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A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.231-999.0, Rotavirus Severe Gastroenteritis for enrolled subjects and cases A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix™ in the EPI) and at least 12 weeks of age Subject admitted to the study hospital for SGE (refer to the glossary) during the study period Onset of SGE <= 14 days prior to admission Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases Written informed consent obtained from the parent or guardian of the subject for controls Admitted for non-GE causes at the same hospital as the case. Note: This criterion is applicable to hospital controls only Living in the same neighbourhood as the case for at least three consecutive months. Note: This criterion is applicable to neighbourhood controls only At least 12 weeks of age and being born within ± 2 weeks from the date of birth of the case. If the list of children born within ± 2 weeks is exhausted, then the range would be extended to ± 4 weeks for enrolled subjects and cases Subject has previously participated as case or control in this study Hospitalisation is unrelated to GE Onset of SGE > 48 hours after admission to the hospital (nosocomial infections) for controls For hospital controls: Child who has symptoms of GE during current hospitalisation or on the day of interview of his/her parent or guardian For neighbourhood controls: Child who has symptoms of GE on the day of interview of his/her parent or guardian children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus Influenzae Type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B Child has participated in the past as a case or control in this study Child living in the same house as the case. Note: This criterion is applicable to neighbourhood controls only | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 1.0-999.0, Varicella (Chickenpox) Chickenpox Vaccines Male or female child at least one year of age, born on or after July 1 2003 Residence in Germany At least one previous well-child visit to the practice Written informed consent obtained from parents/guardians of the subject as per local requirements Specific criterion for cases Suspected primary varicella disease (i.e. chickenpox) at the time of study entry Ineligible for varicella vaccination, due to any medical contraindication. These contraindications are History of hypersensitivity to any of the components of the vaccines Congenital or acquired immunodeficiency Treatment with immunosuppressive therapy HIV-infected patients, when CD4 < 25% of total lymphocytes Previous history of chickenpox by physician record or parental report Lack of documented vaccination history (written or computerised practice records or child's vaccination card/booklet) | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 21.0-80.0, Spasmodic Dysphonia Focal Dystonia Healthy research volunteers and adult patients with ADSD and WC will be eligible for the study Adult patients with ADSD will have clinically documented ADSD established by voice and speech testing and fiberoptic nasolaryngoscopy Patients will be required to have Intermittent uncontrolled voice breaks in vowels, liquids (r & l), semivowels (w & y) during speech in ADSD (at least 3 voice breaks), or Less prominent symptoms during whisper, singing, falsetto, or shout Normal voice and vocal fold movement during protective laryngeal functions and emotional phonation, such as cough, laughter, cry Adult patients with WC will have clinically documented WC established by history and neurological examination Controls will be healthy subjects with a negative history of laryngeal, neurological, or psychiatric problems All participants will be from 21 to 80 years old and right hand dominant All participants should be able to perform a sequential finger-tapping task for 40 seconds consecutively Subjects who are incapable of giving an informed consent Pregnant or breastfeeding women until a time when they are no longer pregnant or breastfeeding Subjects with past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than SD and WC in the patient group), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (b) psychiatric problems, such as schizophrenia, major and/or bipolar depression, obsessive-compulsive disorder; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis. (d) ventricular arrhythmias, renal and hepatic insufficiency, vascular headache, or carcinoid syndrome Patients who are currently taking medications known to affect GABA and dopamine receptor binding. Occasionally, patients report receiving such medication, although dopaminergic and GABA agonist/antagonists are not typically prescribed in these patients Patients who received treatment with botulinum toxin injections into the laryngeal muscles within the past 3 months Patients with vocal and hand tremor or muscle tension dysphonia Subjects who have tattoos with contraindications to MRI, ferromagnetic objects in their bodies (e.g., implanted stimulators, surgical clips, prosthesis, artificial heart valve, etc.) that cannot be removed for the purpose of study participation Subjects who received previous radiation exposure greater than 5.0 rem per year WC patients who experience focal hand dystonia at rest WC patients who have focal hand dystonia associated with trauma or a known neuroanatomic lesion or disease | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.167-1.667, Haemophilus Influenzae Type b Infants of either sex, aged 16 months / 2 months in good health as determined by: medical history physical examination clinical judgment of the investigator available for all visits scheduled in the study and able to comply with all study regulations written informed consent obtained, from at least one parent or legal guardian parent or legal guardian is unwilling or unable to give written informed consent to participate in study infants who presented a previous disease potentially related to Haemophilus influenzae type b infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease infants who have received any other Haemophilus influenzae type b immunization dose before (for 16-20 months old children who have received a booster vaccination already) premature (before 37th week of gestation) or birth weight less than 2500 g history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component fever ≥38.0 °C (axillary body temperature) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-54.0, Haemophilus Influenzae (NTHI) for Inoculated Volunteers Healthy 18-54 years old (male or female) with no chronic medical conditions with the exception of well-controlled hypertension Availability for study visits over the next 1 month Normal hemoglobin, white blood cell count, creatinine, alanine aminotransferase (ALT), platelet count Signed informed consent form In good health as determined by medical history and physical exam on the screening evaluation [including heart rate 55-100 beats per minute (bpm); blood pressure: systolic 90-140 mm Hg and diastolic 50-90 mm Hg]. If the subject is a well trained athlete by the judgment of the Principal Investigator (PI), heart rate of 40-100 bpm is acceptable Negative urine pregnancy test for women of childbearing potential If the subject is female and of childbearing potential, she agrees to use acceptable contraception and not become pregnant for the duration of the study. (Acceptable contraception includes abstinence, implants, injectables, combined oral contraceptives, effective intrauterine devices, or a vasectomized partner) Negative human immunodeficiency virus (HIV) enzyme linked immunosorbent assay (ELISA) for HIV 1 and 2 or indeterminate Western blot or other assay confirming that the serostatus does not reflect HIV infection, negative hepatitis C and hepatitis B serology or other assay confirming that the serostatus does not reflect active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection Negative urine protein and glucose by dipstick for Inoculated Volunteers Acute illness within the week prior to inoculation Acute febrile illness (oral temperature greater than or equal to 100.4 degrees Fahrenheit) on the day of inoculation Allergic rhinitis requiring therapy in the past year Treatment for sinusitis, otitis, chronic bronchitis, pneumonia, bronchospasm or asthma in the past 5 years Abnormal gag reflex Active drug or alcohol abuse Smoking tobacco within the past year Average ingestion of more than one alcoholic beverage per day for women or two alcoholic beverages per day for men Splenectomy or disease that results in functional asplenism such as sickle cell diseases | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-17.0, Intubation months of age to 17 years of age (not yet 18) Male or female English or Spanish speaking Normal airway (Mallampati Classification ) American Society of Anesthesiology Physical Status Classification I or II Elective surgical procedure expected to last at least 45 minutes in length Written informed consent/assent for participation given by the parent legal guardian and subject (if applicable) < 6 months of age, > 17 years of age Difficult airway (Mallampati Classification) History of previous difficult intubation, suspected abnormal airway: *micrognathia facial trauma airway tumor epiglottitis retropharyngeal abscess foreign body, etc Scheduled for non-elective, emergent OR procedure Parent, legal guardian, or subject is unavailable or unwilling to consent for study participation | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-3.0, Croup Written informed consent obtained by parents/legal representative prior to any study-related procedures Male or female subject aged between 6 months and 3 years referring to ER with acute onset barky cough, stridor, hoarseness, and respiratory distress Children with a diagnosis of moderate croup (Westley score 3-8) Symptoms or signs of any other cause of stridor Previous acute angioneurotic oedema Children with diagnosis of severe croup (Wesley score >8) History of congenital or acquired stridor, diagnosis of epiglottitis, chronic pulmonary disease, asthma, severe systemic disease, exposure to chickenpox virus within the previous 21 days, or known immune dysfunction Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study Treatment with oral or parenteral corticosteroids within the previous 2 weeks; Treatment with epinephrine for respiratory distress before enrollment Previous visit to an emergency room department due to croup during