topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Anxiety Depression Posttraumatic Stress Disorder Psychological Distress Adults of 18 years or above Syrian under temporary protection status Arabic-speaking Elevated levels of psychological distress (K10 >15) and reduced psychosocial functioning (WHODAS 2.0 >16) Acute medical conditions Imminent suicide risk or expressed acute needs/protection risks (e.g., a young woman who expresses that she is at acute risk of being assaulted or killed) Severe mental disorder (psychotic disorders, substance-dependence) Severe cognitive impairment (e.g., severe intellectual disability or dementia) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Trismus Head and Neck Cancer Epidermoid carcinoma of the buccal cavity, oropharynx or cavum Radiotherapy (≥ 54Gy in the oropharynx) and concomitant chemotherapy (including targeted therapies) with or without surgery Patients ≥ 18 years old, understanding French Patients who gave their informed consent prior to the study Disease and/or trauma with an effect on jaw mobility with permanent trismus Psychiatric non-stabilized comorbidity Lack of the median and lateral incisors Metastatic patient Legal inability or limited legal capacity. Medical or psychological conditions inducing incapacity of the subject to complete the study or give his/her consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Cervical Cancer Breast Cancer Contraceptive Usage Sexually Transmitted Diseases -Scheduled to leave jail within 3 days not actively intoxicated not show severe psychological distress | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 8.0-15.0, Reproductive Physiological Processes Pediatrics Adolescent Health Adolescent Developement Part 1-Pre-menarche monitoring (holding pattern) Age 8-14.5 years old Healthy weight, defined as having a body weight >85% of expected (EBW) and a body mass index (BMI) <99th percentile Some breast development Pre-menarche Taking or planning to take medications that affect reproductive hormones in the next 2 to 3 years (e.g. birth control pills) Planning to move more than 60 miles from the CRU within the next 2 years Chronic medical condition, including but not limited to diabetes mellitus, congenital adrenal hyperplasia, cystic fibrosis, sickle cell disease, inflammatory bowel disease, juvenile rheumatoid arthritis, and lupus First-degree relative with polycystic ovarian syndrome, premature ovarian insufficiency, hypogonadotropic hypogonadism, or other pubertal development disorder Excessive exercise (defined as running >20 miles per week or its equivalent) Pregnancy Part 2 Post-menarche cycle tracking Age at menarche 10-14.5 years old Healthy weight, defined as having a body weight >85% of expected (EBW) and a body mass index (BMI) <99th percentile Approximately less than or equal to 6 months post-menarchal (will typically have completed 4 or fewer menstrual cycles) Biochemical normal thyroid hormone, prolactin, and testosterone levels | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, B Cell Lymphoma Lymphoma Lymphoma, B-Cell Diffuse Large B Cell Lymphoma High-grade B-cell Lymphoma Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of diffuse large B cell lymphoma or high-grade B cell lymphoma of a non-germinal center phenotype according to Hans are eligible for enrollment in this study. 2. International Prognostic Index (IPI) score of ≥ 3, or an age-adjusted (aa) IPI score of ≥ 2. 3. A male participant must agree to use a contraception during the treatment period and for at least 120 days after the final dose of study treatment and refrain from donating sperm during this period. 4. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) OR 2. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment. 5. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 6. Have measurable disease with one or more measurable lymphoma lesions ( >1.5 cm in the long axis and >1.0 cm in the short axis). 7. Patients must be able to provide an archived tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion. 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 9. Have adequate organ function. See below for adequate organ function laboratory values Hematological Absolute neutrophil count (ANC) less or equal to 1000/microliter Platelets less or equal to 100,000/microliters Hemoglobin less or equal to 8.0/grams per decilitre Renal Creatinine or Measured/calculated creatinine clearance (CrCl) greater or equal to 1.5xULN or less than or equal to 30 mililiter per minute for participants with creatinine levels less than 1.5xULN Hepatic Total bilirubin greater than or equal to 1.5 x ULN or direct bilirubin greater than or equal to ULN for participants with total bilirubin levels less than 1.5 x ULN AST (SGOT) and ALT (SGPT) greater than or equal to 2.5 x ULN (greater than or equal to 2.5 x ULN for participants with liver involvement) Positive urine pregnancy test within 72 hours prior to the initiation of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). 3. Has received prior anti-lymphoma therapy, including radiation therapy, chemotherapy, targeted therapy, or immunotherapy. Note: Prior corticosteroid treatment (<10 days in duration) to alleviate lymphoma-elated symptoms is permitted. Note: If participant received major surgery, he or she must have recovered adequately from complications from the intervention prior to starting study treatment. 4. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. 5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. 6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent, with the exception of short-term corticosteroid use to control lymphoma-related symptoms as outlined above) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. 7. Has a known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Other exceptions may be permitted after discussion with the principal investigator. 8. Has known active CNS involvement by lymphoma. 9. Has a diagnosis of high-grade B cell lymphoma with MYC and BCL2 and/or BCL6 gene rearrangements (double hit lymphoma), primary mediastinal lymphoma, gray zone lymphoma, composite lymphoma, or previously-untreated low-grade lymphoma with disease transformation to DLBCL. 10. Has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients. 11. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 12. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 13. Has an active infection requiring systemic therapy. 14. Has a known history of Human Immunodeficiency Virus (HIV) infection. 15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive, Hepatitis B core [HBc] antibody total reactive, or HBV virus detected) or known active Hepatitis C virus infection (defined as HCV RNA is detected). Note: All patients will be screened for prior Hepatitis B exposure prior to starting therapy. Hepatitis C testing is not required. 16. Has a known history of, or active infection with tuberculosis. 17. Has a history of solid organ transplantation. 18. Has a left ventricular ejection fraction < 45%, myocardial infarction within 6 months of initiating study treatment, New York Heart Assocation class III/IV heart failure, or any uncontrolled cardiovascular conditions. 19. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 20. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 21. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Viral Infection Patients has to have received a prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow, single/double cord blood or PBSC 2. Cells administered as: 1. Treatment of relapsed or persistent reactivation or infection for EBV, CMV, adenovirus, and/or BK virus despite standard therapy. Multiple infections are eligible to enroll. 2. Early treatment for single or multiple infections with EBV, CMV, adenovirus, and/or BK virus following treatment failure or in patients who are unable to tolerate standard therapy 3. Treatment of JC virus infection 3. Steroids less than or equal to 1.0 mg/kg/day methylprednisolone (or equivalent) 4. Hgb ≥ 7.0 gm/dl 5. Available VSTs must be partially HLA matched and verified 6. Negative pregnancy test (if female of childbearing potential after reduced intensity conditioning) 7. Patient or parent/guardian capable of providing informed consent Received ATG (anti-thymocyte globulin), Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days. 2. Patients with other uncontrolled infections 3. Patients who are less than 28 days removed from their allogeneic hematopoietic stem cell transplant or who have received donor lymphocyte infusions (DLI) within 28 days. 4. Evidence of GVHD >= grade 2 5. Active and uncontrolled relapse of malignancy 6. Requirement for FiO2 (fraction of inspired oxygen) > 50% oxygen to maintain arterial oxygen saturation > 90%.Note: patients requiring oxygen at FiO2<=50% to maintain arterial oxygen saturation >90% are eligible to receive VSTs if the reason for this oxygen requirement is believed attributable to the virus being treated | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.0-1.5, Microbiota Complementary Food Nutrition Parent(s) willing to sign consent form; the informed consent document will explicitly request permission to use the collected fecal samples for future studies, including but not limited to culturing component bacterial strains Child age 12-18 months WLZ between <-2 and -3 without bilateral pedal edema at the time of randomization Parent(s) willing to bring the child to the feeding centre twice daily for 4 weeks for nutritional therapy, once daily for next 4 weeks and administer the feeds provided by study staff once daily at home for 4 weeks and twice daily for next 4 weeks Medical conditions: Children with tuberculosis (diagnosis based on WHO 2014 guidelines which have been incorporated in the national TB control guidelines of Bangladesh). The guidelines depend upon the following five diagnostic principles (three out of five should be positive): 1. Specific symptoms of TB, 2. Specific signs, 3. Chest X-ray, 4. Mantoux test, and 5. History of contact,[9] or any congenital/acquired disorder affecting growth i.e. known case of trisomy-21 or cerebral palsy; children on an diet for the treatment of persistent diarrhea; having known history of soy, peanut or milk protein allergy Severe anemia (<8mg/dl), will be assessed by Hemocue (Model no. Hemocue Hb 301) Failure to obtain informed written consent from parents or caretakers | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-64.0, Influenza A Healthy Male or Female age 18 to < 65 years Body mass index (BMI) of 18.0 kg/m^2 to 35.0kg/m^2 Any prior or planned influenza vaccination for the upcoming flu season Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation History of influenza-like illness or confirmed influenza infection within 3 months prior to randomization Fever-like illness within 5 days of randomization History or clinical evidence of conditions considered high risk for developing influenza-related complications | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.164-0.244, Vaccination subjects aged from 60 days to 89 days old at the date of recruitment with informed consent signed by parent(s) or guardians parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions subjects did not receive any vaccines within 14 days axillary temperature ≤37.0℃ allergic to any ingredient of vaccine or with allergy history to any vaccine acute febrile disease or infectious disease serious chronic diseases any other factor that makes the investigator determines the subject is unsuitable for this study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.25-0.25, Vaccination subjects aged 3 months old at the date of recruitment with informed consent signed by parent(s) or guardians parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines subject who has a medical history with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness allergic to any ingredient of vaccine or with allergy history to any vaccine subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone) administration of immunoglobulins within 30 days prior to this study acute febrile disease(temperature ≥ 37.0°C) or infectious disease have a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection any serious chronic illness, acute infectious diseases, or respiratory diseases severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications any kind of infectious, purulent, or allergic skin diseases any other factor that makes the investigator determines the subject is unsuitable for this study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.25-0.25, Vaccination subjects aged 3 months old at the date of recruitment with informed consent signed by parent(s) or guardians parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions subjects have not been vaccinated with IPV vaccine, OPV vaccine, DTP vaccine and related vaccines subject who has a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathy and neurological illness allergic to any ingredient of vaccine or with allergy history to any vaccine subjects with immunodeficiency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone) administration of immunoglobulins within 30 days prior to this study acute febrile disease(temperature ≥ 37.0°C) or infectious disease have a clearly diagnosed history of thrombocytopenia or other coagulopathy may cause contraindications for subcutaneous injection any serious chronic illness, acute infectious diseases, or respiratory diseases severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications any kind of infectious, purulent, or allergic skin diseases | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Steroid Dependent Crohn's Disease Patients with biopsy confirmed, active, steroid dependent CD, without nutrient absorbance problems (Definition of steroid dependency: CD being treated with at least 5 mg/day steroids for the last 3 months; an attempt to reduce the dose induces flare of disease as determined by physician assessment). 2. Age ≥18 years 3. Steroid treatment of at least 3 months and stable steroid dose for at least 2 weeks .If thiopurines and/or biologics are also being administered, then must be administered at stable dose(s) for at least 3 months. 4. Patients will undergo an ECG and QT parameters will be measured for further analysis. 5. Female subjects who are postmenopausal (absence of menses for ≥ 2 years confirmed by a follicle stimulating hormone test), or who are surgically sterilized may be enrolled. Similarly, women of childbearing potential who had a negative pregnancy test at screening, who are willing to use two medically acceptable methods of contraception for the duration of the study as well as for at least three months after cessation of CBD treatment and who are willing to undergo pregnancy testing according to the study protocol may be enrolled. 6. Female subjects who are not breast-feeding and who have no intention to breast-feed during the term of the trial and for at least three months after cessation of CBD treatment may be enrolled. 