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An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 18.0-999.0, Subarachnoid Hemorrhage Written informed consent of the patient or consent of patient's next of kin Spontaneous SAH Age: ≥18 Glasgow coma scale (GCS) ≤ 12. In intubated patients the GCS assessment will be performed after cessation of sedation or if not possible the last GCS score before intubation will be used SAH due to any other cause or structural abnormality of the brain (trauma, dissection, arterio-venous malformation, dural arterio-venous fistula) Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad) | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 7.0-25.0, Sarcoma, Soft Tissue Osteosarcoma Tumor Survivors of paediatric bone or soft tissue sarcomas, who were treated from 1992 onwards in the paediatric haematooncology department of UZLeuven according to one of the following treatment protocols *For soft tissue sarcomas: MMT 95, MMT 98, RMS2005 or NRST2005 *For Ewing sarcoma: 92, Euro-Ewing 99 or Euro-Ewing 2008 *For osteosarcoma: EORTC 80931 or Euramos1 protocols There will be variability in treatment regimens, but the patient group will be clustered into four subgroups Cisplatin and anthracyclines Cisplatin, anthracyclines and methotrexate Alkylating agents Alkylating agents and anthracyclines Mental retardation documented before treatment Inability to perform the tests because of motor or sensory deficits Epilepsy Other cognitive disorders Depression Relapse Parameningeal or intracranial sarcomas Syndrome (e.g. Down) Autologous stemcell transplantation Head/neck/spinal radiotherapy or psychopharmaca | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 18.0-999.0, Substance Withdrawal Syndrome intermittent use or continuous infusion opioids for at least 96 hours Patient and/or relatives unable to communicate in French or English Patients unable to communicate (consent form and evaluation) Patient deaf without appropriate hearing aid Patients unable to communicate (consent form and evaluation) Imminent and predictable death according to medical team Severe brain injury, defined as Glasgow Coma Scale (GCS) score of 8 or less at ICU admission Moderate brain injury, defined as GCS between 9 and 12, with elevated intracranial pressure (ICP > 20 mm Hg) who requires ICP monitoring and osmotherapy Major confounding factors for withdrawal syndrome by causing shivering, sympathetic drive and autonomic disorders Underlying active neurological condition (status epilepticus, encephalopathy, hypoxia) Neurological problems are covariates, which would make the assessment of sedation or IWS difficult Patient previously included in the study at any of the two hospitals (readmission to the ICU at a later date during the period of recruitment for the study, limiting to 1 weaning episode per patient) | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 18.0-999.0, Hematoma, Subdural, Chronic years and older evidence of subacute or chronic supratentorial subdural hematoma by CT (computerized tomography) scan or MRI (magnetic resonance imaging) classified between 0 and 2 using the Markwalder grading scale contraindications or intolerance to corticosteroid therapy patients already undergoing steroid treatment for any other indication previous neurological surgery up to one year prior to being considered for the study concomitant cerebral pathology of neoplastic or presumed infectious origin anticoagulant therapy that could not be stopped for 6 months refusal to participate in the study | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 0.0-15.0, Injuries Trauma Wounds and Injuries Children Child Children 0-15 years inclusive Presenting to either of the study hospitals for assessment or treatment Sustained an injury or suspected to have sustained an injury (i.e. AIS >=0) Due to an incident involving any non-motorized bicycle, tricycle or kick scooter Incidents where the injured child was involved in a motor vehicle collision Incidents where the injured child was injured by another rider (e.g. injured child run over by a cyclist) Incidents involving a bicycle fitted with 'bull bars' Patients for whom neither parent / guardian is fluent in English (if the history is clear from a parent, the patient will be eligible for inclusion) If an eligible patient is dead on arrival the family will not be invited to participate, and they will not subsequently be contacted If an eligible patient dies during their admission, they will be withdrawn from further involvement in the study and the family will not be contacted | 2 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 0.0-6.0, TBI (Traumatic Brain Injury) Children <72 months old in whom a head CT is ordered/obtained with concerns for TBI Present to the Children's Hospital Colorado (CHCO) Emergency Department (ED) or inpatient wards Contraindication to MR (e.g. pacemaker, implanted metallic object incompatible with MR) Prior diagnosis of TBI, structural brain lesion or prior brain surgery including shunted hydrocephalus Prior participation in this study Clinically unstable in the opinion of the patient's attending physician Wards of the State TBI not included in the differential diagnosis of the patient's attending physician (e.g. the indication for imaging is concern for infections, tumor, autoimmune or inflammatory disease) or if imaging has already identified a non-traumatic source for symptoms | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 18.0-999.0, Vestibular Schwannoma Vestibular schwannoma advised to surgical treatment No measurable remaining vestibular function impaired decision making neurofibromatosis signs for central dysfunction remaining vestibular function Patients are advised not to participate in the gentamicin arm if hearing is better than 30 deciBel (dB) in pure tone average (500, 1000, 2000, 3-4000 Hz) and speech discrimination better than 70% the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin associated hearing loss | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 21.0-80.0, Pain Head and Neck Disorder Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 18.0-999.0, Brain Injuries Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay Patients admitted less than 24 hour | 1 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 2.0-17.0, Pain Long-bone Fractures children aged 2 through 17 years (17 years included) accompanied by at least one of their parents in the emergency department accompanied by at least one of their parents in the emergency department suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the inclusion) within the first 12 hours after the injury at least one signed parental informed consent affiliated to health insurance analgesic treatment within the 6 hours before contraindication to one of the study drug cognitive impairment multiple injuries resuscitation manœuvres open fracture non affiliated to social security parental refusal | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 18.0-999.0, Atrial Fibrillation (Prevention of Stroke) Age ≥18 years on the day of the first prescription of the study drug (= index date) during study selection window Diagnosis of NVAF on start date of study or anytime during 365 days before this date Availability of follow-up at least 180 days after the date of the first prescription of study drug within selection window of study (exposure start date) Evidence of patient activity in the database during 90 days before the date of the first prescription of target drug within selection window Patients with valvular AF Prescriptions of Oral Anticoagulants (OACs): VKA, Dabigatran, Rivaroxaban before index date Prescription of more than one OAC on the index date or switch to another OAC during the follow-up period Prescriptions of < 15mg rivaroxaban at index date or during the follow-up period for patients in rivaroxaban cohort | 0 |
An 8-year-old boy fell from his bike striking his left temple on the pavement. There was no immediate loss of consciousness, and a brief examination at the scene noted his pupils were symmetrical, reactive to the light, and he was moving all four limbs. Half an hour after the fall the child became drowsy, pale, and vomited. He was transferred to the emergency department. Upon arrival the heart rate was 52/min, blood pressure of 155/98. The Glasgow Coma Scale (GCS) was 6/15, the pupils were asymmetrical and movement of the right upper and lower extremities was impaired. The neurosurgical team advised deferring the CT scan in favor of initiating immediate treatment. | eligible ages (years): 18.0-999.0, Chronic Subdural Hematoma CT scan demonstrating the existence of a subdural hematoma containing a chronic component Diagnosis within the last 14 days Acute subdural hematoma with no chronic component Active thrombotic, thromboembolic or atheroembolic disease, including deep venous thrombosis within the last six months, cerebral thrombosis within the last six months, symptomatic carotid stenosis who did not undergo surgery or stroke within the last year Past history of unprovoked deep venous thrombosis or idiopathic pulmonary embolism Known hereditary thrombophilia, including Factor V Leiden, Antithrombin III mutation, Protein C deficiency, Protein S deficiency Atrial fibrillation (unless under successful rhythm control therapy) Metallic heart valve Vascular stenting procedure within the last year Cardiac or vascular surgical procedure within the last 6 months, including endarterectomy, bypass or angioplasty Ongoing investigation for suspected malignancy Confirmed active malignancy | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-60.0, Malaria, Falciparum Healthy adult: male or female Asymptomatic mono-infection with P. falciparum parasitemia with a parasite density of 1000 000 parasites/μL Age 18 years to 60 years Willingness to sign and ability to understand consent form Willingness and ability to return for scheduled follow up visits Mixed malaria infection by Giemsa smear History of allergy to or hypersensitivity to chloroquine, Azithromycin or other macrolides (e.g. erythromycin, clarithromycin) Any of the following: a.) Antimalarial therapy administered in the past 4 weeks, including quinine therapy or an artemisinin derivative; or b.) An antibacterial with known antimalarial activity (including, erythromycin, doxycycline, clindamycin, cotrimoxazole) within one week prior to enrollment into the study Fever, history of fever in past 48 hours, or signs/symptoms of malaria (including acute or subacute headache, nausea, or vomiting) Inability to swallow oral medication Laboratory evidence or history of significant cardiovascular, liver, hematologic or renal functional abnormality