5 mm bleeding on probing (BOP) radiographic bone loss probing pocket depth higher or equal to 5 mm in at least six teeth at least 20 teeth in mouth (third molars excluded) an established smoking habit (at least 10 cigarettes per day for the past 4 years) periapical alterations in qualifying teeth medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment periodontal treatment in the past 6 months use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months orthodontic therapy pregnancy and lactation allergy to metronidazole any systemic diseases (e.g.: diabetes and immunological disorders) | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Clostridium Difficile Both genders are eligible for study Age 18 years and older Able to provide written, informed consent Confirmed diagnosis of severe CDAD as defined above (If any of the following apply, the subject MUST NOT enter the study) Pregnant or lactating women Need for prolonged antibiotics for other cause Other known etiology for diarrhea, or clinical infection with other known enteric pathogens Active, chronic conditions such as: Inflammatory bowel disease, Crohn's disease, Short bowel syndrome, Ulcerative or ischemic colitis Laxatives or motility-altering drugs within 12 hours of enrolment Clinically unstable. Hemodynamic instability defined as hypotension (mean arterial pressure < 60) not responsive to fluids Any condition that, in the opinion of the investigator, would preclude safe participation in the trial or compromise the quality of the data obtained Immune suppression, HIV, hematological or solid malignancy (chemotherapy in the past 3 months) Prior colon surgery | 1 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Clostridium Difficile Patients > 18 years of age The patient has been treated with appropriate antimicrobial therapy for CDI The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay Since this study does not involve treatments that have potential teratogenicity, and in general avoidance of antimicrobial treatment during pregnancy is advised (metronidazole is pregnancy category C), women of child-bearing age may be included in the study Patients will be excluded from study participation if one of the following categories of applies Patient is < 18 years of age Patient has an absolute neutrophil count < 750 cells/mm3 Stool donors must be > 18 years of age Complete a screening questionnaire a. One-time donors: Table 1 b. Designated, pre-screened donors: Table 2 Be tested for communicable blood-borne and enteric pathogens One-time donors: Table 3 | 1 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 6.0-999.0, Lymphatic Filariasis Onchocerciasis Soil Transmitted Helminth (STH) Infections Study areas should be endemic for filariasis and onchocerciasis Study population have limited or no prior experience with MDA. Males and Females greater than 5 years of age Children less than 6 years of age Children who weigh less than 15 kg (33 lb) | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-70.0, Gastrointestinal Symptoms Small Intestinal Overgrowth recent onset of typical reflux symptoms (heartburn and regurgitation) age <18 or >70 yrs pregnancy or breast-feeding evidence of major concomitant diseases (i.e., tumors, cardiovascular disorders and hepatic and/or renal failure) use of PPIs or H2-antagonists, non-steroidal anti-inflammatory drugs (NSAIDs) or antibiotics in the previous 3 months presence of Helicobacter pylori (H. pylori) infection erosive esophagitis presence of bowel symptoms such as bloating, flatulence, abdominal pain, diarrhea and constipation in the last 6 months or irritable bowel syndrome (IBS) according to Rome III criteria | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 1.0-999.0, Soil-transmitted Helminthiasis Schistosomiasis Strongyloidiasis Shigellosis Intestinal Salmonellosis Campylobacteriosis Aeromonas Spp. Infections Giardiasis Amoebiasis Dientamoebiasis Cryptosporidium Spp. Infections Individuals aged ≥1 year presenting with persistent diarrhoea (≥3 loose stools per days for ≥2 weeks; symptomatic group) and/or children (aged 1-18 years) with persistent abdominal pain (localized or diffuse abdominal pain lasting for ≥2 weeks, with possible intermittence/recurrence) Individuals with written informed consent provided Individuals in need of immediate intensive or surgical care Individuals who are unable or unwilling to give written informed consent Individuals who do not meet the for being a case or control (e.g. people with acute diarrhoea) Individuals with clinical jaundice (assessed by direct observation of the conjunctivae) Individuals who are unable, in the study physician's opinion, to comply with the study requirements Individuals who are already participating in other ongoing diagnostic studies and/or clinical trials | 2 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-75.0, Dyspepsia Peptic Ulcer Participants with non-investigated/functional dyspepsia or scarred peptic ulcer with indication of H pylori eradication treatment Ability and willingness to participate in the study and to sign and give informed consent confirmed H pylori infection by at least one of the following methods: C13-urea breath test, histology, rapid urease test or bacterial culture patients with peptic ulcer previous H. pylori eradication therapy Age below 18 years major systemic diseases previous gastric surgery pregnancy or breastfeeding allergy to any of the study drugs receipt of anti-secretory therapy, antibiotics or bismuth salts 4 weeks prior to | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 1.917-7.0, Healthy To be attending one of the SOSEP systems assigned daycare centers To maintain an attendance of 80% during the 8 weeks of the fieldwork Aged 23 to 84 months Being apparently healthy and with no dietary restrictions related to the foods offered with the SOSEP menu Children whose parents of caregivers did not sign a consent form Children who refused to participate in the study Children who refused to adhere to the collections routines | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-45.0, Neurocysticercosis Males and females of non-childbearing potential between the ages of 18 and 45 years, inclusive.