topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-120.0, Corona Virus Infection Stroke Stroke survivors with COVID19 Non-stroke individuals with COVID19 Stroke survivors still in inpatient hospital care
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-80.0, Berberine COVID-19 Patients confirmed with COVID-19 and classified as severe inflammatory bowel disease have other sources of infection death is anticipate within 72 hours participated in other clinical trials pregnant or lactating women
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-999.0, Severe COVID-19 Disease Male or female participants ≥ 18 years of age. 2. Participants with SARS-CoV-2 infection, as defined by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent test. 3. Must have pulmonary infiltrate on radiologic examination. 4. Participant must have a clinical diagnosis of high-risk ARDS (as defined by a PaO2-to-FiO2 ratio of < 150 mm Hg) requiring intensive respiratory support, including non-invasive methods such as high-flow nasal cannula or mechanical ventilation. 5. AST and ALT ≤ 3 x upper limit of normal (ULN). 6. Consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn at any time without prejudice to future medical care. Informed consent can be obtained from healthcare proxy if the participant is unable to provide consent due to medical status Active uncontrolled infection with a non-COVID-19 agent. 2. Diagnosis of ARDS that is not considered to be high-risk, as defined by PaO2-to-FiO2 ratio of ≥ 150 mm Hg. 3. Any irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%. 4. End-stage liver disease with ascites unrelated to COVID-19 (Childs Pugh score > 12). 5. Uncontrolled or significant cardiovascular disease, including but not limited to: (a) myocardial infarction, stroke, or transient ischemic attack within the past 30 days; (b) uncontrolled angina within the past 30 days; (c) any history of clinically significant arrhythmias such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes; and (d) history of other clinically significant or uncontrolled heart disease, including: cardiomyopathy, congestive heart failure with New York Heart Association functional classification III or IV, myocarditis, pericarditis, or significant pericardial effusion. 6. Known chronic kidney disease of Stage 4 or 5 severity or requiring hemodialysis. 7. COVID-19-associated acute kidney injury requiring dialysis. 8. HIV, hepatitis B, or hepatitis C seropositive. 9. Patients with baseline QTc interval prolongation, as defined by repeated demonstration of a QTc interval >500 milliseconds. 10. Patients on hydroxychloroquine (must discontinue at least 2-days before study entry). 11. Pregnant or breastfeeding participants. 12. Patients of childbearing age, or males who have a partner of childbearing potential, who are unwilling to practice contraception. Effective forms of birth control, which must be continued through the entire on-study 6-month interval, Abstinence; Intrauterine device (IUD); Hormonal (birth control pills, injections, or implants); Tubal ligation; or Vasectomy. 13. Participants with malignancy requiring active therapy (not including non-melanoma skin cancer). 14. Recipients of allogeneic hematopoietic cell transplant or solid organ transplant. 15. History of WHO Class III or IV pulmonary hypertension. 16. Severe thromboembolic disease, as defined by: administration of thrombolytic agents, insertion of vena cava filter, or pulmonary thrombectomy within one-week interval prior to screening. 17. Participants may be excluded at the discretion of the PI or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 1.0-18.0, Appendicitis Acute Patients with clinically diagnosed as acute appendicitis Age 18 or under Lab tests Hemoglobin ≥ 10g/dl White blood cell count ≥ 4,000/mm3 Platelet count ≥ 100,000/mm3 Creatinine ≤ 1.5 mg/dl Aspartate aminotransferase ≤ 100 IU/L Alanine aminotransferase ≤ 100 IU/L no significant dysfunction in the heart, lungs, kidneys Previous abdominal operation Generalized peritonitis Anticipated extended resection Periappendiceal abscess on preoperative exam
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-999.0, Liver Transplant • Donors evaluated as per institutional protocol for donor hepatectomy and found fit Those who consent Patients refusing to consent for in the study Left lateral hepatectomy
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 7.0-18.0, Type 1 Diabetes Clinical diagnosis of type 1 diabetes >1 year prior to consent date. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required. 2. HbA1c < 12.5% 3. Age 7-17 years at the initiation of the system 4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1-week period 5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software 6. Clinically able to start the AHCL system 7. History of 3 clinic visits in the last year DKA in the 6 months prior to screening visit 2. Pregnancy 3. Untreated diabetes retinopathy, or other causes that ,in the investigator's opinion, precludes the individual from participating in the trial
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 14.0-65.0, Mycobacterium Tuberculosis LTBI (Latent TB Infection) Malnutrition Diabetes Mellitus Helminth Infections (Screening Phase) Individuals who meet the following are eligible to participate in the screening phase Aged 14 to 65 years Willingness to provide blood, urine, and stool samples for examination Willingness to have samples and data stored Able to provide informed consent (Screening Phase) Pulmonary symptoms suggestive of TB (cough >2 weeks in duration and/or intermittent fever >1 week in duration and/or hemoptysis) Two IGRA tests with indeterminate results (mitogen values <10 IU). (Study Phase) Individuals are eligible for the study phase if they meet the requirements for one of the study groups, as follows: 1. LTBI+ and severe to moderate malnutrition (BMI <17 kg/m2); 2. LTBI+ and uncontrolled DM (HbA1c >8%); 3. LTBI+ and helminth infection (positive stool qPCR and/or serology); 4. LTBI+ with more than one of the conditions defined in groups 1 3; 5. healthy LTBI+ controls who are negative for all of the above conditions; and 6. healthy LTBI-negative controls with none of the above conditions (Study Phase) Pulmonary symptoms suggestive of TB (cough >2 weeks in duration and/or intermittent fever >1 week in duration and/or hemoptysis) Pregnant or lactating women Previous treatment for LTBI Anemia with hemoglobin <8 g/dl (evaluated at the screening phase visit) For LTBI+ participants, clinically indicated chest X-ray positive for pulmonary TB For malnourished participants, clinically indicated abdominal ultrasound positive for abdominal TB
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 22.0-69.0, Alcoholic Liver Disease Those who agreed to participate in this study and signed a written consent Those who have no evidence of neurological impairment Those who have decompensated liver cirrhosis Those who have a high MELD score (≥20) Those who have OHE during admission Those who have parients' refusal
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-999.0, Pneumonia, Viral Covid19 ARDS Oxidative Stress Patients admitted to the UTC in the Temporary COVID-19 Citibanamex Center with suspected or diagnosed severe pneumonia due to SARS-COV2 with or without septic shock Patients who accept and sign informed consent. If the patient is clinically unable to authorize, acceptance by a first-degree relative will be requested Diagnosis of septic shock in the last 24 hours characterized by refractory hypotension and vasopressor requirement despite adequate fluid resuscitation (20 mL/kg of colloids or 40 mL/kg of crystalloids) to maintain a blood pressure ≥ 65 mmHg with lactate> two mmol / L Patients with an advance directive format Chronic use of steroids in the past six months or recent Use of statins before admission Patients who are under some antioxidant treatment Any contraindication for the use of Vit C, Vit E, NAC, and melatonin Pregnant women
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-999.0, Ischemic Stroke Transient Ischemic Attack Patients with acute ischemic stroke or high-risk TIA (ABCD2-Score ≥ 4 points) in the last 30 days Age ≥ 18 years Written informed consent Patients living outside the catchment area of the participating centers Patients under law enforcement or within mandatory military service Age < 18 years
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-55.0, Non-Alcoholic Fatty Liver Disease Patients posted for Upper GI endoscopy for other indications 2. 18 yrs of age with NAFLD and 3. BMI ≤ 35 or 4. Body Mass Index (BMI) is ≤30 to 34.9 kg/m2 with at least one treated or untreated comorbid condition (hypertension, dyslipidaemia, cardiovascular disease, glucose intolerance, sleep apnoea, NASH). 5. Ambulatory and able to perform the ILBS healthy lifestyle (diet and exercise program). 6. Failed to life style therapy HIV, HBsAg or HCV positive 2. Prior bariatric surgery 3. Change in weight of ≤5 % within 3 months 4. Malignancy within 5 years 5. Recent major surgery; history of seizure disorder 6. Depression or other major psychiatric disease within 2 years requiring treatment with prescription medication 7. Pregnancy or lactation 8. Significant uncontrolled cardiopulmonary diseases 9. Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening 10. Hypo or hyperthyroidism uncontrolled. If initiation or adjustment of doses of these drugs is anticipated, patients should not be enrolled. 11. Patients being treated for hypothyroidism must be adequately replaced on a stable dose of medication for at least 3 months prior to screening. 12. Uncontrolled DM with HbA1c greater than 9%. 13. Recent treatment (i.e., within 1 month of the screening visit) with weight drugs or products or appetite suppressants (including herbal weight agents) 14. Recent treatment (i.e., within 3 months of the screening visit) with oral or parenteral corticosteroids 15. Recent history (within 2 years prior to the screening visit) of significant alcohol use 16. Significant change in diet or level of physical activity within 1 month prior to enrolment 17. Use of very-low calorie (< 1,000/day) liquid weight diet within 6 months
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-999.0, Coronary Heart Disease the presence of an established diagnosis in patients with coronary artery disease unstable angina pectoris (NS). When making a diagnosis, the recommendations of ESH / ESC (2015) and RCO / WHO (2014) were used stable exertional angina (SSN) I-III FC. When making the diagnosis, the IHD classification was used, adopted at the IV Congress of Cardiologists of the Republic of Uzbekistan (2000), as well as in accordance with the recommendations of ESH / ESC (2019) and RCO / WHO (2017) The patient's refusal to participate in the study Pregnancy and lactation Severe and unstable condition of the patient, making it difficult to conduct a questionnaire (for ethical reasons) Acute violation of cerebral circulation History of acute or chronic psychosis The presence of concomitant acute diseases or chronic diseases in the acute stage. Throughout the study, all patients were assigned the right to voluntarily withdraw from the study at their own request, notifying the researcher in writing or orally
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-999.0, Diarrhea Infectious Algorithms Decision Support Systems, Clinical Clinical Decision-Making Physician providing acute care for children with diarrhea at study hospitals Available to answer survey questionnaire Planning to leave the study site prior to completion of the research Inability to read
|
2
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-999.0, Hemorrhagic Shock Adult patients who would be eligible to receive blood products systolic blood pressure <90 mmHg a shock index of > 0.9 clinical signs of shock as determined by the transport clinicians Age < 18 years old
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 2.0-17.0, Ulcerative Colitis Evidence of a personally signed and dated informed consent document and assent document Males and females 2 to less than18 years old and weighing at least 10 kg Having a pathology report that confirms colonic inflammation consistent with UC with a clinical diagnosis of UC for at least 12 weeks prior to baseline, with biopsy report supporting the diagnosis of UC Participants diagnosed with UC at age less than 6 years old, must have had testing and be negative for monogenic disorders associated with very early onset IBD Moderately to severely active UC as defined (via screening colonoscopy) by a Mayo score of at least 6, with a rectal bleeding score of at least 1 and an endoscopic subscore of at least 2 Pediatric Ulcerative Colitis Activity Index (PUCAI) score greater or equal to 35 No history of dysplasia or colon cancer No evidence or history of untreated or inadequately treated active or latent infection with Mycobacterium Tuberculosis For participants outside of the United States: have had an inadequate response or been intolerant to at least one prior therapy as listed below or have a medical contraindication to such therapies Oral or intravenous (IV) corticosteroids Diagnosis of indeterminate colitis, isolated proctitis, microscopic colitis, infectious colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease History of symptomatic obstructive intestinal strictures or active ostomy, or history of colectomy, extensive small bowel resection ( greater than100 centimetres) or short bowel syndrome, or hospitalization for UC related reason(s) within 4 weeks of baseline visit Any factors or clinical characteristics potentially related to the risk of venous thromboembolism that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study Participants who have previously received tofacitinib or another Janus Kinase inhibitor Vaccination or exposure to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, or who are expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of study drug Participants having received azathioprine, 6-mercaptopurine, methotrexate, thioguanine, infliximab, adalimumab, golimumab, interferon, cyclosporine, mycophenolate, tacrolimus, IV or rectally administered corticosteroids, natalizumab, vedolizumab, other antiadhesion molecules, or investigational drugs during the specified time periods prior to baseline whereby they may still have pharmacokinetic and/or pharmacodynamic effect in the body of the participant Previous treatment by leukocyte apheresis including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline Treatment by specified prohibited concomitant medications, including moderate to potent CYP3A inducers or inhibitors in the specified time periods prior to the first dose of study drug or are expected to receive any of these medications during the study period Chronic and frequent use of antimotility agents for control of diarrhea (ie, diphenoxylate hydrochloride with atropine sulfate or loperamide) History of bowel surgery, including cholecystectomy within 6 months prior to baseline, history of appendectomy within 3 months prior to baseline, or significant trauma or major surgery within 4 weeks of screening visit are excluded