this episode of the disease Inability of the parent to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments Enrollment in another clinical trial in the previous 4 weeks or subject already admitted in this study Lack of a telephone at home | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.0-999.0, Abscess, Peritonsillar clinical existence of a PLA (phlegmon), validated by a senior ENT, usually (but not necessarily) following a request by an emergency. The visible appearance to the merits throat must justify puncture. Cases will be included whether or not they had consulted for a "sore throat" in the 10 days preceding the date of diagnosis Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy | 1 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 19.0-999.0, Dysphagia Dysphonia Patients undergoing revision anterior cervical spine surgery Primary pathology of the upper aero-digestive tract other than mild chronic pharyngitis, pre-existing vocal cord paralysis | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-999.0, Angioedema Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study Must currently be on an ACE inhibitor Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF All females of childbearing age must have a negative pregnancy test prior to administration of the study drug Participation in another investigational study within 30 days prior to enrollment Patients who improve on conventional (standard of care) therapy Patients previously treated with ecallantide Hypersensitivity to ecallantide Pregnancy or breast feeding Other definable causes of angioedema (i.e., hereditary or acquired angioedema) Patients receiving C-1 inhibitor as prophylaxis Treatment requiring tranexamic acid, and epsilon-aminocaproic acid Receiving fresh frozen plasma within 3 days prior to enrollment | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-1.0, Haemophilus Influenzae Type b (Hib) Infection Infants 6-12 months of age Prior Hib vaccine administration History of serious reaction(s) following vaccination Any vaccination within 14 days of study vaccination Known or suspected immune impairment For additional entry please refer to the protocol | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-60.0, Thyroidectomy Distress Surgery (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or (b) a papillary thyroid carcinoma ≤2 cm in diameter (a) previous neck operations (b) age <21 or >65 years (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN) | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 1.083-4.917, Haemophilus Influenzae Type b (Hib) Infection Infants 13-59 months of age Prior Hib vaccine administration History of serious reaction(s) following vaccination Any vaccination within 7 days of study vaccination Known or suspected immune impairment Premature (before 37th week of gestation) or birth weight less than 2500g For additional entry please refer to the protocol | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-999.0, Abscess Patients presenting to the Civic Campus emergency department of The Ottawa Hospital with an abscess less than 5 cm diameter, as judged by the attending emergency physician (measurement with tape measure for diameter) between the hours of 7 am and 10 pm will be approached for possible enrollment. Ultrasound will be used to assess the appropriate Patients under the age of 18 years Patients with a Glasgow coma scale score of <15 (i.e. not completely alert and oriented) Patients suspected of having necrotising fascitis Patients with hemodynamic instability (defined as SBP <90, and/or HR >110) Patients admitted to hospital Patients who are neither French nor English speaking Patients who are not available for telephone follow-up (i.e. homeless) Ultrasound image demonstrates that the abscess is not compressible (generally indicates that the contents of the cyst includes solids, which would not be amenable to aspiration) Ultrasound demonstrates that there is no abscess to manage Patients with perianal abscesses who have either Crohn's disease or ulcerative colitis or known perirectal fistula | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 8.0-21.0, Cystic Fibrosis With Mild to Moderate Lung Disease CMRI of Lung Perfusion Lung Perfusion Lung Vascularization Research subjects must meet the following Age 8 years to age 21 years Weight > 20kg Diagnosis of cystic fibrosis confirmed by a prior sweat chloride evaluation of > 60 mmol/liter or by two identified CFTR mutations on genetic analysis Able to perform acceptable and repeatable spirometry per American Thoracic Society/European Respiratory Society (ATS/ERS) joint consensus criteria Have valid spirometry data for at least 3 years Must have mild to moderate lung disease (Mild lung disease will be defined as an FEV1%p of 80-99% predicted. Moderate lung disease will be defined as an FEV1%p of 60-79% predicted.) If under the age of 18, the subject must assent to participation in the study, and the subject's parent or guardian must be able to give written informed consent and comply with the requirements of the study protocol If 18 years of age or older, the subject must be able to give written parental permission and comply with the requirements of the study protocol For female subjects: negative serum pregnancy test and must be willing to use contraception during study participation Research subjects will be excluded from the study based on History of CF-related liver disease with portal hypertension Currently smoking cigarettes or other tobacco products Use of daytime oxygen supplementation Previous organ transplantation Unstable or uncontrolled hypertension Ongoing use of oral corticosteroids For female subjects: pregnancy or lactation and unwillingness to use contraception during study participation Any hemodynamically significant congenital or acquired cardiac disease or significant cardiomyopathy, hematologic disease (i.e. hemoglobinopathies), or pulmonary disease associated with an increased risk of pulmonary perfusion defects or pulmonary hypertension other than as an outcome of CF History of renal and/or hepatic insufficiency, defined as cystatin-C level that exceeds normal range and a previous diagnosis of liver cirrhosis | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 3.0-12.0, Tonsillectomy children age 3-12 years ASAI,II contraindication for usage of Ketamine, dexamethasone upper respiratory tract infection increase intracranial pressure( ICP) history of allergy ,seizure,psychiatric illness, , bleeding disorders chronic usage of analgesic ,antiemetic ,stroied drugs two weeks before surgery history of peritonsillar abscess, , tonsillitis within two weeks, - | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 1.0-1.559, Haemophilus Influenzae Type b (Hib) Infection Infants 365-569 days of age Subjects who already received a booster dose of Hib vaccine History of serious reaction(s) following vaccination Any vaccination within 7 days of study vaccination Known or suspected immune impairment | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-65.0, Peritonsillar Abscess Criteria:patients with PTA in ages 18-65, who agreed to join the research - cave to dypiron and/or tramadol, pregnant women, mental illness,soldiers | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 20.0-70.0, Dysphagia The Stroke Center inpatients and outpatients with known or suspected dysphagia can be included for study as well as patients who are admitted specifically for this protocol. (Difficulty swallowing food or pills,changed swallowing ability,coughing or choking when eating, shortness of breath during swallowing, food backing up into the mouth or nasal passage, fever or voice changes after swallowing, pain when swallowing, unexplained loss of weight Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions. Non-ambulatory patients will be excluded if they cannot be braced or supported within the fluoroscopy unit. Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 2.0-5.0, Crossbite Openbite Drooling healthy children aged 3-4 years that use a pacifier children suffering from a chronic or developmental disease that can affect the orofacial region finger sucking children children suffering from low muscle tonus, abnormal drooling | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-999.0, Peritonsillar Abscess referring doctor suspects peritonsillar abscess patient is voluntary patient has daily access to his/her e-mail patient speaks and understands Finnish of Swedish female patients have adequate birth-control method patient has peritonsillar abscess allergy to penicillin allergy to metronidazole use of metronidazole in preceding one month pregnancy breast-feeding renal insufficiency liver insufficiency alcoholism (drunk at least once a week) participant in another clinical trial at the moment treatment of peritonsillar abscess requires in-patient care | 2 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 6.0-10.0, Vocal Fold Nodules is contingent on the presence of apparent vocal fold nodules, which are defined as bilateral, localized, benign, superficial growths with protrusion on the medial surface of the true vocal folds at the junction of their anterior and middle thirds. This examination is based on video-stroboscopic examination, or, in rare cases, on operative microsuspension laryngoscopy. In addition, strict are applied toward excluding masses that are not nodules. Defining characteristics for these are based upon the evaluations of three senior otolaryngologists of each participant's exam. Children evaluated by the senior otolaryngologist at each institution suspected to have vocal fold nodules are candidates for to this study. Patient de-identified images of the stroboscopy are reviewed by each of the other two laryngologists; only those children with confirmed vocal fold nodules by the all three senior otolaryngologists will be considered for entry into this study Children 6 to10 years of age will be enrolled. The rationale for this age range was previously noted. In brief, children in this age range (a) have similar educational and social exposures; (b) will likely not yet encounter pubertal changes affecting the larynx; and (c) are relatively cognitively homogeneous. Moreover, children in this age range have the ability to cooperate with voice therapy and have also been shown to be tolerant of stroboscopic examination. Finally, the voice therapy regimen in this protocol has been shown to be clinically effective for many children in this