7. Subject able to provide written informed consent Viral Hepatitis (HAV, HBV, HCV) 2. HIV 3. Serious psychiatric or psychological disorders 4. Active consumption of illicit drugs including cannabis or derivatives for at least 3 months prior to the study 5. Patients with short bowel syndrome, symptomatic stricture, abscess, recent history (within the previous 3 months) of abdominal surgery, nutrient absorbance problems 6. Patients whose disease is inaccessible by endoscopy 7. Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities. 8. Any uncontrolled infection at time of registration 9. Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2) 10. Patient who is taking immunomodulatory medications for other indication 11. Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding - | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Acute Myeloid Leukemia Adult patients (age ≥ 18 years) with de novo or treatment-related AML, eligible and fit for SCT treatment according to national/international guidelines One or more potential haplo-identical related donor(s) AND five or more potential 6/6 HLA-A, -B, and -DRB1 antigen matched unrelated donors identified before randomization Karnofsky Performance Status ≥ 70% at randomization Signed informed consent Patient willing and able to comply with protocol requirements Patients with a suitable HLA-identical sibling donor Patients with < 5 potential HLA-A, -B, and -DRB1 antigen matched URDs available Patients with no potential haplo-identical related donor available Patients scheduled for/receiving cord blood stem cell transplantation Prior allogeneic SCT using any hematopoietic stem cell source Patients seropositive for HIV Pregnancy (positive β-HCG test) within 4 weeks of study entry Cardiac ejection fraction < 45% Karnofsky Performance Status < 70% at time of randomization The presence of any psychological, family-related, social, and/or geographical condition potentially jeopardizing compliance with the study protocol and follow-up schedule | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-75.0, Heart Failure, Diastolic Diabetes Mellitus, Type 2 Age > 18 years old but < 75 years old 2. No HF hospitalization within 6 months 3. Overweight or Obesity defined as BMI > 29 but < 40 4. Insulin resistance or T2DM and on oral diabetes agents other than SGLT2i (HgbA1c > 6.5% and < 10.5%) 5. EF calculated based on a recent echo/cath/nuclear study at screening (pre enrollment) > 50% 6. Stable HFpEF (HF with preserved ejection fraction) medications use of 3-6 months with no plans to changes or add medications for at least 12 weeks (course of the study) Acute HFpEF hospitalization within 6 months of enrollment. 2. CKD stage 4 or 5 (eGFR < 30 ml/min by CKD-EPI equation). 3. Other known causes of HF including poorly controlled hypertension (SBP > 160 mm Hg) or ischemic cardiomyopathy (etc). 4. Anemia (Hgb < 11.5 mg/dL for women and < 12.5 mg/dL for men) or severe thrombocytopenia (platelets < 50,000 mm3) 5. Anticipated changing of HF medication during anticipated study period. 6. HFREF (LV EF < 50%). 7. Acute coronary syndrome, transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months. Severe life threatening illness or live expectancy < 6 months. 8. Contraindications to MRI (metallic implants, severe claustrophobia) or treadmill exercise (limb amputation, severe osteoarthritis or equivalent functional mechanical limitation) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-50.0, Influenza, Human Missed getting the flu vaccine in the last year No history of reactive airway disease No history of allergy to LAIV No history of allergy to IIV Self-identify as healthy without an immunocompromising condition defined as cancer, autoimmune disease, organ transplant or receipt of steroids History of reactive airway disease History of allergy to LAIV or IIV Do not self-identify as healthy | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Diabetic Foot Contact Allergy Age of 18 years or older Diagnosed with type 1 or 2 diabetes mellitus Diagnosed with diabetic foot ulcer Provided written informed consent Patient unwilling or unlikely to comply with the study procedures Patient receiving systemic corticosteroid therapy during PATCH testing (patient should stop with corticosteroid therapy three days before PATCH testing, and may start when testing and reading is done) Patient receiving antihistaminic therapy during PATCH testing (patient should stop with antihistaminic therapy three days before PATCH testing, and may start when testing and reading is done) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-69.0, Hypertension Hypertension Complicated With Type 2 Diabetes Walking Chinese Square Dancing 40-69 years of age 2. Meet any one of the two conditions: 2.1 Hypertension: diagnosed with hypertension, systolic blood pressure is 130-159 mmHg, take no antihypertensive drug or no more than 2 kinds of antihypertensive drugs 2.2 Hypertension complicated with diabetes: diagnosed with hypertension and type 2 diabetes, systolic blood pressure is 130-159 mmHg and the fasting blood glucose in the past 2 weeks was 5.6-16.7 mmol/L (13.8-16.7 mmol/L was negative for urinary ketone) , take no more than 4 kinds of antihypertensive and hypoglycemic drugs 3. Maintain the current state of medication for the next 3 months 4. Lived in the current community in the past six months 5. Have no intention of moving out for the next three months 6. Have no regular exercise habit (moderate intensity activity less than 3 times a week, less than 30 minutes each time or 30 minutes cumulative), at least exercise 3 days a week 7. Sign informed consent Manual works(such as farmers, couriers, athletes and workers, who rely on physical activity to make a living) 2. Physical disability that prevents patients from walking or Chinese square dancing 3. Currently enrolled in another lifestyle intervention trial(interventions such as nutrition, psychology, exercise and health education) 4. Pregnant or planning to become pregnant 5. BMI(body mass index)≥35 kg/m2 6. Answers to questions 2, 3 and 6 of the questionnaire in 2014PAR-Q+ are "yes" 7. Cardio-cerebrovascular events have occurred in the past 6 months(heart disease diagnosed by doctors, such as coronary heart disease, hypertensive heart disease, acute myocarditis, pulmonary heart disease, etc.) 8. Fasting blood glucose of diabetic patients is 13.8-16.7 mmol/L and urinary ketone is positive 9. Severe complications of diabetes affecting exercise , such as foot, eye disease and renal insufficiency 10. Complicated with other serious chronic diseases such as asthma, malignant tumor, chronic heart failure, severe depression or other mental disorders | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.0-6.0, Signs and Symptoms, Respiratory Generally healthy male and female children 6 years of age Children attending kindergarten Signed informed consent by child's parent or legal guardian and willingness to participate in all study activities Immune dysfunction and/or taking an immunosuppressive medication Child who has received flu vaccination Child who is still breastfed Child taking other food supplements Unable or unwilling to comply with study protocol, including ingesting investigational product, and completing subject dairy Current participation in another clinical study Severe co-morbidity or concomitant disease Concurrent disease or condition, which in the judgment of the investigator, would make the child inappropriate for participation in the study High risk of complications from influenza Allergies to yeast-derived products | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Flu, Human People 65+ otherwise healthy Patients of any age diagnosed with at least one of the following conditions: Diabetes, Asthma, COPD, Coronary Disease or Hearth failure No history of flu vaccination in the previous year Patients who have been vaccinated against the flu but who have no record of it in the clinical records Patients with contraindications to flu vaccination Patients that cannot be reached either by phone or letter | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-90.0, Alzheimer Disease Mild Cognitive Impairment Neuropsychiatric Symptoms Sleep Disturbance Males and females of any racial or ethnic group, aged 50-90 (inclusive) Diagnosis of amnestic mild cognitive impairment (aMCI; single or multi domain) or mild AD Subjective complaint of insomnia associated with daytime impairment or distress (ISI ≥ 10) Subjective complaint of sleep disturbance ≥ 3 months in duration Subjective complaint of Neuropsychiatric symptoms (NPI total score ≥ 4) Able to verbalize understanding of involvement in the research and provide written informed consent or provide assent co-signed by a LAR Fluent and literate in English Medications (including any dementia-related meds) stable for at least 4 weeks prior to study baseline Wechsler Memory Scale-Revised Logical Memory II subtest using the following rubric: ≤ 8 for subjects with 16 or more years of education, ≤ 4 for 8-15 years of education, 2 ≤ for 0-7 years of education Global Clinical Dementia Rating (CDR) of 0.5 or 1.0 less than 20 on the Mini-Mental State Examination (MMSE) Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if < 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders (with the exception of mild AD) such as Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months; unstable adult onset diabetes as defined by treatment regimen changes in the prior 3 months Use of medication specifically prescribed for sleep disturbance and unwilling or unable to discontinue > one week prior to baseline data collection Current or lifetime history of bipolar disorder History of psychosis preceding onset of memory impairments Substance abuse or dependence Excessive alcohol consumption (>14 drinks per week or > 4 drinks per occasion) Current exposure to trauma, or exposure to trauma within the past 3 months Presence of suicidal ideations representing high risk as measured by the Sheehan-Suicide Tracking Scale (S-STS). Individuals are considered high risk if they endorse a 3 or 4 on questions 2 or 13, or endorse levels 2 or higher on any Question 1a, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or 14 Mild traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness >5 minutes) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-999.0, Knee Osteoarthritis Arthroplasty Complications Swelling; Leg knee osteoarthritis post-operation of total knee arthroplasty single leg knee arthroplasty vital signs unstable uncontrolled blood pressure diabetes mellitus neoplasm neurological disorder fibromyalgia cardiac pacemaker musculoskeletal involvement other than TKA | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 16.0-999.0, Cystic Fibrosis Patients must meet the following to participate in this study: 1. Males and females age 18 years and above in Germany and Israel; in countries where permitted, males and females age 16 years and above 2. A confirmed diagnosis of nmCF with a documented G542X mutation, homozygote, or compound heterozygote with one of the specified mutations. For heterozygotes, one mutation has to be G542X, and the second mutation could be and Class 1 or Class 2 mutation, excluding F508del. Patients with one G542X allele and a second allele that is not in the above list may be potentially allowed but only after discussion on a case by case basis with and written approval from the Sponsor. 3. Documented SCC ≥ 60 mEq/L 4. FEV1 ≥ 40% predicted normal for age, gender and height at Screening (Knudson Equation) 5. Body Mass Index (BMI) of 19.0 to 30.0 kg/m2 (inclusive). Patients with any of the following characteristics/conditions will not be included in the study: 1. Participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study 2. History of any organ transplantation 3. Major surgery within 180 days (6 months) of Screening 4. Patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides 5. Known allergy to any aminoglycoside 6. Patients with any abnormality at ENT screening, that indicates the presence of a vestibular toxicity associated with prior exposure to aminoglycosides. 7. Dizziness Handicap Inventory (DHI)-H score at screening >16 8. Patients receiving CFTR modulators within 2 months of study treatment | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Perineum; Injury primiparous or multiparous women who have never given birth vaginally term patients (after 37 weeks of amenorrhea) patients delivering a fetus in cephalic presentation patients speaking and understanding French patients suspected of having a fetal macrosomy (greater than the 97th percentile) on the last ultrasound patients with twin pregnancies excised patients patient who has made an acupuncture preparation during pregnancy patients with fetal death in utero patients requiring medical termination of pregnancy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-51.0, Flu, Human Influenza, Human Covid19 Age: See above Education: Less than a college degree Gender: Male Race: Caucasian or African American Miscellaneous: Has not received the flu shot in the current flu season yet Miscellaneous: Has sound on his device turned on Fast survey-taking: subjects who are among the 5% fastest in terms of total time spent on survey within race and treatment group Nonsense answers (those that do not have decipherable English) in the open text sections that suggest low effort Inconsistent responses to questions (such as being willing to give up $10 to receive a flu coupon but not $1) Repeat survey takers as indicated by duplicate emails or IP addresses in survey data | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-65.0, Influenza Written informed consent. 2. Healthy male or female subjects, as determined by medical history and medical examination. 3. Between the ages of 18 and 65 years, inclusive. 4. Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures Subject with a body mass index (BMI) ≥35 kg/m² on the day of vaccination. 2. Previous influenza vaccination within 6 months before the day of vaccination, or planned to receive during the study duration. 3. Any known or suspected immunodeficient conditions. 4. Past or current history of significant autoimmune diseases, as judged by the Investigator. 5. Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator. 6. Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are defined by the Clinical Trial Facilitation Group [CTFG] as follow: "Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable intrauterine device, intrauterine hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse)." 7. Having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines. 8. Planning to receive other vaccines during the first 28 days following the study vaccine administration. 9. Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period. 10. History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period. 11. Presence of an acute febrile illness on the day of vaccination (oral temperature >38.0°C, temporary criterion). 12. Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome. 13. Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study. 14. Past (stopped less than 6 months before enrolment) or current history of alcohol or drug abuse, or current smoking habit above 10 cigarettes per day. 15. Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800 μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (>10 days) use of systemic non-steroidal anti-inflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator. 16. Subjects with known or suspected anemia. 17. Recent blood or platelets donation (less than 3 months before enrolment). History of plasma donation is authorized. 18. History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin, or to any component that may be present in the comparator vaccine, as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin. 19. Any contraindication to intramuscular administration, as judged by the Investigator. 20. Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 21. Technical difficulties in the use of an e-diary. 22. Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-85.0, Intermittent Fasting Obesity, Morbid Comorbidities and Coexisting Conditions Weight Loss Fluid Retention 1. Subjects with complicated obesity grade 2 or higher (Body Mass Index [BMI]>35kg/m2), i.e., obesity associated with renal failure with eGFR<60cc/min or heart failure with preserved ejection fraction (EF) (≥50%) and clinical evidence of fluid retention evidenced by the use of loop diuretic, or the presence of peripheral edema; or treatment in congestive heart failure clinics or history of admission to the hospital for heart failure during the past 3 years; OR • b. Subjects with complicated obesity, grade 2 or higher (BMI>35 kg/m2) [with renal failure as defined above-delete this requirement] and at least one of the following comorbidities: 1) Uncontrolled hypertension despite the use of at least 3 drugs administered at their maximal or close to maximal dose 2) Severe sleep apnea (based on a sleep lab report) 3) Pulmonary hypertension 4) Coronary heart disease 5) Type 2 diabetes mellitus 6) History of stroke (> 3 months prior to the recruitment to the trial) 2) Subjects who failed to lose weight on standard treatment, refuse standard medical treatment or are judged as unable to tolerate/unsuitable to receive standard medical treatment to lower body weight and in whom bariatric surgery is deemed unacceptable due to excessive surgical risk by the referring physician and/ or the PI and / or the patient and fulfill the following 1. Wish to fast 36 hours, twice a week, over three months 2. Committed to attend the clinic at least once a week and perform blood tests every 2-14 days, as detailed in the protocol. 3. Are well trained in-home glucose monitoring and are willing to monitor glucose levels during the fasting days. 4. Are well trained in-home monitoring of blood pressure and are willing to measure blood pressure twice a day during the fasting days. 5. Own and control a dependable means of 24/7 communication device, eg, cell phone, and are committed to avail this route of communication to the study staff Severe renal failure (eGFR<20cc/min) 2. Liver disease other than non-alcoholic fatty liver disease or cardiac cirrhosis or any liver disease with aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase levels>3 times of the upper limit of the normal range, albumin< 3.5 gr% or direct bilirubin>1.2 mg%. 3. Cognitive impairment assessed by a Mini-Mental State Exam (MMSE) score < 24 4. Living in a single household (caretaker is allowed) 5. Age less than 18 or >85 years 6. Pregnancy or intention to conceive or female at the reproductive age not using birth control means. 7. History of documented hypoglycemia during the past year despite attempted adjustment of treatment. 8. Unintended weight loss > 2kg over the past 2 months. 9. The initiation, within the study period of any one of the following medications, including topiramate, lyxumia, byetta, bydureon, belviq, Xenical, victoza, saxenda, trulicity, semaglutide or any other glucagon-like peptide-1 (GLP-1) analog. However, subjects already treated with these agents before the initiation of the trial may be included provided that the medication has been started at least 4 months prior to the beginning of the study and that weight loss during the 2 months preceding the trial did not exceed 2 kgs. 10. A subject who must use drugs whose use is not recommended on an empty stomach and in whom this qualification appears, in the investigator's opinion more critical than the potential chance to lose weight and excrete excess bodily fluids | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Food Allergy in Children Subject has signed the informed consent form 2. 18 years of age or older (inclusive) 3. One of the following Diagnostic Categories: 1. Normal healthy controls with no personal or offspring history of food allergy or atopic dermatitis 2. Mother or father without personal history of food allergy, but with a child diagnosed with peanut allergy. Peanut allergy is defined as fulfilling one of the following 3 i. Clinical history defined as one of the following occurring within 2 hours of exposure to peanut: 1. Involvement of the skin-mucosal tissue (eg, generalized hives, itch-flush, swollen lips-tongue-uvula) 2. Respiratory compromise (eg, dyspnea, wheeze-bronchospasm, stridor, reduced PEF, hypoxemia) 3. Reduced BP or associated symptoms (eg, hypotonia [collapse], syncope, incontinence) 4. Persistent gastrointestinal symptoms (eg, crampy abdominal pain, vomiting) ii. Positive skin prick testing > 8 mm iii. Positive specific IgE to peanut > 14.0 kUA/L Has active flare of atopic dermatitis requiring use of bleach baths, topical corticosteroids, topical immunomodulatory agents, or topical antibiotics on the extremity being evaluated 2. Has a skin disease other than AD that might compromise the stratum corneum barrier such as bullous disease, psoriasis, cutaneous T cell lymphoma, Darier's disease, HaileyHailey, or dermatitis herpetiformis 3. Has a current systemic infection requiring use of systemic antibiotics, antiparasitics, antivirals, or antifungals 4. Has a severe concomitant disease or immunosuppression such as lymphoma, HIV, or Wiskott-Aldrich syndrome 5. Has a history of a severe reaction to latex, tape, or adhesives 6. Has used any biologics within 5 half-lives or 16 weeks, whichever is longer 7. Has received immunotherapy in the last 12 months 8. Has used any investigational drugs within 5 half-lives or 8 weeks, whichever is longer 9. Has used anticoagulants, anxiolytics, or antidepressants within 30 days 10. Has used of systemic immunosuppressive drugs including oral steroids within 30 days 11. Has received total body phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA], tanning beds [>1 visit per week]) within 30 days 12. Is pregnant or lactating (this will be self-verified by the patient) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-75.0, Aging Sleep Disorder Sedentary (≤ two exercise sessions per week for the past 6 months) 2. Aged 50 to 75 years old 3. Cleared by primary care physician or other personal physician to participate in a 12-week moderate-intensity walking exercise program. Clearance can be provided to one of the study investigators either verbally or in writing History of neurological illness (e.g. poorly controlled epilepsy with >1 seizure per month in the last 6mo, stroke with residual motor language deficits, Multiple sclerosis, Parkinson's disease, clinically diagnosed dementia [defined as score <26 on the Mini-Mental State Examination], head trauma in the preceding 6-months with continued cognitive symptoms, cerebral palsy, brain tumor, normal-pressure hydrocephalus, HIV infection, or Huntington's disease) 2. Untreated Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I disorders (i.e., severe depressive symptoms, substance abuse or dependence) 3. Impaired activities of daily living (ADLs) measured by the Lawton and Brody Self-Maintaining and Instrumental Activities of Daily Living Scale. 4. Inability to safely exercise or perform any of the tests 5. Inability to perform the cognitive tests due to lack of English proficiency 6. Known diagnosis of severe sleep apnea (apnea-hypopnea index ≥ 15/hour of sleep) 7. Subject fails Cardiopulmonary Exercise Testing (CPET), i.e. develops symptoms such as shortness of breath, chest pain, palpitations, lightheadedness, or syncope during CPET testing 8. Patients with a pacemaker or an automatic implantable cardioverter-defibrillator | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-80.0, Colorectal Adenoma Colorectal Cancer Endoscopic Surgery Eicosapentaenoic Acid Gastrointestinal Microbiome Participants must meet the following on screening examination to be eligible to participate in the study Underwent screening or surveillance colonoscopy with removal of at least one adenoma Age 18-80 years This study will only adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults. Patients over age 80 will not be enrolled since the benefits and risks of AMR101 over the age of 80 have not yet been well-characterized ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) The effects of AMR101 on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately Subjects must be able and willing to follow study procedures and instructions Ability to understand and the willingness to sign a written informed consent document Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study Currently using or have used any fish oil supplement at any dose more than once per week within the last month Regularly consuming more than three servings of fish per week History of allergic reactions attributed to fish or compounds of similar chemical or biologic composition to omega-3 fatty acid Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis Any prior diagnosis of gastrointestinal cancer (including esophageal, small intestine, colon, pancreatic), or any diagnosis of other cancers (with the exception of nonmelanoma skin) in which there has been any active treatment within the last three years Known diagnosis of Familial Adenomatous Polyposis (FAP) or Hereditary Non-Polyposis Colorectal Cancer (HNPCC, Lynch Syndrome) Any adenoma that was not completely removed during previous colonoscopy Known bleeding tendency/condition (e.g. von Willebrand disease) or history of peptic ulcer or gastrointestinal bleed, endoscopic complications, or contraindication to colonoscopy Current use of anticoagulant therapies, including Heparin, Warfarin, Dalteparin sodium,Bivalirudin, Argatroban, Lepirudin, Heparin Sodium, Heparin/Dextrose, and an unwillingness or inability to discontinue anticoagulants | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 4.0-6.0, Immunization The investigator believes that the parents/LAR(s) of the child can and will comply with requirements of the protocol (e.g. understanding of study procedure, consent process, availability at visits) Written informed consent obtained from parent(s)/LAR(s) of the subject Age from 4y+ 1day up to 6 years (until the day they turn 7y) at time of V1 (first immunisation visit) Born to two white Caucasian (of European descent) parents Participant is healthy as determined by general health assessment Have received all the vaccines specified in the UK immunisation schedule Group 1: Never received the intranasal flu vaccine before Group 2: Must have had at least 1 dose of the intranasal flu vaccine Group 3: Must have had at least 2 doses of the intranasal flu vaccine Group 4 : Must have had at least 3 or 4 doses of the internasal flu vaccine Use (or planned use) of any non-registered or investigational product in 30 days before or after study vaccination Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21) Recommended for inactivated influenza vaccine in UK (e.g. Children in clinical risk groups as specified by Public Health England) according to the Green Book, DoH Meets any contraindications to vaccination as outlined in the Green Book, DoH Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction & HIV) Autoimmune conditions (e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis) and bleeding disorders Use of systemic steroids for more than one week e.g. prednisolone >0.5mg/kg/day in the three months prior to first study intervention Chronic administration (≥14 days in total) of immunosuppressant's or other immune modifying drugs in the 3 months prior to first study intervention Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the three months prior to first study intervention Temporary Participants who have experienced fever (≥38.0°C) or coryzal symptoms within the 24 hours prior to first study intervention | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Exercise Lactate Consenting adults ≥ 18 years old 2. Healthy with no other previous medical history 3. Able to perform moderately intensive exercise without difficulty for at least 30 minutes continuously, and engages in regular aerobic exercise at least twice a week Active inflammatory skin condition such as eczema or dermatitis 2. Active soft tissue infection or infection at any site 3. Known hypersensitivity to any microneedle component or dressings 4. Presence of any implantable electronic devices such as a pacemaker or stimulators | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-5.0, Cow Milk Allergy Food Allergy IgE mediated cow's milk allergy suspected for a cow's milk allergy, but with negative diagnosis (e.g. non-IgE mediated cow's milk allergy) IgE mediated food allergy other than cow's milk healthy brothers and sisters from the first three groups children of 5 years or older | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-80.0, Coronavirus Infections Age 18 to 80. 2. Confirmed COVID-19 diagnosis(including the clinically confirmed cases in Hubei). 3. Accord with any of the following: respiratory distress, RR ≥ 30 breaths/min; or SpO2 ≤ 93% at rest; or partial arterial oxygen pressure (PaO2) / fraction of inspiration O2 (FiO2) >100mmHg and ≤ 300mmHg (1mmHg = 0.133kPa). 4. Chest imaging confirms lung involvement and has inflammatory exudation or pleural effusion Cannot obtain informed consent. 2. Severe hepatic dysfunction (Child Pugh score ≥ C, or AST> 5 times the upper limit); Severe renal dysfunction (estimated glomerular filtration rate ≤ 30mL / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. 3. Unsatisfactory controlled hypertension (seated systolic blood pressure> 160mmHg, or diastolic blood pressure> 100mmHg); previous history of hypertension crisis or hypertensive encephalopathy. 4. Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention. 5. Hereditary bleeding tendency or coagulopathy; received full-dose anticoagulant or thrombolytic therapy within10 days before enrollment, or have taken non-steroidal anti-inflammatory drugs with platelet suppression within 10 days before enrollment (Except those who use small doses of aspirin ≤325mg / day for preventive use). 6. Thrombosis within 6 months before enrollment. And from those patients, screen who had arterial / venous thromboembolic events, such as, ischemic stroke, transient ischemic attack, deep venous thrombosis, pulmonary embolism, etc. within 1 year ahead of enrollment. Severe vascular disease (including aneurysms or arterial thrombosis requiring surgery) within 6 months before enrollment. 7. Unhealed wounds, active gastric ulcers or fractures. Gastrointestinal perforation, gastrointestinal fistula, abdominal abscess, visceral fistula formation within 6 months before enrollment. Major surgery (including preoperative Chest biopsy) or major trauma (such as a fracture) within 28 days before enrollment. May have surgery during the trial. 8. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment. 9. Malignant tumors within 5 years before enrollment. 10. Allergic to bevacizumab or its components. 11. Untreated active hepatitis or HIV-positive patients. 12. Pregnant and lactating women and those planning to get pregnant. 13. Participated in other clinical trials, not considered suitable for this study by the researchers | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.5-999.0, Quality of Life Endometrial Cancer Surgery--Complications Gynecologic Cancer Woman over 18 years of age scheduled for primary surgery for histologically verified endometrial cancer (regardless of histological type or degree) tumor clinically restricted to the uterus (presumptive FIGO stage I or II) speaks and reads Swedish capable of completing the questionnaire independently Clinical or radiological cancer outside the uterus preoperative radio / chemotherapy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Rotator Cuff Tear Arthropathy Shoulder Osteoarthritis Aged 18 years or older 2. Diagnosed with rotator cuff arthropathy, glenohumeral osteoarthritis with a > 1.5-cm rotator cuff tear, or massive irreparable rotator cuff tear 3. Have a normal functioning deltoid 4. Have preserved teres minor function (a negative Hornblower's sign) 5. Have failed conservative management for >3 months younger than 18 years 2. chronic opiate use history 3. fibromyalgia or other conditions that increase susceptibility to pain 4. preoperative stiffness (definition: < 30 degree passive external rotation, < 90 degree passive forward elevation), neurologic disorder affecting the ipsilateral upper extremity, 5. RTSA for acute proximal humerus fracture or fracture sequelae (nonunion, malunion) 6. previous arthroplasty, fracture fixation, or open rotator cuff procedures in the same shoulder 7. deltoid dysfunction 8. inflammatory glenohumeral arthritis 9. non-English speaking or unable to understand English for consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 11.0-999.0, Sickle Cell Disease diagnosis of SCD as reported by provider self-reported history of pain at least once per month caregiver/parent willingness to participate owns a smartphone not under the care of a provider participant cognitive disability or delay that precludes ability to participate, defined as classified severe neurocognitive deficits as documented by neuropsychological evaluation in the medical record lack of wi-fi access | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Breast Cancer Primary Hormone Receptor Positive Breast Cancer Patients with histologically-confirmed, HR-positive (ER and/or PR) stage 1-3 breast cancer Completed anti-HER2 therapy, if HER2-positive Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression At least 3 months post completion of chemotherapy, if administered At least 3 months post radiation, if administered Receiving adjuvant endocrine therapy with an aromatase inhibitor (anastrozole, letrozole, exemestane) ECOG performance status of 0 to 1 Sedentary (i.e., <150 minutes / week of exercise) Age ≥ 18 BMI ≥ 27 Presence of metastatic disease Insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus on medical therapy Enrollment onto any other therapeutic investigational study Mental impairment leading to inability to cooperate Any of the following contraindications to exercise: 1. Acute myocardial infarction within 3-5 days of any planned study procedures; 2. Unstable angina 3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise 4. Recurrent syncope 5. Active endocarditis 6. Acute myocarditis or pericarditis 7. Symptomatic severe aortic stenosis 8. Uncontrolled heart failure 9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures 10. Thrombosis of lower extremities 11. Suspected dissecting aneurysm 12. Uncontrolled asthma 13. Pulmonary edema 14. Respiratory failure 15. Acute non-cardiopulmonary disorders that may affect exercise performance Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation Nut or legume allergy Concurrent participation in weight loss or other exercise programs | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 16.0-45.0, Human Papilloma Virus Female between the ages of 16 and 45 years of age at enrollment Postpartum (Day 1 vaccination to occur within 1 week of delivery) Judged to be in good health on the basis of medical history and physical examination Able to fully understand study procedures, alternative treatments available, the risks involved in the study and voluntarily agrees to participate by giving written informed consent Able to read, understand, and complete the questionnaires Has a known allergy to any vaccine component, including aluminum, yeast, or Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition Is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monoclonal antibody therapies (including rituximab), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if she is currently receiving steroid therapy, has recently (within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. The use of inhaled, nasal, or topical steroids are considered eligible for the study Has received any immune globulin product (including RhoGAM™) or other blood derived product within 3 months prior to Day 1 vaccination or plans to receive such product during the study Has received a marketed HPV vaccine Has had a fever of > 100° within 24-hour period prior to the Day 1 vaccination | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Coronavirus Infections Adults healthcare workers (HCW) OR Chronic patients with at least 2 chronic medical conditions People that have been in contact with people positive for COVID-19 in the previous 14 days People with body temperature >37.5°C People with Dry cough People with Respiratory distress (Respiratory Rate >25/min or O2 Saturation <92%) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 17.0-999.0, Influenza Vaccination Health Promotion Health Behavior Risk Reduction Current Geisinger patient at the time of study Falls in the top 10% of patients at highest risk, as identified by the flu-complication risk scores of Medial's machine learning algorithm (which operates on coded EHR data) May limit to patients that are under Geisinger primary care, depending on algorithm performance of patients who have non-Geisinger PCPs Has contraindications for flu vaccination Has opted out of receiving communications from Geisinger via all of the modalities being tested | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Coronavirus Disease 2019 (COVID-19) Respiratory Illness Corona Virus Infection COVID-19 Over 18 years of age Healthcare worker This is defined as anyone who works in a healthcare setting or has face to face contact with patients Provide a signed and dated informed consent form Australian sites only: If annual influenza vaccination is available, receiving the flu vaccine is an requirement. The flu vaccine will be required a minimum of 3 days in advance of randomisation in the BRACE trial Pre-randomisation blood collected Has any BCG vaccine contraindication Fever or generalised skin infection (where feasible, randomisation can be delayed until cleared) Weakened resistance toward infections due to a disease in/of the immune system Receiving medical treatment that affects the immune response or other immunosuppressive therapy in the last year These therapies systemic corticosteroids (≥20 mg for ≥2 weeks), non-biological immunosuppressant (also known as 'DMARDS'), biological agents (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha) People with congenital cellular immunodeficiencies, including specific deficiencies of the interferon-gamma pathway People with malignancies involving bone marrow or lymphoid systems People with any serious underlying illness (such as malignancy) NB: People with cardiovascular disease, hypertension, diabetes, and/or chronic respiratory disease are eligible if not immunocompromised, and if they meet other Known or suspected HIV infection,even if they are asymptomatic or have normal immune function | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Pelvic Organ Prolapse Stage II-IV pelvic organ prolapse Bothersome bulge symptoms At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form English-speaking Undergoing treatment of prolapse Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data) Able and willing to follow up at 3 months for in-office exam Enrollment in another research study of pelvic organ prolapse Concomitant non-urogynecologic surgery Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, COVID-19 to. Covid 19 positives b. Some of the characteristic symptoms of covid 19: fever, odynophagia, respiratory distress. c. Age between 18 years and 80 years to. Covid 19 negatives b. Kidney failure IV / VI. c. Congestive heart failure. d. Patients taking anticoagulants, particularly warfarin sodium | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Breast Neoplasm Malignant Female women between 18 and 70 years old patient with histologically confirmed breast cancer adjuvant situation spoken language : french patient who never had chemotherapy in the past Patient unable to sit Malformation of the back Wound at the level of the zones to massage Patient placed under the authority of a tutor Pregnant patient | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 30.0-48.0, Osteoporosis Cardiovascular Risk Factor Participants were healthy premenopausal women volunteers between the ages of 30 and 48 years Participants were free of chronic back or joint problems, cardiovascular disease, non-smokers, not pregnant, not taking antihypertensive drugs or any medication that affects bone density Participants didn't have regularly participated in a weight training program and yoga exercise at least 12 months prior to the study Participants were medically stable, ambulatory, and capable of training Individual who were outside of the 30-48 years age range and who exceed the weight limit of the DXA (300 pounds) Individuals who did not have the regular menstrual cycles Pregnancy or the possibility of becoming pregnant during the intervention period Individuals who were taking medications known to affect bone metabolism such as steroid hormones, calcitonin, or corticosteroids Any persons with physical and mental disabilities preventing them from being trained, including orthopedic or arthritic problems, were not allowed to participate Individuals whose radiation exposure from medical and/or research tests in the previous year exceeds the recommended regulator limit | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-55.0, Influenza, Human Male or female, between 18 and 55 years old (extremes included) at screening. 2. In good physical and mental health as determined on the basis of medical history and general physical examination performed at screening. 3. Absent or low levels of detectable pre-existing antibodies to influenza virus subtypes, including as a minimum the challenge strain, as determined by a MNT titre of ≤ 20 at screening. 4. Negative urine test for selected drugs of abuse at screening and upon check-in at the clinical site. 5. Negative alcohol breath test 6. Female subjects should fulfil one of the following 1. At least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone (FSH) > 30 mIU/mL) prior to screening; 2. Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation); 3. Will use contraceptives as outlined in criterion 8 from screening to discharge. 7. Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge Subjects who have received any vaccination within the last 3 months prior to screening or influenza vaccine within the last 12 months prior to screening or who anticipate receiving this during the study. 2. Subjects with a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 6 months prior to screening. 3. Subjects with a positive result for adventitious agent screening (qualitative PCR testing) for any respiratory virus or bacteria on Day -2. 4. Haematology and chemistry parameters, pulse rate and/or blood pressure, and ECG outside the reference range for the population studied and considered as clinical significant by the Investigator. 5. Has an acute or chronic medical condition | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Symptomatic COVID-19 Infection Laboratory-Confirmed Positive polymerase chain reaction (PCR) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) in a respiratory tract sample OR positive anti-SARS CoV2 IgM antibody test that is approved by Food and Drug Administration (FDA) or allowed under an emergency use authorization; either result obtained within 5 days prior to study entry Cough and/or pneumonia on chest imaging Moderate disease with risk factor(s): Peripheral capillary oxygen saturation (SpO2) >= 92% on room air with one of the following risk factors for development of severe disease: age >= 60 years, receiving medication for hypertension, diagnosed diabetes mellitus, known cardiac disease, chronic lung disease, obesity (body mass index [BMI] >= 35 kg/m^2), active malignancy, immunosuppression (receiving biologics or glucocorticoids >= 20 mg/d prednisone equivalent for > 2 weeks) Severe disease: SpO2 =< 92% on room air Ability to understand and the willingness to sign a written informed consent. Adults not competent to consent will be enrolled with the use of an appropriate legally authorized representative (per California Code, Health and Safety Code HSC) FDA regulations generally require that the informed consent of a participant be documented by the use of a written consent form approved by the IRB and signed and dated by the participant or the participant's legally authorized representative at the time of consent (21 case form report [CFR] 50.27[a]). In light of COVID-19 infection control measures, the following procedure would satisfy documentation of this requirement if the participant signing the informed consent is in COVID-19 isolation. If the technology is available, electronic methods of obtaining informed consent will be taken. The electronic consent and Health Insurance Portability and Accountability Act (HIPAA) forms will be uploaded and available through REDCap Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of therapy. NOTE: Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of child-bearing potential should use highly effective methods of birth control. These are those methods of contraception, alone or in combination, that result in a low failure rate (i.e, less than 1% per year) when used consistently and correctly Mechanical ventilation, high-flow nasal oxygen, biphasic positive airway pressure (BiPAP) Venous thromboembolism within 12 weeks or previously diagnosed thrombophilic conditions or conditions that increase the risk of thrombosis. Individuals with > 1 episode of venous thromboembolism or pulmonary embolism in the past will also be excluded Prior receipt of other immunomodulatory drugs (e.g., any JAK inhibitors, immunomodulatory biologics, or other immunomodulatory investigational products) within 14 days prior to enrollment Current treatment with probenecid Known infection