Any situation which could prevent the patient from returning to follow up visits Pregnancy or breast feeding Any other concurrent illness that may confound the result Any other condition or circumstance that in the opinion of the Investigator may pose a threat to the study participant or study | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 15.0-49.0, Malaria in Pregnancy HIV Infections Pregnant women 24 weeks gestation Consent Presenting for ANC at study hospitals/centres Agree to have an HIV test and to be examined for viral load Severe systemic disease AIDS-related disease At-risk pregnancy | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 0.115-4.917, Malaria Ages 6 weeks to 59 months Residence in the study area Informed consent Known allergy to study drugs Serious underlying illness | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 10.0-999.0, Malaria Written informed consent Available for 4 x monthly follow ups or more individuals in household Allergy to repellents / plants Malaria positive at baseline | 1 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 1.0-999.0, Malaria Falciparum Age > 1 year Axillary temperature ≥ 37.5ºC and/or history of fever in the previous 48 hours without any other evident cause Unmixed infection with P. falciparum of between 250 and 100,000 asexual parasites/mm3 as determined by microscopic exam of the thick or thin smear An informed consent obtained from the patient or his/her guardian (in case of patients ≤ 18 years old) and assent for children (8-18 years old) Willingness to come to the health facility for the following 28 days Signs or symptoms of severe malaria Other severe chronic diseases (e.g., cardiologic, renal, or hepatic diseases; HIV/AIDS; severe malnutrition) History of allergy to any of the proposed treatment or its alternatives, i.e. mefloquine, artesunate, quinine, tetracycline, or clindamycin Pregnancy (based on urine test), since this group of patients receives other drugs for malaria treatment in accordance with Peruvian national guidelines | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-999.0, Acute Uncomplicated P. Falciparum Malaria Patients were eligible for if they met all of the following Male or female aged 18 or older (prior to Amendment 1: more than 2 years old) Non-immune patients suffering from acute uncomplicated P. falciparum malaria, or mixed infection including P. falciparum, with parasitemia of less than or equal to 2% asexual P.falciparum parasites, confirmed by microscopy using Giemsa-stained thick film Non-immune patients were regarded as those who had not spent the first five years of their life, nor the last five years in a malaria endemic area, and did not have acute P. falciparum malaria diagnosed during those past five years Non-immune patients who had received prophylaxis with anti-malarials (excluding halofantrine) were included only if clear progression of acute P. falciparum infection was documented Female patients were eligible to participate in the study if they were of non-childbearing potential or had a negative pregnancy test (urine or serum) at screening, and using an acceptable contraceptive method Patients, who had been informed of the study procedures and medication, and had given written informed consent and were willing to comply with the study protocol Patients were to be excluded from participation if they met any of the following Known hypersensitivity to artemether or lumefantrine Signs/symptoms indicative of severe/complicated malaria according to the WHO classification (e.g. cerebral malaria, see Post-text supplement 1) Treatment with artemisinin derivatives within the previous 7 days Concurrent administration of other treatment / prophylaxis for malaria Concurrent administration of medications with potential hemolytic effects Patients taking any drug metabolized by cytochrome isoenzymes CYP3A4 or CYP2D6 Received any other investigational drugs in the last 4 weeks before entry into the study Severe cardiac impairment (i.e. evidence of existing cardiac conduction defect or overt symptoms of cardiac dysfunction or abnormalities of baseline ECG not associated with acute malaria); clinically relevant bradycardia or congestive cardiac failure with reduced left ventricular ejection fraction; pre-existing prolongation of the QT interval; history of symptomatic cardiac arrhythmias Having received halofantrine or any other drug known to influence cardiac function within 4 weeks prior to Screening visit or taking other drugs that are known to prolong the QT interval, including class IA and III antiarrhythmics, neuroleptics, antidepressive agents, certain antibiotics (including some macrolides, fluoroquinolones, imidazole, and triazole antifungal agents), certain non-sedating antihistaminics (terfenadine, astemizole) and cisapride | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 14.0-45.0, Anaemia Malaria Primigravida Secundigravida Permanent resident Hemoglobin (Hb) > 7 g/dl Hb < 7 g/dl Allergy to sulpha Multiple pregnancy Chronic diseases | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 0.25-4.917, Malaria For original trial: Children aged 3-59 months present in participating villages For follow-up: Children who were in original trial for at least 1 year For original trial: None For follow-up: Children with mental or physical disabilities who were unable to do cognitive tests | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-50.0, HIV Infections Permanent residents of the Luanshya district Males and non pregnant adults between 18 and 50 years old Having a CD4 cell count of least 350 perµL at enrolment HIV sero-status determined at the VCT of the health center No obvious underlying disease at time of enrolment Signed informed consent HIV stage III or IV following the WHO classification (see attached documents regarding policy in Zambia) Evidence of underlying chronic diseases (cardiac, renal, hepatic, malnutrition, TB) Intent to move out of the study catchment area during the study period History of allergy to MQ (or related drugs) or sulfa drugs Chorionic gonadotrophic hormone in urine or obvious pregnancy | 1 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 5.0-60.0, Malaria Age: 5 years old Fever (axillary temperature equal or higher than 37,5 °C) or history of fever in the previous 24 hours Monoinfection with P. falciparum, with parasitic density between 1,000 and 200,000 par/µl Informed consent provided by patient or parent or legal tutor Mixed malaria infection Pregnancy or breastfeeding to child ≤ 6 months of age One or more danger signs or any sign of severe or complicated malaria A concomitant severe disease History of treatment with mefloquine in the last 60 days or chloroquine, primaquine or quinine within the 14 days before the present episode History of neuropsychiatric disease History of hypersensitivity reactions to artemisinins or mefloquine History of splenectomy | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-45.0, Falciparum Malaria Age > 18 and < 45 years healthy volunteers (males or females) General good health based on history and clinical examination All volunteers have to sign the informed consent form Negative pregnancy test Use of adequate contraception for females Reachable by phone during the whole study period Volunteer agrees to inform the general practitioner and agrees to sign a request for medical information concerning contra-indications for participation in the trial History of malaria or residence in malaria endemic areas within the past six months Positive serology for P. falciparum Previously participated in any malaria vaccine study Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers Cardiovascular risk >10% according to European guidelines, taking into account sex, age, cholesterol, weight, smoking habits, blood pressure, diabetes Any laboratory abnormalities on screened blood samples beyond the normal range, as defined at UMC St Radboud. Positive HIV, HBV or HCV tests Volunteers should not be enrolled in any other clinical trial during the whole trial period Volunteers should not receive chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the three months preceding the screening visit or during the study period Pregnant or lactating women Volunteers unable to give written informed consent | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 15.0-45.0, Malaria Parasitaemia Birth Weight Anaemia Pregnant women of all parities Second trimester Severely ill pregnant women Pregnant women in first trimester | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 0.0-0.003, Malaria Anemia Born in San Francis Designated District Hospital of Ifakara Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus Twins Birth weight < 1,5 kg Clinical signs of cerebral asphyxia Clinical signs of neonatal or congenital infection Mother unreliable (deaf, mentally handicapped) | 1 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-40.0, Length of Pregnancy Prolongation in Hours All patients admitted with the diagnosis of preterm labor between 24 0/7 and 33 6/7 weeks gestation. Preterm labor will be defined by regular contractions and/or cervical change from last documented exam Cervical exam 4 cm or greater Intact membranes Multiple gestation (>2) Clinical evidence of chorioamnionitis, such as maternal fever, uterine tenderness, fetal tachycardia Lethal fetal anomaly Persistent vaginal bleeding, abruption, or placenta previa Rupture of membranes Maternal illness or fetal indication requiring delivery Inability to give informed consent Serious allergy to study medications. GI discomfort will not be considered a drug allergy | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-85.0, Orthopedic Disorders Unwillingness to sign informed consent Pregnancy | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 0.0-999.0, Malaria in Pregnancy Female First or second trimester of pregnancy First or second pregnancy Resident in the study area Refuse to give informed consent | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-999.0, Malaria in Pregnancy HIV Infections Confirmed HIV seropositivity Permanent residency in the study catchment's area Confirmed pregnancy, gestational age< 28 weeks More than 18 years of age Karnofsky index ≥80 Willingness to deliver at the hospital Written informed consent History of allergy to study drugs : sulpha drugs, mefloquine, quinine History or presence of major illnesses : severe renal disease , severe hepatic disease, severe neuropsychiatric disease Mefloquine or halofantrine received within the 4 weeks prior to enrolment | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-50.0, Malaria A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening Free of clinically