age range Voice-related quality of life must be affected to the extent that baseline scores are <87.5 (on a scale of the worst, 0, to the best, 100) at the time of entry into the trial. Based on previously published data, this subset of scores will be clearly distinct from scores in children with normal voices. In addition, scores <87.5 represent worse than average scores among children diagnosed with vocal fold nodules Dysphonia duration prior to randomization must be at least 12 weeks, in order to ensure that vocal dysfunction is chronic in nature Hearing in better ear of 35 dB or better Agreement by informed consent from the parents and informed assent from the child participant with anticipated commitment to compliance throughout the follow up period of 3 months is necessary for enrollment which includes time commitment of up to 3 hours per week to therapy sessions and homework Vocal fold nodules are a pathology that predominantly affects males. A number of studies and the databases utilized to track this pathology at the clinical sites indicate that the male: female ratio is approximately 7:3. Given this background, the enrollment plan for the current investigation will seek to have a 30% female representation of the patients enrolled in this study to ensure appropriate gender representation. Additionally, patients with a diagnosis of pediatric vocal fold nodules predominantly are found in Caucasian populations. However, in accordance with the National Institute of Health Revitalization Act of 1993 the of minorities in this proposal will be targeted to the representation of minorities in the greater Boston, Philadelphia and Milwaukee metropolitan regions Children with non-standard nodules or masses that are not unequivocally nodules are excluded, including those with irregular epithelium, concern for malignancy requiring biopsy, rapid growth pattern, airway obstruction requiring urgent or operative intervention, and prior laryngeal surgery. Furthermore, since there are several lesions that can present as bilateral true vocal fold masses (such as unilateral cysts or polyps with contralateral fibrovascular reaction, contact granulomas, and Reinke's edema), masses with the following characteristics will be excluded: a) yellow or blue color suggestive of a mucous or fluid-filled component, b) pink friable lesions at the posterior aspect of the true vocal folds, c) watery edematous expansion without a distinct protrusive mass. Defining characteristics for these are determined and corroborated by the evaluations of three senior otolaryngologists of each participant's videostroboscopic exam. This examination is based on video-stroboscopy, or, in rare cases, on operative microsuspension laryngoscopy. The video images will be placed on a password-protected server to which all three senior investigators will have access; these video images will not contain any patient identifying information but rather a study number that will be assigned to each participant. In addition, strict are applied toward excluding masses that are not nodules Children who have previously received any form of speech therapy targeting voice and/or resonance with the exception of articulation or speech therapy Children for whom voice therapy protocols will be problematic are excluded: developmental delay, cognitive disorder, behavioral disorder, neurologic disorder, articulation disorder, phonological disorder, language disorder, expressive and/or receptive language delay, specific language impairment, central auditory processing disorder, fluency disorder, prior knowledge of voice therapy principles through previous interventions (with the exception of articulation or speech therapy), and inability to commit to at least 12 weeks of therapy as determined and evaluated by the treating speech language pathologist and confirmed by consensus of all three PIs Children whose caregivers cannot complete the primary endpoint are excluded: non-English speaking as the instrument is administered in English, and those unable to commit to the 3-month treatment and follow-up schedule Children whose caregivers are not willing to commit up to 3 hours per week to vocal therapy including therapy sessions and homework for up to 12 weeks Children who cannot tolerate a conscious video-stroboscopic examination and whose parents feel that the diagnostic information gained by a planned examination under anesthesia is not valuable for the severity of presenting symptoms are excluded Children with significant confounders of voice-related quality of life are excluded: vocal fold paralysis, neurologic disorder of the larynx (dystonias, tics, tremors, etc), ongoing acute upper respiratory tract infection (defined by at least 2 of the following: sneezing, coughing, nasal congestion, runny nose, or temperature greater than 100.4° F (38.0° C), and untreated or unsuccessfully treated allergic rhinitis/post nasal drip | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-6.0, Infections, Respiratory Tract Subjects who the investigator believes that parent(s)/ legally acceptable representative can and will comply with the requirements of the protocol A male or female child between, and including, six to 72 months of age at the time of enrolment Written informed consent obtained from the parent(s)/ legally acceptable representative of the subject No antibiotic therapy within four weeks prior to the visit No cystic fibrosis or known major immunodeficiency such as agammaglobulinaemia, T cell deficiency or Human Immunodeficiency Virus / Acquired Immune Deficiency Syndrome No documented evidence or suspicion of gastroesophageal reflux disease No evidence of an upper viral respiratory infection four weeks prior to the visit In addition, all subjects regarded as 'cases' must satisfy all the following at study entry Persistent cough greater than eight weeks No response to five-day prednisolone treatment Concurrently participating in another study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product Use of any investigational or non-registered product within 30 days prior to study procedures, or planned use during the study period Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Child in care | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-3.0, Seasonal Influenza; Influenza; Influenza Due to Unspecified Influenza Virus Human Influenza Male and female previously unvaccinated healthy children aged 6 to <36 months Any known or suspected impairment of the immune system, any serious disease Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1 | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.164-0.329, Diphtheria Pertussis Tetanus Hepatitis B Haemophilus Influenzae Infections Infants are at age of DTP vaccination of the local EPI program (60-120 days old) and free from any obvious health problems Have a normal gestational age (≥ 37 weeks); birth weight > 2.5 kg There is no congenital disease detected through interview and clinical examination Already had or not yet received Hepatitis B vaccination at birth Do not have dermatological diseases such as eczema, allergies Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures Already vaccinated with DTP vaccine Have an acute infection at the time of study vaccination Contraindications to Quinvaxem Receiving treatment with systemic corticosteroids Currently participating in another clinical trial In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth Parents intend to move to another location during the study (the next 12 months) | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.167-5.0, Haemophilus Influenzae Type B Infection Male and female children 2 months to 5 years of age scheduled to receive vaccination Contraindications to Vaxem™Hib Korean Prescribing information | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-5.0, Healthy Healthy subjects aged from 6 months to 5years old of normal intelligence The subjects'guardians are able to understand and sign the informed consent Subjects established as healthy after medical history questioning,physical examination and clinical decision and in accordance with vaccination requirements of the experimental vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature ＜37°C on axillary setting for the first dose Subject who has a medical history of Meningitis Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Subject suffering from congenital malformations, dysgenopathy or serious chronic disease Any acute infections | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-5.0, Group A, C Polysaccharide Meningitis Type b Haemophilus Influenza For the children (aged from 2 to 5 years old) Healthy subjects aged from 2 to 5 years old of normal intelligence The subjects' guardians are able to understand and sign the informed consent Subjects established as healthy after medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature ＜37°C on axillary setting Subject who has a medical history of Meningitis Subject that has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Subject suffering from congenital malformations, dysgenopathy or serious chronic disease Any acute infections Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 50.0-55.0, Herpes Esophagitis Vocal Fold Palsy Patient of Herpes esophagitis with vocal palsy presentation Patient of Herpes esophagitis without vocal palsy presentation | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.25-0.417, Meningitis Influenza Healthy subjects aged 3 to 5 months, normal intelligence The subjects' guardians are able to understand and sign the informed consent Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature＜=37°C on axillary setting for the first vaccination Subject who has a medical history of Meningitis Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws Any acute infections in last 7 days | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-999.0, Abrasion of Soft Palate Intubation Complication Informed patient consent ASA I III Age > 18 years Elective surgery, other than head and/or neck surgery Pre-operative Mallampati I III BMI < 35 kg/m2 Fasted (≥6 hours) No informed patient consent ASA ≥ IV Age < 18 year Emergency surgery, surgery of head and/of neck Locoregional anaesthesia Pre-operative Mallampati IV BMI > 35 kg/m2 Fasted < 6 hours Pre-operative expected difficult airway (restrict neck movement, thyromental distance < 65mm, retrognathia) Bad, fragile dentition | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.0-5.0, Infections, Rotavirus