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-999.0, Diffuse Large B Cell Lymphoma histologically confirmed diagnosis of CD20+ DLBCL primary central nervous system lymphoma "double-hit" lymphoma
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-999.0, Chronic Pain Have a complex, prolonged axial neck pain or lower back pain Have been followed by a pain management specialist for at least 3 months or have a history of chronic pain for at least 3 months as recorded by physician Be >18 years of age Have a goal and motivation that is adequate in relation to the program offered Be medically prepared Have no major change in interventional treatment or be a surgical candidate Own a smart phone, tablet or computer or have the knowledge to use one Chronic pain requiring imminent surgical intervention Reported severe or acute psychiatric illness, severe anxiety or depression Current history of substance abuse Serious health risks or scheduled major health interventions for other medical reasons Pain related to malignancy Pain duration <3 months Other areas of pain exceeding the amount of back or neck pain Not currently involved in lawsuit or pending litigation
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-64.0, Corona Virus Infection Has provided informed consent and any authorizations required by local law; 2. Is a male or female patient ≥18 and <65 years of age; 3. Has a laboratory-documented positive test for SARS CoV 2 infection as determined by local laboratory using a standard, Food and Drug Administration (FDA)-approved viral RNA or viral antigen assay from any oral or respiratory sample collected within 48 hours of randomization; 4. Has at least 2 symptoms associated with COVID-19 (fever or chills, cough, shortness of breath or difficulty breathing on exertion, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea) starting no more than 5 days prior to randomization and has mild or moderate disease at screening and at time of randomization, defined as the following Mild COVID-19 Positive testing by standard reverse transcriptase polymerase chain reaction (RT-PCR) assay or equivalent test Symptoms of mild illness with COVID-19 that could fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea; and No clinical signs indicative of moderate, severe, or critical severity Moderate COVID-19 Positive testing by standard RT-PCR assay or equivalent testing Symptoms of moderate illness with COVID-19, which could any symptom of mild illness or shortness of breath with exertion Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥20 breaths per minute, saturation of oxygen (SpO2) >93% on room air at sea level, heart rate ≥90 beats per minute; and No clinical signs indicative of severe or critical severity; 5. Has adequate hepatic function during screening, defined as the following Is hospitalized for COVID-19; 2. Has dyspnea at rest or while talking, or has signs and symptoms of overt or impending respiratory failure; 3. Has significant cardiovascular disease, defined by myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 3 months prior to randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; ≥Grade 3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg); or history of congenital prolonged QT syndrome; 4. Has a history of chronic obstructive pulmonary disease or bronchial asthma requiring continuous treatment and/or intermittent or continuous oxygen within the 90 days prior to screening; Note: Intermittent use of a β2-agonist inhaler is allowed. 5. Has evidence of an ongoing or systemic bacterial, fungal, or viral infection (including upper respiratory tract infections) other than SARS-CoV-2 infection, recurrent or repeat SARS CoV 2 infection, or history of incompletely treated tuberculosis (TB) and/or suspected or known extrapulmonary TB; Note: Patients with localized fungal infections of the skin or nails are eligible. Patients may be receiving topical antifungals. Systemic administration of azole antifungals is prohibited (see Section 5.6). 6. Has significant infiltrates (involving >50% of lung parenchyma) on an optional standard of care chest X-ray or other lung imaging exam within 1 week of screening; 7. Has known significant electrocardiogram abnormalities at screening, including unstable cardiac arrhythmia requiring medication, left bundle branch block, second-degree atrioventricular (AV) block type II, third-degree AV block, ≥Grade 2 bradycardia, or QTcF >450 msec for men or >470 msec for women; 8. Has type 1 diabetes mellitus or type 2 diabetes mellitus; 9. Has a body mass index (BMI) >30 kg/m2; 10. Has received a live vaccine within 30 days prior to randomization; 11. Has had major surgery within 4 weeks (inclusive) prior to randomization; 12. Has had prior solid organ or bone marrow progenitor cell transplantation; 13. Has a malignant tumor (excluding a malignant tumor cured with no recurrence in the past 2 years, completely resected basal cell and squamous cell carcinoma of the skin, and completely resected carcinoma in situ of any type); 14. Has had prior high-dose chemotherapy requiring stem cell rescue; 15. Has a history of or active uncontrolled systemic or local autoimmune disorders or other conditions that might impair or compromise the immune system; 16. Has ongoing immunosuppressive therapy, including systemic corticosteroids; Note: At screening and during study participation, patients may be using systemic corticosteroids (doses ≤10 mg of prednisone or equivalent) or topical or inhaled corticosteroids. 17. Has ongoing use of a therapeutic anticoagulant or history of bleeding disorder; 18. Has ongoing use or plans to use antivirals against COVID-19; 19. Has used a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to randomization or is expected to require use of a moderate or strong CYP3A4 inhibitor or inducer during study participation; 20. Has previously received investigational product in a clinical study within 30 days or within 5 elimination half-lives (whichever is shorter) prior to randomization or is planning to take part in another therapeutic clinical study while participating in this study; Note: Participation in observational studies is allowed. 21. Has a known history of HIV or hepatitis B virus, or active hepatitis C virus infection; 22. Has a known serious allergic reaction or hypersensitivity to components of zotatifin or placebo; 23. Has a history of drug abuse or use of narcotics in the past 2 years that in the opinion of the Investigator will preclude study compliance; or 24. Has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to provide informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 16.0-999.0, Intestinal Graft Dysfunction intestinal transplant recipients younger age (< 16)
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-90.0, Obscure Gastrointestinal Bleeding Anemia, Iron Deficiency Sign Informed Consent Form 2. Patients age between 18-90 years 3. Patients in which retrograde enteroscopy is indicated for any of the following: abnormal video capsule endoscopy non-diagnostic upper and lower endoscopy obscure gastrointestinal bleeding iron deficiency anemia non-diagnostic upper endoscopy and abnormal CT Hemodynamically stable Inability to sign Informed Consent Form 2. Pregnancy and breast feeding 3. Prior colon resection 4. Patients with known strictures 5. Patients with altered anatomy 6. Inadequate bowel preparation
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 2.0-18.0, GRIN Related Disorders Diagnosis of encephalopathy associated with genetic GRIN variant pathogenic or likely pathogenic, causing a loss-of-function Parent(s)/legal representative give written informed consent for participation in the trial; patient assent (if possessing adequate understanding, in the investigator's) Patient & caregiver are willing and able (in the investigator's opinion) to comply with all trial requirements (including the completion of all caregiver assessments by the same caregiver throughout the trial) Diagnosis of encephalopathy with absence of genetic GRIN variant pathogenic or likely pathogenic Currently using or has used within the 30 days prior to screening L-Serine supplement Patient has been previously randomized into this trial
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 19.0-70.0, Gallstone; Colic trainees in general surgery 2. No experience of laparoscopic cholecystectomy 3. Less than 5 experiences of laparoscopic surgery 4. Uncomplicated symptomatic gallstone disease Experience with laparoscopic cholecystectomy. 2. More than 5 experiences of laparoscopic surgery
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 4.0-999.0, Pmm2-CDG CDG1A Molecularly and/or enzymatically-confirmed PMM2-CDG Age ≥4 years old, and Affected with ataxia evidenced by mini International Cooperative Ataxia Rating Scale (Mini-ICARS) score >0 at baseline Hepatic impairment defined as AST/ALT >5x ULN in the last 12 months Renal impairment defined as serum creatinine: > 0.5 mg/dL (<6 years); > 0.7 mg/dL (7-10 years); > 1.24 mg/dL (> 11 years) Hypersensitivity to acetazolamide Hypersensitivity to any of the components of the placebo History of treatment with experimental drug within 28 days of Visit 1 Currently taking Mecamylamine, Sodium Phosphates, Salicylates, Mefloquine, Methenamine and other Carbonic Anhydrase Inhibitors
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 20.0-999.0, Transient Ischemic Attack patient with acute ischemic stroke or TIAs (within one week of onset) history of persistent AF initial ECG is AF primary hemorrhagic stroke acute large vessel dissection inability or refusal of consent
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 7.0-17.0, Metabolic Syndrome , Sims Score and Pediatrics All obese patients aged from 7 to 17 years old All obesechildren With endocrial and syndromatic obesity, (Endocrinal disease as hypothyroidism and Cushing's syndrome etc, syndromic obesity asPrader-Willi syndrome ,Alstrom-Hallgren syndrome, Bardet-Biedl syndrome, Beckwith-Wiedemansyndrome,etc…….) Children on medications that affect lipid profile that (β-Blockers ,Amiodarone ,Loop diuretics, Thiazide diuretics (high dose) ,Sodium-glucose co-transporter 2 (SGLT2) inhibitors ,Steroid Hormones/Anabolic Steroids, Antiviral Therapy ,Immunosuppressants ,Centrally Acting Medications as Anticonvulsants)
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 5.0-999.0, Sickle Cell Disease Pharmacokinetics 5 years of age and older at Screening. 2. Has documented diagnosis of SCD with known genotype (HbSS, HbSβ0 and HbSC). 3. Written informed consent provided by patient or the patient's legally authorized representative. 4. Non-pregnant females of childbearing age must agree to avoid pregnancy during the study and to practice a recognized form of birth control during the course of the study (e.g., barrier, birth control pills, or abstinence). for Healthy Volunteers: 1. No known hematologic illness. 2. No known renal impairment. 3. 18 Years of age or older at screening. 4. Written informed consent provided by patient or the patient's legally authorized representative. 5. African American and Hispanic participants preferred Recent significant medical condition that required hospitalization (other than sickle cell crisis) within 2 months prior to starting L-glutamine therapy. 2. History of chronic kidney disease Stage 4 (glomerular filtration rate [GFR]=15-29) or Stage 5 (GFR<15 mL/min/1.73 m2). 3. History of chronic liver disease Child Pugh class C (10-15 points). 4. Received any blood products 3 months prior to starting L-glutamine therapy. 5. Currently pregnant or lactating or planning to conceive during the study period. 6. Currently taking or has taken any form of glutamine supplement within 30 days prior to starting L-glutamine therapy. 7. Has been treated with an investigational medication/treatment within 30 days prior to starting L-glutamine therapy. 8. Is currently enrolled in an investigational drug or device study and/or has participated in such a study within 30 days prior to starting L-glutamine therapy. 9. Factors that would, in the judgment of the investigator, make it difficult for the patient to comply with study requirements. 10. Patient is currently being treated with crizanlizumab or voxelotor for Healthy Volunteers: 1. Known allergies to L-glutamine. 2. Informed consent document was not completed and signed. 3. Currently pregnant or lactating or planning to conceive during the study period. 4. Known hematologic illness, renal or hepatic impairment. 5. Received any blood products within 3 months of starting L-glutamine therapy
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 12.0-90.0, Scoliosis Spinal Deformity Acute Pain Chronic Pain Postoperative Pain Anesthesia Regional Anesthesia Morbidity Anesthesia, Local Anesthesia Complication Hyperalgesia Intraoperative Complications Intraoperative Hypotension Intraoperative Blood Loss Intraoperative Bleeding Intraoperative Neurological Injury Intraoperative Injury Coagulation Disorder Postoperative Nausea and Vomiting Postoperative Cognitive Dysfunction Neuropathic Pain Nutrient Deficiency Nutrition Disorders Ventilator-Induced Lung Injury Informed consent of the patient or his legal representatives to participate the study. 2. Spinal deformity that requires surgical correction. 3. No known allergies to local anaesthetics. 4. Negative intradermal test for sensitivity to local anaesthetics Refusal of the patient or his legal representatives to participate the study 2. Diabetes mellitus, known allergy to local anaesthetics 3. Acute spinal cord injury 4. Physical status according to classification ASA III and more 5. A positive intradermal test for sensitivity to a local anaesthetic
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 2.0-17.0, Hyperpronated Foot Subject requires surgery for treatment of hyperpronated foot using the Arthrex ProStop® implant 2. Age >2 to 17 years 3. Subject is not pregnant, nursing, prisoner, or ward of the state 4. Subject or subject's representative signed informed consent and assent when, applicable, and is willing and able to comply with all study requirements Insufficient quantity or quality of bone. 2. Blood supply limitations and previous infections, which may retard healing. 3. Foreign-body sensitivity. 4. Any active infection or blood supply limitations. 5. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.167-999.0, Atypical Hemolytic Uremic Syndrome aHUS Written informed consent to study participation. 2. Male and female patients aged 2 months and older with documented atypical hemolytic uremic syndrome (aHUS)diagnosis. 3. By the time of in the study, Elizaria® should be prescribed as a pathogenetic therapy for aHUS Intolerance to eculizumab, or other components of the drug