* *Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have been postmenopausal for >/=1 year confirmed by LH and FSH levels In good health, as judged by the investigator and determined by vital signs* Temperature < 38 degrees Celsius, heart rate </=100 bpm and > 50 bpm, systolic blood pressure </= 140 mmHg and > 89 mmHg, diastolic blood pressure </=90 mmHg and >/= 60 mm Hg, medical history and a targeted physical examination. BMI >/=18 and </= 35. Athletically trained subjects with a pulse >/= 45 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator Acceptable screening laboratories* *Hemoglobin, white blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper limit of normal (for eosinophil count, AST, ALT, creatinine, and total bilirubin values below the normal range are acceptable). Random blood glucose must be <140. Urine dipstick testing must be negative for glucose and negative or trace for protein. The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load PCR testing may be performed for individuals suspected of having indeterminate antibody testing Male participants must be willing to ensure use of condoms and spermicides for 4 months after study drug administration Provide written informed consent before initiation of any study procedures Willing to be available for all study-required procedures, and visits for the duration of the study Able to provide a home phone number, and the name, address, and/or email of a person willing to assist with making contact during the follow-up phase of the study History of residing for 6 or more months in regions with endemic cysticercosis as determined by the principal investigator or a designated study physician Breastfeeding females Body temperature >/=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute illness within 3 days before administration of study drug (subject may be rescheduled) Chronic or acute medical disorder* *Disorders of the cardiac, pulmonary, liver, kidney, neurologic, gastrointestinal or other system, such that in the opinion of the investigator participation in the study creates additional risk to the subject, or to the validity of the study Use of chronic systemic medications* *Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment (please see section 5.6 for instructions on medication use during the study).Topical medications, nasal steroids are permitted throughout the study. Use of the prescription medications used less than once per week on average are permitted for enrollment (see section 5.6 for instructions on medication use during the study). If the subject has taken a short term prescription medication within the past 30 days (e.g. an antibiotic), they should be postponed from enrollment until 30 days have elapsed since the last dose Has history of sensitivity to related benzimidazole compounds (e.g., albendazole, mebendazole) A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt A history of treatment for any other psychiatric disorder in the past 3 years.* *Past treatment for ADHD does not participants from enrollment as long as the medications have been discontinued for a minimum of 3 months and symptoms are well controlled | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-80.0, Intestinal Diseases Travelers who intended to travel to tropical areas Good general health Medication consumption Background diseases | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-65.0, Diarrhea Participant's symptoms of acute diarrhea must manifest within 48 hours prior to entering the trial Participant must have experienced at least three incidences of unformed stool within 24 hours prior to entering the trial (referring to any instances of watery stool or soft stool as determined after placing the stool in a container) Participant's most recently produced stool must be unformed stool Participant must give a positive answer to the following question: "Have you felt any abdominal discomfort caused by gastrointestinal gas accumulation within the last hour" Female participants must take effective contraceptive measures throughout the trial (including oral or injectable contraceptives, contraceptive tools, ligation) or be postmenopausal Participant hospitalized for treatment of severe acute diarrhea or otherwise requires intravenous fluids or antibiotics on an outpatient basis Participant shows an axillary temperature greater than (>) 38.2 degrees Celsius (C) or an oral temperature > 38.6 degrees C Participant shows clinical symptoms of bloody or purulent stool or erythrocytes or leukocytes are detected in the participant's stool at > 3 per high power field Participant shows a sitting systolic blood pressure less than (<) 90 millimeter of mercury (mmHg) and/ or diastolic blood pressure < 60 mmHg Participant is unable to take medication orally or tolerate oral rehydration | 1 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 0.0-4.0, Diarrhea Helminthiasis Children normally resident in households with access to new shared sanitation (the intervention) as selected by implementing organisation (WSUP) or control children normally resident in households sharing existing shared sanitation within geographically delimited project bounds and meeting WSUP site selection (including number of people served) Refusal to participate | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Neoplasm Wounds and Injuries Age ≥ 18 years Diagnosis of malignat wound with odor, regardless of location, etiology and tumor staging; well as in treatment or palliative care Confirmation of participation in the study by signing the Instrument of Consent, personally or through responsible caretaker not smell | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 0.5-1.917, Diarrhea Signed informed consent from at least one parent or primary caregiver Age 6-23 months initially Permanent resident of study area Planned availability during the period of the study Acceptance of home visitors Weight-for-height z-score (WHZ) <-3Z with respect to WHO 2006 standards Presence of bipedal edema Severe illness warranting hospital referral Congenital abnormalities potentially interfering with growth Chronic medical condition (e.g. malignancy) requiring frequent medical attention Known HIV infection of index child or child's mother Hemoglobin <70 g/L Currently consuming zinc supplements Current participation in any other clinical trial | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-75.0, Diarrhea Adult male or nonpregnant female aged ≥ 18 years non-indigenous travelers (e.g., visiting students/faculty or international tourists) affected by naturally acquired acute diarrhea. Diarrhea is defined as the passage of at least three unformed stools in a 24-hour period. Stools are classified as formed (retains shape), soft (assumes shape of container), or watery (can be poured). When using this classification, both soft and watery stools are unformed and abnormal At least three unformed stools recorded within the 24 hours immediately preceding randomization At least one of the following signs and symptoms of enteric infection abdominal pain or cramps nausea vomiting fecal urgency excessive gas/flatulence tenesmus Women of child-bearing potential have a negative pregnancy test prior to beginning therapy and agree to use effective contraceptive