Continuously enrolled from birth. (Note: Due to the absence of birth dates in insurance claims data, this criterion will be met if a child's year of first enrollment and year of birth are the same. If so, then the date of first enrollment will be used as proxy for date of birth.) Received both medical and pharmacy benefits Enrolled in capitation-based health plans For MarketScan Commercial, residence in states with universal vaccination programs that the RV vaccine or where RV vaccine cannot be ascertained (i.e., Alaska, Idaho, Massachusetts, Maine, North Dakota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming) Lost to follow-up or had RV prior to 6 weeks of age | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-999.0, Peritonsillar Abscess Older than 18 years of age Diagnosed with a peritonsillar abscess that has been drained and purulence has been obtained Pregnant Under the age of 18 Bilateral peritonsillar abscesses Recently drained peritonsillar abscess Immunocomprimised | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.0-999.0, Streptococcus Pneumoniae Neisseria Meningitidis Haemophilus Influenzae Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol Written informed consent obtained from the subject/from the parent(s)/LAR of the subject A male or female subject who visits the hospital with suspected bacterial meningitis CSF sample taken as part of routine practice Child in care | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-70.0, Airway Morbidity ASA (American Society of Anesthesiologists patient fitness category) I, II, III Age 18-70 General anesthetic for where LMA placement is not contraindicated will be included Small mouth opening Preoperative sore throat/dysphagia/dysphonia Patients at increased risk for aspiration Morbid obesity BMI > 40 Untreated chronic GERD Pregnancy Suspected supraglottic abnormalities N2O use Need for oral-pharyngeal suctioning Undergoing oral and nasal surgery | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-999.0, Recurrent Tonsillitis Recurrent Peritonsillar Abscess Obstructive Sleep Apnea Any adult patient who meets and is scheduled for tonsillectomy Any patient with prior use of acupuncture Individuals under age 18 Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy Patients with a known personal or family history of a bleeding disorder will be excluded Patients with a history of kidney or liver problems will also be excluded Patients found to be pregnant will be excluded from participation Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-70.0, Sleep Apnea, Obstructive for OSA Patients OSA (elevated AHI) Age range 18-70 years Any known cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease Susceptible to stomach ulcers Pregnant women History of hypersensitivity to Afrin, Lidocaine, trazodone and/or donepezil History of bleeding diathesis and/or gastrointestinal bleeding Use of any medications that may affect sleep or breathing A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day Desaturations to below 70% lasting greater than 10 seconds in duration per event on polysomnography | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 60.0-85.0, Pulmonary Aspiration Age 60-85 years' old Both male and female patients ASA I-II Body mass index (BMI) ≤ 30 kg/m2 Elective surgery under general anaesthesia with the use of laryngeal mask airway (LMA) / LMA Proseal / LMA Supreme Type of surgery: Urogynecological, General Surgery, Orthopedics, Eye, Vascular, Plastic Surgery/anaesthesia lasting for 0.5-3 hours Patients with difficulty in swallowing, preexisting neuromuscular or central nervous system disorder Patients undergoing intra abdominal, thoracic, face, nasal or throat surgery Known condition interfering with gastric emptying Patients with cognitive or hearing impairment and inability to provide informed consent ASA III-IV patients Use of muscle relaxant during the course of general anesthesia Contraindication or previous adverse response to any of the study drugs | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-999.0, Esophageal Cancer age ≥ 18 years dysphagia due to unresectable esophageal cancer participant resides within 50 km of Tenwek Hospital tumor is ≤ 9 cm in length and > 2 cm distal to the upper esophageal sphincter (UES) no esophago-respiratory fistula (ERF) or suspected perforation is present unable to provide written informed consent | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 3.0-9.0, Nasopharyngeal Carriage of Streptococcus Pneumoniae for FinIP-vaccinated children age 3 to 5 years enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1) at least one parent with fluent Finnish informed consent from one parent for FinIP-vaccinated children PCV vaccination administered, other than the randomized study vaccine history of antimicrobial treatment within 4 weeks (the child can be enrolled later) for unvaccinated siblings age 5 to 9 years younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule) at least one parent with fluent Finnish informed consent from one parent for unvaccinated siblings PCV vaccination administered | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 3.0-9.0, Pain Postoperative, Intraoperative Hemorrhage children aged 3-9 years American Society of Anesthesiologists 1-2 status, scheduled for adenotonsillectomy Children with systemic disease, metabolic and endocrin disorders, growth developmental and motor-mental retardation, those who had a history of allergy to any of the study drugs, peritonsillar abscess, hypertension, psychiatric and epileptic disorders, chronic pain syndrome, and those who received analgesics within 24 h prior to surgery were excluded from study | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 20.0-60.0, Voice Disorders Age between 20-60 No occurence of speech therapy simultaneously to the intervention Professional voice use in another activity Frequent use of alcohol and tobacco Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 4.0-11.0, Vocal Fold Nodules Diagnosis of vocal fold nodules Age 4-11 yr Informed Consent English comprehension and production sufficient to participate in the protocol and in voice therapy Considered behaviorally and cognitively appropriate by the ear, nose, and throat physician and speech-language pathologist for voice therapy Parent and child willingness to participate in all aspects of the protocol and voice therapy Co-morbid medical conditions or medications that would mask or amplify the outcome of voice therapy, including (a) developmental or other neuromuscular conditions, (b) major illness, chronic or acute, with the exception of laryngopharyngeal reflux disease (LPR) or allergies and their treatments, which are common in both children and adults with voice disorders, thus their would severely restrict the participant pool and, moreover, threaten external validity Hearing loss: > 20 dB hearing loss at 1000, 2000, 4000 Hz in at least one ear | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-70.0, Obstructive Sleep Apnea Ages 18-70 years sleep study (with apnea hypopnea index>5) Diagnosis of obstructive sleep apnea Any known unstable cardiac (apart from treated hypertension), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, or hepatic disease Susceptible to stomach ulcers Pregnant women or Nursing mothers Using positive airway pressure (PAP) therapy over one week or longer Body weight <55kg History of hypersensitivity to Afrin, Lidocaine and/or Donepezil History of bleeding diathesis and/or gastrointestinal bleeding Use of any medications that may affect sleep or breathing A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders Substantial cigarette (>5/day), alcohol (>3oz/day) or use of illicit drugs | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.083-65.0, Abscess Soft tissue abscess suspected by patient history and physical exam and confirmed by bedside ultrasound Able to provide written consent/ assent Incision and drainage to be performed by ED physician Peritonsillar abscess Pilonidal cyst, genital or perirectal abscess Post-surgical wound infections Pregnant Prisoners Previous incision and drainage for current abscess | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 2.5-4.0, Premature Birth Child was born between 26 and 37 weeks gestational age Infant is a singleton (matched between groups) Mother is 18 years of age or older Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent) Child demonstrates developmental deficit (language, cognition, motor, emotion) The child has severe congenital anomalies including chromosomal anomalies The child has severe motor or physical disability Mother currently presents with psychosis or is currently taking antipsychotic medication Status of enrolled subject changes and subject no longer falls in Mother and/or infant has a medical condition that precludes intervention components Mother and/or infant has a contagion that endangers other participants in the study | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-60.0, Sleep Apnea, Obstructive Healthy control subjects Cardiovascular disease other than well controlled hypertension Depression | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-60.0, Sleep Apnea, Obstructive Diagnosed OSA (moderate-to-severe; apnea hypopnea index >15 events/hr) Cardiovascular disease other than well controlled hypertension Depression | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 2.0-3.917, Autism Spectrum Disorder Diagnosis of autism Currently do not emit vocalizations or minimally verbal Willingness of the participant's parent/guardian to bring their child to the Marcus Autism Center for one-hour appointments, five days a week, for six weeks Children with significant problem behavior that interferes with structured intervention | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-85.0, Sialorrhea Seeking treatment for troublesome sialorrhea for at least 3 months that is occurring secondary to any disorder or related to any cause, including, but not limited to, Parkinson's Disease (PD), adult cerebral palsy, amyotrophic lateral sclerosis (ALS), stroke, traumatic brain injury, oral cancer, and side effects of other medications Able to read and provide written informed consent before enrollment into the study, or the subject's caregiver (Legally Authorized Representative) can provide written informed consent Male or female, 18 to 85 years of age (inclusive) Minimum unstimulated salivary flow rate of 0.2 g/min at screening Minimum