significant health problems Baseline ECG before entering into the study Available to participate for duration of study (approximately 4 months, not including screening period) If the participant is female, not pregnant or lactating and willing to use contraception to prevent pregnancy BMI between 19 and 30 History of malaria or travel to a malarious country within the previous 12 months History of participation in a study in which potential exposure to malaria or vaccination against malaria occurred Planned travel to malarious areas during the study period History of malaria chemoprophylaxis within 60 days prior to time of study entry Chronic use of antibiotics with anti-malarial effects Chronic use (defined as more than 14 days)of immunosuppressants or other immune-modifying drugs within six months of study entry Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination, ECG or laboratory screening tests Significant unexplained anemia History of sickle cell disease or sickle cell trait | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-50.0, Malaria Subject is willing and able to give informed consent for participation in the study Healthy, non pregnant adult aged 18 years Resident in or near Oxford for the duration of the challenge study Seropositive for CMV and EBV Female subjects of child bearing potential must be willing to ensure that they practice effective contraception during the study Males must be willing to use barrier contraception from day of first vaccination onwards until 3 months after the second vaccination Able (in the Investigator's opinion) and willing to comply with all study requirements Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study Agreement to permanently refrain from blood donation Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix B Female patient/subject who is pregnant, lactating or planning pregnancy during the course of the study Healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks Subjects who have previously received an investigational malaria vaccine History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge Travel to a malaria endemic area within the previous 6 months Planned travel to malarious areas during the study period Any history of malaria Contraindication to both anti-malarial drugs (Riamet® and chloroquine) concomitant use of other drugs known to cause QT-interval prolongation, ( e.g. macrolides, quinolones, amiodarone etc) | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-65.0, Influenza Age 18 -65 Have the ability to provide informed consent If a woman of child-bearing potential, willing to use contraception for the period of the trial Acute influenza-like illness at screening History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease Pregnancy or breast feeding Current use of medication with known serious hepatotoxic effects Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin Current severe depression (as indicated by current use of antidepressant medication) Known serious retinal disease Current or recent (within the past 30 days) participation in any other clinical intervention trial Known G6PD deficiency Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-35.0, Plasmodium Falciparum Malaria Age > 18 and < 35 years healthy volunteers (males or females) Good health based on history and clinical examination Negative pregnancy test Use of adequate contraception for females All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study Willingness to undergo a Pf mosquito challenge For volunteers not living in Leiden: agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till 3 days after treatment) Reachable (24/7) by mobile phone during the whole study period Living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till 3 days after treatment) History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-35.0, Plasmodium Falciparum Malaria Age > 18 and < 35 years healthy volunteers (males or females) Good health based on history and clinical examination Negative pregnancy test Use of adequate contraception for females All volunteers must sign the informed consent form demonstrating their understanding of the meaning and procedures of the study Volunteer agrees to inform the general practitioner and agrees to sign a request to release medical information concerning contra-indications for participation in the study Willingness to undergo a Pf mosquito or blood stage challenge For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial center during a part of the study (for groups 1 and 3 from challenge day till 3 days after treatment, for groups 2 and 4 from 5 days after challenge till 3 days after treatment) Reachable (24/7) by mobile phone during the whole study period Living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial center during a part of the study (for groups 1 and 3 from challenge day till 3 days after treatment, for groups 2 and 4 from 5 days after challenge till 3 days after treatment) History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history in 1st and 2nd degree relatives for cardiac disease < 50 years old An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-35.0, Malaria Plasmodium Falciparum Age > 18 and < 35 years healthy volunteers (males or females) Good health based on history and clinical examination Negative pregnancy test Use of adequate contraception for females Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study Agreement to inform the general practitioner and to sign a request to release medical information concerning contra-indications for participation in the study Willingness to undergo a Pf controlled infection through mosquito bites Agreement to stay in a hotel room close to the trial center during a part of the study (Day 5 after challenge till treatment is finished) Reachable (24/7) by mobile phone during the whole study period Available to attend all study visits History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history in 1st and 2nd degree relatives for cardiac events < 50 years old An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-50.0, Vivax Malaria Age 18-50 years Gestational age (ultrasound confirmed) > 13.0 weeks Viable fetus as assessed by ultrasound scanning Microscopically confirmed uncomplicated P.vivax malaria Willingness and ability to comply with the study protocol for the duration of the trial Written informed consent provided No signs of labour Known hypersensitivity to chloroquine Clinical or laboratory features of severe malaria based on WHO criteria-Appendix 1 Gastrointestinal dysfunction that could alter absorption or motility History or known liver diseases or other chronic diseases (excluding thalassaemia & G6PD deficiency) Presence of intercurrent illness or any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study Splenectomy Hematocrit (HCT) < 20% (based on field reading i.e. capillary sample) Taking contraindicated medications History of narcotic or alcohol abuse | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-999.0, Immune Reconstitution Inflammatory Syndrome Opportunistic Infections Age > 18 years Informed consent ART naive No informed consent History of ART use Pregnancy | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-35.0, Malaria Plasmodium Falciparum Healthy volunteers (males or females) of ≥ 18 and ≤ 35 years of age Good health based on history and clinical examination (physical examination and laboratory screening) Negative pregnancy test Use of adequate contraception for females Signing of the informed consent form, thereby demonstrating understanding of the meaning and procedures of the study Agreement to inform the general practitioner and to sign a request to release medical information concerning contraindications for participation in the study Willingness to undergo administration of PfSPZ Challenge by needle and syringe and willingness to undergo challenge by mosquito bites For volunteers not living in Nijmegen: agreement to stay in a hotel room close to the trial centre or living in Nijmegen with a third party that could contact the clinicians in case of alteration of consciousness during a part of the study (day 5 after challenge until treatment is finished) Reachable (24/7) by mobile phone during the whole study period For volunteers living in Nijmegen: living with a third party that could contact the clinicians in case of alteration of consciousness or agreement to stay in a hotel room close to the trial centre during a part of the study (day 5 after challenge until treatment is finished) History of malaria Plans to travel to malaria endemic areas during the study period Plans to travel outside of the Netherlands during the challenge period Previous participation in any malaria vaccine study and/or positive serology for Pf Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers History of diabetes mellitus or cancer (except basal cell carcinoma of the skin) History of arrhythmias or prolonged QT-interval Positive family history of 1st and/or 2nd degree relatives who experienced cardiac events when < 50 years old An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system Clinically significant abnormalities in electrocardiogram (ECG) at screening | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-999.0, Venous Thromboembolic Disease Deep Vein Thrombosis Pulmonary Embolism Admitted to Scripps Mercy Trauma Service ≥18 Years old Stratified to either Significant or Highest risk of VTE by ACCP guidelines Estimated Injury Severity Score (ISS) ≤9 Likely to be discharged before hospital day 7 Systemic coagulopathy (International Normalized Ratio [INR] of ≥1.2) Body Mass Index (BMI) >40 Likely to Survive for <7 Days Pregnancy Evidence of renal insufficiency (Cr ≥1.3) Delayed transfer to this facility (>24 hrs) Prisoners | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-999.0, Malaria in Pregnancy HIV Infection age ≥ 18 years HIV positivity gestational age between 16 and 28 weeks CD4+ count > 350 cells/mm3 and no sign of WHO stage 2, 3 or 4 agreement to attend all the antenatal consultations for the study willingness to adhere to all requirements of the study (including HIV-1 voluntary counseling and testing) signed informed consent psychological instability that could interfere with compliance hypersensitivity to sulfamides or dermatological disease(eczema, pemphigoid exanthema) that would increase the risk for severe reactions to the drugs being tested severe anaemia (Hb<7 g/dl)and any other severe disease known hepatic cardiac or renal disease | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-35.0, Malaria Subject is aged ≥ 18 and ≤ 35 years and in good health Subject has adequate understanding of the procedures of the study and agrees to abide thereby Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre or is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). The subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period Subject agrees to inform his/her general practitioner (GP) about participation in the study and to sign a request to release by the GP any relevant medical information concerning possible contra-indications for participation Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to Sanquin guidelines For female subjects: agrees to use adequate contraception and not to breastfeed for the duration of study Subject has signed informed consent Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These but are not limited to, any of the following 1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening 2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation; history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old 3 Functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency 4 History of epilepsy in the period of five years prior to study onset. 