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 2.0-999.0, Primary Mediastinal (Thymic) Large B-Cell Lymphoma Age >= 2 years Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma Children's Oncology Group (COG) Institutions: Use Karnofsky for patients >= 17 and < 18 years of age and Lansky for patients < 17 years of age Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight Pediatric Patients (age < 18 years): The following must have been obtained within 14 days prior to registration Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or Serum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/gender as follows Age : 2 to < 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female) Age : 6 to < 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female) Administration of prior anti-cancer therapy except as outlined below A short course (=< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms A single course of COP (cyclophosphamide, vincristine, and prednisone) One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, or a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131) that has not started more than 21 days prior to enrollment Active ischemic heart disease or heart failure Active uncontrolled infection Central nervous system (CNS) involvement of lymphoma Previous cancer that required systemic chemotherapy and/or thoracic radiation. Other cancers will be permitted if in remission x 3 years Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment In patients < 18 years of age hepatitis B serologies consistent with past or current infections
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-999.0, Dysentery Amebic Patients complaining of dysentery or diarrhea with any age & sex groups Patients taking amoebicidal drugs
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-999.0, Liver Function Tests Abnormalities Patients with Covid19 positive PCR Patients with chronic liver diseases as liver cirrhosis, Hbs Ag positive, or patients having anti-HCV antibodies positive and HCV RNA positive
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 8.0-100.0, Iron Deficiency Anemia GastroIntestinal Bleeding Patients from external consultation, hospital ward or urgency department, with suspected GI bleeding presenting in the occult form as IDA (Hb <12.0 g/dL in female gender or <13.0 g/dL in male gender) and/or overt GI bleeding presenting as melaena and/or haematochezia, and with prior non-diagnostic upper GI endoscopy (esophagogastroduodenoscopy, EGD) Lack of informed consent 2. Suspected lesions at index EGD that could justify the anemia or digestive bleeding 3. Known history of gastroparesis or bowel dysmotility 4. Known or suspected intestinal stricture 5. Female patients with potential gynaecological source of bleeding causative of the clinical condition 6. Patients with severe malnutrition 7. Patients unable to walk at least for short periods and/or with neurological and/or psychiatric condition potentially favouring protocol deviations 8. Allergy or contra-indications to any of the drugs or products used in the study 9. Pregnancy or breastfeeding
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-999.0, Charcot-Marie-Tooth Disease Definitive diagnosis of Charcot-Marie-Tooth disease osteoporosis intestinal malabsorption chronic inflammatory diseases chronic renal failure severe heart failure neoplastic diseases
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-38.0, Premature Ovarian Failure Signed and dated informed consent 2. Married female, 18-38 years old 3. Diagnosis of premature ovarian insufficiency: At least two menopausal FSH levels (≥ 20 IU/L) and/or Primary or secondary amenorrhea at least for 6 months 4. Evidence of low ovarian reserve defined as: AMH < _0.3 ng/ML & FSH >20 IU/L, AFC < 4, and/or failure of prior attempts of assisted reproductive techniques due to limited ovarian response (poor responder). 5. Normal karyotype 46, XX. 6. Presence of at least one ovary 7. Normal thyroid function as evidence by normal serum Thyroid Stimulating Hormone (TSH) levels. 8. Agree to report any pregnancy to the research staff immediately. 9. Cooperative patient 10. Negative for infectious panel (HIV, HBV, HCV, and VDRL) Currently breast-feeding 2. Has a history of, or evidence of current malignancy 3. Major mental health disorder that precludes participation in the study 4. Current or recent (within the past 2 weeks) use of the following medications: Oral or systemic corticosteroids, Hormones (estrogen, progestins, oral contraceptives), Danazol, anticoagulants, herbal or botanical supplements with possible hormonal effects. Washout will be allowed. 5. Type I or Type II diabetes mellitus, or if receiving antidiabetic medications 6. Significant anemia (Hemoglobin <8 g/dL). 7. Untreated deep venous thrombosis, and/or pulmonary embolus 8. Known heart disease (New York Heart Association Class II or higher). 9. Known Liver disease (defined as Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT)>2 times normal, or total bilirubin >2.5 mg/dL). 10. Known Renal disease (defined as Blood urea nitrogen (BUN)>30 mg/dL or serum creatinine > 1.6 mg/dL). 11. Clinically active autoimmune condition
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 17.0-999.0, IBS - Irritable Bowel Syndrome College students from all over the country, over 17 years old, have a physical examination before entering school Sign the informed consent form, voluntarily participate and fill in the questionnaire People with diabetes, hyperthyroidism or hypothyroidism, peptic ulcer, inflammatory bowel disease, digestive tract tumor or severe medical and surgical disease History of abdominal surgery (such as esophagus, stomach, small intestine, colon, rectum, appendix, gallbladder, hysterectomy, cesarean section) Recently, there are some alarm symptoms, such as relieving black stool, bloody stool, hematemesis, abnormal anemia, fever, abnormal weight loss (no intention to lose weight, weight loss 5 kg in 3 months), change of defecation habits, dysphagia and so on In the past 4 weeks, he has taken drugs that affect the judgment of gastrointestinal symptoms, such as anti-inflammatory painkillers, diazepam drugs, anti-anxiety drugs, depressants and so on
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-75.0, Ovarian Cancer Voluntary agreement to provide written informed consent. 2. Aged 18 to 75 years, female. 3. Histologically or cytologically confirmed epithelial ovarian cancer, carcinoma tubae, or primary peritoneal carcinoma. 4. Patients have previously received platinum-containing chemotherapy. 5. Patients must provide tissue samples that are certified as qualified by the central laboratory, and the HER2 status of the tissue samples is determined by the central laboratory:Part1: HER2 overexpressing: IHC 2+ or IHC 3+; Part2a: HER2 overexpressing: IHC 2+ or IHC 3+; Part2b: HER2 low expressing: IHC1+; 6. The Eastern Cooperative Oncology Group (ECOG) score is 0 to 2, and life expectancy ≥ 3 months. 7. At least one measurable lesion at baseline per v1.1. 8. The function of major organs must meet the following within 7 days before enrollment (Have not received blood transfusion, EPO, G-CSF or other medical supportive treatment within 14 days before the first dose of study drug): Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet ≥100×109 /L; Hemoglobin ≥90 g/L or ≥5.6 mmol/L; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Creatinine clearance rate ≥30 mL/min (Calculated by Cockcroft-Gualt formula); Total bilirubin ≤1.5×ULN or ≤3×ULN for patients with Gilbert's syndrome or liver metastasis: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.5×ULN or ≤5×ULN for patients with liver metastasis: 9. Female patient of childbearing age must agree to take adequate contraceptive measures during the entire study period and through at least 6 months after the last dose of study drug. Women of childbearing age must have a negative pregnancy test within 7 days before study entry. 10. Patients will be able to communicate well with the investigator, understand and comply with the requirements of the study Pregnant or breastfeeding women. 2. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0), except for alopecia, pigmentation and other toxicity judged no safety risk by the investigator . 3. Patients who have previously received trastuzumab or trastuzumab analogues that have related toxicity, resulting in permanent discontinuation. 4. Patients with allergic history or delayed allergic reaction to any components (trastuzumab analogues, MMAE, sodium citrate dihydrate, citrate monohydrate, polysorbate 20 and sucrose, etc.) of DP303c. 5. Patients with brain or pia mater metastasis, except for patients with central nervous system (CNS) metastases in the following conditions: untreated but asymptomatic, or progression-free status in imaging evidence for at least 4 weeks after treatment and not requiring hormone therapy for at least 4 weeks. 6. Chemotherapy, radiotherapy, biotherapy, targeted therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first dose of study drug, 6 weeks for nitrosourea (such as carmustine, lomustine, etc.) or mitomycin C, 5 half-lives for oral fluorouracil and small molecule targeted drugs, 2 weeks for endocrine therapy and Chinese medicine treatment with anti-tumor indications; or local palliative radiotherapy for bone metastasis and pain relief within 2 weeks. 7. People who currently have corneal diseases that require medication or surgical intervention, or have a history of serious corneal diseases, or are unwilling to stop wearing contact lenses during the study. 8. History of any other malignant tumors within five years (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, local prostate cancer, cervical cancer in situ, stage I ductal carcinoma in situ and stage I grade 1 endometrial carcinoma that have been radically removed and have not recurred; breast cancer with no recurrence for more than 3 years after radical operation). 9. History of (non-infectious) interstitial lung disease (ILD)/pulmonary disease that required steroids, or current ILD/pulmonary disease, or suspected ILD/ pulmonary disease that cannot be excluded by imaging examination; except for patients with radiation pneumonitis without clinical symptoms after 3 months of radiotherapy. 10. Patients with dyspnea at rest induced by complications of advanced malignant tumors or need for continuous oxygen therapy. 11. Patients with complete intestinal obstruction, or pleural effusions or ascites that are difficult to control within 4 weeks before entry (the frequency of percutaneous drainage is more than twice a week, or continuous drainage daily volume is ≥ 1000 mL). 12. Patients with serious cardiovascular and cerebrovascular diseases, including but not limited to Uncontrolled angina, congestive heart failure (NYHA III-IV), myocardial infarction or severe arrhythmia within 6 months before enrollment Left ventricular ejection fraction (LVEF) <50% or lower limit of normal in echocardiogram (ECHO) or multi-gate detection scan (MUGA) Average adjusted QT interval prolongation >470 ms, QT interval corrected by Fridericia's formula (QTcF). 13. The cumulative amount of previous exposure to anthracyclines has reached the following doses: doxorubicin or liposomal doxorubicin>500 mg/m2; epirubicin>900 mg/m2; mitoxantrone>120 mg/m2; Others (liposomal doxorubicin or other anthracyclines is equivalent to a dose of > 500 mg/m2 adriamycin); if more than one anthracycline is used, the cumulative dose is equivalent to a total dose of >500 mg/m2 adriamycin. 14. Peripheral neuropathy ≥grade 2 before entry (NCI CTCAE 5.0). 15. Uncontrollable electrolyte imbalances hypokalemia, hypocalcemia or hypomagnesemia (refer to NCI CTCAE 5.0, ≥2 grade). 16. HIV positive, or syphilis infection requiring systematic treatment. 17. Patients with active hepatitis B or C (HBsAg positive, with HBV DNA positive, and the ALT continues to be higher than the upper limit of normal, without other causes of ALT elevation; HCVAb positive with HCV RNA higher than the upper limit of normal). 18. Patients have used strong CYP3A4 inhibitors or CYP3A4 strong inducers with a washout period less than 28 days or 5 half-lives (whichever is shorter) before the first dose of the study drug. 19. Patients underwent major surgery within 4 weeks and did not fully recover before the first dose of study drug. 20. Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug. 21. Have previously received antibody drug conjugate targeting HER2. 22. Patients with any mental or cognitive impairment that may restrict their understanding and implementation of the informed consent form. 23. Other serious or uncontrollable diseases or conditions that may affect the evaluation of the primary endpoint or the investigator believes that participation in this study may bring risks to the patient
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-18.0, Ultrasound Children Surgery Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia are included in the study will be, having a nasogastric tube inserted and patient refusal
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-999.0, Diffuse Large B-cell Lymphoma Histologically proven DLBCL and associated subtypes, according to the WHO 2016 classification including DLBCL not otherwise specified (NOS) High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double hit lymphoma/triple hit lymphoma) High-grade BCL, NOS Primary (thymic) large mediastinal BCL Disease transformed from an earlier diagnosis of low-grade lymphoma (e.g. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with DLBCL disease progression subsequent to DLBCL directed systemic treatment. 2. Relapsed or refractory disease after first-line chemoimmunotherapy Refractory disease is defined as no CR to first-line therapy PD as best response after at least 4 full cycles of R-CHOP (rituximab, cyclophosphamide, hydroxydaunorubicin, oncovin and prednisone) cycles as first-line therapy Stable disease (SD) after 6 R-CHOP cycles as first-line therapy PR as best response after at least 6 R-CHOP cycles and biopsy-proven disease progression (except where prohibited due to comorbidities) within ≤ 12 months from the completion of the first-line therapy Contraindications for R-GemOx and BR plus polatuzumab vedotin as judged by the treating physician. 2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy. 3. ECOG performance status > 2. 4. Absolute neutrophil count < 1,000/μL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy required for screening). 5. Platelet count < 50,000/μL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy required for screening). 6. Absolute lymphocyte count < 100/μL. 7. Participants who have CNS lymphoma involvement in present or past medical history. 8. Known history of infection with human immunodeficiency virus or active infection with hepatitis B (hepatitis B surface antigen positive). 9. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction negative. 10. Active infection with SARS-CoV-2. 11. Known history or evidence of severely immunocompromised state; i.e. corticosteroid treatment > 10 mg/day for more than 6 months. 12. Has received vaccination with live virus vaccines within 6 weeks prior to randomisation. 13. Prior CD19 targeted therapy 14. Known history or presence of seizure activities or on active antiseizure medications within the previous 12 months. 15. Presence of CNS disease that, in the judgement of the investigator, may impair the ability to evaluate neurotoxicity. 16. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease. 17. Known history or presence of cerebral vascular accident (CVA) within 12 months prior to randomisation. Note: In case of history of CVA > 12 months prior to leukapheresis, then the participant must not have any unstable or life-threatening neurological deficits. 18. Participants with Richter's transformation or Richter's syndrome. 19. Participants who are concurrently on any other experimental treatments or during the previous 4 weeks or 5-half-lives. 20. Clinical heart failure with New York Heart Association class ≥ 2 or LVEF < 30%. 21. Resting peripheral oxygen saturation < 90% on room air. 22. Liver dysfunction as indicated by total bilirubin, aspartate aminotransferase and/or alanine aminotransferase > 5 × institutional upper limit of normal (ULN). 23. Serum creatinine ≥ 2.0 × ULN or CrCl < 30 mL/min calculated according to the modified formula of MDRD. 24. Pregnant or breast-feeding woman. 25. Prior history of malignancies other than DLBCL, unless the participant has been free of the disease for ≥ 3 years prior to screening. Exceptions to the ≥ 3-year time limit history of the following Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Carcinoma in situ of the bladder Incidental histological finding of untreated localized (T1a or T1b) prostate cancer under surveillance. 26. History of severe immediate hypersensitivity reaction against any drug or its ingredients/impurities that is scheduled to be given during study participation e.g. as part of the mandatory lymphodepletion protocol, premedication for infusion, or rescue medication/salvage therapies for treatment-related toxicities. 27. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment. 28. Refusal to participate in CAR T long-term follow-up (LTFU)