Investigator's Drooling Frequency and Severity Scale (DFSS) score of 4 at screening Ability and availability to participate in the study for up to 1 year (ALS subjects: ability and availability to participate in the study for at least 6 months), based on overall health of the subject and disease prognosis A moderate to high risk of aspiration will participation in this study. Subjects whose risk of aspiration are judged by the Investigator to be satisfactorily controlled by placement of PEG tube or G-tube for nutritional support are eligible to participate Respiratory forced vital capacity (FVC) of <20% of predicted Prior botulinum toxin type A or B treatment in the salivary gland(s) identified for treatment in this study within 24 weeks before screening. Prior botulinum toxin type A or B treatment into other anatomical regions not selected for treatment in this study is not exclusionary, but must have occurred at least 12 weeks before screening Subjects should be excluded if, in the Investigator's opinion, the subject failed to respond to previous treatment with botulinum toxin. Subjects should not receive nor have any plans for receiving any botulinum toxin treatment, other than the study drug (MYOBLOC), during the entire course of the study (from the point the informed consent is signed until subject's participation is complete) Concomitant use, or exposure within 5 half-lives of screening, of aminoglycoside antibiotics, curare-like agents, or other agents that interfere with neuromuscular function Prior salivary gland surgery Current treatment or treatment at any time during the study with Coumadin® (warfarin) or similar anti-coagulant medications. Anti-platelet medications are not specifically exclusionary Evidence of any clinically significant neurologic disease Pregnancy or lactation Anticipated or scheduled surgery during the study period. A PEG tube/G tube may be placed for nutritional support at any time during the study and will not the subject from continued study participation | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 0.0-999.0, Anemia, Hemolytic, Autoimmune Felty Syndrome Purpura, Thrombocytopenic Autoimmune Diseases ENTRY --Disease Characteristics-- Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants) Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3 --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Age: Not specified Performance status: Not specified | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 0.5-10.0, Malaria presentation at health centre with febrile illness monoinfection with P falciparum parasitaemia >=500/microlitre fever or history of fever signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul) severe malnutrition clinically evident concomitant disease PCV <20% history of allergy to the study medications residence outside the study area and hence difficult to follow up | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 0.0-999.0, Myelodysplastic Syndromes diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction refractory anaemia (RA): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts ≤ 15% of the erythroid cells refractory anaemia with ringed sideroblasts (RARS): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: < 5% blasts, ringed sideroblasts > 15% of the erythroid cells refractory anaemia with excess blasts (RAEB): blood: < 5% blasts, ≤ 1 x 109 monocytes; bone marrow: blasts ≥ 5 -≤ 20% chronic myelomonocytic leukaemia (CMML): blood: >1 x 109/l monocytes, <5% blasts; bone marrow: blasts < 20%, increase of the monocytic component erythrocyte transfusion need working knowledge of the national language written consent for participating this study (informed consent) candidate for bone marrow or organ transplantation medication: growth factors (GM-CSF), or EPO patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks refractory anaemia with excess blasts in transformation (RAEB-t): blood: ≥ 5% blasts or Auer rods; bone marrow: or blasts > 20 < 30% or Auer rods pregnancy at the moment of patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia patients with AIDS or a severe congenital or acquired (e.g. iatrogenic) immunological disorder severe active infections at the moment of | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 9.0-15.0, Schistosomiasis Helminthiases Anaemia Criteria:all schoolchildren, in grade 2 and 3, at four selected schools - | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 0.0-999.0, Rh Isoimmunization Pregnant women with red cell alloimmunization associated with a risk of fetal anemia (D, E, c or Duffy (Fya )antibodies, alone or in combination with other antibodies) Gestational age between 12 and 34 weeks at study entry, viable fetus and accurate dating Maternal serum test-result, above the threshold at which the fetus is considered to be at risk of developing hemolytic anemia and thus a potential candidate for invasive testing Presence of Kell-antibodies Presence of fetal hydrops at first ultrasonographic examination Major fetal congenital or chromosomal anomalies | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Schistosomiasis For screening Female, age 18 or over Present to a study midwife with suspected pregnancy Live in a study village For the main study Infected with S. japonicum Pregnancy as determined by urine pregnancy test Age 18 or older Participant is otherwise healthy as determined by history, physical exam, ultrasound and laboratory assessment Pregnancy between 12-16 weeks gestation Presence of significant disease/illness that is either acute or chronic. This will be defined by history, physical examination, ultrasound and laboratory assessment. In particular History of seizures or other neurologic disorder, chronic medical problem determined by history or physical examination, e.g. active hepatitis, tuberculosis, heart disease Grade 3 or higher laboratory abnormality of blood urea nitrogen (BUN), Creatinine, bilirubin, white blood cell count, or platelet count will warrant exclusion. Grade 2 or higher abnormality of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) will warrant exclusion. For hemoglobin, women with severe anemia defined as hemoglobin less than 7.0 g/dl will be excluded Women with myoma on ultrasound that are sub-mucosal or women with myoma that is in any location and greater than 5 cm in size Women with congenital anomalies of the reproductive tract that would be expected to cause decreased fetal weight or greatly increase the risk of prematurity such as duplicate uterus, uterine septum For less clear cases, the researchers will define significant illness as one that significantly alters a woman's ability to perform activities of daily living, causes symptoms at least two days per week, or necessitates regular use of medication. In the case of acute medical conditions such as urinary tract infection, pneumonia, febrile illness, enrollment may be postponed until the illness is successfully treated (not currently on any medication for the illness) or the illness self resolves if this occurs before 16 weeks gestation Presence of cysts in the eye suggestive of neurocysticercosis Regular use of a medication for a chronic medical condition History of severe allergic reaction (anaphylaxis, facial swelling, or difficulty breathing) or seizure with praziquantel administration Fetus has congenital anomaly determined by 12-16 week ultrasound or is determined to be nonviable (e.g. blighted ovum) | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 0.5-18.0, Leukemia All children greater than 6 months of age and less than 18 years of age with newly-diagnosed previously untreated or previously diagnosed JMML, which has reoccurred after treatment with chemotherapy, stem cell transplantation, and/or cis-retinoic acid A diagnosis of JMML is confirmed only if the following for JMML are met: a) ALL of the following: Absence of t(9;22) or BCR-ABL by PCR or FISH; Absolute monocyte count >1000 (1 X 109/µL); <20% bone marrow blasts; b) At least 2 of the following: Elevated Hb F hemoglobin; Myeloid precursors in peripheral blood; WBC >10,000 (10 X 109/µL); GM-CSF hypersensitivity in methylcellulose culture of bone marrow progenitors cells Adequate hepatic function (bilirubin equal or less than 2.0 mg/dl; ALT equal or less than 3x normal) Adequate renal function (serum creatinine equal or less than 2 x normal) Performance Status: Have a Karnofsky score >50 Written, informed consent according to institution guidelines Pregnant or lactating Receiving any other chemotherapy. Patients must have been off chemotherapy for at least 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrollment Febrile neutropenia at study entry | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Iron Deficiency Anemia > 18 years of age and signed written informed consent Patients scheduled to undergo major orthopaedic surgery (hip or knee arthroplasty or back surgery) g/dl < Hb < 13.0 g/dl for men and 10 g/dl < Hb < 12.0 g/dl for women, at screening ( 3 weeks prior to surgery) Ferritin < 100 μg/l or 100-300 with TSat < 20% Suspicion of iron overload (Ferritin >300 μg/l or/and TSAT>50%) Active severe infection/inflammation (defined as serum CRP > 20 mg/l) or diagnosed malignancy Folate-and/or Vitamin B12 deficiency (according to local lab reference range) Known history of hepatitis B/C or HIV-positive Liver values 3 times higher than normal Immunosuppressive or myelosuppressive therapy A concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients Pregnancy or lactation Transfusion within 1 month prior to study EPO treatment with in the last 4 weeks, any iron treatment within 4 weeks prior to the in the trail Participation in any other therapeutic trial within the previous month | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-45.0, Iron Deficiency Folic Acid Deficiency Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age) Normal Hb (Hb≥110g/L and Hb≤144g/L) Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases) A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative colitis A history of or current use of IV iron therapy or erythropoietin therapy A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia, etc Current acute illness and/or taking antibiotics Known or suspected allergies to Materna®, or any ingredient present in Materna or SuppleFem Sprinkles or any of the foods to be consumed during the trial Mildly to severely anemic women (Hb<110 g/L) or elevated hemoglobin (above 144g/L) Complications in pregnancy (including