1.5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests 6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period 7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, in the past 5 years 8 Any history of treatment for severe psychiatric disease in the past year. 1.9 History of drug or alcohol abuse one year prior to study onset, or positive urine toxicology test for cocaine or amphetamines at screening or prior to infection Females: positive urine pregnancy test at screening or prior to infection Any history of malaria, positive serology for P. falciparum, or previous participation in any malaria study | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 5.0-65.0, Malaria, Falciparum Age between 5 and 65 years old inclusive Monoinfection of P. falciparum confirmed by microscopy Documented fever (axillary temperature > 37.5°C) and/or history of fever during the previous 48 hours in the absence of other obvious causes of fever (such as pneumonia, otitis media, etc) Infection with P. falciparum of 1000 and 100,000 asexual parasites per microliter (μl) to be determined by microscopic examination of a thick or thin smear, and positive confirmation by polymerase chain reaction (PCR); * Presence of sexual form of P. vivax is acceptable; ** PCR confirmation is not an enrollment requirement Informed consent must be obtained from the participant or both parents/guardian (in the case of children), and assent from the child (from 8 to 17 years old) Willingness of the participant to return to the health facility for regular check-ups during the follow-up period of 42 days Willingness of the participant to transfer to the Hospital de Apoyo Iquitos to start treatment Severe malaria signs (as defined by the World Health Organization) Cerebral malaria (irreversible coma) Severe anemia (hematocrit < 15%, or clinic signs) Clinic signs of kidney failure (e.g., serum creatinine > 3 mg/dL) Pulmonary edema Hypoglycemia (glucose in the blood <40mg/dL or clinic signs) Shock (PA systolic < 70 mm Hg in adults; < 50 in children) Spontaneous bleeding/Disseminated intravascular coagulation (CID) Recurrent generalized convulsions Acidemia/acidosis (clinic signs) | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-35.0, Malaria In order to be eligible to participate in this study, a subject must meet all of the following Subject is aged ≥ 18 and ≤ 35 years and in good health Subject has adequate understanding of the procedures of the study and agrees to abide strictly thereby Subject is able to communicate well with the investigator, is available to attend all study visits, lives in proximity to the trial centre (<10 km) or (if >10km) is willing to stay in a hotel close to the trial centre during part of the study (day 5 post-infection until three days post-treatment). Furthermore the subject will remain within the Netherlands during the challenge period, not travel to a malaria-endemic area during the study period, and is reachable (24/7) by mobile telephone throughout the entire study period Subject agrees to inform his/her general practitioner about participation in the study and to sign a request to release by the General Practitioner (GP) any relevant medical information concerning possible contra-indications for participation in the study Subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period and for a defined period thereafter according to current Sanquin guidelines For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study Subject has signed informed consent Subject agrees to refrain from intensive physical exercise (disproportionate to the subjects usual daily activity or exercise routine) for ten days following each immunization and during the malaria challenge period A potential subject who meets any of the following will be excluded from participation in this study Any history, or evidence at screening, of clinically significant symptoms, physical signs or abnormal laboratory values suggestive of systemic conditions, such as cardiovascular, pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant, haematological, infectious, immunodeficient, psychiatric and other disorders, which could compromise the health of the volunteer during the study or interfere with the interpretation of the study results. These but are not limited to, any of the following 1 Body weight <50 kg or Body Mass Index (BMI) <18.0 or >30.0 kg/m2 at screening 2 A heightened risk of cardiovascular disease, as determined by: an estimated ten year risk of fatal cardiovascular disease of ≥5% at screening, as determined by the Systematic Coronary Risk Evaluation (SCORE); history, or evidence at screening, of clinically significant arrhythmia's, prolonged QT-interval or other clinically relevant ECG abnormalities; or a positive family history of cardiac events in 1st or 2nd degree relatives <50 years old 3 A medical history of functional asplenia, sickle cell trait/disease, thalassaemia trait/disease or G6PD deficiency 4 History of epilepsy in the period of five years prior to study onset, even if no longer on medication 5 Positive Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) screening tests 6 Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other immune modifying drugs within three months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period 7 History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years 8 Any history of treatment for severe psychiatric disease by a psychiatrist in the past year | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-999.0, Travelers' Diarrhea Functional Bowel Disorders Reactive Arthritis An Institutional Review Board (IRB) / Ethics Committee (EC)-approved informed consent form is signed and dated Subject is at least 18 years of age Subject's duration of prophylaxis will be least 2 weeks Subject is capable of and willing to comply with all study procedures and available for the end of study visits and sample collection at COO (within 6 months from start of prophylaxis) Women: Non-nursing and negative urine/serum pregnancy test with understanding (through informed consent process) to avoid pregnancy while on study drug. Sole reliance on oral contraceptives (OCPs) for birth control will not be recommended (see section 6.3.2.1.) Should an individual have a documented surgical sterilization in her medical record, a pregnancy test will not be required. If a volunteer becomes pregnant during the study, the principal investigator will notify the study research monitor and the IRBs. The pregnancy outcome will be followed per IRB and other regulatory requirements for US and UK personnel (For US Personnel Only). Have consented to participate in TravMil protocol Subject received any systemic or gastrointestinal antibiotic in the 7 days prior to enrollment (except anti-malarial prophylaxis agents) Subject has hypersensitivity or allergy to rifaximin or rifampicin Subject has acute diarrhea within 7 days prior to enrollment Subject has a concomitant disease or condition that could interfere with, or for which treatment could interfere with, the conduct of the study, or could in the opinion of the investigator increase the risk of AEs during the subject's participation in the study Subject is currently taking or plans to take during deployment at least one of the following medications: theophylline or warfarin (Coumadin) | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-50.0, Malaria All of the following must be fulfilled for a subject to participate in this trial Age greater than or equal to 18 and less than or equal to 50 years In good general health and without clinically significant medical history Malaria comprehension exam completed, passed (a score of greater than or equal to 80% or per investigator s discretion) and reviewed prior to enrollment Reliable access to the clinical trial center and availability to participate for duration of study Females of childbearing potential must be willing to use reliable contraception (as defined below) from 21 days prior to study day -2 to 28 days following last Sanaria Subject to the judgment and discretion of the PI, female participants who meet ANY ONE of the listed immediately below, may not be required to take any additional measures to avoid pregnancy. Such participants will be counseled on risks at the time of consent and at appropriate points (e.g. when pregnancy testing occurs) during the study Females who have had their uterus, and/or BOTH ovaries removed Females who have had BOTH fallopian tubes surgically tied or removed Females who are above the age of 45 and have spontaneously had no menses at any point during the past 12 or more consecutive months (i.e. have reached menopause) A subject will be excluded from participating in this trial if any one of the following is fulfilled Currently is breast-feeding (if female) Pregnancy as determined by a positive urine or serum human choriogonadotropin (beta-hCG) test at any point during the study (if female) Recent travel to a malaria endemic area within 5 years of enrollment Planned travel to a malaria endemic area during the study period History of confirmed malaria diagnosis on peripheral blood smear or by clinical history in the past 10 years Hemoglobin, WBC, platelets, ALT, and creatinine outside of local lab normal range (subjects may be included at the investigator s discretion for not clinically significant values outside of normal range) Abnormal urinalysis as defined by positive urine glucose, protein, and hemoglobin. Subject can be included if investigator determine the abnormality is not clinically significant Anticipated use during the study period, or use within the following periods prior to enrollment Investigational malaria vaccine within the last five years | 0 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 0.833-3.167, Neurobehavioral Manifestations Enrolled in Makerere University-UCSF II study HIV-uninfected 12 months of age at the time of enrollment Within 30 km of the clinic Serious adverse event to the study drugs requiring cessation of study drug Active illness at enrollment (child can be enrolled once active illness has been treated and they are back to baseline health) Previous history of head trauma or coma in the child Cerebral palsy or other severe neurologic disease Known chronic illness requiring medical care Major medical abnormalities on screening history of past health Known developmental delay | 1 |