methods during the study Pregnant, breast feeding, or planning a pregnancy Immediately prior to randomization, acute diarrhea for > 72 hours Presence of fever (≥ 100 °F or ≥ 37.8 °C), or hematochezia (blood in stool), or clinical findings suggesting moderate or severe dehydration Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, GI tract (other than infectious diarrhea in travelers), or central nervous system Administration of any of the following any antimicrobial agents with an expected activity against enteric bacterial pathogens within 7 days preceding randomization more than two doses of a symptomatic antidiarrheal compound such as antimotility agents, absorbent agents, and antisecretory agents within 8 hours preceding randomization | 2 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-60.0, Gingivitis Dental Plaque Recent Punjabi immigrants who are Montreal residents Having minimum 20 natural teeth Be in good general health Will give written informed consent Non permanent residents e.g. refugees Presence of orthodontic appliances Presence of partial removable denture Having any disease of soft/ hard oral tissues e.g. advanced periodontitis Having any systemic disease e.g. diabetes On certain medications such as phenytoin | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-54.0, Signs and Symptoms, Digestive Subject is male or female, 18-54 years of age, inclusive Subject has a body mass index (BMI) ≥18.50 and ≤39.99 kg/m2 at visit 1 (day -7) and has been weight stable (± 4.5 kg) for the previous 3 months Subject is judged to be in good health on the basis of medical history Subject is willing to maintain his or her habitual diet and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period Subject is willing to avoid foods/beverages that cause GI-distress, as well as high-fiber foods for 24 h prior to, and following, visits 2, 4, 6, 8, and 10 Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators Subject reports any clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, gastroparesis, and clinically important lactose intolerance) History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Investigator, could interfere with the interpretation of the study results Recent history (within 6 weeks of screening, visit 1) of constipation (defined as <3 bowel movements per week), and/or diarrhea (defined as ≥3 loose or liquid stools/d) Recent (within 6 weeks of screening, visit 1) episode of acute GI illness such as nausea, vomiting or diarrhea Daily use of non-steroidal anti-inflammatory drugs (NSAIDS) Daily use of antacids, proton pump inhibitors, H2 blockers Recent use of antibiotics (within 3 months of visit 2, day 0) Use of medications (over-the-counter and prescription) or dietary supplements (within 3 weeks of visit 2, day 0) known to influence GI function such as constipation medications and supplements (including laxatives, enemas, fiber supplements and/or suppositories); anti-diarrheal agents; anti-spasmodic; prebiotic and probiotic supplements Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet Known allergy or sensitivity to food ingredients such as: soy, dairy (milk), wheat, egg, peanuts, tree nuts, fin fish and crustacean | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-65.0, Celiac Disease Coeliac Disease Celiac Sprue Gluten Enteropathy Patients newly diagnosed with coeliac disease Male or female Able to give informed consent Able to schedule the first MRI scan (Visit 2 of the study) within a month of having had a duodenal biopsy and not yet commenced on a gluten free diet Pilot study in healthy volunteers Healthy volunteers (without any comorbidities) Able to give informed consent Pilot study in patients Any past serious, unstable medical condition, unstable/uncontrolled diabetes mellitus, major psychiatric diagnosis Any reported history of gastrointestinal surgery that could affect gastrointestinal function (colectomy, small bowel resection) | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-70.0, Dyspepsia Signed Informed Consent Participants aged 18 years Clinical diagnosis of functional dyspepsia according to Rome III criteria Minimum score of 15 points in PADYQ questionnaire Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological Positive diagnosis for Helicobacter pylori Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization History of esophageal surgery, gastrointestinal or other intra-abdominal surgery Hypersensitivity to the components of the formulations Allergy tartrazine yellow dye Allergy to aspirin Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit Use of NSAIDs or aspirin more than two days a week (except AAS <325mg / day), other drugs that induce gastrointestinal symptoms Pregnant women or women without adequate contraception | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 8.0-18.0, Irritable Bowel Syndrome Males and non-pregnant females between 8 years and 18 years at the time of consent Able to obtain parental or legal guardian informed consent from subjects as applicable d-IBS determined by ROME III criteria. A Rome III diagnosis consists of recurrent abdominal pain or discomfort at least 2days/week in the last 3 months prior to enrollment associated with two or more of the following10 Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool Children taking pharmacologic treatment for d-IBS will be excluded Children who are unable to articulate symptoms of IBS will be excluded Non-English speaking children will be excluded Children with known allergy or hypersensitivity to beef or any component of SBI Pregnancy | 0 |
A 32-year-old male presents to your office complaining of diarrhea, abdominal cramping and flatulence. Stools are greasy and foul-smelling. He also has loss of appetite and malaise. He recently returned home from a hiking trip in the mountains where he drank water from natural sources. An iodine-stained stool smear revealed ellipsoidal cysts with smooth, well-defined walls and 2+ nuclei. | eligible ages (years): 18.0-999.0, Travel Medicine Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada Travellers with an expected return date after September 1, 2016 Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 0.0-999.0, Acquired Immunodeficiency Syndrome Aspergillosis HIV Infections Immunologic Deficiency Syndromes Neutropenia Males and females of greater than 12 years of age with any of the following conditions Allogeneic or autologous bone marrow/ peripheral stem cell transplant Hematological malignancy (including lymphoma) Aplastic anemia and myelodysplastic syndromes (currently on immunosuppressive treatment) Solid organ transplantation Solid organ malignancy (after cytotoxic chemotherapy) HIV infection/AIDS High dose prolonged corticosteroid therapy (greater than or equal to 20 mg daily of prednisone or equivalent for greater than 3 weeks) or prolonged therapy with other immunosuppressive agents (e.g., azathioprine, methotrexate) WITH a diagnosis of definite or probable acute invasive aspergillosis The fungal infection at baseline should represent a new episode of acute invasive aspergillosis. Any course of systemic treatment with amphotericin B (conventional or lipid formulation) or itraconazole should have been completed at least 8 weeks prior to study entry | 2 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 2.0-999.0, Tuberculosis Males or nonpregnant, non-nursing females > 2 years old Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as > 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as > 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of > 10 mm within two years of a nonreactive test or persons with an increase of > 10 mm within a two-year period HIV-seropositive, TST positive (> 5 mm induration) persons Persons with > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no prior history of TB treatment, > 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible Willing to provide signed informed consent, or parental consent and participant assent Current confirmed culture-positive or clinical TB Suspected TB (as defined by the site investigator) Tuberculosis resistant to isoniazid or rifampin in the source case A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years A documented history of a completing an adequate course of treatment for active TB or latent TB infection in a person who is HIV-seronegative History of sensitivity/intolerance to isoniazid or rifamycins Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal among persons in whom AST is determined Pregnant or nursing females Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment Weight < 10.0 kg | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 2.0-999.0, Infection Unspecified Adult Solid Tumor, Protocol Specific Proven or probable invasive aspergillosis or other filamentous fungal infection by cytology, histopathology, or culture within the past 7 days Presenting with 1 of the following Cancer Aplastic anemia Inherited immunodeficiencies Autoimmune deficiency disorders Acquired immunodeficiencies Recipient of autologous peripheral blood stem cell or bone marrow transplantation CNS aspergillosis or other filamentous fungal infection allowed No invasive zygomycosis infection | 1 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 0.083-999.0, Invasive Aspergillosis Other Fungal Infections Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-80.0, Invasive Aspergillosis Patients fulfilling all the following will be eligible for enrolment 1. Aged 18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent Patients with any of the following will be ineligible for enrolment 1. Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the above 2. Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial) 3. Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other active invasive fungal infection 5. Prior enrolment in this study | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-75.0, Arthritis, Rheumatoid Diagnosis of RA according to the revised 1987 of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed at least 6 months prior to screening Active disease at the time of screening and pre-infusion as defined by >=6 swollen joints >=6 tender joints and 2 of the following morning stiffness >=45 min ESR >=28 mm/h CRP >=20 mg/L Men and women, >=18 to <=75 years of age Men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, IUD, barrier method with spermicide or, surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion Patients must have been using oral or parenteral MTX for at least 3 months with no break(s) in treatment of more than 2 weeks total during this period. Patients must have been on a stable dose of >=12.5 mg/wk (maximum 20mg/wk) for at least 4 weeks prior to screening Pregnant women, nursing mothers or a planned pregnancy within 1.5 years of enrollment Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the Infliximab therapy, eg Lyme disease, or a rheumatic disease other than RA Use of DMARDs other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.) Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab) Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months Treatment with any investigational drug within the previous 3 months Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-75.0, Psoriasis Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months prior to study screening (subjects with concurrent psoriatic arthritis may also be enrolled) Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved at Baseline Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study Subjects must also meet the tuberculosis (TB) assessment and screening as follows: Have no history of latent or active TB prior to screening; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB Specific parameters must also be met with regard to screening laboratory test results and liver enzymes in order to be eligible to participate in the study Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are pregnant, nursing, or planning pregnancy Subjects previously treated with MTX or infliximab; subjects who are taking specific drugs within the specified time frame prior to Baseline as follows: any therapeutic agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or bacterial vaccinations within 3 months; any systemic medications or treatments that could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or lithium within 4 weeks; any topical medications or treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing tar or salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit Subjects with poor health, including concomitant congestive heart failure (CHF); history of chronic or recurrent infectious disease, as specified; human immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who have been hospitalized or received IV antibiotics, or who had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB), or a transplanted organ within specified time frames; or other conditions as specified in the protocol Subjects who have used any investigational drugs within 4 weeks of Screening, who are participating in other clinical studies, staff or family members of study staff are excluded from participation in the study | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Aspergillosis Male or female hospitalized patients aged > 18 yr The patient has a hematologic malignancy or will receive a bone-marrow transplant The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission The expected duration of severe neutropenia (PMN<0.5x10*9/L) following study entry is > 10 days The patient is receiving oral antibiotic prophylaxis and fluconazole Written informed consent has been obtained The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry Known hypersensitivity to amphotericin B Any evidence of pneumonia or pneumonitis at trial entry Any impossibility to use a nebulizer properly Expected survival < 3 months at entry Pregnancy | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-85.0, Non-small Cell Lung Cancer Histologic confirmation of non-small cell lung cancer, mesothelioma or a radiographic lesion highly suspicious for malignancy Written informed consent Must be scheduled for a biopsy or surgical resection Subjects with any "other" prior cancer (other than lung) within 5 years of date of surgery are NOT eligible (unless there is preoperative pathologic confirmation that the lung mass is a second primary cancer) Subjects with any type of lung cancer other than non-small cell lung cancer(NSCLC) | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 10.0-999.0, Invasive Aspergillosis Adults and children > 10 years old The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtain prior to the initiation of any study procedures Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (≥ 20 mg Prednisone or equivalent for ≥ 3 weeks) or treatment with other immunosuppressant medications Evidence of Proven or Probable Invasive Aspergillosis, by modified EORTC (Appendix 2), as modified below: • Proven Invasive Aspergillosis • Histopathologic or cytopathologic examination showing hyphae consistent with the presence of aspergillus from needle aspiration or biopsy specimen with evidence of associated tissue damage (either microscopically or unequivocally by imaging); or • Positive culture result for aspergillosis from a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes • Probable Invasive Aspergillosis • At least 1 host factor criterion; and • 1 microbiological criterion; and major (or 2 minor) clinical from abnormal site consistent with infection; and • No other pathogens detected to account for the clinical or radiographic signs of infection Or (Modification of EORTC Criteria): • Patients with recent Neutropenia (absolute neutrophil count < 500 cells/mm3 within 14 days of study enrollment); and • Chest CT scan positive for "Halo" or "Air Crescent" Sign (see Section 4.2.1, Diagnostic Considerations, below) and • No other pathogens detected to account for the clinical or radiographic signs of infection Females of childbearing potential must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline Life expectancy < 30 days Allogenic stem cell transplant in the 6 previous months Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study Prior anti-fungal systemic therapy of ≥ 96 hours for the current, documented IA. (On the other hand, is permissible prior systemic anti-fungal therapy for prophylaxis or as empiric therapy for febrile neutropenia) Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug • Serum creatinine > 2x upper limit of normal (ULN) Serum ALT or AST > 5 x ULN Pregnant or lactating women History of allergy or serious adverse reaction to any polyene anti-fungal agent or echinochandin derivatives | 2 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 12.0-999.0, Aspergillosis Patients with newly diagnosed acute leukemia or high risk myelodysplastic syndrome (MDS) receiving induction chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days Patients with relapsed acute leukemia or MDS receiving salvage chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens Patients are at least 12 years of age, with Karnofsky score of 70%.? Patients on consolidation chemo regimens like HIDAC and HyperCVAD type B with expected duration of neutropenia (ANC < 500/ml) of at least 10 days Patients who are human immunodeficiency virus (HIV) infected Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation Patients with pre-existing proven and probable invasive fungal infections, according to the definitions of the invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Disease [10] Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid Patients on palliative chemotherapy Patients with history of allergy to triazoles Patients with prior history of anaphylactic reaction to conventional amphotericin B Patients with serum levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin more than 5 times the upper limit of normal or renal impairment with calculated creatinine clearance < 30ml/min Patients with expected life-expectancy < 72 hours | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Acute Myeloid Leukemia Allogeneic Haematopoietic Progenitor Cell Transplant Patient has decided voluntary to consent his or her participation signing the consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant The patient is >18 years old Patient with prior Invasive Pulmonary Aspergillosis (IPA) history History of allergy or hypersensitivity to Amphotericin B Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding Pregnancy or breastfeeding Patient has received other investigational drug or non traded product within 30 days before trial beginning Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason Patient had major surgery within 4 weeks before enrollment | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 19.0-65.0, Rheumatoid Arthritis Patients aged >35 and <=65 years with a diagnosis of rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) for at least 1 year and no more than 10 years prior to start of therapy; have active disease (Disease Activity Score [DAS] 28 >2.8 and <3.5), with changes in the DAS 28 score <0.6 within the 6 weeks before inclusion; have stable RA basic therapy according to standard for at least 3 months; have a chest X-ray within 1 month prior to first infusion with no evidence of malignancy, infections, or fibrosis; and have screening laboratory test results that meet prespecified criteria. Patient must have at least one swollen joint. Patient must have evidence of erosive disease by x-ray at baseline Patients were excluded if they met any of the following Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion) Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer History of any other therapeutic agent targeted at reducing tumor necrosis factor (TNF) History of previous administration of infliximab History of receiving human/murine recombinant products or has a known allergy to murine products Serious infection (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator Active tuberculosis (TB) or evidence of latent TB (positive purified protein derivative [PPD] skin test, a history of old or latent TB or chest X-ray without adequate therapy for TB