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 0.0-18.0, Covid19 SARS-CoV-2 Younger than 18 years of age Had SARS-CoV-2 NAT testing performed during the ED visit as part of an ongoing active asymptomatic surveillance program: 1. Exposed (SARS-CoV-2 positive) specific: Was found positive by SARS-CoV-2 NAT testing in the ongoing active surveillance program 2. Unexposed (SARS-CoV-2 negative/control) specific: Was found negative by SARS-CoV-2 NAT testing in the ongoing active surveillance program Presence of any of the following viral symptoms commonly associated with SARS-CoV infection: fever, cough, dyspnea/difficulty breathing, generalized fatigue/weakness, myalgia (muscle or body aches), chills, feeling very unwell, sore throat, runny nose, gastrointestinal symptoms (vomiting, diarrhea), conjunctivitis, headache, anosmia (loss of smell), ageusia (loss of taste) or rash in the 24 hours preceding the index visit (when the child was tested for the presence of SARS-CoV-2) Previously diagnosed with SARS-CoV-2 infection based on a positive swab or serology (blood) test Decline to provide informed consent and/or assent, as required
|
0
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 12.0-999.0, Atypical Hemolytic Uremic Syndrome Body weight >= 40 kg at screening Vaccination against Neisseria meningitidis For participants receiving other therapies (e.g., immunosuppressants, corticosteroids, mTORi, or calcineurin inhibitors: stable dose for 28 days For female participants of childbearing potential: an agreement to remain abstinent or use contraception Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant Evidence of TMA (for Naive Cohort only) Onset of TMA =<28 days prior to first crovalimab administration (for Naive Cohort only) Documented treatment with a C5 inhibitor (for Switch Cohort only) Clinical evidence of response to a C5 inhibitor (for Switch Cohort only) Known C5 polymorphism (for C5 SNP Cohort only) TMA associated with non-aHUS related renal disease Positive direct Coombs test Chronic dialysis and/or end stage renal disease Identified drug exposure-related TMA Presence or history of a condition that could trigger TMA, such as malignancy, organ transplant (other than kidney transplant) or autoimmune disease History of a kidney disease, other than aHUS History of Neisseria meningitidis infection within 6 months Known or suspected immune deficiency (e.g., history of frequent recurrent infections) Positive HIV test Multi-system organ dysfunction or failure
|
1
|
A 17 year old boy complains of vomiting, non-bloody diarrhea, abdominal pain, fever, chills and loss of appetite for the past 3 days. He ate a salad at a restaurant prior to his diarrhea onset. Physical exam was remarkable for pallor, jaundice, and diffuse abdominal tenderness. Lab results were as follows: Hemoglobin: 9.7 g/dL Platelet: 110,000 /cu.mm Creatinine: 3.6 mg/dL blood urea nitrogen (BUN): 73 mg/dL direct bilirubin: 2.4 mg/dL lactate dehydrogenase (LDH): 881 IU/L (normal: 110-265 IU/L) Peripheral blood smear showed a moderate number of schistocytes and helmet cells. Shiga-like toxin-producing E. coli (STEC) stx1/stx2 were found in stools. He has no other underlying disease and he is not on any medications.
|
eligible ages (years): 18.0-999.0, COVID-19 Patients must be 18 years of age or older, of either gender Patients must be tested positive for SARS-CoV-2 by RT-PCR Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc Patients must be in the early stage of COVID-19 disease who do not require hospitalisation at the time of screening Patients must be under the care of a Physician for diagnosis of COVID-19 Patients who have signed informed consent Patients with proven hypersensitivity or allergic reaction to quercetin Patients with known chronic kidney disease with estimated creatinine clearance < 50 mL/minute or need for dialysis Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure Patients with moderate or severe thrombocytopenia (platelet count <100 × 10⁹/L) Pregnant patients Patients declining to participate
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 16.0-999.0, HIV Infections Patients may be eligible for the main study if they Became infected with HIV within the last 120 days Are at least age 16 and have written consent of a parent or guardian if under 18 Are willing to practice abstinence or use barrier methods of birth control, such as condoms Are available for at least 72 weeks Patients may be eligible for 1 of the 2 substudies if they Are at least age 16 and have written consent of a parent or guardian if under 18 Have had HIV infection for more than 1 year and have a CD4 cell count greater than 500 cells/mm3, or do not have HIV infection but are at risk of getting HIV because of their lifestyle, such as sexual activity or injection drug use Have never had hepatitis B infection or a hepatitis B vaccine and they are available for 28 weeks (hepatitis B vaccine substudy only) Have not received a tetanus shot in the past 5 years, have never had an allergic reaction to a tetanus shot, and are available for 8 weeks (tetanus shot substudy only) Patients will not be eligible for the main study if they Have taken anti-HIV drugs for more than 7 days for the treatment of HIV. However, anti-HIV drugs taken to help prevent HIV are acceptable Have certain types of cancer Are receiving an experimental treatment Are pregnant or breast-feeding Are allergic to study drugs Have taken certain medications that may interfere with the study Patients will not be eligible for 1 of the 2 substudies if they Are receiving an experimental treatment Are pregnant or breast-feeding
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 8.0-99.0, Pulmonary Disease Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician. Consenting to pregnancy testing in minors of childbearing age: We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end Patients without symptoms of pulmonary disease will be excluded from this protocol
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-55.0, Breast Cancer Perioperative/Postoperative Complications Women age 18 to 55 years 2. Regular menstrual cycles of 21 to 35-days duration 3. Pathologic stages I to II breast cancer, in whom all gross disease-including ductal carcinoma in situ-was surgically removed either in a one-stage or two-stage procedure. 4. required serum be drawn within 1 calendar day of the lumpectomy/mastectomy for women who underwent a one-stage procedure and within 1 calendar day of each stage for women who underwent a two-stage procedure Lactation within the past 3 months 2. galactorrhea 3. neoadjuvant therapy 4. previous breast cancer, and history of any cancer (except squamous or basal cell skin carcinoma) in which the patient was not disease-free for at least 10 years
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, Influenza Volunteers may be eligible for this trial if they Are able to and have given informed consent Are able to understand and comply with all study procedures and to complete study diary Are aged 18 to 49 years Are female, and are not pregnant Are available for all study visits Volunteers will not be eligible for this trial if they Are allergic to eggs or egg products Have a current chronic medical condition for which influenza vaccine is normally recommended Have received experimental vaccines or medications within 30 days of study entry Have received parenteral immunoglobulin within 30 days of study entry
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-100.0, Breast Cancer Menstrual Cycle Study: To participate in the Menstrual Cycle Pilot Study, a woman must: Must be at least 25 years of age (or 5 years younger than the age at diagnosis of the youngest family member with a tumor associated with the Breast-Ovarian Cancer Syndrome) and less than 46 years of age. Must be premenopausal as determined by menstrual history (no change in menstrual pattern in prior 6 months) and an FSH level less than 15 mIU/ml obtained on the third day of the menstrual cycle. Have undergone genetic counseling and risk assessment. Must be a known mutation carrier or be a first or second-degree relative of an individual with a tumor associated with the Breast-Ovarian Cancer Syndrome in a family with a known BRCA mutation. Agree to release of genetic test result for stratification purposes, whether or not she has chosen to receive individual test results for clinical decision-making. Be willing to use non-hormonal methods of contraception until completion of the 3 month follow-up studies. Have an ECOG performance status of 0-1. Be able to provide informed consent Menstrual Cycle Study: Any of the following will result in from the Menstrual Cycle Pilot Study: A history of menstrual cycle irregularities over the previous 6 months, including history of cycles less than 26 days or more than 35 days. Steroid therapy, use of selective estrogen receptor modulators (SERMs) or hormonal agents (including tamoxifen, raloxifene, estrogen, DHEA, anabolic steroids, oral contraceptives, depoprovera, progestin IUD, oral progestins, norplant, or drugs to induce ovulation) within 6 months prior to study entry and must agree not to use these compounds until completion of the three-month follow-up study. Pregnancy or lactation within 12 months of enrollment. History of infertility with a suspected ovarian etiology or persistent ovarian cyst. Abnormal CA-125 level. History of invasive cancer except for non-melanoma skin cancer or cervical carcinoma in situ. Creatinine greater than 2. Previous bilateral mastectomy, bilateral radiation therapy to the breast, or oophorectomy. History of DCIS or LCIS . Weight over 136 kilograms. Allergy to gadolinium. Allergy to lidocaine or Marcaine (bupivacaine) (excluded from breast duct lavage only). Medical or psychiatric disorder which, in the opinion of the Principal Investigator, would preclude informed consent or ability to participate in clinical research Training Cohort: To participate in the Training Cohort a volunteer must Be female and at least 18 years and less than 51 years of age Have at least one breast considered eligible for study Provide evidence (either films or radiologist's report) of a mammogram done within the 12 months prior to enrollment showing low or no suspicion of carcinoma in at least one breast. (Mammograms will not be provided to participants as part of the training cohort.) Have a physical examination of the breast to be studied consistent with low or no suspicion of carcinoma at the time of enrollment Provide the name of a primary care physician to whom the results of breast duct lavage cytologies can be sent Have signed the informed consent for breast duct lavage Training Cohort: Any of the following will a potential participant from the Training Cohort Pregnancy or lactation within the past 12 prior to enrollment
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Usher Syndrome Retinitis Pigmentosa Congenital Hearing Impairment Any Ashkenazi Jewish individual with combined hearing and visual loss that is or may be any type of Usher syndrome, or a family member of said individual Any individual who is not an Ashkenazi Jew or does not have combined hearing and visual loss or whose disease has been previously determined not to be Usher syndrome