A group of 14 humanitarian service workers is preparing a trip to the Amazon Rainforest region in Brazil. All the members of the group have traveled on multiple occasions and have up-to-date vaccine certificates. Malaria Chemoprophylaxis is indicated but three of the women are in different stages of pregnancy. | eligible ages (years): 18.0-60.0, Rabies Provide signed and dated informed consent form Willing to comply with all study procedures and be available for the duration of the study Male or female, aged ≥ 18 to ≤ 60 years on day of inclusion In good general health based on medical history and physical exam Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination Participation in the 4 weeks preceding the first trial vaccination, or planned participation during the present trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Previous history of receiving the rabies vaccine Previous history of receiving rabies immune globulin Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that are well controlled are not criteria Use of any immunosuppressive drug at the time of the study or 30 days previously. Topical steroids will not be considered an immunosuppressive drug and their use will not be considered an Any immunosuppressive disorder, such as HIV infection, common variable immunodeficiency, active cancers or chemotherapy History of renal insufficiency or requiring dialysis Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-80.0, Colorectal Cancer Small Intestine Cancer One of the following diagnosis Diagnosis of familial adenomatous polyposis Prior total or subtotal colectomy Attenuated adenomatous polyposis coli May have colon intact 40 duodenal polyps from second portion to 10 cm distal to papilla of Vater Age to 80 Performance status Not specified | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 0.0-70.0, Colorectal Cancer Diagnosis of colon cancer or polyps at age 70 or under Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under No history of familial adenomatous polyposis syndrome No hereditary nonpolyposis colon cancer, according to Amsterdam No known I1370K adenomatous polyposis of the colon susceptibility variant Enrolled on 1 of the following clinical trials CLB-9581 CLB-89803 CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible Age | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-999.0, Adenomatous Polyposis Coli Males or females at least 18 years of age with familial adenomatous polyposis | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-75.0, Colon Adenomas Patients are aged between 18 and 75 years At least 3 adenomas irrespective size or at least one measuring 6mm or more All subjects had a clean colon at the study entry No personal history of colon cancer, no inflammatory bowel disease, no familial adenomatous polyposis, no regular use of aspirin | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-999.0, Familial Adenomatous Polyposis Patients with Familial adenomatous polyposis who have had ileo-rectal anastomosis and had 20 or less adenomas at previous surveillance examination poor bowel preparation, unable or unwilling to give informed consent, under 18 years of age,those with more than 20 adenoma | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 16.0-999.0, Adenomatous Polyposis Coli Clinically or genetically proven familial adenomatous polyposis Restorative proctocolectomy with ileal pouch anal anastomosis Chronic or acute renal or hepatic disease History of oesophageal, gastric or duodenal ulcers Known hypersensitivity to sulindac Daily use during the last three months of Aspirin Non-Steroidal Anti-Inflammatory Agents Probiotics | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 20.0-999.0, Parkinson Disease Parkinson's Disease Subjects eligible for enrollment in the study must meet all of the following criteria. Note that both inpatients and outpatients are eligible Patients with a diagnosis of PD (including juvenile parkinsonism) with Modified Hoehn & Yahr Stages I to IV Patients who have been receiving another dopamine agonist for at least 4 weeks prior to the start of the screening phase and are expected to benefit from conversion to ROP Age: 20 years (at the time of written informed consent) Informed consent: Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own) Gender: Male or female Females of childbearing potential are eligible for enrollment in the study, only if the subject has a negative pregnancy test at the start of the screening phase and agrees to conduct pregnancy testing at the protocol-specified visits during the study and use one of the following acceptable methods of contraceptions properly and accurately Abstinence Oral contraceptive, either combined or progestogen alone Injectable progestogen Subjects meeting any of the following must not be enrolled in the study Patients who present with any serious medical condition other than PD (e.g., cardiac, hepatic or renal disorder or hematopoietic disorder) Serious is defined as Grade 3 as a rule according to the Classification of the Severity of Adverse Experiences Patients with postural hypotension with any subjective symptoms (e.g., dizziness and syncope) Patients who have had any serious psychiatric symptoms (e.g., confusion, hallucination, delusion, abnormal behavior) (including symptoms caused by anti-PD drugs) within 6 months (26 weeks) prior to written informed consent Patients who have initiated any of the following drugs within 4 weeks of the start of the screening phase and have the dosing regimen of the drug changed within 4 weeks of the start of the screening phase L-dopa (+DCI) (NOTE: This does not apply to the monotherapy group.) Anticholinergic agents: trihexyphenidyl hydrochloride, piroheptine hydrochloride, mazaticol hydrochloride, metixene hydrochloride, biperiden, profenamine amantadine hydrochloride droxidopa | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 13.0-24.0, Familial Adenomatous Polyposis Colorectal Cancer (List All Criteria) 1) Having a confirmed genetic or clinical diagnosis of FAP between the age of 13-24 at the time of recruitment to this study 18-21 year old with a previous cancer diagnosis Able to read and speak English n/a | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 40.0-999.0, Colorectal Neoplasms Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency Age ≥ 40 -100 years Known or highly suspected primary colorectal neoplasms > 10 mm (n = 160) Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency Less than 1/2 of colorectum remaining Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis) Familial Polyposis Melena, hematochezia | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-85.0, Familial Adenomatous Polyposis Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total coloctomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. s/p ileostomy Female patients of childbearing age not on effective birth control Pregnant women WBC < 3500/ml Platelet count < 100,000/ml BUN > 25mg% Creatinine > 1.5mg% Patients unable to stop aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial Malignancy other than nonmelanoma skin cancer Active bacterial infection Patients with symptoms of active GERD (symptomatic despite medication or current erosive esophagitis on endoscopy) | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-999.0, Rectal Cancer Ulcerative Colitis Familial Adenomatous Polyposis Diverticulitis Subjects who will undergo restorative proctectomy or proctocolectomy (<10 cm from anal verge) with a low circular stapled colorectal, coloanal or ileoanal anastomosis with or without reservoir, including treatment for rectal cancer, ulcerative colitis, familial adenomatous polyposis diverticulitis, perforation of the bowel/trauma Subjects undergoing Hartmann's reversal with restorative proctectomy (<10 cm from the anal verge) Subjects may or may not have a diverting loop ileostomy as a component of their initial surgery Subjects who meet the requirements of number 1 and 2, and are being treated for rectal cancer may or may not have preoperative chemoradiation therapy in the treatment of their rectal cancer Subjects being treated for rectal cancer with a diagnosis of inflammatory bowel disease Subjects who have significant intraoperative hypotension or cardiac events Subjects with collagen vascular disease, coagulopathy, significant renal or hepatic dysfunction (creatinine >1.6 or liver enzymes > 50% upper limit of normal values) | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 10.0-14.0, Colorectal Cancer Precancerous Condition Diagnosis of familial adenomatous polyposis (FAP) based on genetic predisposition testing Genotype-positive FAP (pathologic Adenomatous polyposis coli (APC) mutation) No attenuated FAP genotype, defined by any of the following Mutation at the 5' end of APC and exon 4 Exon 9-associated phenotypes region mutations Has an intact colon No requirement for colectomy Parent(s) do not desire colectomy (regardless of adenoma burden) Colorectal adenoma burden as assessed by baseline colonoscopy | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 5.0-18.0, Vomiting Syndrome Irritable Bowel Syndrome Postural Orthostatic Tachycardia Syndrome Abdominal Pain Chronic Nausea Outpatient services Inpatient services | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-80.0, Colorectal Cancer Surveillance of patients with a personal history of advanced adenoma or CRC Informed consent obtained Age ≥ 18 and ≤ 80 years old History of advanced adenomatous polyps Or history of non metastatic CRC with curative surgery and without other treatment more than 2 years before enrollment Previous medical examination Screening of patients with a Family history of CRC at high risk Informed consent obtained Age ≥ 18 and ≤ 80 years old First degree family history of colorectal cancer diagnosed <60yrs during the five previous years-Previous medical examination Personal histories Age < 18 or >80 years old history of non adenomatous