with human immunodeficiency syndrome (HIV), or active infection with hepatitis B or hepatitis C Participant with known active or latent tuberculosis infection Pregnancy and lactation Any serious acute infections or known active or latent tuberculosis All enrolled participants will be screened for latent tuberculosis infection by testing QuantiFERON-TB Gold Plus, but a documented negative test will not be required prior to entry. If a participant is found to have positive QuantiFERON that results after enrollment, baricitinib will be discontinued Solid organ transplant recipient | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-99.0, COVID Sars-CoV2 Age ≥18 years Laboratory-confirmed SARS-CoV-2 infection within the past 7 days or the presence of symptoms or physical examination signs providing high probability of COVID-19 disease Patients must have adequate organ and marrow function measured within the last 6 months Subjects must have at least one of the following high-risk features for clinical deterioration Hypertension Diabetes Mellitus Moderate to severe Chronic Obstructive Pulmonary Disease, Emphysema, Cystic Fibrosis, or Asthma Cancer patients who have received any immunosuppressive drugs within a year from enrollment Sickle Cell disease or thalessemia Age > or = 50 Severe or life threating COVID Weight less than 45 kg Pregnant or breast-feeding females Subjects on dialysis or with creatinine clearance < 45 ml/min Existing DMID Toxicity Scale for Determining Severity of Adverse Events grade 3 or greater hepatic failure Previously documented moderate or severe retinopathy or macular degeneration Uncontrolled Seizure disorder Prolonged QT, defined as QTc ≥470 milliseconds for men and as QTc ≥480 for women using Bazett's formula Known allergy to artesunate, artemisia annua, hydroxychloroquine, macrolides, 4-aminoquinolines, camostat mesilate, or other agents to be used in the trial Currently receiving any study medications for other indications | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Covid19 Patient with clinical symptomatology suspecting COVID-19, that is to say: severe dyspnea, and/or serious extra pulmonary signs (myalgia, diarrhea, etc.) OR Patient with clinical symptomatology (cough or dyspnea or fever with ENT signs) AND at least one of the following comorbidities: COPD stage 1 or 2 (dyspnea usually absent or for marked efforts), Asthma with daily inhaled corticosteroid therapy, Immunosuppression or cancer during chemotherapy, Coronary history, Heart failure (Stages 2 and 3, dyspnea with moderate or low effort), Obesity (BMI> 30), Type 1 or 2 diabetes, cirrhosis from Child B, pregnant woman in the 3rd trimester Patient with a phone monitoring of at least more than 2 calls, if no aggravation of disease Person deprived of liberty by judicial or administrative decision Person being subject to a legal protection measure Person who expressed opposition to participating in the study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, COVID-19 Acute Respiratory Failure Adult (≥18 years old) at the time of consent 2. Positive COVID-19 test result or highly suspicious for COVID-19 infection and have a test pending 3. Acute Respiratory Failure (new requirement for supplemental oxygen or acute increase in required supplemental oxygen) Expected death or withdrawal of life-sustaining treatments within 3 days 2. Unable to walk ≥150 feet prior to COVID-19 (due to 6-minute walk test being primary outcome for in-person testing) 3. Hemoglobin ≤7.0 at the time of consent 4. Pre-existing cognitive/language impairment prohibiting clinical outcomes assessment 5. Prior lung resection (due to spirometry as part of in-person outcome assessment) 6. Unable to provide consent and no legally authorized representative (LAR) identified or reached by phone 7. Pregnant 8. Incarcerated 9. Homelessness 10. Physician declines patient enrollment (attending physician or study physician) 11. Patient or LAR do not consent to participate in the study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-25.0, Non-small-lung-cell Cancer, NSCLC Pembrolizumab - 1. Volunteer for clinical research, fully understand, inform and sign informed consent forms (Informed Consent Form, ICF), willing to follow and be able to complete all trial procedures. 2. 18 to 75 years old (with critical values) when signing ICF. 3. Hemology diagnostics of phase IV (AJCC Version 8) NSCLC that cannot be surgicalor-able or radiotherapy. 4. No known EGFR sensitivity mutations or ALK, ROS1 gene rearrangement; 5. Patients have never received systemic treatment throughout the body for phase IV NSCLC. 6. The end of non-systematic anti-tumor therapy is not only 2 weeks from the end of the study drug, and the treatment-related AE is restored to CTCAE 4.03 to level 1 (except for level 2 hair loss). 7. Within 4 weeks prior to randomization, at least one measurable target lesions assessed by irRC in accordance with 1.1 requirements. 8. Patients must provide the required tumor tissue for PD-L1 expression level determination, and PD-L1 is 1%. Note: Samples of tumor tissue fixed by Formalin within 6 months prior to the first study of the drug use are recommended. Paraffin encapsulated tumor specimens (preferred) or unstained newly cut continuous tissue slices (preferred anti-stripping slides). A relevant pathological report of the above specimen sits must also be provided. Freshly collected specimens, excision, hollow needle core biopsy, excision, cut, stamping or clamp biopsy are all within acceptable range (preferred newly acquired tissue). Needle-absorbing samples (i.e., samples that lack a complete tissue structure only provide cell suspension and/or cell smears), brush samples, cell precipitation samples from chest or celiac fluidares are not accepted. The organization sample requirements are detailed in the laboratory operating manual. 9. The ECOG PS score for 7 days prior to the first drug use of the study drug was 0 or 1. 10. After 6 cycles of combination chemotherapy with Pembrolizumab 200mg Q3W or Pembrolizumab 200mg Q3W immunotherapy, the efficacy was assessed as CR, PR, SD. 11. The expected lifetime is 12 weeks. 12. The main organ function sits well, i.e. meets the following (no blood transfusion, albumin, recombinant human platelet production or csphylitosin (CSF) treatment within 14 days prior to the first drug use in this study): 13. Organ function is normal: 1. White blood cells s.0 x 109/L 2. Absolute Neutlyte Granucyte Count (ANC) s2.0 x 109/L 3. Platelet count: 100 x 109/L 4. Hemoglobin s 90 g/L 5. Creatine s 1.5 x ULN; 6. Total bilirubin s 1.5 x ULN (except Gilbert syndrome, total bilirubin 3.0 mg/dL); 7. AST (SGOT) is 2.5 x ULN, for patients with liver metastiars, s.5 x ULN; 8. ALT (SGPT) is 2.5 x ULN, for patients with liver metastasis, s.5 x ULN; 9. Alkaline phosphatase is 3 times the normal upper limit; 10. Clotting function: activated part of the clotting enzyme time (APTT) s1.5 x ULN, clotting enzyme raw time (PT) or international standardized ratio (INR) s1.5 x ULN; 11. Female patients must meet one of the following: (1) menopause (defined as having no menstruation for at least 1 year and no other reason for confirmation other than menopause); (2) sterilization performed (removal of the ovaries and/or uterus); (3) Fertility, but must meet: Serum pregnancy tests must be negative within 7 days of randomization and agree to use 1% annual failure rate of contraception or to maintain abstinence (avoiding heterosexual intercourse) (at least 120 days after the signing of an informed consent form to the last time the drug was administered) (1% annual failure rate of contraceptive methods including bilateral tubal ligation, male sterilization, correct use of ovulation-suppressing hormones, release of intrauterine and intrauterine devices) and intrauterine devices. 12) Male patients must meet the requirement to consent to abstinence (avoiding heterosexual intercourse) or to take contraception, provided that when the partner is a woman of childbearing age or who is pregnant, male patients must maintain abstinence or use condom contraception to prevent exposure to the embryo during treatment and for at least 150 days after the end of administration of the drug. Regular abstinence (e.g. calendar days, ovulation periods, basic body temperature or late-stage contraception) and in vitro ejaculation are substandard methods of contraception Histological type is small cell lung cancer or mixed tumors with small cell lung cancer, neuroendocrine cancer components. 2. Within 5 years or at the same time, there are other active malignancies. Cured limited tumors, such as skin base cell carcinoma, skin squamous carcinoma, superficial bladder cancer, prostate in situ cancer, cervical in situ cancer, breast in situ cancer, etc. can be included in the group. 3. A patient who is prepared to undergo or have received an organ or bone marrow transplant in the past. 4. Chest fluid, cardiac fluid or ascites that cannot be controlled by appropriate intervention. 5. Known or screened examinations found in patients with active central nervous system (CNS) metastasis and/or cancerous meningitis. However, the following patients are allowed to join the group: 1) Asymptomatic brain metastasis patients (i.e. no brain metastasis caused by the development of sexual central nervous system symptoms, do not require glucocorticoid therapy, and the size of the lesions of 1.5cm) can participate, but the disease site needs to be regularly examined for brain imaging. 2) In patients with after treatment of brain metastasis, and brain metastasis lesions are stable for at least 1 month, there is no new or enlarged evidence of brain metastasis, and glucocorticoids are discontinued for 3 days before administration. Stable brain metastasis should be determined prior to the first drug use. 6. Surgery and/or radiotherapy fail to cure spinal cord compression. 7. Obviously hemorrhagic, combined patients with venous syndrome. 8. Myocardial infarction and poor control of arrhythmia (including QTc interstitallated men with a period of 450 ms and female s470 ms) occurred in the first six months prior to the first drug use (QTc interstitallator is calculated using the Fridericia formula). 9. In accordance with NYHA Standard III IV level cardiac insufficiency or cardiac color super-examination: LVEF (left ventricular blood score) 50%. 10. Poor control of hypertension (i.e. systolic pressure (BP) of 150 mmHg and/or diastolic pressure of 100 mmHg), has previously appeared high blood pressure risk or hypertension encephalopathy. 11. The patient had CTCAE 4.03 peripheral neuropathy level 2. 12. Human immunodeficiency virus (HIV) infection. 13. He suffers from active tuberculosis. 14. Past and current patients with interstitial pneumonia, dust lung, radiocopmedy, drug-related pneumonia, severe lung function, etc., may interfere with the monitoring and treatment of suspected drug-related pulmonary toxicity. 15. Patients have known active or suspected autoimmune diseases. Patients who are allowed to be in a stable state and do not require systemic immunosuppressants. 16. Hepatitis B (HBsAg or HBcAb tested positive and HBV-DNA tested positive), hepatitis C (hCV antibody tested positive and HCV-RNA positive). Subjects with a common infection with hepatitis B and C (HBsAg or HBcAb tested positive and HCV antibodies tested positive). 17. A live vaccine is treated within 28 days of the first drug use, but seasonal influenza is permitted, but the detoxified live flu vaccine is not allowed to be administered with nasal medication. 18. Patients who need to be treated with systemic glucocortical extrex (?10 mg/temponnison) or other immunosuppressive medications within 14 days of the first drug use or during the study. However, admission is permitted in the group where patients are allowed to use topical or inhaled glucocorticoids and adrenal corticosteroid replacement therapy at a dose of 10 mg/templiison. 19. Any active infectionthat that requires systemic anti-infection treatment occurs within 14 days of the first drug use. 20. Within 28 days of the first drug use, major surgery was undergone, and the study defined major surgery: at least 3 weeks of recovery time after surgery to be able to undergo surgery for this study. Tumor punctures or lymph node cut biopsies are allowed into the group. 21. Within 3 months of the first drug use, he received thetogenive radiation therapy. Note: Palliative radiotherapy for bone palliative radiotherapy or superficial lesions is permitted, the course of treatment is based on local standards and is completed 2 weeks prior to the first dose. Radiotherapy covering more than 30% of the bone marrow area is not permitted within 28 days of the first use. 22. Patients have previously received other antibodies/drugs against immuno-checking points, such as PD-1, PD-L1, CTLA4, etc. 23. Participating in other clinical studies, or planning to begin treatment for this study is less than 14 days from the end of the previous clinical study. 24. A history of severe allergies to any monoclonal antibody is known. 25. Pregnant or lactating women. 26. Patients are known to have a history of psychotropic substance abuse or drug abuse; 27. The researchers determined that the patient had other factors that might have caused the study to be forced to terminate in the middle. - | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, COVID Corona Virus Infection COVID19 The patient or legally authorized representative (LAR) must have the ability to understand and the willingness to provide a signed and dated informed consent form. 2. Age 18 years and over 3. The patient agrees to use adequate contraception for the duration of the treatment protocol and for 6 months post treatment. 4. Positive RT PCR testing for COVID-19 nucleic acid using nasopharyngeal swabbing or any other site 5. Patient meets ARDS as defined by Berlin and is on mechanical ventilation a. Berlin for ARDS are: i. bilateral opacities on chest imaging consistent with pulmonary edema ii. A need for positive pressure ventilation via endotracheal or tracheostomy tube iii. PaO2/FiO2 ratio ≤ 300mmHg with a minimum of 5 cmH20 PEEP iv. Infiltrates not fully explained by cardiac failure or fluid overload in the physician's best clinical judgement ARDS onset is considered the time that the last of 1-4 is met. Infiltrates considered "consistent with pulmonary edema" any infiltrate not due to mass, atelectasis, or effusion, or opacities known to be chronic (greater than 1 week old). Vascular redistribution or indistinct vessels or heart border alone do not qualify as opacities Evidence of multiorgan failure involving one or more organs, excluding the lungs as defined below: 1. Presence of shock, defined as MAP < 65 mmHg with signs of peripheral hypoperfusion, or continuous infusion of 2 or more vasopressor or inotrope agents to maintain MAP ≥ 65 mmHg. 2. Serum bilirubin > 10 mg/dl 3. Platelet count < 50,000/ml 2. Evidence of acquired or congenital immunodeficiency (due to immunosuppressive therapy, HIV, previous treatment for cancer, etc.) 3. History of metastatic cancer in the past 3 years 4. History of previous treatments with MSCs or other cell therapies 5. Patient is co-enrolled in any other IND-sponsored clinical trials for COVID-19 6. Evidence of pregnancy or lactation 7. Moribund patient not expected to survive > 24 hours 8. Unable/unwilling to deliver lung protective ventilation 9. Patient is receiving Extracorporeal Membrane Oxygenation (ECMO) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-99.0, COVID-19 Admitted to a hospital with symptoms suggestive of COVID-19. 2. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures. 4. Male or non-pregnant female adult > / = 18 years of age at time of enrollment. 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either of the following PCR positive in sample collected < 72 hours prior to randomization; OR PCR positive in sample collected >/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection. 6. Illness of any duration, and at least one of the following Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR SpO2 < / = 94% on room air, OR Requiring supplemental oxygen, OR Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO). 7. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29. 8. Agrees to not participate in another clinical trial for the treatment of COVID-19 through Day 29 Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal. 2. Estimated glomerular filtration rate (eGFR) < 30 ml/min or patient is receiving hemodialysis or hemofiltration at time of screening. 3. Neutropenia (absolute neutrophil count <1000 cells/microliter) (<1.0 x 103/microliter or <1.0 GI/L). 4. Lymphopenia (absolute lymphocyte count <200 cells/microliter) (<0.20 x 103/microliter or <0.20 GI/L) 5. Pregnancy or breast feeding. 6. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. 7. Allergy to any study medication. 8. Received three or more doses of remdesivir, including the loading dose, outside of the study under the EUA (or similar mechanism) for COVID-19. 9. Received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19, the current illness for which they are being enrolled. 10. Received small molecule tyrosine kinase inhibitors (e.g. baricitinib, imatibib, genfinitib), in the 1 week prior to screening 11. Received monoclonal antibodies targeting cytokines (e.g., TNF inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab]), or T-cells (e.g., abatacept) in the 4 weeks prior to screening. 12. Received monoclonal antibodies targeting B-cell (e.g., rituximab, and including any targeting multiple cell lines including B-cells) in the 3 months prior to screening. 13. Received other immunosuppressants in the 4 weeks prior to screening and in the judgement of the investigator, the risk of immunosuppression with baricitinib is larger than the risk of COVID-19. 14. Received >/= 20 mg/day of prednisone or equivalent for >/=14 consecutive days in the 4 weeks prior to screening. 15. Use of probenecid that cannot be discontinued at study enrollment. 16. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required). 17. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 18. Have received any live vaccine (that is, live attenuated) within 4 weeks before screening, or intend to receive a live vaccine (or live attenuated) during the study. Note: Use of non-live (inactivated) vaccinations is allowed for all subjects. 19. Have a history of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within 12 weeks prior to screening or have a history of recurrent (>1) VTE (DVT/PE). 20. Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrollment, who, in the judgment of PI, are at increased risk for serious infections or other safety concerns given the study products | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 16.0-999.0, Covid19 Convalescence Respiratory rate > 30 breaths/min; PLUS 2. Severe respiratory distress; or SpO2 ≤ 88% on room air or PaO2/FiO2≤ 300 mm of Hg, PLUS 3. Radiological evidence of bilateral lung infiltrate, AND OR 4. Systolic BP < 90 mm of Hg or diastolic BP <60 mm of Hg. AND OR 5. 1 to 4 AND or patient in Ventilator support Patients below18 years. 2. Pregnant women and breast-feeding mothers. 3. Previous history of allergic reaction to plasma 4. Those who will not give consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 19.0-99.0, Hypertension Able to provide signed and dated informed consent form Persistant arterial hypertension with systolic blood pressure above 150 mmHg during hospitalisation and the day of randomisation Stable anti-hypertensive medication with at least two guideline-recommended anti-hypertensive drugs Systolic blood pressure ≥180mmHg on the day of randomisation Spermidine intolerance Significant renal impairment defined as glomerular filtration rate < 45ml/min Insulin-dependent diabetes mellitus (IDDM) Wheat allergy or gluten intolerance Life expectancy of less than 12 months Participation in another clinical trial | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, COVID-19 SARS-CoV-2 Infection Previous laboratory confirmation of SARS-Cov-2 infection defined as a positive result of reverse polymerase-transcriptase chain reaction test in real-time of a sample taken by nasal and/or pharyngeal swab; and Severe pneumonia defined by the presence of fever or suspected lower respiratory infection, plus one of the following respiratory rate> 30 movements/min; severe respiratory distress; SpO2≤93% in room air; or pulmonary infiltrates>50% on chest imaging within 24-48hrs of acute symptoms onset; and/or Acute respiratory distress syndrome (ARDS) defined according to COVID-19 operational management guide of World Health Organization and classified as mild (200 mmHg <PaO2 / FiO2 ≤ 300 mmHg), moderate (100 mmHg <PaO2 / FiO2 ≤ 200 mmHg) or severe (PaO2 / FiO2 ≤ 100 mmHg). When the PaO2 is not available, SpO2 / FiO2 ≤ 315 suggests ARDS Lack of clinical stability for 2 months before (including those who remain hospitalized) Active respiratory tract infection (of any cause); or Any clinical condition that prevents the performance of the study procedures | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.083-999.0, Coronavirus Coronavirus Infection Covid19 Sars-CoV2 Population 1 Children of priority staff welcomed in the crèche during the period of confinement, i.e. from 15 March to 9 May, regardless of the length of time they are in the crèche during this period and their "symptomatic or not" status during this period or on the day of inclusion Consent of the holders of parental authority Affiliated to a social security system or entitled person Population 2 Nursery staff, regardless of their status/occupation and having had contact with the children during the period of confinement regardless of how long they have been in the nursery during this period and their "symptomatic or not" status during this period or on the day of inclusion Consent to participate Affiliated to a social security system or entitled person Population 3 Hospital staff not exposed to patients and/or children, with or without children in day care, working in the bacteriology, biochemistry and biological haematology laboratories or in an administrative department of the participating hospitals Affiliated to a social security system or entitled person Population 1 Refusal to sign consent by parents Clinical condition requiring urgent medical assessment (attending physician or transfer to paediatric emergency) Population 2 and 3 Refusal to sign consent for staff Clinical condition requiring urgent medical evaluation | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, COVID-19 Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) test or other commercial or public health assay in any specimen, as documented by either of the following PCR positive in sample collected <72 hours prior to randomization; OR PCR positive in sample collected ≥72 hours prior to randomization (but no more than 14 days prior to randomization), documented inability to obtain a repeat sample (for example, due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection Requires supplemental oxygen at the time of study entry and at randomization Have indicators of risk of progression: at least 1 inflammatory markers >upper limit of normal (ULN) (C reactive protein [CRP], D dimer, lactate dehydrogenase [LDH], ferritin) with at least 1 instance of elevation >ULN within 2 days before study entry Are receiving cytotoxic or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening Have ever received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19 Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry Strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry Have received neutralizing antibodies, such as bamlanivimab, casirivimab and imdevimab for COVID-19 Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required) Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: Use of nonlive (inactivated) vaccinations is allowed for all participants Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Contraception Women 18 years and older currently using COCs or who have a COC prescription and are intending to initiate COCs for contraception Women who have contraindications to using a COC or a contraceptive implant (Category 3 or 4 in the CDC Medical [MEC]) Because the CDC MEC are continuously revised, the most updated will be used (http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5904a3.htm) Women who are currently participating in a clinical trial or have participated within the past 30 days Less than 2 weeks from the end of a pregnancy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Chronic Spontaneous Urticaria Patients with active CSU for at least 4 months which was treated with anti-histamines as well as at least one course of steroids (ex. Prednisone) Age ≥18 years Patients will undergo an ECG and QT parameters will be measured for further analysis Female subjects who are postmenopausal (absence of menses for ≥ 2 years confirmed by a follicle stimulating hormone test), or who are surgically sterilized may be enrolled. Similarly, women of childbearing potential who had a negative pregnancy test at screening, who are willing to use two medically acceptable methods of contraception for the duration of the study as well as for at least three months after cessation of CBD treatment and who are willing to undergo pregnancy testing according to the study protocol may be enrolled Female subjects who are not breast-feeding and who have no intention to breast-feed during the term of the trial and for at least three months after cessation of CBD treatment may be enrolled Subject able to provide written informed consent Viral Hepatitis (HAV, HBV, HCV) HIV Serious psychiatric or psychological disorders Other chronic dermatological conditions under active treatment Active consumption of illicit drugs including cannabis or derivatives for at least three months prior to the study Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities Any uncontrolled infection at time of registration Renal comorbidity: eGFR < 30 mL/min/1.73m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2) Patient who is taking immunomodulatory medications for other indication Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, COVID-19 Pneumonia confirmed COVID-19 infection (diagnosed by nasopharyngeal swab performed on admission) severe pneumonia with baseline chest X-ray abnormalities Oxygen saturation <94% on room air, and tachypnea with respiratory rate exceeding 30 per minute Informed consent signed Not willing to participate in the study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 16.0-999.0, COVID-19 SARS-CoV 2 ARDS, Human Immune System Disorder All patients ≥16 years old with confirmation of COVID-19 2. All patients ≥ 16 years old with chronic lung disease (CF, non-CF bronchiectasis, asthma, COPD or Idiopathic Pulmonary Fibrosis) or with no evidence of prior chronic lung disease 3. Healthy volunteers None | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-80.0, Covid19 Chronic Inflammation Non-Communicable Chronic Diseases Patients (18 -80 years) with mild to moderate COVID-19 cases consented to home or hospital isolation to follow them Severe cases not fulfilling the definition of mild and moderate cases. Definition of mild cases according to The Egyptian Ministry Of Health: (MOH) 1. Age < 60 2. Temperature <38.5 3. SaO2 >92% 4. Heart Rate <110 5. Respiratory Rate <25 /min. 6. Neutrophil / lymphocyte ratio on CBC < 3.1 7. No co-morbidities that necessitates hospital admission: Pregnancy, severe uncontrolled Diabetes, Chronic lung disease, Chronic kidney disease, Chronic liver disease, Serious heart diseases (arrythmia, Ischemic heart disease, uncontrolled hypertension), immunocompromised: prolonged use of corticosteroids and other immunosuppressive drugs/ organ transplantation/ HIV/ Immunodeficiency, Obesity (BMI > 40) Any patient not fulfilling the above mild is considered having moderate disease as well as any positive pulmonary imaging findings | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-999.0, COPD Exacerbation Participant is willing and able to give informed consent for participation in the trial Male or Female, aged 40 years or above Diagnosed with COPD (primary or secondary care diagnosis) with spirometric confirmation of airflow obstruction (FEV1/FVC ratio <0.7) A history of at least 1 exacerbation in the previous 12 months, requiring systemic corticosteroids and/or antibiotics Current or ex-smoker with at least a 10 pack year smoking history In the opinion of the research staff, is able and willing to comply with all trial requirements History of atopic childhood asthma Current history of primary lung malignancy or current active pulmonary TB Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject's ability to participate in the study Any clinically relevant lung disease, other than COPD considered by the investigator to be the primary diagnosis. For example mild-to-moderate bronchiectasis is acceptable in addition to COPD unless the bronchiectasis is considered to be the primary diagnosis An alternative cause for the increase in symptoms of COPD that are unrelated to an exacerbation such as i) suspicion or clinical evidence of pneumonia; ii) high probability and suspicion of pulmonary embolism; iii) suspicion or clinical evidence of a pneumothorax; iv) primary ischaemic event ST or Non ST elevation myocardial infarct and left ventricular failure [i.e. not an exacerbation of COPD] A known allergy to the IMP (prednisolone), NIMP (doxycycline) or to any of the constituents of the placebo Patients on maintenance corticosteroids (prednisolone, hydrocortisone, fludrocortisone) Known adrenal insufficiency Currently enrolled in another CTIMP trial and receiving an intervention as part of the trial | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, COVID19 Coronavirus Infection Pregnancy Disease Severe Acute Respiratory Syndrome Pregnant or puerperal women Diagnosis of flu syndrome on admission Testing for COVID-19 performed Clinical impossibility of signing the Informed Consent Form (ICF), either by the patient or guardian (in the prospective arm) Incomplete or not located medical records (retrospective arm) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Single Embryo Pregnancy Gestational Weeks 24-42 Pain/Sensitivity >5 on Numeric Rating Scale (NRS) Women > 18 years Single embryo pregnancy in week 24-42 was diagnosed with symphysiolisis according to written above Pain/sensitivity >5 on NRS scale in symphysis pubis area for more than two weeks Lack of proficiency in Hebrew or English Pain from a different source pelvic bone disease or history of severe pelvic bone injury Thrombocytopenia (plt<50.000) Acupuncture treatment is contraindicated High risk pregnancy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-35.0, Healthy Has a regular menstrual cycle (for women only) 2. Young adult (18-35 years) 3. Right-side dominant 4. At least 30 min of moderate-intensity, physical activity on at least 3 days of the week for at least the last 3 months 5. Without chronic neurological, psychiatric, or medical conditions 6. Not taking any psychoactive medications Pregnant 2. Known holes or fissures in the skull 3. Metallic objects or implanted devices in the skull (e.g., metal plate) 4. Women on hormonal contraceptives/supplements | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Treatment of Covid-19 Virus Infection Gender: Either male or non-pregnant, non-lactating female aged > 18-70 Patients with RT-PCR confirmed diagnosis of COVID-19 Patients with mild to moderate COVID-19 infection having either one of the following oPaO2/FiO2:200-300 OR Respiratory rate ? 