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Recurrent Non-small Cell Lung Cancer Recurrent Ovarian Epithelial Cancer Recurrent Squamous Cell Carcinoma of the Hypopharynx Recurrent Squamous Cell Carcinoma of the Larynx Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity Recurrent Squamous Cell Carcinoma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Oropharynx Stage III Squamous Cell Carcinoma of the Hypopharynx Stage III Squamous Cell Carcinoma of the Larynx Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity Stage III Squamous Cell Carcinoma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Oropharynx Stage IIIA Non-small Cell Lung Cancer Stage IIIA Ovarian Epithelial Cancer Stage IIIB Non-small Cell Lung Cancer Stage IIIB Ovarian Epithelial Cancer Stage IIIC Ovarian Epithelial Cancer Stage IV Non-small Cell Lung Cancer Stage IV Ovarian Epithelial Cancer Stage IV Squamous Cell Carcinoma of the Hypopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx Stage IVA Squamous Cell Carcinoma of the Larynx Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVA Squamous Cell Carcinoma of the Oropharynx Stage IVB Squamous Cell Carcinoma of the Larynx Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVB Squamous Cell Carcinoma of the Oropharynx Stage IVC Squamous Cell Carcinoma of the Larynx Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity Stage IVC Squamous Cell Carcinoma of the Oropharynx Patients must have histologically or cytologically confirmed metastatic or unresectable non-small cell lung cancer, squamous cell carcinoma of the head and neck, or ovarian cancer Eligible patients must have been off previous anticancer therapy including chemotherapy, radiotherapy, biological therapy, or other investigational therapy for at least 4 weeks before study entry (6 weeks if prior therapy included nitrosoureas or mitomycin C) ECOG performance status =< 2 (Karnofsky >= 60%) Life expectancy of greater than 12 weeks Leukocytes >= 3,000/ul Absolute neutrophil count >= 1,500/ul Platelets >= 100,000/ul Total bilirubin within normal institutional limits Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal Patients must have measurable or assessable disease Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients with prior treatment with small molecule inhibitors of EGFR, including erlotinib and gefitinib, are not eligible for this study Patients may not be receiving any other investigational agents Patients with uncontrolled brain metastasis; patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 4 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because OSI-774 is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with either agent HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated Patients with significant ophthalmologic abnormalities, including: severe dry eye syndrome, kerato-conjunctivitis sicca, Sjogren's syndrome, severe exposure keratopathy, disorders that might increase the risk for epithelium-related complications (e.g. bullous keratopathy, aniridia, severe chemical burns, neutrophilic keratitis); patients with mild forms of any of the above, an asymptomatic history, or a normal ophthalmologic examination may be considered for at the discretion of the investigator; an ophthalmologic exam is not needed prior to this study unless clinically indicated; patients with treatable conditions (e.g. infectious keratitis/conjunctivitis, allergic conjunctivitis) may be reevaluated for study after treatment or resolution of the condition; use of contact lenses during the course of this trial may increase the risk of corneal complications and will be strongly discouraged Serious, non-healing wound ulcer, or bone fracture Major surgical procedure, open biopsy or significant traumatic injury within 14 days prior to Day 1; following such procedures or injuries, wound healing should be evident prior to initiation of therapy
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Asthma Asthma symptoms brought on by allergies Patient has any lung disease Currently have a sinus infection or cold symptoms
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Neoplasms Patients must have a solid tumor malignancy that is metastatic or unresectable and for which standard curative therapies do not exist or are no longer effective. Patients must have histological documentation of cancer confirmed in the Laboratory of Pathology/NCI. Patients must be off prior chemotherapy, radiation therapy, hormonal therapy, or biological therapy for at least 4 weeks. Patients who were receiving mitomycin C, nitrosoureas, or carboplatin must be 6 weeks from the last administration of chemotherapy. Patients with prostate cancer must continue to receive LHRH agonist (unless orchiectomy has been performed). Patients should not be receiving complementary/alternative therapy while on study. Furthermore, complementary therapy should be stopped at least 7 days prior to enrollment. Any patient who has undergone therapy with a monoclonal antibody must be at least 8 weeks from the last treatment. All patients enrolling in cohort 2 must have at least one lesion amenable to biopsy. This determination will be made by a member of the interventional radiology team or surgical associate investigator and an associate investigator. This requirement is not necessary for patients in cohort 1. Age greater than 18 years. ECOG performance status 0 or 1. Life expectancy of greater than 3 months. Patients must have adequate organ and marrow function as defined below Leukocytes greater than 3,000/microliter Absolute neutrophil count greater than 1,200/microliter Platelets greater than 100,000/microliter Total Bilirubin less than or equal to 1.5 times the institutional upper limits of normal AST(SGOT) and ALT(SGPT) less than or equal to 2.5 times the institutional upper limit of normal Creatinine less than or equal to 1.5 mg/dL OR creatinine clearance greater than 45 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal Activated partial thromboplastin time (PTT) less than 1.25 times the institutional upper limits of normal Prothrombin Time (PT) OR INR less than 1.25 times the institutional upper limits of normal Amylase and Lipase less than or equal to the institutional upper limit of normal Spot Urine Protein Creatinine Ratio less than 0.5; If result is 0.5 or more, a 24-hour urine for protein excretion must be less than 1000mg Patients must have recovered from toxicity related to prior therapy to at least CTEP grade 1 (defined by CTC 3.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis by the Principal Investigator. Women of child-bearing potential and men must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 months after completion. Pregnant women will not be eligible for study. Ability to understand and the willingness to sign a written informed consent document Brain metastases Patients who have a history of remote CNS metastases that have undergone "curative therapy" by radiation therapy, gamma knife therapy, or surgery and have remained without recurrence for a period of greater than or equal to 2 years will be considered on a case-by-case basis CNS imaging will not be mandated for all patients. However, if there is clinical suspicion of CNS involvement, a contrast CT or MRI of the brain will be required. Screening CNS scans should be required for certain tumor types with relatively high risk of CNS metastases, including but not limited to melanoma, RCC, breast, lung. Thrombotic or embolic events within the past 6 months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism, unstable angina, or myocardial infarction. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (AHA Class II or worse), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. -Patients with evidence of active infection will become eligible for reconsideration 7 days after completing antibiotic therapy. HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006, bevacizumab, and/or the combination. Patients who have been treated with BAY 43-9006 or bevacizumab will be excluded Hypertension defined as systolic blood pressure greater than 140 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management. Proteinuria defined as a 24-hour urine protein excretion greater than 1000 mg. Spot urine analysis for protein creatinine ratio (UPC) of 0.5 or greater will require a 24-hour urine to determine for enrollment. Therapeutic anticoagulation with coumadin, heparins, or heparinoids. Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months of fracture. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abcesses within 28 days will be excluded. Evidence of bleeding diathesis Impairment of swallowing that would preclude administration of BAY 43-9006. History of hemoptysis or surgery within the past 28 days. Patients with squamous cell carcinoma of the lungs will be excluded due to risk of fatal pulmonary hemorrhage. If a patient has a history of any type primary lung cancer and hemoptysis, they will be excluded. History of high grade varices. Use of herbal supplements are not permitted within 14 days of trial commencement and on study. Vitamin supplement (above a typical single multi-vitamin) usage is discouraged unless clearly indicated by an existing medical condition. An Associate or Principal Investigator will have the discretion regarding which vitamin supplements are permitted. Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.5-17.0, Influenza Informed consent from parent/guardian and assent from participants, when applicable, must have been obtained and signed freely Between the ages of 6 months and 17 years Three months have elapsed since liver transplantation Recipient of a liver transplant or live with a sibling who is the recipient of a liver transplant Must have the ability to comply with the study procedures for the entire length of the study Previous immunization with an influenza vaccine for the 2004-2005 or 2005-2006 influenza season Known hypersensitivity reaction to the vaccine or vaccine component including eggs or gelatin History of Guillian-Barré syndrome Receipt of an immunoglobulin product (including intravenous or intramuscular immunoglobulin preparations, cytomegalovirus hyperimmunoglobulin and varicella-zoster immunoglobulin) within 3 months of vaccination Receipt of any live viral vaccines within 4 weeks or an inactivated viral vaccine within 2 weeks of enrollment Subjects who have experienced an acute febrile illness within the preceding 48 hours will have immunization deferred and be rescheduled once their fever has resolved
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 14.0-999.0, Tonsillitis At least 3 tonsillitis episodes during the preceding year (at least one verified by culture or antigen testing) Other serious illness Long term antibiotic treatment for other disease Documented immunologic disorder Pregnancy
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Influenza The subject is a part-time or full-time employee at a major corporation. 2. The subject is eighteen years of age or older. 3. The subject is comfortable reading and writing in English. 4. The subject has reliable internet access at home, at school, or at work. 5. The subject uses email regularly (i.e. at least once every 2 days) 6. The subject does not have a known allergy to chicken eggs or a history of a severe reaction to an influenza vaccination in the past
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Ambulatory Children With Single Ventricle Patients with single ventricle anatomy undergoing routine, elective cardiac catheterization prior to second stage palliation. 2. Parental consent to participate in the study - Admission to the Intensive Care Unit or intubation prior to catheterization 2. Emergent catheterization -
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-64.0, Influenza Subject is healthy, as determined by medical history 2. Over 18 years of age and not yet 65 years old 3. Provides written informed consent 4. Able to attend all scheduled visits and to comply with all trial procedures 5. Women may be menopausal of 1 year or more or sugically sterile. Women of child-bearing potential must agree to be abstinent or to use a licensed form of barrier or hormonal contraception for the entire study period, and have a negative pregnancy test within 24 hours prior to vaccination Breast-feeding 2. Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination 3. Planned participation in another clinical trial during the present trial period 4. History of Guillain-Barré Syndrome 5. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy 6. Hypersensitivity to any of the vaccine components (including eggs or egg products or thimerosol and gelatin) or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances 7. Chronic illness that could interfere with trial conduct or completion 8. Blood or blood-derived products received in the past 3 months 9. Has received any inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to enrollment into this study 10. Vaccination planned within the 4 weeks following the trial vaccination 11. Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity 12. Prior vaccination against influenza within the past 6 months 13. Allergy shot in the 7-day period prior to enrollment and must not be scheduled to receive any allergy shots in the 7-day period after enrollment 14. On coumadin or heparin therapy or has known thrombocytopenia or bleeding disorder contraindicating vaccination 15. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent 16. Febrile illness temperature >= 37.5°C on Day 0, prior to enrollment and vaccination 17. Any condition, that, in the opinion of the investigator, would pose a health risk to the participant 18. History of alcohol or drug abuse in the last 5 years 19. Planned travel outside the US between vaccination and the second study visit 20. Presence of any active skin disease at the injection site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 1.0-30.0, Acute Lymphocytic Leukemia Newly Diagnosed ALL, excluding mature B-cell ALL (surface Ig positive) Patients with overt CNS (central nervous system) or testicular disease are eligible Informed consent according to institutional and FDA guidelines Adequate organ function is required HIV seropositive patients will not be excluded from this study Patients greater than 1 year of age and less than 29.99 years of age are eligible Patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible All patients with evidence of significant organ dysfunction not thought to be attributable to ALL (patients with clinically significant congestive heart failure, cardiac ejection fraction <40%, total bilirubin >2, serum creatinine >2) will be ineligible. Note: echocardiogram or MUGA are required prior to therapy ONLY for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or ALL. Note: Patients with total bilirubin >2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. These patients should be evaluated for deficiency of the enzyme glucuronyl transferase
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Von Willebrand Disease Females of reproductive age with regular menstrual cycles and a diagnosis of von Willebrand disease according to the International Society of Thrombosis and Hemostasis diagnostic criteria Females who are pregnant, or have a history of endocrinopathy or hormone imbalance History of hysterectomy or bilateral oophorectomy History of ovarian or uterine cancer Use of intrauterine device Use of antifibrinolytic therapy, hemostatic agents, or anti-platelet agents
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-65.0, Major Depressive Disorder Depression Women, ages 18-65 years old Fulfilling DSM-IV for major depressive disorder, which is not secondary to another pre-existing psychiatric condition or to a medical condition Hamilton Depression Rating Scale (HAM-D-17) total score of at least 16 Able and willing to give meaningful written consent women premenopausal (having monthly periods); 28 women perimenopausal (having irregular periods); and 28 women menopausal (without a period for at least one year) In good physical health Subjects who are taking the birth control pill currently or within the last 3 months Subjects who plan to become pregnant or were pregnant within the last year Subjects who are taking hormone replacement therapy (or received it within the last three [3] months) Subjects who meet DSM-IV for substance abuse (consume > 4 alcoholic beverages per day) Subjects who have tried 2 antidepressants for this episode Subjects who have additional diagnosed psychiatric conditions (i.e. anxiety, substance use and psychotic disorders) Subjects who have had both ovaries surgically removed