polyps history of Metastatic CRC familial adenomatous polyposis, Peutz-Jeghers syndrome, hereditary non polyposis colorectal cancer (HNPCC), juvenile polyposis syndrome Familial history of familial adenomatous polyposis Personal history of subtotal colectomy (but not of hemicolectomy, to confer to criteria) Colonoscopy with a polyps resection dated more than 5 years and less than 2 years prior to enrollment Enrollment in another protocol no health insurance affiliation Family histories | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-999.0, Familial Adenomatous Polyposis Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy Have an endoscopically assessable rectal segment Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration Known allergies or hypersensitivity to berries Diabetes mellitus Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-70.0, Familial Adenomatous Polyposis Duodenal Neoplasms Duodenal Polyps Patients with Familial adenomatous Polyposis: APC-mutation identified or more than 100 colorectal polyps on diagnosis Spigelman score of duodenal adenoma equal to II or III Incapability of signing informed consent Active gastric or duodenal ulcer, gastrointestinal bleeding Cardiovascular disease or risk Congestive cardiac failure: NYHA class II to IV Proven ischemic heart disease and/or cerebrovascular disease Risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members <55 years) Renal dysfunction: creatinine clearance below 50mL/min Liver dysfunction: albumin below 25 g/L or Child-Pugh-score equal to or below 10 Known allergic reaction to sulfonamides, NSAIDs or ursodeoxycholic acid Use of NSAIDs or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 20.0-999.0, Parkinson Disease Parkinson's Disease at the start of the screening Patients who are diagnosed with advanced Parkinson's disease (PD) with severity of the modified Hoehn & Yahr Stages II-IV Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening phase and demonstrating lack of control with L-dopa therapy in the following circumstances. Wearing-off phenomena. On-off fluctuations. Delayed-on/No on phenomena. Not adequately controlled on L-dopa QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block values based on either single ECG values or triplicate electrocardiogram (ECG) averaged QTc values obtained over a brief recording period Age:20 years or older(at the time of informed written consent) Informed consent: Patients who are able to give informed written consent in person. (i.e. patients who are capable of giving informed written consent on one's own) Sex: either sex. Female of child-bearing potential will be eligible for in this study. However they have to have a negative pregnancy test at the screening visit, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the screening visit until the end of the follow-up examination. Abstinence. Injectable progestogen. Implants of levonorgestrel. Estrogenic vaginal ring. Percutaneous contraceptive patches. Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness as stated in the product label. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository) Both inpatient and outpatient status at the start of the non-inferiority verification phase Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992) Patients with symptomatic postural hypotension. (e.g. dizziness and syncope) Patients with a current or history of drug abuse or alcoholism Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation) Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug Patients with chronic hepatitis typeB and/or type C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody Patients with a history of drug allergy to ropinirole hydrochloride (HCl) Patients with a current or history of cancer or malignant tumor Others whom the investigator (subinvestigator) considers ineligible for the study | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-999.0, Colonic Neoplasms Willing to sign informed consent Able to physically tolerate removal of up to 58 ml of blood at one to two different time points Adults at least 18 years old Willing to collect 1-2 stool samples and prepare a FOBT card and five specimen vials from each stool sample Pregnant or nursing women who otherwise meet the may participate Subjects with one of the following Colorectal adenocarcinoma—not treated and in colon at time of stool collection (CRC bin) Adenoma-pathologically confirmed adenoma present in colon at time of stool collection (Adenoma Bin) Higher Risk Normal Bin Subjects with a personal history of adenomas (confirmed by pathology) with none present on qualifying colonoscopy Subjects with a personal history of CRC (longer than 3 years ago because of of cancer within last 3 years) with none present at time of qualifying colonoscopy Any family history of CRC (1st degree relative) Normal Control Bin No history or current finding of any colon neoplasia including CRC, adenomas, no personal or family history of HNPCC or FAP Subjects who had CRC that was successfully treated at least three years ago may be considered eligible for the adenoma bin if their polyps are adenomas and there is no evidence of CRC or for the higher risk normal bin as noted above Subjects whose screening colonoscopy shows any of these types of polyps may be included in the normal or the higher risk normal bin if they meet the other noted above Hyperplastic polyps Benign mucosal polyps Polypoid granulation tissue Prolapsed mucosal polyps Inflammatory polyp | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 0.0-999.0, Pancreatic Cancer Biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer Localized disease Scheduled to undergo a resection or exploration of their pancreatic tumor Not specified See Disease Characteristics | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 20.0-70.0, Lynch Syndrome proven carrier of a MLH1, MSH2 or MSH6 mutation age between 20 and 70 years written informed consent previous large bowel surgery psychological/physical conditions hampering compliance with the study protocol | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 0.0-999.0, Ulcerative Colitis Familial Adenomatous Polyposis patients having total proctocolectomy with ileal pouch anal anastomosis hypoalbuminemia prolonged steroid use anemia anastomosis under tension leak with air test bleeding poor vascular supply of anastomosis | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-69.0, Adenomatous Polyposis Coli Patients who are 18 years or older with a clinical or genetic diagnosis of FAP or attenuated FAP Presence of duodenal polyps with a sum of diameters ≥ 5mm Minimum of two weeks since any major surgery WHO performance status ≤1 Adequate bone marrow function as show by: normal leukocyte count, platelet count ≥ 120 x 109/L, Hgb > 12 g/dL Adequate liver function as shown by: normal serum bilirubin(≤ 1.5 Upper Limit Normal {ULN}) and serum transaminases (≤ 2.0 ULN) Patient must discontinue taking any Nonsteroidal anti-inflammatory drugs (NSAIDS) within one month of treatment initiation Patients must be able to provide written informed consent Prior treatment with any investigational drug within the preceding 4 weeks Malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skins Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study as determined by the Principle Investigator such as Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia Severely impaired lung function Any active (acute or chronic) or uncontrolled infection/ disorders Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis Screening clinical laboratory values that indicate any of the following anemia | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-65.0, Familial Adenomatous Polyposis Diagnosis of phenotypic Familial Adenomatous Polyposis (FAP) of the colorectum based on meeting the in one of two groups: Group 1-Greater than 100 adenomatous colorectal polyps prior to age 40. Group 2-Greater than 10 adenomatous polyps and age <40 or greater than 25 polyps and age >40; combined with a dominant family history or genotype: More than 100 polyps in a first-degree relative; More than 25 polyps in 2 relatives in 2 generations, including a first-degree family member; Genetic diagnosis in a relative; Genetic diagnosis by in vitro synthesized truncated protein or similar assay No colorectal surgery or prior colon surgery for polyposis at least 1 year prior (total abdominal colectomy with ileal-rectal anastomosis, or total proctocolectomy with ilea pouch-anal reconstruction Baseline endoscopy If no prior colorectal surgery, at least 3 polyps in a cluster each ≥ 2 mm in diameter; or If rectum is in situ and to be assessed, baseline rectal segment endoscopy documenting 3 or more rectal polyps each at least 2 mm in diameter in a defined cluster and/or at least 6 polyps, ≥ 2 mm in diameter, in the distal 10 cm of rectum If ileal pouch neo-rectum is in place, 3 or more pouch polyps in a cluster ≥ 2 mm in diameter, or at least 6 polyps, ≥ 2 mm in diameter, in the distal 10 cm of pouch Clinical/pathological grading of duodenal polyps will utilize the Spigelman Classification Hematopoietic: no significant hematologic dysfunction; WBC ≥3,000/mm3; platelet count ≥100,000/mm3; hemoglobin ≥10g/dL; no known or prior clinical coagulopathy Hepatic: bilirubin ≤ 1.5 times ULN; AST and ALT ≤ 1.5 times ULN; Alkaline phosphatase ≤ 1.5 times ULN Renal: No significant renal dysfunction; creatinine ≤ 1.5 times ULN High Risk for cardiovascular disease including clinical diabetes mellitus (Type I or II) requiring glycemic medications; Prior personal history of cardiovascular disease or, two or more of the following hypertension or use of anti-hypertensive medications, hyperlipidemia or use of lipid-lowering medications or current smoker Hearing loss that affects everyday life and or for which a hearing aid is required | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 40.0-999.0, Colonic Adenomas Asymptomatic subjects undergoing screening colonoscopy age > 40 average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of Familial adenomatous polyposis (FAP) or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma no colonoscopy in past 5 years ability to provide a written consent to trial participation Patient age < 50 Patients with prior colorectal surgery Pregnant or lactating women Colonoscopy done within the past 5 years Lack of consent | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-999.0, Familial Adenomatous Polyposis Diagnosis of phenotypic classical FAP with disease involvement of the duodenum and/or colon/rectum/pouch Genotype: APC mutation (with or without family history) required Classical FAP Phenotype: 100's to 1,000's of colorectal adenomatous