24/min and SaO2/SpO2 > 90% on room air Subjects willing to give written informed consent Subjects able to take the drug orally and comply with the study protocol Women of child bearing potential must have a negative urine pregnancy test prior to study entry Patients with persistent vomiting Critically ill patients P/F ratio less than 200 (moderate-severe ARDS) Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65) Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections Patients with altered mental state Patients with multiple organ failure requiring ICU monitoring and treatment Patients with respiratory failure and requiring mechanical ventilation Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subject's participation in the study or interferes with the interpretation of the study results Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, COVID-19 SARS-CoV2 Part 1 and Part 2: Resident or facility staff in a skilled nursing or assisted living facility with at least one confirmed case of SARS-CoV-2 detection less than or equal to (≤)7 days prior to randomization Are men or non-pregnant women who agree to contraceptive requirements Agree to the collection of nasal, mid-turbinate, oropharyngeal, and nasopharyngeal swabs, and venous blood as specified in the schedule of activities Have venous access sufficient to allow intravenous infusions and blood sampling The participant or legally authorized representative give signed informed consent Part 3 only: Resident or staff in a skilled nursing or assisted living facility who satisfy at least one of the following at the time of screening Are greater than or equal to (≥) 65 years of age Have a body mass index (BMI) ≥ 35 Have chronic kidney disease Have type 1 or type 2 diabetes Parts 1 and 2 Recovered from confirmed COVID-19 disease or asymptomatic infection Prior history of a positive SARS-CoV-2 serology test History of convalescent COVID-19 plasma treatment Participation in a previous SARS-CoV-2 vaccine trial or received an approved SARS-CoV-2 vaccine Previous receipt of SAR-CoV-2-specific monoclonal antibodies Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, COVID-19 Inclusion/ for INDEX CASES: 1. Adults aged 18 years or older who are newly diagnosed with COVID-19 infection within 7 days of testing. 2. Ability and willingness to understand and provide informed consent Known current pregnancy. 2. Current hospitalization. 3. Unable to complete online questionnaires or adhere to study requirements. 4. Consume more than 1000 IU per day of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium plus vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins) in the past 4 weeks. 5. Use of prescription vitamin D treatments (Calcitriol [Rocaltrol, Calcitrol, Vectical, Calcijex] or Paricalcitol [Zemplar]). 6. Consume supplements with more than 1200 mg calcium per day. 7. Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity. 8. Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy, or immunotherapy. 9. Kidney failure or dialysis; severe liver disease or cirrhosis. 10. Any parathyroid conditions. 11. Use of medications for seizures or epilepsy. Examples: Carbamazepine (Carbatrol, Tegretol), Phenytoin (Dilantin, Phenytek), Valproic acid (Depakene), Oxcarbazepine (Oxtellar, Trileptal), Phenobarbital, Topiramate (Topamax). 12. Use of digoxin. 13. Inability to receive an overnight express mail shipment of study pills at a home address. 14. Participation in other COVID-19 trials. Inclusion/ for 1. Persons aged 18 years or older who live in the same household with an index individual and have been identified as the closest household contact within the same household (limited to 1 per household). 2. Persons aged 18 years or older who live in household with someone who tested positive for COVID-19 within past 7 days but not participating in VIVID. 3. Ability and willingness to understand and provide informed consent Known current pregnancy. 2. History of SARS-CoV-2 infection. 3. Receipt of a SARS-CoV-2 vaccination or monoclonal antibody. 4. Unable to complete online questionnaires or adhere to study requirements. 5. Consume more than 1000 IU per day of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium plus vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins) in the past 4 weeks. 6. Use of prescription vitamin D treatments (Calcitriol [Rocaltrol, Calcitrol, Vectical, Calcijex] or Paricalcitol [Zemplar]). 7. Consume supplements with more than 1200 mg calcium per day. 8. Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity. 9. Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy, or immunotherapy. 10. Kidney failure or dialysis; severe liver disease or cirrhosis. 11. Any parathyroid condition. 12. Use of medications for seizures or epilepsy. Examples: Carbamazepine (Carbatrol, Tegretol), Phenytoin (Dilantin, Phenytek), Valproic acid (Depakene), Oxcarbazepine (Oxtellar, Trileptal), Phenobarbital, Topiramate (Topamax). 13. Use of digoxin. 14. Inability to receive an overnight express mail shipment of study pills at a home address. 15. Participation in other COVID-19 trials | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Coronavirus African American older adults aged 65 years Have at least one risk factor for COVID-19 Resident of care facility Cognitive deficit (identified by short version of mini-mental instrument) Does not self-identify as African American and/or Black Under the age of 65 Unable to speak and/or read English | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-85.0, Hypertension Blood Pressure age between 65 and 85 years practice exercise (almost 3 days-week) use of anti-hypertensive drugs systolic blood pressure (SBP) ≤160 mmHg and diastolic blood pressure (DBP) ≤100 mmHg documented by a physician body mass index (BMI) >35 kg/m2 decompensated diabetes mellitus and/or cardiac failure active smoker any febrile condition and/or infectious diseases cardiovascular event in the 3 months preceding the study hepatopathy physical or mental limitations that prevent exercising | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | 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 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-0.058, Maternal Depressive Disorder Complicating Childbirth Preterm Birth Maternal Anxiety Disorder Complicating Childbirth Mother Commitment to finish all questionnaires and to participate in the creation of a CD to be played to her baby Older than 18 years of age Infant • Gestational age between 26 0/7 and 30 6/7 weeks Mother • Younger than 18 years Infant • Major congenital or chromosomal anomalies | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza, Human Penn Medicine and Geisinger patients will be included if they Have a cell phone number recorded in a Penn Medicine or Geisinger database Have a new or routine primary care appointment during the study recruitment period (not a sick visit) Have documentation of allergy or adverse event to influenza vaccination in medical records Have documentation of already receiving their 2020 influenza vaccination prior to randomization in medical records Have opted out of receiving text message appointment reminders Have asked not to be contacted for research purposes Have an appointment with someone other than their primary care physician Have an appointment with someone other than a physician, resident, nurse practitioner, or physician assistant We will recruit as many patients as possible starting in September 2020. We will stop enrolling participants with appointments scheduled to occur after December 31, 2020 if we have reached 4,000 participants per condition. If we do not have 4,000 participants per condition by December 31, 2020, we will continue enrolling participants until we have reached 4,000 per condition, or until March 31, 2021 (discontinuing enrollment at whichever milestone arrives sooner 000 people enrolled or 3/31/21) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Adenovirus Type-5 Vectored COVID-19 Vaccine Participants who has received prime vaccination of adenovirus type-5 vectored COVID-19 vaccine Able to understand the content of informed consent and willing to sign the informed consent Negative in HIV diagnostic test Axillary temperature ≤37.0°C General good health as established by medical history and physical examination Able to complete 12 months visit Family history of seizure, epilepsy, brain or mental disease Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past Woman who is pregnant, breast-feeding on day of enrollment, or become pregnant during the next 12 months Any acute fever disease or infections History of SARS Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc Hereditary angioneurotic edema or acquired angioneurotic edema Urticaria in last one year No spleen or functional spleen | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Dementia Alzheimer Disease Anomia Person with mild/moderate dementia Self-reported proper naming difficulty which we will then assess at Time Point 1 English as their dominant language Able to tolerate MRI brain scan Able to give informed consent Able to use the DNI (app) No diagnosis of developmental language disorders No diagnosis of severe dementia or primary progressive aphasia No major co-existing neurological or psychiatric diagnosis No contraindications to brain scanner (e.g. the presence of ferromagnetic implants or other metallic or electronic objects in the body, weight over 24 stone, claustrophobia or pregnancy) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | 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 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-64.0, Corona Virus Infection Flu Vaccine Immunity Adults enrolled in study 55689 (NCT04373148) Adults diagnosed with severe or moderate COVID-19 at least 2 months prior enrollment Adults without COVID-19 diagnosis for healthy controls Healthy controls may also be recruited outside of IRB#55689 Received the influenza vaccine less than 4 months ago Pregnant or lactating Patients with special risks attendant to venipuncture Adults who test positive for COVID-19 (pcr test) Use of immunomodulatory medications Immunodeficiency or autoimmune disease | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Influenza A healthcare provider practicing at The Southeast Permanente Medical Group in a specialty for which the performance measure being studied is relevant. Health care providers Physicians, Nurse Practitioner, Certified Nurse Midwife, Psych Nurse Specialist, Optometrist, Podiatrist, and Physician Assistant Non-Physicians: Registered Nurses excluding nurse practitioners | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza, Human Have agreed to receive SMS messages from the pharmacy 2. Received a flu shot from the pharmacy in the 2019-2020 flu season, as documented in their pharmacy records | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 5.0-11.0, Epidemic Parotitis, Mumps Healthy people aged 5-11 years (including boundary values), both men and women Proven legal identity Participants and parent(s)/legal guardian(s) should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form, and be capable of using thermometers, scales, and filling in diary cards and contact cards as required Participants and parent(s)/legal guardian(s) should be able to communicate well with investigators, understand and comply with the requirements of this trial Axillary temperature ≤37.0 ℃ Contraindications for vaccination History of allergy to vaccines or drugs Have a history of mumps disease Except for one dose of vaccine containing mumps at the age of 18~24 months before enrollment, any vaccine containing mumps has been vaccinated Any prior administration of attenuated live vaccine in last 15 days;Any prior administration of subunit or inactivated vaccines in last 7 days Convulsant,encephalopathy,psychosis or family history of epileptics Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days For any reason, the spleen was removed partially or completely Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder,it will cause the contraindication of subcutaneous injection Suffering from congenital deformity or serious chronic disease(congenital heart disease，Down's syndrome,diabetes,sickle cell anemia,nervous illness,angiocardiopathy,hypertension,bronchitis,pneumonia,asthma,infectious skin diseases) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-80.0, Nutrition Immunology Able to provide written Informed Consent and follow verbal and written study directions in English Adult men and women between ages 40-80 years Body Mass Index (BMI) 25 to 40 kg/m2 (overweight, mild and moderate obesity) Must not be taking or be willing to stop taking cranberries or any products and supplements containing cranberries for seven days prior to the start of the study and for the duration of the study Must not be taking or be willing to stop taking supplements containing probiotics, or polyphenols and flavonoids (e.g., quercetin, anthocyanins, green tea extract) for seven days prior to the start of the study and for the duration of the study Able to maintain consistent diet and lifestyle habits throughout the study Healthy, noninstitutionalized participants or those with chronic but stable and well controlled medical conditions (i.e., hypertension controlled by a consistent dose of medication for a minimum of six months; chronic use of consistent dose of blood-thinning medication; diet-controlled Type II diabetes; statin controlled high blood cholesterol) may participate at the discretion of the primary investigator (PI) Willing and able to provide fasting blood samples and 24-hour urine samples Able to attend four scheduled visits at the AppState Human Performance Laboratory at the North Carolina Research Campus facility in Kannapolis, NC Willing to receive the 2020-21 seasonal influenza vaccination (with high-dose vaccinations given to those 65 years of age and older, as recommended by the Centers for Disease Control and Prevention) Current active treatment for heart disease or cancer (excluding skin cancer), or medically complicated conditions (i.e., diabetes requiring insulin, uncontrolled high blood pressure), at the discretion of the primary investigator Inability to provide a venous blood sample or 24-hour urine sample Unable or unwilling to provide written informed consent for participation in study History of allergic reactions to cranberry juice or products containing cranberries Have already received the 2020-21 seasonal influenza vaccination | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Cancer Covid19 Patients with proven COVID-19 and a diagnosis of cancer who are enrolled into any Tier of the Principal CCP-UK protocol None in addition to those specified in the Principal CCP-UK protocol | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.5-2.0, Vaccination subjects aged from 18 to 24 months old at the date of recruitment; 2. with informed consent signed by parent(s) or guardians; 3. parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions; 4. subjects have not been vaccinated with any type of Hepatitis A vaccines; 5. subjects have no Hepatitis A disease and contraindication of vaccination; 6. subjects did not receive any vaccines within 14 days; 7. before joining this trial, subjects must be qualified and passed their medical history and clinical examinations, and axillary's temperature must be ≤37℃ Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history; 2. Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3. Patients with immunodeficiency, in process of cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or in close contact with any family members who has congenital immune diseases; 4. Receive non-specific immunoglobulin within 1 month before recruitment; 5. Subjects with acute febrile diseases with body temperature > 37.0 ℃ or infectious diseases; 6. Subjects with a history of thrombocytopenia or other coagulation disorders that may be contraindicated for hypodermic injection; 7. With known or suspected concurrent diseases respiratory disease, acute infection or active chronic disease; 8. With severe cardiovascular diseases (Pulmonary heart disease, Pulmonary edema, hypertension cannot be controlled to normal range by drugs), liver and kidney diseases and diabetic complications; 9. Various infectious, suppurative or allergic dermatitis; 10. Other circumstances judged by investigators that are not suitable for this clinical trial | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-100.0, Head and Neck Cancer Covid19 Any head and neck cancer patients (including salivary gland, thyroid, nasal and paranasal cancer with a COVID-19 diagnosis defined as any of the following Laboratory confirmed [Real Time Polymerase Chain Reaction (RT-PCR) technique] COVID-19 Suspected COVID-19 cases; diagnosed clinically based on symptoms (fever >37.5°, decrease of oximeter saturation of at least 5 %, cough, diarrhoea, otitis, dysgeusia, anosmia, myalgia, arthralgia, conjunctivitis and rhinorrhea and exposure to confirmed COVID-19 positive case (laboratory confirmation) Clinically diagnosed cases; suspected cases with lung imaging features consistent with coronavirus pneumonia Asymptomatic cases; diagnosed based on positive viral nucleic acid test results but without any COVID symptoms | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Obesity Weight Loss Eating Behavior overweight to obese (BMI 25-45 kg/m2) not currently engaged in exercise or weight loss activities free of any cardiac, pulmonary, or metabolic health conditions able to safely engage in exercise female participants must be premenopausal and not pregnant or nursing Lost or gained over 5% of their current bodyweight in the previous 12 months taking any medications or dietary supplements which may influence energy expenditure or intake have not been diagnosed with an eating disorder, clinical depression, or an anxiety disorder engage in less than 150 minutes of moderate to vigorous physical activity per week (assessed via accelerometry at baseline) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Rectal Cancer At least 18 years of age. Both men and women and members of all races and ethnic groups will be included. 2. Willing and able to provide written informed consent 3. Pathologic diagnosis of rectal adenocarcinoma 4. T3-4 and/or N+ disease 5. No prior treatment for rectal adenocarcinoma 6. Eastern Cooperative Group (ECOG) performance status of 0-2. 7. Laboratory values supporting acceptable organ and marrow function within 30 days of confirmation. Defined as follows WBC ≥ 3,000/mL ANC WBC ≥ 1,500/mL PLT ≥ 75,000/mL T Bili ≤ 1.5 x upper limit of normal (ULN) AST/ALT ≤ 2.5 x ULN Creatinine not above ULN, or creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. 8. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) starting with the first dose of study therapy through 90 days after the last dose of study drugs. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following 8.1 Has not undergone a hysterectomy or bilateral oophorectomy; or 8.2 Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) Distant nodal disease (retroperitoneal nodes) including inguinal nodes, or any metastatic disease by CT or PET 2. Prior RT to the pelvis. 3. Uncontrolled comorbid illness or condition including an infection, congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness that would limit compliance with the study requirements. 4. Psychiatric illness/social situations that would limit consenting and compliance with study requirements. 5. Participants who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Esophageal Adenocarcinoma Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal adenocarcinoma Have an ECOG performance status of 0-1 Have the ability to swallow and retain oral medication (Note: Placement of an enteric feeding tube after the patient has signed informed consent will not make them ineligible to participate in the study liquid formula propranolol will be made available) Participants of child-bearing potential must have a negative pregnancy test at study entry And then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Contraindications to the use of beta-blockers, e.g.; uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association (NYHA) Grade III or IV), hypotension ( systolic blood pressure <100 mmHg), severe asthma or COPD, uncontrolled type I or type II diabetes mellitus (HbA1C >8.5 or fasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements, cardiac arrhythmia (atrial fibrillation/flutter), severe bradycardia (heart rate of <50 beats per minute or 1st/ 2nd /3rd degree heart block) Pregnant or nursing female participants Unwilling or unable to follow protocol requirements Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Thoracic Cancer Abdominal Cancer Patients must be willing and capable to provide informed consent to participate in the protocol. 2. Patient with presumed pulmonary function capable of holding breath for at least 30 seconds later to be confirmed. 3. All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, and until study imaging is complete. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 3.1 A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 3.2 Patients must be compliant to all required pretreatment evaluations Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus 2. Patients are not compliant to all required pretreatment evaluations | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Trust Healthy adults over 18 years old None | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Covid19 Aged 18 or older If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use one effective method of contraception from 10 days prior to the antibody administration until 6 months after investigational product (IP) administration Weight > 110 kg for groups S1 and S2 only History of prior positive SARS-CoV-2 RT-PCR or SARS-CoV-2 serology Active respiratory or non-respiratory symptoms consistent with COVID-19 Medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations, or uncontrolled hypertension, as defined by a systolic blood pressure > 180 and/or diastolic blood pressure > 120, in the presence or absence of anti-hypertensive medications) in the past 6 months prior to screening Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months Other clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation Laboratory abnormalities in the parameters listed Absolute neutrophil count less than 1,500 K/mcL Hemoglobin less than 10.5 gm/dL if female; less than 11 gm/dL if male | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Complex Regional Pain Syndrome Type I for patients CRPS Type I (fulfilling Budapest for research) Suffering of CRPS in a distal limb (hand or foot) Age >18 years Pain lasting less than 6 months Good understanding of the French language for control Not suffering from chronic pain, including CRPS Age >18 years for both group Known or suspected non-compliance, drug or alcohol abuse Inability to follow the procedures of the study, e.g. due to language problems, severe psychological disorders, dementia, etc For blood sample: diabetes and history of hepatitis B, C, D or HIV infection | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-80.0, Healthy Chronic Disease Both sexes Age >18 years Signed informed consent for the donation / sample storage in the Biological Bank for healthy subjects: all those who have shown any symptoms, albeit mild, in the 28 days prior to the donation for patients: who have not signed the informed consent for the conservation of their samples in the Biological Bank | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, COVID-19 SARS-CoV-2 Male or female patients aged 18 years and older infected with the SARS-CoV-2 infection Patients with COVID-19 symptoms and have a positive PCR test result Patients in a stable clinical condition and basically in an outpatient condition Patients who sign the informed consent Patients with a partial oxygen pressure < 90% and who have required hospitalization Patients who have required intensive care Any condition which, in the opinion of the Principal Investigator, would prevent full participation in and compliance with the trial protocol Patients who have been involved in any other interventional studies Patients with uncontrolled Type I or Type II diabetes mellitus (DM) Patients with severe liver failure (Child Pugh score ≥ C, AST> 5 times the upper limit of normal (ULN) Patients with severe renal failure (GFR ≤30 mL/min/1.73 m2) or continuous dialysis (hemodialysis, peritoneal dialysis) or continuous renal replacement therapy Patients with serious cardiac problems such as heart failure Patients with hypersensitivity to montelukast or other drugs in the study Patients with rare hereditary problems of galactose / fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 45.0-64.0, Menopause We will all menopausal health-care providers working in CAD of Women's Health and Pediatric CAD UMC, NCCR, and RDC, Nur-Sultan Kazakhstan. In order to get the highest possible response rate as well as evaluate the non-response bias, there is a need to follow-up to those who did not responded Women with serious health problems, such as severe chronic diseases, including psychological/psychiatric comorbidities, and use of specific drugs for them, will not be included in the study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Covid19 SARS-Associated Coronavirus Patients over 18 years old with the ability to provide free and informed consent 2. Acute Flu-Like symptoms < 07 days. 3. All patient need to have at lease ONE enhancement factor: 1. Age > 50 years; 2. Diabetes mellitus requiring oral medication or insulin 3. Systemic arterial hypertension requiring at least 01 oral medication for BP control; 4. Known cardiovascular diseases (heart failure, congenital heart disease, valvar heart valve disease, coronary artery disease, cardiomyopathies) 5. Symptomatic lung disease (emphysema, chronic bronchitis) 6. Symptomatic asthma patients requiring chronic use of agents for control of symptoms. 7. Smoking 8. Obesity, defined as BMI> 30 kg / m2 body weight 9. Transplanted patients 10. Patient with stage IV chronic kidney disease or on dialysis. 11. Immunosuppressed patients / using corticosteroid therapy (equivalent to at least 10 mg of prednisone per day) and / or immunosuppressive therapy) 12. Patients with a history of cancer in the last 05 years or undergoing treatment of a current cancer 13. Chronic renal disease KDIGO IV or End-Stage Renal Disease on chronic ambulatory renal replacement therapy 4. Patient with positive rapid test for SARS-CoV2 antigen performed on occasion of the screening or patient with a positive SARS-CoV2 diagnostic test within 07 days of the onset of symptoms. 5. Willingness to use the proposed investigative treatment and follow the protocol-related procedures foreseen in the research Negative SARS-CoV2 test. 2. Flu-like symptom onset 08 days or more. 3. Patients with COVID-19 being referred for hospitalization; 4. Patients with history of SARS-CoV-2 vaccine shot; 5. Patients with acute respiratory conditions due to other causes; 6. Dyspnea secondary to other acute and chronic respiratory causes or infections (eg: Decompensated COPD, acute bronchitis, pneumonia, primary pulmonary arterial hypertension) 7. Acute Flu-Like condition presenting with at least ONE of the below: 1. Respiratory Rate> 28 / min; 2. SaO2 <90% or <93% in nasal oxygen therapy at 10 l / min; 3. PaO2 / FIO2 <300 mmHg 8. Patients using serotonin reception inhibitors (Donepezil, Sertraline) 9. Use of the following medications in the last 14 days: 1. Monoamine Oxide Inhibitors (MAOIs): Phenelzine, Tranylcypromine, Selegiline, Isocarboxazide, moclobemide; 2. Use of iodinated contrasts during start of treatment through D14; 3. Use of antiretroviral agents 10. Patients with severe psychiatric disorders or major uncontrolled depression or controlled with any of the prohibited drugs (see above); 11. Pregnant or breastfeeding patients; 12. History of severe ventricular cardiac arrhythmia (ventricular tachycardia, patients with ventricular fibrillation recovered) or Long QT Syndrome; 13. History of diabetic ketoacidosis or clinical condition that maintains persistent acidosis 14. Surgical procedure or use of contrast designed to occur during treatment or up to 04 days after the last dose of the study medication; 15. Current daily and / or uncontrolled alcoholism; 16. History of seizures in the last month or uncontrolled medical condition; 17. Clinical history of Liver Cirrhosis or Child-Pugh C classification; 18. Patients with known severe degenerative neurological diseases and / or diseases serious mental disorders; 19. Inability of the patient or representative to give consent or adhere to the procedures proposed in the protocol; 20. Known hypersensitivity and / or intolerance to Fluvoxamine, Ivermectin or Metformin; 21. Inability to take oral or sublingual medications; 22. Inability to follow protocol-related procedures | 0 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.