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Perennial Allergic Rhinitis Have a documented history of allergy to perennial allergens and demonstrated sensitivity by the results of prick or intradermal skin testing Have a self-reported history of at least mild, intermittent rhinorrhea and nasal blockage/stuffiness due to allergies Have not started or had a change in immunotherapy regimen Have a physical obstruction in the nose Will likely have an acute increase in severity of allergic rhinitis due to seasonal aeroallergens during the trial Have acute or chronic sinusitis or had previous sinus surgery resulting in a significant change in the sinus or nasal anatomy Have rhinitis medicamentosa or any other acute or chronic condition that could confound evaluations of nasal symptoms Have asthma of sufficient severity to require use of excluded medications Have taken any medications excluded as listed in the protocol Have a clinically significant acute or chronic disease or clinically significant laboratory abnormality Are a current smoker, recent smoker or past smoker as defined in the protocol
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.673-999.0, Language Development Disorders Intention to receive primary care in the well-child clinic (FCC or newborn clinic) at Bellevue Hospital Center Intention to remain in the New York City area for at least 3 years Primary caregiver's language is English or Spanish Birthweight 2000gm or higher Gestational age 35 weeks or higher Significant newborn medical complication Significant congenital anomaly or syndrome
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 25.0-49.0, Leiomyoma patients who are willing and able to participate in the study patients from whom written informed consent has been obtained patients who contribute to the National Insurance Scheme patients with an age between 25 and 49 years old non menopausal patients patients who use a non hormonal contraception patients with one or several , interstitial or subserous, uterine leiomyomas echographic diameter of leiomyomas must be equal or higher than 30 mm leiomyomas must be symptomatic
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 10.0-999.0, Allergic Conjunctivitis history of ocular allergies and a positive skin test reaction to cat hair cat dander, grasses, ragweed, and/or trees within the past 24 months calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction narrow angle glaucoma clinically significant blepharitis, follicular conjunctivitis, iritis pterygium or diagnosis of dry eye ocular surgical intervention within 3 months history of refractive surgery within 6 months known history of retinal detachment, diabetic retinopathy, or progressive retinal disease presence of active ocular infection positive history of an ocular herpetic infection preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 10.0-999.0, Allergic Conjunctivitis history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; calculated best-corrected visual acuity of 0.6 logMar or better in each eye; positive bilateral conjunctival allergy challenge reaction - narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or diagnosis of dry eye; ocular surgical intervention within 3 months; history of refractive surgery within 6 months; known history of retinal detachment, diabetic retinopathy, or progressive retinal disease; presence of active ocular infection positive history of an ocular herpetic infection; preauricular lymphadenopath; manifest signs or symptoms of clinically active allergic conjunctivitis
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-55.0, Plague Healthy males or females. 2. Aged between 18-55 years (inclusive) on Day 0 of the Study. 3. Of a body mass index (BMI) of 18-35 inclusive. 4. Able to understand the informed consent form and other documents required to be read by the subject. 5. Willing to give signed informed consent 6. Able to give a medical history without major organ pathology (e.g. cardiac, immunological, psychiatric, endocrine or neurological disorders, cancer or other wasting diseases (adequately treated actinic keratosis, or basal cell carcinoma [BCC], or carcinoma in situ [CIS] of the cervix are permitted). 7. In the case of female subjects, they may be enrolled if one of the following applies: Either Is not pregnant or breast feeding AND is routinely using adequate injectable or transdermal (administered at the recommended frequency) or oral contraception (at a stable dose for at least three months prior to the first dose of vaccine) and will continue to do so during the study, augmenting this contraceptive measure with a barrier method OR is sexually abstinent OR is monogamous and has a partner who has had a vasectomy (>1 month previously) OR is using a commonly recognised copper and hormone implanted intrauterine device (IUD) such as TCu-380A, TCu-220C, MLCu-375, Nova-T or LNG-20. In addition, the subject must have a negative blood pregnancy test prior to enrolment into the study (see also Criterion 9 below). Or Is post menopausal (defined as a female with no menstrual cycle for at least the previous 24 months AND is of menopausal age (>45 years) Or Has not had a menstrual cycle for between 12 and 24 months AND is of menopausal age (>45 years) AND has had a negative blood pregnancy test prior to enrolment into the study and a negative urine pregnancy test pre-dose. Or Has been surgically sterilised (confirmed by review of medical record). Or Has had a total hysterectomy at least 3 months prior to the start of the study (confirmed by review of medical record). 8. A male may be enrolled if willing to use barrier methods of contraception and whose partner is using an acceptable form of contraception for 3 months after each dose. 9. A female subject must have a negative urine pregnancy test prior to each dosing (unless post-menopausal, surgically sterilised, or has had a total hysterectomy, as defined in Criterion 7 above). 10. 12-lead electrocardiogram (ECG) recording without signs of pathology and conduction disturbances and with a QTc interval of < 450 msec for males and < 470 msec for females. ECGs will be analysed automatically for study entry purposes and will also be analysed by a cardiologist within 24 hours. QT intervals will be recorded automatically by the ECG machines used Presence of any clinically significant medical condition as determined by the Investigator. 2. History of clinically significant hypersensitivity or idiosyncratic reaction related to any medical product, including vaccines and aminoglycoside antibiotics (such as kanamycin). 3. History or evidence of drug misuse. 4. Participation in a clinical study of an investigational vaccine within 3 months prior to the start of the study (Day 0) or an investigational drug product within 30 days prior to the start of the study. 5. Use of any prescription or non-prescription medication within 7 days prior to the first dosing with the exception of over-the-counter (OTC) antihistamines, non-steroidal anti-inflammatory drugs (NSAID) including aspirin, acetaminophen, OTC decongestants, herbal medicines (except St. John's Wort), oral/injectable/transdermal contraceptives, OTC multi-vitamin preparations (not high-dose preparations) or oral iron supplements. Any medication taken within 7 days of the first dosing will be documented. 6. History or suspicion of inability to co-operate adequately. 7. Donation of blood or blood products during the 4 weeks prior to participation in the study (Day 0). 8. Immunodeficiency or clinically active autoimmune disease. 9. Positive urine alcohol and/or drug screen for drugs of misuse (opiates, methadone, cocaine, amphetamines, cannabinoids, and barbiturates). 10. Positive serological test for human immunodeficiency virus (HIV), and/or hepatitis B virus and/or hepatitis C virus. 11. Vaccination(s) with a live vaccine in the 4 weeks prior to participation in the study, (or 'flu vaccine in the 2 weeks prior to participation), or killed / inactivated / sub-unit vaccines in the previous 3 weeks. 12. Receipt of blood or plasma transfusions, or pooled gamma globulin, in the 3 months prior to participation in the study (Day 0) and/or a need for future blood or plasma transfusions during this study. 13. Prior receipt of any plague vaccine. 14. Prior history of plague infection (confirmed or suspected) or significant exposure to Y. pestis (e.g. a laboratory worker who regularly handles Y. pestis) as judged by the investigator. 15. Clinically relevant abnormal findings on routine physical examination. 16. Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatinine, serum electrolytes (sodium, potassium, chloride and bicarbonate), liver function tests (ALT, AST and GGT), lactate dehydrogenase (LDH), white blood cell count, absolute neutrophil count, platelet count, clotting and blood haemoglobin. Minor, out-of-range laboratory test results for the above tests may be allowable, at the discretion of the Investigator, if such results are within 10% of the normal ranges and considered to be not clinically significant. 17. Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator. 18. Presence of tattoos that cover or partially cover the upper arm, and which would limit adequate assessment of the injection site
|
1
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, Influenza Subject is healthy, as determined by medical history and clinical assessment before entering the study Between the ages of 18 and 49 (greater than or equal to 18 and less than 50) Provides written informed consent Able to attend all scheduled visits and to comply with all trial procedures For a woman, menopausal or surgically sterile or negative serum/urine pregnancy test within 24 hours prior to the time of vaccination Breast-feeding or pregnant History of receiving 2003-2004, 2004-2005 or 2005-2006 influenza vaccine Known allergy to eggs or other components of the vaccine (e.g., thimerosal) History of a severe reaction following influenza vaccination, systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing the same substances History of Guillain-Barre Syndrome Immunosuppression as a result of underlying illness or treatment Use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 mcg per day of beclomethasone dipropionate or equivalent) within 1 month prior to vaccination Use of other immunosuppressive or cytotoxic drugs or radiation therapy within the six months prior to vaccination Active neoplastic disease or history of any hematologic malignancy in the past 5 years (except localized skin or prostate cancer that is stable in the absence of therapy) Acute or chronic condition that (in the opinion of the Investigator) would render vaccination unsafe or would interfere with the evaluation of responses including, but not limited to the following: known chronic liver disease, significant renal disease, oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV, unstable or progressive neurologic disorder, insulin-treated diabetes mellitus
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-40.0, Tobacco Use Disorder History of smoking 10-25 cigarettes daily for the past 12 months Score of at least 5 on the Fagerström Nicotine Tolerance Questionnaire Carbon monoxide level greater than 10 ppm Body mass index between 19 to 36 Currently in good health, as determined by medical history, screening examination, and laboratory tests If female, regular menstrual cycle every 25 to 35 days If female, willing to use non-hormonal contraception throughout the study Seeking treatment for nicotine dependence History of major medical illness, including liver disease; abnormal vaginal bleeding; suspected or known tumors; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; stroke; or other medical conditions that are considered unsafe for study participants by the investigator Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) Recent diagnosis and treatment for Axis I disorders, including major depression, bipolar affective disorder, schizophrenia, or panic disorder Currently abusing alcohol or other recreational or prescription drugs Current use of any tobacco products other than cigarettes, including smokeless tobacco and nicotine products Known allergy to progesterone Known allergy to peanuts If female, amenorrhea Pregnant or breastfeeding
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Cyclic Breast Pain, Cyclic Mastalgia A woman is eligible for this study if she is pre-menopausal and at least 18 years of age has a history of cyclical mastalgia for each of the four months prior to study entry moderate or severe mastalgia as determined by >40 mm on the VAS for ≥7 days per cycle in the second part of the cycle, i.e. 13 days prior to menses and the first two days of the next cycle with a substantial decrease during the two weeks following the onset of menses, assessed during the two month run-in period has a history of regular menstrual cycles of 28 plus/minus 3 days
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-120.0, Chronic Myeloproliferative Disorders Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Chronic idiopathic myelofibrosis or myelodysplastic/myeloproliferative disorders (MDS/MPD), including the following subtypes Chronic idiopathic myelofibrosis (with extramedullary hematopoiesis) Chronic myelomonocytic leukemia (CMML) Atypical chronic myeloid leukemia MDS/MPD disease, unclassifiable MDS with ≥ 2+ fibrosis present in the bone marrow Patients with MPD must be negative by fluorescent in situ hybridization (FISH) for the BCR/ABL fusion gene ECOG performance status 0-2 Life expectancy of at least 3 months Platelet count > 10,000/mm³
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-64.0, Influenza Able to understand and comply with all study procedures including availability for all study visits and follow up surveys within 6 months following study enrollment DEERS eligible beneficiaries eligible for influenza vaccination and able to give informed consent Age 18-49 Patients presenting to travel clinic with no Household contacts and out-of-home caretakers of infants from 6-23 months of age Hospital and/or employees providing service to the public who are not eligible for the post-October 5th recommendations for priority immunization DOD employees eligible for influenza vaccination prior to October 5th but excluded in the post October 5th guidelines People living in dormitories or under other crowded conditions, to prevent outbreaks Ages 50-64 years of age who are not eligible for the post-October 5th recommendations for priority immunization and with no standard of care contraindications to vaccination Eligible in the Department of Defense for influenza vaccination all children aged < 18 years (includes children aged 6 months-18 years on chronic aspirin therapy) adults aged >65 years persons aged 2-64 years with underlying chronic medical conditions includes persons with chronic cardiac or pulmonary disease, diabetes mellitus, hemoglobinopathy, or immunosuppressive illness