polyps, usually appearing in teenage years UGI endoscopy/LGI endoscopy (proctoscopy/colonoscopy) performed within 30 days of randomization Patients with an intact colon/rectum, except for clinical polyposis, and prophylactic surgery is being considered as a stratification site Rectal/pouch polyposis as a stratification site as follows At least three years since colectomy with IRA/proctocolectomy with pouch, and demonstrating polyposis as defined by Stage 1, 2, 3, of the proposed InSiGHT 2011 Staging System (Appendix B) and summarized as follows Stage 1: 10-25 polyps, all < 5 mm Stage 2: 10-25 polyps, at least one > 1 cm Stage 3: >25 polyps amenable to complete removal, or any incompletely removed sessile polyp, or any evidence of high grade dysplasia, even if completely removed. [Note: For staging purposes only.] For all subjects, any rectal/pouch polyps > 5 mm must be excised at "baseline" Duodenal polyposis as a stratification site; one or more of the following Prior pelvic irradiation Patients receiving oral corticosteroids within 30 days of enrollment Treatment with other investigational agents in the prior 4 weeks Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks Regular use of aspirin in excess of 700 mg per week Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within 12 weeks of study enrollment Hypersensitivity to cyclooxygenase-2 inhibitors, sulfonamides, NSAIDs, or salicylates; NSAID associated symptoms of gastritis Patients must not have cardiovascular disease risk factors as defined below Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg Unstable angina | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 8.0-18.0, Functional Gastrointestinal Disorders abdominal pain related disorder (functional dyspepsia, irritable bowel syndrome or functional abdominal pain (FAPS) diagnosed according to Rome III criteria organic gastrointestinal disease (as established by medical history, complete blood count, urinalysis, stool examination for occult blood, ova and parasites, blood chemistries, abdominal ultrasound, breath hydrogen testing and endoscopy, if needed) other chronic disease growth failure | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 30.0-80.0, Colon Cancer patients undergoing routine colonoscopy at University Hospitals, Cleveland Ohio Unable to give written consents Unable to fill the questionnaires Aged younger than 30 or older than 80 Unwilling to donate blood samples Diagnosis of colorectal cancer or any cancer Recurrent cases Family history of Familial Adenomatous Polyposis (FAP) or Non-polyposis Colorectal Cancer (HNPCC) History of inflammatory bowel diseases Non-English Speaking | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-999.0, Colon Polyp Surveillance Any adenoma found on screening/surveillance colonoscopy (ICD9-211.3, Procedure code 45385 or 45380) Greater than 18 years old Less than 18 years old Diagnosis of IBD | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-75.0, Malignant Pleural Mesothelioma Histologically or cytologically confirmed and documented malignant pleural mesothelioma with pleural effusion Signed Informed Consent after being informed Patients medically and/or functionally at screening not accessible for surgical treatment with planned third cycle of palliative chemotherapy in 21 days Bone marrow function: hemoglobin = 100 g/L; white blood cell count (WBC) = 3.0 x 109/L; absolute neutrophile count (ANC) = 1.5 x 109/L; platelet count = 100 x 109/L Hepatic: aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 times upper limit of normal (ULN)); bilirubin = 1.5 x ULN Renal: creatinine = 2 mg/dL and creatinine clearance = 45 mL/min No concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents The patient has received no major organ allograft HIV-negative HBV and HCV negative Contra-indications to the class of TpP, e.g. known hypersensitivity or allergy to the investigational product Contra-indications on ethical grounds Women who are pregnant or breast feeding Intention to become pregnant during the course of the study Lack of safe contraception: Safe contraception is defined as follows:Female and male subjects of childbearing potential, using and willing to continue using a medically reliable method of double barrier contraception for the entire study duration and the next 2 years, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices in combination with preservatives. Or subjects who are using any other method considered sufficiently reliable by the investigator in individual cases.Subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential Known or suspected non-compliance drug or alcohol abuse Patients with medical history of coronary heart disease (CHD), stroke or peripheral vascular disease (PVD) Patients with medical history of autoimmune disease such as multiple sclerosis, lupus, rheumatoid arthritis, inflammatory bowel disease or small vessel vasculitis Regular intake of immune-modulating drugs | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 20.0-65.0, Familial Adenomatous Polyposis Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age FAP patients who have colonic or duodenal polyp FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization FAP patients with malignant disease, including colorectal cancer FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization. 4. FAP patients with diabetes mellitus. 5. Pregnant or breast-feeding patients. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test) and significant infectious or respiratory diseases | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 50.0-999.0, Tubular Adenoma Colon Cancer Hyperplastic Polyp Age ≥50 years Individuals able to provide informed consent Individuals presenting for average-risk colorectal cancer screening by colonoscopy Individuals presenting for surveillance of adenomatous/sessile serrated colon polyps as per the US multi-society taskforce on colorectal cancer Patients who decline to participate Prior partial or complete colectomy Patients with history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) Patients with prior history of colorectal cancer Patients with history of screening colonoscopy within the past 10 years Patients with history of familial polyposis syndromes (Familial Adenomatous Polyposis, Lynch Syndrome) | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 50.0-99.0, Colonic Adenomas Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation personal history of inflammatory bowel disease, colon adenoma or cancer family history of FAP or Familial nonpolyposis syndrome first degree relatives having diagnosed to have colorectal carcinoma no colonoscopy in past 5 years | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 60.0-74.0, Colonic Polyps Patients found to have colonic polyps up to 10mm in size Poor bowel preparation Inflammatory bowel disease Polyposis syndrome | 2 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 45.0-75.0, Colorectal Adenoma Asymptomatic subjects aged 45 years Subjects who will give the written consent Subjects with past history of colorectal cancer Subjects with familial histories of familial adenomatous polyposis(FAP) or Hereditary nonpolyposis colorectal cancer(HNPCC) Subjects with familial history of colorectal cancer more than 2 familial member in direct line Subjects with inflammatory bowel disease(IBD) Subjects with more than 3 point of American Society of Anesthesiologists (ASA) physical classification Subjects with past history of colectomy Subjects with history of colonoscopy within 5 years Subjects with history of sigmoidoscopy within 3 years Subjects with history of CT colonoscopy within 10 years Subjects with symptoms that could present the colorectal cancer such as hematochezia, melena, weight loss more than 10kg/6months | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-85.0, TTR-mediated Amyloidosis Amyloidosis, Hereditary Amyloid Neuropathies, Familial Familial Amyloid Polyneuropathies Amyloid Neuropathies Amyloidosis, Hereditary, Transthyretin-Related Male or female of 18 to 85 years of age (inclusive) Have a diagnosis of FAP Neuropathy Impairment Score requirement of 5-130 Meet Karnofsky performance status requirements Have adequate complete blood counts and liver function tests Have adequate cardiac function Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV) Had a prior liver transplant or is planned to undergo liver transplant during the study period Has untreated hypo or hyperthyroidism Has known human immunodeficiency virus (HIV) infection Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated Recently received an investigational agent or device Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-74.0, Colorectal Cancer All increased risk patients (Patients with family history or personal history of colon polyps or colon cancer and FOBT positive) referred for a screening colonoscopy at the Forzani and MacPhail Colon Cancer Screening Centre will be considered for enrollment Average Risk patients Previous colon surgery Hereditary Polyposis Syndromes Suspected polyps or CRC before colonoscopy that have been suggested by another modality (Barium Enema, Virtual Colonoscopy, Flexible Sigmoidoscopy) | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 50.0-69.0, Colonic Polyps Adenoma The main objective in this study is compare two non-invasive techniques in the study of colorectal cancer. When we calculate the sample size we observed that we need more than 1000 patients per group. In this moment this study is very expensive and it is not feasible. Our proposal is population with a higher prevalence of lesions: individuals with positive FIT (fecal immunochemical test) in which the prevalence of lesions is 60%. In this case, sample size is reduced considerably The eligible population will be men and women, 50-69 years old, with no known risk factors and positive FIT Individuals who have symptoms suggestive of colorectal disease (rectorrhagia, change in bowel movement frequency, constitutional syndrome, anaemia) History of inflammatory bowel disease, colorectal polyposis, colorectal adenoma or CRC, and total or partial colectomy History of familial adenomatous polyposis or other hereditary polyposis syndromes; hereditary colorectal cancer not associated with polyposis (diagnosed by the presence of germinal mutation in the DNA repair genes and/or by fulfilment of the Amsterdam II criteria) Severe co-morbidity that carries a poor short-term prognosis (disease with an average life expectancy of less than 5 years) or a chronic illness that involves significant limitation of physical activity Contraindication to undergoing colon capsule or virtual colonoscopy | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-70.0, Adenomatous Polyposis Coli Patients with genetically or clinically proven Familial Adenomatous Polyposis. Genetically proven: Adenomatous Polyposis Coli (APC)-mutation identified. Clinically proven: more than 100 colorectal polyps at diagnosis Age 18 to 70 years Written informed consent Adequate potential for follow-up Medical or psychiatric conditions that compromise the patient's ability to give informed consent Proctocolectomy MutYH mutation Concurrent uncontrolled medical conditions Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre-menopausal women with intact reproductive organs and women less than two years after menopause | 1 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 0.0-999.0, Polyps Cases Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014 Controls Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA) | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 40.0-70.0, Colorectal Cancer Colorectal Adenoma First-degree relatives (aged 40 to 70 years) of individuals diagnosed with non-advanced adenoma on screening colonoscopy as Cases FDR of patients with negative findings on colonoscopy identified during the same study period, who are of the same age group as the studied as Cohort A FDR history of CRC A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam Known Familial Adenomatous Polyposis (FAP) syndrome Patients and siblings with known inflammatory bowel disease Undergone colonoscopy examinations in the past 5 years Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination | 0 |