initiated prior to first infusion of study drug), or evidence of an old or latent TB infection without documented adequate therapy. Patients with a current close contact with an individual with active TB and patients who have completed treatment for active TB within the previous 2 years are explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies Hepatitis B surface antigen or Hepatitis C (HCV) antibody positive; documented Human Immunodeficiency Virus (HIV) infection Have an opportunistic infection, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterium infection, etc, within the previous 6 months | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 6.0-999.0, Cystic Fibrosis Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations Patient must be known to be chronically colonized with Aspergillus fumigatus Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization Patients must weigh at least 20 kg Post-menarche females must be using an effective form of contraception Inability to give informed consent Respiratory culture positive for B.cepacia complex Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization Neutropenia, absolute neutrophil count< or = 1000 within a 3-day period prior to randomization History of biliary cirrhosis documented by liver biopsy or imaging History of portal hypertension Investigational drug use within 30 days of randomization date History of alcohol, illicit drug or medication abuse within 1 year of randomization Women who are pregnant, breastfeeding or trying to conceive | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-75.0, Arthritis, Rheumatoid Patients received placebo in main double-blind study (P04280, NCT00202852) Patients received Infliximab-containing regimen showing clinical response at week 30 in main double-blind study (P04280) [Main double-blind study (P04280, NCT00202852) criteria] Diagnosis of rheumatoid arthritis (RA) according to the revised 1987 of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed >6 months prior to screening Active disease at the time of screening and pre-infusion as defined by >=6 swollen joints >=6 tender joints and of the following morning stiffness >=45 min erythrocyte sedimentation rate (ESR) >=28 mm/h below of main double-blind study (P04280, NCT00202852) [Main double-blind study (P04280, NCT00202852) Pregnant women, nursing mothers, or a planned pregnancy within 1.5 years of enrollment Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from infliximab, eg Lyme disease, or a rheumatic disease other than RA Use of disease modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.) Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab) Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months Treatment with any investigational drug within the previous 3 months | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Hidradenitis Suppurativa Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following HS >1 year duration with multiple ER or doctors visits related to HS Intralesional kenalog injection >5/year, however none within 2 weeks of entry Failed systemic retinoids, but not within 3 months of entry Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment) History of surgery (reconstructive), but not within 3 months of entry Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection) Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent) If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly Have a concomitant diagnosis or history of congestive heart failure Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 16.0-999.0, Hematological Diseases Invasive Aspergillosis Age > 16 years Allogeneic HSCT for a haematological disease Written informed consent to the study Pediatric patients | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Lung Cancer Diagnosis of non-small cell lung cancer Stage I-IIIB disease No prior surgical tumor resection Respiration-induced tumor motion > 5 mm Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals Not pregnant No insufficient lung function or other parameters prohibiting a bronchoscopy Not a prisoner or institutionalized See Disease Characteristics Concurrent chemotherapy allowed | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 4.0-45.0, Cystic Fibrosis, informed consent age between 4 and 45 years well-known Cystic fibrosis Lung function: FEV1 (% pred.) ≥ 70% age < 4 and > 45 years lung function: FEV1 (% pred.)< 70% other chronic diseases or infections (e.g., HIV, tuberculosis, malignancy) pregnancy known alcohol, drug and/or drug abuse inability to capture the scale and scope of the study participation in another study | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 1.0-999.0, Immunocompromised Host Invasive Pulmonary Fungal Infection Invasive Pulmonary Aspergillosis Invasive Pulmonary Zygomycosis Patients currently enrolled in any NIH IRB approved Clinical Center protocol or under treatment at the CNMC who are undergoing bronchoscopy or lung biopsy for diagnosis of possible invasive pulmonary aspergillosis or invasive pulmonary zygomycosis Informed consent of the patient or the patient's legally authorized representative Fulfillment of one or more of the following EORTC/MSG host History of neutropenia (ANC < 500/mm(3)) within the past 3 months temporally related to the onset of radiographic changes Receipt of an allogeneic HSCT Receipt of solid organ transplantation Prolonged use of corticosteroids at an average minimum dose of 0.3 mg/kg/day prednisone equivalent for > 3 weeks Treatment with other recognized T-cell immune suppressants such as cyclosporine, TNF alpha blockers, specific monoclonal antibodies such as alemtuzumab, nucleoside analogues during the past 90 days Myelodysplastic syndrome Severe aplastic anemia Interstitial or diffuse infiltrates on chest CT or radiograph Inability to provide informed consent Children weighing less than 10 kg Any other concomitant condition, which in the opinion of the investigator would place the patient at risk by participating in the study | 1 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, HIV Infection Pulmonary TB Age above 18 years HIV-1/2 infected patients with Pulmonary TB. This includes sputum smear positive disease Initially smear negative but (Becton-Dickinson) culture positive (e.g. miliary TB, Mediastinal adenitis and Chest x-ray with persistent abnormality after antibiotics) Persistent X-ray abnormality will be included for allocation. However final into both ITT and efficacy analysis will depend on positivity in LJ culture Living within 40 km radius from the nearest sub centre of TRC and willing for attendance as prescribed Likely to remain in the same area for at least one and half years after start of treatment Willing for house