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 1.0-999.0, Influenza Avian Influenza Severe Influenza At least one of the following respiratory symptoms: cough, dyspnea, sore throat Evidence of severe influenza or avian influenza, as defined below Severe influenza infection 1. Need for hospitalization 2. One of the following: 1. New infiltrate on chest x-ray (or any infiltrate if no prior chest x-ray or not known) 2. Severe tachypnea (more information on this criterion can be found in the protocol) 3. Severe dyspnea 4. Arterial oxygen saturation of 92% or less on room air by trans-cutaneous method 3. Positive diagnostic testing for influenza, as defined by either rapid influenza antigen (Ag) positive (A or B) or qualitative reverse transcriptase-polymerase chain reaction (RT-PCR) positive for any influenza 4. Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 10 days before study enrollment Avian influenza infection 1. Nasal wash, nasopharyngeal aspirate, endotracheal aspirate, nasal swab, or throat swab that is RT-PCR positive influenza for H5 influenza 2. Illness (defined by onset of fever, respiratory symptoms, or constitutional symptoms) began within 14 days before study enrollment Received more than 72 hours of oseltamivir (six doses) within 14 days Received oseltamivir at higher than standard doses within the last 14 days or during current acute illness, whichever is longer History of allergy or severe intolerance of oseltamivir, as determined by the investigator Alternate explanation for the clinical findings, as determined by the investigator and with the information immediately available Creatine clearance less than 10 ml/minute Pregnant or breastfeeding
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Neural Tube Defects Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Malformations Non-pregnant post menarcheal, premenopausal females who agree to use the assigned study medication as contraception during the study Non-vegan Non-smoker or no history of tobacco use within 6 months Willing to follow protocol-specific prohibitions and restrictions regarding diet, smoking and use of other medications Have taken multivitamins, folic-acid containing supplements, or highly fortified (i.e., >200 mcg folic acid/serving) cereals within 30 days of entry in to the study history or presence of blood clots in the veins, strokes or other blood clotting disorder, liver tumor from pervious contraceptive or estrogen use, disease of the blood vessels of the brain or heart disease, uncontrolled high blood pressure, cancer in any part of the body, diabetes mellitus with complications in the flow of blood in the body, jaundice, visual disturbance, liver disease, undiagnosed vaginal bleeding, gastric bypass surgery, ulcerative colitis or other digestive system disorders, abnormal thyroid function, Vitamin B 12 deficiency or very high red blood cell folate levels, alcohol or substance abuse, positive for drugs of abuse recent use of hormonal contraceptives on any weight reduction diet blood donation within 30 days of study entry
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, HIV Infections HIV-negative Willing to participate and sign and informed consent form Willing to be tested for HIV and to use an experimental vaginal gel Willing to use a reliable form of contraception during the study Willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study Normal cervical assessment Willing to abstain from using any vaginal product (other than the study product) Willing to be sexually abstinent from Day 1 until completion of study product use on Day 10 Currently pregnant or breast-feeding Currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix Currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has Genital Ulcer Disease (GUD) or vaginal candidiasis symptoms; or has an HSV-2 lesion as indicated by clinical diagnosis or laboratory test Symptomatic bacterial vaginosis (BV) and unwilling to undergo treatment Current use of injection drugs
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, HIV Infections HIV-negative Willing to participate and sign an informed consent form Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group Willing to use two forms of contraception during the study Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses Currently pregnant or breast-feeding Clinically detectable genital abnormality on the vulva, vaginal walls or cervix Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment Women who require treatment for tuberculosis (TB) within 21 days prior to randomization
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 60.0-999.0, Influenza Influenza Vaccines Subjects who the investigator believes that they can and will comply with the requirements of the protocol A male or female aged over 60 years at the time of vaccination Written informed consent obtained from the subject Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period Participation in an earlier study with a candidate pandemic H9N2 vaccine Acute disease at the time of enrolment Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality History of allergic disease or reactions likely to be exacerbated by any component of the vaccine Drug and/or alcohol dependency
|
1
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, HIV Infections HIV-1 HIV-negative Willing to participate and sign an informed consent form Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group Willing to use two forms of contraception during the study Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses Currently pregnant or breast-feeding Clinically detectable genital abnormality on the vulva, vaginal walls or cervix Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment Women who require treatment for tuberculosis (TB) within 21 days prior to randomization
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Influenza Working in the production of H5N1 vaccine at Aventis Pasteur facilities at Swiftwater, Pennsylvania. 2. Male or nonpregnant female (as indicated by a negative urine pregnancy test prior to each dose of vaccine), aged 18 years and older. 3. Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (ie, barrier method, abstinence, and licensed hormonal methods) for the entire study period. 4. Is in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history. 5. Able to understand and comply with planned study procedures. 6. Provides informed consent prior to any study procedures and is available for all study visits Has a known allergy to eggs or other components of the vaccine. 2. Has a known allergy or sensitivity to latex (in the stopper). 3. Is breastfeeding. 4. Is undergoing immunosuppression as a result of an underlying illness or treatment. 5. Has an active neoplastic disease or a history of any hematologic malignancy. 6. Is using oral or parenteral steroids, high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs. 7. Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study. 8. Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of vaccination. 9. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 6-month study period. 10. Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 16.0-65.0, Recurrent Aphthous Stomatitis Diagnosis of minor recurrent aphthous stomatitis or more mouth ulcers per month for more than 6 No current treatment for oral ulceration or willing to stop treatment Age 16 to 65 years Taking ketorolac, theophylline or anti-hypertensive medication except diuretics (contra-indicated in patients treated with pentoxifylline) Systemic diseases that contra-indicate the use of pentoxifylline i.e. pregnancy, hypotension, ischaemic heart disease, acute myocardial infarction, cerebral or occular hemorrhage, renal or hepatic failure, porphyria or allergy to pentoxifylline Patients with an underlying deficiency state or systemic disease that could cause recurrent mouth ulcers e.g. iron, vitamin B12 or foliate deficience, coeliac disease, Crohn's disease, ulcerative colitis, Behcet's disease or Aids
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 50.0-999.0, Herpes Zoster Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment History of allergy to any vaccine component Prior receipt of a varicella or zoster vaccine Ability to defend against infection is suppressed by a medical condition or medication
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Abortion, Induced Criteria:Healthy females: 1) 18 years of age or older, 2) requesting an elective termination of pregnancy by medical abortion, 3) with an intrauterine pregnancy no more than 63 days gestation on the day of mifepristone administration as documented by endovaginal ultrasound, 4) willing and able to sign informed consent, 5) willing to comply with the study protocol and visit schedule, 6) willing to have a surgical abortion/D&C if indicated, and 7) with easy and ready access to a telephone. - ultrasound evidence at the evaluation(s) prior to mifepristone treatment of an early pregnancy failure, 2) contraindication to mifepristone (known allergy to mifepristone, chronic corticosteroid administration, adrenal disease), 3) contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, poorly controlled seizure disorder, or known allergy to prostaglandin), 4) known or suspected extrauterine pregnancy, 5) known or suspected pelvic infection, 6) hemoglobin <10 mg/dL, 7) known clotting defect or receiving anticoagulants, 8) cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure), 9) current breastfeeding, 10) pregnancy with an IUD in situ, 11) current use of any experimental drug, 12) suspected or confirmed endometrial arteriovenous malformation, 13) active oral herpes lesions per subject report, 14) prior participation in this research study, or 15) current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study. -
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 35.0-64.0, Breast Cancer Original recruitment were cases identified by the Surveillance, Epidemiology and End Results (SEER) cancer registry several years ago for the data set. Accrual is now completed
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 15.0-19.0, Teen Pregnancy The following will determine for the study: 1. African American and Latino primiparous pregnant or newly parenting (0-6 weeks); 2. Age 15-18 years inclusive; and 3. Teens who are 19 years old if they have not graduated from high school Non-English speaking; 2. Any serious medical condition or disability that would interfere with the participant responding adequately to evaluation measures; 3. Obvious cognitive impairment that interferes in participating in informed consent; 4. Incarceration at enrollment or during the study
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Influenza (Pandemic) Healthy adults volunteers (women must be of nonchild-bearing potential) Provided written informed consent - No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Influenza Healthy adult volunteers (women must be of non child-bearing potential) Provided written informed consent No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment Pre-existing protective level of antibody against the challenge virus strain
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Influenza Ages Eligible for Study Years Years Genders Eligible for Study: Both Accepts Healthy Volunteers Healthy adult volunteers (women must be of non child-bearing potential) Provided written informed consent No significant concomitant illness No allergy to gold No immunosuppression due to disease or treatment No previous flu vaccination in 2005 or 2006
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Healthy Subjects Men or women aged 18 to 50 years Healthy as determined by the investigator History or active presence of clinically important medical disease History of drug or alcohol abuse
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 21.0-49.0, Influenza Subject is between the ages of 21 to 49 years of age on day of enrollment, visit 1(day 0). 2. Provides written informed consent. 3. Subject is judged to be healthy on the basis of verbal medical and concomitant medications history and has been medically stable prior to screening 4. Subject is able to attend scheduled visits and to comply with the study procedures during the entire duration of the study and will be available for 1 month after enrollment. 5. Female is not at risk of pregnancy, based on the following: 1. Utilizing adequate method of birth control and agree to continue using this method for at least 1 month after enrollment. Adequate methods of birth control may hormonal (oral, transdermal, or injectable) or double barrier methods (eg condom with spermicide, vaginal combined ring) or intra-uterine device. If using hormonal method or intra-uterine device, usage should be stable for 1 month prior to vaccination and should continue for 1 month post vaccination. 2. Negative urine pregnancy test is required for all females at study entry. Females surgically sterilized (history of tubal ligation or total or subtotal hysterectomy) or post-menopausal for 2 years must still have a negative pregnancy test at time of enrollment. 6. Subject should be available through telephone contact and agree to participate in all scheduled visits Adults younger than 21 years of age or 50 years and older 2. Subject had physician-diagnosed (preferably by culture) influenza at any time during the past 2 years. 3. Subject received an influenza vaccine in the 6 months preceding enrollment in the study 4. Subjects who receive any live virus vaccine within one month of enrollment and any inactivated or subunit vaccine within 2 weeks of enrollment or with plans to receive any vaccine during this study will be excluded from the study, eg, pneumococcal vaccine. 5. Subject received blood or blood products in the last 3 months. 6. Subject has asthma or reactive airway disease. 7. Subject has a history of any serious vaccine reactions or anaphylaxis or reactions likely to be exacerbated by any component of the study vaccine, 8. Subject is allergic to eggs, egg products or gentamycin. 9. Subject has known or suspected disease(s) of the immune system with immunosuppression, eg, rheumatoid arthritis, systemic lupus erythematosus (SLE), lymphoma, human immunodeficiency virus (HIV), cancer diagnoses or treatment within the last 5 years (except skin cancer), etc. 10. Subject is currently being treated with an immunosuppressive medications (ie, cancer therapeutic agents such as tamoxifen, systemic corticosteroids such as prednisone, and arthritis medications such as methotrexate). Please note that inhaled or topical corticosteriods are acceptable. 11. FluMist recipients in close contact (eg, within the same household) with immunocompromised individuals during periods in which the immunosuppressed person requires care in a protective environment. (contact should be avoided for at least 21 days). Contact with small children is not an exclusion. Females who breastfeed are excluded. 12. Drug interactions: On antiviral therapy in 48 hours preceding scheduled vaccination 13. Antiviral agents administered until 3 weeks after FluMist vaccination. 14. Participation in any other interventional drug or vaccine trial within 30 days prior to enrollment. Therefore subject is not to receive other investigational products (drug or vaccine) during the length of their participation in the trial. 15. Subject has acute respiratory illness. Administration of FluMist should be postponed until after the acute phase (at least 72 hours) of respiratory illnesses. 16. Subject has active infections or illnesses. 17. Subject had an acute illness with or without fever (temperature >/= 99.5 F [oral]) in the 72 hours preceding vaccination. Administration of FluMist should be postponed until after the acute phase (at least 72 hours) of febrile and/or acute illnesses. 18. Subject has acute or chronic medical health condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions but are not limited to health problems associated with 1. heart disease, (if heart failure is present, New York Heart Association Functional Class III or IV), 2. kidney disease, (history of significant renal impairment e.g., dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease), 3. chronic liver disorders (e.g. hepatitis B or C), 4. diabetes mellitus (excluding diet-controlled diabetes), 5. arteriosclerotic event during the 6 months prior to enrollment (eg, history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack), 6. functional or anatomic asplenia, 7. cancer diagnosed and treated within the past 5 years with chemotherapy, radiation therapy and/or surgery 8. significant anemia or other blood disorders. 9. Underlying unstable chronic disease e.g.uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg at Visit 1), etc. 19. Subject has any active neurologic disorders (ie, encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy). 20. Subject is pregnant or planning to become pregnant within the next 2 months. 21. Subject is breastfeeding. 22. Subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 23. Subject has a prior history of Guillain-Barré syndrome. 24. Subject has a history of drug or alcohol abuse