A 21-year-old college student undergoes colonoscopy due to family history of multiple polyps in his older siblings. His brother underwent total proctocolectomy at age 22, and his sister underwent a total proctocolectomy at age 28, after both were found to have hundreds of colonic adenomas on colonoscopy. Both siblings are currently well without any findings of neoplasms. The patient undergoes sigmoidoscopy and is found to have dozens of small colonic polyps within rectosigmoid. Several of these are biopsied and are all benign adenomas. | eligible ages (years): 18.0-80.0, Adenomatous Polyp of Colon Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes Patients with a prior history of colonic surgeries Patient with Crohns colitis or ulcerative colitis Patient with prior history of colon cancer Patient with poor bowel preparation Pregnant women | 2 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 8.0-13.0, Osteoporosis Pubertal stage II Calcium intake below a threshold level Caucasian Normal health Medications affecting calcium and bone metabolism Chronic diseases Metabolic bone disease Abnormality in calcium metabolism | 0 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 60.0-999.0, Osteopenia Osteoporosis Women at least 60 years of age Good general health Willingness to participate in this 3.5 year study Ability to give informed consent Ability to live independently and travel to the research center for visits (we will provide transportation on a limited basis) Spine bone mineral density (BMD) (L1-4) T-score between -1.0 and -2.5, or a hip T-score between -1.0 and -2.5. A T-score of -1.0 is equal to a bone mass of one standard deviation below the mean peak bone mass in healthy young adult women Any history of cancer except the following: (a) superficial basal or squamous cell carcinoma of the skin which has been completely resected or resolved by a topical chemotherapeutic agent, and (b) other malignancies treated curatively at least 10 years previously, without any evidence of recurrence Abnormal transvaginal ultrasound that has not been investigated and cleared by endometrial biopsy History of low-trauma hip or spine fracture previously diagnosed Serious residuals from cerebral vascular disease Diabetes mellitus, except for easily controlled, non-insulin dependent or insulin dependent diabetes mellitus without significant microvascular or neuropathic disease Serum creatinine >1.9 mg/dl Chronic liver disease or alcoholism Treatment with bone active agents such as fluoride or bisphosphonates within the previous 2 years Treatment with calcitonin, estrogen, or a selective estrogen receptor modulator within the previous 6 months Systemic corticosteroid therapy at pharmacologic levels for more than 6 months duration | 0 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 0.0-999.0, Osteoporosis Chronological age: 6.0 0 years. Study population will be restricted to children greater than 12 years of age until 8 patients have completed 6 months of the study or safety data is available from a comparable study AP Lumbar spine bone mineral density less than or equal to -2 standard deviations for age matched controls (z-score) using Hologic QDR machine Normative data published by Faulkner will be used to calculate Z-scores Patients with Idiopathic Juvenile Osteoporosis, osteoporosis (BMD less than -2 SD compared to age-matched controls) in a child with no identifiable etiology. Children with IJO and delayed puberty will have their z-score calculated on the basis of bone age Inability to swallow pills or comply with administration instructions Upper gastrointestinal tract disease Creatinine clearance greater than or equal to 35 mL per min per 1.73 square meters Prior treatment with bisphosphonates Concurrent therapy with oral aspirin or salicylate containing compounds, excluding delayed-release salicylates which act in the distal gastrointestinal tract (for example, mesalamine, sulfasalazine, etc...) Hypocalcemia Treatment with hGH or calcitonin in the preceding 6 months Inability to undergo dual energy x-ray absorptiometry Positive pregnancy test In females, sexual activity without an effective method of contraception | 0 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 18.0-32.0, Healthy Osteoporosis Premature Ovarian Failure Patients with karyotypically normal spontaneous premature ovarian failure (as defined by screening protocol 91-CH-0127, i.e. women who have at least 4 months of amenorrhea, two FSH levels above 40 mIU/ml, at least one month apart, and a normal 46, XX karotype, diagnosed with premature ovarian failure prior to the age of 40) who are between the age of 18 and 42 years will be candidates General Smokers (more than 2 cigarettes per day) Alcohol users (more than 2 drinks of alcohol per day) Body mass index (BMI, kg/m(2)) greater than or equal to 30 and less than or equal to 19 Previous history of hip fracture or other active hip pathology Abnormalities of the hip precluding the assessment of bone mineral density Major dermatologic disorders, or a history of skin sensitivity to adhesive bandages, tape or transdermal matrix patches Hirsutism score greater than 8 Acne score greater than 1 Hysterectomy | 0 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 50.0-72.0, Osteoporosis Postmenopausal Weight within 90% to 120% of ideal body weight or more months since last menstrual period New York Metro Area resident History of cancer, diabetes, or heart disease Smoker | 0 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 45.0-70.0, Postmenopause Hot Flashes Osteoporosis, Postmenopausal Resident of the New York Metro Area Postmenopausal Weight within 90% to 120% of ideal body weight | 1 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 50.0-999.0, Osteoporosis Veterans aged 50 and older drawn from two existing VA cohorts, the Normative Aging Study (NAS) and the Veterans Health Study (VHS) | 0 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 50.0-75.0, Osteoporosis Healthy caucasian postmenopausal females between 50-75 years of age with low bone mineral density at the lumbar spine or hip as measured using dual energy x-ray absorptiometry or DXA ON estrogen replacement treatment for at least three years Heart, vascular, kidney, liver, lung, hormonal, musculo-skeletal disease (other than osteoporosis), rheumatic, blood diseases are High blood pressure Pregnancy Cancer Alcohol or drug dependence Prior use of a drug treatment for osteoporosis such as PTH, bisphosphonates, raloxifene, or calcitonin within the preceding five years | 1 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 65.0-999.0, Osteoporosis Osteoporosis, Postmenopausal For Patients PACE beneficiaries who filled at least one prescription for a drug of any type in the year prior to the study At high risk for osteoporosis: women and men 75 years or older, patients taking glucocorticoids or psychoactive medications, patients diagnosed with rheumatoid arthritis, and patients with a past fracture Have had an outpatient visit with a participating doctor based on Medicare outpatient claims For Physicians Primary prescribing physicians for PACE beneficiaries | 1 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 50.0-999.0, Postmenopausal Osteoporosis -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: [BMD > 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by each individual manufacturer] willing to take study-supplied calcium and vitamin D supplement (or equivalent) and to discontinue any non-study calcium supplements for run-in period and the duration of the study -pregnant or lactating, or of childbearing potential participated in another therapeutic trial with an investigational compound within 30 days of randomization history of hypersensitivity to any component of ibandronate tablets or has hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia unable to stand or sit upright for at least 60 minutes once a month current use of illicit drugs, or history of drug or alcohol abuse within the past five years has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction within six months of entry into the study; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary) history of or evidence of metabolic bone disease (other than postmenopausal bone loss) clinical fracture in the past year is receiving or has received treatment prior to randomization which might influence bone turnover | 0 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 50.0-64.0, Osteoporosis Members of the Harvard Pilgrim Health Plan Individuals who are not members of the Harvard Pilgrim Health Plan | 1 |
A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention. | eligible ages (years): 18.0-50.0, Opiate Dependence Osteoporosis Erectile Dysfunction Hypogonadism age 18 to 50 methadone maintenance for at least 12 months (for cases) stable dose of methadone for 6 months (for cases) willing to participate in the study competency in English male previous diagnosis of sexual dysfunction previous diagnosis of osteoporosis serum creatinine > 2 mg/dL chronic opiate use (for controls) congestive heart failure illicit drug use | 0 |
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