pregnancy induced hypertension, preeclampsia, a history of severe antepartum hemorrhage) Blood transfusion within last 3 months | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-55.0, Anemia Every patient followed at the HME at the beginnig of the pregnancy pregnency women who don't speak french pregnancy women affected by béta thalassemia pregnancy woman having had a périconceptionnel treatment against the anaemia | 1 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 5.0-999.0, Sickle Cell Disease Hemolytic Anemia Established Diagnosis of Hemolysis Sickle Cell Disease (e.g., HbSS, HbS/β-thalassemia, HbSC) Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH) Age SCD participants: 5 years of age up to 19th birthday All other participants: 5 years of age and up (no age limit) Previous cardiac surgery Known left ventricle dysfunction (i.e. shortening fraction < 28%) Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-65.0, Chronic Hepatitis C Male and female patients aged 18-65 years Elevated liver enzymes levels Compensated liver disease Available liver histology confirming F2 fibrosis Written consent to participation Age <18, >65 Prior ribavirin treatment Intolerance towards ribavirin, PegIFN or erythropoetin Pregnancy or breast feeding Relevant cardiovascular or pulmonary disease Kidney insufficiency (creatinine clearance <50ml/min) Coinfection with HIV or hepatitis B virus Hepatic comorbidities (hemochromatosis, Wilson's disease, autoimmune disorders) Alcohol consumption > 40g/day Psychiatric disorders | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Iron Overload Oxidative Stress Iron-deficiency Anemia Women less than 4 weeks postpartum years of age or older Took prenatal vitamins for at least 3 months during pregnancy Successfully initiated breastfeeding Anemic (Hgb < 110 g/L) | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-40.0, Anemia Caucasian Primiparous Singleton pregnancy (wk 20 to wk 30) Non smokers Pre pregnancy BMI between 19.8 and 26 Healthy, free from iron metabolism disorders (pregnancy induced hypertension Not taking medicines known to influence iron status Not taking iron supplements (multivitamins will be accounted for) Free from gastrointestinal disorders No allergies Pregnancy haemoglobin concentrations are not within the normal range (below 70g/l or over 160g/l) | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 16.0-85.0, End-Stage Renal Failure Functional Iron Deficiency Two groups of random routine anonamised blood samples (for use in determinimg a local normal range for the Reticulated Haemoglobin Content [RetHe])will be included in the study Normal red blood cell (RBC) Indices (Hb , Haematocrit, Mean Cell Volume ande Mean Cell Haemoglobin Content) ; an attempt will be made to select an equal mixture of men / women and an appropriate age spread to provide a valid control range for the group of test subjects (renal patients) The student Investigator will ask Haematology staff to record minimum details of iron deficient patients and "normal" test results noted at routine validation [positive identification number (barcode)/ age / sex] these samples will be coded and additionally analysed for RetHe test All renal patient who have had surgery and / or a Blood Transfusion OR bleeding episodes within the last month prior to the study are excluded as this would interfere with red cell parameters All patients < 16 years and >85 years are excluded from the study | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Anaemia Pregnant women aged ≥18, gestational week ≥20, ≤33 at baseline visit with normal antenatal screening test results Iron deficiency anaemia defined as Hb concentration ≥8 g/dl and ≤10.4 g/dL and serum ferritin ≤20 mcg/L at screening Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dl or outside reference range), any acute infection at screening Pre-eclampsia Multiple pregnancy Evidence on any significant abnormalities on anomaly ultrasound Haemochromatosis or other iron storage disorders Folate deficiency (S-folate <4.5 nmol/L) at screening Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Warm Autoimmune Hemolytic Anemia Age > 18 years AIHA defined at time of diagnosis by a Hgb level £ 10 g/dL, with a reticulocytes count > 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern) Disease duration equal or less than 6 weeks at time of --> removed by amendment n°4 and substituted by :First episode of AIHA to "hot" antibody previously untreated or treated corticosteroids for less than 6 weeks Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be eligible for the study if the platelet count is over 30 x 109/L at inclusion Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion Absence of detectable lymph nodes on a total body CT-scan (to be performed before if not performed at diagnosis) Effective means of contraception during treatment and for six months after completion of treatment for all women of child bearing age Negative serum pregnancy test within 14 days prior to study entry Written informed consent Previous treatment with rituximab AIHA diagnosed and treated more than 6 weeks prior to removed by amendment n°4 and substituted by AIHA relapsed or newly diagnosed but treated with corticosteroids for more than 6 weeks Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment administered within 2 weeks prior to the beginning of the study treatment Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient had not been disease-free for at least 5 years Autoimmune disorder such as SLE with at least one extra-hematological manifestation requiring a treatment with steroids and/or immunosuppressive drugs Any other associated cause congenital or acquired hemolytic anemia (except thalassemia trait or heterozygous sickle cell anemia) Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of a monoclonal IgM with cold agglutinin properties Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus surface antigen (HbsAg) Neutrophils count < 1,000/mm 3 at inclusion | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 20.0-45.0, Pregnancy Iron Deficiency Iron Deficiency Anemia pregnant women with one of genetic thrombophilia markers as factor V Leiden, prothrombin 20210A mutation, antiphospholipid antibodies, hyperhomocysteinemia and deficiencies of antithrombin, protein C, or protein S pregnant women affected by HT and suffering of iron deficiency (ID) and iron deficiency anemia (IDA) different trimester of pregnancy previous miscarriage/s previous preterm delivery/ies iron disorders as iron deficiency and iron deficiency anemia are defined by the number of red blood cells <4.000.000/mL, the hemoglobin concentration ≤ 11 g/dL, the total serum iron ≤ 30 mg/dL and serum ferritin ≤12 ng/mL absence of iron deficiency and iron deficiency anemia non-pregnant women uncomplicated pregnancies no informed consent other treatments of iron supplementation recent blood transfusion other concomitant diseases ascertained allergy to milk proteins or to iron products | 1 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 15.0-45.0, Malaria Women aged 15-45 years resident in the predefined study area Pregnant, with gestational age <23 weeks Failure to provide a blood sample Initial haemoglobin concentration <90 g/L Reported medical history suggestive of sickle cell anaemia, epilepsy, diabetes Obstetric history suggestive of eclampsia or pre-eclampsia Obvious mental retardation or metabolic disorder No written consent Carrying multiples Woman planning to leave the homestead or to be absent for prolonged periods in the course of the pregnancy or within a 1-month period thereafter Woman planning to deliver outside the research clinic | 2 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Autoimmune Hemolytic Disease (Cold Type) (Warm Type) Newly diagnosed "warm" or "cold" AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria) Idiopathic "warm" or "cold" AIHA relapsed after first line treatment with oral prednisone Aged >18 years ECOG performance status grade 0, 1 or 2 No psychiatric illness that precludes understanding concepts of the trial or signing informed consent Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice Cell or humoral immunologic deficit (congenital or acquired) Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients History of malignancies within 3 years prior to study entry Concomitant immunosuppressive or cytotoxic treatment Positive pregnancy test. Lactation The presence of associated organ-specific autoimmune diseases do not constitute Previous splenectomy does not constitute | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 1.0-3.333, Non-anemic Iron Deficiency Age between 18 and 36 months attending any well child visit Informed parental consent Previously diagnosed: developmental disorder, genetic, chromosomal or syndromic condition, chronic medical condition, (with the exception of asthma and allergies), including chronic anemia, iron deficiency or recent oral iron supplementation or treatment Prematurity with a gestational age less than 35 weeks; low birth weight less than 2500 grams Attending the office for an acute illness, such as a viral illness, or other health concern other than well-child assessment Any contraindications to receiving elemental iron (i.e. NHP [natural health product], comparator or placebo) The use of any Natural Health Product containing the same medicinal ingredient(s) as the investigational product English not spoken to the child in the home or in a child care setting | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Sickle Cell Disease Sickle Cell Anemia Anemia, Sickle Cell All volunteer subjects must be at least 18 years of age and have provided informed, written consent for participation in this study. in the study is determined prior to enrollment on the basis of the following and Laboratory values obtained within the preceding 60 days are sufficient for screening purposes for SCD Cohort Males or females 18 years of age or older Diagnosis of sickle cell disease (any form; electrophoretic or HPLC documentation is required) for SCD Cohort Chronic scheduled transfusions Current known pregnancy or lactation Hemoglobin < 5.0 g/dL; however, subjects may return for repeat evaluation at a later date Currently smoking and unable to refrain from smoking for 24 hours Subjects previously known to have conditions that may independently affect hemolytic rate | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 15.0-35.0, Iron Deficiency Singleton