visits and surprise checks Willing to participate and give informed consent after going through the terms and conditions of the trial Patients with known hypersensitivity to rifampicin Pregnancy and lactation at initial presentation Major complications like HIV encephalopathy, renal dysfunction (serum creatinine > 1.5 mg% in the absence of dehydration) or jaundice (serum bilirubin > 2 mgs% along with SGOT /SGPT elevation > 2.5 times the upper limit of normal) Previous anti-tuberculosis treatment for more than 1 month. Prophylaxis (non-rifampicin containing regimen) will not be considered as prior antituberculosis treatment Moribund, bedridden or unconscious patients Co-morbid conditions like uncontrolled diabetes mellitus, cardiac failure, and malignancy at initial presentation Major psychiatric illness Patients on second line ART, mainly protease inhibitors, at initial presentation | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 0.0-999.0, Allergic Bronchopulmonary Aspergillosis Diagnosis of ABPA Presence of all the following three immediate cutaneous hyperreactivity on aspergillus skin test elevated total IgE levels > 1000 IU/mL A fumigatus specific IgE levels > 0.35 kU/L, AND Presence of two of the following presence of serum precipitating antibodies against A fumigatus fixed or transient radiographic pulmonary opacities absolute eosinophil count > 1000/µL central bronchiectasis on HRCT If they have taken glucocorticoids for more than three weeks in the preceding six months Failure to give informed consent Enrollment in another trial of ABPA | 1 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-65.0, Liver Transplantation Aspergillus Interleukin-17 Treg Cell Immune Tolerance Liver transplantation patients Psychopath | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 0.0-999.0, Invasive Aspergillosis BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason Patients without fulfilling criteria Patients with some contraindication to perform a bronchoscopy | 2 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 35.0-85.0, Osteoarthritis, Knee Adults ≥ age 35 but ≤ age 85 Painful knees for 3-60 months VAS joint pain score greater than 30 mm (scale 0-100) Knee radiograph showing minimal to moderate change (early OA) No NSAID therapy for at least one week Have the capacity to understand and sign an informed consent form Gender: Male or female Women must be postmenopausal (no menstrual period for a minimum of 1 year) or surgically sterilized and have a negative serum pregnancy test on entry in the study. Men must agree to use adequate birth control during the study for 6 months after the infusion of study agent Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion The screening laboratory test results must meet the following Moderate to Severe OA, as determined by severe joint space narrowing (Kellgren grade IV) (7) in medial and lateral compartments Insulin-dependent diabetes mellitus Systemic inflammatory illness, e.g. rheumatoid arthritis Intra-articular injections within 3 months Prior treatment with infliximab or other anti-TNF drug Acute injury to knees (< 2 weeks) Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion) Have had any previous treatment with monoclonal antibodies or antibody fragments History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an criterion Documentation of a positive test for hepatitis B surface antigen or hepatitis C | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-90.0, Invasive Aspergillosis proven or probable invasive aspergillosis with positive GM antigen test Seronegative aspergillosis | 2 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 16.0-999.0, Hematologic Disease Solid Organ Transplantation IPA cases with solid organ transplant recipients and hematologic disease patients proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG under 16 years old possible cases of invasive pulmonary aspergillosis | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Aspergillosis The patient or legally authorized representative has signed an informed consent/assent Assent will be obtained as required by the UAMS IRB The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI The patient is 18 years of age or older The patient is being treated with an unlicensed investigational drug for aspergillosis The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for > 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled Patient has invasive aspergillosis but with negative Aspergillus GM index The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal The patient has hepatic cirrhosis Patients with creatinine > 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours) The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents The patient has previously enrolled into this study | 2 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 16.0-999.0, Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis A. Fumigatus Male or female ≥ 12 years of age at enrollment Confirmed diagnosis of CF based on the following One or more clinical features consistent with the CF phenotype AND (b or c) Positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) two identifiable mutations consistent with CF Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Clinically stable at enrollment as assessed by the site investigator Past or present respiratory culture positive for Aspergillus fumigatus IgE ≥ 250 and/or presence of class II or higher aspergillus specific IgE on enrollment Ability to comply with medication use, study visits and study procedures as judged by the site investigator - Systemic corticosteroids (1 mg/kg if < 20 kg or > 20 mg of prednisone per day) Investigational drug use within 30 days of screening 3. Laboratory abnormalities at screening a. Serum Calcium > 11 mg/dl b. 25(OH) D > 50 ng/ml at screening. c. Creatinine ≥ 1.5, or estimated GFR <60 by Cockcroft-Gault or MDRD equation. d. LFT≥ 3xULN History of transplantation or currently on lung transplant list 5. Positive serum pregnancy test at screening (to be performed on all post-menarche females) 6. Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study 7. Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data 8. Diagnosis of HIV and a CD4+ T cell count below 500 cells/ml or active hepatitis B or C infection Undergoing therapy for non-tuberculous mycobacterial infection | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 16.0-999.0, Invasive Pulmonary Aspergillosis hospitalisation in the hematology or intensive care department age > 16 years informed consent proven or probable IPA (EORTC/ MSG criteria) galactomannan positivity in BAL or serum age < 16 years | 1 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Lung Transplant Recipient Single or double lung transplant recipients who are at least one year out of transplantation Age >18yrs of age Able to understand and complete informed consent Pregnant woman or woman capable of bearing children, who will not perform urine pregnancy test Nursing mothers Subjects with hypersensitivity to Amphotericin deoxycholate or liposomal Amphotericin Subjects with a past history of bronchospasm associated with aerosol drug use Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications Subjects treated with cytolytic medications (Campath /Thymoglobulin) within the last month Subjects with an FEV1< 30% Predicted or FVC% <30% Subjects requiring supplemental oxygen Receipt of Inhaled or IV Amphotericin B within last 30 days Subjects with known fungal infection as per MSG on therapy with antifungal drugs or diagnosed on the day of bronchoscopy | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 14.0-80.0, Chronic Cavitary Pulmonary Aspergillosis Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks Radiological findings Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species The diagnosis of CCPA will be made if Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria FNAC from the cavity wall will be considered in atypical cases Invasive aspergillosis Allergic broncho-pulmonary aspergillosis (ABPA) Active tuberculosis or malignancy Pregnant females | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Infection The for participants to enter the study mandates that each patient have received a standard (current clinical practice) diagnostic evaluation that includes a CT scan of the chest to document bronchiectasis, prior to enrolling in the Consortium study. To enter this protocol, adults must have bronchiectasis and meet the following Males or females, age greater than or equal to18 years Chronic cough An available CT of the chest (on a CD) that shows evidence of dilated airways fulfilling radiographic for bronchiectasis in more than one lobe Ability to provide informed consent, including HIPAA consent A participant should not be in the study if they have not had a standard clinical evaluation to rule out other potential causes of chronic sino-pulmonary disease Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing CFTR mutations History of tuberculosis or other known explanation for bronchiectasis, such as alpha 1-antitrypsin deficiency (ZZ or ZS), confirmed or probable PCD, inflammatory bowel disease, rheumatoid arthritis, Sjogren s syndrome, allergic bronchopulmonary aspergillosis, or documented primary or acquired immunodeficiency Current smoker or > 10 pack-year history of tobacco use Prior solid organ transplant | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 0.083-14.0, Tuberculosis Any child with at least one of the following Unexplained weight loss or documented failure to thrive or stagnant weight or Growth faltering on the growth charts over the past 3 months despite adequate nutrition and deworming Non remittent cough or wheeze for more than 2 weeks Night sweats persistent or intermittent during the last 2 weeks Prolonged fever (temperature > 38°C) for 7 days, after common causes such malaria or pneumonia has been excluded Wheeze/Stridor persistent, non remitting during the last 2 weeks Chest pain Persistent, localized, pleuritic in nature during the last 2 weeks Current TB treatment (patient who received < 3 days of treatment or patients receiving IPT could be still included) or TB treatment completed within the past 6 months Absence of informed consent Living outside of Greater Mbarara region Unable or unwilling to attend to the follow-up visits | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 5.0-80.0, Invasive Aspergillosis hematological patients with lung infiltrates at high risk for invasive aspergillosis patients without informed consent | 1 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 5.0-85.0, Invasive Aspergillosis immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates informed consent Children under the age of 5 years Informed consent not available | 2 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-80.0, Ventilator Associated Pneumonia All adult patients above 18 years old admitted into the Intensive Care unit and who is to be intubated and likely to receive more than 72 hours of ventilation would be admitted into the trial presence of cavitary lung disease based on chest x-ray findings primary lung cancer or another metastatic malignancy to the lungs, or known or suspected viral or fungal etiology pneumocystis carinii pneumonia legionella OR Mycoplasma pneumonia or active tuberculosis | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-999.0, Psoriasis Subjects are non-immunocompromised males or females 18 years of age or older Subjects have moderate-to-severe (≥10% total body surface area) plaque psoriasis Subject diagnosed at least 6 months prior to entering the study Negative urine pregnancy test within 7 days before the first dose of ustekinumab in all women (except those surgically sterile or at least 5 years postmenopausal) Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study Are considered eligible according to the following tuberculosis (TB) screening Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent Within 1 month prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and ongoing treatment for latent TB or documentation of having completed adequate treatment as described above; Subjects with documentation of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB Subject is younger than 18 years of age Subject has less than 10% body surface involvement of his/her psoriasis Subjects with erythrodermic, pustular, or guttate psoriasis History of known or suspected intolerance to any of the ingredients of the investigational study product Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits Subject has a history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, or oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening Refer to for information regarding with a history of latent TB Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening | 0 |
A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls. | eligible ages (years): 18.0-65.0, Cystic Fibrosis Healthy control subjects Age 18-65 No history of lung disease Cystic fibrosis subjects Age 18-65 No history of lung disease other than cystic fibrosis Diagnosis of CF if sweat chloride values > 60 mM on two separate pilocarpine iontophoresis sweat tests and/or two allelic CF-producing mutations in genetic analysis Use of recreational drugs within 30 days prior to enrollment Use of tobacco within 30 days prior to enrollment, or > 10 pack-year tobacco history Pregnant or lactating females | 0 |
Subsets and Splits