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.5-4.917, Respiratory Infections Diarrhea Malnutrition Age 6-59 months 2. Either sex 3. Severe malnutrition as defined by the presence of any of the followings Bipedal oedema Weight (measured after correction of dehydration) for height Z score <-3 of the National Center for Health Statistics (NCHS) reference Written informed consent of respective parents/ guardians for participation of the children in the study. 4. Children having diarrhoea (watery or invasive) or cough and cold or both for the last 48 hours Failure to obtain consent 2. Received a dose of vitamin A within the last three months 3. History of night blindness or eye signs of vitamin A deficiency 4. Measles or history of measles within last 8 weeks [56] 5. Clinical suspicion of TB (evening rise of temperature, loss of appetite, gradual loss of weight, cough, night sweating) after applying modified Kenneth Jones [57], shock other than due to hypovolaemia or hypoglycaemia, congestive cardiac failure, severe sepsis (hypothermia, tachycardia, tachypnea, hypotension) [58], and seizure disorders 6. Trisomy-21 7. Cerebral palsy 8. Any other known chronic disease (e.g. hepatic, renal or congenital disorder) or malignant condition
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-30.0, Breast Cancer Obesity Healthy women Self-reported menstrual cycle length of 25-35 days within the past 2 months Nonsmoker Sedentary (exercise < 3 times weekly within the past 6 months) Intact ovaries and uterus No history of gynecological problems (e.g., fibroids, endometriosis, polycystic ovary syndrome) Female Premenopausal Body mass index 18.5 to 40 Stable weight (no changes ≥ 10% within the past year) No pregnancy or breast feeding within the past 6 months No plans to become pregnant during study treatment No cancer within the past 5 years except for nonmelanoma skin cancers No medical condition that would prohibit participation in a vigorous program of weight-bearing aerobic exercise including, but not limited to, any of the following Fibromyalgia Chronic fatigue syndrome Metabolic disorders Recent cardiovascular event Orthopedic limitations Psychiatric disorders requiring antipsychotic drugs
|
1
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 21.0-999.0, Influenza Healthy males and females 21 to 40 years of age or between 60 and 89, or 90 years or older at the time of enrollment Subjects must provide written informed consent prior to first study intervention Subject is judged to be healthy on the basis of verbal history and physical examination Subject is able to cooperate with the requirements of the study (must be able to complete the diary cards and will be available for 6 months after enrollment) Subject is mentally capable to give consent based on investigator judgment Females of childbearing potential (all women under the age of 40) must agree to use medically approved contraception and must agree to continue using this method for at least three months after enrollment. Females of childbearing potential on hormonal contraception must be stable on hormonal contraception and must agree to use this method of contraception for at least three months after enrollment. Acceptable forms of medically approved contraception the use of: oral contraceptives, injectable contraceptives (i.e., Depo-Provera), transdermal contraceptives or double barrier method All females 40 years of age and under must have a negative urine pregnancy test prior to any vaccination in this trial. Please note that even those participants that have a history of tubal ligation or hysterectomy or are post menopausal (at least one year of no menses) must still have a negative urine pregnancy test prior to any vaccination in this trial Physical examination must be normal, or abnormal findings must be judged not clinically significant for this patient population by the Physician Investigator Had physician-diagnosed influenza at any time during the past two years Received an influenza vaccine 6 months preceding enrollment in the study Received any other vaccine within 30 days before starting this study or plan to receive any vaccine during the 30 days after enrollment Received immunoglobulin therapy or transfusion with blood or blood products within the previous three months Have known chemical dependency liable to compromise immune function (e.g., alcoholism or illegal drug use not including nicotine or caffeine) Are allergic to eggs or egg products, contact lens solution, or have ever had a severe reaction to any vaccine Have a history of hypersensitivity (allergy) to thimerosal or formaldehyde Have chronic respiratory illnesses (clinically significant and/or on systemic immunosuppressive medications e.g., asthma, COPD, emphysema) Have had symptoms of an active acute respiratory or other active infections or illnesses in the past 72 hours Have a temperature greater than or equal to 100.4 degrees F (38 degrees C) at enrollment
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Influenza Hospital employees, staff physicians, residents, rn's, lpn's non patient care hospital employees
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-60.0, Influenza A Virus, H5N1 Subtype Influenza A Virus Influenzavirus A Orthomyxoviridae H5N1 Virus A participant must meet all of the following 1. 18 to 60 years old. 2. Available for clinical follow-up through Week 42. 3. Immunized with the current season FDA-approved influenza vaccine prior to enrollment at the specified interval [14 days to 24 weeks prior to enrollment for the inactivated influenza vaccine OR 30 days to 24 weeks prior to enrollment for the live-attenuated influenza vaccine (FluMist)]. 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 5. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly. 6. Able and willing to complete the informed consent process. 7. Willing to donate blood for sample storage to be used for future research. 8. In good general health without clinically significant medical history. 9. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than 40 within the 28 days prior to enrollment. Laboratory within 28 days prior to enrollment: 10. Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men. 11. White blood cells (WBC) equal 3,300-12,000 cells/mm(3). 12. Differential either within institutional normal range or accompanied by site physician approval. 13. Total lymphocyte count greater than or equal to 800 cells/mm(3). 14. Platelets equal 125,000 000/mm(3). 15. Alanine aminotransferase (ALT) less than or equal to 1.25 times the upper limit of normal. 16. Serum creatinine less than or equal to 1 x upper limits of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males). 17. Normal urinalysis, defined as negative glucose, negative or trace protein and no clinically significant blood in the urine. 18. Negative FDA-approved HIV blood test. [Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]. 19. Negative hepatitis B surface antigen (HBsAg) 20. Negative anti-hepatitis C virus (HCV) antibody and negative HCV PCR. Female-Specific 21. Negative beta-HCG pregnancy test (urine or serum) for women presumed to be of reproductive potential. 22. A female participant must meet one of the following No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation, OR Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 26 of the study, OR Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 26 of the study by one of the following methods: condoms, male or female, with or without a spermicide; diaphragm or cervical cap with spermicide; intrauterine device; contraceptive pills, patch, implant or any other FDA-approved contraceptive method; male partner has previously undergone a vasectomy A volunteer will be excluded if one or more of the following conditions apply. Women Specific: 1. Breast-feeding or planning to become pregnant during the study. Volunteer has received any of the following substances: 2. Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. [With the exceptions that use of corticosteroid nasal spray for rhinitis; topical corticosteroids for an acute uncomplicated dermatitis; short-acting beta-agonist use in controlled asthmatics; or a short course (10 days or less) of corticosteroids for a non-chronic condition at least 2 weeks prior to enrollment in this study will not study participation.] 3. Blood products within 120 days prior to HIV screening. 4. Immunoglobulin within 60 days prior to HIV screening. 5. Live attenuated vaccines within 30 days prior to initial study vaccine administration. 6. Investigational research agents within 30 days prior to initial study vaccine administration. 7. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration. 8. Current anti-TB prophylaxis or therapy. 9. Previous H5 avian influenza investigational vaccine. Volunteer has a history of any of the following clinically significant conditions: 10. Autoimmune disease or immunodeficiency. 11. Contraindication to receiving an FDA approved 2006-2007 seasonal influenza vaccination (e.g., egg allergy). 12. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain. 13. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema. 14. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids. 15. Diabetes mellitus (type I or II), with the exception of gestational diabetes. 16. History of thyroidectomy or thyroid disease that required medication within the past 12 months. 17. Idiopathic urticaria within the past 2 years. 18. Hypertension that is not well controlled by medication or is more than 145/95 at enrollment. 19. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. 20. Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study. 21. Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years. 22. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. 23. Allergic reaction to aminoglycoside antibiotics. 24. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrollment, a history of suicide plan or attempt. 25. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 20.0-45.0, Healthy Japanese healthy male subjects age 20 to 45 years of age, and in good health At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis Body mass index within the range of 17 to 25 kg/m2 and weigh at least 50 kg Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine 'high' level in checking by NicCheck® I Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable Participation in any clinical investigation within 4 months prior to study start Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to study start Subjects considered unsuitable for participation in the study within 2 weeks prior to dosing A past medical history of clinically significant abnormality detected during electrocardiogram (ECG) examination or an evident family history (grandparents, parents and siblings) of a ECG abnormality (i.e. prolonged QT-interval syndrome) History of fainting, hypotension when standing up, arrhythmia History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated) History of clinically significant drug allergy, history or presence of atopic allergy (asthma, urticaria, eczematous dermatitis) unless inactive seasonal allergy, or history of food allergy. A known hypersensitivity to the study drug or drugs similar to the study drug Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-30.0, Healthy Age equal to or greater than18 years of age 2. No history of allergy or adverse reaction to any NSAID 3. No use of any NSAID in past 2 weeks 4. No history of peptic ulcer disease (PUD), gastroesophageal disease (GERD), or gastritis 5. No major medical history including but not limited to diabetes, hypertension, asthma, kidney disease and coronary artery disease 6. Currently not taking any medication including oral contraceptives Age < 18 years of age 2. History of allergy or adverse reaction to any NSAID 3. Use of any NSAID in past 2 weeks 4. History of a bleeding disorder 5. History of PUD, GERD, or gastritis 6. Pregnant 7. A medical history of diabetes, hypertension, asthma, kidney disease or coronary artery disease 8. Taking any medication including oral contraceptives
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 10.0-999.0, Conjunctivitis, Allergic At least 10 years of age & either sex, any race Willing and able to follow all instructions and attend all study visits Positive history of ocular allergies Have planned surgery during trial period Female currently pregnant, planning a pregnancy, or lactating
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Asthma baseline FEV1 > or = 65% predicted positive methacholine challenge (i.e. methacholine PC20 < or = 16mg/ml positive allergen challenge negative skin prick test lung condition/disease other than asthma currently use montelukast and/or desloratadine
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 1.0-999.0, Influenza Participants should be informed and assent to participate in this study. For children, informed consent should be provided by their parents or legal guardians. Children aged from 10 years old to 18 years old will be asked to assent Adults or children older than 1 year old Satisfying above definition of cases and controls Infants younger than 12 months For any cases or controls who need proxy, they should be excluded under below situations: 1. Proxy can not provide sufficient information for this study, or 2. Proxy refuses to participate in this study, or 3. No suitable proxy can be found
|
2
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.