pregnancy Non-smoker No pre-existing medical complications (such as HIV-infection, eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) Complicated pregnancy (including gestational diabetes, pregnancy-induced hypertension, or preeclampsia) Individuals been previously treated for lead exposure, or those that have been identified as having elevated blood lead concentrations during childhood, will be excluded from the study | 2 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 0.75-2.0, Iron Deficiency Iron Deficiency Anemia Between 9-24 months of age Weighed 5.5 lbs or more at birth Born at 34 week gestation or more Consumed infant formula within the past 3 months Inflammatory bowel disease, cystic fibrosis, liver or kidney disease, cancer, HIV, primary immune deficiencies, anemia unrelated to iron status, chronic blood loss in stool, inherited disorders or iron status, or bleeding or coagulation disorders) Previous diagnosis of iron deficiency or iron deficiency anemia Previous treatment of iron deficiency or iron deficiency anemia | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 0.5-49.0, Malnutrition Gestational age ≤ 20 weeks Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area) Pregnancy identified and registered in the CHDP program before the beginning of the enrollment | 1 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-45.0, Iron Deficiency Anemia Women 18-45 years old with iron deficiency anaemia haemoglobin level between 85 g/L and 105 g/L serum ferritin level < 15 µg/L D14 + 7 days of the menstruation cycle on the day of pharmacokinetic evaluation Standard diet Anaemia related to other causes than iron deficiency and particularly inflammatory anaemia, anaemia due to marrow failure, haemopathy, haemoglobinopathies (sickle cell disease, thalassemia), haemolytic anaemia, anaemia due to acute haemorrhage, or anaemia related to chronic renal failure Haemochromatosis or iron overload of secondary origin (blood transfusion) Long term treatment known to modify iron absorption Gastro duodenal ulcer Inflammatory bowel disease or any digestive disease which could modify iron absorption Fructose intolerance, syndrome of malabsorption of glucose, galactose, deficit of sucrase-isomaltase Serious or progressive disease (cardiac, pulmonary, hepatic, renal, haematological, malignancy, autoimmune disease, infectious disease or neuropsychiatric disorders) Surgery undergone within 1 month prior to selection visit or a surgery planned during the study realization | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Lung Hypoxia Pulmonary Arterial Hypertension Iron Deficiency Willing and able to give informed consent for participation in the study Men and women aged 18 years or older and generally in good health Detectable tricuspid regurgitation on echocardiography during both normoxia and hypoxia enabling measurement of pulmonary arterial pressure For iron-deficient volunteers: ferritin ≤15microg/L and transferrin saturation <16% For iron-replete volunteers: ferritin ≥20microg/L and transferrin saturation ≥20% Haemoglobin <8.0g/dl Haemoglobinopathy Iron overload defined as ferritin >300microg/L Hypoxia at rest or on walking (SaO2 <94%) or significant comorbidity that may affect haematinics, pulmonary vascular or ventilatory responses, e.g. current infection, a chronic inflammatory condition, known cardiovalvular lesion or pulmonary hypertension, uncontrolled asthma or chronic obstructive pulmonary disease Exposure to high altitude (>2,500m) within the previous six weeks or air travel >4 hours within the previous week Iron supplementation or blood transfusion within the previous 6 weeks Pregnancy or breast feeding | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 9.0-25.0, Autoimmune Diseases in Subjects Receiving Cervarix® Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses for the exposed female cohort Female aged from 9 to 25 years at the reference date (01 September 2008 through 31 August 2010) Recorded in the CPRD GOLD for at least 12 months before the reference date The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available Subject defined as acceptable in CPRD GOLD for the unexposed historical female cohort Female aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007) Recorded in the CPRD GOLD for at least 12 months before the reference date Subject defined as acceptable in CPRD GOLD for all cohorts Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date Subjects who have been included in the other cohort for the non-exposed cohorts • Subjects who received any dose of Cervarix at any time before the reference date | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 13.0-80.0, Ulcerative Colitis Crohn's Disease Patients with proven iron deficiency anaemia on World Health Organisation (WHO)criteria Patients aged 13 will be considered adolescents, and aged >18 as adults Anaemia caused by B12 or folate deficiency, or secondary to drugs used to treat IBD; haemoglobinopathies or myelodysplasia; severe cardiopulmonary, hepatic or renal disease; severe cardiopulmonary, hepatic or renal disease; pregnancy and breast feeding females | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-49.0, Iron Deficiency Anemia 49 years Regular menstruation in the last three months Hemoglobin <12 mg/dl Serum Ferittin<20mcg/L BMI 18.5Kg/m^2 to 29.9 kg/m^2 history of gastrointestinal or hematological disorders taking medications that could interfere with hematopoiesis or dietary iron absorption pregnant (based on pregnancy test) | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-75.0, Amyotrophic Lateral Sclerosis The patient has been correctly informed The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is at least 18 years old and less than 75 years old Probable, or laboratory-supported probable or definite ALS as defined by El Escorial Revised ALS diagnostic (according to Airlie House Conference 1988) Stable on riluzole treatment for more than 3 months with liver function test results < 2ULN Disease duration ≤ 5 years Vital capacity ≥ 70% of normal Ability to swallow without the requirement for nasogastric or PEG feeding Agreement for patient to use an adequate method of contraception throughout the study and for 2 weeks after post study visit The patient is participating in another interventional study Within the past three months, the patient has participated in another interventional The patient is in an period determined by a previous study The patient is under judicial protection The patient is an adult under guardianship The patient refuses to sign the consent It is impossible to correctly inform the patient Other life threatening disease Presence of contra-indicated concomitant treatments or with potential neuroprotective benefit (see section 11.2 of the protocol) Presence of tracheostomy or non-invasive ventilation | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 20.0-35.0, Treatment of Iron Deficiency Anemia in Pregnancy Maternal age 20-35 years old Singleton pregnancy between 16 weeks Iron deficiency anemia with average hemoglobin ranging from 7-9 g % at the onset of the study Extremes of reproductive age (less than 20 years old or more than 35 years old) Patients with multiple pregnancies Anemia not linked to iron deficiency Allergy to iron derivatives Any medical disorder like diabetes or tuberculosis (TB), viral hepatitis cirrhosis, cardiovascular disease, renal disease, autoimmune disease, suspected acute infection, cancer Those who had received parenteral iron treatment earlier within 3 months before the start of the study Any obstetric complicating factors like pregnancy induced hypertension Patients with history of chronic blood loss | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 16.0-999.0, Autoimmune Hemolytic Anemia Patients diagnosed with primary warm Autoimmune Hemolytic Anemia Secondary Autoimmune Hemolytic Anemia (infections, hemopathy, systemic diseases) Naive to any treatment for hemolytic anemia or in relapse Older than 16 years of age Able to understand written and spoken French who have provided written informed consent • for Persons without an auto-immune disease, or cancer or an active infection Older than 16 years of age Able to understand written and spoken French Cold agglutinin disease Pregnant women Persons not covered by national health insurance Non-Inclusion controls Persons treated with corticoids or immunosuppressants Pregnant women Persons not covered by national health insurance | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-45.0, Iron Deficiency Anemia Iron Deficiency Anemia Female, 18 to 45 years old Serum ferritin levels <20 µg/L Normal body Mass Index (18.5-25 kg/m2) Body weight <65 kg Signed informed consent Anaemia (Hb < 11.7 g/dL) Elevated c-reactive protein or alpha1-glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) Continuous/long-term use of medication during the whole studies (except for contraceptives) Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Earlier participation in a study using stable iron isotopes Known hypersensitivity or allergy to iron supplements Women who are pregnant or breast feeding Intention to become pregnant during the course of the studies | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-45.0, Iron Deficiency Anemia Iron Deficiency Anemia Female, 18 to 45 years old Serum Ferritin levels <20 µg/L Normal body Mass Index (18.5-25 kg/m2) Body weight <65 kg Signed informed consent Anaemia (Hb < 11.7 g/dL) Elevated c-reactive protein or alpha1 glycoprotein concentrations >5.0 mg/L, >1.0 g/L, respectively Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, renal failure, hepatic dysfunction, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement) Continuous/long-term use of medication during the whole studies (except for contraceptives) Consumption of mineral and vitamin supplements within 2 weeks prior to 1st supplement administration Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months Earlier participation in a study using stable iron isotopes Known hypersensitivity or allergy to iron supplements Women who are pregnant or breast feeding Intention to become pregnant during the course of the studies | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-45.0, Anemia mildly anemic (on the basis of screening) volunteer males and non-pregnant and non-lactating females, giving written informed consent normolipidemic, normotensive no history of: i. diabetes, hyperlipidemia, obesity, asthma, cancer, respiratory, cardiovascular, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, sexually-transmitted disease, during the last 5 years ii. severe acute or chronic blood loss during last 6 months. iii. bleeding or clotting abnormality during last 1 year. iv. regular cigarette smoking, tobacco chewing v. consumption of vitamin E, vitamin B12, folate, iron or antioxidant during the last 6 months prior to enrollment pregnant and lactating females cigarette smoking, tobacco chewing, alcohol consumers blood transfusions during the last 1 year history of diabetes mellitus, hypertension, dyslipidemia , obesity asthma, cancer, respiratory, renal, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, cardiovascular disorder/disease during the last five years severe acute blood loss during last 6 months bleeding or clotting abnormalities during the last 1 year consumed vitamin E, B12, folate, iron or antioxidants supplements during the last 6 months | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Iron Deficiency Iron Deficiency Anemia uncomplicated singleton pregnancy, first enrollment visit ≤ 20 weeks gestation - < 18 years of age did not live in the county did not anticipate delivery at participating hospital were not mentally competent had a chronic health problem or hemoglobin < 100 g/L at the initial visit were taking iron at the time | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-50.0, Pregnancy Morning Sickness Nausea Vomiting Hyperemesis Gravidarum Any woman who discontinued her standard vitamins due to gastrointestinal symptoms or due to the tablet size, with one ofthe following conditions Morning sickness Gastrointestinal disorders: Crohn's disease, ulcerative colitis, peptic or duodenal ulcer, irritable colon, celiac disease Iron deficiency anemia Hypothyroidism Depression Women who do not agree to consent to this protocol Women with a known hypersensitivity to any of the ingredients of Pregvit®, or Orifer® F | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-50.0, Iron-deficiency Anemia Pregnant women of any age in their first trimester of pregnancy with anemia defined as a Hemoglobin less than 11 and/or a hematocrit less than 33 Willingness and ability to cook in provided cast iron pot at least 3x/week Singleton gestations Any secondary cause of anemia including inherited and acquired hemolytic anemias (sickle cell disease, thalessemia, malaria, etc) Inability or unwillingness to try to use cast iron pot approximately 3x/week Women with severe chronic illness and high likelihood of preterm birth and/or expected long-term hospitalizations during pregnancy. Multifetal gestations | 2 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Pregnancy Singleton pregnancy Iron deficiency anemia Intolerance or low compliance for oral iron Known allergy for iron supplements Anemia not due to iron deficiency Acute infection Liver failure or viral hepatitis Thalassemia or hemoglobinopathies Asthma Multiple pregnancy | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 2.0-17.0, Sickle Cell Anemia Pediatric participants with a severe form of sickle cell anemia (HbSS, HbSβ0 thalassemia, HbSD, HbSOArab) Age: ≥ 2 and ≤ 17 years of age, at the time of enrollment Time-averaged maximum velocity (TAMV) TCD Velocity in the conditional (170 cm/sec) or abnormal (≥200 cm/sec) range by Transcranial Doppler ultrasonography examination within 6 months of enrollment, abnormal or conditional TCD velocity and currently on commercial hydroxyurea for primary stroke prevention, or previously enrolled in SCATE, a previous stroke with abnormal or conditional TCD prior to stroke event Parent or guardian willing and able to provide informed consent and child gives assent Ability to comply with study related treatments, evaluations, and follow up visits Inability to take or tolerate daily oral hydroxyurea, including Known allergy to hydroxyurea therapy Known positive serology to HIV infection Known malignancy Current lactation Abnormal historical laboratory values (most recent pre-enrollment values unless previously enrolled in SCATE) Hemoglobin concentration < 6.0 gm/dL Absolute reticulocyte count < 100 x 109/L with a hemoglobin concentration < 8.0 gm/dL White Blood Cell (WBC) count < 3.0 x 109/L Absolute neutrophil count (ANC) < 1.0 x 109/L | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-999.0, Warm Antibody Autoimmune Hemolytic Anemia Subject must have had a diagnosis of primary or secondary warm antibody AIHA Must have previously received at least 1 prior treatment regimen for AIHA and have evidence of relapse Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria Subject with a platelet count of < 100,000/μL Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg | 0 |
A 27-year-old woman at 11 weeks gestation in her second pregnancy is found to have a hemoglobin (Hb) of 9.0 g/dL, white blood cell count 6.3 x 109/L, platelet count 119 x 109/L, mean corpuscular volume 109 fL. Further investigations reveal mild iron deficiency. She already receives iron supplementation. The obstetrician repeats the complete blood cell count 2 weeks later. The Hb is 8.9 g/dL, WBC count 7.1 x 109/L, and platelets 108 x 109/L. She describes difficulty swallowing. A reticulocyte count is performed and found elevated at 180 x 109/L. The obstetrician requests a hematology consult. The following additional results were found: Negative DAT, normal clotting screen, elevated LDH (2000 IU/L), normal urea and electrolytes, normal alanine aminotransferase (ALT), anisocytosis, poikilocytosis, no fragments, no agglutination, polychromasia and presence of hemosiderin in the urine. | eligible ages (years): 18.0-65.0, Anemia, Iron-Deficiency Hemoglobin (Hb) < 120 g/L in men and Hb < 110 g/L in women; Mean Corpuscular Volume(MCV) < 80 fl, Mean Corpuscular Hemoglobin(MCH) < 27 pg, and Mean Corpuscular Hemoglobin Concentration(MCHC) < 0.32; the blood biochemical examination: serum ferritin < 12 g/L, serum iron < 8.95 mol/L, transferrin saturation <15%, and total iron binding capacity>64.44 mol/L; with a history of Menorrhagia, monophagia or eating disorders; Willing to sign a Informed consent form Pregnant women; drug allergy; the patients with serious gastrorrhagia, other peptic ulcers, active bleeding, hepatic insufficiency, heart disease or renal insufficiency; those patients can't tolerate the medicine orally, or participate in other clinical study, or refuse to sign a Informed consent Form | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 60.0-999.0, Cardiovascular Diseases Heart Diseases Hypertension Vascular Diseases Men and women, aged 60 or over. Isolated systolic hypertension. Normal diastolic pressure of less than 90 mm Hg | 2 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 65.0-999.0, Arrhythmia Atrial Fibrillation Cardiovascular Diseases Heart Diseases Elderly men and women with atrial fibrillation and other risk factors for stroke | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Carotid Atherosclerosis Cerebrovascular Accident Diabetes Mellitus Hypercholesterolemia Hypertension Male or female greater than 18 years of age Patient must have documented hypertension (diastolic BP greater than 90 mmHg or systolic BP greater than 140 mmHg) for greater than 1 year OR hypercholesterolemia (LDL greater than 160 or total Chol greater than 240 with a total cholesterol/HDL-Chol ratio more than 1.6 for greater that 1 year OR Diabetes (blood glucose greater than 150 mg/dl requiring oral antihyperglycemics or insulin dependent) for greater than 1 year OR any combination Subgroup for risk factors with cerebral ischemic events must meet #2 plus documented stroke by physical exam and CT and/or MRI consistent with ischemic infarction or TIA witnessed and recorded by medical personnel Patient will be excluded if enrollment time is within 30 days of a stroke, myocardial infarction, or surgery. Patient may be enrolled after 30 days of the above events No patients on immunosuppressive therapy No patients who are unable to follow up for 1 year from the time of enrollment No stroke patients with an identifiable cardiac source (including atrial fibrillation, mural thrombus, valvular disease with vegetation) | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Cardiomyopathy, Hypertrophic Heart Hypertrophy Patients of either gender, aged 18-75 years, with HCM caused by sarcomeric gene mutations determined by existing protocols LV wall thickness of greater than or equal to 20 mm measured in any LV segment by MRI Severe symptoms refractory to medical treatment (New York Heart Association functional class III or IV) No LV outflow tract obstruction at rest greater than 30 mm Hg as determined by cardiac catheterization No coronary artery disease (greater than 50% arterial luminal narrowing of a major epicardial vessel) No chronic atrial fibrillation No bleeding disorder (PTT greater than 35 sec, pro time greater than 14 sec, platelet count less than 154 k/mm(3) No anemia (Hb less than 12.7 g/dl in males and less than 11.0 g/dl in females) No renal impairment (serum creatinine greater than 1.3 mg/dl) No hepatitis B or C; nor unexplained abnormal LFTs | 1 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Coronary Disease Cerebrovascular Accident Heart Diseases Heart Failure, Congestive Myocardial Infarction Asthma Emphysema Lung Diseases, Obstructive Aortic Aneurysm, Abdominal Bronchitis Dementia Hypertension Chronic Obstructive Pulmonary Disease Heart Failure | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 65.0-999.0, Cardiovascular Diseases Coronary Disease Heart Diseases Cerebrovascular Accident Diabetes Mellitus Hypertension Heart Failure, Congestive | 0 |
Karen is a 72-year-old woman with hypertension and type 2 diabetes, who was hospitalized for cryptogenic stroke two weeks ago. At the time, computed tomography was negative for brain hemorrhage and she was given thrombolytic therapy with resolution of her symptoms. Transesophageal echocardiogram and magnetic resonance angiogram of brain and great vessels found no evidence of abnormalities. She presents currently with a blood pressure of 120/70 mm Hg, normal glucose, and normal sinus rhythm on a 12-lead electrocardiogram. She reports history of occasional palpitations, shortness of breath and chest pain lasting for a few minutes and then stopping on their own. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Heart Diseases Hypertension Carotid Artery Diseases Atherosclerosis | 0 |
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